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From the 11/12/2021 release of VAERS data:

Found 875,292 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 518 out of 8,753

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VAERS ID: 1736334 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Anxiety, Chest pain, Chills, Decreased appetite, Depression, Diarrhoea, Illness, Influenza, Influenza like illness, Pain in extremity, Pyrexia, Vertigo
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: chills; diarrhea; fever; flu symptoms; Anxiety; Chest pain; Sickness; Stomach pain; Vertigo; Depression; Flu like symptoms; Appetite lost; Pain in arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25946431) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (chills), DIARRHOEA (diarrhea), PYREXIA (fever), INFLUENZA (flu symptoms), ANXIETY (Anxiety), CHEST PAIN (Chest pain), ILLNESS (Sickness), ABDOMINAL PAIN UPPER (Stomach pain), VERTIGO (Vertigo), DEPRESSION (Depression), INFLUENZA LIKE ILLNESS (Flu like symptoms), DECREASED APPETITE (Appetite lost) and PAIN IN EXTREMITY (Pain in arm) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant), ILLNESS (Sickness) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant), VERTIGO (Vertigo) (seriousness criterion medically significant), DEPRESSION (Depression) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant), DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). On 15-Sep-2021, the patient experienced ANXIETY (Anxiety) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant), DIARRHOEA (diarrhea) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant) and INFLUENZA (flu symptoms) (seriousness criterion medically significant). At the time of the report, CHILLS (chills), DIARRHOEA (diarrhea), PYREXIA (fever), INFLUENZA (flu symptoms), ANXIETY (Anxiety), CHEST PAIN (Chest pain), ILLNESS (Sickness) and ABDOMINAL PAIN UPPER (Stomach pain) had not resolved and VERTIGO (Vertigo), DEPRESSION (Depression), INFLUENZA LIKE ILLNESS (Flu like symptoms), DECREASED APPETITE (Appetite lost) and PAIN IN EXTREMITY (Pain in arm) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Patient started with sore arm, 24 hours after injection began to get flu symptoms such as fever, chills and aches, a few hours later patient began to get moderate chest and stomach pain which has not yet resolved. Also with all this patient have had sickness and diarrhea, stomach pains. Treatment medication was not provided by the reporter. Company comment- This case concerns a 30-year-old, unknown gender patient with no relevant medical history, who experienced the unexpected events of, vertigo, chest pain and anxiety. The events occurred between 2 and 3 days after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The events were considered related to the product per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 30-year-old, unknown gender patient with no relevant medical history, who experienced the unexpected events of, vertigo, chest pain and anxiety. The events occurred between 2 and 3 days after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The events were considered related to the product per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.


VAERS ID: 1738689 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004668 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210912; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative (No - Negative COVID-19 test)
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever; Headache; Fatigue; Swollen glands; Painful arm; This case was received via United Kingdom MHRA (Reference number: ADR 25951324) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen glands), PAIN IN EXTREMITY (Painful arm), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004668) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 15-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Swollen glands), PAIN IN EXTREMITY (Painful arm), PYREXIA (Fever) and FATIGUE (Fatigue) was resolving and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2021, SARS-CoV-2 test: negative (Negative) negative (No - Negative COVID-19 test). The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The treatment history was not reported. The concomitant medications was not provided. Patient has not had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 22-year-old, female patient with no relevant medical history, who experienced the unexpected events of lymphadenopathy pain in extremity, pyrexia, headache and fatigue. The events occurred 1 to 2 days after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 22-year-old, female patient with no relevant medical history, who experienced the unexpected events of lymphadenopathy pain in extremity, pyrexia, headache and fatigue. The events occurred 1 to 2 days after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1738819 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myalgia, Oropharyngeal pain, Rhinorrhoea
SMQs:, Rhabdomyolysis/myopathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101211324

Write-up: Generalised muscle aches; Runny nose; Sore throat; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number GB-MHRA-WEBCOVID-202109141533280600-WFO2S, Safety Report Unique Identifier GB-MHRA-ADR 25939666. A 29-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number was not reported), via an unspecified route of administration on 13Sep2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19. Patient has not had COVID-19 test. Thus, the patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. On 14Sep2021, the patient experienced generalised muscle aches, runny nose, and sore throat; all were reported as serious for being medically significant. The clinical outcome of the events generalised muscle aches, runny nose, and sore throat was not resolved at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1738836 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211374

Write-up: Influenza; This is a spontaneous report from a contactable consumer or other non-health care professional received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109141920312770-MZBHZ, safety report unique identifier is GB-MHRA-ADR 25940794. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 14Sep2021, the patient experienced influenza. On an unspecified date, the patient underwent covid-19 virus test which resulted negative. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1738845 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Hunger, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201106; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101211514

Write-up: Fever; Headache; Muscle pain; Hunger; Fatigue; This is a spontaneous report from a contactable Consumer received from the Regulatory Authority (MHRA). Regulatory authority report number [GB-MHRA-WEBCOVID-202109142035236650-OB3D0], Safety Report Unique Identifier [GB-MHRA-ADR 25941625]. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number, Expiry date was not reported), via an unspecified route of administration on 14Sep2021 (at the age of 41-year-old) as dose 2, single for COVID-19 immunization. Medical history included suspected COVID-19 from 01Nov2020 to 03Jan2021. Patient was not enrolled in clinical trial. The patient was not breastfeeding. The patient concomitant medications were not reported. Historical Vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient has not tested positive for COVID-19 since having the vaccine. On 14Sep2021, patient experienced fever, headache, muscle pain, hunger, fatigue. The patient underwent lab tests and procedures which included sars-cov-2 test was positive (yes - Positive COVID-19 test) on 06Nov2020. The outcome of the events fever, muscle pain and headache was recovering. The outcome of the events hunger and fatigue was not recovered. No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further information was expected.


VAERS ID: 1738860 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211387

Write-up: Lymph node pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109142235472010-8VZLR Safety Report Unique Identifier GB-MHRA-ADR 25942192. A 32-year-old male patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FE3380), via an unspecified route of administration on 12Sep2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunization. On 14Sep2021 the patient experienced lymph node pain. The event was assessed as medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. outcome of event was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738865 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211530

Write-up: Painful periods; This is a spontaneous report from a contactable consumer received from the regulatory authority, The regulatory authority report number is GB-MHRA-WEBCOVID-202109150042342010-UTJN4, Safety Report Unique Identifier GB-MHRA-ADR 25942232. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF2153) dose 2 via an unspecified route of administration on 11Sep2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported) vis an unspecified route of administration on an unknown date for COVID-19 Immunisation. On 14Sep2021, the patient experienced really painful periods, never felt pain like this before. The patient underwent lab tests and procedures which included COVID-19 virus test no-negative covid-19 test. The outcome of the event was not resolved. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738872 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Nausea, Paraesthesia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101217733

Write-up: dizzy spells; pins and needles; tummy churning; Fainting; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109150815362200-RRSWB, Safety Report Unique Identifier GB-MHRA-ADR 25944012. A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Sep2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2, dose 1 on an unspecified date for COVID-19 immunisation. The patient experienced dizzy spells on an unspecified date, pins and needles on an unspecified date, fainting on 14Sep2021, tummy churning on an unspecified date. Dizzy spells, fainting, pins and needles throughout body, tummy churning. All events are medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 17Jul2021 Yes - Positive COVID-19 test. The outcome of the event fainting was recovering and unknown for other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1738873 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Migraine, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101217623

Write-up: Migraine; General body pain; Feverish; Dose 1: 09Jul2021; Dose 2: 14Sep2021; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109150845324810-C1IP2, Safety Report Unique Identifier GB-MHRA-ADR 25944095. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 14Sep2021 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Jul2021 as a single dose for COVID-19 immunisation. On 14Sep2021, the patient experienced migraine, general body pain and feverish; all reported as a serious for being medically significant. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event migraine, general body pain and feverish was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738877 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Heart rate, Migraine, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210914; Test Name: Heart rate; Result Unstructured Data: elevated
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Tiredness; Headache; Fever; Migraine; Dizziness; Joint pain; Exhaustion; Pain; Nausea; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 25944326) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), HEADACHE (Headache), PYREXIA (Fever), MIGRAINE (Migraine), DIZZINESS (Dizziness), ARTHRALGIA (Joint pain), FATIGUE (Exhaustion), PAIN (Pain) and NAUSEA (Nausea) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. No Medical History information was reported. On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), MIGRAINE (Migraine) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), FATIGUE (Exhaustion) (seriousness criterion medically significant), PAIN (Pain) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, FATIGUE (Tiredness) and HEADACHE (Headache) had not resolved, PYREXIA (Fever), MIGRAINE (Migraine), DIZZINESS (Dizziness), ARTHRALGIA (Joint pain), FATIGUE (Exhaustion) and PAIN (Pain) was resolving and NAUSEA (Nausea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, Heart rate: elevated (High) elevated. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant product information were provided by the reporter. No treatment information was provided. Company Comment - This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected events of pyrexia, migraine, dizziness, arthralgia, fatigue, pain, nausea, fatigue, and headache. The events occurred approximately 1 day after the second dose of Modena covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected events of pyrexia, migraine, dizziness, arthralgia, fatigue, pain, nausea, fatigue, and headache. The events occurred approximately 1 day after the second dose of Modena covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1738894 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Headache, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: OVRANETTE; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Back pain; Headache; Nausea; Fever; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25945074) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 26-Dec-2019 to 03-Jan-2020. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (OVRANETTE) for Contraception, SERTRALINE for Depression. On 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced BACK PAIN (Back pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 15-Sep-2021, PYREXIA (Fever) had resolved. At the time of the report, BACK PAIN (Back pain) and NAUSEA (Nausea) was resolving and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication were not reported. Patient had not tested positive for COVID-19 since having vaccine and was not enrolled in clinical trial. Company Comment: This case concerns a 30-year-old female with a medical history of depression, who experienced the unexpected events of back pain, headache, nausea and pyrexia on the same day after the second dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report.; Sender''s Comments: This case concerns a 30-year-old female with a medical history of depression, who experienced the unexpected events of back pain, headache, nausea and pyrexia on the same day after the second dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report.


VAERS ID: 1738971 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-09-14
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Heart racing; Painful arm; Headache; Fever; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25955158) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing), PAIN IN EXTREMITY (Painful arm), HEADACHE (Headache) and PYREXIA (Fever) in a 40-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004222) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced PALPITATIONS (Heart racing) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 14-Sep-2021, PYREXIA (Fever) had resolved. On 16-Sep-2021, PAIN IN EXTREMITY (Painful arm) and HEADACHE (Headache) had resolved. At the time of the report, PALPITATIONS (Heart racing) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) , the reporter did not provide any causality assessments. Post vaccination patient not tested positive for COVID-19. Also patient was not enrolled in any clinical trials.It was reported that patient had no symptoms associated with COVID-19. Company Comment : This case concerns a 40-year-old male patient, with no relevant medical history provided, who experienced the unexpected events of PAIN IN EXTREMITY, HEADACHE, PYEXIA and PALPITATIONS. Inappropriate schedule of product administration was also considered an event having in mind that the second dose was administered two months following the first dose. The reported events of pain in extremity, headache, pyrexia and palpitations occurred on the same day than the second dose of COVID-19 Vaccine Moderna was administered. Except the event of palpitations which was resolving at the time of the report, the remaining events resolved. Rechallenge results and action taken with the suspect product were retained as per RA source document, although, the events developed after the second dose. The benefit-risk relation of COVID-19 Vaccine Moderna is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events met seriousness criteria.; Sender''s Comments: This case concerns a 40-year-old male patient, with no relevant medical history provided, who experienced the unexpected events of PAIN IN EXTREMITY, HEADACHE, PYEXIA and PALPITATIONS. Inappropriate schedule of product administration was also considered an event having in mind that the second dose was administered two months following the first dose. The reported events of pain in extremity, headache, pyrexia and palpitations occurred on the same day than the second dose of COVID-19 Vaccine Moderna was administered. Except the event of palpitations which was resolving at the time of the report, the remaining events resolved. Rechallenge results and action taken with the suspect product were retained as per RA source document, although, the events developed after the second dose. The benefit-risk relation of COVID-19 Vaccine Moderna is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events met seriousness criteria.


VAERS ID: 1738978 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Eye irritation, Fatigue, Injection site pain, Injection site warmth, Lymphadenopathy, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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: Swollen lymph nodes; Redness; Fatigue; Muscle ache; High temperature; Burning eyes; Pain injection site; Injection site warmth; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25958193) on 19-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes), MYALGIA (Muscle ache), PYREXIA (High temperature), EYE IRRITATION (Burning eyes), INJECTION SITE PAIN (Pain injection site), INJECTION SITE WARMTH (Injection site warmth), ERYTHEMA (Redness) and FATIGUE (Fatigue) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced INJECTION SITE PAIN (Pain injection site) (seriousness criterion medically significant) and INJECTION SITE WARMTH (Injection site warmth) (seriousness criterion medically significant). On 15-Sep-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), EYE IRRITATION (Burning eyes) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 16-Sep-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant) and ERYTHEMA (Redness) (seriousness criterion medically significant). On 16-Sep-2021, PYREXIA (High temperature) and EYE IRRITATION (Burning eyes) had resolved. On 17-Sep-2021, MYALGIA (Muscle ache) and FATIGUE (Fatigue) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes), INJECTION SITE PAIN (Pain injection site), INJECTION SITE WARMTH (Injection site warmth) and ERYTHEMA (Redness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. Company comment: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected event of Lymphadenopathy, Myalgia, Pyrexia, Eye irritation, Injection site pain, Injection site warmth, Erythema and Fatigue. The events of Injection site Pain and warmth occurred on the same day after the second dose of mRNA-1273, Fatigue Myalgia, Pyrexia and Eye irritation occurred one day after the administration of the second dose and Lymphadenopathy and Erythema occurred two days after the administration of the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.; Sender''s Comments: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected event of Lymphadenopathy, Myalgia, Pyrexia, Eye irritation, Injection site pain, Injection site warmth, Erythema and Fatigue. The events of Injection site Pain and warmth occurred on the same day after the second dose of mRNA-1273, Fatigue Myalgia, Pyrexia and Eye irritation occurred one day after the administration of the second dose and Lymphadenopathy and Erythema occurred two days after the administration of the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1738985 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain lower, Blood urine present, Headache, Loss of consciousness, Myalgia, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: passed out; lower abdominal pain; headache; high temperature; Achy muscles; Blood in urine; unconscious; This case was received via Regulatory Authority RA (Reference number: GB-MHRA-ADR 25959792) on 19-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (unconscious), LOSS OF CONSCIOUSNESS (passed out), ABDOMINAL PAIN LOWER (lower abdominal pain), BLOOD URINE PRESENT (Blood in urine), HEADACHE (headache) and PYREXIA (high temperature) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced BLOOD URINE PRESENT (Blood in urine) (seriousness criterion medically significant). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (unconscious) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), ABDOMINAL PAIN LOWER (lower abdominal pain) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant), PYREXIA (high temperature) (seriousness criterion medically significant) and MYALGIA (Achy muscles). At the time of the report, LOSS OF CONSCIOUSNESS (unconscious), LOSS OF CONSCIOUSNESS (passed out), ABDOMINAL PAIN LOWER (lower abdominal pain), HEADACHE (headache), PYREXIA (high temperature) and MYALGIA (Achy muscles) outcome was unknown and BLOOD URINE PRESENT (Blood in urine) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had a lot of blood in urine in the morning. Lower abdominal pain similar to a UTI. High temperature and headache. Achy muscles. Passed out in the afternoon after having the vaccine. Unconscious for approximately 2 minutes. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. This case concerns a 28 year-old, female patient with no previous relevant medical history who experienced the unexpected events of loss of consciousness, abdominal pain lower, blood urine present, headache and pyrexia. The events occurred on the same day of the second dose of COVID-19 Vaccine Moderna (mRNA-1273) and on unknown dates. The rechallenge was unknown since no information about the first dose was disclosed. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. Events seriousness was assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events seemed to be serious by medical judgement and from a clinical or regulatory standpoint.; Sender''s Comments: This case concerns a 28 year-old, female patient with no previous relevant medical history who experienced the unexpected events of loss of consciousness, abdominal pain lower, blood urine present, headache and pyrexia. The events occurred on the same day of the second dose of COVID-19 Vaccine Moderna (mRNA-1273) and on unknown dates. The rechallenge was unknown since no information about the first dose was disclosed. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. Events seriousness was assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events seemed to be serious by medical judgement and from a clinical or regulatory standpoint.


VAERS ID: 1739003 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Lip swelling, Pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: fatigue; aches; Lip swelling; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25962564) on 19-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PAIN (aches) and LIP SWELLING (Lip swelling) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Gastritis chronic. Concomitant products included ESOMEPRAZOLE for Gastritis chronic. On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced LIP SWELLING (Lip swelling) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (fatigue) (seriousness criterion medically significant) and PAIN (aches) (seriousness criterion medically significant). At the time of the report, FATIGUE (fatigue), PAIN (aches) and LIP SWELLING (Lip swelling) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had dermal fillers in lips 12 months prior to vaccine. she had zero side effects to first Moderna jab but 2nd absolutely floored her. Aches, pain, fatigue. However, the dramatic lip swelling was absolutely terrifying. lips are almost back to normal now. Company Comment: This case concerns a 39-year-old, female patient with relevant medical history of gastritis chronic, who experienced the unexpected events of pain, lip swelling and fatigue. The events occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 39-year-old, female patient with relevant medical history of gastritis chronic, who experienced the unexpected events of pain, lip swelling and fatigue. The events occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1740501 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005288 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Oropharyngeal discomfort
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Discomfort in the throat; Possible of anaphylaxis; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP094999 ) on 15-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, initially reported to the Regulatory Authority by a (physician), was received via the regulatory authority (Ref, v21126807). The patient had a history of anaphylaxis caused by sting of yellow hornet (2020). On an unknown date, body temperature before the vaccination: 36.5 degrees Celsius. On 14-Sep-2021, at 10:07, the patient received the 1st dose of this vaccine. At 10:10, body temperature 128/78, pulse rate 82, and SPO2 97%. At 10:14, feeling of swollen throat developed. The patient had a discomfort in the throat. At 10:19, blood pressure 116/78, pulse rate 86, and SPO2 97%. At 10:37, blood pressure 125/58, pulse rate 88, and SPoO2 98%. Anaphylaxis was suspected because the symptoms were similar to bee stings and tended to worsen; thus, the patient transported to a hospital by ambulance. The outcome of discomfort in the throat and possible of anaphylaxis was unknown. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 34-year-old, male patient with previous medical history of yellow hornet sting allergy, who experienced the expected event of anaphylactic reaction and unexpected event of oropharyngeal discomfort. The events occurred on the same day after the first dose of Moderna vaccine The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The medical history of allergy remains a confounder. The event anaphylactic reaction is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Moderna vaccine is not affected by this report.


VAERS ID: 1742501 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemoptysis, Haemorrhage, Inappropriate schedule of product administration, Pharyngeal erythema, SARS-CoV-2 test, Throat irritation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Medication errors (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217922

Write-up: bleeding; first dose 13Jul2021 and second dose 14Sep2021; spitting out blood; red raw throat; red raw throat; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109150757328910-YTJFM, Safety Report Unique Identifier GB-MHRA-ADR 25943928. A 39-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: FF2153), via an unspecified route of administration on 14Sep2021 as dose 2, single and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 13Jul2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. 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. On 15Sep2021, the patient experienced bleeding and on an unspecified date in 2021, the patient experienced spitting out blood and red raw throat. The patient underwent lab tests which included SARS-Cov-2 test: negative on unknown date. The patient had not yet recovered from bleeding and outcome other events were unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1742503 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hallucination, Headache, Hyperhidrosis, Influenza, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217736

Write-up: hallucinations; fever; sweating; vomiting; headache; Flu; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109150821552990-RQH40 and Safety Report Unique Identifier GB-MHRA-ADR 25944017. A 22-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solu-tion for injection, Batch/Lot Number: FF2153) via an unspecified route of administration on 14Sep2021 as DOSE 2, SINGLE (age at vaccination: 22-year-old) for covid-19 immunisation. The patient medical his-tory and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Historical vaccine received bnt162b2 (Batch/Lot Number not reported) via an unspecified route of administration on an unspecified date for covid-19 immunisation. On an unspecified date, the patient experienced fever, sweating, vomiting, headache and hallucinations. On 14Sep2021, patient experienced flu. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not en-rolled in clinical trial.The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on an unspecified date. The outcome of the events (fever, sweating, vomiting, headache, hallucinations) was unknown, event (Flu) was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1742564 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Breast pain, Musculoskeletal pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Lipodystrophy (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217813

Write-up: Breast pain; Shoulder blade pain; Armpit pain; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109151907234920-MTJEK, Safety Report Unique Identifier GB-MHRA-ADR 25948000. A 37-year-old female patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot Number: FF8222), via an unspecified route of administration on 13Sep2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Previously, the patient received first dose of BNT162B2 via unspecified route of administration on an unknown date for COVID-19 immunisation. On 14Sep2021, the patient experienced Sore armpit and arm where injection was given and on 15Sep2021, patient experienced Pain down side of arm and breast on the side of the injection (sore breast and shoulder blade). The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 12Sep2021 (No - Negative COVID-19 test). The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The patient has not had symptoms associated with COVID-19. The patient was not pregnant. The patient was not currently breastfeeding. The outcome of the events armpit pain and breast pain was not recovered, shoulder blade pain was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1742566 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Diarrhoea, Headache, Illness, SARS-CoV-2 test, Sinus headache
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data: Test Date: 20210110; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101217789

Write-up: Sickness; Diarrhea; Sinus headache; Frontal headache; Armpit pain; This is a spontaneous report from a contactable consumer.This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109152021411610-LBYU8 Safety Report Unique Identifier GB-MHRA-ADR 25948009. A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Sep2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included fibromyalgia from an unknown date and unknown if ongoing, suspected covid-19 from 10Jan2021 and ongoing, immunodeficiency from an unknown date and unknown if ongoing Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef. The patient''s concomitant medications were not reported. On 14Sep2021, the patient experienced sickness, diarrhea, sinus headache, frontal headache, armpit pain. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 10Jan2021 Yes - Positive COVID-19 test. The outcome of the events (sickness, diarrhea) was recovering, events (sinus headache, frontal headache, armpit pain) was not recovered. No follow-up attempts are possible, Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742568 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Dysmenorrhoea, Eye pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217620

Write-up: Fever; Dizziness; Period pains; Painful hips; Painful L arm; Eye pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109152046036100-OE4YB, Safety Report Unique Identifier GB-MHRA-ADR 25948067. A 30-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3380) via an unspecified route of administration on 14Sep2021 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant and was not breastfeeding at the time of this report. The patient had no symptoms associated with COVID-19 and was not enrolled in the clinical trial. Concomitant medications were not reported. On 14Sep2021, the patient underwent COVID-19 virus test and the result was negative. On 14Sep2021, the patient experienced eye pain and on 15Sep2021, 1 day after the vaccination, the patient experienced fever, dizziness, period pains, painful hips and painful L arm; all the events were reported as serious for being medically significant. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event eye pain, fever, dizziness, period pains, painful hips and painful L arm was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1742569 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lethargy, Nasal congestion, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217592

Write-up: Feverish; Sore throat; Nose congestion; Lethargy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109152102135030-EY9FU with Safety Report Unique Identifier GB-MHRA-ADR 25948092. A 32-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10Sep2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in a clinical trial. On 14Sep2021, 4 days after vaccination, the patient experienced sore throat, feverish, nose congestion, and lethargy; all events were reported as serious for being medically significant. On 14Sep2021, the patient underwent a COVID-19 virus test and the result was negative. The clinical outcome of the events feverish, sore throat, nose congestion, and lethargy was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742587 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Dyspepsia, Dyspnoea, Hyperhidrosis, Inappropriate schedule of product administration, Inflammation
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific dysfunction (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101217810

Write-up: shortness of breath; heart pain and inflammation; inflammation; 1st dose on 19Jun2021 and 2nd dose on 12Sep2021; heart pain; Heartburn; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109160552201280-IFHX5, Safety Report Unique Identifier GB-MHRA-ADR 25949268. A 20-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF2153) via an unspecified route of administration on 12Sep2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on 19Jun2021 as single dose for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 14Sep2021 (after 2 days of vaccination), patient experienced heartburn. On an unspecified date, patient experienced slight shortness of breath when it comes, heart pain and inflammation, with a fluttering feeling. Adverse reaction did not occur as a result of an exposure during pregnancy. All events were medically significant. The outcome for event heartburn was not resolved and for other events was unknown. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1742636 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Limb injury, Muscular weakness, Paraesthesia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101224738

Write-up: pins and needles; Weakness in my left arm; Arm injury; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161252085040-XUPCR. Safety Report Unique Identifier GB-MHRA-ADR 25952481. A 35-year-old non pregnant female patient received bnt162b2 (PFIZER- BIOTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: FE3380), dose 2 via an unspecified route of administration in left arm on 13sep2021 as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER- BIOTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had not tested positive for covid-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, patient experienced pins and needles, weakness in my left arm and arm injury on 14Sep2021. On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test: negative (no - negative covid-19 test). The outcome of arm injury was not recovered, pins and needles, weakness in my left arm was unknown. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1742647 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101224812

Write-up: pain; Backache; This is a spontaneous report from a contactable consumer (Patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161406325370-IX7QE, safety report unique identifier is GB-MHRA-ADR 25953123. A 29-year-old male patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, lot number not reported), via an unspecified route of administration on 12Sep2021 as dose 2, single for COVID-19 immunisation. The patient medical history and patient concomitant medications were not reported. Patient had no symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, lot number not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On 14Sep2021, the patient experienced backache, and on an unspecified date, the patient had pain. It was reported that the bottom of patient spine was painful. Almost as if he had slipped a disc (he had not ever done this, but the pain described reminded him fiance of it), patient had not been injured recently or any other reason for this to happen, so he do believe it was a side effect of the vaccine. It was so bad that he could not walk for 24 hours. It hurt to sit and move in general for 24-hours. He consulted a doctor but nothing was done at this time. The next day, it still hurt but a sudden change around lunch time made it much better. It still hurts now, but not nearly the same as it was. The patient underwent lab tests which included SARS-CoV-2 test: Negative (No - Negative COVID-19 test) on 13Sep2021. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of event pain was recovering, and backache was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742726 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-09-14
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Amnesia, Anaphylactic reaction, Blood test, Fatigue, Headache, Insomnia
SMQs:, Anaphylactic reaction (narrow), Taste and smell disorders (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Noninfectious encephalopathy/delirium (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina attack; Asthma
Allergies:
Diagnostic Lab Data: Test Name: Blood tests; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101258920

Write-up: Tired every day; Could not sleep properly; Head pain; Lost of memory; Lost of taste; Anaphylaxis; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109221439081110-O62BH, Safety Report Unique Identifier is GB-MHRA-ADR 25979405. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Aug2021 (Lot Number: FE3380, Expiry date not reported) as dose 1, single for COVID-19 immunization. Medical history included angina pectoris (angina attack) and asthma. Patient had not had symptoms associated with COVID-19, not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant medications were not reported. The patient experienced anaphylaxis on 14Sep2021 with outcome of recovered with sequelae on an unspecified date, tired every day on an unspecified date with outcome of unknown, could not sleep properly on an unspecified date with outcome of unknown, head pain on an unspecified date with outcome of unknown, lost of memory on an unspecified date with outcome of unknown, and lost of taste on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date. Therapeutic measure was taken as a result of anaphylaxis that included Epipen. The events were assessed as serious, hospitalization, medically significant, and life threatening. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1743077 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Auscultation, Body temperature, Cough, Dyspnoea, Feeling hot, Pharyngeal stenosis, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Infective pneumonia (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: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Colitis ulcerative (Currently being treated with AZANIN and HUMIRA.)
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: Auscultation; Result Unstructured Data: Test Result:Pharyngeal stenosis sound; Test Date: 20210914; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101207322

Write-up: Anaphylaxis; Pharyngeal stenosis sound; Hot feeling generalised; Pharynx closed sensation of; Dyspnoea exacerbated; cough/cough aggravated; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126781. A 35-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: FF9942, Expiration date: 30Nov2021) via an intramuscular route of administration on 14Sep2021 at 12:18 (the day of vaccination, at the age of 35-year-old) as dose 1, single for COVID-19 immunization. Body temperature before vaccination was 36.4 degrees centigrade on 14Sep2021. The patient medical history included Colitis ulcerative. Patient was currently being treated with concomitant medications Azathioprine (AZANIN) and Adalimumab (HUMIRA) taken for Colitis ulcerative. The patient previously received REMICADE and experienced infusion reaction. On 14Sep2021 at 12:23 (5 minutes after the vaccination), the patient experienced Anaphylaxis. The course of the event was as follows: On 14Sep2021 around 12:18, the patient received the Comirnaty vaccination. Right after the intramuscular vaccination, the patient experienced Hot feeling generalized and Pharynx closed sensation of but she thought that was just her illusion, so she kept on observation. Then the patient slowly felt Dyspnoea exacerbated and cough appeared, so she contacted the nurse, called the doctor. During Auscultation, Pharyngeal stenosis sound was heard and BOSMIN was administrated. POLARAMINE, HYDROCORTONE, Famotidine and Rinderon treatment started. After that cough aggravated, Pharyngeal stenosis sound was heard, BOSMIN was administrated again (3 times in total). After that the symptoms relieved. The patient underwent lab tests and procedures on 14Sep2021 which included body temperature result included 36.4 Centigrade and auscultation showed Pharyngeal stenosis sound. The outcome of the events was recovered on an unspecified date in Sep2021. The reporting physician classified the event as serious (Medically significant) and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Treated as Anaphylaxis, planned to consult if the patient need hospitalization. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1743220 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005236 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Depressed level of consciousness, Dysarthria, Feeling abnormal, Head discomfort, Headache, Pyrexia, Somnolence
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Decreased level of consciousness; Somnolence tendency; Sick feeling; Slurred speech; Low grade fever; Headache; Feeling of heaviness of head developed; This case was received via regulatory agency (Reference number: 2021TJP095737) on 16-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, initially reported to the regulatory agency by a physician, was received via the RA (Ref, v21126990). On an unknown date, body temperature before the vaccination: 36.7 degrees Celsius. On 14-Sep-2021, at 21:15, the patient received the 1st dose of this vaccine. At 21::25, feeling of heaviness of head developed. The patient was encouraged fluid intake. Headache and decreased level of consciousness were noted. At 21:30, the patient complained of slight sick feeling. The patient moved to the first aid room in a wheelchair. BP 128/91, P 84, SpO2 99 to 100%, JCS 1-1. At 21:45, OS1 was taken. The patient had headache. The patient had a severe pain in the forehead. Somnolence tendency was noted. Queasiness persisted. At 22:03, BT 37.5 degrees Celsius, BP 127/95, P 91, Sp02 100%, JCS1-1. Slurred speech persisted. At 22:05, emergency call was made. After that, blood test and computed tomography (CT) from head to pelvis were performed at the emergency outpatient department. Although there were no obvious abnormal findings, the patient was admitted the hospital because of decreased level of consciousness. The outcome of headache, decreased level of consciousness, sick feeling, somnolence tendency, slurred speech, and low grade fever was unknown. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 19-year-old, female subject with no relevant history reported, who experienced the unexpected events of depressed level of consciousness, somnolence, feeling abnormal, dysarthria, pyrexia, headache and head discomfort. The events occurred on the same day of the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The events was considered related to the study drug per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1744942 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-09-14
   Days after vaccination:224
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Drug ineffective, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: 20210913; Test Name: Sars-CoV-2 PCR test; Test Result: Negative ; Comments: nasal swab; Test Date: 20210918; Test Name: Sars-CoV-2 PCR test; Test Result: Positive ; Comments: nasal swab
CDC Split Type: BEPFIZER INC202101229903

Write-up: Lack of efficacy: PCR test positive despite being vaccinated; Lack of efficacy: PCR test positive despite being vaccinated; cough; sore throat; This is a spontaneous report from a contactable Pfizer colleague. A 51-years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EM0477) via an unspecified route of administration on 02Feb2021, (at the age of 50-years-old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 14Sep2021, the patient experienced cough and sore throat and on 18Sep2021, lack of efficacy: PCR test positive despite being vaccinated. The patient underwent lab tests and procedures which included nasal swab: negative on 13Sep2021 and nasal swab positive on 18Sep2021. Therapeutic measures were taken as a result of lack of efficacy: PCR test positive despite being vaccinated, cough, and sore throat including Colludol and Strepsil. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1746042 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-09-14
   Days after vaccination:194
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101239627

Write-up: Herpes zoster; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-1002612. An adult non-pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ET1831) via an unspecified route of administration, in left arm on 04Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Whether patient has passed COVID-19 was unknown. On 14Sep2021, the patient experienced herpes zoster. The outcome of the event was unknown. No follow up attempts possible, no further information expected.


VAERS ID: 1746507 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyskinesia, Eye disorder
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad), Corneal disorders (broad), Retinal 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101225379

Write-up: Lips closing on one side and one eye blinking faster then the other one; Lips closing on one side and one eye blinking faster then the other one; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-EYC 00260801. Safety Report Unique Identifier GB-MHRA-ADR 25951333. A female patient of unspecified age (age also reported as 1-month) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), parenteral on 11Sep2021 (Batch/Lot Number: Ff2153) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history and concurrent conditions. The patient''s concomitant medications were not reported. The patient experienced lips closing on one side and one eye blinking faster than the other one on 14Sep2021. The patient needed to seek advice from the doctor. The event was reported as serious (medically significant). The outcome of the event was not recovered. No follow-up attempts are needed; No further information is expected.


VAERS ID: 1746602 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Breast pain, Lymphoma, SARS-CoV-2 test
SMQs:, Lipodystrophy (broad), Malignant lymphomas (narrow), Haematological malignant tumours (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217802

Write-up: Lymphoma; sharp pain under armpit of the injected arm; pain in left breast same side as injection; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109152021389430-KEPBU, Sender''s (Case) Safety Report Unique Identifier-GB-MHRA-ADR 25948018. A 22-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: Ff2153), via an unspecified route of administration, administered in arm on 13Sep2021 as dose 2, single for covid-19 immunization. Medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. It was stated that, on 14Sep2021, the patient was presented with lymphoma. On unspecified date in 2021, the patient experienced sharp pain under armpit of the injected arm and pain in left breast same side as injection. The patient underwent lab tests and procedures which included COVID-19 virus test (sars-cov-2 test) with negative result (No - Negative COVID-19 test) on an unspecified date. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome for the event lymphoma was not recovered, at the time of report and the outcome for other events was unknown. No follow-up attempts are Needed. No further information is expected.


VAERS ID: 1746751 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225178

Write-up: Perimyocarditis; This is a spontaneous report from a contactable pharmacist received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109161554127380-ZKLYN, Safety Report Unique Identifier: GB-MHRA-ADR 25953794. A 20-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not known), via an unspecified route of administration on 01Sep2021 as dose 1, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient was not on any regular medications prior to admission and not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 14Sep2021, the patient experienced perimyocarditis. Peri-myocarditis 2 weeks post first dose of Pfizer. The patient underwent lab tests and procedures which included Covid-19 virus test: negative (No - Negative COVID-19 test) on 15Sep2021. The reporter considered the event as serious (medically significant). The outcome of event was recovering. The report does not relate to possible blood clots or low platelet counts. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1746757 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225012

Write-up: Painful arm; Headache; This is a spontaneous report from a contactable other health care professional, This report is received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161616495470-ZJOCR and Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25953923. A 39-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 14Sep2021 (age at vaccination: 39-year-old) as single dose for COVID-19 immunisation. Patient last menstrual period date was 07Sep2021.The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. On 14Sep2021, the patient experienced headache. On an unspecified date, the patient experienced painful arm. Painful arm Bad head Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: No - Negative COVID-19 test on 16Sep2021. The outcome of the event headache was not resolved and event painful arm was unknown. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1746778 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-09-14
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Dysmenorrhoea, Maternal exposure timing unspecified, Pain, Pregnancy, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Infertility; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: pregnancy; Result Unstructured Data: Test Result:14Aug2021; Comments: On the 14Aug I had a positive pregnancy test; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225130

Write-up: pain; Maternal exposure during pregnancy; Period pains; On the 14Sep I miscarried; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161855055250-MSXAA, Safety Report Unique Identifier GB-MHRA-ADR 25954887. A 32-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 31Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included pregnancy from an unknown date and unknown if ongoing Patient no longer pregnant at the time of reporting, infertility from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19 Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was exposed to the medicine Before pregnancy. Patient is not enrolled in clinical trial. Concomitant medications included folic acid 5mg taken for folic acid supplementation, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 05Jun2021 as dose 1, single for COVID-19 immunisation. On an unspecified date, the patient experienced pain, maternal exposure during pregnancy, period pains. On the 14Aug I had a positive pregnancy test. Once I knew I was pregnant I told my GP about the pain I had experienced 11 days after my second dose but was told it could have been implantation bleeding. On the 14Sep I miscarried. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test and pregnancy: 14aug2021 positive pregnancy test. The outcome of the events pain and period pains was recovered and unknown for other events. No follow-up at tempts are possible, information about Lot/Batch number cannot be obtained. No further information is expected.


VAERS ID: 1746786 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101225479

Write-up: asthma; Asthma aggravated; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161941456510-ICSBU, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25955000. A 23-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Sep2021 (Lot Number: FF8222) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient is not pregnant nor currently breastfeeding. The patient experienced asthma on an unknown date and asthma aggravated on 14Sep2021. Events described as follows: asthma became much more difficult to control, and had to be treated with a course of steroids. The events were considered medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The patient was recovering from the events. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1746825 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101224960

Write-up: Swollen lymph nodes; This is a spontaneous report from a contactable non-health care professional. This is report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109170023524490-ATTEQ, Safety Report Unique Identifier number is GB-MHRA-ADR 25956595. A 19-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported) via an unspecified route of administration on 13Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received historical vaccine first dose of BNT162B2 as dose 1, single for COVID-19 immunization. The patient experienced swollen lymph nodes (medically significant) on 14Sep2021. The patient underwent lab tests and procedures which included COVID-19 virus test (negative covid-19 test) on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event swollen lymph nodes was not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1746874 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-09-14
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Glossodynia, Headache, Oropharyngeal pain, Pruritus, Rash, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: rash all over; itchy; chills; sore throat; Tender tongue; Hives; Headache; Tiredness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25972271) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (rash all over), PRURITUS (itchy), CHILLS (chills), OROPHARYNGEAL PAIN (sore throat), FATIGUE (Tiredness), URTICARIA (Hives), GLOSSODYNIA (Tender tongue) and HEADACHE (Headache) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 14-Jun-2021. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 15-Sep-2021, the patient experienced URTICARIA (Hives) (seriousness criterion medically significant). On 19-Sep-2021, the patient experienced GLOSSODYNIA (Tender tongue) (seriousness criterion medically significant). On an unknown date, the patient experienced RASH (rash all over) (seriousness criterion medically significant), PRURITUS (itchy) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant) and OROPHARYNGEAL PAIN (sore throat) (seriousness criterion medically significant). On 15-Sep-2021, HEADACHE (Headache) had resolved. At the time of the report, RASH (rash all over), PRURITUS (itchy), CHILLS (chills), OROPHARYNGEAL PAIN (sore throat), FATIGUE (Tiredness) and URTICARIA (Hives) had not resolved and GLOSSODYNIA (Tender tongue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication details was reported. No treatment medication details was reported. The patient experienced chills, headaches, tiredness - need extra sleep throughout day, sore throat, tender at vaccine insertion site.Some of these the patient thought may happen. The next part the patient have not expected. The patient have rash all over body and every night midway through sleep, the patient have woke up extremely hot. Happened every day since vaccine and rash/ hives appeared the following day after injection. Today it''s getting itchy as before it was just raised, giving the appearance of dappled skin, all over (less on face) Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial This case concerns a 38-year-old male patient with medical history of Suspected COVID-19., who experienced Urticaria 2 months 2 days after, Glossodynia 2 months 6 days after, Fatigue and Headache 2 months 1 day after Oropharyngeal pain Rash, Pruritus, Chills unspecified days after first dose of Spikevax. The reporter did not provide causality assessment. The rechallenge was unknown. The benefit-risk relationship of Spikevax in not affected by this report.; Sender''s Comments: This case concerns a 38-year-old male patient with medical history of Suspected COVID-19., who experienced Urticaria 2 months 2 days after, Glossodynia 2 months 6 days after, Fatigue and Headache 2 months 1 day after Oropharyngeal pain Rash, Pruritus, Chills unspecified days after first dose of Spikevax. The reporter did not provide causality assessment. The rechallenge was unknown. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1749148 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7204 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Feeling hot, Flushing, Hypoaesthesia, Muscle spasms, Muscle spasticity
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Hypersensitivity (broad), Sexual dysfunction (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: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Complex regional pain syndrome; Spinal stenosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101226333

Write-up: Within one minute of injection, my left arm, neck, head started to feel warm, my jaw turned numb, my face started to droop, my face flushed a bright red, then all my head got numb; my left arm, neck, head started to feel warm,; my jaw turned numb; my face flushed a bright red; then all my head got numb,; started getting spasms in my arms and legs.; I started getting spasms in my arms and legs.; This is a spontaneous report received via Regulatory Authority from a contactable consumer (patient). A 52-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: fd7204) dose 1 via an unspecified route of administration, administered in Arm Left on 14Sep2021 as dose 1, single (At the age of 52-years) for covid-19 immunisation. Medical history included spinal stenosis, complex regional pain syndrome both from an unknown date and unknown if ongoing. Concomitant medications included nabilone, hydrochlorothiazide (APO HYDRO) both taken for an unspecified indication from an unspecified start date and ongoing. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 14Sep2021 15:00, the patient experienced within one minute of injection, my left arm, neck, head started to feel warm, my jaw turned numb, my face started to droop, my face flushed a bright red, then all my head got numb, started getting spasms in my arms and legs. The intensity went down after 15 minutes but the numbness and spasms were present for 48hrs. Events required Doctor or other healthcare professional office/clinic visit. Patient did not receive treatment for the adverse event. The outcome of the event was recovered on an unspecified date. No follow up attempts are possible. No further information is expected.


VAERS ID: 1749150 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Dizziness, Dyspnoea, Headache, Heart rate, Heart rate increased
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), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: OZEMPIC
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: Heart rate; Result Unstructured Data: Test Result:140-150
CDC Split Type: CAPFIZER INC202101227241

Write-up: Heart rate 140-150; Hard to breathe; dizzy; Headache; cold sweats; This is a spontaneous report from a contactable healthcare professional (patient) received via Regulatory Authority. A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 13Sep2021 (at the age of 37-years-old) at dose 2, single for COVID-19 immunisation. The patient''s medical history was not reported. Prior to vaccination, she was not diagnosed with COVID-19. Concomitant medications included semaglutide (OZEMPIC) and birth control pill. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 22Aug2021 (at the age of 37-years-old) at dose 1, single for COVID-19 immunisation. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. Since the vaccination, she has not been tested for COVID-19. On 14Sep2021, the patient experienced heart rate of 140-150. Her heart rate went up if she exerted any energy. She also reported that it was hard to breathe, she was dizzy, and experienced headache and cold sweats. The events required emergency room/department or urgent care visit. She did not receive any treatment in response to the events. The outcome of the events was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event heart rate increased and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1749202 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-09-14
   Days after vaccination:96
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002620 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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: DEMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: DE-PEI-202100189730) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VENTRICULAR FIBRILLATION in a 57-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002620) for COVID-19 vaccination. No Medical History information was reported. On 10-Jun-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced VENTRICULAR FIBRILLATION (seriousness criterion medically significant). At the time of the report, VENTRICULAR FIBRILLATION had resolved with sequelae. Concomitant product was not provided by the reporter. Treatment information was not provided. Company Comment: This case concerns a 57-year-old, male patient with no relevant medical history, who experienced the unexpected event of ventricular fibrillation.. The events occurred approximately 3 months and 5 days after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation received on 27-SEP-2021 as live follow up contained no new information.; Sender''s Comments: This case concerns a 57-year-old, male patient with no relevant medical history, who experienced the unexpected event of ventricular fibrillation.. The events occurred approximately 3 months and 5 days after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1750917 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-09-14
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menstrual disorder, Menstruation irregular, Off label use, Product use issue, SARS-CoV-2 test
SMQs:, Fertility disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Gave birth on 17Ju2021)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225404

Write-up: bleeding/ Sudden onset of period; breastfeeding; Breastfeeding; Irregular periods; This is a spontaneous report from a contactable consumer (patient). This report was received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109160939113690-LMOQL. Safety Report Unique Identifier GB-MHRA-ADR 25951337. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 21Aug2021 (Lot Number: FE3380) as dose 1, single for COVID-19 immunisation. The patient medical history included pregnancy (gave birth on 17Jul2021) and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant at the time of the report and not enrolled in clinical trial. The patient experienced bleeding/ Sudden onset of period on an unspecified date with outcome of recovering and irregular periods on 14Sep2021 with outcome of not recovered. The events were reported as serious and medically significant. The patient is also breastfeeding. The patient underwent lab tests and procedures which included Covid-19 virus test: No - Negative COVID-19 test on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The clinical course was reported as follows: Sudden onset of period which should not have happen and very unusual. Gave birth 17th July, bleeding stopped beginning of September and all of a sudden I experience a period despite Breastfeeding entirely. I had 2 previous children entirely BF and never experienced a period until 9 month in. Adverse reaction did not occur as result of an exposure during pregnancy. No follow-up attempts are needed; No further information is expected.


VAERS ID: 1750926 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dizziness, Heart rate, Heart rate increased, Palpitations, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: heart rate; Result Unstructured Data: Test Result:155 bpm; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225252

Write-up: dizzy; heart rate/heart rate was very fast; Chest pain; Palpitations; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161206224010-W4DMY. Safety Report Unique Identifier GB-MHRA-ADR 25952203. A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Sep2021 (Lot Number: FF2153) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced dizzy on an unspecified date with outcome of recovering, heart rate/heart rate was very fast on 14Sep2021 with outcome of not recovered, chest pain on 14Sep2021 with outcome of not recovered, palpitations on 14Sep2021 with outcome of not recovered. The patient was hospitalized due to the events. The patient underwent lab tests and procedures which included heart rate: 155 bpm on an unspecified date, Covid-19 virus test: negative on an unspecified date (No - Negative COVID-19 test). Therapeutic measures were taken as result of the events of heart rate/heart rate was very fast and palpitations. Patient has not tested positive for COVID-19 since having the vaccine. The events were reported as serious caused hospitalization and medically significant. The clinical course was reported as follows: I woke up and my heart rate was very fast, then I went dizzy and called ambulance. In the ER I had resting heart rate of 155bpm non stop, my heart remained elevated for 12 hours and they gave me medication to help slow it down a little. It is still fast now. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1750961 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Lymphadenopathy, Malaise, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test; Test Date: 20210915; Test Name: temperature; Result Unstructured Data: Test Result:37.3 Centigrade
CDC Split Type: GBPFIZER INC202101226587

Write-up: Swollen glands; nauseous; unwell; High temperature/raised temperature to 37.3 c; Painful arm; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109170901133130-CKGEC. Safety Report Unique Identifier GB-MHRA-ADR 25957738. A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 14Sep2021 (at the age of 12 years old) (Lot Number: FF8222) as dose 1, single for COVID-19 immunization. Medical history included suspected COVID-19 from 24Jul2021 to 01Aug2021. The patient''s concomitant medications were not reported. On 14Sep2021, the patient experienced sore and painful arm pretty much straight away and continued the following day. On 15Sep2021, the patient felt unwell, had high temperature/raised temperature to 37.3 c, painful to move arm that had vaccine, felt nauseous after eating evening meal. On 17Sep2021, arm was less sore but gland under left arm (vaccinated arm) was swollen and sore. The outcome of the event painful arm was recovering, the outcome of unwell, and nausea was unknown. The outcome of high temperature was recovered on 16Sep2021. The outcome of swollen glands was not recovered. The patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included positive COVID-19 test on 24Jul2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1751042 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226538

Write-up: Swollen lymph nodes; painful lymph nodes; Off-label use; booster; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109171659456100-TCQY0, Safety Report Unique Identifier GB-MHRA-ADR 25960228. A 42-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FE3380) via an unspecified route of administration, on 14Sep2021 as DOSE 3a (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history included suspected covid-19 from 26Mar2020 to 18Apr2020. The patient''s concomitant medications were not reported. The patient''s historical vaccine included the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported) both doses via an unspecified route of administration, on an unspecified date as dose 1, dose 2 single for covid-19 immunization. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient experienced swollen lymph nodes, painful lymph nodes on 16Sep2021; off-label use and booster on 14Sep2021. Clinical information included swollen, painful lymph nodes from ear to clavicle. The patient underwent lab tests and procedures which included sars-cov-2 test/ COVID-19 virus test was negative (no - negative covid-19 test) on 10Sep2021. Outcome of the events swollen lymph nodes, painful lymph nodes was not recovered. No follow up attempts are needed. No further information is expected.


VAERS ID: 1751089 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Dizziness, Headache, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226528

Write-up: Stomach cramps; Swollen lymph nodes; Dizziness; Headache; This is a spontaneous report from a contactable consumer or other non hcp received from a Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109172150263000-DNMTX. Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25961701. A 23-year-old non pregnant female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection), via an unspecified route of administration on 13Sep2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. Historical vaccine included first dose of BNT162B2, via an unspecified route of administration on unknown date for COVID-19 immunisation. The patient experienced stomach cramps on 15Sep2021, swollen lymph nodes, dizziness and headache on 14Sep2021. Patient has not tested positive for COVID-19 since having the vaccine. All events are medically significant. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative 14Sep2021, No - Negative COVID-19 test. The outcome of the event swollen lymph nodes was recovered with sequel and not recovered for other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1751212 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Psychotic disorder, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (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
CDC Split Type: GBPFIZER INC202101227124

Write-up: Psychosis; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109190142330620-CIMFT. Safety Report Unique Identifier GB-MHRA-ADR 25965302. A 23-year-old (non-pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 13Sep2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced psychosis on 14Sep2021 with outcome of recovered with sequel. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unknown date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Seriousness criteria of the event was reported as serious (medically significant). No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1751468 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-09-14
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Immune thrombocytopenia, Platelet count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Alopecia areata
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: Platelet count; Result Unstructured Data: 3000
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Recurrence of idiopathic thrombocytopenic purpura; This case was received via regulatory authority on 15-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case was reported by a physician via a medical representative. On 15-Sep-2021, follow-up information was reported by a physician via a medical representative. The patient was diagnosed with idiopathic thrombocytopenic purpura (in 2013) and received a treatment with corticosteroids (9 month in total until 2014), and remission of the disease had been maintained with no treatment after that. On 29-Jul-2021, the patient received the 1st dose of the vaccine. On 26-Aug-2021, the patient received the 2nd dose of the vaccine. On 14-Sep-2021, the patient had purpura, and the result of a blood test showed platelet counts with a low level of 3,000. Idiopathic thrombocytopenic purpura relapsed. On 15-Sep-2021, the patient was admitted to the reporting hospital. PSL: 1 mg/kg + intravenous injection of immunoglobulin (IVIG) was started. Subsequently, an increase in platelet counts was confirmed. The outcome of recurrence of idiopathic thrombocytopenic purpura was reported as unknown. Follow-up investigation will be made. Follow-up received on 15-SEP-2021 Updated: Patient Information, Other Relevant History, Product Information, Event Information, Narrative, Reporter Comments Company Comment: This case concerns a 30-year-old, female patient with relevant medical history of idiopathic thrombocytopenic purpura, who experienced the unexpected event of idiopathic thrombocytopenic purpura. The event idiopathic thrombocytopenic purpura occurred 19 days after the second dose of mRNA-1273 vaccine administration. The rechallenge was unknown as there''s no information available about the first dose. The events were considered possibly related to the product per the reporter''s assessment. The medical history of idiopathic thrombocytopenic purpura remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reporter''s Comments: This vaccine is the suspect product. The patient received no other new medications or developed concurrent infection. Sender''s comments: Although the event "immune thrombocytopenia" developed after the administration of COVID-19 vaccine mRNA (mRNA 1273), factors such as concurrent conditions may have also had an influence.; Sender''s Comments: This case concerns a 30-year-old, female patient with relevant medical history of idiopathic thrombocytopenic purpura, who experienced the unexpected event of idiopathic thrombocytopenic purpura. The event idiopathic thrombocytopenic purpura occurred 19 days after the second dose of mRNA-1273 vaccine administration.The rechallenge was unknown as there''s no information available about the first dose. The events were considered possibly related to the product per the reporter''s assessment. The medical history of idiopathic thrombocytopenic purpura remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1751475 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005694 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperhidrosis, Hypertensive emergency, Peripheral coldness
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Suspected hypertensive emergency; Cold feeling of fingers; Sweating on the trunk; This case was received via regulatory authority (Reference number: 2021TJP095149) on 15-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, initially reported to the regulatory authority by a (physician), was received via the RA (Ref, v21127834). Suspected hypertensive emergency was assessed as serious by the RA. On an unknown date, body temperature before the vaccination: 36.6 degrees Celsius. On 14-Sep-2021, at 10:00, the patient received the 1st dose of this vaccine. At 10:15, the patient had cold sweat and cold feeling of the fingers. The patient was awake and alert. Blood pressure 155/93 mmHg, pulse rate 93/min, and SpO2 99% during bed rest. Hypertensive emergency was suspected. At 10:35, cold sweat improved. Although blood pressure improved to 138/93 mmHg, it was usually high. At 11:05, cold feeling of fingers resolved. At 11:45, the symptoms were resolving. Blood pressure improved to 117/75. The patient recovered and left the room walking without assistance. The outcome of suspected hypertensive emergency, cold feeling of fingers, and sweating on the trunk was reported as recovered. Follow-up investigation will be made. Company Comment : The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 52-year-old, male patient with no relevant medical history reported, who experienced the unexpected event of hypertensive emergency. The event occurred approximately 15 minutes after the first dose of Moderna COVID-19 Vaccine. The patient had cold sweat and cold feeling of the fingers and blood pressure 155/93 mmHg with pulse rate 93/min. The event resolved after half an hour. The rechallenge was unknown since events occurred after first dose and no information about the second dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per information provided in source document.


VAERS ID: 1751476 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-09-14
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Brugada syndrome
SMQs:, Congenital and neonatal arrhythmias (narrow), Conduction defects (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP095741) on 16-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, initially reported to the Agency (RA) by an administrator, was received via the RA (Ref, v21126974). On 16-Aug-2021, the patient received the 1st dose of the vaccine. On an unknown date, body temperature before the vaccination: 36.5 degrees Celsius. On 13-Sep-2021, in the afternoon, the patient received the 2nd dose of the vaccine. At night, pyrexia occurred. On 14-Sep-2021, in the early evening, the patient suddenly lost consciousness and was transported to hospital by ambulance. In ambulance, the patient suffered cardiopulmonary arrest and was hospitalized. On 15-Sep-2021, the patient had been treated in ICU. The patient was told by a physician that there was a possibility of Brugada syndrome. The outcome of Brugada syndrome was reported as ongoing and unchanged. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 26 year-old male with no medical history provided, who experienced the unexpected event of Brugada syndrome, This event started the night after the second dose of COVID-19 vaccine mRNA.The event was considered related to the study drug per the reporter''s assessment.The benefit-risk relationship of COVID-19 vaccine mRNA in not affected by this report


VAERS ID: 1751491 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-09-14
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004496 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Asthma
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Eosinophilic pneumonia (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? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nasal stuffiness; Sputum
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Bronchial asthma; Anaphylaxis; This case was received via the RA (Reference number: JP-TAKEDA-2021TJP097654 ) on 22-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This case, reported by a physician, was received by the RA via Moderna''s adverse reaction reporting site (TASK0021836), and this case, initially reported to the RA by a physician, was received via the RA (Ref, v21127529). On 17-Aug-2021, at 14:00, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before vaccination: 36.6 degrees Celsius. On 14-Sep-2021, at 14:27, the patient received the 2nd dose of this vaccine. At 14:40, the patient complained of feels poorly in the waiting room after vaccination and moved to the treatment room. The patient''s symptoms developed suddenly with rapid progression. Blood pressure was 144/80 and SPO2 was 91 to 92%. Because wheezing was noted in both breasts, administration of 2 L/min of oxygen was started. SPO2 improved to 98%. The blood pressure was good at 134/90, but the patient had persistent dyspnoea and wheezing in both breasts; thus, the patient was considered to have anaphylaxis. At 15:08, adrenaline 0.3 mg was injected intramuscularly into the right thigh, and dyspnoea tended to improve. However, wheezing persisted in the chest, and the patient was admitted to the hospital for treatment after drip infusion of hydrocortisone 100 mg. Mild dyspnea and wheezing persisted after admission. On 15-Sep-2021, at 00:20, intramuscular injection of adrenaline 0.3 mg was added. The patient''s wheezing was then diagnosed as a condition of bronchial asthma. Inhaled steroid was started, and the symptoms gradually improved. On 21-Sep-2021, since the patient''s symptoms improved, the patient was discharged from the hospital. The patient was scheduled to be an outpatient at the department of respiratory medicine. The outcome of anaphylaxis and bronchial asthma was reported as resolving. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 20-year-old, male patient with medical history nasal stuffiness, who experienced the unexpected event of Asthma and expected event of Anaphylactic reaction. The events occurred the same day as the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened only after the second dose. The events were considered related to the product per the reporter''s assessment. The event of Anaphylactic reaction is consistent with the current understanding of the mechanism of action of the study medication The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.


VAERS ID: 1751492 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005699 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: JPMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; This case was received via Regulatory Authority (Reference number: 2021TJP097754) on 22-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the RA (Ref, v21127426). Anaphylaxis was assessed as serious. On an unknown date, the patient received the 1st dose of the vaccine. On 14-Sep-2021, at 15:27, the patient received the 2nd dose of the vaccine. At 16:21, anaphylaxis developed. Rash appeared on both legs. About 80 minutes after the vaccination, abdominal pain, and discomfort and swelling of pharyngeal mucosa developed, and methylprednisolone sodium succinate 125 mg and d-chlorpheniramine maleate were administered intravenously. After the vaccination, symptoms were resolving and eventually resolved. A little over 2 hours after the vaccination, the patient returned home. The outcome of anaphylaxis was reported as resolved. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 24-year-old, female patient with no previous relevant medical history, who experienced the expected event of Anaphylactic reaction. The event occurred on the same day (54mins) after the second dose of mRNA-1273. The rechallenge was not applicable since the event occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1752911 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-09-14
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Peripheral swelling, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Shaking; Swollen arm; Throbbing headache; Fever; Fatigue; This case was received via RA (Reference number: RA-ADR 25976603) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TREMOR (Shaking), PERIPHERAL SWELLING (Swollen arm), HEADACHE (Throbbing headache), PYREXIA (Fever) and FATIGUE (Fatigue) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced TREMOR (Shaking) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), HEADACHE (Throbbing headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 15-Sep-2021, TREMOR (Shaking) had resolved. On 16-Sep-2021, PERIPHERAL SWELLING (Swollen arm), HEADACHE (Throbbing headache) and PYREXIA (Fever) had resolved. On 17-Sep-2021, FATIGUE (Fatigue) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. Patient experienced uncontrollable shaking about 5 hours after the vaccine and could barely walk and had intense fever, painful sore arm. The next day patient fatigued, slept all day with fever. Company Comment : This case concerns a 29-year-old, female patient with no reported medical history. Reportedly, the second dose of the vaccine was given 2 months and 25 days after the first dose which is considered to be Inappropriate schedule of product administration. The patient experienced serious (Medically significant) events Pain in extremity, Gait disturbance, Tremor, Peripheral swelling, Headache, Pyrexia and Fatigue during the same day after the second dose of Moderna CoviD-19 Vaccine. The outcome of events was recovered, except for the events of Pain in extremity and Gait disturbance for which the outcome was not specified. Causality was not provided by reporter. Although the action taken was captured as per RA source document, the patient experienced AEs after the second dose, therefore the rechallenge is not applicable. The company causality for the Inappropriate schedule of product administration is not applicable. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 29-year-old, female patient with no reported medical history. Reportedly, the second dose of the vaccine was given 2 months and 25 days after the first dose which is considered to be Inappropriate schedule of product administration. The patient experienced serious (Medically significant) events Pain in extremity, Gait disturbance, Tremor, Peripheral swelling, Headache, Pyrexia and Fatigue during the same day after the second dose of Moderna CoviD-19 Vaccine. The outcome of events was recovered, except for the events of Pain in extremity and Gait disturbance for which the outcome was not specified. Causality was not provided by reporter. Although the action taken was captured as per RA source document, the patient experienced AEs after the second dose, therefore the rechallenge is not applicable. The company causality for the Inappropriate schedule of product administration is not applicable. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.


VAERS ID: 1752974 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, 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: PHMODERNATX, INC.MOD20213

Write-up: Rash; Itching; Redness; This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Rash), PRURITUS (Itching) and ERYTHEMA (Redness) in a 32-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 12-Sep-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant), PRURITUS (Itching) (seriousness criterion medically significant) and ERYTHEMA (Redness) (seriousness criterion medically significant). At the time of the report, RASH (Rash), PRURITUS (Itching) and ERYTHEMA (Redness) had not resolved. No Concomitant medications was provided. No Treatment medications was provided. Company Comment: This case concerns a 32-year-old female patient with no relevant medical history reported, who experienced serious unexpected events of rash, pruritus and erythema. The events occurred approximately 3 days after the second dose of mRNA-1273. The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however, there was no information in the source document of seriousness from a clinical or regulatory standpoint.; Sender''s Comments: This case concerns a 32-year-old female patient with no relevant medical history reported, who experienced serious unexpected events of rash, pruritus and erythema. The events occurred approximately 3 days after the second dose of mRNA-1273. The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however, there was no information in the source document of seriousness from a clinical or regulatory standpoint.


VAERS ID: 1755083 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Glossodynia, Internal haemorrhage, Mouth ulceration, SARS-CoV-2 test, Tongue disorder
SMQs:, Severe cutaneous adverse reactions (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (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: C-section (I had a baby by c section 10 weeks ago)
Allergies:
Diagnostic Lab Data: Test Date: 20210918; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101233710

Write-up: internal mouth; painful bump has appeared on side of tongue; Sore under tongue and on top as well.; Mouth ulcer; This is a spontaneous report from a contactable consumer (Patient). This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109192051410200-7OWXK. Safety Report Unique Identifier GB-MHRA-ADR 25966312. A 35-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on 11Sep2021 as dose 2, single for COVID-19 immunization. Medical history included caesarean section (patient had a baby by c section 10 weeks ago). Patient had no symptoms associated with COVID-19. Concomitant medications were not reported. Patient previously received bnt162b2 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced internal mouth, painful bump had appeared on side of tongue and sore under tongue and on top as well. On 14Sep2021, the patient experienced mouth ulcer. Patient reported that all of her inner lips and gums had gone red raw. Now a painful bump had appeared on side of tongue. Sore under tongue and on top as well. Her whole internal mouth was sore. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: no- negative covid-19 test on 18Sep2021.The outcome of the event (internal mouth, painful bump has appeared on side of tongue and sore under tongue and on top as well) was unknown and event (mouth ulcer) was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1755392 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-09-14
   Days after vaccination:204
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute on chronic renal failure; Benign prostatic hypertrophy; Cachexia; Cholelithiasis; Cognitive deterioration; COPD; Hernia inguinal; Hypopotassaemia; Osteoarthrosis; Vascular encephalopathy
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive
CDC Split Type: ITPFIZER INC202101239735

Write-up: positive molecular test; vaccination failure; This is a spontaneous report from a contactable other healthcare professional downloaded from the REGULATORY AUTHORITYWEB:IT-MINISAL02-787391. A 84-year-old elderly male patient received BNT162B2 (COMIRNATY, Solution for injection, lot/batch number: EK9788 and expiry date: 31May2021), via an intramuscular route of administration at right shoulder, on 29Jan2021, as a dose 1, 0.3ml single (booster dose 1) for COVID-19 immunization and received BNT162B2 (COMIRNATY, Solution for injection, lot/batch number: EP9598 and expiry date: 30Jun2021), via an intramuscular route of administration at right shoulder, on 22feb2021, as a dose 2, 0.3ml single (booster dose 2) for COVID-19 immunization. The patient''s medical history includes hypopotassaemia, cholelithiasis, COPD, cachexia, benign prostatic hypertrophy, vascular encephalopathy, cognitive deterioration, hernia inguinal, acute on chronic renal failure and osteoarthrosis. The patient concomitant medications was not reported. On 14Sep2021, the patient had positive molecular test and vaccination failure. The patient hospitalized due to positive molecular test. The hospitalization details were unspecified. Reportedly on 14Sep2021, the patient had laboratory test COVID-19 PCR test and result was positive. Reportedly at emergency room visit the patient received therapy: perfalgan intravenous 12 vial 100ml10mg / ml, sodium chloride Fresenius Kabi Italia 0.9 percent 500ml, ringer acetate intravenous 10 vial 500ml. Outcome was not recovered for the event positive molecular test. Conclusion: 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 EK9788 (Dose 1) and lot EP9598 (Dose 2). 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. Site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1756465 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Injection site cellulitis, Injection site erythema, Lymphadenopathy, Malaise, Sepsis
SMQs:, Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202101249848

Write-up: Large lump in my armpit; Painfail and the arm was warm to the touch; I felt unwell; Cellulitis at injection site; Blood poisoning at the injection site; A bit red at injection site; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program Vaccine Helpline. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Sep2021 (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient took off the cotton wool and strip that patient had placed on the needle prick on the night of 14Sep2021. The patient noticed that it was a bit red and thought it was normal. On 15Sep2021, it was more red and it had got worse. On 17Sep2021 morning. the patient had a large lump in armpit that felt like an extra breast. It was very painfail and the arm was warm to the touch and patient felt unwell. The patient saw doctor and was informed by doctor that patient got blood poisoning at the injection site and also mentioned cellulitis. The patient was also told by doctor that patient would have ended up in hospital if patient had to wait another day to see him. Patient reported that patient was extremely upset and had to get antibiotics for the problem which patient has not expected. Patient''s arm still looked sore after 3 days of antibiotics and the site was now turning brown. The patient received treatment for the events. The outcome of the event malaise was unknown and the outcome of other events was not recovered. No further information was available at the time of this report


VAERS ID: 1757810 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Hyperpyrexia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Psoriasis
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: Body temperature; Result Unstructured Data: over 38 degrees
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-788505) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERPYREXIA in a 46-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214024) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Asthma and Psoriasis. On 14-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Sep-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant), DYSPNOEA and MYALGIA at the time of the report, HYPERPYREXIA, DYSPNOEA and MYALGIA had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, Body temperature: over 38 (High) over 38 degrees. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medications were provided. No treatment information was provided. It was reported that report relating to Moderna vaccine of 14 SEP 2021 with fever in the evening, over 38 degrees, myalgia in the arms, legs and joints, mild dyspnea the following day and fever, muscle pain. It was reported that the patient had asthma and psoriasis. Company comment: This case concerns a 46-year-old, female patient with relevant medical history of asthma, who experienced the serious unexpected event of Hyperpyrexia, non-serious unexpected event of dyspnoea and non-serious expected event of myalgia. The events occurred the same day after the first dose of Spikevax. The rechallenge was not applicable since only information about one dose was disclosed. The medical history of asthma remains a confounder. The event Myalgia is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax in not affected by this report. Asthma and Psoriasis are requested to be added in other relevant history. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received on 29-SEP-2021 included updated Reaction/event asreported by primary source, lab data added, updated Reporter''s comments and updated Narrative.; Sender''s Comments: This case concerns a 46-year-old, female patient with relevant medical history of asthma, who experienced the serious unexpected event of Hyperpyrexia, non-serious unexpected event of dyspnoea and non-serious expected event of myalgia. The events occurred the same day after the first dose of Spikevax. The rechallenge was not applicable since only information about one dose was disclosed. The medical history of asthma remains a confounder. The event Myalgia is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax in not affected by this report. Asthma and Psoriasis are requested to be added in other relevant history.


VAERS ID: 1757814 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       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? 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: Oestrone
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: ; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-788670) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of TACHYCARDIA in a 19-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Oestrone. On 13-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Sep-2021, the patient experienced TACHYCARDIA (seriousness criterion medically significant). On 14-Sep-2021, TACHYCARDIA had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by reporter. Treatment information was not provided Patient was suspected TPSV Tachycardia the day after the administration of modern a vaccine. Patient was admitted to the emergency room, symptoms in remission . Company comment:: This case concerns a 19 year old female patient with no relevant medical history, who experienced the unexpected event of tachycardia. The event occurred approximately1 day after the first dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received on 29-Sep-2021 as live follow up and updated with event verbatim and Reporter''s comments; Sender''s Comments: This case concerns a 19 year old female patient with no relevant medical history, who experienced the unexpected event of tachycardia. The event occurred approximately1 day after the first dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1758290 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: Cardiac troponin T; Result Unstructured Data: 352 nanogram per litre
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: PERIMYOCARDITIS; This case was received via Regulatory Authority (Reference number: E2B_00051163) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (PERIMYOCARDITIS) in a 22-year-old male patient who received mRNA-1273 for COVID-19 vaccination. Previously administered products included for Vaccination: mRNA-1273 (Substance / Specified Substance Name - 5''capped mRNA encoding full length SARS-CoV-2 spike protein). On 11-Sep-2021, the patient received second dose of mRNA-1273 (Intramuscular) 1 dosage form. On 14-Sep-2021, the patient experienced MYOCARDITIS (PERIMYOCARDITIS) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (PERIMYOCARDITIS) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, Troponin T: abnormal (abnormal) 352 nanogram per litre. For mRNA-1273 (Intramuscular), the reporter considered MYOCARDITIS (PERIMYOCARDITIS) to be possibly related. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: This case concerns a 22-year-old, male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event Myocarditis occurred 2 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened only after the second dose. The event was considered related to the product per the reporter''s assessment. The event of Myocarditis is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received. Translation done on reporter comment, Additional information on drug and dosage form.; Sender''s Comments: This case concerns a 22-year-old, male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event Myocarditis occurred 2 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened only after the second dose. The event was considered related to the product per the reporter''s assessment. The event of Myocarditis is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.


VAERS ID: 1758332 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Chills, Palpitations, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (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? 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: Endometriosis
Preexisting Conditions: Medical History/Concurrent Conditions: Gallbladder operation; Migraine (As a previous suspected adverse reaction of the vaccine against German measles.); Removal of wisdom teeth
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20213

Write-up: ABDOMINAL PAIN; PALPITATIONS; FEBER; CHILLS; This case was received via regulatory authority (Reference number: SE-MPA-2021-084178) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (ABDOMINAL PAIN), PALPITATIONS (PALPITATIONS), PYREXIA (FEBER) and CHILLS (CHILLS) in a 40-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Migraine (As a previous suspected adverse reaction of the vaccine against German measles.), Removal of wisdom teeth and Gallbladder operation in 2020. Concurrent medical conditions included Endometriosis. On 14-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced ABDOMINAL PAIN (ABDOMINAL PAIN) (seriousness criterion hospitalization), PALPITATIONS (PALPITATIONS) (seriousness criterion hospitalization), PYREXIA (FEBER) (seriousness criterion hospitalization) and CHILLS (CHILLS) (seriousness criterion hospitalization). At the time of the report, ABDOMINAL PAIN (ABDOMINAL PAIN), PALPITATIONS (PALPITATIONS) and CHILLS (CHILLS) was resolving and PYREXIA (FEBER) had not resolved. Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter. Company comment: This case concerns a 40-year-old, female subject with no relevant medical history reported, who experienced the unexpected events of ABDOMINAL PAIN, PALPITATIONS, PYREXIA and CHILLS. The event occurred on the same day after the second dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation document received 29-SEP-2021 has information on dose number.; Sender''s Comments: This case concerns a 40-year-old, female subject with no relevant medical history reported, who experienced the unexpected events of ABDOMINAL PAIN, PALPITATIONS, PYREXIA and CHILLS. The event occurred on the same day after the second dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1759844 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Pain in extremity
SMQs:, Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101243037

Write-up: Abortion spontaneous; Pain in extremity; This is a spontaneous report from a contactable healthcare professional via the regulatory authority. Regulatory authority report number is 624153. A 41-year-old female patient received BNT162b2 (Comirnaty reported as Comirnaty COVID-19 vaccine (BNT162b2 (mRNA)), via an unspecified route of administration on 07Sep2021 (batch/lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Sep2021, the patient experienced abortion spontaneous and pain in extremity. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1760526 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ophthalmic herpes zoster
SMQs:, Ocular infections (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to animals; Atopic dermatitis; Celiac disease; Food allergy; Pollen allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101256288

Write-up: Ophthalmic herpes zoster; This is a spontaneous report received from a contactable consumer downloaded from the WEB. The regulatory authority report number is FI-FIMEA-20214873. A 38-year-old female patient received bnt162b2 (COMIRNATY, formulation: solution for injection, lot number and expiration date were not reported), dose 2 via an unspecified route of administration on 09Sep2021 as dose 2, single for covid-19 immunisation. Medical history included food allergy, pollen allergy, allergy to animal, coeliac disease, atopic dermatitis. The patient''s concomitant medications were not reported. On 14Sep2021 the patient experienced ophthalmic herpes zoster. Patient reported that she had an itchy red rash with small blisters appeared in the right corner of the eye. The rash spread all over the right eye and cheek. The blistering rash was really sore. Dg shingles that had time to go very close to sair. With medication, the ailment was improving but caused several on, patient was on sick leave and serious inconvenience to all activities. Vision was compromised. Therapeutic measures were taken. The outcome of event was not recovered. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.


VAERS ID: 1760726 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Headache, Nausea, Paraesthesia, Rectal haemorrhage, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN; KLONOPIN; LAMICTAL; MIRTAZAPINE; NORETHINDRONE ACETATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Endometriosis; Ovarian cyst; Pineal gland cyst; Seizures
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: NEGATIVE
CDC Split Type: GBPFIZER INC202101242842

Write-up: weakness; tingling sensation; abdominal pain; Headache; Nausea; Tingling feet/hands; Rectal bleeding; Vaginal bleeding; This is a spontaneous report from a contactable consumer, received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109200856117790-R4BBQ, Safety Report Unique Identifier GB-MHRA-ADR 25969437. A 23-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration on 14Sep2021 as dose 1, single for covid-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. Medical history included pineal gland cyst from an unknown date and unknown if ongoing, seizure from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, endometriosis from an unknown date and unknown if ongoing, ovarian cyst from an unknown date and unknown if ongoing. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for dysmenorrhoea from 04Apr2020 to an unspecified stop date; clonazepam (KLONOPIN) taken for anxiety disorder from 05Jan2016 to an unspecified stop date; lamotrigine (LAMICTAL) taken for depressed mood from 03Feb2018 to an unspecified stop date; mirtazapine (MIRTAZAPINE) taken for major depression from 04Dec2020 to an unspecified stop date; norethindrone acetate (NORETHINDRONE ACETATE) taken for endometritis from 01Mar2021 to an unspecified stop date. It was reported that on an unspecified date the patient experienced weakness, tingling sensation, abdominal pain. On 14Sep2021 the patient experienced rectal bleeding, vaginal bleeding. On 17Sep2021 the patient experienced nausea, tingling feet/hands. On 18Sep2021 the patient experienced headache. The seriousness criteria of the event were medically significant. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. On an unspecified date the patient underwent lab tests and procedures which included covid-19 virus test which was resulted as no - negative covid-19 test (NEGATIVE). The outcome of the events nausea and rectal bleeding was not recovered, outcome of the events weakness, tingling sensation and abdominal pain was unknown and that of the rest of the events headache, vaginal bleeding, tingling feet/hands was recovering. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.


VAERS ID: 1761090 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-14
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Peripheral swelling, Vasculitis
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vasculitis (narrow), Arthritis (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: ATJNJFOC20211005261

Write-up: MASSIVE ARTHRALGIA OF THE LARGE JOINTS, SWELLING OVER METACARPALS; MASSIVE ARTHRALGIA OF THE LARGE JOINTS, SWELLING OVER METACARPALS; SEVERE VASCULITIS (DD) IN BOTH LOWER EXTREMITIES; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-048916) on 04-OCT-2021 and concerned a 58 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE423 expiry: UNKNOWN) 1 dosage forms, 1 total administered on 10-SEP-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-SEP-2021, the patient experienced massive arthralgia of the large joints, swelling over metacarpals and severe vasculitis (dd) in both lower extremities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from massive arthralgia of the large joints, swelling over metacarpals, massive arthralgia of the large joints, swelling over metacarpals, and severe vasculitis (dd) in both lower extremities. This report was serious (Other Medically Important Condition).


VAERS ID: 1761155 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Palpitations, Pneumonia, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), 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: AUPFIZER INC202101244430

Write-up: Pneumonia; Palpitations; Tachycardia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 627343. A 35-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration on 12Sep2021 as dose number unknown, single for COVID- 19 Immunization. Medical history and concomitant medications were not reported. It was reported that on 14Sep2021 (2 days after the vaccination) patient experienced Pneumonia, Palpitations, Tachycardia. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1761164 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-14
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101244505

Write-up: Facial paralysis; This is a spontaneous report from a contactable other healthcare professional via the Regulatory Authority. Regulatory authority report number is 627360. A 42-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Sep2021, the patient experienced facial paralysis. The outcome of the event facial paralysis was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1762472 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Circulatory collapse, Hemiplegia, Palpitations, Rash macular
SMQs:, Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; COVID-19 (in the first wave for 6 weeks)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101268658

Write-up: anaphylactic reaction; heart racing; Circulatory collapse; left-sided paralysis; red spots with itching all over as skin rash; This is a spontaneous report from a contactable consumer (patient) based on information received by regulatory authority [manufacturer control number: 88567 and 90017]. A 54-year-old non-pregnant female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Sep2021 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (in the first wave for 6 weeks) and polysorbate allergy. The patient''s concomitant medications were not reported. After the vaccination she had heart racing, circulatory collapse, and left-sided paralysis on 14Sep2021. She was admitted into the hospital. Additionally, she experienced red spots with itching all over as skin rash. She had anaphylactic shock after the first vaccination. Her physician has issued her in writing that she cannot be vaccinated. Events started on 14Sep2021. Outcome of the events was recovered with sequel. The lot number for bnt162b2 was not provided and will be requested during follow up


VAERS ID: 1762758 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Antibody test, Antinuclear antibody, Cardiolipin antibody, Computerised tomogram, Fall, Headache, Investigation, Ischaemic stroke, Magnetic resonance imaging head, NIH stroke scale, SARS-CoV-2 test, Ultrasound Doppler, Urine analysis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEELOO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Scarring; Smoker (5 cigarettes/day); Tooth fracture; Tooth pain (due to a tooth fracture on 08Sep2021)
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: Computerized tomography angiogram; Result Unstructured Data: Test Result:No constituted ischemic or hemorrhagic lesion..; Comments: ..but presence of a right proximal M1 thrombus, with repercussions on the perfusion mapping in the right superficial sylvian territory suspicion of thrombus of the left auricle (kinetic artefacts +++); Test Date: 20210915; Test Name: Anti-B2 glycoprotein 1 antibodies; Result Unstructured Data: Test Result:in progress; Test Date: 20210915; Test Name: Antinuclear antibodies; Result Unstructured Data: Test Result:in porgress; Test Date: 20210915; Test Name: Anticardiolipin antibodies; Result Unstructured Data: Test Result:in porgress; Test Date: 20210915; Test Name: Computerized tomography; Result Unstructured Data: Test Result:No bleeding, no constitution; Test Date: 20210915; Test Name: Family investigation; Result Unstructured Data: Test Result:in porgress; Test Date: 20210914; Test Name: Magnetic resonance imaging brain; Result Unstructured Data: Test Result:Right M1 thrombus responsible..; Comments: ..for slowing downstream flow and oligemia (61 ml of parenchyma); Test Date: 20210914; Test Name: Stroke Scale; Result Unstructured Data: Test Result:0; Test Date: 20210915; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210915; Test Name: Doppler ultrasound; Result Unstructured Data: Test Result:supra-aortic trunks satisfactory; Test Date: 20210915; Test Name: tTanscranial doppler; Result Unstructured Data: Test Result:Satisfactory flow at the level of the middle..; Comments: ..cerebral arteries M1 and M2; Test Date: 20210915; Test Name: Urinalysis; Result Unstructured Data: Test Result:testing for urinary toxic substances: negative for; Comments: testing for urinary toxic substances: negative for cocaine, amphetamine, opiates and cannabis
CDC Split Type: FRPFIZER INC202101256307

Write-up: Ischemic stroke; Slight fall on the isolated bar; Temporal headaches; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB. The regulatory authority report number is FR-AFSSAPS-PO20214915. A 16-year-old female patient received BNT162B2 (COMIRNATY; solution for injection; lot number was not reported), intramuscularly administered in the arm (unspecified which side) on 09Sep2021 (at the age of 16-years-old) as dose 1, 0.3 ml single for COVID-19 immunization. Medical history included smoker (5 cigarettes/day), traces of scarring, dental pain due to a tooth fracture on 08Sep2021. Concomitant medication included ethinylestradiol, levonorgestrel (LEELOO). The patient previously took amoxicillin and experienced cutaneous intolerance. On 14Sep2021 07:00, upon wakening, the patient experienced sudden left-side body deficit without facial involvement. The patient hospitalized in the emergency department. The patient had no recent infection, no trauma, no cervical manipulation, just dental pain due to a tooth fracture on 08Sep2021. On an unspecified date, the patient reported having had right temporal headaches, pulsatile within minutes after the first symptoms. Numerical scale: 4/10, no other symptoms, Stroke scale: 0, during the transfer to imaging, recovery of the deficit of the left hand. Computerized tomography angiogram at 10:58, no constituted ischemic or hemorrhagic lesion but presence of a right proximal M1 thrombus, with repercussions on the perfusion mapping in the right superficial sylvian territory suspicion of thrombus of the left auricle (kinetic artefacts +++). Magnetic resonance imaging of the brain at 11:26: right M1 thrombus responsible for slowing downstream flow and oligemia (61 ml of parenchyma). Intravenous thrombolysis performed at 11:55. At 12:10, on the examination, the patient had slight fall on the isolated bar. Additional examinations on 15Sep2021 included testing for urinary toxic substances: negative for cocaine, amphetamine, opiates, and cannabis. Anticardiolipin antibodies (in progress), antinuclear antibodies (in progress), anti-B2 glycoprotein 1 antibodies (in progress), family investigation (in progress). COVID polymerase chain reaction test negative. Doppler ultrasound of the supra-aortic trunks satisfactory. Transcranial Doppler ultrasound: satisfactory flow at the level of the middle cerebral arteries M1 and M2. Computerized tomography follow-up: no bleeding, no constitution. The patient was diagnosed with ischemic stroke. The patient was doing well as of 15Sep2021. The outcome of event ischemic stroke was recovering while the outcome of the remaining events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1762836 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-09-14
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood test, Chest pain, Dyspnoea, Electrocardiogram, Headache
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? 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: Test Name: Blood test; Result Unstructured Data: Test Result:UNKNOWN results; Comments: UNKNOWN results; Test Name: ECG; Result Unstructured Data: Test Result:UNKNOWN results; Comments: UNKNOWN results
CDC Split Type: GBPFIZER INC202101242826

Write-up: chest pain; shortness of breath; headache; feeling weak; Breath shortness; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109202147315760-HUTRS. Safety Report Unique Identifier GB-MHRA-ADR 25971619. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF3319), via an unspecified route of administration on 14Aug2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patients concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown), via unspecified route on an unspecified date as single dose for COVID-19 immunization. The patient had experienced chest pain, shortness of breath, headache on an unspecified date and breath shortness on 14Sep2021. Therapeutic measures were taken as a result of shortness of breath, headache, breath shortness. The events seriousness was assessed as hospitalization, medically significant. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. A month after receiving the second dose patient develop a severe headache, shortness of breath and chest pain after exercising, feeling week, had to attend AE and was admitted overnight. The patient underwent lab tests and procedures which included Blood test: unknown results on an unspecified date unknown result, ECG (Electrocardiogram): unknown result on an unspecified date unknown result. The outcome of the events chest pain, shortness of breath, headache and feeling weak was unknown and breath shortness was not recovered. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1762838 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210920; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101243136

Write-up: swollen armpit; Swollen lymph nodes; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109202231535710-ZBFMH, Safety Report Unique Identifier GB-MHRA-ADR 25971988. A 24-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Lot Number: unknown) via an unspecified route of administration on 09Sep2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since had the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, the patient experienced swollen armpit and swollen lymph nodes on 14Sep2021. The case classified as serious (medically significant). The clinical course was reported as swollen armpit, feels painful. Left breast more tender. She now had a moveable large lump on her collar bone. She was presume this was a lymph node. On 20Sep2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative (no-negative COVID-19 test). The outcome of the event swollen armpit was unknown and event swollen lymph nodes was not recovered. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained


VAERS ID: 1762932 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Chest X-ray normal, Chest pain, Dizziness, Dyspnoea, Myalgia, SARS-CoV-2 test, Syncope, Thrombosis, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clot blood (run in her family); DVT (in my entire family); Heart disorder (run in her family); Prolapsed mitral valve (with mild regurgitation); Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: Blood Test; Result Unstructured Data: Test Result:came back clear; Comments: came back clear; Test Date: 20210920; Test Name: Chest x-ray; Result Unstructured Data: Test Result:Normal; Comments: Normal; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: no, negative COVID-19 test; Test Name: X-ray; Result Unstructured Data: Test Result:X-ray came back clear; Comments: X-ray came back clear
CDC Split Type: GBPFIZER INC202101252660

Write-up: Heart condition and blood clots; Increased shortness of breath; Chest pain; Myalgia; Chest X-ray normal; Dizziness; Fainting; Shortness of breath; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109211637269620-XPLQB. Safety Report Unique Identifier GB-MHRA-ADR 25975757. A 27-years-old non pregnant female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was unknown), via an unspecified route of administration on 10Sep2021 as dose 1, single for COVID-19 immunisation. Medical history included mitral valve prolapse with mild regurgitation, deep vein thrombosis in my entire family, suspected COVID-19 (unsure when symptoms started, unsure when symptoms stopped). Have a prolapsed mitral valve with mild regurgitation, also a history of DVT in her entire family, both of which she informed the lady giving her the vaccine and joked that it would kill her and she laughed and said she will be fine. She did point out to the lady that issued the vaccine she has a heart condition and blood clots run in her family and was assured it would not kill her and she would be fine. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced heart condition and blood clots on unspecified date, shortness of breath on 14Sep2021, increased shortness of breath on 20Sep2021, chest pain on 20Sep2021, myalgia on 20Sep2021, chest x-ray normal on 20Sep2021, dizziness on 20Sep2021, fainting on 20Sep2021. Hospital bloods and X-ray came back clear. Heart still under investigation. The patient''s hospitalization was prolonged as a result of events. All events contain seriousness criteria hospitalization, medically significant. Awaiting call from DR for any relevant investigations or tests conducted. The patient underwent lab tests and procedures which included blood test: came back clear, chest x-ray: normal on 20Sep2021, sars-cov-2 test: negative (no, negative COVID-19 test), x-ray: x-ray came back clear. The outcome of the event heart condition and blood clots was recovering, and the other events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1763069 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF222 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inflammation, Parosmia, SARS-CoV-2 test
SMQs:, Taste and smell disorders (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210620; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101287176

Write-up: inflammation; Parosmia; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority. Regulatory authority report number (GB-MHRA-WEBCOVID-202109281724352480-I9EZM). Safety Report Unique Identifier (GB-MHRA-ADR 26005931). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 13Sep2021 (Lot Number: FF222) as single dose for covid-19 immunization. The patient medical history was not reported. The patient was fit and healthy before this. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Jun2021 (Batch/Lot Number: unknown) at single dose for covid-19 immunization with events lost of smell and loss of taste. The patient experienced inflammation on an unspecified date, parosmia on 14Sep2021. Events were considered as serious (hospitalization, disability, medically significant, life threatening). The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on 15Sep2021. The outcome of inflammation was recovering. The outcome of parosmia was not recovered. Clinical details: I had the first Pfizer jab on the 17th of June 21, on the 20th I tested positive for coronavirus. I lost my smell and taste for 3 days between the 22nd-25th June 21. My taste came back but my smell has been slightly dulled ever since. I got my second vaccination on the 13th September 21. The next morning food tasted and smelt REPULSIVE. It still does and I am concerned I cannot get the right nutrients. The doctors confirmed I have Parosmia from the inflammation from the vaccine. I also suffered from a 2 week long period. SURELY if I have natural immunity and 1 vaccine this should be enough. SURELY you follow France and Spain in this movement! No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1763294 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005689 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bone pain, Hyperpyrexia, Maternal exposure during pregnancy, Myalgia, Nausea, Pyrexia, Vertigo, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), Osteonecrosis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via European Medicines Agency (Reference number: IT-MINISAL02-788225) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of VERTIGO nausea, in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005689) for SARS-CoV-2 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Pregnancy. On 14-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 14-Sep-2021, the patient experienced VERTIGO . On 14-Sep-2021, MATERNAL EXPOSURE DURING PREGNANCY HYPERPYREXIA The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant information was reported. No treatment information was reported. This case concerns a 36-year-old, female patient with no relevant medical history, who experienced the unexpected events of vaccine exposure during pregnancy and serious events of vertigo, nausea, vomiting, pyrexia, hyperpyrexia , myalgia and bone pain. The patient received a dose of vaccine at 5 days of gestation. events occurred approximately 1 day after a dose of Spikevax (SD doesn?t clarify if it was 1st or 2nd). Rechallenge is UNK (no information regarding other dose was provided) The benefit-risk relationship of Spikevax in not affected by this report. Events were assessed as serious (Criteria MS) as per Regulatory Authority reporting, however there was no information in the source document supporting that the events were serious. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Followup received on 28-SEP-2021, Added pregnancy status. additional events of bone pain, Head revolving around, maternal exposure during pregnancy, updated patient route of administration and suspect indication as per follow-up. On 30-Sep-2021: follow-up appended new event as Hyperpyrexia added.; Sender''s Comments: This case concerns a 36-year-old, female patient with no relevant medical history, who experienced the unexpected events of vaccine exposure during pregnancy and serious events of vertigo, nausea, vomiting, pyrexia, hyperpyrexia , myalgia and bone pain. The patient received a dose of vaccine at 5 days of gestation. events occurred approximately 1 day after a dose of Spikevax (SD doesn?t clarify if it was 1st or 2nd). Rechallenge is UNK (no information regarding other dose was provided) The benefit-risk relationship of Spikevax in not affected by this report. Events were assessed as serious (Criteria MS) as per Regulatory Authority reporting, however there was no information in the source document supporting that the events were serious.


VAERS ID: 1763323 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-14
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3739 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure abnormal, Blood pressure systolic, Headache, Vertigo
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (broad), Vestibular 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: Endometriosis (operated in 2017 with intestinal resection and persistence of diaphragmatic endometriosis); Hashimoto''s thyroiditis
Preexisting Conditions: Medical History/Concurrent Conditions: Pollen allergy (poplar)
Allergies:
Diagnostic Lab Data: Test Name: systolic pressure; Result Unstructured Data: Test Result:90 mmHg; Test Name: systolic pressure; Result Unstructured Data: Test Result:160 mmHg
CDC Split Type: ITPFIZER INC202101246309

Write-up: pressure changes, the maximum sometimes 90 sometimes 160 measured in time cycles throughout the day; Persistent vertigo; strange headache; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-788431. A 39-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, (Batch/Lot Number: FG3739)), intramuscular on an unspecified date as dose number unknown, single (1DF) for COVID-19 immunisation. The patient''s medical history included ongoing Hashimoto''s thyroiditis, pollen allergy from unknown date to unknown if ongoing, endometriosis from 2017 to 2017 (operated in 2017 with intestinal resection and persistence of diaphragmatic endometriosis). The patient''s concomitant medications were not reported. On 14Sep2021, the patient experienced persistent vertigo, strange headache, pressure changes, the maximum sometimes 90 sometimes 160 measured in time cycles throughout the day. The outcome of the events was reported as unknown. Reporter''s comment: Allergy to poplar pollen, severe endometriosis (operated in 2017 with intestinal resection and persistence of diaphragmatic endometriosis) thyroiditis of h. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Allergy to poplar pollen, severe endometriosis (operated in 2017 with intestinal resection and persistence of diaphragmatic endometriosis) thyroiditis of h.


VAERS ID: 1763355 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Feeling hot, Hypersensitivity, Oral discomfort, Paraesthesia, Rash, Thrombosis, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACETAMOL; IBUPROFEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101250580

Write-up: Allergic reaction; Burning effect in the body; Thrombosis left leg; Burning rash in the mouth; Tingling feet; Hives; Burning in the mouth; This is a spontaneous report from a contactable other healthcare professional downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB regulatory authority number IT-MINISAL02-788679. A 35-years-old female patient received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: FG7387, Expiry date: 30Nov2021), via intramuscular route in right arm (shoulder) on 12Sep2021 at 09:40 as dose 1, single for covid-19 immunization. The patient''s medical history was not provided. Concomitant medication included paracetamol and ibuprofen. On 14Sep2021, patient experienced burning effect in the body plus allergic reaction with burning rash in the mouth and hives, thrombosis left leg and tingling feet. She was making a second report because everything in the first phase began 12 hours after vaccination, followed by the attending physician who without positive outcome sent me to the emergency room. Therapeutic measure was reported as yes. The outcome of the events was reported as not recovered.; Reporter''s Comments: Thrombosis left leg. Tingling feet. Burning effect in the body plus allergic reaction with burning rash in the mouth and hives. I am making a second report because everything in the first phase began 12 hours after vaccination, followed by the attending physician who without positive outcome sent me to the emergency room.; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-202101273799 same patient/ reporter, different events


VAERS ID: 1763421 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2018 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Anaphylactic reaction, Body temperature, Dysphoria, Erythema, Oxygen saturation, Vital signs measurement
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy (Penicillin allergy (mild in severity, childhood))
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination.; Test Date: 20210914; Test Name: Spo2; Result Unstructured Data: Test Result:There was no big changes; Test Date: 20210914; Test Name: vital; Result Unstructured Data: Test Result:There was no big changes
CDC Split Type: JPPFIZER INC202101236563

Write-up: Anaphylaxis; II-10 consciousness disturbed; dysphoria; Redness of upper body; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21127389. The patient was a 46-year-old female.(age at second dose of vaccination). Body temperature before vaccination was 36.7 degrees Centigrade on 14Sep2021. The patient had no family history. There were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) as follows: Penicillin allergy (mild in severity, childhood). On 14Sep2021 at 15:40(the day of vaccination), the patient received the second dose of bnt162b2(COMIRNATY, Solution for injection, Lot number FF2018, Expiration date 31Dec2021).via an unspecified route of administration as a single dose for COVID-19 immunization. On 14Sep2021 at 16:10(30 minutes after the vaccination), the patient experienced Anaphylaxis. On 14Sep2021 (the day of vaccination), the patient was admitted to the hospital and discharged on 16Sep2021. On 17Sep2021 (3days after the vaccination), the outcome of the event was recovering. The course of the event was as follows: "30 minutes after vaccination, the patient experienced dysphoria. Immediately after, the patient experienced II-10 consciousness disturbed. Redness of upper body occurred. There was no big change in SPO2 and vital signs. The symptoms were considered as initial symptoms of anaphylaxis. O2 was administered. Fluid replacement and intramuscular injection of adrenaline 0.3 ml were given. The patient requested ambulance transport and was transferred to Medical Center." The outcome of the events dysphoria, II-10 consciousness disturbed and Redness of upper body was recovering. The reporting physician classified the event as serious(caused hospitalization from 14Sep2021 to 16Sep2021) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: There was no big change in vital signs. The event was obviously different from vasovagal reflex.


VAERS ID: 1763458 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Body temperature, Cough, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: degrees
CDC Split Type: JPPFIZER INC202101244744

Write-up: dyspnoea; Asthmatic attack; cough; This is a spontaneous report from a contactable physician. This is the first of two reports. The first report is a report from the Regulatory Authority. Regulatory authority report number is v21127420. A 43-year and 0-month-old female patient received bnt162b2 (COMIRNATY, solution for injection), via unspecified route of administration on 14Sep2021 16:15 (batch/lot number FF3620 and expiry date 30Nov2021) at 43 years of age as dose 2, single for covid-19 immunisation. The patient''s body temperature before vaccination was 37.0 degrees centigrade. Medical history included asthma. There were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status): the patient had asthma before. The patient''s concomitant medications were not reported. The patient previously took dose 1 of COMIRNATY on 24Aug2021 (batch/lot number unknown) for COVID-19 immunisation and experienced dyspnoea, headache, asthmatic attack. On 14Sep2021 16:20, the patient experienced cough. On 14Sep2021 17:00 (the day of the vaccination), the patient experienced dyspnoea, asthmatic attack. The course of the event was as follows: On 14Sep2021 at 16:15, the patient received Comirnaty (Pfizer) vaccine, after 5 minutes the patient experienced cough after that appeared dyspnoea and had an emergency consultation. From 18:00, the patient was given nebulizer, and from 18:50 was given Decadron for IV drip, symptoms were recovering, at 20:40 the patient went back home. On 14Sep2021 (the day of the vaccination), the outcome of the events was recovering. The reporting physician classified the events as serious and assessed that the event was related to bnt162b2 There was no other possible cause of the event such as any other diseases. The reporter commented as follows: On 24Aug2021, after the first vaccination, the patient experienced asthmatic attack, too. It occurred after the second vaccination, so it was considered that asthma occurred by vaccination. It did not cause big problem.; Reporter''s Comments: On 24Aug2021, after the first vaccination, the patient experienced asthmatic attack, too. It occurred after the second vaccination, so it was considered that asthma occurred by vaccination. It did not cause big problem.


VAERS ID: 1763813 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Arthralgia, Fatigue, Headache, Myalgia, Pain, Pyrexia, Uterine pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101239829

Write-up: Joint pain; Uterine pain; Pan in the abdomen; Headache; MUSCLE PAIN; Fatigue; Fever; BODY PAIN; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB SE-MPA-2021-084587. Safety Report Unique Identifier SE-VISMA-1631703951834. A 33-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 13Sep2021 as DOSE 2, SINGLE for covid-19 immunisation . The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously took the first dose bnt162b2 on 02Aug2021 for covid-19 immunization and experienced Uterine pain, Pain menstrual, Abdominal pain. The patient experienced joint pain, uterine pain, pan in the abdomen, headache , muscle pain , fatigue , fever, body pain on 14Sep2021, 12 hours after the vaccination. The woman was bedridden all day. Seriousness criteria reported as disability. The outcome of events Uterine pain, Pain abdominal, Headache was not recovered; outcome of other events was recovering. Information on the lot/batch number has been requested.


VAERS ID: 1764146 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005294 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Body temperature, Headache, Hyperpyrexia, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 40 fever
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was initially received via the Regulatory Authority Reference number: IT-MINISAL02-789079) on 27-Sep-2021. The most recent information was received on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERPYREXIA, ASTHENIA, ARTHRALGIA, NAUSEA and HEADACHE in a 49-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 immunisation. No Medical History information was reported. On 14-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 14-Sep-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant), ASTHENIA (seriousness criterion medically significant), ARTHRALGIA (seriousness criterion medically significant), NAUSEA (seriousness criterion medically significant) and HEADACHE (seriousness criterion medically significant). At the time of the report, HYPERPYREXIA, ASTHENIA, ARTHRALGIA, NAUSEA and HEADACHE had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 40 (High) 40 fever. No concomitant or treatment medications were reported. Patient experienced post-vaccine symptoms: fever of 40, joint pain, weakness, nausea, swollen limbs and severe headache for about 4 days. Company Comment - This case concerns 49-year-old female patient with no relevant medical history, who experienced the unexpected serious events of hyperpyrexia, asthenia, arthralgia, nausea and headache. The events occurred approximately on the same day after the first dose of Spikevax. The rechallenge was unknown since there is no information about the second dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Sender''s comment and lab test updated, seriousness upgraded. On 28-Sep-2021: FU received on 30-SEP-2021 includes no new information; Sender''s Comments: This case concerns 49-year-old female patient with no relevant medical history, who experienced the unexpected serious events of hyperpyrexia, asthenia, arthralgia, nausea and headache. The events occurred approximately on the same day after the first dose of Spikevax. The rechallenge was unknown since there is no information about the second dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1764164 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005835 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blepharospasm, Headache
SMQs:, Dystonia (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Headache
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: SE-MPA-2021-084931) on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BLEPHAROSPASM and HEADACHE in a 37-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005835) for COVID-19 vaccination. Concurrent medical conditions included Headache since 2015. On 14-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced HEADACHE (seriousness criterion disability). On 15-Sep-2021, the patient experienced BLEPHAROSPASM (seriousness criterion disability). At the time of the report, BLEPHAROSPASM and HEADACHE had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant informations were reported. No Treatment informations were reported. Company Comment: This case concerns a 37 year old female with a history of headaches who experienced the serious, unlisted events of Blepharospasm and Headache two days after the first dose of Spikevax. Re-challenge is not applicable as this was the first dose. The history of headaches remains a confounder for th eevent headaches as the patient would be more likely to have headaches. Benefit-risk relationship of Spikevax is not affected by this report. The events are assessed as serious by the RA; however, there is no information in the source documents to support the events being disabling. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Translation Received on 30-Sep-2021 contains dose number.; Sender''s Comments: This case concerns a 37 year old female with a history of headaches who experienced the serious, unlisted events of Blepharospasm and Headache two days after the first dose of Spikevax. Re-challenge is not applicable as this was the first dose. The history of headaches remains a confounder for th eevent headaches as the patient would be more likely to have headaches. Benefit-risk relationship of Spikevax is not affected by this report. The events are assessed as serious by the RA; however, there is no information in the source documents to support the events being disabling.


VAERS ID: 1764491 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Epistaxis, Nasopharyngitis, Pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101253082

Write-up: nose bleed/ 4-5 nose bleeds a day; chills; cold; achy feeling; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 54-years-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Sep2021 as dose 2, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. One day following vaccination on 14Sep2021, the patient had experienced chills, cold, achy feeling, but was fine. The next day on 15Sep2021 afternoon, the patient had got a nosebleed which was hemorrhaging for 30 minutes before that had stopped. Since then, she had been getting 4-5 nose bleeds a day. So, the patient had gone to the hospital on that night, and the doctors had not found anything, except one doctor had told that they didn''t think it was a side effect of the vaccine. The patient then had a talk with another doctor and he said that may have been vaccine. The patient was due to have a test to check platelets. The outcome of the events was unknown at the time of report. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1766221 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis, Haemorrhage, Heavy menstrual bleeding, Pyrexia, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MEDROXYPROGESTERONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101252567

Write-up: bleeding; Heavy periods/period was extremely heavy and has lasted longer than usual; Nose bleeds; Fever; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109211645110350-LYZC7, Safety Report Unique Identifier GB-MHRA-ADR 25975773. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Sep2021 (Batch/Lot number was not reported), at the age of 26-years-old, as dose 2, single for COVID-19 immunisation. The historical vaccine included BNT162B2. Medical history included contraception from an unknown date and unknown if ongoing. Unsure if patient is enrolled in clinical trial. Concomitant medication included medroxyprogesterone taken for contraception from 14Sep2021 to an unspecified stop date. The patient previously received the dose 1 of BNT162B2 on an unspecified date (batch/lot number was not reported) for COVID-19 immunisation. The patient experienced bleeding on an unspecified date with outcome of recovered on unspecified date, heavy periods/ period was extremely heavy and has lasted longer than usual on 16Sep2021 with outcome of recovering, nose bleeds on 15Sep2021 with outcome of recovered on 19Sep2021, fever on 14Sep2021 with outcome of recovered in Sep2021. The patient underwent lab tests and procedures which Covid-19 virus test: No - Negative COVID-19 test, on unspecified date. The clinical course was reported as follows: My period was extremely heavy and has lasted longer than usual, and I thought this was due to my new contraception, however my sister just had the same vaccine (also second dose) and is now having the veaieat period of her life too. I was bleeding more in several hours than I usually do in a day. I usually bleed for 4 days and have now been bleeding for 6 days, but it is finally lightening up. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1766475 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Chest X-ray, Chest pain, Pulmonary embolism, Spinal X-ray
SMQs:, Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: X-ray of cervical spine; Result Unstructured Data: Test Result:The profile of the hemidiaphragms with free costop; Comments: The profile of the hemidiaphragms with free costophrenic sinuses is clear; Back of the neck in axis. The physiological lordosis has been rectified. Vertebral bodies of regular height and morphology. Not fractures. Disc thicknesses preserved. In the trans-oral projection for the axis of the axis, odontogenic process in axis, the atlanto-axial spaces are symmetrical; Test Date: 20210916; Test Name: CT angiography; Result Unstructured Data: Test Result:examination carried out after administration of co; Comments: examination carried out after administration of contrast medium intravenously, in the clinical suspicion of pulmonary embolism. In relation to the question of a filling defect in the lumen of some segmental branches for the lower right lobe. No foci parenchymal lesions are evident. No pleural effusion; Test Date: 20210916; Test Name: CXR; Result Unstructured Data: Test Result:Pectus Excavatum. Normally expanded lung fields. N; Comments: Pectus Excavatum. Normally expanded lung fields. No active foci parenchymal lesions. Vascular illi. Heart and great vessels within limits
CDC Split Type: ITPFIZER INC202101263056

Write-up: pulmonary embolism; retrosternal pain; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-789186. A 38-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), via intramuscularly on 11Sep2021 as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 14Sep2021, the patient experienced pulmonary embolism and retrosternal pain. On 16Sep2021, the patient was hospitalized for pulmonary embolism and retrosternal pain (chest pain) Angiogram was carried out after administration of contrast medium intravenously, in the clinical suspicion of pulmonary embolism. In relation to the question of a filling defect in the lumen of some segmental branches for the lower right lobe. No foci parenchymal lesions are evident. No pleural effusion. Chest x-ray: pectus excavatum. Normally expanded lung fields. No active foci parenchymal lesions, Vascular illi, Heart and great vessels within limits. Spinal x-ray: the profile of the hemidiaphragms with free costophrenic sinuses is clear; Back of the neck in axis. The physiological lordosis has been rectified. Vertebral bodies of regular height and morphology. Not fractures. Disc thicknesses preserved. In the trans-oral projection for the axis of the axis, odontogenic process in axis, the atlanto-axial spaces are symmetrical. On 20Sep2021, Regulatory Authority follow up information: "Access to the Emergency Room for retrosternal pain, Performed CT angiography of the pulmonary circulation showing Pulmonary embolism of the subsegmentary branches for the lower right lobe. Diagnosis: Pulmonary embolism, hospitalization from Emergency Room to cardiology on 16Sep2021". The events were reported as serious (seriousness criteria: hospitalization, medically significant). The outcome of the events was unknown. Reporter Comment: pulmonary embolism second dose PFIZER on last 11Sep. No follow-up attempts possible. No further information expected. Information on lot/batch numbers and expiry date cannot be obtained.; Reporter''s Comments: pulmonary embolism second dose PFIZER on last 11Sep


VAERS ID: 1766480 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Retinal artery occlusion
SMQs:, Embolic and thrombotic events, arterial (narrow), Retinal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101263096

Write-up: central retinal artery occlusion OD (right eye); This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-789237. A 59-years-old male patient second dose of received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: FF2834), via an unspecified route of administration on 12Sep2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Sep2021, the patient experienced central retinal artery occlusion OD (right eye) (hospitalization). The patient was treated with clexane, bentelan, and trental. The outcome was not recovered for the event. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1766629 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-09-14
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8838 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Echocardiogram, Heart rate, Pericardial effusion, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis (attributed to the second dose of the vaccine for the dose I received)
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: echocardiogram; Result Unstructured Data: Test Result:Global and segmental mobility preserved.; Comments: Left ventricular ejection fraction 64% by TEICH and 57%. Pseudonormalized diastolic function. Anterior and posterior pericardial hyperrefringence. Mild pericardial effusion 3 mm. No masses, thrombi or vegetations.; Test Name: heart rate; Result Unstructured Data: Test Result:68 Bpm
CDC Split Type: MXPFIZER INC202101280860

Write-up: pericarditis with mild pericardial effusion 3 mm; pericarditis with mild pericardial effusion 3 mm; This is a spontaneous report from a contactable consumer or other non hcp (patient herself) received via email. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF8838, Expiry date: Unknown) via an unspecified route of administration on 24Aug2021 as dose 2, single for COVID-19 immunization. The patient previously received first dose of BNT162B2 on 30Jul2021 for COVID-19 immunization. During first dose patient experienced Swelling, Erythema, Feeling hot, pruritus. Medical history included allergic reaction was attributed to the second dose of the vaccine for the dose patient received on an unspecified date and unknown if ongoing. The patient''s concomitant medications were not reported. On 14Sep2021, 21 days later, the patient experienced pericarditis with mild pericardial effusion 3 mm. The patient was hospitalized for pericarditis with mild pericardial effusion 3 mm for 5 days. The patient underwent lab tests and procedures which included echocardiogram on 15Sep2021 Global and segmental mobility preserved. Left ventricular ejection fraction 64% by TEICH and 57%. Pseudonormalized diastolic function. Anterior and posterior pericardial hyperrefringence. Mild pericardial effusion 3 mm. No masses, thrombi or vegetations. A transthoracic echocardiogram was performed, with sonoscape s2 equipment, in two-dimensional mode, color Doppler, pulsed Doppler and continuous Doppler, in sinus rhythm, with HR of 68 bpm, demonstrating the following. Situs solitus, normal atrio-ventricular and ventriculo arterial connections. Left ventricle with preserved global and segmental mobility, not dilated, with preserved systolic thickening, preserved ejection fraction of 64 percent by Teich, 57 percent by Simpson. 56 mL end diastolic volume, 20 mL end diastolic volume, 35 mL stroke volume, 3.1 L per min cardiac output, 23 mL per m2 stroke index, 1.8 L per min per m2 carciated index. Right ventricle with preserved global and segmental mobility, not dilated, tricuspid s wave 0.18 m per s, RV end-systolic diameter 11 mm, RV end systolic diameter 7 mm, RV end diastolic volume 6 mL, RV end systolic volume 2 mL, ADF 36 percent, FEVD 66 percnet, TAPSE 20 mm. Right atrium not dilated, with adequately opening of the vena cavae, measuring 36x28 mm, AD area 8 cm2, volume 20 cm3, without thrombi inside. Left atrium not dilated, 42x25 mm, adequate connection with pulmonary veins, Area Al of 8 cm2, volume of 17 cm3. No thrombi inside. Aortic valve: trivalve, non-calcified annulus, adequate valve opening, without valve thickening, with complete central closure, without color Doppler aortic regurgitation. Aortic valve with maximum velocity of 1.89 m per s, generates maximum gradient of 2.64 mmHg, mean gradient of 1.35 mmHg, aortic valve area of 2.72 cm2. 23 mm aortic root, 19 mm LVOT. Mitral valve with adequate opening movement, non-dilated, non-calcified mitral annulus, adequate movements of the papillary muscles. Maximum gradient of 2.3 mmHg is estimated, mean gradient of 1.2 mmHg, mitral valve area of 3.8 cm2, E 0.22 m per s, A 0.12 m per s, E/A ratio of 1.81, isovolumic relaxation time of 90 ms, with dysfunction Pseudonormalized diastolic, mitral regurgitation is not observed by color Doppler. Pulmonary valve no color Doppler insufficiency. Pulmonary valve with maximum velocity of 0.43 m per s, pulmonary acceleration time of 150 ms, maximum Gte of 0.72 mmHg. Tricuspid valve well implanted, adequate closure opening is observed, by color Doppler without evidence of tricuspid regurgitation. Pulmonary artery not dilated, without internal thrombi, adequate echogeneity, 15 mm pulmonary artery trunk, 12 mm right branch and 10 mm left branch. Pericardium anterior and posterior hyperrefringence, data of slight anterior 3 mm pericardial effusion without data of cardiac tamponade. No masses, thrombi or vegetations are observed. The outcome of events was unknown. Follow-up is required.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-202101047956 2nd dose


VAERS ID: 1766702 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / 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: 20210914; Test Name: blood pressure; Result Unstructured Data: Test Result:180/100
CDC Split Type: PHPFIZER INC202101259352

Write-up: Elevated BP; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300105836 A 46-years-old male patient received bnt162b2, intramuscular on 14Sep2021 (Batch/Lot Number: FD0350), at the age of 46-years-old, as dose number unknown, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced elevated BP (medically significant) on 14Sep2021 at 12:01 with outcome of recovering. The patient underwent lab test which included blood pressure: 180/100 on 14Sep2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1766761 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005242 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Insomnia
SMQs:

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: SEMODERNATX, INC.MOD20213

Write-up: Insomnia; This regulatory authority case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia) in a 43-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005242) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced INSOMNIA (Insomnia) (seriousness criterion life threatening). At the time of the report, INSOMNIA (Insomnia) had not resolved. No concomitant medication was mentioned. No treatment medication was mentioned. Company Comment: This case concerns a 43-year-old, male patient with no relevant medical history, who experienced the unexpected event of Insomnia. The event Insomnia occurred the same day as the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened only after the second dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Translation document received on 30-Sep-2021 contains no new information.; Sender''s Comments: This case concerns a 43-year-old, male patient with no relevant medical history, who experienced the unexpected event of Insomnia. The event Insomnia occurred the same day as the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened only after the second dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.


VAERS ID: 1767678 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was initially received via a regulatory authority (Reference number: IT-MINISAL02-789192) on 28-Sep-2021. The most recent information was received on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERPYREXIA and LYMPHADENOPATHY in a 37-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. No Medical History information was reported. On 14-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant) and LYMPHADENOPATHY (seriousness criterion medically significant). At the time of the report, HYPERPYREXIA and LYMPHADENOPATHY had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant product use was not provided by the reporter. On 14-Sep-2021, Patient swelling in supraclavicular lymph node. On 15-Sep-2021, it was worse, both in terms of the swelling and the fact that it was painful to the touch. During the night, patient felt feverish and temperature was 40 degrees. No treatment information was provided. This case concerns a 37-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of hyperpyrexia, and lymphadenopathy. The events occurred on the same day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. 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 28-Sep-2021: Translation received on 01-Oct-2021 included event description. On 29-Sep-2021: Case upgraded to serious (other medically important condition), additional event included and outcome of the event (enlargement of lymph nodes) was updated to not recovered.; Sender''s Comments: This case concerns a 37-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of hyperpyrexia, and lymphadenopathy. The events occurred on the same day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1769464 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Fatigue, Headache, Hypertensive crisis, SARS-CoV-2 test, Tachycardia, Vertigo
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Vestibular disorders (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: KETOPROFENE ARROW
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug hypersensitivity (Skin rash following anesthesia); Hypovitaminosis (Vitamin B12-B9 deficiencies); Lymphopenia; Mixed connective tissue disease (complicated by antiphospholipid antibody syndrome responsible for miscarriages); Osteonecrosis (Bilateral osteonecrosis of the femoral heads); Pre-eclamptic toxaemia (36 weeks); Pulmonary malformation; Spontaneous abortion (7 times); Venous insufficiency (Chronic venous insufficiency)
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101261330

Write-up: Crisis hypertensive; Tachycardia; Headache; Chest tightness; Vertigo; Tired; This is a spontaneous report received from a contactable consumer downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-TO20217992. A 37-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: FF2834, at the age of 37 years) via intramuscularly, administered in left arm on 14Sep2021 as dose 1, single for COVID-19 immunisation. Medical history included pre-eclampsia (36 weeks), lymphopenia, abortion spontaneous (7 times), hypovitaminosis (Vitamin B12-B9 deficiencies), mixed connective tissue disease (complicated by antiphospholipid antibody syndrome responsible for miscarriages), Bilateral osteonecrosis of the femoral heads, peripheral venous disease, drug hypersensitivity (skin rash following anesthesia), pulmonary malformation. The patient previously had diphtheria vaccine [diphtheria vaccine toxoid] intolerance. Concomitant medication(s) included ketoprofen (KETOPROFENE ARROW). On 14Sep2021, 15 minutes after vaccination, the patient reports Arterial hypertension since post-vaccination surveillance (medically significant), tachycardia, headache, chest tightness, vertigo and tired. Requiring consultation. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 12Sep2021. Time interval between beginning of drug administration and start of all reaction / event 1 days. time interval between last dose of drug and start of all reaction / event 1 days. Outcome of the events was Not recovered/Not resolved. No follow-up attempts possible. No further information expected.


VAERS ID: 1769531 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Gait disturbance, Guillain-Barre syndrome, Lumbar puncture
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Hypoglycaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: Lumbar puncture; Result Unstructured Data: Test Result:Guillain Barre Syndrome
CDC Split Type: GBPFIZER INC202101266474

Write-up: Guillain-Barre syndrome; Gait disturbance; This is a spontaneous report from a contactable Other Healthcare Professional. This is a report received from the regulatory authority report number is GB-MHRA-ADR 25973799, Safety Report Unique Identifier GB-MHRA-ADR 25973799. A 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF3319 and Expiration Date: 31Oct2021), parenteral on 07Sep2021 as dose 2, single and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF3319 and Expiration Date: 31Oct2021), parenteral on 14Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced guillain-barre syndrome on 14Sep2021 and gait disturbance on an unspecified date in 2021. She was struggling to walk and flown. It was reported that she was improving and able to weight bear once more. All the events were medically significant. The patient was hospitalized for guillain-barre syndrome and for gait disturbance from 2021. The patient underwent lab tests and procedures which included lumbar puncture: guillain barre syndrome on 14Sep2021. The outcome of all the events was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1769621 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-09-14
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3380 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Pregnancy test; Test Result: Negative ; Comments: all negative; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101266489

Write-up: Period always 30-32 day cycle. Day 40 and still no period; Irregular periods; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109241628514970-VNQNM. Safety Report Unique Identifier GB-MHRA-ADR 25990707. A 28-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: FF3380 and Expiry date was not reported), dose 2 via an unspecified route of administration on 17Aug2021 as dose 2, single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history was not reported. Not on any medication. Patient was not enrolled in clinical trial. Concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and Expiry date was not reported), dose 1 via an unspecified route of administration on 25Jul2021 as dose 1, single dose for COVID-19 immunisation. On an unspecified date patient experienced, period always 30-32-day cycle. day 40 and still no period, on 14Sep2021 patient experienced irregular periods. Suspect reactions were pregnancy test- all negative. The patient underwent lab tests and procedures which included pregnancy test: negative, all negative, sars-cov-2 test negative no -negative COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Seriousness for the events was reported as medically significant. Outcome of the event irregular periods was not resolved, and rest of the event was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1769727 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-14
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH RE8087 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Depressed mood, Lethargy, Polymenorrhoea, SARS-CoV-2 test
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: JADELLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Irregular periods
Allergies:
Diagnostic Lab Data: Test Date: 20210902; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101266334

Write-up: lethargic; Depressed; Anxious; Periods 3 times in 5 weeks; This is a spontaneous report from a contactable consumer received from the regulatory authority report number GB-MHRA-WEBCOVID-202109251631501550-YIYFX, Safety Report Unique Identifier GB-MHRA-ADR 25996868. A 17-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 03Sep2021 (Batch/Lot Number: RE8087) at dose 1, single for COVID-19 immunization. Medical history included menstruation irregular, contraception from an unknown date. Concomitant medication included levonorgestrel (JADELLE) taken for contraception from 01Jul2021 to an unspecified stop date. Patient did not had symptoms associated with COVID-19. Patient was not pregnant; Patient was not currently breastfeeding. Patient did not test positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 14Sep2021, after receiving the vaccine the patient experienced, Periods 3 times in 5 weeks, and on unspecified date she had Depressed, anxious, lethargic. Never had feelings like this or irregular periods before. Very depressed now. The patient underwent lab tests and procedures which included COVID-19 virus test: Negative COVID-19 test on 02Sep2021. The events were serious (medically significant). The outcome of the event periods 3 times in 5 weeks was not recovered and other events were unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1769897 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Headache, Lymphadenopathy, Myocarditis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101262525

Write-up: Fever; Swollen lymph nodes in the armpit on the administration side;; Pain in the head; Pain in the chest.; Myocarditis; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Agency-WEB, regulatory authority number IT-MINISAL02-789381. A 22-year-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: FG6273) intramuscular, administered in arm left on 11Sep2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 14Sep2021, patient experienced fever, myocarditis, Swollen lymph nodes in the armpit on the administration side, pain in the head and chest. Seriousness of all the events was medically significant. It was reported that adverse events resulted in family doctor visit. Therapeutic measures were taken as a result of the adverse events which included 3-day ibuprofen intake. Impact on quality of life was reported as (4/10). The outcome of all the events was recovering. Sender Comment: Follow up of 20Sep2021: The severity status of the adverse reaction is changed to SEVERE-another clinically relevant pathology, as ''myocarditis'' is present in the IME list. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1769912 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004669 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-790322) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDITIS, CHEST PAIN and PAIN IN EXTREMITY in a 17-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004669) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 14-Sep-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant), CHEST PAIN (seriousness criterion hospitalization) and PAIN IN EXTREMITY (seriousness criterion hospitalization). At the time of the report, MYOCARDITIS, CHEST PAIN and PAIN IN EXTREMITY had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant product was not provided by the reporter. Treatment product was not provided by the reporter. Patient had taken second dose on 08-Sep-2021 after 6 days patient developed chest pain, left arm pain and vaccine induced myocarditis. Company comment: This case concerns a 17-year-old, female patient with no relevant medical history, who experienced the unexpected events of myocarditis, chest pain and pain in extremity which required hospitalization. Myocarditis is expected event for adult patients. The events occurred approximately 6 days after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Chest pain is likely the consequence of myocarditis. Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Translation document received on 01-Oct-2021, added dose information in I-narrative.; Reporter''s Comments: Hospitalized due to finding of myocarditis induced by the covid-19 vaccine; Sender''s Comments: This case concerns a 17-year-old, female patient with no relevant medical history, who experienced the unexpected events of myocarditis, chest pain and pain in extremity which required hospitalization. Myocarditis is expected event for adult patients. The events occurred approximately 6 days after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Chest pain is likely the consequence of myocarditis.


VAERS ID: 1769918 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005294 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Hyperhidrosis, Migraine, Myalgia, Nausea, Pyrexia, Seizure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Agency (Reference number: IT-MINISAL02-790356) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE, HYPERHIDROSIS, CHEST PAIN, MYALGIA, PYREXIA, NAUSEA and SEIZURE in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .3 milliliter in total. On 14-Sep-2021, the patient experienced MIGRAINE (seriousness criterion hospitalization), HYPERHIDROSIS (seriousness criterion hospitalization), CHEST PAIN (seriousness criterion hospitalization), MYALGIA (seriousness criterion hospitalization), PYREXIA (seriousness criterion hospitalization), NAUSEA (seriousness criterion hospitalization) and SEIZURE (seriousness criteria hospitalization and medically significant). At the time of the report, MIGRAINE, HYPERHIDROSIS, CHEST PAIN, MYALGIA, PYREXIA, NAUSEA and SEIZURE was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Reported patient administered dose was less than the normal recommended dosage of 0.5ml for Moderna COVID-19 vaccine. No relevant concomitant medications were reported. No treatment information was provided. Patient was experienced body temperature of 37.8?C. Company Comment: This case concerns a 27 year-old, male patient with no relevant medical history, who experienced the serious unexpected events of migraine, hyperhidrosis, chest pain, myalgia, pyrexia and nausea and the serious unexpected event of special interest of seizure. The events occurred the same day after the Spikevax vaccination, dose number not provided. The rechallenge was not applicable since dose number was not provided. Underdose was considered as an additional event. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Translation received on 04 Oct 2021 contain significant information that include I narrative updated. On 04-Oct-2021: Follow-up information included no new information . On 04-Oct-2021: Translation document received on 06 Oct 2021 and contain no new information.; Reporter''s Comments: 23/09/2021; Sender''s Comments: This case concerns a 27 year-old, male patient with no relevant medical history, who experienced the serious unexpected events of migraine, hyperhidrosis, chest pain, myalgia, pyrexia and nausea and the serious unexpected event of special interest of seizure. The events occurred the same day after the Spikevax vaccination, dose number not provided. The rechallenge was not applicable since dose number was not provided. Underdose was considered as an additional event. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1769961 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Feeling abnormal, Pallor
SMQs:, Dementia (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101266825

Write-up: Feels poorly; Pallor facial; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. The regulatory authority report number is v21127615. A 17-year and 2-month-old female patient received BNT162B2 (COMIRNATY; lot number: FE8206 and expiration date: 31Oct2021), via an unspecified route of administration in the upper left arm on 14Sep2021 at 14:59 (the day of vaccination), at the age of 17-year and 2-month-old, dose 1, single for COVID-19 immunisation. Body temperature before vaccination was 36.3 Centigrade. The patient had no medical history, and the concomitant medications were not reported. On 14Sep2021 at about 15:10 (11 minutes after the vaccination), the patient experienced feels poorly. The clinical course of the event was as follows: About 10 minutes after the patient received the vaccine in the upper arm left, the patient complained of feels poorly. The patient had pallor facial. A drip infusion of Solita-T No.1 and an intravenous injection of Primperan was performed. On The outcome of the events was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. No follow-up attempts are possible; No further information is expected.


VAERS ID: 1770182 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-09-14
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2832 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrioventricular block first degree, Pneumothorax spontaneous
SMQs:, Conduction defects (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101263176

Write-up: AV block 1; spontaneous pneumothorax; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is SE-MPA-2021-084221. A 16-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Aug2021 (Lot Number: FF2832, unknown expiration) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced AV block 1 and spontaneous pneumothorax on 14Sep2021 (32 days after the vaccination). The patient suddenly felt pain in his chest and back and then difficulty breathing during a quiet lesson at school. The patient visited the pediatric emergency department where he got diagnosed with AV block 1 and spontaneous pneumothorax, which he has never had before. The patient has not yet recovered from the events. The events were assessed as serious (other medically important event). No follow-up attempts are possible; information about batch number was already obtained.


VAERS ID: 1770288 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-09-14
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214016 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: Syncope; This case was received via regulatory authority (Reference number: ES-AEMPS-1009930) on 30-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of SYNCOPE (Syncope) in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214016) for SARS-CoV-2 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced SYNCOPE (Syncope) (seriousness criteria hospitalization and medically significant). On 17-Sep-2021, SYNCOPE (Syncope) had resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. Company comment: This case concerns an 18 year old male patient with no relevant medical history, who experienced the unexpected event of syncope. The event occurred approximately 29 days after a dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Translation Received on 02-Oct-2021 which contains no new information.; Sender''s Comments: This case concerns an 18 year old male patient with no relevant medical history, who experienced the unexpected event of syncope. The event occurred approximately 29 days after a dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1770299 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: FRMODERNATX, INC.MOD20213

Write-up: Pericarditis sicca; This case was received via the RA (Reference number: FR-AFSSAPS-TO20218092) on 30-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of PERICARDITIS (Pericarditis sicca) in a 22-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Sep-2021, the patient experienced PERICARDITIS (Pericarditis sicca) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Pericarditis sicca) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. Company comment: This case concerns a 22 year-old, female subject, with no relevant medical history, who experienced the expected, event of Pericarditis. The event occurred approximately 1 day after vaccination with the first dose of Spikevax. The rechallenge is unknown, as no information about the second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Translation document received on 04-OCT-2021 Contain updated Dosage text ( Single dose).; Sender''s Comments: This case concerns a 22 year-old, female subject, with no relevant medical history, who experienced the expected, event of Pericarditis. The event occurred approximately 1 day after vaccination with the first dose of Spikevax. The rechallenge is unknown, as no information about the second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.


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