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From the 1/21/2022 release of VAERS data:

Found 1,049,249 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 159 out of 10,493

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VAERS ID: 2023218 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Nausea, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: chills; fever; vomiting; Nausea; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26407386) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), VOMITING (vomiting) and NAUSEA (Nausea) in a 40-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 06-Sep-2021 to 16-Sep-2021. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant) and VOMITING (vomiting) (seriousness criterion medically significant). On 26-Dec-2021, NAUSEA (Nausea) had resolved. At the time of the report, CHILLS (chills), PYREXIA (fever) and VOMITING (vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by reporter. Treatment information was not provided. Patient was not tested positive for COVID-19 since having the vaccine. It was reported that the patient had dead arm around 18 hours post vaccination. Fever around 36 hours post vaccination followed by headaches and excessive vomiting and chills throughout the night. Company comment: This is a regulatory case concerning a 40 year-old, female patient with a history of COVID-19, who experienced the serious (due to medically important condition) unexpected, according Regulatory Authority, events of chills, pyrexia, vomiting and nausea. Events were assessed as serious by the Regulatory Authority. The event nausea occurred approximately 1 day after the booster dose of mRNA-1273 vaccine and the rest of the events on an unknown date. The outcome of the event nausea was reported as recovered and the rest of the events as unknown. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The medical history, of COVID-19 remain a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 40 year-old, female patient with a history of COVID-19, who experienced the serious (due to medically important condition) unexpected, according Regulatory Authority, events of chills, pyrexia, vomiting and nausea. Events were assessed as serious by the Regulatory Authority. The event nausea occurred approximately 1 day after the booster dose of mRNA-1273 vaccine and the rest of the events on an unknown date. The outcome of the event nausea was reported as recovered and the rest of the events as unknown. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The medical history, of COVID-19 remain a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023219 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Skin rash; Muscle ache; This case was received via RA (Reference number: GB-MHRA-ADR 26407340) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Skin rash) and MYALGIA (Muscle ache) in a 27-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. No Medical History information was reported. On 24-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced RASH (Skin rash) (seriousness criterion medically significant). On 29-Dec-2021, MYALGIA (Muscle ache) was resolving. At the time of the report, RASH (Skin rash) had not resolved. 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. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial.; Sender''s Comments: This case concerns a 27-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of Rash and Myalgia. The events occurred approximately 5 days after the third dose of mRNA-1273 (Modrna covid-19 vaccine). The rechallenge was not applicable as events occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 2023316 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-18
Onset:2021-12-24
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angioedema, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (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:
Allergies:
Diagnostic Lab Data: Test Date: 20211030; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Giant hives; This case was received via RA (Reference number: GB-MHRA-ADR 26410687) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Giant hives) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced ANGIOEDEMA (Giant hives) (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA (Giant hives) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient last menstrual period date 24-DEC-2021 No concomitant medication was provided by reporter. No treatment drug was provided by reporter. Patient had ongoing Hives Covering Entire body, itching, hot, very swollen. Company Comment : This RA case concerns a 36 year old female with no relevant medical history reported, who experienced Serious ( Medically significant ) unexpected event of Angioedema which occurred 7 days after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . This patient made an ER consult given steroids but the reactions has not improved or resolved. The re-challenge for this case was captured as unknown by this RA report. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender''s Comments: This RA case concerns a 36 year old female with no relevant medical history reported, who experienced Serious ( Medically significant ) unexpected event of Angioedema which occurred 7 days after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . This patient made an ER consult given steroids but the reactions has not improved or resolved. The re-challenge for this case was captured as unknown by this RA report. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.


VAERS ID: 2023325 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-12
Onset:2021-12-24
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004737 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Date: 20211219; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Itching; Itchy rash; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26411210) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and RASH PRURITIC (Itchy rash) in a 41-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004737) for an unknown indication. The patient''s past medical history included Clinical trial participant. On 12-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced RASH PRURITIC (Itchy rash) (seriousness criterion medically significant). On an unknown date, the patient experienced PRURITUS (Itching) (seriousness criterion medically significant). At the time of the report, PRURITUS (Itching) and RASH PRURITIC (Itchy rash) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported . Treatment information was provided zirtek and 30mg dose of corticosteroids. The patient experienced severe itching started during the night of the 24 Dec. In the morning, (8am), the itching had happened a bright red rash was present. Out of hours medical advice was received and two Zirtek was advised and monitor for other symptoms. During the following 6 hours there were number of flare ups of red rash and extreme body itching including in the scalp but not near the injection site. a further Zirtek and 30mg of corticosteroids was prescribed. The patient advised to continue the 30mg dose of corticosteroids for another 4 days and take 180mg of Telfast till symptoms resolve. The treatment to date has provided some symptom relief however the symptoms persist daily with acute flare ups. Symptoms remain today 29 Dec and today was the last day of corticosteroid treatment. Company Comment: This case concerns a 41-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Pruritus and Rash pruritic. The events occurred 12 days after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). Events seriousness assessed as per Regulatory Authority report and retained for consistency. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender''s Comments: This case concerns a 41-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Pruritus and Rash pruritic. The events occurred 12 days after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). Events seriousness assessed as per Regulatory Authority report and retained for consistency. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.


VAERS ID: 2023338 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:1972-01-11
Onset:2021-12-24
   Days after vaccination:18245
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005686 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Pericarditis, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA
Current Illness: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthritis)); Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211224; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID 19
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fatigue/unusual tiredness; Chest pain; Fever; Shortness of breath; Pericarditis; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26411878) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERICARDITIS (Pericarditis), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), PYREXIA (Fever) and DYSPNOEA (Shortness of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005686) for an unknown indication. Concurrent medical conditions included Suspected COVID-19 since 24-Dec-2021 and Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthritis)). Concomitant products included COVID-19 VACCINE (COVID-19 VACCINE ASTRAZENECA) and COVID-19 VACCINE (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 11-Jan-1972, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Pericarditis) was resolving and FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), PYREXIA (Fever) and DYSPNOEA (Shortness of breath) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID 19. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had shortness of breath, pain on left side of chest and shoulder when tried to breathe. Report was related to possible inflammation of heart. Asthma Inhaler was prescribed to treat her symptoms. Patient had not tested positive for COVID-19 since she had received the vaccine. Company comment: This Regulatory Authority case concerns a female patient of unknown age, with medical history of rheumatoid arthritis and suspected COVID-19, who experienced the expected, serious (Medically significant) and AESI of pericarditis, among others. The event occurred after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule, exact time to onset cannot be assessed as vaccination date was reported as 11 January 1972. The patient received as first and second dose of his COVID-19 vaccination schedule two doses AstraZeneca''s COVID-19 vaccine. It was reported that the patient tested negative for COVID-19 on the same day of vaccination. Regulatory authority captured the rechallenge as unknown. The medical history of rheumatoid arthritis and suspected COVID-19 remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This Regulatory Authority case concerns a female patient of unknown age, with medical history of rheumatoid arthritis and suspected COVID-19, who experienced the expected, serious (Medically significant) and AESI of pericarditis, among others. The event occurred after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule, exact time to onset cannot be assessed as vaccination date was reported as 11 January 1972. The patient received as first and second dose of his COVID-19 vaccination schedule two doses AstraZeneca''s COVID-19 vaccine. It was reported that the patient tested negative for COVID-19 on the same day of vaccination. Regulatory authority captured the rechallenge as unknown. The medical history of rheumatoid arthritis and suspected COVID-19 remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023356 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ageusia, Anosmia, Headache, SARS-CoV-2 test
SMQs:, Taste and smell disorders (narrow), 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 Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Loss of smell; Loss of taste; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26412878) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of smell), AGEUSIA (Loss of taste) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced ANOSMIA (Loss of smell) (seriousness criterion medically significant), AGEUSIA (Loss of taste) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) had not resolved and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication was not reported. Relevant concomitant medications were not provided by the reporter. Patient was not enrolled in clinical trial. Company Comment : This RA case concerns a female patient with unknown age, with no medical information reported, who experienced Serious , unexpected , AESI events of anosmia and ageusia which occurred one day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . This was accompanied by serious ( Medically significant ) , unexpected event of Headache which also occurred one day after vaccination with the 3rd dose. The re-challenge for this case was captured as unknown by this RA case. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report. Sender''s Comments: This RA case concerns a female patient with unknown age, with no medical information reported, who experienced Serious , unexpected , AESI events of anosmia and ageusia which occurred one day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . This was accompanied by serious ( Medically significant ) , unexpected event of Headache which also occurred one day after vaccination with the 3rd dose. The re-challenge for this case was captured as unknown by this RA case. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.


VAERS ID: 2023442 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Feeling of body temperature change, Headache, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

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

Write-up: Feeling hot and cold; Fatigue; Headache; This case was received via regulatory authority on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), FATIGUE (Fatigue) and HEADACHE (Headache) in a 25-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. No Medical History information was reported. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 25-Dec-2021, FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant Medication use information was not provided by reporter. Patient has not tested positive for COVID-19 since having the vaccine and has not had symptoms associated with COVID-19 Patient was not enrolled in clinical trial Report not related to possible inflammation of the heart (myocarditis or pericarditis Treatment Medication use information was not provided by reporter. Company comment: This regulatory authority case concerns a 25-year-old male patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of FEELING OF BODY TEMPERATURE CHANGE, FATIGUE and HEADACHE. The events occurred one day after receiving a third dose of mRNA-1273 and had resolved by the time of this report. No information about previous vaccination schedule was provided. No clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.; Sender''s Comments: This regulatory authority case concerns a 25-year-old male patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of FEELING OF BODY TEMPERATURE CHANGE, FATIGUE and HEADACHE. The events occurred one day after receiving a third dose of mRNA-1273 and had resolved by the time of this report. No information about previous vaccination schedule was provided. No clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.


VAERS ID: 2023568 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-12-24
   Days after vaccination:128
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202112; Test Name: Gene sequencing; Result Unstructured Data: Test Result:carried the Variant of Concern Omicron; Test Date: 202112; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: HKPFIZER INC202200016785

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH VARIANT OF CONCERN OMICRON; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH VARIANT OF CONCERN OMICRON; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party(BioNTech SE) and Regulatory Authority. Other Case identifier(s): HK-Fosun-2021FOS007596 (RA). This is a spontaneous report received from a non-contactable HCP received via regulatory authority, report number is not applicable. As of 0:00 am, 26-Dec-2021, DH announced that six additional confirmed cases of COVID-19 after Comirnaty vaccination. This case was split for 1 of 6 cases that confirmed COVID-19 after Comirnaty vaccination. A 57-year-old female patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 06-Jul-2021 and 18-Aug-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. On 22-Dec-2021, she arrived. On 24-Dec-2021, the patient had symptoms. In Dec-2021, the patient tested positive. She was confirmed as COVID-19. In Dec-2021,the whole genome sequencing analysis conducted by the DH''s Public Health Laboratory Services Branch confirmed that the case carried the Variant of Concern Omicron. This case was a close contact of another confirmed cases of COVID-19. The adverse event ''confirmed case of COVID-19/imported case with Variant of Concern Omicron'' was considered as Important Medical Event. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 27-Dec-2021, 30-Dec-2021 and 04-Jan-2022. This case was split from AER (master case No. 2021FOS007543) due to same reporter/product, different event/patient. Follow-up closed, no further information is possible Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101884323 same reporter/drug, different event/patient;HK-PFIZER INC-202200028626 same reporter/patient/drug, different dose/event


VAERS ID: 2023574 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-12-24
   Days after vaccination:202
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202112; Test Name: Gene sequencing; Result Unstructured Data: Test Result:carried the Variant of Concern Omicron; Test Date: 202112; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: HKPFIZER INC202200020664

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAINS OF N501Y AND T478K/CARRIED THE VARIANT OF CONCERN OMICRON; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAINS OF N501Y AND T478K/CARRIED THE VARIANT OF CONCERN OMICRON; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from Regulatory Authority. Other Case identifier(s): HK-Fosun-2021FOS007604. This is a spontaneous report received from a non-contactable HCP received via Department of Health (RA). The regulatory authority report number is not applicable. As of 0:00 am, 27-Dec-2021, RA announced that seven additional confirmed cases of COVID-19 after Comirnaty vaccination. This report was split for 1 of 7 patients that confirmed COVID-19 after Comirnaty vaccination. A 26-year-old male patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 15-May-2021 and 05-Jun-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. On 23-Dec-2021, the patient arrived via flight. On 24-Dec-2021, the patient developed symptoms. In Dec-2021, the patient tested positive. He was confirmed as COVID-19 with mutant strains of N501Y and T478K. The patient was a close contact of another imported case confirmed as COVID-19 previously. In Dec-2021, whole genome sequencing analysis conducted by the RA''s confirmed that the patient carried the Variant of Concern Omicron. The adverse event ''confirmed case of COVID-19/imported case with mutant strains of N501Y and T478K/carried the Variant of Concern Omicron'' was considered as Important Medical Event. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 28-Dec-2021 and 01-Jan-2022. This case was split from AER 2021FOS007543 due to same reporter/product, different event/patient. BNT162b2 (COMIRNATY) is under agreement with BioNTech SE. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101884323 same reporter/product, different event/patient


VAERS ID: 2025699 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-24
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient had no known allergies
Allergies:
Diagnostic Lab Data: Test Date: 20211224; Test Name: COVID-19 virus test; Result Unstructured Data: positive
CDC Split Type: CAJNJFOC20220111029

Write-up: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a 72 year old male (local case ID# EZR20210224916). Initial information was processed along with the additional information received on 10-JAN-2022. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series: 1), the patient felt awful and went to the hospital where he was tested positive for Covid-19 (Confirmed COVID-19 infection) and (Confirmed clinical vaccination Failure). On unspecified date, the patient was discharged from the hospital but he reported that he was feeling the same and has nothing left in him and if anyone comes near him with a needle it will kill him as everything hurts (Dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000210785. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20211264693 (dose number in series: 2, booster dose).; Sender''s Comments: V0: 20220111029-covid-19 vaccine ad26.cov2.s- Confirmed COVID-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20220111029-covid-19 vaccine ad26.cov2.s- Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 2025703 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Ageusia, Anosmia, Anxiety, Cardiac disorder, Chest pain, Chills, Computerised tomogram, Dyspepsia, Dysphagia, Dyspnoea, Electrocardiogram, Fatigue, Feeling cold, Haematochezia, Head discomfort, Heart rate, Heart rate increased, Heart rate irregular, Hyperhidrosis, Movement disorder, Pericarditis, Presyncope, Pyrexia, Somnolence, Tremor, Ultrasound scan, Vision blurred, X-ray
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Panic attack (He also mentioned that he had an ECG in July and that all was normal. He had an ECG because he had a panic attack.)
Allergies:
Diagnostic Lab Data: Test Date: 20211225; Test Name: CT-Scan; Result Unstructured Data: Test Result:Unknown; Test Date: 202107; Test Name: ECG; Result Unstructured Data: Test Result:normal; Comments: he had an ECG in July and that all was normal. He had an ECG because he had a panic attack. He mentioned that; Test Date: 20211225; Test Name: ECG; Result Unstructured Data: Test Result:Unknown; Comments: ECG. They checked his heart for a bout 10 hours; Test Date: 20211225; Test Name: Heart rate; Result Unstructured Data: Test Result:irregular; Comments: he also had irregular heartbeats.; Test Date: 20211225; Test Name: Ultrasound; Result Unstructured Data: Test Result:unknown; Comments: He had an Ultrasound; Test Date: 20211225; Test Name: X-ray; Result Unstructured Data: Test Result:unknown
CDC Split Type: CAPFIZER INC202101863809

Write-up: his heart was beating fast; bad chills; shaking; feeling cold and sweathing; feeling cold and sweathing; fever; pressure in head; lost of taste and smell; lost of taste and smell; fatigue (slept the whole day); experiencing serious heart issues; slept the whole day; heart and stomach cramps; he felt like he was having a heart attack, went to the bathroom and almost fainted; he also had irregular heartbeats; pericarditis; had blood in his stool; he felt like he was having a heart attack, went to the bathroom and almost fainted; he could not control his movement; blurry vision; his heart was burning; heart and stomach cramps; had a hard time to swallow; He had trouble breathing and still have trouble breathing.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 19 year-old male patient received bnt162b2 (COMIRNATY), administration date 22Dec2021 (Batch/Lot number: unknown) at the age of 19 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "panic attack", start date: Jul2021 (unspecified if ongoing), notes: He also mentioned that he had an ECG in July and that all was normal. He had an ECG because he had a panic attack. Concomitant medications include antidepressant and antipsychotic medications for one year and three months but stopped before receiving first dose of vaccine. Vaccination history included: Bnt162b2 (1st Dose: 01Dec2021, Batch/Lot: N/A, Vaccination Facility: [Redacted]), administration date: 01Dec2021, for COVID-19 immunisation. The following information was reported: PERICARDITIS (medically significant) with onset 25Dec2021, outcome "unknown", described as "pericarditis"; SYNCOPE (medically significant), MYOCARDIAL INFARCTION (medically significant) all with onset 25Dec2021, outcome "unknown" and all described as "he felt like he was having a heart attack, went to the bathroom and almost fainted"; HAEMATOCHEZIA (medically significant) with onset 25Dec2021, outcome "unknown", described as "had blood in his stool"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "experiencing serious heart issues"; HEART RATE IRREGULAR (non-serious) with onset 25Dec2021, outcome "unknown", described as "he also had irregular heartbeats"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "his heart was beating fast"; CHILLS (non-serious), outcome "unknown", described as "bad chills"; TREMOR (non-serious), outcome "unknown", described as "shaking"; FEELING COLD (non-serious), HYPERHIDROSIS (non-serious), outcome "unknown" and all described as "feeling cold and sweathing"; PYREXIA (non-serious), outcome "unknown", described as "fever"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "pressure in head"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "lost of taste and smell"; FATIGUE (non-serious), outcome "unknown", described as "fatigue (slept the whole day)"; DYSPNOEA (non-serious) with onset 24Dec2021, outcome "unknown", described as "He had trouble breathing and still have trouble breathing."; MOVEMENT DISORDER (non-serious) with onset 25Dec2021, outcome "unknown", described as "he could not control his movement"; VISION BLURRED (non-serious) with onset 25Dec2021, outcome "unknown", described as "blurry vision"; DYSPEPSIA (non-serious) with onset 25Dec2021, outcome "unknown", described as "his heart was burning"; CHEST PAIN (non-serious), ABDOMINAL PAIN UPPER (non-serious) all with onset 25Dec2021, outcome "unknown" and all described as "heart and stomach cramps"; DYSPHAGIA (non-serious) with onset 25Dec2021, outcome "unknown", described as "had a hard time to swallow"; SOMNOLENCE (non-serious), outcome "unknown", described as "slept the whole day". The events "pericarditis" and "he also had irregular heartbeats" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (25Dec2021) unknown; electrocardiogram: (Jul2021) normal, notes: he had an ECG in July and that all was normal. He had an ECG because he had a panic attack. He mentioned that; (25Dec2021) unknown, notes: ECG. They checked his heart for a bout 10 hours; heart rate: (25Dec2021) irregular, notes: he also had irregular heartbeats; ultrasound scan: (25Dec2021) unknown, notes: He had an Ultrasound; x-ray: (25Dec2021) unknown. Therapeutic measures were taken as a result of pericarditis, heart rate irregular. Clinical course: It was reported that 11 to 12 hours after second dose, patient heart was beating fast, bad chills, shaking, feeling cold and sweating, fever, pressure in head, loss of taste and smell, fatigue (slept the whole day). Two days after, he had trouble breathing and still have trouble breathing. On 25Dec2021, he could not control his movement, had blurry vision, he felt like he was having a heart attack, went to the bathroom and almost fainted, his heart was burning, had blood in his stool, heart and stomach cramps and had a hard time to swallow. Three hours later, he went to the hospital to the emergency and that said he had pericarditis and that it was possible or most likely from the vaccine. They kept him for about 14 hours. He had an ultrasound, Xray, CT scan, ECG. They checked his heart for about 10 hours; he also had irregular heartbeats. He also mentioned that he had an ECG in July and that all was normal. He had an ECG because he had a panic attack. Patient mentioned that he takes the following medication after being treated at the emergency: Aspirine 8 pills a day and Pantoprazole 1 a day. He also wants compensation for his condition. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2026291 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005889 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Dry throat, Headache, Insomnia, Peripheral swelling, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211224; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Vomited; Dry throat; Insomnia; Swelling arm; Headache; Joint ache; Fever chills; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26402229) on 29-Dec-2021 and was forwarded to Moderna on 29-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), DRY THROAT (Dry throat), HEADACHE (Headache), VOMITING (Vomited), ARTHRALGIA (Joint ache), PYREXIA (Fever chills) and INSOMNIA (Insomnia) in a 29-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005889) for an unknown indication. No Medical History information was reported. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On 25-Dec-2021, the patient experienced DRY THROAT (Dry throat) (seriousness criterion medically significant) and INSOMNIA (Insomnia) (seriousness criterion medically significant). On 28-Dec-2021, the patient experienced VOMITING (Vomited) (seriousness criterion medically significant). On 28-Dec-2021, VOMITING (Vomited) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling arm), DRY THROAT (Dry throat), HEADACHE (Headache), ARTHRALGIA (Joint ache), PYREXIA (Fever chills) and INSOMNIA (Insomnia) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant Medication use information was provided by reporter that includes SARS-COV-2 VIRUS On 28 April 2021 with an indication of Vaccination. Patient was not had symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. Treatment Medication use information was not provided by reporter. Company comment: This regulatory authority case concerns a 29-year-old male patient with no medical history, who experienced the unexpected serious events of Insomnia Peripheral swelling, Dry throat, Headache, Arthralgia, Pyrexia, and vomiting. The events Peripheral swelling, Headache, Arthralgia and Pyrexia which occurred one day after, Insomnia, Dry throat 2 days after and Vomiting occurred 3 days after receiving the third dose of mRNA-1273 Vaccine. The outcome was reported as not resolved for all events, but Vomiting resolved on same day. Patients underlying medical history and steroid therapy remains confounders. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority''s report due to important medical condition.; Sender''s Comments: This regulatory authority case concerns a 29-year-old male patient with no medical history, who experienced the unexpected serious events of Insomnia Peripheral swelling, Dry throat, Headache, Arthralgia, Pyrexia, and vomiting. The events Peripheral swelling, Headache, Arthralgia and Pyrexia which occurred one day after, Insomnia, Dry throat 2 days after and Vomiting occurred 3 days after receiving the third dose of mRNA-1273 Vaccine. The outcome was reported as not resolved for all events, but Vomiting resolved on same day. Patients underlying medical history and steroid therapy remains confounders. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority''s report due to important medical condition.


VAERS ID: 2026355 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Chest pain, Decreased appetite, Fatigue, Headache, Palpitations, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101877546

Write-up: Fatigue/unusual tiredness; Chest pain; Fever; pain under the left armpit; Loss of appetite; Headaches; Heart throbbing/Heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112281347581240-9QXTT. Other Case identifier(s): GB-MHRA-ADR 26403585. A 17 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 23Dec2021 (Lot number: FN3543) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SALBUTAMOL taken for asthma, start date: 09Nov2021. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunisation. The following information was reported: PALPITATIONS (medically significant) with onset 24Dec2021, outcome "recovered" (26Dec2021), described as "Heart throbbing/Heart palpitations"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; PYREXIA (medically significant), outcome "unknown", described as "Fever"; AXILLARY PAIN (medically significant), outcome "unknown", described as "pain under the left armpit"; DECREASED APPETITE (medically significant), outcome "unknown", described as "Loss of appetite"; HEADACHE (medically significant), outcome "unknown", described as "Headaches". Therapeutic measures were taken as a result of headache, paracetamol. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: "Yes". Did the symptoms lead to a hospital stay?: "No". Was a diagnosis made by a medical professional?: "No". Were any blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken?: "No" No follow-up attempts are possible. No further information is expected.


VAERS ID: 2026363 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Immunisation
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101877639

Write-up: Dizziness; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112281425310240-ASGSP (RA). Other Case identifier: GB-MHRA-ADR 26403964 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 24Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19. Vaccination history included: Bnt162b2 (Dose 1 (Lot # not provided)) and Bnt162b2 (Dose 2 (Lot # not provided)) both given for COVID-19 immunization. Then, received the booster dose on 24Dec2021. On 25Dec2021, the patient had dizziness. The events were considered serious (medically significant). Patient was not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine and also reported that not had a COVID-19 test. The patient had not yet recovered from dizziness. The patient does not relate the events to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026372 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Erectile dysfunction, Interchange of vaccine products, Off label use, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Medication errors (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow), Sexual dysfunction (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: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101877718

Write-up: SARS-CoV-2 infection/Positive COVID-19 test; racing heart beat; Erection failure; Off label use; interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112281501290740-JVDDN (RA). Other Case identifier(s): GB-MHRA-ADR 26404370 (RA). A 43 year-old male patient received bnt162b2 (COMIRNATY), administration date 24Dec2021 (Batch/Lot number: unknown) as dose 2 (initial pfizer dose), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19" (ongoing), notes: Unsure when symptoms started; "High blood pressure" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Amlodipine for High blood pressure. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1), administration date: 18May2021, for COVID-19 immunisation, reaction(s): "heart beat racing", "erection failure". The following information was reported: ERECTILE DYSFUNCTION (medically significant) with onset 25Dec2021, outcome "not recovered", described as "Erection failure"; COVID-19 (non-serious) with onset 26Dec2021, outcome "recovering", described as "SARS-CoV-2 infection/Positive COVID-19 test"; PALPITATIONS (non-serious) with onset 25Dec2021, outcome "unknown", described as "racing heart beat"; OFF LABEL USE (non-serious) with onset 24Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 24Dec2021, outcome "unknown", described as "interchange of vaccine products". When patient took the first vaccine back in May, patient noticed his heart beat racing and a very serious erection failure which lasted for a good three months , patient thought it was because of stress as he was going through a lot at that time, but this time the very next day patient noticed the same erection problems and racing heart beat and know this was not co-incidence. Patient is not enrolled in clinical trial. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Dec2021) yes - positive covid-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026397 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-24
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, SARS-CoV-2 test, Tension headache
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 Date: 20211225; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101877719

Write-up: Headache tension; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202112281657454650-CMDPW (RA). Other Case identifier(s): GB-MHRA-ADR 26405045 (RA). A male patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "Booster"; TENSION HEADACHE (medically significant) with onset 24Dec2021, outcome "not recovered", described as "Headache tension". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Dec2021) negative, notes: No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The reporter considered the report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026473 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Fatigue, Immunisation, Interchange of vaccine products, Lacrimation increased, Off label use, Rhinorrhoea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Lacrimal disorders (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101877608

Write-up: Booster; off label use; Interchange of vaccine product; fatigue; watering eyes; Stomach cramps; running nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112282351417820-WUKZ6. Other Case identifier(s): GB-MHRA-ADR 26406044. A 47-year-old male patient received bnt162b2 (COMIRNATY), administration date 24Dec2021 (Lot number: FK9706) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 23Apr2021, for COVID-19 Immunisation; Covid-19 vaccine astrazeneca (Dose 2), administration date: 24Jun2021, for COVID-19 Immunisation. He had no prior health issues Patient has not had symptoms associated with COVID-19. The following information was reported: IMMUNISATION (medically significant) with onset 24Dec2021, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 24Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Dec2021, outcome "unknown", described as "Interchange of vaccine product"; FATIGUE (medically significant) with onset 24Dec2021, outcome "not recovered", described as "fatigue"; LACRIMATION INCREASED (medically significant) with onset 24Dec2021, outcome "not recovered", described as "watering eyes"; ABDOMINAL PAIN UPPER (medically significant) with onset 24Dec2021, outcome "not recovered", described as "Stomach cramps"; RHINORRHOEA (medically significant) with onset 24Dec2021, outcome "recovered", described as "running nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: After an hour from vaccine he had watering eyes, running nose, fatigue and stomach cramps. Stomach cramps and fatigue remaining differently from watering eyes and running nose ended. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Report not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2026511 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Dysmenorrhoea, Rash, Rash vesicular, SARS-CoV-2 test, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101882509

Write-up: Cramps menstrual/Very severe menstrual cramps to the point of vomiting with the pain; Skin rash; Vomiting/Very severe menstrual cramps to the point of vomiting with the pain; Severe blister type rash on body hands feet with burning sensation; Severe blister type rash on body hands feet with burning sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112291127574650-8EIVH (RA). Other Case identifier(s): GB-MHRA-ADR 26408069 (RA). A 17 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Fit and healthy. Patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Patient last menstrual period date was 28Dec2021. The following information was reported: RASH (medically significant) with onset 24Dec2021, outcome "not recovered", described as "Skin rash"; DYSMENORRHOEA (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Cramps menstrual/Very severe menstrual cramps to the point of vomiting with the pain"; VOMITING (medically significant) with onset 2021, outcome "not recovered", described as "Vomiting/Very severe menstrual cramps to the point of vomiting with the pain"; RASH VESICULAR (medically significant), BURNING SENSATION (medically significant) all with onset 2021, outcome "unknown" and all described as "Severe blister type rash on body hands feet with burning sensation". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Adverse reaction did not occur as a result of an exposure during pregnancy. The report of the patient was not related to possible inflammation of the heart (myocarditis or pericarditis). Clinical course: Severe blister type rash on body hands feet with burning sensation 12 hours after vaccine told not to take same vaccine for second dose No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026548 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-20
Onset:2021-12-24
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005686 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vulvovaginal candidiasis
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: GBMODERNATX, INC.MOD20214

Write-up: Thrush vaginal; This case was received via RA (Reference number: GB-MHRA-ADR 26411113) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VULVOVAGINAL CANDIDIASIS (Thrush vaginal) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005686) for an unknown indication. No Medical History information was reported. On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced VULVOVAGINAL CANDIDIASIS (Thrush vaginal) (seriousness criterion medically significant). At the time of the report, VULVOVAGINAL CANDIDIASIS (Thrush vaginal) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has 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. Company Comment: This case refers to a female patient of unspecified age with no known medical history who experienced the unexpected event of Vulvovaginal candidiasis approximately 4 days after the third dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case refers to a female patient of unspecified age with no known medical history who experienced the unexpected event of Vulvovaginal candidiasis approximately 4 days after the third dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2026569 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Immunisation, Pyrexia, SARS-CoV-2 test
SMQs:, 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? 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: High temperature; Result Unstructured Data: Test Result:High; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101882567

Write-up: Booster; High temperature; Shivers; This is a spontaneous report received from a contactable reporter (consumer) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112292235314680-U88UE. Other Case identifier(s): GB-MHRA-ADR 26412674. A 25 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 24Dec2021 (Batch/Lot number: unknown) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Vaccination history included: Bnt162b2 (Dose-2), administration date: 08Aug2021, for COVID-19 immunisation, reaction(s): "High temperature", "Shivers"; Bnt162b2 (Dose-1), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 24Dec2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant) with onset 24Dec2021, outcome "recovered" (26Dec2021), described as "High temperature"; CHILLS (medically significant) with onset 24Dec2021, outcome "recovered" (26Dec2021), described as "Shivers". The patient underwent the following laboratory tests and procedures: body temperature: high; sars-cov-2 test: no - negative covid-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200008356 same patient/same product, different dose/events.


VAERS ID: 2026602 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Herpes zoster, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Asthma; Blood pressure high; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: rash; Shingles; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26415617) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (rash) and HERPES ZOSTER (Shingles) in a 47-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Asthma, Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...) and Blood pressure high. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced HERPES ZOSTER (Shingles) (seriousness criterion medically significant). On an unknown date, the patient experienced RASH (rash) (seriousness criterion medically significant). At the time of the report, RASH (rash) and HERPES ZOSTER (Shingles) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Rang dr after rash appeared. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided.; Sender''s Comments: This case concerns a patient, with medical history Asthma, Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response and Blood pressure high, who experienced the serious unexpected event(s) of rash and herpes zoster. The event(s) started occurring approximately within 1 day(s) after the 3rd dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered NA. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 2026859 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5929 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Toxic skin eruption
SMQs:, Severe cutaneous adverse reactions (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202200011011

Write-up: Toxicoderma; booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: v21132619 (PMDA). A 56 year-old female patient received bnt162b2 (COMIRNATY), administration date 24Dec2021 15:00 (Lot number: FJ5929, Expiration Date: 30Apr2022) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1., Manufacturer Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2., Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 24Dec2021 15:00, outcome "unknown", described as "booster"; TOXIC SKIN ERUPTION (medically significant) with onset 25Dec2021 17:00, outcome "unknown", described as "Toxicoderma". The event "booster" was evaluated at the physician office visit. The event "toxicoderma" was evaluated at the physician office visit and emergency room visit. Additional Info: There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Clinical course: Event onset date was reported as 25Dec2021 at 17:00 (1 day 2 hours after vaccination). On an unspecified date, the outcome of the event was not provided. On 24Dec2021 at 15:00, the 3rd dose of covid-19 vaccine was inoculated. Around 17:00 on the following day, rash appeared on both upper limbs.On 27Dec2021, the patient visited an emergency department and was to concurrently visit the reporting department. Fine rash and erythema were observed mainly on both the upper limbs, diagnosed as toxicoderma. Although the causality of the symptoms to vaccination could not be determined, the symptoms were considered to be probably related to the vaccination. As the symptoms were gradually improving, her clinical course was to be followed with external medications. The reporter classified the event as non-serious and assessed that the event was related to bnt162b2. Other possible cause(s) of the event such as any other diseases was reported as follows: there was possibility that it was other infectious Toxicoderma. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2027610 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Fatigue, Pyrexia, SARS-CoV-2 test
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 (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Chest pain; Fever; Fatigue/unusual tiredness; Chest pain; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26424512) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of the second episode of CHEST PAIN (Chest pain), PYREXIA (Fever), FATIGUE (Fatigue/unusual tiredness) and the first episode of CHEST PAIN (Chest pain) in a 53-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. No Medical History information was reported. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced the first episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced the second episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant). At the time of the report, last episode of CHEST PAIN (Chest pain), PYREXIA (Fever) and FATIGUE (Fatigue/unusual tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Other medications not provided by the reporter. Treatment medications was not provided by the reporter. Patient had flue like symptom followed by sharp burning pain to left side of sternum and a dull ache to left arm, and lasted for 5 days. Patient had appointment with GP on 29-Dec-2021 and carried out tests but didn''t determine the cause, Patient had attended a spin class on 27-Dec-2021 with no issues during the excercise and Patient was in intermitant pain, GP was arranging tests at hospital. Patient''s report relates to possible inflammation of the heart (myocarditis or pericarditis) Patient has not had symptoms associated with COVID-19, Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company comment: This regulatory authority case concerns a 53-year-old male patient with no relevant medical history who experienced serious unexpected events of two episodes of chest pain, pyrexia and fatigue, that occurred approximately 1 day after the 3rd dose of the mRNA-1273 . The rechallenge was not applicable due to occurrence after the 3rd dose. Patient''s relevant medical history confounds causality. The regulatory authority assessed the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Seriousness as per regulatory authority.; Sender''s Comments: This regulatory authority case concerns a 53-year-old male patient with no relevant medical history who experienced serious unexpected events of two episodes of chest pain, pyrexia and fatigue, that occurred approximately 1 day after the 3rd dose of the mRNA-1273 . The rechallenge was not applicable due to occurrence after the 3rd dose. Patient''s relevant medical history confounds causality. The regulatory authority assessed the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Seriousness as per regulatory authority.


VAERS ID: 2029181 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Decreased appetite, Dehydration, Disorientation, Fatigue, Headache, Immunisation, Limb discomfort, Nausea, Somnolence, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad), Dehydration (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: GABAPENTIN; BRICANYL TURBUHALER; PULMICORT; AVAMYS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrosis; Asthma; Depression (Recovered); Hypertension; Irritable bowel; Reflux gastritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101883005

Write-up: sleeping a lot; fatigue extreme; appetite loss; nausea; vomiting x3; cough; headache; upper and lower limbs heaviness (entire body); disorientated; dehydration; fatigue; 3rd dose; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Dec2021 13:15 (Lot number: Unknown) at the age of 56 years as dose (booster), single for covid-19 immunisation. Relevant medical history included: "arthrosis" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing), notes: Recovered; "asthma" (unspecified if ongoing); "gastric reflux" (unspecified if ongoing); "irritable bowel" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; BRICANYL TURBUHALER; PULMICORT; AVAMYS. Past drug history included: Trimethoprim sulfamethoxazole, reaction(s): "Allergy"; Propofol, reaction(s): "drug Allergy"; Pregabalin, reaction(s): "drug Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 30May2021, for covid-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 06Feb2021, for covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 24Dec2021, outcome "unknown", described as "3rd dose"; FATIGUE (medically significant) with onset 26Dec2021, outcome "recovered with sequelae", described as "fatigue extreme"; FATIGUE (non-serious) with onset 24Dec2021 13:45, outcome "recovered with sequelae", described as "fatigue"; DECREASED APPETITE (non-serious) with onset 26Dec2021, outcome "recovered with sequelae", described as "appetite loss"; NAUSEA (non-serious) with onset 26Dec2021, outcome "recovered with sequelae", described as "nausea"; VOMITING (non-serious) with onset 26Dec2021, outcome "recovered with sequelae", described as "vomiting x3"; COUGH (non-serious) with onset 26Dec2021, outcome "recovered with sequelae", described as "cough"; HEADACHE (non-serious) with onset 26Dec2021, outcome "recovered with sequelae", described as "headache"; LIMB DISCOMFORT (non-serious) with onset 26Dec2021, outcome "recovered with sequelae", described as "upper and lower limbs heaviness (entire body)"; DISORIENTATION (non-serious) with onset 26Dec2021, outcome "recovered with sequelae", described as "disorientated"; DEHYDRATION (non-serious) with onset 26Dec2021, outcome "recovered with sequelae", described as "dehydration"; SOMNOLENCE (non-serious) with onset 27Dec2021, outcome "recovered with sequelae", described as "sleeping a lot". The events "fatigue extreme", "fatigue", "appetite loss", "nausea", "vomiting x3", "cough", "headache", "upper and lower limbs heaviness (entire body)", "disorientated" and "dehydration" were evaluated at the physician office visit. Therapeutic measures were taken as a result of fatigue, fatigue, decreased appetite, nausea, vomiting, cough, headache, limb discomfort, disorientation, dehydration, somnolence. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event fatigue extreme. 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: 2029604 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast swelling, Immunisation, Interchange of vaccine products, Limb discomfort, Off label use, Pain in extremity, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament 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:
Allergies:
Diagnostic Lab Data: Test Date: 20211029; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101882792

Write-up: pain and tenderness on the arm; discomfort; swelling under the armpit/swelling is the side where I had the injection; Breast swelling; Off label use; interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112290854125440-N7RQF. Other Case identifier: GB-MHRA-ADR 26407403. A 43 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 24Dec2021 (Lot number: FN5254) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 24Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 24Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant), outcome "recovered", described as "pain and tenderness on the arm "; SWELLING (medically significant) with onset 24Dec2021, outcome "not recovered", described as "swelling under the armpit/swelling is the side where I had the injection"; BREAST SWELLING (medically significant) with onset 24Dec2021, outcome "not recovered", described as "Breast swelling"; LIMB DISCOMFORT (medically significant), outcome "unknown", described as "discomfort". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Oct2021) negative, notes: No - Negative COVID-19 test. Additional information: Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient last menstrual period date: 17Dec2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029778 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-19
Onset:2021-12-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Carditis, Chest pain, Dyspnoea, Fatigue, Palpitations, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101882785

Write-up: fatigue/unusual tiredness; racing heart (tachycardia); possible inflammation of the heart (myocarditis or pericarditis); chest pain/sharp pain in the chest; shortness of breath; heart palpitations; heart racing; This is a spontaneous report received from a contactable reporter consumer or other non HCP from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112292211108170-FBP8X (RA). Other Case identifiers: GB-MHRA-ADR 26412239 (RA). A 36 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Dec2021 (batch/lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient has not had symptoms associated with COVID-19, not had a COVID-19 test, not currently breastfeeding, not enrolled in clinical trial. The patient''s concomitant medications were not reported. The following information was reported: FATIGUE (medically significant), outcome "not recovered", described as "fatigue/unusual tiredness"; TACHYCARDIA (medically significant), outcome "unknown", described as "racing heart (tachycardia)"; CARDITIS (medically significant), outcome "unknown", described as "possible inflammation of the heart (myocarditis or pericarditis)"; PALPITATIONS (medically significant) with onset 24Dec2021, outcome "not recovered", described as "heart racing"; CHEST PAIN (medically significant), outcome "unknown", described as "chest pain/sharp pain in the chest"; DYSPNOEA (medically significant), outcome "unknown", described as "shortness of breath"; PALPITATIONS (medically significant), outcome "unknown", described as "heart palpitations". The patient has not tested positive for COVID-19 since having the vaccine. Additional information: The reporter informed that the symptoms did not lead to a hospital stay. The reporter related the report to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029810 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-13
Onset:2021-12-24
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL1939 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Excessive cerumen production, Immunisation, Interchange of vaccine products, Myalgia, Off label use, SARS-CoV-2 test, Wheezing
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101882849

Write-up: Off label use; Interchange of vaccine products; Booster; Wheezing in chest; Chest pressure; Muscle ache; Chest heaviness; Wax in ear; This is a spontaneous report received from a non-contactable reporter (consumer) from the regulatory authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112300211268800-YLQ4R (MHRA). Other Case identifier: GB-MHRA-ADR 26412963 (MHRA). A 51 year-old patient received bnt162b2 (COMIRNATY), administration date 13Dec2021 (Lot number: FL1939) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE: 1; MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (DOSE: 2; MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: OFF LABEL USE (disability), outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability), outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability), outcome "unknown", described as "Booster"; CHEST DISCOMFORT (disability) with onset 24Dec2021, outcome "not recovered", described as "Chest pressure"; MYALGIA (disability) with onset 24Dec2021, outcome "not recovered", described as "Muscle ache"; CHEST DISCOMFORT (disability) with onset 24Dec2021, outcome "not recovered", described as "Chest heaviness"; EXCESSIVE CERUMEN PRODUCTION (disability) with onset 24Dec2021, outcome "not recovered", described as "Wax in ear". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (16Jun2021) no - negative covid-19 test. Clinical course: Wheezing in chest when patient sleeps at night every night since she/he had the booster on 13Dec2021. 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. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029916 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Immunisation, Off label use, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101885640

Write-up: Off label use; Booster; Cardiac arrest; This is a spontaneous report received from a contactable reporter(s) (Physician) from the RA. Regulatory number: GB-MHRA-WEBCOVID-202112301436395740-FCZX2. Other Case identifier(s): GB-MHRA-ADR 26416332. A female patient received bnt162b2 (COMIRNATY), administration date 24Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: OFF LABEL USE (hospitalization, disability, medically significant) with onset 24Dec2021, outcome "unknown", described as "Off label use"; IMMUNISATION (hospitalization, disability, medically significant) with onset 24Dec2021, outcome "unknown", described as "Booster"; CARDIAC ARREST (hospitalization, disability, medically significant) with onset 24Dec2021, outcome "not recovered", described as "Cardiac arrest". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Jun2021) no - negative covid-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2030145 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Loss of consciousness, Pain in extremity, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), 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: OMEPRAZOLE [OMEPRAZOLE SODIUM]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: really sore arm; Passed out; This case was received via the RA (Reference number: GB-MHRA-ADR 26421868) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (really sore arm) and LOSS OF CONSCIOUSNESS (Passed out) in a 56-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]) for an unknown indication. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (really sore arm) (seriousness criterion medically significant). On 30-Dec-2021, LOSS OF CONSCIOUSNESS (Passed out) had resolved. At the time of the report, PAIN IN EXTREMITY (really sore arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced sore Arm, hard and burning swelling, passed out 24 hours after booster while walking around supermarket. No treatment drug information was provided. Company comment: This regulatory authority concerns a 56-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Painful arm and Loss of consciousness after mRNA- 1273 vaccine. Loss of consciousness occurred 1 day after the booster dose of mRNA- 1273 vaccine. Temporal relationship of Painful arm was not reported. Very limited information is available regarding medical assessment and diagnostic work-up for the event Loss of consciousness. Painful arm is consistent with the known safety profile of the vaccine, but since it was reported with a seriousness criteria it is considered unexpected. The seriousness criterion of the event was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Patient had 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.; Sender''s Comments: This regulatory authority concerns a 56-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Painful arm and Loss of consciousness after mRNA- 1273 vaccine. Loss of consciousness occurred 1 day after the booster dose of mRNA- 1273 vaccine. Temporal relationship of Painful arm was not reported. Very limited information is available regarding medical assessment and diagnostic work-up for the event Loss of consciousness. Painful arm is consistent with the known safety profile of the vaccine, but since it was reported with a seriousness criteria it is considered unexpected. The seriousness criterion of the event was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 2030193 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-12-24
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, 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 Date: 20211227; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Headache; This case was received via RA (Reference number: GB-MHRA-ADR 26423554) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 63-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No medical history and Concomitant medications were reported. Patient has not had symptoms associated with COVID-19 Patient developed almost unbearable headache which painkillers have no impact on, including prescribed cocodomol. When patient stand still the rear of his legs begin to cramp resulting in an inability to continue to stand. If patient move, he was fine. These symptoms initially commenced with a feeling he wanted to be sick, and patient seemed to be constipated. Patient purchased some medication for that issued which moved things on as it were. Patient do not have an appetite. Patient urine is dark and yet he was drinking more than he do to alleviate this. Patient had no temperature, his blood pressure is fine but he remain in pain and corned. Covid test - negative. Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial. Patient relevant investigations or tests conducted were reported as physical examination, blood/temperature etc Attendance at casualty dept. Company comment This case concerns a 63-year-old male patient, with no reported medical history, who experienced the unexpected serious event of HEADACHE. The event occurred approximately 1 month after the administration of the third dose of mRNA-1273 vaccine. Patient reported that he had developed almost unbearable headache which painkillers have no impact on, including prescribed cocodomol. When patient stand still the rear of his legs begin to cramp resulting in an inability to continue to stand. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 63-year-old male patient, with no reported medical history, who experienced the unexpected serious event of HEADACHE. The event occurred approximately 1 month after the administration of the third dose of mRNA-1273 vaccine. Patient reported that he had developed almost unbearable headache which painkillers have no impact on, including prescribed cocodomol. When patient stand still the rear of his legs begin to cramp resulting in an inability to continue to stand. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030262 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Neck pain, Pain in jaw, SARS-CoV-2 test
SMQs:, Osteonecrosis (broad), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Jaw pain; Shoulder pain; Neck pain; This case was received via regulatory authority on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), PAIN IN JAW (Jaw pain) and ARTHRALGIA (Shoulder pain) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef.). On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced NECK PAIN (Neck pain) (seriousness criteria hospitalization and medically significant). On 25-Dec-2021, the patient experienced ARTHRALGIA (Shoulder pain) (seriousness criteria hospitalization and medically significant). On 31-Dec-2021, the patient experienced PAIN IN JAW (Jaw pain) (seriousness criteria hospitalization and medically significant). At the time of the report, NECK PAIN (Neck pain), PAIN IN JAW (Jaw pain) and ARTHRALGIA (Shoulder pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. No treatment information was provided by the reporter. Patient not tested positive for COVID-19 since had the vaccine. Patient not had symptoms associated with COVID-19 . Patient was not pregnant ,Patient was not breastfeeding Patient was not enrolled in clinical trial Patient last menstrual period date was16-DEC-2021. Company comment: This is a regulatory case concerning a 38 year-old, female patient with no relevant medical history, who experienced the serious (due to medically important condition and hospitalization) unexpected, according RA, events of neck pain, pain in jaw and arthralgia. The events occurred approximately 2 to 9 days after the booster dose of mRNA-1273 vaccine. The outcome of the events was reported as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 38 year-old, female patient with no relevant medical history, who experienced the serious (due to medically important condition and hospitalization) unexpected, according RA, events of neck pain, pain in jaw and arthralgia. The events occurred approximately 2 to 9 days after the booster dose of mRNA-1273 vaccine. The outcome of the events was reported as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030287 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005686 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, SARS-CoV-2 test
SMQs:, Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Wrist pain; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26424479) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Wrist pain) in a 42-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005686) for an unknown indication. No Medical History information was reported. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced ARTHRALGIA (Wrist pain) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (Wrist pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. No concomitant medication provided. No treatment information mentioned. Company Comment: This case concerns a 42-year-old, male subject with unknown medical history, who experienced the serious (Seriousness criterion-Other medically important condition) unexpected event of Arthralgia (wrist pain). The event occurred 1 day after the third dose of mRNA-1273 vaccine. There is no available information regarding clinical course and treatment medication. At the time of the report, the event had not resolved. Rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 42-year-old, male subject with unknown medical history, who experienced the serious (Seriousness criterion-Other medically important condition) unexpected event of Arthralgia (wrist pain). The event occurred 1 day after the third dose of mRNA-1273 vaccine. There is no available information regarding clinical course and treatment medication. At the time of the report, the event had not resolved. Rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030325 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, 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; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: tiredness; Frontal headache; Chills; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424823) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (tiredness), HEADACHE (Frontal headache) and CHILLS (Chills) in a 51-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced HEADACHE (Frontal headache) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (tiredness) (seriousness criterion medically significant). On 28-Dec-2021, CHILLS (Chills) had resolved. At the time of the report, FATIGUE (tiredness) and HEADACHE (Frontal headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant medical history reported. No relevant concomitant medication information provided. No relevant treatment medication information provided. Patient experienced chills which resulted in going to bed, feet and hands were extremely cold and rest of the body was very warm. Tiredness but woke several times during the night but did not want to move or get out of bed. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial; Sender''s Comments: This case concerns a 51-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Fatigue, Headache, and Chills. The events of Headache and chills occurred approximately 1 day after the third dose of mRNA-1273 (Moderna covid-19 vaccine); while Fatigue occurred at an unspecified interval after third dose. The rechallenge was not applicable as events occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 2032644 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Headache, Malaise, Paraesthesia, Sensory loss, Suspected COVID-19
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (I was hospitalized for 5 days); Hypoesthesia; Kidney pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202200004392

Write-up: headache; discomfort; malaise; I have a tingling in the shin of the sleeping foot; Loss of sensation in the lower parts (feet); Started tingling on the outside of my right foot; I thought I was with Covid-19 again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 23Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Jan2021 (unspecified if ongoing), notes: I was hospitalized for 5 days; "big numbness in the same place", start date: 01Jan2021 (unspecified if ongoing); "pain in the left kidney", start date: 01Jan2021 (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 24Dec2021, outcome "unknown", described as "I thought I was with Covid-19 again"; SENSORY LOSS (non-serious), outcome "unknown", described as "Loss of sensation in the lower parts (feet)"; PARAESTHESIA (non-serious) with onset 26Dec2021, outcome "unknown", described as "Started tingling on the outside of my right foot"; HEADACHE (non-serious), outcome "recovered", described as "headache"; DISCOMFORT (non-serious), outcome "unknown", described as "discomfort"; MALAISE (non-serious), outcome "recovered", described as "malaise"; PARAESTHESIA (non-serious), outcome "unknown", described as "I have a tingling in the shin of the sleeping foot". The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2033005 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9706 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Heart rate, Heart rate increased, Immunisation, Pain in extremity
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: Heart rate; Result Unstructured Data: Test Result:increased; Comments: very elevated
CDC Split Type: GBPFIZER INC202200000645

Write-up: Shoulder pain; Very Painful stabbing pain in chest.; Constant pain in left arm.; Heart rate increased; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-EYC 00270184 (RA). Other Case identifier(s): GB-MHRA-ADR 26407691 (RA). A 24 year-old male patient received bnt162b2 (COMIRNATY), parenteral, administration date 24Dec2021 (Lot number: FK9706) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Past drug history included: Iodine, reaction(s): "Scar". Vaccination history included: Covid-19 vaccine ("DOSE X; MANUFACTUERER UNKNOWN" (where X=1, 2, or number unknown)), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 24Dec2021, outcome "unknown", described as "Booster"; CHEST PAIN (medically significant) with onset 26Dec2021, outcome "recovered" (26Dec2021), described as "Very Painful stabbing pain in chest."; PAIN IN EXTREMITY (medically significant) with onset 26Dec2021, outcome "not recovered", described as "Constant pain in left arm."; HEART RATE INCREASED (medically significant) with onset 26Dec2021, outcome "recovered" (26Dec2021), described as "Heart rate increased"; ARTHRALGIA (medically significant), outcome "unknown", described as "Shoulder pain". The patient underwent the following laboratory tests and procedures: heart rate: (26Dec2021) increased, notes: very elevated. Clinical course included patient was sat in a chair at his mums on boxing day. Out of nowhere patient had what felt like someone punching me straight in the left side of my chest. It caused patient whole body to recoil and then heart rate was very elevated until about 20 minutes after. Now patient had a pain in left arm that was constant and moved up to my shoulder. This pain was very uncomfortable and didn''t go with any exercise. Patient had not taken any medication as she was unsure what was happening with him as of now. After having a stabbing pain in chest that seemed like a heart attack. Patient now had constant pain in left arm sometimes going up to shoulder and it came in waves. Very uncomfortable. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033010 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acne, Rash macular, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (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: CHLORPHENAMINE MALEATE; IBUPROFEN; LORATADINE; PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Acne; Red blotches on face which peal and flake; Red blotches on face which peal and flake; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26422915) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of ACNE (Acne), RASH MACULAR (Red blotches on face which peal and flake) and SKIN EXFOLIATION (Red blotches on face which peal and flake) in a 47-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included CHLORPHENAMINE MALEATE, IBUPROFEN, LORATADINE and PARACETAMOL for an unknown indication. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 5 milliliter. On 24-Dec-2021, the patient experienced ACNE (Acne) (seriousness criterion medically significant), RASH MACULAR (Red blotches on face which peal and flake) (seriousness criterion medically significant) and SKIN EXFOLIATION (Red blotches on face which peal and flake) (seriousness criterion medically significant). At the time of the report, ACNE (Acne), RASH MACULAR (Red blotches on face which peal and flake) and SKIN EXFOLIATION (Red blotches on face which peal and flake) had not resolved. No Medical History information was reported. Patient was not really allergic to anything. Patient reported acne, red blotches on face which peal and flake. Vaccine leaflet says urgent medical attention to be sought if hives or rash appear. Not sure if this counts as hives or rash. Seek Advice Details: After a week acne and red patches which flake remain. Uncomfortable and unsightly - no previous issue with skin problems. Spoke to pharmacist, would have contacted doctor, but it was (a holiday). Took the allergy relief to try and combat the acne / blotches / flaky skin, but had no impact. Company comment This case concerns a 47-year-old female patient, with no reported medical history, who experienced the unexpected serious events of ACNE, RASH MACULAR and SKIN EXFOLIATION. The events occurred on the following day after the administration of the third dose of mRNA-1273 vaccine. Patient reported acne, red blotches on face which peal and flake. Took the allergy relief to try and combat the acne/blotches/flaky skin, but had no impact. At the time of the report, events had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 47-year-old female patient, with no reported medical history, who experienced the unexpected serious events of ACNE, RASH MACULAR and SKIN EXFOLIATION. The events occurred on the following day after the administration of the third dose of mRNA-1273 vaccine. Patient reported acne, red blotches on face which peal and flake. Took the allergy relief to try and combat the acne/blotches/flaky skin, but had no impact. At the time of the report, events had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2033012 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse drug reaction
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CONTRACEPTIVE LD
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Pain in my ovaries, kidneys, every part of my body hurt, headache, upper trapezius and neck muscles became awfully tight, swollen and painful gland at my armoit; This case was received (Reference number: GB-RA-ADR 26430299) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Pain in my ovaries, kidneys, every part of my body hurt, headache, upper trapezius and neck muscles became awfully tight, swollen and painful gland at my armoit) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for Booster. Concomitant products included ETHINYLESTRADIOL, NORGESTREL (CONTRACEPTIVE LD) for Ill-defined disorder. On 23-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 24-Dec-2021, the patient experienced ADVERSE DRUG REACTION (Pain in my ovaries, kidneys, every part of my body hurt, headache, upper trapezius and neck muscles became awfully tight, swollen and painful gland at my armoit) (seriousness criterion medically significant). On 26-Dec-2021, ADVERSE DRUG REACTION (Pain in my ovaries, kidneys, every part of my body hurt, headache, upper trapezius and neck muscles became awfully tight, swollen and painful gland at my armoit) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) was unknown. No concomitant medication was reported. Treatment medication was not provided by the reporter. Company comment This case concerns a 40-year-old female patient, with no reported relevant medical history, who experienced the unexpected serious event of ADVERSE DRUG REACTION. The events occurred on the following day of the administration of the third dose of mRNA-1273 vaccine. Patient describes: Pain in my ovaries, kidneys, every part of my body hurt, headache, upper trapezius and neck muscles became awfully tight, swollen and painful gland at my armoit. Three days later, event had resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 40-year-old female patient, with no reported relevant medical history, who experienced the unexpected serious event of ADVERSE DRUG REACTION. The event occurred on the following day of the administration of the third dose of mRNA-1273 vaccine. Patient describes: Pain in my ovaries, kidneys, every part of my body hurt, headache, upper trapezius and neck muscles became awfully tight, swollen and painful gland at my armoit. Three days later, event had resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2033220 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Non-epileptic seizure
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000846

Write-up: Seizure; she felt lightheaded and faint; she felt lightheaded and faint; This is a spontaneous report received from a contactable reporter (Pharmacist) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112311647408550-DT1LB. Other Case identifier: GB-MHRA-ADR 26422682. A female patient received BNT162B2 (COMIRNATY), administration date 24Dec2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "non epileptic seizures" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: SEIZURE (medically significant) with onset 24Dec2021, outcome "recovered" (24Dec2021), described as "Seizure"; SYNCOPE (medically significant), DIZZINESS (non-serious) all with onset 24Dec2021, outcome "recovered" (24Dec2021) and all described as "she felt lightheaded and faint". Clinical course: patient came in for COVID jab (Pfizer) first dose- she explained previous she does suffer from non epileptic seizures not on any medication, after clinical screening patient was eligible- pharmacist injected patient however after 5 mins she felt lightheaded and faint- then fell off the chair and started to seizure. Pharmacy advisor was on the phone to ambulance patient was breathing and her partner was there he knew what to do as she suffers from these often. the rescue team said they would ring back with a clinician however the patient didn''t want to wait. She waited till she felt ok and then went out the shop. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033357 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Drug ineffective, Immunisation, Pain in extremity, Pyrexia, Suspected COVID-19
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000610

Write-up: Cough; Suspected COVID-19; Suspected COVID-19; Fever; Pain in arm; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201011340310950-RHBGX. Other Case identifier(s): GB-MHRA-ADR 26424053. A 20 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 24Dec2021 (Batch/Lot number: unknown) at the age of 20 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunisation; Bnt162b2 (DOSE 2), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 24Dec2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant) with onset 24Dec2021, outcome "not recovered", described as "Fever"; PAIN IN EXTREMITY (medically significant) with onset 24Dec2021, outcome "not recovered", described as "Pain in arm"; SUSPECTED COVID-19 (medically significant) with onset 27Dec2021, outcome "not recovered", COUGH (medically significant) with onset 28Dec2021, outcome "not recovered" and all described as "Cough"; DRUG INEFFECTIVE (medically significant) with onset 27Dec2021, outcome "unknown", described as "Suspected COVID-19". Clinical course: Patient was not having COVID-19 test. Patient was not pregnant, Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033489 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lymphadenopathy, Neck pain, Pain in extremity, Pain in jaw, Pruritus, Pyrexia, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Osteonecrosis (broad), Hypersensitivity (narrow), Arthritis (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: AZITHROMYCIN; PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE; RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Jaw pain; Neck pain; Itchy; Rash on leg; Swollen glands; Feverish; Pain in arm; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26424889) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Feverish), PAIN IN JAW (Jaw pain), LYMPHADENOPATHY (Swollen glands), RASH (Rash on leg), NECK PAIN (Neck pain), PAIN IN EXTREMITY (Pain in arm) and PRURITUS (Itchy) in a 21-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for COVID-19 vaccination. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 26-Jun-2021 to 22-Aug-2021 and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination, AZITHROMYCIN from 20-Dec-2021 to 22-Dec-2021 for Chlamydial infection, ETHINYLESTRADIOL, LEVONORGESTREL (RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]) for Contraception. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). On 25-Dec-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant). On 02-Jan-2022, the patient experienced RASH (Rash on leg) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN JAW (Jaw pain) (seriousness criterion medically significant), NECK PAIN (Neck pain) (seriousness criterion medically significant) and PRURITUS (Itchy) (seriousness criterion medically significant). At the time of the report, PYREXIA (Feverish) and PAIN IN JAW (Jaw pain) had resolved, LYMPHADENOPATHY (Swollen glands) was resolving, RASH (Rash on leg) had not resolved and NECK PAIN (Neck pain), PAIN IN EXTREMITY (Pain in arm) and PRURITUS (Itchy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. No medical history was provided by the reporter. The patient had typical arm pain and felt feverish the day after the booster. She then developed an uncomfortable pressure/mild pain in both sides of the neck, causing some associated ear/back jaw pain, which she think must be swollen glands. That lasted around a week. She had developed a hot and itchy rash on the front of both thighs. The patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient was not pregnant and not breastfeeding at the time of report. Report related to possible inflammation of the heart (myocarditis or pericarditis) No treatment medications were reported. COMPANY COMMENT: This is a Regulatory case concerning a ~21-years-old female patient with no clinical history who experienced the unexpected events of PYREXIA, PAIN IN JAW , LYMPHADENOPATHY, RASH, NECK PAIN, PAIN IN EXTREMITY and PRURITUS The events occurred 2 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority; Sender''s Comments: COMPANY COMMENT: This is a Regulatory case concerning a 21-years-old female patient with no clinical history who experienced the unexpected events of PYREXIA, PAIN IN JAW , LYMPHADENOPATHY, RASH, NECK PAIN, PAIN IN EXTREMITY and PRURITUS The events occurred 2 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority


VAERS ID: 2033547 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Pyrexia, SARS-CoV-2 test
SMQs:, 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? 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: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201215; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes-positive COVID-19 test
CDC Split Type: GBPFIZER INC202200003585

Write-up: Feverish/Fever; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202201022210046630-W3PRI. Other Case identifier(s): GB-MHRA-ADR 26425277. A 73 year-old female patient received bnt162b2 (COMIRNATY), administration date 24Dec2021 (Lot number: FN5254) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 15Dec2020 (unspecified if ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. Patient is not enrolled in clinical trial. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunisation; Bnt162b2 (Dose 2), for COVID-19 Immunisation, reaction(s): "Suspected COVID-19". The following information was reported: IMMUNISATION (medically significant) with onset 24Dec2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant) with onset 25Dec2021, outcome "recovered" (25Dec2021), described as "Feverish/Fever". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Dec2020) yes-positive covid-19 test. Therapeutic measures were taken with paracetamol as a result of pyrexia. The clinical course was reported as follows: Fever began 11 hours after vaccination and abated after 15 hours, with paracetamol. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033567 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Monoparesis, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: KEPPRA [LEVETIRACETAM]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211221; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Right arm paresis; This case was received via regulatory authority on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of MONOPARESIS (Right arm paresis) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 03-Jun-2021 to an unknown date and TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) for COVID-19 vaccination, LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for Epilepsy. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced MONOPARESIS (Right arm paresis) (seriousness criterion medically significant). At the time of the report, MONOPARESIS (Right arm paresis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Patient received injection in left arm (standard intramuscular site). The following morning, patient had pain and reduced movement with the right arm. This made her typing (and therefore work) difficult. Patient mentioned that it was still present to a slightly lesser degree. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 32-year-old female patient, with medical history of epilepsy (under treatment since 2020), who experienced the serious unexpected event of monoparesis after the third dose of mRNA-1273. The event occurred 2 days after third dose of mRNA-1273. It was reported that the patient experienced the following morning, pain and reduced movement with the right arm. Vaccination arm was reported as left arm. Still present to a slightly lesser degree at the time of report. Patient underlying epilepsy remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event assessed as serious by the Regulatory Authority.; Sender''s Comments: This case concerns a 32-year-old female patient, with medical history of epilepsy (under treatment since 2020), who experienced the serious unexpected event of monoparesis after the third dose of mRNA-1273. The event occurred 2 days after third dose of mRNA-1273. It was reported that the patient experienced the following morning, pain and reduced movement with the right arm. Vaccination arm was reported as left arm. Still present to a slightly lesser degree at the time of report. Patient underlying epilepsy remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event assessed as serious by the Regulatory Authority.


VAERS ID: 2033576 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000040A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Migraine, Photophobia, SARS-CoV-2 test
SMQs:, Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal 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: ALBUTEROL SULFATE; COVID-19 VACCINE ASTRAZENECA; PARACETAMOL; DESOGESTREL; INFLUENZA VIRUS
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.MOD20224

Write-up: Migraine headache; Migraine headache; Light sensitivity to eye; Migraine headache; Migraine headache; Migraine headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26426983) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of the first episode of MIGRAINE (Migraine headache), the second episode of MIGRAINE (Migraine headache), the third episode of MIGRAINE (Migraine headache), PHOTOPHOBIA (Light sensitivity to eye), the fourth episode of MIGRAINE (Migraine headache) and the fifth episode of MIGRAINE (Migraine headache) in a 47-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040A) for an unknown indication. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL SULFATE) for Asthma, PARACETAMOL from 24-Dec-2021 to an unknown date for Migraine, DESOGESTREL from March 2021 to an unknown date for Oral contraception, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 19-Apr-2021 to an unknown date and INFLUENZA VACCINE (INFLUENZA VIRUS) from 07-Oct-2021 to an unknown date for Vaccination. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced the first episode of MIGRAINE (Migraine headache) (seriousness criterion medically significant). On 25-Dec-2021, the patient experienced the second episode of MIGRAINE (Migraine headache) (seriousness criterion medically significant). On 27-Dec-2021, the patient experienced the third episode of MIGRAINE (Migraine headache) (seriousness criterion medically significant). On 28-Dec-2021, the patient experienced PHOTOPHOBIA (Light sensitivity to eye) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced the fourth episode of MIGRAINE (Migraine headache) (seriousness criterion medically significant). On 02-Jan-2022, the patient experienced the fifth episode of MIGRAINE (Migraine headache) (seriousness criterion medically significant). On 28-Dec-2021, PHOTOPHOBIA (Light sensitivity to eye) had resolved. On 03-Jan-2022, last episode of MIGRAINE (Migraine headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. Typically occurred after meals. Patient had food allergies/sensitivities, but no problem food was eaten. Nauseous on all occasions. Migraine pain located over left eye on all occasions. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 47-year-old female patient with no medical history provided, who experienced serious unexpected events of Migraine (five episodes) and Photophobia. The first episode of Migraine occurred two days after the patient had received the mRNA-1273 vaccine (as third dose), and the remaining episodes occurred on three, five, nine and eleven days after this vaccination. The event of Photophobia (which most likely occurred in the setting of Migraine) occurred six days after the vaccination and had resolved during the same day. As per case description, it was stated that migraine typically occurred after meals. Migraine pain was located over left eye and the patient felt nauseous on all occasions. At the time of this report, the last episode of migraine was resolving. Paracetamol was used as treatment medication for Migraine (however, it was coded as concomitant medication as per source document). The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such, however, could have been considered as not applicable as the patient experienced the events following the third dose of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Having in mind that this patient received the COVID-19 VACCINE ASTRAZENECA prior to vaccination with the company product, Interchange of vaccine products should have been considered in this specific case.; Sender''s Comments: This case concerns a 47-year-old female patient with no medical history provided, who experienced serious unexpected events of Migraine (five episodes) and Photophobia. The first episode of Migraine occurred two days after the patient had received the mRNA-1273 vaccine (as third dose), and the remaining episodes occurred on three, five, nine and eleven days after this vaccination. The event of Photophobia (which most likely occurred in the setting of Migraine) occurred six days after the vaccination and had resolved during the same day. As per case description, it was stated that migraine typically occurred after meals. Migraine pain was located over left eye and the patient felt nauseous on all occasions. At the time of this report, the last episode of migraine was resolving. Paracetamol was used as treatment medication for Migraine (however, it was coded as concomitant medication as per source document). The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such, however, could have been considered as not applicable as the patient experienced the events following the third dose of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Having in mind that this patient received the COVID-19 VACCINE ASTRAZENECA prior to vaccination with the company product, Interchange of vaccine products should have been considered in this specific case.


VAERS ID: 2033582 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-21
Onset:2021-12-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrial fibrillation, Palpitations, SARS-CoV-2 test, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation (Patient get episodes of Atrial fibrillation)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211224; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Heart palpitations; Racing heart (tachycardia); Atrial fibrillation aggravated; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26427166) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations), TACHYCARDIA (Racing heart (tachycardia)) and ATRIAL FIBRILLATION (Atrial fibrillation aggravated) in a 27-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. Concurrent medical conditions included Atrial fibrillation (Patient get episodes of Atrial fibrillation). On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation aggravated) (seriousness criterion medically significant). On an unknown date, the patient experienced PALPITATIONS (Heart palpitations) (seriousness criterion medically significant) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant). On 27-Dec-2021, ATRIAL FIBRILLATION (Atrial fibrillation aggravated) had resolved. At the time of the report, PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported Patient woke up at night with pounding heart that turned into a fast atrial fibrillation episode Patient was treated at hospital with beta blockers and given a prescription. The AF went away after 3 days. It went away after during a light jog. Patient had recurring atrial fibrillation and he think that this AF episode could have been triggered by the vaccine. Patient was hospitalized for 3 hours and diagnosed with fast atrial fibrillation Patient was treated with "Magnesium IV, Metroprolol IV, bisoprolol prescription 5mg once per day for 2 weeks" Company comment: This case concerns a 27-year-old, male patient with medical history of atrial fibrillation episodes, who experienced the unexpected events of atrial fibrillation, palpitations and tachycardia, which were considered as medically significant. The events occurred approximately 3 days after the third dose of mRNA-1273. As reported, patient woke up at night with pounding heart that turned into a fast atrial fibrillation episode. Patient was hospitalized for 3 hours and diagnosed with fast atrial fibrillation and was treated at hospital with Magnesium IV, Metroprolol IV, and was given bisoprolol prescription. The AF went away after 3 days, as reported. Reportedly, it went away after during a light jog. Patient has recurring atrial fibrillation and he thought that this AF episode could have been triggered by the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 27-year-old, male patient with medical history of atrial fibrillation episodes, who experienced the unexpected events of atrial fibrillation, palpitations and tachycardia, which were considered as medically significant. The events occurred approximately 3 days after the third dose of mRNA-1273. As reported, patient woke up at night with pounding heart that turned into a fast atrial fibrillation episode. Patient was hospitalized for 3 hours and diagnosed with fast atrial fibrillation and was treated at hospital with Magnesium IV, Metroprolol IV, and was given bisoprolol prescription. The AF went away after 3 days, as reported. Reportedly, it went away after during a light jog. Patient has recurring atrial fibrillation and he thought that this AF episode could have been triggered by the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2033664 (history)  
Form: Version 2.0  
Age: 0.67  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-10
Onset:2021-12-24
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Neuralgia, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Scalp rash; Nerve pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26432100) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Scalp rash) and NEURALGIA (Nerve pain) in an 8-month-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced RASH (Scalp rash) (seriousness criterion medically significant) and NEURALGIA (Nerve pain) (seriousness criterion medically significant). At the time of the report, RASH (Scalp rash) and NEURALGIA (Nerve pain) 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) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. As patient is male but in source document mentioned as Adverse reaction did not occur as a result of an exposure during pregnancy. Relevant concomitant medications were not reported. Treatment information was not provided. Company Comment: This regulatory authority case concerns a male patient (8 months as reported by RA) with no medical history, who experienced the unexpected serious events of Rash and Neuralgia. The events occurred 14 days after the third mRNA- 1273 vaccine. The outcome of the events was reported as resolving. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. The seriousness criteria of the events were assessed as per regulatory authority report. (There is a discrepancy in case regarding the age of the patient it was reported in RA SD as 8 months, weight 81 kg and height 172 cm.); Sender''s Comments: This regulatory authority case concerns a male patient (8 months as reported by RA) with no medical history, who experienced the unexpected serious events of Rash and Neuralgia. The events occurred 14 days after the third mRNA- 1273 vaccine. The outcome of the events was reported as resolving. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. The seriousness criteria of the events were assessed as per regulatory authority report. (There is a discrepancy in case regarding the age of the patient it was reported in RA SD as 8 months, weight 81 kg and height 172 cm.)


VAERS ID: 2033906 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK8562 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood immunoglobulin G, Blood immunoglobulin G increased, Blood test, Body temperature, Computerised tomogram head, Facial paralysis, Immunisation, Investigation
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: VZV IgG(EIA); Result Unstructured Data: Test Result:49.2; Comments: high; Test Date: 20211231; Test Name: blood test; Result Unstructured Data: Test Result:normal; Test Date: 20211224; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20211231; Test Name: Head CT; Result Unstructured Data: Test Result:normal; Test Date: 20211231; Test Name: otorhinolaryngologist examined; Result Unstructured Data: Test Result:6/40; Comments: diagnosed highly palsy with a Yanagihara score of 6/40
CDC Split Type: JPPFIZER INC202200021464

Write-up: VZV IgG(EIA) was 49.2; Left facial palsy / highly palsy with a Yanagihara score of 6/40; booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: v21133220 (RA). A 56-year and 5-month-old male patient received the third (booster) dose of BNT162B2 (COMIRNATY, Solution for injection), administration date 24Dec2021 14:00 (the day of vaccination), (Lot number: FK8562, Expiration Date: 30Apr2022) via an unspecified route of administration as dose 3 (booster), single for covid-19 immunization. Body temperature before vaccination was 36.5 degrees Centigrade on 24Dec2021. 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 received the second dose for about a week, he experienced Right occipital headache, Suspected neuralgia due to herpes zoster. Took Valaciclovir Hydrochloride (VALACICLOVIR) orally and recovering. The patient''s relevant medical history and concomitant medications were not reported. On unspecified date, the patient previously received the second dose of BNT162b2 (COVID-19 vaccine). Past drug history included: Valaciclovir, notes: After the second dose. Vaccination history included: Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN, took VALACICLOVIR orally and recovering), for COVID-19 immunization, reaction(s): "Right occipital headache", "Suspected neuralgia due to herpes zoster", "Suspected neuralgia due to herpes zoster"; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "Suspected varicella-zoster virus reactivation"; Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. On 30Dec2021 at 13:00 (5 days and 23 hours after the vaccination), the patient experienced adverse events. The course of the events was as follows: On 24Dec2021, the patient received the third dose of a new corona vaccine with no adverse events, and on the afternoon of 30Dec2021, he developed left facial palsy. On 31Dec2021, he was admitted to the hospital emergency room. An otorhinolaryngologist examined him and diagnosed highly palsy with a Yanagihara score of 6/40. No other cranial nerve symptoms, no abnormality was found on blood test and Computerised tomogram head (HEAD CT). The varicella-zoster virus Blood immunoglobulin G (Enzyme immunoassay) (VZV IgG (ELA)) was high at 49.2. On the same day, the patient was started on Prednisolone Sodium Succinate (PREDONINE) infusion 60 mg and VALACICLOVIR 3000 mg, and PREDONINE was gradually decreased. The patient was re-examined on 04Jan2022, and facial palsy showed no improvement. The treatment was continued with a gradual decrease in oral PREDONINE and continued oral Mecobalamin (Methycobal). On 04Jan2022 (11 days after the vaccination), the outcome of the events was not recovered. The reporting physician classified the events as serious (Disability) and assessed that the events was related to BNT162b2. There was no other possible cause of the events such as any other diseases. The reporting physician commented as follows: There was a history of suspected varicella-zoster virus reactivation after the second vaccination with the new corona vaccine, and since the left facial palsy due to varicella-zoster virus reactivation occurred during the first week of vaccination as well, a causal relationship was assumed. This report meet the criteria of Facial palsy. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202200037326 same patient,product/different dose,event


VAERS ID: 2034049 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-20
Onset:2021-12-24
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Myocardial oedema, Palpitations, SARS-CoV-2 test, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211227; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Chest pain; Heart palpitations; Racing heart (tachycardia); Shortness of breath; Fatigue/unusual tiredness; Fainting; Myocardial edema; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26430151) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26430151) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDIAL OEDEMA (Myocardial edema), CHEST PAIN (Chest pain), PALPITATIONS (Heart palpitations), TACHYCARDIA (Racing heart (tachycardia)), DYSPNOEA (Shortness of breath), FATIGUE (Fatigue/unusual tiredness) and SYNCOPE (Fainting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Vaccination. On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced MYOCARDIAL OEDEMA (Myocardial edema) (seriousness criteria hospitalization, medically significant and life threatening). On an unknown date, the patient experienced CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening), PALPITATIONS (Heart palpitations) (seriousness criteria hospitalization and life threatening), TACHYCARDIA (Racing heart (tachycardia)) (seriousness criteria hospitalization and life threatening), DYSPNOEA (Shortness of breath) (seriousness criteria hospitalization and life threatening), FATIGUE (Fatigue/unusual tiredness) (seriousness criteria hospitalization and life threatening) and SYNCOPE (Fainting) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, MYOCARDIAL OEDEMA (Myocardial edema) had not resolved and CHEST PAIN (Chest pain), PALPITATIONS (Heart palpitations), TACHYCARDIA (Racing heart (tachycardia)), DYSPNOEA (Shortness of breath), FATIGUE (Fatigue/unusual tiredness) and SYNCOPE (Fainting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was experience of large clot in lung pressing on lower ventricle. Diagnosis was made by a medical professional in hospital. The symptoms were lead to a hospital stay. Patient was admitted to the hospital for 3 day. The laboratory exam was done that includes ECG, MRA, X ray and the result were unknown, also blood tests such as for certain proteins called troponin that signal heart muscle damage and troponin was raised. Patient had not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial Patient took a treatment medication that include blood thinning tablets name not specified. Re-challenge was reported as unknown. This is a regulatory case concerning a patient of unknown gender and age with no medical history reported, who experienced the unexpected events of myocardial oedema, chest pain, palpitations, tachycardia, dyspnea, fatigue and syncope. A concomitant product in this case is the Covid-19 AstraZeneca vaccine. The event myocardial oedema occurred approximately 4 days after the second dose of mRNA ? 1273 vaccine, while the other events was experienced on an unknown date. Events caused hospitalization and was reported as life threatening and at the time of report outcome was still unknown. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a patient of unknown gender and age with no medical history reported, who experienced the unexpected events of myocardial oedema, chest pain, palpitations, tachycardia, dyspnea, fatigue and syncope. A concomitant product in this case is the Covid-19 AstraZeneca vaccine. The event myocardial oedema occurred approximately 4 days after the second dose of mRNA ? 1273 vaccine, while the other events was experienced on an unknown date. Events caused hospitalization and was reported as life threatening and at the time of report outcome was still unknown. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 2036986 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9712 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Heart rate, Heart rate irregular, Lymphadenopathy, Myocarditis, Nausea, Pain in extremity, Palpitations, Pericarditis, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Chronic kidney disease (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20211224; Test Name: Heart rate; Result Unstructured Data: Test Result:Irreglar pulse; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200009264

Write-up: Racing heart; Fever; Myocarditis; Pericarditis; Painful arm; Irregular pulse; Tachycardia/Racing heart (tachycardia); Tiredness/Fatigue/unusual tiredness; Headache; Nausea; Enlarged lymph nodes (excl infective); This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202201031009454070-HVN50. Other Case identifier(s): GB-MHRA-ADR 26426817. A 16 year-old male patient received bnt162b2 (COMIRNATY), administration date 23Dec2021 (Lot number: FK9712) as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (DOSE 1 MANUFACTURER UNKNOWN), for COVID-19 immunization. Patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The following information was reported: HEART RATE IRREGULAR (medically significant) with onset 24Dec2021, outcome "recovering", described as "Irregular pulse"; TACHYCARDIA (medically significant) with onset 24Dec2021, outcome "recovering", described as "Tachycardia/Racing heart (tachycardia)"; FATIGUE (medically significant) with onset 24Dec2021, outcome "recovering", described as "Tiredness/Fatigue/unusual tiredness"; HEADACHE (medically significant) with onset 24Dec2021, outcome "recovering", described as "Headache"; NAUSEA (medically significant) with onset 24Dec2021, outcome "recovered" (26Dec2021), described as "Nausea"; LYMPHADENOPATHY (medically significant) with onset 24Dec2021, outcome "recovering", described as "Enlarged lymph nodes (excl infective)"; PAIN IN EXTREMITY (medically significant) with onset 25Dec2021, outcome "recovered" (27Dec2021), described as "Painful arm"; PALPITATIONS (medically significant), outcome "not recovered", described as "Racing heart"; PYREXIA (medically significant), outcome "unknown", described as "Fever"; MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis"; PERICARDITIS (medically significant), outcome "unknown", described as "Pericarditis". The events "irregular pulse", "tachycardia/racing heart (tachycardia)", "tiredness/fatigue/unusual tiredness", "headache", "enlarged lymph nodes (excl infective)", "racing heart", "fever", "myocarditis" and "pericarditis" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: heart rate: (24Dec2021) irreglar pulse; sars-cov-2 test: (unspecified date) no - negative covid-19 test. Patient discussed with General Physician on 29Dec2021. The report did relate to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to hospital stay. No blood tests, such as for certain proteins (called troponin) that signal heart muscle damage were taken. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2036990 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-21
Onset:2021-12-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Gait disturbance, Grip strength decreased, Joint swelling, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200009298

Write-up: Barely move up and down stairs; No grip or strength; Swollen ankles; Painful feet/pain on top of feet/severe pain on balls of heel/ lots of pain on underside of feet/pain in back of legs/pain in fingers; Painful joints/ pain in elbows and shoulders; Fatigue extreme; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201031135213430-B5UZJ. Other Case identifier(s): GB-MHRA-ADR 26427374. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 21Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19 and did not have a COVID-19 test. Patient was not enrolled in clinical trial. The following information was reported: JOINT SWELLING (medically significant) with onset 24Dec2021, outcome "not recovered", described as "Swollen ankles"; PAIN IN EXTREMITY (medically significant) with onset 24Dec2021, outcome "not recovered", described as "Painful feet/pain on top of feet/severe pain on balls of heel/ lots of pain on underside of feet/pain in back of legs/pain in fingers"; ARTHRALGIA (medically significant) with onset 24Dec2021, outcome "not recovered", described as "Painful joints/ pain in elbows and shoulders"; FATIGUE (medically significant) with onset 24Dec2021, outcome "not recovered", described as "Fatigue extreme"; GAIT DISTURBANCE (medically significant), outcome "unknown", described as "Barely move up and down stairs"; GRIP STRENGTH DECREASED (medically significant), outcome "unknown", described as "No grip or strength". Reportedly, the patient had swollen ankles, pain on top of feet, severe pain on balls of heel, lots of pain on underside of feet, pain in back of legs, elbows and shoulders, could barely move up and down stairs. Latest issues were now developing pain in fingers, no grip or strength. She imagines its what arthritis feels like. She also had extreme tiredness, usually about 16:00 and which point she could sleep for 2 hours. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2037012 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Breast pain, Breast swelling, Dysmenorrhoea, Immunisation, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201001; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200009308

Write-up: Abdominal pain/ Extreme abdominal pain; Breast swollen immensely; Painful periods; Sore breasts; Booster; Painful arm; This is a spontaneous report received from a contactable reporter(Consumer) The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201031606295970-VPFBX. Other Case identifier(s): GB-MHRA-ADR 26429251. A 20 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 24Dec2021 (Lot number: FN3543) at the age of 20 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19" (unspecified if ongoing), notes: Unsure when symptoms started, Unsure when symptoms stopped. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 16Jun2021, for COVID-19 immunisation; Bnt162b2 (Dose 2), administration date: 11Aug2021, for COVID-19 immunisation, reaction(s): "COVID-19", "Drug ineffective", "Inappropriate schedule of vaccine administered". Patient''s Last menstrual period was 18Dec2021. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The following information was reported: IMMUNISATION (medically significant) with onset 24Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant) with onset 24Dec2021, outcome "recovered", described as "Painful arm"; BREAST PAIN (medically significant) with onset 25Dec2021, outcome "recovering", described as "Sore breasts"; DYSMENORRHOEA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Painful periods"; ABDOMINAL PAIN (medically significant), outcome "recovering", described as "Abdominal pain/ Extreme abdominal pain"; BREAST SWELLING (medically significant), outcome "unknown", described as "Breast swollen immensely". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Oct2020) yes - positive COVID-19 test. Clinical course: It was reported that the patient''s Breasts were very sore and had swollen immensely. That had been ongoing for 1 week. Her first period after the booster had been much more painful than usual with extreme abdominal pain. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2037081 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Colitis ulcerative, Fatigue, Gastrointestinal pain, SARS-CoV-2 test, Skin haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal ulceration (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Immune-mediated/autoimmune disorders (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: Autoimmune disorder (I have an autoimmune disease which I am not being treated); Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220102; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: back pain; ulcerative colitis; Gut pain; Skin bleeding; Chronic fatigue; This case was received via regulatory authority on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), COLITIS ULCERATIVE (ulcerative colitis), GASTROINTESTINAL PAIN (Gut pain), FATIGUE (Chronic fatigue) and SKIN HAEMORRHAGE (Skin bleeding) in a 42-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Autoimmune disorder (I have an autoimmune disease which I am not being treated) and Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced FATIGUE (Chronic fatigue) (seriousness criterion medically significant). On 25-Dec-2021, the patient experienced GASTROINTESTINAL PAIN (Gut pain) (seriousness criterion medically significant) and SKIN HAEMORRHAGE (Skin bleeding) (seriousness criterion medically significant). On an unknown date, the patient experienced BACK PAIN (back pain) (seriousness criterion medically significant) and COLITIS ULCERATIVE (ulcerative colitis) (seriousness criterion medically significant). On 02-Jan-2022, SKIN HAEMORRHAGE (Skin bleeding) had resolved. At the time of the report, BACK PAIN (back pain) and COLITIS ULCERATIVE (ulcerative colitis) was resolving and GASTROINTESTINAL PAIN (Gut pain) and FATIGUE (Chronic fatigue) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2022, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Reported that patient have an autoimmune disease which was undiagnosed, but its most likely ulcerative colitis, which runs in his family (could also be crohn''s disease). As such patient have various food allergies and intolerances which patient manage mainly through the food. patient eat to avoid gut inflammation and a general flareup. All this was being followed when patient took the booster vaccine, and yet starting from day 2, all the symptoms of him worse flareup and reactions started to appear. patient was bleeding from cysts that inflamed on his scalp, patient bloated and was extremely gassy, patient had (and still slightly suffering from) chronic fatigue, and patient was constipated with sharp back pain in his mid to upper back (which is usually associated with a gut issue) Reported that patient have an autoimmune disease which patient not being treated for. Treatment product was not provided by the reporter Patient has not had symptoms associated with COVID-19 Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial Company comment: This is a regulatory case concerning a 42-year-old male patient with medical history of untreated Autoimmune disorder and Immunodeficiency, who experienced the serious unexpected, according RA, events of back pain, colitis ulcerative, gastrointestinal pain, fatigue and skin haemorrhage. The event fatigue occurred on the day after the third dose of mRNA-1273 vaccine. The events gastrointestinal pain and skin haemorrhage occurred 2 days after the third dose of mRNA-1273 vaccine. Back pain and colitis ulcerative occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge is unknown according to SD. The medical history of Autoimmune disorder and Immunodeficiency remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a 42-year-old male patient with medical history of untreated Autoimmune disorder and Immunodeficiency, who experienced the serious unexpected, according CCDS, events of back pain, colitis ulcerative, gastrointestinal pain, fatigue and skin haemorrhage. The event fatigue occurred on the day after the third dose of mRNA-1273 vaccine. The events gastrointestinal pain and skin haemorrhage occurred 2 days after the third dose of mRNA-1273 vaccine. Back pain and colitis ulcerative occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge is unknown according to SD. The medical history of Autoimmune disorder and Immunodeficiency remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2037083 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Pain in extremity, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unspecified immunity deficiency ((probably due to being raised in an industrial area - chemical and steel works))
Preexisting Conditions: Medical History/Concurrent Conditions: Spleen disorder; Spleen pain
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: arm pain and dull aching; Diarrhea; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26432842) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain and dull aching) and DIARRHOEA (Diarrhea) in a 59-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Spleen pain and Spleen disorder. Concurrent medical conditions included Unspecified immunity deficiency ((probably due to being raised in an industrial area - chemical and steel works)). On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion disability). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain and dull aching) (seriousness criterion disability). On 28-Dec-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, PAIN IN EXTREMITY (arm pain and dull aching) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication information was reported. No concomitant medication information was reported. Patient had diarrhea for 4 days with gastric wind. Patient was surprised that this kind of vaccine has an effect on the digestive system. Previously the patient had also felt arm pain and dull aching. If patient had known the possible outcome, he wouldn''t have bothered with the vaccine, instead using the previous 1st 2nd doses - Astra Zeneca. Company comment This case concerns a 59-year-old male patient, with medical history of Spleen disorder and Unspecified immunity deficiency, who experienced the unexpected serious events of PAIN IN EXTREMITY and DIARRHOEA. The events occurred on the following day after the administration of the third dose of mRNA-1273 vaccine. Patient?s medical history of Spleen disorder and Unspecified immunity deficiency, remains as a confounder. Patient had previous 1st 2nd doses - Astra Zeneca. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 59-year-old male patient, with medical history of Spleen disorder and Unspecified immunity deficiency, who experienced the unexpected serious events of PAIN IN EXTREMITY and DIARRHOEA. The events occurred on the following day after the administration of the third dose of mRNA-1273 vaccine. Patient?s medical history of Spleen disorder and Unspecified immunity deficiency, remains as a confounder. Patient had previous 1st 2nd doses - Astra Zeneca. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2037188 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, 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: None
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202200019403

Write-up: Primary immunisation: BNT162b2; Booster: COMIRNATY; Headache had gotten worse. Constant full pain getting Sharp intermittently for short periods; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The Regulatory Authority number GB-MHRA-WEBCOVID-202201051840513670-RI1KC, other case identifier(s) GB-MHRA-ADR 26440619. A 42 year-old male patient received bnt162b2 (COMIRNATY), administration date 24Dec2021 (Lot number: unknown) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Vaccination history included Bnt162b2 (DOSE 2, SINGLE, Lot Number: Unknown, Route of administration: Unspecified), administration date: Jun2021, for COVID-19 immunisation, reaction(s) Headache; Bnt162b2 (DOSE 1, SINGLE, Lot Number: Unknown, Route of administration: Unspecified), for COVID-19 immunisation. The following information was reported IMMUNISATION (medically significant) with onset 24Dec2021, outcome unknown, described as Primary immunisation BNT162b2; Booster: COMIRNATY; HEADACHE (medically significant) with onset 24Dec2021, outcome not recovered. The patient underwent the following laboratory tests and procedures sars-cov-2 test (08Jan2021) no - negative covid-19 test. It was unsure if patient had symptoms associated with COVID-19. The patient was not enrolled in clinical trial. The patient had headache since the second vaccine on an unknown date in Jun2021. Since he had the booster jab in December, the headache had gotten worse and constant full pain getting sharp intermittently for short periods. The patient had not been tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Linked Report(s) GB-PFIZER INC-202200052664 same patient/drug/different dose/event.


VAERS ID: 2037210 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-12-24
   Days after vaccination:276
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER PU46691 / UNK - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER 4120Z003 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; COLCHICINE; COLCHICINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201231; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Aching pain in hands, forearms, elbows; Armpit pain; This case was received via the Regulatory Authority (Reference number GB-MHRA-ADR 26433376) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aching pain in hands, forearms, elbows) and AXILLARY PAIN in a 52-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Co-suspect products included non-company products COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. Concomitant products included ALLOPURINOL from 26-May-2021 to an unknown date and COLCHICINE from 27-Apr-2021 to 03-May-2021 for Gout, COLCHICINE from 23-Jun-2021 to 28-Jun-2021 for an unknown indication. On 23-Mar-2021, the patient received dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 13-Jun-2021, the patient received dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced PAIN IN EXTREMITY (Aching pain in hands, forearms, elbows) (seriousness criterion medically significant) and AXILLARY PAIN (seriousness criterion medically significant). On 26-Dec-2021, PAIN IN EXTREMITY (Aching pain in hands, forearms, elbows) had resolved. On 27-Dec-2021, AXILLARY PAIN had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 31-Dec-2020, SARS-CoV-2 test No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had not tested positive for COVID-19 since having the vaccine. No medical history was reported. Patient was not enrolled in clinical trial. No treatment medications provided by the reporter. Most recent FOLLOW-UP information incorporated above includes on 07-Jan-2022 the Follow up contains no new information. This is an RA case concerning a 52-year-old, male patient with no relevant medical history reported who experienced pain in hands, forearms, elbows, and armpit. The events started 1 day after receiving the 3rd dose of mRNA1273 and lasted 2-3 days. Event seriousness was captured as provided by the Regulatory Authority. The benefit-risk relationship of mRNA-1273 in not affected by this report.


VAERS ID: 2037316 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-24
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac fibrillation, Immunisation, Infarction
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Tachyarrhythmia terms, nonspecific (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202200043630

Write-up: This is a spontaneous report received from a contactable reporter(s) (consumer or other non-HCP) from Regulatory Authority. Regulatory number: IT-MINISAL02-827754 (RA). A 75-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left (Lot number: Unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (1st dose, lot number unknown), for COVID-19 immunisation; Comirnaty (2nd dose, lot number unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (life threatening), outcome "unknown", described as "Booster"; INFARCTION (life threatening) with onset 24Dec2021, outcome "not recovered", described as "Diagnosis: microinfarction, now needs bypass operation"; CARDIAC FIBRILLATION (life threatening) with onset 24Dec2021, outcome "not recovered", described as "Onset of cardiac fibrillation.". Impact on quality of life (10/10). The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2037334 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: LTJNJFOC20220122363

Write-up: URTICARIA; This spontaneous report received from a physician by a Regulatory Authority (LT-SMCA-4429) and concerned a 28 year old female of unspecified race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: unknown) dose was not reported, dose number in series was 01, 01 in total administered on 23-DEC-2021 for Covid-19 (coronavirus disease). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 24-DEC-2021, the patient experienced urticarial (dose number in series was 01). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from urticaria on 26-DEC-2021. This report was serious (Other Medically Important Condition).


VAERS ID: 2038721 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Heavy menstrual bleeding, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: This case received via the regulatory authority (reference number: GB-MHRA-ADR 26435916) on Jan 5, 2022, forwarded to Moderna, reported by a consumer, describes the occurrence of heavy menstrual bleeding (prolonged periods) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for immunization. No medical history reported. On Dec 23, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Dec 24, 2021, patient experienced heavy menstrual bleeding/prolonged periods (medically significant). On Dec 31, 2021, heavy menstrual bleeding (prolonged periods): resolving. Diagnostic results: On an unknown date, SARS-CoV-2 test: No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided. Reportedly, patient experienced prolonged and irregular periods since her first jab. Patient did not have possible inflammation of the heart like myocarditis or pericarditis. The investigations or tests conducted: not applicable. Sender''s comments: This case refers to a 42-year-old female patient with no known medical history who experienced the unexpected, heavy menstrual bleeding approximately 1 day after receiving the third dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 not affected by this report.


VAERS ID: 2038852 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 018J21A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chest discomfort, Chills, Dizziness, Dyspnoea, Fatigue, General physical health deterioration, Headache, Hyperpyrexia, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Malaise, Myalgia, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE; LIOTHYRONINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211225; Test Name: hyperpyrexia; Result Unstructured Data: Fever: 40.5 to 42 degrees Celcius
CDC Split Type: NLMODERNATX, INC.MOD20224

Write-up: fainting; stuffy; chest pressure; vertigo; Muscle Pain; headache; One day after vaccination unable to walk to the first floor and still. Condition decreased by 90%; Don''t feel good; Response to or around the injection site: heat; Response to or around the injection site: itching; Cold shivers; Response to or around the injection site: pain; Inflammatory reaction at the reaction site: heat, pain, swelling, arising within a week of vaccination; Fever: 40.5 to 42 degrees Celcius; fatigue; nausea; Joint pain; Response to or around the injection site: swelling, occurring within a week of vaccination; This case was received (Reference number: NL-LRB-00741239) on 13-Jan-2022 and was forwarded to Moderna on 13-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERPYREXIA (Fever: 40.5 to 42 degrees Celcius) and SYNCOPE (fainting) in a 59-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 018J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: BioNTech/Pfizer vaccin (Comirnaty) COVID-19 VACCIN PFIZER INJVLST 0,3MLCOVID-19 VACCIN PFIZER INJVLST on 25-May-2021, BioNTech/Pfizer vaccin (Comirnaty) COVID-19 VACCIN PFIZER INJVLST 0,3MLCOVID-19 VACCIN PFIZER INJVLST on 25-May-2021, BioNTech/Pfizer vaccin (Comirnaty) COVID-19 VACCIN PFIZER INJVLST 0,3MLCOVID-19 VACCIN PFIZER INJVLST on 29-Jun-2021, BioNTech/Pfizer vaccin (Comirnaty) COVID-19 VACCIN PFIZER INJVLST 0,3MLCOVID-19 VACCIN PFIZER INJVLST on 29-Jun-2021, BioNTech/Pfizer vaccin (Comirnaty) COVID-19 VACCIN PFIZER INJVLST 0 and3MLCOVID-19 VACCIN PFIZER INJVLST on 29-Jun-2021. Past adverse reactions to the above products included Body temperature increased with BioNTech/Pfizer vaccin (Comirnaty) COVID-19 VACCIN PFIZER INJVLST 0 and3MLCOVID-19 VACCIN PFIZER INJVLST; Fatigue with BioNTech/Pfizer vaccin (Comirnaty) COVID-19 VACCIN PFIZER INJVLST 0 and3MLCOVID-19 VACCIN PFIZER INJVLST; Pain in arm with BioNTech/Pfizer vaccin (Comirnaty) COVID-19 VACCIN PFIZER INJVLST 0,3MLCOVID-19 VACCIN PFIZER INJVLST, BioNTech/Pfizer vaccin (Comirnaty) COVID-19 VACCIN PFIZER INJVLST 0 and3MLCOVID-19 VACCIN PFIZER INJVLST; and Pyrexia with BioNTech/Pfizer vaccin (Comirnaty) COVID-19 VACCIN PFIZER INJVLST 0 and3MLCOVID-19 VACCIN PFIZER INJVLST. Concomitant products included LEVOTHYROXINE and LIOTHYRONINE for an unknown indication. On 24-Dec-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced HYPERPYREXIA (Fever: 40.5 to 42 degrees Celcius) (seriousness criterion medically significant), MALAISE (Don''t feel good), INJECTION SITE WARMTH (Response to or around the injection site: heat), INJECTION SITE PRURITUS (Response to or around the injection site: itching), CHILLS (Cold shivers), INJECTION SITE PAIN (Response to or around the injection site: pain), INJECTION SITE INFLAMMATION (Inflammatory reaction at the reaction site: heat, pain, swelling, arising within a week of vaccination), FATIGUE (fatigue), NAUSEA (nausea), ARTHRALGIA (Joint pain) and INJECTION SITE SWELLING (Response to or around the injection site: swelling, occurring within a week of vaccination). On 26-Dec-2021, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (One day after vaccination unable to walk to the first floor and still. Condition decreased by 90%). On an unknown date, the patient experienced SYNCOPE (fainting) (seriousness criterion medically significant), DYSPNOEA (stuffy), CHEST DISCOMFORT (chest pressure), DIZZINESS (vertigo), HEADACHE (headache) and MYALGIA (Muscle Pain). At the time of the report, HYPERPYREXIA (Fever: 40.5 to 42 degrees Celcius), INJECTION SITE WARMTH (Response to or around the injection site: heat), INJECTION SITE PRURITUS (Response to or around the injection site: itching), CHILLS (Cold shivers), INJECTION SITE PAIN (Response to or around the injection site: pain), INJECTION SITE INFLAMMATION (Inflammatory reaction at the reaction site: heat, pain, swelling, arising within a week of vaccination) and INJECTION SITE SWELLING (Response to or around the injection site: swelling, occurring within a week of vaccination) was resolving, SYNCOPE (fainting), DYSPNOEA (stuffy), CHEST DISCOMFORT (chest pressure) and DIZZINESS (vertigo) outcome was unknown, GENERAL PHYSICAL HEALTH DETERIORATION (One day after vaccination unable to walk to the first floor and still. Condition decreased by 90%), MALAISE (Don''t feel good), FATIGUE (fatigue) and NAUSEA (nausea) had not resolved and HEADACHE (headache), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2021, Hyperpyrexia: fever: 40.5 to 42 degrees celcius (High) Fever: 40.5 to 42 degrees Celcius. No treatment information was provided. Sender''s Diagnosis was reported as Injection site inflammation.; Reporter''s Comments: Since the nature of the reported reaction does not imply seriousness according to one of the CIOMS critera, the reaction was considered as non-seriousSender''s Comments: This case concerns a patient, with medical history of BioNTech/Pfizer vaccine (Comirnaty) COVID-19, who experienced the serious unexpected event(s) of Hyperpyrexia and additional non-serious event(s). The event(s) started occurring after the 1st dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered unknown. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 2040708 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH P100352292 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Emotional distress, Immunisation, Insomnia, Tinnitus
SMQs:, Depression (excl suicide and self injury) (broad), Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202200014225

Write-up: The tinnitus is unbearably loud/ the ringing in ears increased again/ only this time in BOTH ears for the first time; prevented patient from sleeping; very distressing; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Agency Agency-WEB. The reporter is the patient. Regulatory number: DE-PEI-CADR2021220565. Other Case identifier(s): DE-CADRPEI-2021220565 (Webportal), DE-PEI-202100274463. A 56 year-old female patient received bnt162b2 (COMIRNATY), administration date 24Dec2021 (Lot number: P100352292) as dose 3 (booster), 0,3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 2,Dose 2), administration date: 25May2021, for covid-19 immunization, reaction(s): "short-term memory loss", "Tinnitus"; Comirnaty (Dose 1), for covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 24Dec2021, outcome "unknown", described as "Booster"; TINNITUS (hospitalization), outcome "unknown", described as "The tinnitus is unbearably loud/ the ringing in ears increased again/ only this time in BOTH ears for the first time"; INSOMNIA (hospitalization), outcome "unknown", described as "prevented patient from sleeping"; EMOTIONAL DISTRESS (hospitalization), outcome "unknown", described as "very distressing". Clinical course: About two weeks after the third (booster) vaccination - again with BioNTech - the ringing in ears increased again, just as it had done with the second vaccination, only this time in BOTH ears for the first time. The tinnitus was unbearably loud. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202200054718 same reporter, product / Different patient, dose, event;DE-PFIZER INC-202200054717 same repoter, patient, product/ Different dose, event


VAERS ID: 2040783 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-16
Onset:2021-12-24
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACETYLSALICYLIC ACID; METFORMINE [METFORMIN HYDROCHLORIDE]; ESOMEPRAZOLE [ESOMEPRAZOLE MAGNESIUM]; CANDESARTAN CILEXETIL; FUROSEMIDE; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (in poor management); Impaired work ability (impaired functioning but living independently and moving without aids.); Multimorbidity
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:192/107 mmHg
CDC Split Type: FIPFIZER INC202200031799

Write-up: Middle cerebral artery infarct; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority. Regulatory number: FI-FIMEA-20218057 (Agency). A 94 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "multiple diseases" (unspecified if ongoing); "hypertension" (unspecified if ongoing), notes: in poor management; "impaired functioning " (unspecified if ongoing), notes: impaired functioning but living independently and moving without aids. Concomitant medication(s) included: ACETYLSALICYLIC ACID; METFORMINE [METFORMIN HYDROCHLORIDE]; ESOMEPRAZOLE [ESOMEPRAZOLE MAGNESIUM]; CANDESARTAN CILEXETIL; FUROSEMIDE; PARACETAMOL. The following information was reported: CEREBRAL INFARCTION (medically significant, life threatening) with onset 24Dec2021, outcome "unknown", described as "Middle cerebral artery infarct". The patient underwent the following laboratory tests and procedures: blood pressure measurement: 192/107 mmHg. Additional information: General condition stable Has not taken Covid vaccine earlier but with Omikron variant decided to take first vaccine on 16 Dec2021. No immediate adverse effects from vaccine, no local reaction or fever. Happened to have a massive cerebral infarction of the middle cerebral artery area, With high risk factors, on 24Dec2021 and will probably die due to this in the next few days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2041052 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-03
Onset:2021-12-24
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (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: Moderna CoviD-19 Vaccine; ASPIRIN (E.C.); ATORVASTATIN; BISOPROLOL; RAMIPRIL
Current Illness: Chest pain; Chest X-ray; Chest X-ray normal; Ex-smoker; Hemoptysis; Motor vehicle accident; Non ST segment elevation myocardial infarction; Percutaneous transluminal coronary angioplasty
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Acute non-ST segment elevation myocardial infarction; This case was received via Regulatory Authority, MHRA (Reference number: GB-MHRA-ADR 26449639) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by an other health care professional and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (Acute non-ST segment elevation myocardial infarction) in a 50-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Chest pain since 22-Dec-2021, Chest X-ray normal since 22-Dec-2021, Chest pain since 22-Dec-2021, Motor vehicle accident since 05-Nov-2021, Chest X-ray normal since 09-Oct-2021, Chest X-ray since 09-Oct-2021, Hemoptysis since 04-Oct-2021, Hemoptysis since 04-Oct-2021, Motor vehicle accident since 29-Dec-2021 and Percutaneous transluminal coronary angioplasty since 24-Dec-2021. Concurrent medical conditions included Non ST segment elevation myocardial infarction since 29-Dec-2021, Ex-smoker since 29-Dec-2021 and Non ST segment elevation myocardial infarction since 24-Dec-2021. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) from 24-Dec-2021 to an unknown date, ATORVASTATIN from 24-Dec-2021 to 04-Jan-2022, BISOPROLOL from 24-Dec-2021 to an unknown date and RAMIPRIL from 24-Dec-2021 to an unknown date for Non ST segment elevation myocardial infarction, mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. On 03-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (Acute non-ST segment elevation myocardial infarction) (seriousness criterion medically significant). At the time of the report, ACUTE MYOCARDIAL INFARCTION (Acute non-ST segment elevation myocardial infarction) was resolving. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Historical condition not given for dates: 29-dec-2021, 24-dec-2021(Reported twice), 23-dec-2021, 22-dec-2021(reported-47 times), 03-dec-2021(reported twice), 02-dec-2021, 01-dec-2021, 03-nov-2021, 05-oct-2021, 04-oct-2021, 27-may-2021, 25-mar-2021 with continuing as YES were reported. Patient admitted, angioplasty done. Drugs remapped include: Atorvastatin 80mg tablets, Aspirin 75mg dispersible tablets, Ramipril 2.5mg capsules, Bisoprolol 2.5mg tablets company comment This is a regulatory case concerning a 50 year old male patient, with relevant medical history of chest pain, Motor vehicle accident and Hemoptysis, who experienced the unexpected, serious (seriousness criteria-medically significant,) AESI event of acute myocardial infarction 21 days after the administration of third dose of mRNA-1273 vaccine for an unknown indication. Patient had medical history of Chest pain, Chest X-ray normal and Chest pain since 22-Dec-2021, Motor vehicle accident ,Chest X-ray normal since 09-Oct-2021, Hemoptysis since 04-Oct-2021, Motor vehicle accident since 29-Dec-2021 and Percutaneous transluminal coronary angioplasty since 24-Dec-2021. Concurrent medical conditions included Non ST segment elevation myocardial infarction since 29-Dec-2021, Ex-smoker since 29-Dec-2021 and Non ST segment elevation myocardial infarction since 24-Dec-2021. Concomitant products included acetylsalicylic acid, atorvastatin, bisoprolol and ramipril for non ST segment elevation myocardial infarction and mRNA-1273 vaccine for an unknown indication. The Patient was admitted, angioplasty was done, was given Atorvastatin as 80mg tablets, Aspirin 75mg dispersible tablets, Ramipril 2.5mg capsules and Bisoprolol 2.5mg tablets. At the time of the report, the event Acute Myocardial Infarction was resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious, as per Regulatory Authority report.; Sender''s Comments: This is a regulatory case concerning a 50 year old male patient, with relevant medical history of chest pain, Motor vehicle accident and Hemoptysis, who experienced the unexpected, serious (seriousness criteria-medically significant,) AESI event of acute myocardial infarction 21 days after the administration of third dose of mRNA-1273 vaccine for an unknown indication. Patient had medical history of Chest pain, Chest X-ray normal and Chest pain since 22-Dec-2021, Motor vehicle accident ,Chest X-ray normal since 09-Oct-2021, Hemoptysis since 04-Oct-2021, Motor vehicle accident since 29-Dec-2021 and Percutaneous transluminal coronary angioplasty since 24-Dec-2021. Concurrent medical conditions included Non ST segment elevation myocardial infarction since 29-Dec-2021, Ex-smoker since 29-Dec-2021 and Non ST segment elevation myocardial infarction since 24-Dec-2021. Concomitant products included acetylsalicylic acid, atorvastatin, bisoprolol and ramipril for non ST segment elevation myocardial infarction and mRNA-1273 vaccine for an unknown indication. The Patient was admitted, angioplasty was done, was given Atorvastatin as 80mg tablets, Aspirin 75mg dispersible tablets, Ramipril 2.5mg capsules and Bisoprolol 2.5mg tablets. At the time of the report, the event Acute Myocardial Infarction was resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious, as per Regulatory Authority report.


VAERS ID: 2041053 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000040A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Decreased appetite, Feeling of body temperature change, Influenza like illness, Pain
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: ASACOL; FOSTAIR; PARACETAMOL; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Generalised aching; Flu symptoms, not eating for 9 days, causing my Asthma to flare up; Appetite lost; Flu symptoms, not eating for 9 days, causing my Asthma to flare up; Feeling hot and cold; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26424867) on 07-Jan-2022 and was forwarded to Moderna on 07-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu symptoms, not eating for 9 days, causing my Asthma to flare up), DECREASED APPETITE (Appetite lost), ASTHMA (Flu symptoms, not eating for 9 days, causing my Asthma to flare up), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) and PAIN (Generalised aching) in a 53-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040A) for COVID-19 vaccination. The patient''s past medical history included Asthma. Previously administered products included for Product used for unknown indication: SARS-COV-2 VACCINE; for COVID-19 vaccination: SARS-COV-2 VACCINE. Past adverse reactions to the above products included No adverse effect with SARS-COV-2 VACCINE and SARS-COV-2 VACCINE. Concomitant products included MESALAZINE (ASACOL), BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE (FOSTAIR), PARACETAMOL and SALBUTAMOL for an unknown indication. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 24-Dec-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu symptoms, not eating for 9 days, causing my Asthma to flare up) (seriousness criterion medically significant), DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant), ASTHMA (Flu symptoms, not eating for 9 days, causing my Asthma to flare up) (seriousness criterion medically significant) and FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (Generalised aching) (seriousness criterion medically significant). On 31-Dec-2021, FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu symptoms, not eating for 9 days, causing my Asthma to flare up), DECREASED APPETITE (Appetite lost) and ASTHMA (Flu symptoms, not eating for 9 days, causing my Asthma to flare up) had not resolved and PAIN (Generalised aching) outcome was unknown. No treatment information was provided by the reporter. It was reported that the patient felt hot and cold with flu like symptoms. His asthma was extremely worse. His body ached and hardly ate (two slices of toast, two bowls of cereal and two oranges). On 31/Dec/2021 his hot and cold temperatures died down so he was informed it could be the virus that came to an end. He was ill again the next day. Company comment: This case concerns a 53-year-old male patient with medical history of asthma, who experienced the serious unexpected events of influenza like illness, decreased appetite, asthma, feeling of body temperature change and pain. The event pain occurred on an unknown date after the third dose of mRNA-1273 vaccine administered via parenteral route. The rest of the events occurred the day after the third dose of mRNA-1273 vaccine administered via parenteral route. The rechallenge was unknown according to SD. The medical history of asthma remains a confounder for asthma. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 53-year-old male patient with medical history of asthma, who experienced the serious unexpected events of influenza like illness, decreased appetite, asthma, feeling of body temperature change and pain. The event pain occurred on an unknown date after the third dose of mRNA-1273 vaccine administered via parenteral route. The rest of the events occurred the day after the third dose of mRNA-1273 vaccine administered via parenteral route. The rechallenge was unknown according to SD. The medical history of asthma remains a confounder for asthma. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2041270 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Menstruation delayed, Menstruation irregular, 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: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200019292

Write-up: Late period; Missed period; Primary immunisation: BNT162b2 ; Booster: COMIRNATY; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the RA. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201060015468980-CO2WS. Other Case identifier(s): GB-MHRA-ADR 26441556. A female patient received bnt162b2 (COMIRNATY), administration date 24Dec2021 (Lot number: FK9706) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: Unknown, Route of administration: Unspecified), administration date: 24Aug2021, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered"; Bnt162b2 (DOSE 1, SINGLE, Lot number: Unknown, Route of administration: Unspecified), administration date: 28Jun2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 24Dec2021, outcome "unknown", described as "Primary immunisation: BNT162b2 ; Booster: COMIRNATY"; MENSTRUATION DELAYED (medically significant), outcome "not recovered", described as "Late period"; MENSTRUATION IRREGULAR (medically significant), outcome "unknown", described as "Missed period". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical information: The patient missed her period for Nov2021 and Dec2021. The patient had not test positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200067276 same patient/drug/different dose/ event


VAERS ID: 2041329 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000029A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Conjunctivitis, Deafness, Dizziness, Ear pain, Headache, Influenza, SARS-CoV-2 test
SMQs:, Severe cutaneous adverse reactions (broad), Anticholinergic syndrome (broad), Hearing impairment (narrow), Vestibular disorders (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (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: COVID-19 MRNA VACCINE BNT162B2; COVID-19 MRNA VACCINE BNT162B2
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Conjunctivitis; Flu; Headache; Earache; Hearing loss; Dizziness; This case was received via the RA (Reference number: GB-MHRA-ADR 26444798) on 07-Jan-2022 and was forwarded to Moderna on 07-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA (Flu), HEADACHE (Headache), EAR PAIN (Earache), DEAFNESS (Hearing loss), DIZZINESS (Dizziness) and CONJUNCTIVITIS (Conjunctivitis) in a 39-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000029A) for an unknown indication. Concurrent medical conditions included Suspected COVID-19 since 24-Dec-2021. Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 24-May-2021 to an unknown date and TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) for COVID-19. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced INFLUENZA (Flu) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), EAR PAIN (Earache) (seriousness criterion medically significant), DEAFNESS (Hearing loss) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On 27-Dec-2021, the patient experienced CONJUNCTIVITIS (Conjunctivitis) (seriousness criterion medically significant). On 04-Jan-2022, CONJUNCTIVITIS (Conjunctivitis) had resolved with sequelae. At the time of the report, INFLUENZA (Flu), HEADACHE (Headache), EAR PAIN (Earache) and DEAFNESS (Hearing loss) had not resolved and DIZZINESS (Dizziness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced intense, headache, dizziness and fever 24 hours after the booster dose. After a further 48 hours the headaches and dizziness continued and also started to feel heavy cold symptoms sore throat, congestion, ear pain. After a further 24-48 hours patient had started to experience conjuctivitis symptoms discharge from my eyes, blood shot eyes and disrupted vision. Patient had general lethargy and aching throughout the period. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. No treatment information was provided by the reporter. Company comment: This is a regulatory case concerning a 39-year-old male patient with no medical history reported, who experienced the serious unexpected, according CCDS, events of influenza, headache, ear pain, deafness, dizziness and conjunctivitis. The events influenza, headache, ear pain, deafness, dizziness occurred the day after the third dose of mRNA-1273 vaccine. The event conjunctivitis occurred approximately 4 days after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a 39-year-old male patient with no medical history reported, who experienced the serious unexpected, according CCDS, events of influenza, headache, ear pain, deafness, dizziness and conjunctivitis. The events influenza, headache, ear pain, deafness, dizziness occurred the day after the third dose of mRNA-1273 vaccine. The event conjunctivitis occurred approximately 4 days after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2041400 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-16
Onset:2021-12-24
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005686 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Intermenstrual bleeding, Menstruation irregular, Ovulation pain, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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: PFIZER BIONTECH COVID-19 VACCINE; ZELLETA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Intermenstrual pain; Intermenstrual bleeding; Spotting menstrual; Irregular menstruation; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 26447093) on 07-Jan-2022 and was forwarded to Moderna on 07-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of OVULATION PAIN (Intermenstrual pain), INTERMENSTRUAL BLEEDING (Intermenstrual bleeding), INTERMENSTRUAL BLEEDING (Spotting menstrual) and MENSTRUATION IRREGULAR (Irregular menstruation) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005686) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination, DESOGESTREL (ZELLETA) for Contraception. On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced OVULATION PAIN (Intermenstrual pain) (seriousness criterion medically significant), INTERMENSTRUAL BLEEDING (Intermenstrual bleeding) (seriousness criterion medically significant), INTERMENSTRUAL BLEEDING (Spotting menstrual) (seriousness criterion medically significant) and MENSTRUATION IRREGULAR (Irregular menstruation) (seriousness criterion medically significant). At the time of the report, OVULATION PAIN (Intermenstrual pain), INTERMENSTRUAL BLEEDING (Intermenstrual bleeding), INTERMENSTRUAL BLEEDING (Spotting menstrual) and MENSTRUATION IRREGULAR (Irregular menstruation) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was taken contraceptive that had stopped period for about 12 months and few days after her booster had felt like a period -pain, bleeding which lasted for 10 days, stopped for a week and returned yesterday Patient was not tested positive for COVID-19 since had the vaccine Patient was not enrolled in clinical trial Company Comment: This is a regulatory case concerning a 24-year-old, female patient with no relevant medical history reported, concomitant medication with contraceptives (desogestrel) and Interchange of vaccine products (TOZINAMERAN), who experienced the unexpected serious event of Intermenstrual pain, Intermenstrual bleeding and Menstruation irregular. The events occurred approximately 8 days after the third (booster) dose of mRNA-1273 vaccine and lasted for 10 days. The patient referred that 1 week after the events stopped, these reappeared. The concomitant medication desogestrel remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.; Sender''s Comments: This is a regulatory case concerning a 24-year-old, female patient with no relevant medical history reported, concomitant medication with contraceptives (desogestrel) and Interchange of vaccine products (TOZINAMERAN), who experienced the unexpected serious event of Intermenstrual pain, Intermenstrual bleeding and Menstruation irregular. The events occurred approximately 8 days after the third (booster) dose of mRNA-1273 vaccine and lasted for 10 days. The patient referred that 1 week after the events stopped, these reappeared. The concomitant medication desogestrel remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.


VAERS ID: 2041404 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-10
Onset:2021-12-24
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Neck pain, Pain in extremity
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; OMEPRAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (oesophageal)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Shoulder pain; Pain in arm; Neck pain; Pain in elbow; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26448700) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain), PAIN IN EXTREMITY (Pain in arm), NECK PAIN (Neck pain) and ARTHRALGIA (Pain in elbow) in a 58-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Acid reflux (oesophageal). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 25-Feb-2021 to an unknown date and OMEPRAZOL for an unknown indication. On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced ARTHRALGIA (Shoulder pain) (seriousness criteria disability and medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criteria disability and medically significant), NECK PAIN (Neck pain) (seriousness criteria disability and medically significant) and ARTHRALGIA (Pain in elbow) (seriousness criteria disability and medically significant). At the time of the report, ARTHRALGIA (Shoulder pain), PAIN IN EXTREMITY (Pain in arm), NECK PAIN (Neck pain) and ARTHRALGIA (Pain in elbow) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient did not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not tested positive for COVID-19 since having the vaccine. It was reported that periods of intense pain that radiated along the left arm, left shoulder and neck. This started as intense pain in the location of the booster before moving. The pain moved around as to been in one location. Patient was currently under the care of his doctor who had prescribed anti-inflammatories (usually prescribed for gout). Company Comment This case concerns a 58-year-old male patient with no relevant medical history, who experienced the serious unexpected events of Arthralgia, Pain in Extremity, Neck Pain and Arthralgia. The events occurred 14 days after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting as medically significant/disability and retained for consistency with the RA report.; Sender''s Comments: This case concerns a 58-year-old male patient with no relevant medical history, who experienced the serious unexpected events of Arthralgia, Pain in Extremity, Neck Pain and Arthralgia. The events occurred 14 days after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting as medically significant/disability and retained for consistency with the RA report.


VAERS ID: 2041463 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-22
Onset:2021-12-24
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESCITALOPRAM
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211224; Test Name: PCR; Test Result: Positive ; Test Date: 20211224; Test Name: LFT; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: GBPFIZER INC202200018655

Write-up: Contracted Covid-19 on 24Dec2021. Confirmed by LFT and PCR testing.; Contracted Covid-19 on 24Dec2021. Confirmed by LFT and PCR testing.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 18 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 22Sep2021 (Lot number: FF8222) as dose 2, single and administered in arm left, administration date 16Aug2021 (Lot number: FF3319) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESCITALOPRAM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Dec2021, outcome "recovering" and all described as "Contracted Covid-19 on 24Dec2021. Confirmed by LFT and PCR testing.". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (24Dec2021) positive; sars-cov-2 test: (24Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2041663 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-24
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20211224; Test Name: COVID-19 PCR test; Test Result: Positive.
CDC Split Type: ITPFIZER INC202200014940

Write-up: This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB and product quality group. Regulatory number: IT-MINISAL02-825898 (RA). A 49-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 24Jul2021 (Lot number: FF2752, Expiration Date: 30Nov2021) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 24Dec2021, outcome "unknown", described as "Drug Ineffective"; COVID-19 (medically significant) with onset 24Dec2021, outcome "not recovered", described as "COVID-19"; HEADACHE (non-serious) with onset 24Dec2021, outcome "not recovered", described as "Headache"; PYREXIA (non-serious) with onset 24Dec2021, outcome "not recovered", described as "Fever"; COUGH (non-serious) with onset 24Dec2021, outcome "not recovered", described as "Cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Dec2021) positive. Product Quality Group provided investigational results on 07Jan2022 for bnt162b2: The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, 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 FF2752. 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. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2044904 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Immunisation, SARS-CoV-2 test
SMQs:, Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected 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 INC202200015729

Write-up: Shingles; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201041852163870-SM8OB. Other Case identifier: GB-MHRA-ADR 26435664. A 38 year-old male patient received bnt162b2 (COMIRNATY), administration date 24Dec2021 (Lot number: FN5254) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 01Aug2020, stop date: 05Aug2020. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 09Jun2021, for COVID-19 immunisation; Comirnaty (Dose 2), administration date: 22Aug2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 24Dec2021, outcome "unknown", described as "Booster"; HERPES ZOSTER (medically significant) with onset 31Dec2021, outcome "recovering", described as "Shingles". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: Started with backpain approx. 3 days after vaccination then rash occur on approx. 7 days after vaccination (as reported). Report did not relate to possible inflammation of the heart (myocarditis or pericarditis). Extensive red rash with painful blisters across one side of the body lower right abdomen and upper right thigh. No follow-up attempts are needed. No further information is expected.


VAERS ID: 2044973 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-16
Onset:2021-12-24
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Urticaria
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy; Shellfish allergy (Mild allergy to shellfish (but never previously showed any allergic reaction))
Preexisting Conditions: Medical History/Concurrent Conditions: Rhinitis (discovered whilst looking at causes of rhinitis.)
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Hives; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26448019) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 41-year-old male patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) for an unknown indication. The patient''s past medical history included Rhinitis (discovered whilst looking at causes of rhinitis.). Concurrent medical conditions included Allergy and Shellfish allergy (Mild allergy to shellfish (but never previously showed any allergic reaction). On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced URTICARIA (Hives) (seriousness criterion hospitalization). At the time of the report, URTICARIA (Hives) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Patient had severe allergic reaction - inflammation markers in blood - non blanching rash led to a and e admission - high temperature for 3 days - head to toe hives/itching - hot rashes/areas of skin moving quickly around the body Patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial The relevant investigations or tests conducted included blood tests showing inflammation markers but otherwise negative for vital infections. Treatment information was not provided. Company comment: This case concerns a 41-year-old male patient, with medical history of allergy and shellfish allergy, who experienced the serious (hospitalization) unexpected event of urticaria after the third dose of mRNA-1273. The event occurred 9 days after the third dose of mRNA-1273. Event outcome was not recovered. Patient?s medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 41-year-old male patient, with medical history of allergy and shellfish allergy, who experienced the serious (hospitalization) unexpected event of urticaria after the third dose of mRNA-1273. The event occurred 9 days after the third dose of mRNA-1273. Event outcome was not recovered. Patient?s medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2045077 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-21
Onset:2021-12-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211223; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Fatigue/unusual tiredness; Chest pain; Fever; Shortness of breath; Heart palpitations; short of breath; feverish; Fainting; Myocarditis; This case was received via regulatory authority on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), PYREXIA (Fever), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations), DYSPNOEA (short of breath), PYREXIA (feverish), SYNCOPE (Fainting) and MYOCARDITIS (Myocarditis) in a 21-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. No Medical History information was reported. On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization, disability and medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue/unusual tiredness) (seriousness criteria hospitalization, disability and medically significant), CHEST PAIN (Chest pain) (seriousness criteria hospitalization, disability and medically significant), PYREXIA (Fever) (seriousness criteria hospitalization, disability and medically significant), DYSPNOEA (Shortness of breath) (seriousness criteria hospitalization, disability and medically significant), PALPITATIONS (Heart palpitations) (seriousness criteria hospitalization, disability and medically significant), DYSPNOEA (short of breath) (seriousness criteria hospitalization, disability and medically significant), PYREXIA (feverish) (seriousness criteria hospitalization, disability and medically significant) and SYNCOPE (Fainting) (seriousness criteria hospitalization, disability and medically significant). At the time of the report, FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), PYREXIA (Fever), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and SYNCOPE (Fainting) outcome was unknown, DYSPNOEA (short of breath) and PYREXIA (feverish) was resolving and MYOCARDITIS (Myocarditis) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. Patient became very feverish for 3 days with very sore jabbed arm, essentially unable to leave bed, even with paracetamol & ibuprofen from the day of booster. Patient Fainted whilst feeling nauseous the evening On 23rd/24th of December 2021 noticed weird sensation in heart/sternum area of feeling very week/fluttery with achy pains in vicinity and feeling very short of breath got worsened a steadily. Patient had ECG, blood pressure, X-ray, blood tests certain proteins (called troponin), stethoscope and result for all came back fine. Doctor suggested that cause could be immune related inflammation of cartilage in sternum resulting in pressure in chest area. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Report was related to possible inflammation of the heart myocarditis or pericarditis. Patient stayed in hospital for 3 hours. Patient was treated with Painkillers. Patient had no recent or ongoing illness Company comment This case concerns a 21-year-old male patient, with no reported medical history, who experienced the unexpected serious events of FATIGUE, CHEST PAIN, PYREXIA, DYSPNOEA, PALPITATIONS, DYSPNOEA, PYREXIA, SYNCOPE and the expected serious event of MYOCARDITIS (AESI). The events started on the following day, and on the next 3 days after the administration of the third dose of mRNA-1273 vaccine. Patient went to A&E, to have ECG, blood pressure, X-ray, blood tests, stethoscope; all came back fine, and doctor suggested that cause could be immune related inflammation of cartilage in sternum resulting in pressure in chest area. Report was related to possible inflammation of the heart myocarditis or pericarditis. Patient stayed in hospital for 3 hours. Patient was treated with Painkillers. Patient had no recent or ongoing illness. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 21-year-old male patient, with no reported medical history, who experienced the unexpected serious events of FATIGUE, CHEST PAIN, PYREXIA, DYSPNOEA, PALPITATIONS, DYSPNOEA, PYREXIA, SYNCOPE and the expected serious event of MYOCARDITIS (AESI). The events started on the following day, and on the next 3 days after the administration of the third dose of mRNA-1273 vaccine. Patient went to A&E, to have ECG, blood pressure, X-ray, blood tests, stethoscope; all came back fine, and doctor suggested that cause could be immune related inflammation of cartilage in sternum resulting in pressure in chest area. Report was related to possible inflammation of the heart myocarditis or pericarditis. Patient stayed in hospital for 3 hours. Patient was treated with Painkillers. Patient had no recent or ongoing illness. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2045198 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-21
Onset:2021-12-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Chest pain; Myocarditis; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26461449) on 12-Jan-2022 and was forwarded to Moderna on 12-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 27-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (Chest pain). At the time of the report, MYOCARDITIS (Myocarditis) had not resolved and CHEST PAIN (Chest pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication provided. No treatment information mentioned. Patient had not had symptoms associated with COVID-19. Patient stated mild chest pain Fri 24th Dec, ongoing since then. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case refers to a 27-year-old male patient with no known medical history who experienced the expected event of Myocarditis (event of special interest) approximately 3 days after the third dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case refers to a 27-year-old male patient with no known medical history who experienced the expected event of Myocarditis (event of special interest) approximately 3 days after the third dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2045581 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK8562 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased, Blood alkaline phosphatase, Blood lactate dehydrogenase, Blood lactate dehydrogenase increased, Body temperature, Gamma-glutamyltransferase, Gamma-glutamyltransferase increased, Hepatic function abnormal, Immunisation, Pyrexia
SMQs:, Liver related investigations, signs and symptoms (narrow), 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? Yes
Office Visit? Yes
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: 20211227; Test Name: ALT; Result Unstructured Data: Test Result:176; Comments: Hepatic function abnormal was noted; Test Date: 20211227; Test Name: AST; Result Unstructured Data: Test Result:110; Comments: Hepatic function abnormal was noted; Test Date: 20211227; Test Name: ALP; Result Unstructured Data: Test Result:126; Comments: Hepatic function abnormal was noted; Test Date: 20211227; Test Name: LDH; Result Unstructured Data: Test Result:337; Comments: Hepatic function abnormal was noted; Test Date: 20211224; Test Name: body temperature/Pyrexia; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20211224; Test Name: body temperature/Pyrexia; Result Unstructured Data: Test Result:39s Centigrade; Comments: until 26Dec2021; Test Date: 20211227; Test Name: y-GTP; Result Unstructured Data: Test Result:164; Comments: Hepatic function abnormal was noted
CDC Split Type: JPPFIZER INC202200038875

Write-up: AST110; ALT176; LDH337; y-GTP164; Hepatic function disorder; booster; Pyrexia of 39s degrees centigrade; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: v21132681 (PMDA). A 50-year-old female patient received bnt162b2 (COMIRNATY), administration date 24Dec2021 14:00 (Lot number: FK8562, Expiration Date: 30Apr2022) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 24Dec2021 14:00, outcome "unknown", described as "booster"; HEPATIC FUNCTION ABNORMAL (medically significant) with onset 27Dec2021, outcome "unknown", described as "Hepatic function disorder"; PYREXIA (medically significant) with onset 24Dec2021, outcome "recovered" (26Dec2021), described as "Pyrexia of 39s degrees centigrade"; ASPARTATE AMINOTRANSFERASE INCREASED (medically significant) with onset 27Dec2021, outcome "unknown", described as "AST110"; ALANINE AMINOTRANSFERASE INCREASED (medically significant) with onset 27Dec2021, outcome "unknown", described as "ALT176"; BLOOD LACTATE DEHYDROGENASE INCREASED (medically significant) with onset 27Dec2021, outcome "unknown", described as "LDH337"; GAMMA-GLUTAMYLTRANSFERASE INCREASED (medically significant) with onset 27Dec2021, outcome "unknown", described as "y-GTP164". The events "hepatic function disorder", "pyrexia of 39s degrees centigrade", "ast110", "alt176", "ldh337" and "y-gtp164" were evaluated at the physician office visit. Clinical course: The patient was a 50-year and 03-month-old female. Family history of the patient was unknown. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The event onset date was on an unknown day in December as source reported, the patient experienced Hepatic function abnormal. On 24Dec2021, the patient received the vaccination, the patient experienced Pyrexia of 39s degrees centigrade until 26Dec2021 (2 days after the vaccination). On 27Dec2021 (3 days after the vaccination), regular blood sampling at the medical examination revealed AST110, ALT176, LDH337, ALP126, y-GTP164 and Hepatic function abnormal was noted, no Pyrexia at the time of consultation. The patient underwent the following laboratory tests and procedures: body temperature: (24Dec2021) 36.3 Centigrade, notes: before vaccination; (24Dec2021) 39s, notes: until 26Dec2021. The reporting physician classified the event as serious (Can lead to disability) but the causality between the event and bnt162b2 was not provided. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2045587 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK7441 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dysphonia, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylactic shock; Insect bite allergy
Allergies:
Diagnostic Lab Data: Test Date: 20211224; Test Name: blood pressure; Result Unstructured Data: Test Result:within normal range
CDC Split Type: JPPFIZER INC202200049884

Write-up: hoarse voice; numbness in hand/both hands numbness; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: v21132759 (PMDA). A 54-year and 4-month-old female patient received bnt162b2 (COMIRNATY, solution for injection), administration date 24Dec2021 15:30 (Lot number: FK7441, Expiration Date: 30Apr2022) at the age of 54-year and 4-month-old as dose 1, single for covid-19 immunisation. Relevant medical history included: "anaphylactic shock" (unspecified if ongoing); "Insect bite" (unspecified if ongoing); "the patient''s constitution was prone to allergic reactions" (ongoing). Patient family history was unknown. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) as follows: the patient had experienced anaphylactic shock before (insect bite), and the patient was taking anti-allergic drugs regularly. The patient took concomitant medications. Clinical course: on 24Dec2021 at 15:35 (5 minutes after the vaccination), the patient experienced numbness in hand and hoarse voice. On 24Dec2021 (the day of the vaccination), the outcome of the event(s) was recovered. The course of the event(s) as follows: a few minutes after the vaccination, the patient had both hands numbness. 20 minutes after the vaccination (at 15:50), the patient had hoarse voice. Blood pressure within normal range. No deterioration of respiratory condition. Symptoms were alleviated by IV drip and IV drip of RINDERON (4) 1A. No particular problem after IV drip. The patient was prescribed RINDERON (0.5) 3 tablets in 3 divided doses (after each meal) for 3 days and then went home. The reporting physician classified the event(s) as non-serious and assessed that the event(s) was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: the patient''s constitution was prone to allergic reactions. And there was no particular problem after steroid administration. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2045713 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-13
Onset:2021-12-24
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hypoaesthesia, Myalgia, Pyrexia, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202200020347

Write-up: Fever greater than or equal to 38 degrees centigrade; Dizziness; Muscle pain; Numbness; Rashes all over body; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300129230. A 13 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 13Dec2021 (Lot number: Unknown) at the age of 13 years as dose 2, single and intramuscular, administration date 22Nov2021 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (hospitalization) with onset 24Dec2021 10:07, outcome "recovered" (24Dec2021 10:07), described as "Fever greater than or equal to 38 degrees centigrade"; DIZZINESS (hospitalization) with onset 24Dec2021 10:07, outcome "recovered" (24Dec2021 10:07), described as "Dizziness"; MYALGIA (hospitalization) with onset 24Dec2021 10:07, outcome "recovered" (24Dec2021 10:07), described as "Muscle pain"; HYPOAESTHESIA (hospitalization) with onset 24Dec2021 10:07, outcome "recovered" (24Dec2021 10:07), described as "Numbness"; RASH (hospitalization) with onset 24Dec2021 10:07, outcome "recovered" (24Dec2021 10:07), described as "Rashes all over body". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2045874 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-03
Onset:2021-12-24
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005841 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Bradycardia, Dizziness, Heart rate, Oxygen saturation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appetite impaired; Dizziness; Fainting
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: BP=92/44; Test Name: pulse rate; Result Unstructured Data: abnormal; Test Name: oxygen; Result Unstructured Data: normal
CDC Split Type: THMODERNATX, INC.MOD20224

Write-up: Unstable Bradycadia; fainting; dizziness; This case was received via the regulatory authority (Reference number: MOD-2022-223) on 10-Jan-2022 and was forwarded to Moderna on 11-Jan-2022. This regulatory authority case was reported by an other health care professional and describes the occurrence of BRADYCARDIA (Unstable Bradycadia), SYNCOPE (fainting) and DIZZINESS (dizziness) in an 88-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3005841) for an unknown indication. The patient''s past medical history included Dizziness, Fainting and Appetite impaired. On 03-Dec-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced BRADYCARDIA (Unstable Bradycadia) (seriousness criterion medically significant), SYNCOPE (fainting) (seriousness criterion medically significant) and DIZZINESS (dizziness) (seriousness criterion medically significant). At the time of the report, BRADYCARDIA (Unstable Bradycadia), SYNCOPE (fainting) and DIZZINESS (dizziness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 92/44 (abnormal) BP=92/44. On an unknown date, Heart rate: 50 (abnormal) abnormal. On an unknown date, Oxygen saturation: 100 (normal) normal. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. Treatment medication was not provided by the reporter. Company Comment - This regulatory authority case concerns an 88 year old female patient with medical history of dizziness and fainting, who experienced the serious (medically significant) unexpected events of bradycardia and dizziness, expected events of syncope. The events occurred 21 day after the first dose of mRNA-1273 vaccine. Patient''s blood pressure was measured at 92/44. Patient''s medical history of dizziness and fainting remains a confounder. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns an 88 year old female patient with medical history of dizziness and fainting, who experienced the serious (medically significant) unexpected events of bradycardia and dizziness, expected events of syncope. The events occurred 21 day after the first dose of mRNA-1273 vaccine. Patient''s blood pressure was measured at 92/44. Patient''s medical history of dizziness and fainting remains a confounder. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2046024 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1IO70A-CDC / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Electrocardiogram, Overdose, Viral myocarditis
SMQs:, Drug abuse and dependence (broad), Cardiomyopathy (broad), Medication errors (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: taking the blood; Result Unstructured Data: Test Result:Unknown; Comments: Unknown; Test Date: 20211225; Test Name: electrocardiogram (Ekg); Result Unstructured Data: Test Result:ST inverted
CDC Split Type: TWPFIZER INC202200064821

Write-up: viral myocarditis / fever reaction; received 0.5 ml dose of BNT162B2; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100015999 Agency Regulatory Authority. Other Case identifier(s): TW-Fosun-2022FOS000456 Regulatory Authority. A 15 year-old male patient received bnt162b2 (COMIRNATY), administration date 24Dec2021 (Batch/Lot number: 1IO70A-CDC) at the age of 15 years as dose 2, 0.5 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1), for COVID-19 immunization. The following information was reported: VIRAL MYOCARDITIS (hospitalization) with onset 25Dec2021, outcome "recovering", described as "viral myocarditis / fever reaction"; OVERDOSE (hospitalization) with onset 24Dec2021, outcome "recovering", described as "received 0.5 ml dose of BNT162B2". The patient was hospitalized for viral myocarditis (start date: 25Dec2021). The event "viral myocarditis / fever reaction" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) unknown, notes: Unknown; electrocardiogram: (25Dec2021) st inverted. Therapeutic measures were taken as a result of viral myocarditis. Addition information: The patient was given 0.9% ns 500 ml, paran (acetaminophen) 1, then was sent to the hospital after taking the blood. BNT162B2 (COMIRNATY) is under agreement with BioNTech. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2049135 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Acidosis, Back pain, Headache, Immunisation, Nausea, Palpitations, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Tumour lysis 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200019097

Write-up: Headache; Nausea; Stomach pain; Back ache; Stomach acid; Heart pounding; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201052334014110-ZYHJH. Other Case identifier(s): GB-MHRA-ADR 26441538. A female patient received bnt162b2 (COMIRNATY), administration date 24Dec2021 (Lot number: FK9712) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2), for COVID-19 immunisation; Bnt162b2 (DOSE 1), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The following information was reported: IMMUNISATION (medically significant) with onset 24Dec2021, outcome "unknown", described as "Booster"; PALPITATIONS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Heart pounding"; HEADACHE (medically significant), outcome "unknown", described as "Headache"; NAUSEA (medically significant), outcome "unknown", described as "Nausea"; ABDOMINAL PAIN UPPER (medically significant), outcome "unknown", described as "Stomach pain"; BACK PAIN (medically significant), outcome "unknown", described as "Back ache"; ACIDOSIS (medically significant), outcome "unknown", described as "Stomach acid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2049217 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-19
Onset:2021-12-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholestasis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Headache; Rash; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26453629) on 10-Jan-2022 and was forwarded to Moderna on 10-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Rash) and HEADACHE (Headache) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Previously administered products included for Product used for unknown indication: PENICILLIN [PENICILLIN NOS]. Past adverse reactions to the above products included Hives with PENICILLIN [PENICILLIN NOS]. Concurrent medical conditions included Cholestasis. On 19-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, RASH (Rash) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant product was provided. No treatment information was provided. No other allergies. No serious reactions to first or second vaccine. Round peach/red slightly raised, not itchy spots at tops of both arms. A bit smaller than a 5p. These had slowly spread down the insides of patient arms and under arms. They were now past elbows. They had also appeared on the sides of patient waist and are spreading over back. The headache was mostly in mid-morning and mid-evening. They were quite mild. No possible inflammation of the heart (myocarditis or pericarditis). Company comment: This case concerns a 33-year-old, female patient with no relevant medical history, who experienced the unexpected events of rash and headache. The events occurred approximately 5 days after the third dose of mRNA-1273. As reported, patient experienced round peach/red slightly raised, not itchy spots at tops of both arms which had slowly spread down the insides of patient arms and under arms. They had also appeared on the sides of patient waist and are spreading over back. The headache was mostly in mid-morning and mid-evening, as reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 33-year-old, female patient with no relevant medical history, who experienced the unexpected events of rash and headache. The events occurred approximately 5 days after the third dose of mRNA-1273. As reported, patient experienced round peach/red slightly raised, not itchy spots at tops of both arms which had slowly spread down the insides of patient arms and under arms. They had also appeared on the sides of patient waist and are spreading over back. The headache was mostly in mid-morning and mid-evening, as reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2049310 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-20
Onset:2021-12-24
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Pericarditis, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: Medical History/Concurrent Conditions: Knee operation
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Fatigue/unusual tiredness; Chest pain; Shortness of breath; Racing heart (tachycardia); Difficulty breathing; Pericarditis; Shortness of breath; This case was received via Agency Regulatory Authority(Reference number: GB-MHRA-ADR 26458296) on 11-Jan-2022 and was forwarded to Moderna on 11-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), PERICARDITIS (Pericarditis), the first episode of DYSPNOEA (Shortness of breath), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), the second episode of DYSPNOEA (Shortness of breath) and TACHYCARDIA (Racing heart (tachycardia)) in a 40-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. The patient''s past medical history included Knee operation. On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced the first episode of DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion medically significant), PERICARDITIS (Pericarditis) (seriousness criterion medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), the second episode of DYSPNOEA (Shortness of breath) (seriousness criterion medically significant) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Difficulty breathing) and PERICARDITIS (Pericarditis) was resolving and FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), the last episode of DYSPNOEA (Shortness of breath) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. patient felt unwell and had shortness of breath and a tight chest. On 27-Dec-2021 the patient rang emergency number and was advised to attend A and E. The wait time was too long so he returned home and started to feel better after a few days. He went to A and E and they took blood tests, ECG and a chest X-ray. All came back fine but the symptoms all suggested pericarditis he was advised to rest and take ibuprofen. The patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The diagnosis and any specific details of the diagnosis were given by doctor at A and E. Patient was on treatment medication "Ibuprofen". CC: This case concerns a 40-year-old male patient, with no relevant medical history reported in this case, who experience the serious unexpected events of Dyspnoea (reported as Difficulty breathing), Pericarditis (AESI), the first episode of Dyspnoea (Reported as Shortness of breath), Fatigue, Chest Pain and the second episode of Dyspnoea (Reported as Shortness of breath) and Tachycardia. The events Dyspnoea (reported as Difficulty breathing), Pericarditis (AESI), Fatigue, Chest Pain and the second episode of Dyspnoea (Reported as Shortness of breath) and Tachycardia occurred in an unknown date and the outcome at the time of the report was Recovering/Resolving for Dyspnoea (reported as Difficulty breathing) and Pericarditis and was Unknown for the events Fatigue, Chest Pain and the second episode of Dyspnoea (Reported as Shortness of breath) and Tachycardia. The event first episode of Dyspnoea (Reported as Shortness of breath) occurred approximately 4 days after the administration of the 3rd dose of the mRNA-1273 vaccine and the outcome at the time of the report was Not Recovered/Not Resolved. The rechallenge could be considered not applicable since the events occurred after the 3rd dose and no additional dosing will be given. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 40-year-old male patient, with no relevant medical history reported in this case, who experience the serious unexpected events of Dyspnoea (reported as Difficulty breathing), Pericarditis (AESI), the first episode of Dyspnoea (Reported as Shortness of breath), Fatigue, Chest Pain and the second episode of Dyspnoea (Reported as Shortness of breath) and Tachycardia. The events Dyspnoea (reported as Difficulty breathing), Pericarditis (AESI), Fatigue, Chest Pain and the second episode of Dyspnoea (Reported as Shortness of breath) and Tachycardia occurred in an unknown date and the outcome at the time of the report was Recovering/Resolving for Dyspnoea (reported as Difficulty breathing) and Pericarditis and was Unknown for the events Fatigue, Chest Pain and the second episode of Dyspnoea (Reported as Shortness of breath) and Tachycardia. The event first episode of Dyspnoea (Reported as Shortness of breath) occurred approximately 4 days after the administration of the 3rd dose of the mRNA-1273 vaccine and the outcome at the time of the report was Not Recovered/Not Resolved. The rechallenge could be considered not applicable since the events occurred after the 3rd dose and no additional dosing will be given. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2049316 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-17
Onset:2021-12-24
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angioedema, Dyspnoea, Mechanical urticaria, Stridor, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Angioedema; Stridor; Breathlessness; Urticaria; Dermographism; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26458717) on 11-Jan-2022 and was forwarded to Moderna on 11-Jan-2022. This regulatory authority case was reported by a physician and describes the occurrence of URTICARIA (Urticaria), MECHANICAL URTICARIA (Dermographism), ANGIOEDEMA (Angioedema), STRIDOR (Stridor) and DYSPNOEA (Breathlessness) in a 37-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced URTICARIA (Urticaria) (seriousness criterion medically significant) and MECHANICAL URTICARIA (Dermographism) (seriousness criterion medically significant). On 28-Dec-2021, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), STRIDOR (Stridor) (seriousness criterion medically significant) and DYSPNOEA (Breathlessness) (seriousness criterion medically significant). At the time of the report, URTICARIA (Urticaria), MECHANICAL URTICARIA (Dermographism) and ANGIOEDEMA (Angioedema) had not resolved and STRIDOR (Stridor) and DYSPNOEA (Breathlessness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. After seven days of vaccine,patient had erythematous rash to hands spread globally to urticaria with dermographism. He was prescribed with cetirizine 10mg which gradually increased to 30mg daily. After 4 days, patient reported SOB with increased symptoms when laying flat, a degree of stridor. Patient did not have signs of heart failure. Course of prednisolone 30mg x5d gave good effect settling urticaria, but breathing symptoms had increased. Added montelukast to 40mg cetirizine and SOB resolved. Patient continued at day 17 of reaction (24 day post vaccination) and required the above to avoid symptom recurrence. Company Comment: This is a regulatory case concerning a 37-year-old, male patient with no medical history reported, who experienced the unexpected serious events of urticaria and mechanical urticaria. The events occurred approximately 7 days after the third dose of mRNA-1273 vaccine. He was prescribed with cetirizine 10mg which gradually increased to 30mg daily. Later, he also experienced the unexpected serious event of angioedema, with stridor and dyspnoea (11 days after vaccination). Prednisolone 30mg x5d was started, with improvement in urticaria, but as the respiratory symptoms increased, montelukast was added ( to cetirizine 40mg). The reaction was ongoing at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.; Sender''s Comments: This is a regulatory case concerning a 37-year-old, male patient with no medical history reported, who experienced the unexpected serious events of urticaria and mechanical urticaria. The events occurred approximately 7 days after the third dose of mRNA-1273 vaccine. He was prescribed with cetirizine 10mg which gradually increased to 30mg daily. Later, he also experienced the unexpected serious event of angioedema, with stridor and dyspnoea (11 days after vaccination). Prednisolone 30mg x5d was started, with improvement in urticaria, but as the respiratory symptoms increased, montelukast was added ( to cetirizine 40mg). The reaction was ongoing at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.


VAERS ID: 2049330 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Neuropathy peripheral, Pyrexia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (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 Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Neuropathy; Fever chills; This case was received via RA (Reference number: GB-MHRA-ADR 26459089) on 11-Jan-2022 and was forwarded to Moderna on 11-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) and PYREXIA (Fever chills) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On 25-Dec-2021, PYREXIA (Fever chills) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment information was provided. Patient was not enrolled in clinical trial Company comment: This is a regulatory case concerning a 33-year-old, female patient with no medical history reported, who experienced the serious unexpected, according RA, events of Neuropathy peripheral and Pyrexia. The events occurred approximately one day after the third dose of mRNA-1273 vaccine. The rechallenge was reported as unknown. At the time of the report, the outcome of the events was recovered/ resolved. No treatment information was provided for reported events. The case was assessed as serious as per Regulatory Authority?s report due to important medical event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. .; Sender''s Comments: This is a regulatory case concerning a 33-year-old, female patient with no medical history reported, who experienced the serious unexpected, according CCDS, events of Neuropathy peripheral and Pyrexia. The events occurred approximately one day after the third dose of mRNA-1273 vaccine. The rechallenge was reported as unknown. At the time of the report, the outcome of the events was recovered/ resolved. No treatment information was provided for reported events. The case was assessed as serious as per Regulatory Authority?s report due to important medical event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. .


VAERS ID: 2049599 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK6304 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Erythema, Facial pain, Feeling cold, Feeling hot, Headache, Hemianaesthesia, Immunisation, Interchange of vaccine products, Localised oedema, Nausea, Pain, Sensory disturbance, Swelling
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (broad), Hypersensitivity (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain stem disorder NOS (Previous brain stem injury)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202200025647

Write-up: The left side of the face very warm and pinkish; The left side of the face very warm and pinkish; the right side cold; swelling of the neck; different sensitivity of the left side; loss of sensitivity of the left hemiface; severe pain; 1st dose of AstraZeneca, 2nd dose and 3rd dose of BNT162B2; Dose 3; Bell''s palsy; Atypical face pain; Headache; Nausea; Localised oedema; This is a Pfizer-sponsored Expanded Access Program report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: IT-MINISAL02-826412 Regulatory Authority. Other Case identifier(s): V-202112-03C75C5-5 Regulatory Authority. A 46 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 24Dec2021 08:15 (Lot number: FK6304, Expiration Date: 31Jan2022) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Brain stem disorder NOS" (unknown if ongoing), notes: Previous brain stem injury. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine AstraZeneca (Dose 1, Single, Time of administration: 9:27 , Lot/batch: ABW1277, expiry date 31Jul2021, left deltoid), administration date: 13Mar2021, for Covid-19 immunisation; Comirnaty (Dose 2, Single, Time of administration: 7:09 PM , Lot/batch: FF3318), administration date: 21Jul2021, for Covid-19 immunisation, reaction(s): "no adverse reaction occurred". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Dec2021 08:15, outcome "unknown", described as "1st dose of AstraZeneca, 2nd dose and 3rd dose of BNT162B2"; IMMUNISATION (medically significant) with onset 24Dec2021 08:15, outcome "unknown", described as "Dose 3"; BELL''S PALSY (medically significant) with onset 24Dec2021, outcome "not recovered", described as "Bell''s palsy"; FACIAL PAIN (medically significant) with onset 24Dec2021, outcome "not recovered", described as "Atypical face pain"; HEADACHE (medically significant) with onset 24Dec2021, outcome "not recovered", described as "Headache"; NAUSEA (medically significant) with onset 24Dec2021, outcome "not recovered", described as "Nausea"; LOCALISED OEDEMA (medically significant) with onset 24Dec2021, outcome "not recovered", described as "Localised oedema"; HEMIANAESTHESIA (medically significant) with onset 24Dec2021 16:00, outcome "unknown", described as "loss of sensitivity of the left hemiface"; PAIN (non-serious) with onset 24Dec2021 16:00, outcome "unknown", described as "severe pain"; FEELING HOT (non-serious), ERYTHEMA (non-serious), outcome "unknown" and all described as "The left side of the face very warm and pinkish"; FEELING COLD (non-serious), outcome "unknown", described as "the right side cold"; SWELLING (non-serious), outcome "unknown", described as "swelling of the neck"; SENSORY DISTURBANCE (non-serious), outcome "unknown", described as "different sensitivity of the left side". Clinical course: After the 3rd Comirnaty dose, at 4:00 PM on 24Dec2021 the first episode of loss of sensitivity of the left hemiface, difficulty in moving the lower eyelid of the left eye and the left side of the mouth, accompanied by severe pain. The left side of the face very warm and pinkish, the right side cold. This first episode lasted about 2 hours, accompanied by nausea, strong headache and left sensation problems on the left side of the face. At 3 in the morning, 2nd episode, much more intense, with difficulty in facial movements and pain and also swelling of the neck. After these two reactions a different sensitivity of the left side of the face remains. The reporter''s assessment of the causal relationship of the "1st dose of AstraZeneca, 2nd dose and 3rd dose of bnt162b2", "dose 3", "bell''s palsy", "atypical face pain", "headache", "nausea", "localised oedema", "loss of sensitivity of the left hemiface", "severe pain", "the left side of the face very warm and pinkish", "the right side cold", "swelling of the neck" and "different sensitivity of the left side" with the suspect product(s) bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on available information and the drug temporal relationship, the causality between the events - Interchange of vaccine products, immunization, Bell''s palsy, facial pain, headache, nausea, localized oedema, hemianesthesia, pain, feeling hot, erythema, feeling cold, swelling, sensory disturbance, and the suspect drug "BNT162B2" cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 2050020 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202200060223

Write-up: CHEST PAIN; CHEST TIGHTNESS; PALPITATION; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100015972. Other Case identifier(s): TW-Fosun-2022FOS000433. A 16-year-old male patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 22-Dec-2021 via unknown route at unknown dose with unspecified dosing frequency for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history was not reported. No past medical history, no smoking, no alcohol drinking, no allergy. Concomitant medications and past product were not reported. The patient experienced chest pain, chest tightness and palpitation on 24-Dec-2021. On 24-Dec-2021, the patient visited emergency room (ER). The patient experienced chest pain and chest tightness since this night (22:00 pm), no cough, no rhinorrhea, no vomiting, no diarrhea and fatigue, felt palpitation, no family sick, no obvious contact history, no cluster history denied travelling history, denied oversea traveling history, denied foreign contact history, denied double foreign tourism history, denied COVID-19 home searzer autonomous management contact history, denied hotspot exposure history, denied received cell news. Chest pain, chest tightness and palpitation met the seriousness criterion of Other Medically Important Condition. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of chest pain were recovering, and the outcomes of other events were unknown. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. The causality assessment of the events chest pain, chest tightness, palpitation per the reporter and the company (BioNTech SE) was possible No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2050023 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Diarrhoea, Dyspnoea, Palpitations, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from alcohol; Non-smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202200060216

Write-up: CHEST PAIN; NON-BILIOUS VOMITING; DIARRHEA; DYSPNEA; PALPITATION; This is a spontaneous report received from non-contactable reporter (other healthcare professional) from License Party (BIONTECH SE) and Regulatory Authority. The Regulatory number is TW-TFDA-TVS-1100015977 and the Other Case identifier is TW-Fosun-2022FOS000439. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100015977. A 16-year-old male patient received the second dose of BNT162B2 (COMIRNATY, reported as Tozinameran) via an unspecified route of administration on 22Dec2021 (batch/lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included patient had no smoking, no alcohol drinking, and no allergy. Concomitant medications and past drugs/ products were not reported. Vaccination history included the first dose of Comirnaty via an unspecified route of administration on an unspecified date (batch/lot number: unknown) as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced chest pain, non-bilious vomiting, diarrhea, dyspnea, and palpitation on 24Dec2021. The clinical course was reported as follows: On 24Dec2021, the patient experienced chest pain since this night (00:00 am) and visit the emergency room (ER). The patient had no fever, no cough, no rhinorhea, but non-bilious vomiting once, diarrhea once, no mucus, no bloody ting, no abdominal pain, felt dyspnea, felt palpitation, no hernia, no scrotum swelling or pain, no family sick, no obvious contact history, no cluster history, denied travelling history, denied overseas travelling history, denied a history of exposure to foreign twin, denied the north, Ilan, outside the county tourism history, denied COVID-19 home isolated residential authority management contact history, denied hot spot exposure history, denied received cell news. Chest pain, non-bilious vomiting, diarrhea, dyspnea, and palpitation met the seriousness criterion of Other Medically Important Condition. At the time of the report, the outcomes of the events were recovering. Initial report was received on 05Jan2022. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE Causality assessment: Events Chest pain, Vomiting, Diarrhea, Dyspnea, Palpitation; Per Reporter =Possible and Per Company=Possible. The batch/lot number for BNT162B2 was not provided and will be requested during follow-up.


VAERS ID: 2052153 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-12-24
   Days after vaccination:109
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXICILLIN; CODEINE; SALBUTAMOL
Current Illness: Chest pain; Non-smoker; Pulmonary embolism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Pulmonary embolism; This case was received (Reference number: GB-MHRA-ADR 26450274) on 12-Jan-2022 and was forwarded to Moderna on 12-Jan-2022. This regulatory authority case was reported by a pharmacist and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 40-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 immunisation. Concurrent medical conditions included Pulmonary embolism since 30-Dec-2021, Non-smoker since 30-Dec-2021 and Chest pain since 26-Dec-2021. Concomitant products included AMOXICILLIN from 24-Dec-2021 to an unknown date, CODEINE from 30-Dec-2021 to an unknown date and SALBUTAMOL from 24-Dec-2021 to an unknown date for an unknown indication. On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2021, received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion life threatening). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) was resolving. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication were reported The patient had multiple pulmonary embolism Apixaban. Company comment This case concerns a 40-year-old male patient, with no reported medical history, who experienced the unexpected serious event of PULMONARY EMBOLISM (AESI). The events occurred approximately 3 months and 18 days after the administration of the first dose of mRNA-1273 vaccine, and 6 days before the administration of the second dose of mRNA-1273 vaccine. At the time of the report, PULMONARY EMBOLISM was resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 40-year-old male patient, with no reported medical history, who experienced the unexpected serious event of PULMONARY EMBOLISM (AESI). The events occurred approximately 3 months and 18 days after the administration of the first dose of mRNA-1273 vaccine, and 6 days before the administration of the second dose of mRNA-1273 vaccine. At the time of the report, PULMONARY EMBOLISM was resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2052159 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200027708

Write-up: Heart Palpitations, severe alopecia, flu; Heart Palpitations, severe alopecia, flu; Heart Palpitations, severe alopecia, flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the RA. The reporter is the patient. Regulatory number: GB-MHRA-EYC 00270640. Other Case identifier(s): GB-MHRA-ADR 26438461. A 32 year-old male patient received bnt162b2 (COMIRNATY), administration date 22Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient felt really ill with horrible alopecia. The following information was reported: PALPITATIONS (medically significant), ALOPECIA UNIVERSALIS (medically significant), INFLUENZA LIKE ILLNESS (medically significant) all with onset 24Dec2021, outcome "not recovered" and all described as "Heart Palpitations, severe alopecia, flu". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2052178 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-09
Onset:2021-12-24
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9712 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200025913

Write-up: Nose bleeds; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from the Regulatory Authority.-WEB. Regulatory number: GB-MHRA-WEBCOVID-202112281427283430-YIYAE. A 72 year-old male patient received bnt162b2 (COMIRNATY), administration date 09Dec2021 (Lot number: FK9712) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Past drug history included: Biquelle xl, notes: Biquelle xl tabs p/r 50mg Biquelle xl tabs p/r 200mg; Atorvastatin, notes: 20mg; Tamsulosin, notes: 400mg caps mr; Pregabalin, notes: 25mg caps. Patient medical history provided in patient notes: Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The following information was reported: EPISTAXIS (hospitalization, medically significant) with onset 24Dec2021, outcome "recovered" (26Dec2021), described as "Nose bleeds". Clinical course: Patient had two nose bleeds on the 24Dec2021, then had five nose bleeds on the 25Dec2021, where the patient then sought medical assistance and dialed REDACTED. Patient was hospitalised in REDACTED and nose was cottised which resulted in bleeding stopping. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The reporter does not relate to possible myocarditis or pericarditis. Details of the event: "patient nose bleed which would not stop". It was unknown if the platelet count was <150 to 109/L and if D-dimer $g4000. It was unknown if anti-PF4 antibodies were identified. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2052756 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Burning sensation, Chest X-ray, Chest discomfort, Chest pain, Dysgeusia, Electrocardiogram, Electrocardiogram normal, Immunisation, Non-cardiac chest pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Taste and smell disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TECFIDERA
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain; Chest pressure; Multiple sclerosis (Taking medicines for multiple sclerosis)
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:Normal; Test Name: chest X-ray; Result Unstructured Data: Test Result:Clear; Test Name: ecg; Result Unstructured Data: Test Result:Normal; Test Date: 20211112; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200027731

Write-up: chest pain; ecg normal; sour taste in mouth; chest pain/pressure; Booster; Burning sensation; Chest pain (non-cardiac); This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201080855347400-YSCKY. Other Case identifier(s): GB-MHRA-ADR 26452265. A 35 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 24Dec2021 (Batch/Lot number: unknown) at the age of 35 years as dose 3(booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 10Nov2021 (ongoing); "Multiple sclerosis" (unspecified if ongoing), notes: Taking medicines for multiple sclerosis; "chest pain/pressure" (unspecified if ongoing); "chest pain/pressure" (unspecified if ongoing). Patient last menstrual period date was 08Jan2022. Patient was not currently breastfeeding. Concomitant medication(s) included: TECFIDERA. Vaccination history included: Bnt162b2 (DOSE number unknown;), for Covid-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 24Dec2021, outcome "unknown", described as "Booster"; CHEST PAIN (hospitalization, medically significant), outcome "not recovered", described as "chest pain"; ELECTROCARDIOGRAM NORMAL (hospitalization, medically significant), outcome "not recovered", described as "ecg normal"; BURNING SENSATION (hospitalization, medically significant) with onset 24Dec2021, outcome "not recovered", described as "Burning sensation"; NON-CARDIAC CHEST PAIN (hospitalization, medically significant) with onset 24Dec2021, outcome "not recovered", described as "Chest pain (non-cardiac)"; DYSGEUSIA (hospitalization, medically significant), outcome "not recovered", described as "sour taste in mouth"; CHEST DISCOMFORT (hospitalization, medically significant), outcome "not recovered", described as "chest pain/pressure". The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) normal; chest x-ray: (unspecified date) clear; electrocardiogram: (unspecified date) normal; sars-cov-2 test: (12Nov2021) positive, notes: Yes - Positive COVID-19 test. Clinical course: Post booster immediately 5 mins after burning sensation rushing through internal body to chest and since reoccurring burning sensation in lungs/chest and pressure with sour taste in mouth that lasts a few days, which went and then returned again. Post covid (8 weeks ago) intermittent chest pain/pressure. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2052865 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-24
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Tension headache
SMQs:, 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:
Allergies:
Diagnostic Lab Data: Test Date: 20220104; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200028212

Write-up: Off label use; Interchange of vaccine products; Booster; started experiencing mild headache; Tension headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201082158264570-AUYJF. Other Case identifier(s): GB-MHRA-ADR 26453032. A 34 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; TENSION HEADACHE (medically significant) with onset 24Dec2021, outcome "not recovered", described as "Tension headache"; HEADACHE (medically significant), outcome "not recovered", described as "started experiencing mild headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) negative. Patient has not had symptoms associated with COVID-19. 48 hours after he received the vaccine he started experiencing mild headache. Until now he is still having headache which frequently appears at night. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Does your report relate to possible blood clots or low platelet counts? If yes, we will ask you additional questions at the end of this report: "No" Does your report relate to possible myocarditis or pericarditis? If yes, we will ask you additional questions at the end of this report: "No" No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2052969 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspepsia, Dyspnoea, Fatigue, Palpitations, Pyrexia, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breathlessness; Difficulty breathing; Fatigue; Palpitations
Preexisting Conditions: Medical History/Concurrent Conditions: Cold; Flu; Panic attacks; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: indigestion; Fatigue/unusual tiredness; Chest pain; Fever; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Palpitations; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26462168) on 12-Jan-2022 and was forwarded to Moderna on 12-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), DYSPEPSIA (indigestion), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), PYREXIA (Fever), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) in a 58-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. The patient''s past medical history included Panic attacks, Cold, Flu and Suspected COVID-19 (Unsure when symptoms stopped) on 25-Feb-2020. Concurrent medical conditions included Breathlessness, Palpitations, Difficulty breathing and Fatigue. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion medically significant). On an unknown date, the patient experienced DYSPEPSIA (indigestion) (seriousness criterion medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations) (seriousness criterion medically significant) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant). At the time of the report, PALPITATIONS (Palpitations) had not resolved and DYSPEPSIA (indigestion), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), PYREXIA (Fever), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Lab data: Blood pressure: 147/71 (averaged over last week). ECG scan didn''t find anything major. Blood tests showed nothing untoward. No concomitant medications were reported. No treatment medications were reported. It was stated that the patient had experienced palpitations, chest pain, stomach pains and indigestion after evening meal. Patient stated that the report related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay. The diagnosis was not made by a medical professional. Company comment: This is a regulatory case concerning a 58-year-old male patient with medical history of fatigue, difficulty concentrating, breathlessness and occasional milder palpitations, who experienced the unexpected serious events of Palpitations (two occurrences), Dyspepsia, Fatigue, Chest pain, Pyrexia, Dyspnoea and Tachycardia. Majority of events occurred in an unknown timeframe after the third dose of mRNA-1273 vaccine. The patient reported that this report related to possible inflammation of the heart (myocarditis or pericarditis), however the diagnosis was not made by a medical professional. Patient''s medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event selection, seriousness of the events, rechallenge and action taken with the suspect product were kept as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a 58-year-old male patient with medical history of fatigue, difficulty concentrating, breathlessness and occasional milder palpitations, who experienced the unexpected serious events of Palpitations (two occurrences), Dyspepsia, Fatigue, Chest pain, Pyrexia, Dyspnoea and Tachycardia. Majority of events occurred in an unknown timeframe after the third dose of mRNA-1273 vaccine. The patient reported that this report related to possible inflammation of the heart (myocarditis or pericarditis), however the diagnosis was not made by a medical professional. Patient''s medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event selection, seriousness of the events, rechallenge and action taken with the suspect product were kept as per Regulatory Authority reporting.


VAERS ID: 2053130 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Back pain, Cough, Headache, Immunisation, Off label use, Palpitations, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN; OMPRAZOLE; ATORVASTATIN; PARACETAMOL; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cervical myelopathy; Diabetic
Allergies:
Diagnostic Lab Data: Test Date: 20220103; Test Name: lateral flow test; Result Unstructured Data: Test Result:Positive; Test Date: 20220104; Test Name: PCR; Result Unstructured Data: Test Result:Positive
CDC Split Type: GBPFIZER INC202200030938

Write-up: heart palpitation; back ache; cough; Headache; shoulder ache; feeling weak and wobbly; the patient recieved the Pfizer booster dose; the patient recieved the Pfizer booster dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63 year-old male patient received bnt162b2 (COMIRNATY), administration date 24Dec2021 (Batch/Lot number: unknown) at the age of 63 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing); "Cervical myelopathy" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; OMPRAZOLE; ATORVASTATIN; PARACETAMOL; SALBUTAMOL; and Steriod Inhalor. Vaccination history included: Covid-19 vaccine (Dose number unknown, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 24Dec2021, outcome "unknown" and all described as "the patient recieved the Pfizer booster dose"; PALPITATIONS (medically significant) with onset 03Jan2022, outcome "unknown", described as "heart palpitation"; BACK PAIN (non-serious) with onset 24Dec2021, outcome "unknown", described as "back ache"; HEADACHE (non-serious) with onset 24Dec2021, outcome "unknown", described as "Headache"; ARTHRALGIA (non-serious) with onset 24Dec2021, outcome "unknown", described as "shoulder ache"; COUGH (non-serious) with onset 24Dec2021, outcome "unknown", described as "cough"; ASTHENIA (non-serious) with onset 24Dec2021, outcome "unknown", described as "feeling weak and wobbly". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive; (03Jan2022) positive. The patient had the Pfizer booster on holiday eve and couple of days later he started having heart palpitation. He went with Covid related heart palpitation on the 03Jan he had a lateral flow test which was positive then he went for a PCR and was positive the day after. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2053204 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-09
Onset:2021-12-24
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Polymerase chain reaction
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OESTRIOL; OMEPRAZOL; SIMVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis (arthritis in hands and knees); Cholesterol; Irritable stomach; Suspected COVID-19; Vaginal dryness
Allergies:
Diagnostic Lab Data: Test Date: 20211224; Test Name: PCR; Test Result: Positive ; Comments: Positive
CDC Split Type: GBPFIZER INC202200080238

Write-up: Drug ineffective; SARS-CoV-2 infection; This is a solicited report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA) and product quality group for a sponsored program. The reporter is the patient. A 74 year-old female patient received bnt162b2 (COMIRNATY), administration date 09Oct2021 (Lot number: FG3712) at the age of 74 years as dose 3 (booster), single, administration date 08Apr2021 (Lot number: ER1749) as dose 2, single and administration date 22Jan2021 (Lot number: EL0739) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 04Feb2020, stop date: 07Feb2020; "arthritis" (unspecified if ongoing), notes: arthritis in hands and knees; "Vaginal dryness" (unspecified if ongoing); "Irritable stomach" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: OESTRIOL taken for vulvovaginal dryness; OMEPRAZOL taken for epigastric discomfort; SIMVASTATIN taken for blood cholesterol, blood cholesterol; INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) taken for influenza immunisation, administration date 27Sep2021. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 24Dec2021, outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant) with onset 24Dec2021, outcome "unknown", described as "SARS-CoV-2 infection". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (24Dec2021) positive, notes: Positive. Clinical course: The patient was PCR tested positive with Covid on 24th December 2021 and was isolated for the full 10 days as a Lateral Flow test was still negative on Day 7. The patient had cold/flu symptoms which meant that the patient needed to go to bed. The patient lost appetite and had headaches at the time although no raised temperature. The patient had been PCR tested negative a week earlier. The patient have more antibodies now but it has made the patient a little nervous about going out. Patient was not enrolled in clinical trial. The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and covid19 cannot be totally excluded.,Linked Report(s) : GB-PFIZER INC-202101367861 Master case


VAERS ID: 2053609 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021F21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (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: THMODERNATX, INC.MOD20224

Write-up: Acute ischemic stroke; This regulatory authority case was reported by an other health care professional and describes the occurrence of ISCHAEMIC STROKE (Acute ischemic stroke) in a 61-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 021F21A) for an unknown indication. No Medical History information was reported. On 24-Dec-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced ISCHAEMIC STROKE (Acute ischemic stroke) (seriousness criterion medically significant). At the time of the report, ISCHAEMIC STROKE (Acute ischemic stroke) was resolving. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. On 30 Nov 2021, the vaccine recipient received the first dose and did not find any abnormal symptoms. After second injection (could not remember the time), patient felt weakness of her right arm, fingertip twitching, loss of appetite, no leg weakness, no hard tongue, no crooked mouth, no slurred speech. On 26-Dec-2021, patient came for examination at the hospital, then referred to the second hospital. On 27-Dec-2021, the second hospital referred patient back for further treatment at the first hospital. The diagnosis was given as acute ischemic stroke. Date of treatment was given as 26-Dec-2021. The type of patient was reported. No concomitant medication details was provided. The serial number was reported as 14133MDN10004. This is a regulatory authority case concerning a 61-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Acute ischemic stroke. The events occurred approximately on the same day after the second dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as resolving. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 61-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Acute ischemic stroke. The events occurred approximately on the same day after the second dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as resolving. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 1971512 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-12-22
Onset:2021-12-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

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

Write-up: Blurry vision with lightheaded


VAERS ID: 1974142 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-05
Onset:2021-12-23
   Days after vaccination:109
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Menstruation irregular
SMQs:, Fertility disorders (broad)

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

Write-up: Menstrual cycle is off!


VAERS ID: 1974448 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-12-16
Onset:2021-12-23
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Chest X-ray normal, Dyspnoea, Fibrin D dimer normal, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Intensive care, Mycoplasma test negative, Positive airway pressure therapy, Respiratory viral panel, SARS-CoV-2 test negative, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Daily medications: 6-MP, methotrexate, epidiolex BID, lacosamide BID, keppra BID, baclofen BID. Weekly methotrexate.
Current Illness: None reported
Preexisting Conditions: B cell ALL on maintenance therapy, OSA, Aicardi Syndrome
Allergies: Itching, rash (local) with tegaderm. Pancreatitis with Pegaspargase.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient admitted due to sudden onset tachypnea. No fevers or any other associated symptoms. Work up thus far includes a negative Quad panel (COVID, influenza A and B), negative respiratory viral panel, negative mycoplasma PCR, normal chest x-ray, and negative D-dimer. Patient is supposed to be on CPAP overnight at home but hasn''t been using it for the past year due to her device being recalled and it has not been replaced yet. However, Mom reports that she did not have tachypnea or increased work of breathing until that evening after she received her COVID vaccine. She is currently in the ICU requiring CPAP during the day and at night (which is higher than her baseline support). We are slowly sprinting her during the day to room air as tolerated. Pulmonology, Oncology, and Infectious Diseases are involved in her management. If unable to wean her back to baseline support of CPAP at night only, plan is to consider chest CT and/or bronchoscopy. Per oncology, her chemotherapy medications are not associated with such side affects and wouldn''t expect such an acute presentation. She is on pentamidine prophylaxis (against PJP) taken monthly. Per ID, this regimen is less than ideal so she does have a beta-d-glucan test pending, however, clinical suspicion for PCP is low given no associated hypoxia.


VAERS ID: 1974473 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-12-17
Onset:2021-12-23
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Unevaluable event
SMQs:

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

Write-up: None stated.


VAERS ID: 1974491 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Vermont  
Vaccinated:2021-12-23
Onset:2021-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213D21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Axillary pain, Discomfort, Feeling abnormal, Headache, Injection site pain, Myalgia, Pain, Pain in extremity, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), 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: MMR
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: allergic to all artificial sweeteners; severe reaction to MMR vaccine
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Around 4PM my arm started to ache - i didn''t give it much thought. As the evening went on, the discomfort radiated to my axilla and down the left arm with occasional shooting pain from the injection site down my arm. I woke up during the night with severe muscle pain. I feel like someone has used a club on my entire body. I also have a headache. Tylenol and ibuprofen do nothing.


VAERS ID: 1974626 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-05-19
Onset:2021-12-23
   Days after vaccination:218
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 - / -

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: COVID + 12/23/21
CDC Split Type:

Write-up: BREAKTHROUGH COVID CASE


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