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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 113 out of 10,493

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VAERS ID: 2038916 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: patients received Expired Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received Expired Moderna COVID-19 vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received Expired Moderna COVID-19 vaccine). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (patients received Expired Moderna COVID-19 vaccine) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported by reporter No treatment medications provided by the reporter. Patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days.


VAERS ID: 2038917 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-01-28
Onset:2021-12-30
   Days after vaccination:336
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012020A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B and 012020A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medication was not reported. Patients received expired vaccine which was stored in the refrigerator beyond 30 days.


VAERS ID: 2038918 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were provided No treatment medications were provided.


VAERS ID: 2038919 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Unknown  
Location: Oregon  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator betond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator betond 30 days) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator betond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator betond 30 days) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication was reported. No concomitant medication was reported. None of the patients have reported side effects, so far.


VAERS ID: 2039052 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered, Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Vial was stored in the refrigerator beyond 30 days; All patients received Expired Moderna COVID-19 vaccine from a vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator beyond 30 days) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vial was stored in the refrigerator beyond 30 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment and concomitant medications were provided.


VAERS ID: 2039053 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator ) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator ). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator ) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant products were reported. No treatment information was reported. Patient received vaccine from a vial that was stored in the refrigerator beyond 30 days. There were no side effects reported so far. This case was linked to MOD-2022-446648 (Patient Link).


VAERS ID: 2039054 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: patients received Expired Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received Expired Moderna COVID-19 vaccine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received Expired Moderna COVID-19 vaccine). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (patients received Expired Moderna COVID-19 vaccine) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication was reported. No concomitant medication was reported. Patient received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days.


VAERS ID: 2039055 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Oregon  
Vaccinated:0000-00-00
Onset:2021-12-30
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by the reporter No treatment medication was provided by the reporter.


VAERS ID: 2039056 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported.


VAERS ID: 2039057 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: Patients received Expired Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received Expired Moderna COVID-19 vaccine) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received Expired Moderna COVID-19 vaccine). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patients received Expired Moderna COVID-19 vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. No treatment details were provided.


VAERS ID: 2039058 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant information was reported. No treatment information was reported.


VAERS ID: 2039106 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered, Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Vial was stored in the refrigerator beyond 30 days; All patients received Expired Moderna COVID-19 vaccine from a vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator beyond 30 days) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vial was stored in the refrigerator beyond 30 days) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment information were provided.


VAERS ID: 2039114 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were reported. No Treatment medications were reported.


VAERS ID: 2039181 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-27
Onset:2021-12-30
   Days after vaccination:156
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Chest pain, Computerised tomogram abnormal, Dysphagia, Dyspnoea, Heart rate increased, Pulmonary thrombosis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (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 symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Dehydration (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: Gabapentin, Atorvastatin
Current Illness: N/A
Preexisting Conditions: Chronic Pain, Headaches, High Cholesterol
Allergies: N/A
Diagnostic Lab Data: Blood Work 12/30/2021 Cat-Scan 12/30/2021 Chest X-Ray 12/30/2021
CDC Split Type:

Write-up: Pt. states that after receiving the 1st dose of J&J 07/27/2021, started experiencing symptoms 07/27/2021 (8hrs after) possible throat swelling (difficulty swallowing) lasting estimated 2hrs before subsiding. Started experiencing symptoms 12/30/2021 of shortness of breath with chest pain and rapid heart-beat. Emergency Room visit 12/30/2021 resulting in Blood Work, Chest X-Ray, and Cat-Scan, located a blood-clot in the Left Lung Lobe. Recommendations of Follow-Up with Primary and treatment of Long-Term Blood Thinners.


VAERS ID: 2042055 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. Patient did not report side effects, so far.


VAERS ID: 2042056 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: received expired Moderna COVID-19 vaccine for their booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine for their booster dose.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine for their booster dose.). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine for their booster dose.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that patient received expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days. No concomitant medications were reported. No treatment medications were reported.


VAERS ID: 2042401 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 ER8737 / 3 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Immunisation, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVAQUIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastrointestinal disorder; Sinusitis
Allergies:
Diagnostic Lab Data: Test Date: 20220101; Test Name: fever; Result Unstructured Data: Test Result:102 degree
CDC Split Type: USPFIZER INC202200001180

Write-up: 102 degree fever; rash under arms and in groin area; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 32 year-old male patient received BNT162b2 (BNT162B2), administered in arm right, administration date 30Dec2021 15:00 (Lot number: Er8737) at the age of 32 years as dose 3(booster), single for covid-19 immunisation. Relevant medical history included: "Sinusitis" (unspecified if ongoing); "some GI issues" (unspecified if ongoing). Concomitant medication(s) included: LEVAQUIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0170, Vaccine Administration Time: 04:30 PM), administration date: 30Apr2021, when the patient was 31 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Fj1611, Location of injection: Arm Right, Vaccine Administration Time: 03:30 PM), administration date: 09Apr2021, when the patient was 31 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021 15:00, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 01Jan2022 18:00, outcome "not recovered", described as "102 degree fever"; RASH (non-serious) with onset 01Jan2022 18:00, outcome "not recovered", described as "rash under arms and in groin area". The events "102 degree fever" and "rash under arms and in groin area" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, rash. Additional Information: The patient did not have other vaccine in four weeks. The patient did not have covid prior to vaccination. The patient did not test post vaccination. The patient did not have known food allergies that have resulted in a rash. It was also mentioned that the patient had 102 degree fever for 12 hours the 1st day after vaccine, and experience rash under arms and in groin area 2nd and 3rd day after vaccine. The patient used Antihistamine as treatment for AE . No follow-up attempts are possible. No further information is expected.


VAERS ID: 2042579 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-03-03
Onset:2021-12-30
   Days after vaccination:302
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6199 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (other medical history: allergies); Asthma; GERD; Hashimoto''s disease (other medical history: Hashimotos)
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: SARS COVID 2 PCR; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202200050394

Write-up: SARS COVID 2 PCR : positive; SARS COVID 2 PCR : positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 10:00 (Lot number: EN6199) at the age of 37 years as dose 2, single and administered in arm left, administration date 10Feb2021 11:00 (Lot number: EL9289) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimotos" (unspecified if ongoing), notes: other medical history: Hashimotos; "allergies" (unspecified if ongoing), notes: other medical history: allergies; "GERD" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Top 8 allergens plus, reaction(s): "Known allergies: Yes-top 8 allergens plus", notes: Known allergies: Yes-top 8 allergens plus. Patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Other medications the patient received within 2 weeks of vaccination: Yes. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "SARS COVID 2 PCR : positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive, notes: Nasal Swab.


VAERS ID: 2042863 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-10-27
Onset:2021-12-30
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012L20A / 1 - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 004M20A / 2 - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939904 / 3 - / -

Administered by: Pharmacy       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: dementia, hyperlipidemia, osteoarthritis
Allergies:
Diagnostic Lab Data: COVID+ 12/30/2021
CDC Split Type:

Write-up: COVID BREAKTHROUGH CASE


VAERS ID: 2042960 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013F21A / 3 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

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

Write-up: Client came in seeking Moderna booster at age 17 and staff failed to screen him out for this. Moderna booster was given


VAERS ID: 2043084 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-26
Onset:2021-12-30
   Days after vaccination:218
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047C21A / UNK - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053C21A / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal wall infection, COVID-19, SARS-CoV-2 test positive
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: 12/30/21 SARS-CoV-2 (COVID-19) by NAA detected
CDC Split Type:

Write-up: 12/30/21 presents to ED for "infection of her abdominal wall". PMHx of "insulin dependent diabetes"


VAERS ID: 2043142 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-08-27
Onset:2021-12-30
   Days after vaccination:125
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Acute myocardial infarction, Anaemia of chronic disease, Anticoagulant therapy, Antiplatelet therapy, Back pain, Blood creatinine increased, Blood culture negative, Blood loss anaemia, Blood sodium increased, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Chronic kidney disease, Clostridium test, Computerised tomogram abdomen, Computerised tomogram head normal, Condition aggravated, Culture urine negative, Deep vein thrombosis, Dehydration, Diarrhoea, Echocardiogram, Endarterectomy, Exposure to SARS-CoV-2, Febrile neutropenia, Fibrin D dimer, Full blood count, Gastrooesophageal reflux disease, Glycosylated haemoglobin increased, Haematoma muscle, Haemoglobin decreased, Hypernatraemia, Hypertension, Hypophagia, Immunosuppression, Inflammatory marker test, Intensive care, Intra-abdominal haematoma, Metabolic encephalopathy, Nausea, Peripheral artery occlusion, Pulmonary congestion, Pyrexia, Renal mass, Retroperitoneal haemorrhage, SARS-CoV-2 test positive, Shock haemorrhagic, Somnolence, Transfusion, Troponin normal, Ultrasound Doppler abnormal, Urine analysis normal, Vena cava filter insertion, Vertigo, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Acute pancreatitis (broad), Agranulocytosis (narrow), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Chronic kidney disease (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 57 y.o. male with history as outlined below as well as pertinent history of focal segmental glomerulosclerosis (status post living donor renal transplant; on chronic immunosuppression with tacrolimus), coronary artery disease (status post CABG x2 on DAPT), anemia of chronic disease; Diagnosis Date ? Adenomatous colon polyp 04/12/2019 ? Angina pectoris ? Atypical migraine 11/06/2020 ? Atypical migraine ? CAD (coronary artery disease) 2009 STEMI 7/2009 sp DES to mid LAD, s/p CABG 4/2014 ? Chronic pain " bilateral legs" ? COVID-19 01/03/2022 ? Diastolic dysfunction 04/2014 ECHO: EF 55%, akinetic apical wall, moderate LVH, and mild diastolic dysfunction ? DVT (deep venous thrombosis), unspecified laterality occured in his fistula ( right arm) ? Erectile dysfunction of organic origin 07/28/2021 ? ESRD on hemodialysis no more dialysis, had a right kidney transplant May 2016 ? FSGS (focal segmental glomerulosclerosis) ? Gastroesophageal reflux disease without esophagitis 04/13/2018 ? Heartburn ? HTN (hypertension) ? Hyperlipidemia ? MI (myocardial infarction) 2009 ? OSA (obstructive sleep apnea) 07/19/2001 AHI 132, desats to 68% Respiratory ? PAD (peripheral artery disease) 07/28/2021 ? S/P kidney transplant 12/03/2016 ? Screening 10/07/2015 ? Trigeminal neuralgia syndrome 02/09/2017 ? Type II diabetes mellitus ? Vertigo "occasional"
Allergies: Morphine and Nsaids (non-steroidal anti-inflammatory drug)
Diagnostic Lab Data: COVID POSITIVE 12/30/2021
CDC Split Type:

Write-up: Patient is a 57 y.o. male with history as outlined below as well as pertinent history of focal segmental glomerulosclerosis (status post living donor renal transplant; on chronic immunosuppression with tacrolimus), coronary artery disease (status post CABG x2 on DAPT), anemia of chronic disease; admitted to the hospital on 1/7/2022 for COVID-19 infection, following presentation with typical symptoms. Patient was transferred to larger hospital due to anticipated multiple specialist need - nephrology for possible dialysis and interventional radiology for possible IVC filter. Please see discharge summary from today authored by RN for further details regarding hospital course. Admission Date: 1/7/2022 Discharge Date: 1/14/2022 He will be transferred to Rehab care. DISCHARGE DIAGNOSES: 1. COVID-19 infection 2. RLE DVT 3. Massive right sided / psoas hematoma with hemorrhagic shock 4. Native left kidney masslike lesion (12cm) 5. AKI on CKD3 6. ESTD previously on hemodialysis now s/p LDKT 7. Tacrolimus toxicity, resolved 8. Sepsis (presumably ruled out with sepsis parameters ultimately felt d/t hemorrhagic shock) 9. Immunosuppressed, febrile neutropenia 10. Acute metabolic encephalopathy 11. Diarrhea, resolved 12. Pulmonary vascular congestion 13. CAD s/p stent and CABGx2v, recent NSTEMI 14. PAD 15. T2DM 16. HTN 17. Obesity s/p gastric bypass surgery ASSESSMENT/PLAN COVID-19 infection Suspected to be likely the etiology of his presenting symptoms. Fully vaccinated and boosted. Symptom onset 12/30, tested positive at home 12/31 (known exposure over Christmas). - Currently stable on room air, continue pulmonary monitor - Continue dexamethasone 6mg BID (in place of PTA prednisone 10mg daily) - Not a candidate for tocilizumab or baricitinib d/t not having high flow O2 needs - Trend inflammatory markers being trended RLE DVT D-dimer 1.62. Venous US showed partially occlusive thrombus on the right extending from the proximal femoral vein to the posterior tibial vein. Patient is treated with IV heparin infusion (PTA aspirin 81 mg continued, Plavix held). Heparin discontinued on 1/13 due to hemorrhagic shock see below. - Now holding PTA ASA 81mg and PTA Plavix - No longer a candidate for anticoagulation - Transferred to larger hospital for possible IVC filter placement by interventional radiology; will consult Hemorrhagic shock d/t massive right psoas muscle/right abdomen hematoma with acute blood loss anemia on anemia of chronic disease: -- Patient was anemic on presentation, suspected secondary to tacrolimus use. Subsequently developed severe right-sided back pain on 1/14 and worsening anemia (hemoglobin 5.5). Clinical evaluation showed massive multiloculated hematoma in the right side of the abdomen involving the right psoas muscle with large components extending into the right lateral abdomen and right midabdomen. -- CT angio done without evidence of active hemorrhage. Briefly required pressors (Levophed and vasopressin) until resuscitated with blood products. Hemodynamics have improved and are now stable. - Continue to hold all forms of anticoagulation and antiplatelet - Type and cross - Monitor hemoglobin - Transfuse for hemoglobin less than 7 AKI on CKD3 Baseline Cr ~ 1.4-1.6. Creatinine trended up to 3.8 at time of transfer. Status post transplant and managed by transplant team. AKI initially thought to be secondary to prerenal azotemia in setting of dehydration; other factors considered include tacrolimus toxicity, worsened by hemorrhagic shock and contrast exposure. - Continue to coordinate care with kidney transplant team at hospital (it appears that they were engaged by hospital medicine service at hospital. - Nephrology consult service was part of his treatment team at Hospital; will consult to address need for dialysis if indicated - Holding azathioprine (per discharge summary recommended by transplant team), will need close coordination with this team to determine when to restart patient''s transplant medications - Holding prednisone - currently replaced with dexamethasone - Holding prophylactic Bactrim d/t AKI Tacrolimus toxicity Appearance patient had supratherapeutic tacrolimus levels prior to arrival. Again notes close coordination between hospitalist service and Transplant team, who recommended resuming tacrolimus after brief period of holding. - Continue tacrolimus at 3mg BID on 1/9 (down from his PTA 4mg BID dose) - Goal tacrolimus level is 4-6 Chronic immunosuppression Neutropenic fever Neutropenia thought to be secondary to tacrolimus toxicity. Patient had febrile episodes which was initially thought to be from COVID but with persistent fever, immunosuppression and neutropenia, patient was empirically treated under infectious disease consult service guidance. BCx2 NGTD, UA/UC negative. Completed antibiotic course on 1/14. - Monitor fever curve - Consult ID (consult service was part of the treatment team) Acute metabolic encephalopathy Vertigo Occurred on 1/10/2022 with associated nausea and vomiting. Stat head CT negative. Waxing and waning with episodes of somnolence; wonder if component of ICU delirium. - Repeat head CT to ensure no ICH Diarrhea, improving Suspected to be multifactorial, secondary to COVID-19 infection tacrolimus toxicity. C.diff negative. - Continue probiotic - Consider testing for enteric pathogens as this was not performed at the hospital Pulmonary vascular congestion Noted on CXR on admission to the hospital. Held off on aggressive diuresis due to AKI. Recent echo at medical center therefore not repeated at Hospital. - Continue cardiopulmonary monitor - Patient closely being followed by pulmonology consult service over at Hospital; and accepted this patient to larger hospital; will consult CAD s/p stent and CABGx2v, recent NSTEMI PAD On ASA and Plavix PT. Recent NSTEMI 1/3/22 in setting of Covid, no intervention. Trops negative. S/p endarterectomy. Complications from anticoagulation and antiplatelets as outlined above. - ASA and Plavix being held as outlined above HTN: - Restart PTA carvedilol, clonidine, minoxidil, hydralazine which were held prior to transfer as a result of hemorrhagic shock - Losartan was held since admission d/t AKI; continue to hold - Hydralazine IV as needed for SBP greater than 170 HLD - PTA atorvastatin OSA - Nocturnal CPAP T2DM A1c 9.2%. - PTA metformin on hold - Continue SSI, QID glucose checks - Monitor for hypoglycemia and treat as clinically indicated (as needed medications ordered) GERD PTA Pepcid and Nexium - PPI IV ordered Obesity S/p gastric bypass surgery. No acute concerns at this time. FEN/GI: None/Replete PRN/Enteral VTE PPX: Hold Home Medication List Reconciliation: Completed Access: PIV Code Status: Full Disposition: Anticipate likely greater than 2 midnights. PROGRESS NOTE 1/17/2021 Patient received additional unit of blood at normal hospital. IVC filter placed on January 15. Patient had acute metabolic encephalopathy due to multiple medical illnesses including suspected infectious process, COVID, he was able to be weaned off of oxygen however. January 17: Hemoglobin increasing up to 8.9 from 8.3. Sodium up to 147, creatinine down to 2.4 from 3.1. Patient continues to be encephalopathic, oxygen saturation is 100% on room air and all vital signs are stable however. Temperature is normal. Net volume status is -16 L. Patient has had inability to take oral intake for approximately 4 days, has missed all oral medication during this time, speech pathology is indicated that he is able to swallow, will encourage oral intake and oral medications immediately. Will direct nursing staff to give medications, otherwise need enteral access immediately. PLAN Suspected COVID-pneumonia Chronic immunosuppression Neutropenic fever Acute metabolic encephalopathy -Infectious disease consulted -Received vancomycin, cefepime, Flagyl, antifungal, all discontinued -Dexamethasone 6 mg twice daily, home prednisone dose is 10 mg daily Right lower extremity DVT status post IVC filter Hemorrhagic shock due to retroperitoneal bleed, abdomen hematoma, right psoas muscle hematoma Hypernatremia Acute renal failure Chronic renal failure stage III History of live donor kidney transplant On chronic tacrolimus, tacrolimus toxicity -Nephrology consulted -Lasix drip per nephrology -Hold chemical anticoagulation, reassess daily -Hold azathioprine -Continue tacrolimus with lower than home dose -Goal tacrolimus level is 4-6 -Hemoglobin every 6 hours -Daily CBC Chronic coronary disease, peripheral artery disease Chronic hypertension, hyperlipidemia Chronic obstructive apnea Obesity Chronic GERD Chronic type 2 diabetes with acute hyperglycemia, A1c 9.2 In the hospital diabetes management will be according to the guidelines with goal blood sugar 140-180 generally. -Continue home long-acting insulin: -Insulin may be ordered using basal, prandial, and correction doses based on this patient''s previous insulin needs and/or weight -Sliding scale insulin available for now -Carbohydrate controlled diet -Hold metformin -IV PPI, transition to oral when appropriate -CPAP nightly when able -Continue home statin -Hold home aspirin and Plavix in the setting of hemorrhage, reassess daily -Holding losartan -Continue home carvedilol, clonidine, minoxidil, hydralazine


VAERS ID: 2043218 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 FK5618 / 2 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NOT KNOWN
Current Illness: UNKNOWN
Preexisting Conditions: UNKNOWN
Allergies: NKA
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: ADULT CLIENT COMPLETED PEDIATRIC CONSENT. ACCORDING TO PRE-STAMPED LOT AND DOSE, RECEIVED A PEDIATRIC LOT# AND DOSE INSTEAD OF APPROPRIATE ADULT LOT AND DOSE.


VAERS ID: 2043298 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 FE3954 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anxiety, Ataxia, Blood test normal, Chest pain, Computerised tomogram head normal, Computerised tomogram normal, Fibrin D dimer increased, Full blood count normal, Glomerular filtration rate decreased, Laboratory test normal, Metabolic function test normal, Paraesthesia, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Citalopram Intrarosa
Current Illness: None known
Preexisting Conditions: Anxiety, Postmenopausal
Allergies: yellow dye
Diagnostic Lab Data: Blood tests: CBC, CMP, SOB Panel (EGFR 57 and DDimer 772 only significant findings.) CT PE study 01/03/22: Negative. CT head/Brain: Negative
CDC Split Type:

Write-up: Anxiety, Vertigo, Chest Pain, Ataxia, paresthesia. Developed several hours after the shot 12/30/21 but did not seek care immediately. Seen in my office on 01/03/22 and evaluated with appropriate blood and image testing. Seen in follow up on 01/14/21. Mild vertigo but otherwise resolved symptoms with normal tests results.


VAERS ID: 2043590 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-07
Onset:2021-12-30
   Days after vaccination:84
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30158BA / 3 LA / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR UJ745AC / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Computerised tomogram abdomen, Diverticulitis, Laboratory test
SMQs:, Gastrointestinal nonspecific inflammation (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: Lansoprazole, Duloxetine, Rizatriptan, vitamins
Current Illness: None
Preexisting Conditions: Migraine headaches, GERD
Allergies: Sulfa, tape
Diagnostic Lab Data: Lab test 1/3/2021; abdominal CT with contrast 1/5/2021.
CDC Split Type:

Write-up: I developed diverticulitis on January 30, 2021.


VAERS ID: 2043595 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: Angiogram, Anxiety, Chest X-ray, Chest pain, Dizziness, Electrocardiogram, Feeling hot, Heart rate increased, Hypoaesthesia, Laboratory test, Palpitations
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad), Sexual dysfunction (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: none
Current Illness: none
Preexisting Conditions: none
Allergies: denies
Diagnostic Lab Data: labs, CXR 1/8/2022 no active disease, ekg 1/8/22 NSR 78, CT angiogram 1/4/2022 negative for PE, negative thoracic aneurysm, no pneumonia. Diagnosed anxiety, given hydroxyzine,
CDC Split Type:

Write-up: patient reports that 5 min after vaccine, felt hot, heart racing, she reports HR went to 150 and she felt like she was going to pass out. Since then patient has felt chest pain, numbness toe to head on the left side, right elbow numbness, warmth abdomen and chest seen in the ER 12/30/2021 01/01/22 01/04/2022 and 01/08/22


VAERS ID: 2043606 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-12-28
Onset:2021-12-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 059H21A / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Chest discomfort, Chest pain, Computerised tomogram, Costochondritis, Decreased appetite, Dry mouth, Dyspnoea, Electrocardiogram, Fatigue, Gastrooesophageal reflux disease, Muscular weakness, Oesophagogastroduodenoscopy, Pain in extremity, Ultrasound biliary tract
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Dehydration (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: None.
Current Illness: None.
Preexisting Conditions: High cholesterol.
Allergies: None.
Diagnostic Lab Data: Chest x-ray, EKG, blood work in ED - 1/2/22 Chest x-ray, EKG, blood work, CT Scan w/ contrast in ED - 1/5/22 EGD - 1/14/22 Gallbladder U/S - 1/19/22
CDC Split Type:

Write-up: Two days after receiving vaccine, I had arrived at work and felt the need to take a deep breath. After that, my chest became tight followed by shortness of breath. That evening began having severe reflux with pain at the lower sternum. In the following days chest tightness continued along with shortness of breath and calves became extremely sore. Reported to ED 4 days after symptoms began, cardiology workup and blood work was normal. Lost appetite with dry mouth two days after ER visit and experiencing weakness in arms and legs. Scheduled appointment with PCP. Diagnosed with reflux brought on by the shot. Sent home with meds. That evening extreme chest pain and shortness of breath with fatigue. Went to ED by Ambulance. Blood work, cardiology workup and CT scan were all normal. Sent home with additional medicine. All symptoms persisted until the following week. Saw PCP again to be evaluated for Guillain Barre syndrome; was negative. Sent back home and told to "ride it out". Three weeks post vaccine, still pain in calves, weakness in limbs, random heart burn, tightness in chest and sometimes shortness of breath. Had EGD which was negative and waiting to do a gallbladder ultrasound. Currently also on multiple supplements and OTC meds. Now suspected that I may also have Costochondritis.


VAERS ID: 2043674 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-12-27
Onset:2021-12-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 068H21A / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Blood urine present, Glucose tolerance impaired, Laboratory test, Nodule, Pain, Urge incontinence
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Lipodystrophy (broad), Arthritis (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: Geriatric multivitamin with iron; calcium citrate; LEXAPRO generic; tramadol
Current Illness: None
Preexisting Conditions: Used to be pre diabetic but not anymore
Allergies: I am allergic to shellfish
Diagnostic Lab Data: lab results came back negative for a UTI.
CDC Split Type: vsafe

Write-up: About 3 days after I received the vaccination I started to experience knots in the chest and breast area. I experienced body aching in my joints. The knots are on my right side of my body and they are still here. I also had blood in my urine this month on 01/14/2022 and I did get labs done on 01/18/2022 but no infection found. It feels like a UTI but not a UTI. I feel the sensation of having to go to the bathroom but does not have to go. I did as well have a culture done.


VAERS ID: 2045556 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: California  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 068H21A / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Injection site pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Site: Pain at Injection Site-Severe, Systemic: arm pain-Severe, Systemic: Joint Pain-Severe, Additional Details: Pt called stating she thinks the vaccine was given too high, cause her immense pain and she had to visit the urgent care. Arm is now in a sling and patient is taking tylenol #3 for the pain.


VAERS ID: 2046091 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-12-30
Submitted: 0000-00-00
Entered: 2022-01-19
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? No
Previous Vaccinations:
Other Medications:
Current Illness: Non-smoker; Social alcohol drinker
Preexisting Conditions: Comments: Patient had no known allergies.
Allergies:
Diagnostic Lab Data: Test Date: 20211225; Test Name: COVID-19 virus test; Result Unstructured Data: negative; Test Date: 20220103; Test Name: COVID-19 PCR test; Result Unstructured Data: positive; Test Date: 20220104; Test Name: COVID-19 antigen test; Result Unstructured Data: positive
CDC Split Type: USJNJFOC20220105653

Write-up: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 37 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: light/social drinker, and non-smoker, and patient had no known allergies. The patient received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 30-DEC-2021 for prophylactic vaccination on right deltoid (dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported. On 25-DEC-2021, Laboratory data included: COVID-19 virus test (first at home test) (NR: not provided) negative. Symptoms (reported as "basically all the symptoms") started on 30-DEC-2021.The patient started getting sick after the booster, at onset patient had chills, diarrhea, and mild fever. On 03-JAN-2022, patient underwent COVID-19 PCR (polymerase chain reaction) test which was positive (confirmed covid-19 infection and confirmed clinical vaccination failure) (dose number in series 1). On 04-JAN-2022 (at the time of report), patient had cough, congestion, and light headache. Patient did not know if fatigue was due to the COVID (COVID-19 Infection) or vaccine. On 04-JAN-2022, patient underwent another rapid test Laboratory data included: COVID-19 antigen test which was positive. Patient works but was on condolence leave. 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 (Other Medically Important Condition). This report was associated with product quality complaint: 90000210755. 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.; Sender''s Comments: V0 - 20220105653- 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: 2046263 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 067H21A / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Incorrect route of product administration
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

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

Write-up: Error: Wrong Route (SC, IM, etc.)-


VAERS ID: 2047407 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013H21B / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dyspnoea, Injection site rash, Rash
SMQs:, Anaphylactic reaction (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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: nothing - but had epipen because she reacted to flu vaccine in 2020
Current Illness: none
Preexisting Conditions: none
Allergies: flu shot - not sure of other allergies- narrowed down to preservatives, artificial dyes
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient started to get a rash around the injection site but then it spread all the up to her jawline. She started to have trouble breathing shortly after. She had an EpiPen on hand and injected herself with it and was fine.


VAERS ID: 2047661 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 33033BD / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Additional Details: myocarditis


VAERS ID: 2047804 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-02-25
Onset:2021-12-30
   Days after vaccination:308
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive
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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Breakthrough COVID-19.


VAERS ID: 2047822 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Chills, Computerised tomogram, Electrocardiogram, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin, Aspirin low dose, simvastain, triamterine/Hctz, Glipizide, B-12, Vitamin D3, Gabapentin, lisinopril,
Current Illness: None
Preexisting Conditions: Diabetes, High blood pressure, high Cholesterol, Anemia
Allergies: None
Diagnostic Lab Data: EKG, Blood work, CT scan with dye, observation
CDC Split Type:

Write-up: Temp 102, uncontrollable chills, tachycardia one day after injection lasted all day and night into hospital stay


VAERS ID: 2048157 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: California  
Vaccinated:2021-12-10
Onset:2021-12-30
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213D21A / 1 - / SYR

Administered by: Public       Purchased by: ?
Symptoms: Chills, Haemoptysis, Pyrexia, SARS-CoV-2 test negative
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: 4 Covid tests day of, during and after event. All negative test results
CDC Split Type:

Write-up: High fever/chills, followed by coughing up large amounts of dark red blood for 5 days. No other symptoms besides this. Abruptly stopped on 5th day


VAERS ID: 2050374 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Immunisation, Mouth swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101885346

Write-up: Mouth is swollen; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 64 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed but manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021, outcome "unknown", described as "booster dose"; MOUTH SWELLING (non-serious), outcome "unknown", described as "Mouth is swollen". Additional information:This consumer is also the patient who got the Pfizer Covid Vaccine on 30Dec2021. She called to figure out what to do because her mouth is swollen, which is not too bad, just swollen a little. She was trying to figure out how long will this event last; it''s not her whole face, just her mouth that is a little swollen. She wanted to know if she can smoke a cigarette, can she drink, she needed to know how long this event will last No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2050375 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 33B0BA / 3 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: JUNEL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: Binax NOW; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202101885457

Write-up: Booster; headache; joint soreness; swollen/painful L armpit lymph node; swollen/painful L armpit lymph node; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 16:00 (Lot number: 33B0BA) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: JUNEL taken for contraception. Vaccination history included: Bnt162b2 (dose number: 1, lot number: EL0142, administration date: 03Jan2021 in Left arm), administration date: 03Jan2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (dose number: 2, lot number: EL3247, administration date: 20Jan2021 at 08:30 AM in Left arm), administration date: 20Jan2021, when the patient was 26 years old, for Covid-19 immunization, reaction(s): "Dose 1 on 03Jan2021 and Dose 2 on 20Jan2021". The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset 30Dec2021, outcome "not recovered", described as "headache"; ARTHRALGIA (non-serious) with onset 30Dec2021, outcome "not recovered", described as "joint soreness"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 30Dec2021, outcome "not recovered" and all described as "swollen/painful L armpit lymph node". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, arthralgia, lymphadenopathy, lymph node pain. Additional information: On 31Dec2021, patient was tested for covid using nasal swab result of which was negative. Patient had no known allergies. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid in the past. Follow-up attempts are completed. No further information is expected.


VAERS ID: 2050682 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: West Virginia  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Catheterisation cardiac, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: cath
CDC Split Type:

Write-up: Myocardial Infarction


VAERS ID: 2050843 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-12-24
Onset:2021-12-30
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 241021A / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest X-ray abnormal, Dyspnoea, Fatigue, Headache, Pneumonia, Respiratory tract congestion, SARS-CoV-2 test negative
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 03/23/3021
Other Medications: Vitamins
Current Illness: None other than daily smoket
Preexisting Conditions: None other than daily smoke r
Allergies: Penicillin and sulfa
Diagnostic Lab Data: On 01/05/2022 Covid test. Negative result. On 01/12/2022 appt with PCP and chest X-ray. Confirmed pneumonia Prescribed prednisone, zpac and albuterol neubilizer treatments.
CDC Split Type:

Write-up: On 12/25/2021 fatigue and headache. On 12/30/2021 congestion and issues breathing.


VAERS ID: 2050879 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 33036BD / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Angina pectoris, Dizziness, Fatigue, Headache, Immediate post-injection reaction, Malaise, Pain, Paranasal sinus hypersecretion, Productive cough, Syncope, X-ray normal
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? Yes
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: Normal cold/flu like symptoms first shot; none second
Other Medications: Plavix 75 mg Toprol ER 25 mg Metorpolol 12.5 mg 2 x''s a day Furosemide 20 mg 5 MeQ Potassium Flaxseed Oil 1000 mg Zinc 100 mg D3 One A Day Silver
Current Illness: None
Preexisting Conditions: AICD EF 48% Prior Viral Cardiomyopathy PAD Abdominal Aneurism Type II Diabetic
Allergies: Mold June Grass
Diagnostic Lab Data: DOC ORDERED XRAYS WEEK 3 VIA EMERGENCY ROOM; NORMAL XRAY. TREATED AT ER WITH CODEINE, TWO INHALERS ISSUED VIA SCRIPT.
CDC Split Type:

Write-up: IMMEDIATE STABBING PAINS IN MY HEART; SUBSEQUENT COVID SYMPTOMS, SEVERE: PRODUCTIVE COUGH, PRODUCTIVE SINUS DISCHARGE (MASSIVE FOR WEEKS); ACHES; HEADACHE; DIZINESS; EXTREME FATIGUE; EXHAUSTION; COLLAPSING. THIS IS MY BOOSTER.


VAERS ID: 2051099 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: California  
Vaccinated:2021-12-04
Onset:2021-12-30
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032F21A / 3 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Blood triglycerides increased, Heavy menstrual bleeding, Ultrasound scan normal, Urine analysis
SMQs:, Dyslipidaemia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Lipodystrophy (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: Pfizer CoVid 2nd dose, Radiating pain, 36yr, 04/03/2021
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: NKA
Diagnostic Lab Data: 01/16 Blood panel, Urinalyses (From Lipid test, found spike in triglycerides) 01/17 Ultrasound (Clear)
CDC Split Type: vsafe

Write-up: 12/30Blood clot the size of a golf ball showed up in my period. I went to get it checked at lab after a consultation with my PCP. 01/16 Had Blood panel, Urinalyses, and on 01/17 Ultrasound. Found that my triglycerides were skyrocketing but no correlation with blood clot. Was told to start taking fish oil and will do a fasting test in a couple months.


VAERS ID: 2051262 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 031H21A / 4 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered
SMQs:, Medication errors (narrow)

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

Write-up: Patient reported no adverse event. Patient''s brother brought her for the booster and assisted her in completing her attestation form/consent. The first two doses were verified via database. Later that afternoon it was discovered the patient was in the database twice under different first names. While attempting to merge the duplicate files, it appeared on 11/09/2021 she already received her booster. I called to verify with that facility and faxed the doctor. The booster was given on 11/09/2021 at another facility, but not documented on the patient''s vaccination record card.


VAERS ID: 2052223 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Hawaii  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032H21A / 3 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Laboratory test normal, Ultrasound scan normal
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Psillium husk, maca
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Labs to rule out pancreatitis 01/03/2022 - all normal Ultrasound to investigate for gallbladder issues 01/07/2022 - all normal
CDC Split Type:

Write-up: Intense stomach pain, off and on from the day after injection until the 14th, two full weeks.


VAERS ID: 2007130 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-12-30
   Days after vaccination:176
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA9094 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19; Result Unstructured Data: Test Result:positive
CDC Split Type: CAPFIZER INC202101882952

Write-up: COVID-19 positive; COVID-19 positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 20 year-old male patient received bnt162b2 (BNT162B2), administration date 07Jul2021 (Lot number: FA9094) at the age of 20 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer-biontech comirnaty covid-19 (Dose Number: 1 Batch/Lot No: EW0216), administration date: 30May2021. The following information was reported: COVID-19 (medically significant) with onset 30Dec2021, outcome "recovering", DRUG INEFFECTIVE (medically significant) with onset 30Dec2021, outcome "unknown" and all described as "COVID-19 positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Additional Information: It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if, prior to vaccination, was the patient diagnosed with COVID-19. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 2015182 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-12-30
   Days after vaccination:230
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN1196 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 Name: sars-cov-2 test; Result Unstructured Data: Test Result:unknown; Test Date: 20211230; Test Name: sars-cov-2 test; Result Unstructured Data: Test Result:positive
CDC Split Type: CAPFIZER INC202200003331

Write-up: COVID-19 Positive; COVID-19 Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 14May2021 (Lot number: EN1196) at the age of 54 years as dose 2, single and administration date 22Apr2021 (Lot number: EN1194) 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), SUSPECTED COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovering" and all described as "COVID-19 Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) unknown; (30Dec2021) positive. Therapeutic measures were not taken as a result of suspected covid-19. Clinical course: The patient was not diagnosed with COVID-19 prior to vaccination. The patient had been tested for C OVID-19 since the vaccination.


VAERS ID: 2015183 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-12-30
   Days after vaccination:230
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN1196 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: tested for COVID-19; Result Unstructured Data: Test Result:Positive.
CDC Split Type: CAPFIZER INC202200004008

Write-up: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from product quality group and a sales representative. The reporter is the patient. A 55-year-old male patient received bnt162b2 (BNT162B2), administration date 14May2021 (Lot number: EN1196) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer-biontech comirnaty covid-19 (Dose Number: 1, Batch/Lot No: EN1194), administration date: 22Apr2021, for Covid-19 Immunization. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 30Dec2021, outcome "recovering", and all described as "COVID-19 Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive. It was unknown if therapeutic measures were taken as a result of covid-19, vaccination failure. Additional Information: It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if, prior to vaccination, was the patient diagnosed with COVID-19.


VAERS ID: 2015184 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Lip swelling, Pharyngeal swelling, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID; CELEXA [CELECOXIB]; VENTOLIN [SALBUTAMOL]; NAPROXEN; PROPRANOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to nuts; Anxiety; Asthma; COVID-19; Depression; Eczema; Fish allergy; Food allergy; Hypothyroidism; Peanut allergy; Shellfish allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202200004121

Write-up: My throat started to feel scratchy; My throat ... started swelling; my lips swelled up; Dose Number 3; This is a spontaneous report received from contactable Consumer. The reporter is the patient. A 44 year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), administered in arm right, administration date 30Dec2021 16:15 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "eczema" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Allergy: fish" (unspecified if ongoing); "Allergy: shellfish" (unspecified if ongoing); "Allergy: nuts" (unspecified if ongoing); "Allergy: peanuts" (unspecified if ongoing); "Allergy: avocado" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medications included: SYNTHROID (ongoing); CELEXA [CELECOXIB] (ongoing); VENTOLIN [SALBUTAMOL] (ongoing); NAPROXEN (ongoing); PROPRANOLOL (ongoing). Vaccination history included: BNT162b2 (Dose 1, Location of injection: Arm Left, Vaccine Administration Time: 12:00), administration date: 20Aug2021, when the patient was 43 years old, for COVID-19 Immunization; BNT162b2 (Dose 2; Location of injection: Arm Right, Vaccine Administration Time: 13:15), administration date: 11Sep2021, when the patient was 43 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (life threatening) with onset 30Dec2021 16:15, outcome "unknown", described as "Dose Number 3"; THROAT IRRITATION (life threatening) with onset 30Dec2021 17:15, outcome "recovering", described as "My throat started to feel scratchy"; PHARYNGEAL SWELLING (life threatening) with onset 30Dec2021 17:15, outcome "recovering", described as "My throat ... started swelling"; LIP SWELLING (life threatening) with onset 30Dec2021 17:15, outcome "recovering", described as "my lips swelled up". Therapeutic measures were taken as a result of throat irritation, pharyngeal swelling, lip swelling which included the patient gave herself her epipen. Since the vaccination, the patient had not been tested for COVID-19. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 2016277 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Maternal exposure during pregnancy, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; SERTRALINE
Current Illness: Depression; Pregnancy (Estimated due date: 20220822)
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: stomach cramps; Maternal exposure during pregnancy; Vaginal bleeding; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26424505) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), VAGINAL HAEMORRHAGE (Vaginal bleeding) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for Vaccination. Previously administered products included for Irritable bowel syndrome: MOVICOL. Past adverse reactions to the above products included No adverse event with MOVICOL. Concurrent medical conditions included Depression and Pregnancy (Estimated due date: 20220822). Concomitant products included SERTRALINE from 15-Oct-2021 to 18-Dec-2021 for Depression, FOLIC ACID for Folic acid supplementation. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. The patient''s last menstrual period was on an unknown date and the estimated date of delivery was 22-Aug-2022. On 30-Dec-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps) (seriousness criteria medically significant and life threatening) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criteria medically significant and life threatening). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps) was resolving, VAGINAL HAEMORRHAGE (Vaginal bleeding) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was reported that the patient had no issue with the pregnancy up until that point and the day after started getting stomach cramps and spotting. 2 days later was having bad cramps and bleeding and passing tissue. Awaiting a scan to determine if the patient had miscarried. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations were awaiting due to possible miscarriage. No treatment details were reported. Company comment: This is a regulatory case concerning a 37 year-old, female patient with concomitant use of sertraline and Maternal exposure during pregnancy, who experienced the serious (due to medically important condition and life-threatening) unexpected, according CCDS, events of Abdominal pain upper and Vaginal haemorrhage. The event Vaginal haemorrhage occurred approximately 1 day after the booster dose of mRNA-1273 vaccine and the event Abdominal pain upper on an unknown date. The patient received the mRNA-1273 vaccine at approximately 6 weeks of gestation. The outcome of the event Abdominal pain upper was reported as recovering and the event Vaginal haemorrhage as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The concomitant use of sertraline remains 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 37 year-old, female patient with concomitant use of sertraline and Maternal exposure during pregnancy, who experienced the serious (due to medically important condition and life-threatening) unexpected, according CCDS, events of Abdominal pain upper and Vaginal haemorrhage. The event Vaginal haemorrhage occurred approximately 1 day after the booster dose of mRNA-1273 vaccine and the event Abdominal pain upper on an unknown date. The patient received the mRNA-1273 vaccine at approximately 6 weeks of gestation. The outcome of the event Abdominal pain upper was reported as recovering and the event Vaginal haemorrhage as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The concomitant use of sertraline remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2016329 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Immunisation, Polymerase chain reaction, SARS-CoV-2 antibody 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: 20211230; Test Name: molecular testing; Test Result: Positive; Comments: vaccinated with a third dose of 30 December 2021, at midday on the same day was diagnosed as positive rapid test coronavirus, which was also confirmed by molecular testing; Test Date: 20211230; Test Name: rapid test coronavirus; Test Result: Positive; Comments: vaccinated with a third dose of 30 December 2021, at midday on the same day was diagnosed as positive rapid test coronavirus, which was also confirmed by molecular testing.
CDC Split Type: GRPFIZER INC202101885473

Write-up: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 19 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 19 years as dose 3 (booster), single, administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jul2021 (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: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "3rd dose of Comirnaty"; DRUG INEFFECTIVE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Vaccination Failure"; COVID-19 (medically significant) with onset 30Dec2021, outcome "unknown", described as "Covid-19 positive". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (30Dec2021) positive, notes: vaccinated with a third dose of 30 December 2021, at midday on the same day was diagnosed as positive rapid test coronavirus, which was also confirmed by molecular testing; sars-cov-2 antibody test: (30Dec2021) positive, notes: vaccinated with a third dose of 30 December 2021, at midday on the same day was diagnosed as positive rapid test coronavirus, which was also confirmed by molecular testing. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2020386 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fatigue, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), COVID-19 (broad)

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

Write-up: Felt faint; Fatigue; Large arm swelling; This case was received via Regulatory authority. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Felt faint), FATIGUE (Fatigue) and PERIPHERAL SWELLING (Large arm swelling) 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 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced DIZZINESS (Felt faint) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Large arm swelling) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Felt faint) had not resolved and FATIGUE (Fatigue) and PERIPHERAL SWELLING (Large arm swelling) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Concomitant medication information was reported. Patient last menstrual period was 18-DEC-2021 Patient reported feeling faint on repeated occasions, having to sit down to recover. General fatigue and arm were swollen and red. No treatment medications were provided. Patient did not relate the report to possible inflammation of the heart (myocarditis or pericarditis). Company Comment: This is a regulatory case concerning a 33-year-old female patient with no medical history, who experienced the unexpected serious events of Dizziness, Fatigue and Peripheral swelling. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The outcome of the event Dizziness was reported as not resolved and Fatigue and Peripheral swelling as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authoritys report.; Sender''s Comments: This is a regulatory case concerning a 33-year-old female patient with no medical history, who experienced the unexpected serious events of Dizziness, Fatigue and Peripheral swelling. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The outcome of the event Dizziness was reported as not resolved and Fatigue and Peripheral swelling as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authoritys report.


VAERS ID: 2020404 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Write-up: Dizzy spells; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26418747) 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 DIZZINESS (Dizzy spells) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced DIZZINESS (Dizzy spells) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizzy spells) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant product was provided. No treatment information was provided. Patient had not symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. No possible inflammation of the heart (myocarditis or pericarditis). Company Comment: This is a regulatory case concerning a 29-year-old female patient with no medical history, who experienced the unexpected serious event of Dizziness. The events occurred on the same day after the third dose of mRNA-1273 vaccine. The outcome of the event Dizziness was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authoritys report.; Sender''s Comments: This is a regulatory case concerning a 29-year-old female patient with no medical history, who experienced the unexpected serious event of Dizziness. The events occurred on the same day after the third dose of mRNA-1273 vaccine. The outcome of the event Dizziness was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authoritys report.


VAERS ID: 2022784 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse drug reaction, Medication error
SMQs:, Medication errors (narrow)

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

Write-up: medication error; High temperatur over 40, blocked ears, aches and fatigue, nausea, chills, headache; This regulatory authority case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (High temperatur over 40, blocked ears, aches and fatigue, nausea, chills, headache) and MEDICATION ERROR (medication error) in a 22-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for Ill-defined disorder. No Medical History information was reported. On 30-Dec-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 30-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced ADVERSE DRUG REACTION (High temperatur over 40, blocked ears, aches and fatigue, nausea, chills, headache) (seriousness criterion medically significant). On an unknown date, the patient experienced MEDICATION ERROR (medication error) (seriousness criterion medically significant). On 30-Dec-2021, ADVERSE DRUG REACTION (High temperatur over 40, blocked ears, aches and fatigue, nausea, chills, headache) had not resolved. At the time of the report, MEDICATION ERROR (medication error) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) was unknown. No concomitant medications were reported. No treatment medications were reported. Reaction Description: Already explained Medication Error Details: The vaccine Seek Advice Details: Partner has never been so ill The patient was taking Moderna vaccine for: Required for job. This is a regulatory authority case concerning a 22-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of adverse drug reaction, medication error. 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 unknown. 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 22-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of adverse drug reaction, medication error. 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 unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 2023372 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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: 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: Comments: Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
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: Joint pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26414028) 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 ARTHRALGIA (Joint pain) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (Joint 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. Patient has Joint pains, including knees, elbow, wrist, shoulders and jawwith Severe back pain and fuzzy head that she cannot focus on anything for too long Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Concomitant product was not provided by the reporter Treatment information was not provided This case concerns a 25-year-old female patient with no medical history, who experienced the unexpected serious event of Arthralgia, the event was medically significant as reported by the regulatory authority. The event occurred 1 day after receiving the third dose of mRNA-1273. The rechallenge was reported as unknown by the regulatory authority. No clinical or treatment details were given. It is reported that the outcome of the event has resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 25-year-old female patient with no medical history, who experienced the unexpected serious event of Arthralgia, the event was medically significant as reported by the regulatory authority. The event occurred 1 day after receiving the third dose of mRNA-1273. The rechallenge was reported as unknown by the regulatory authority. No clinical or treatment details were given. It is reported that the outcome of the event has resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2023410 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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: 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZOMORPH
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID- 19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fever chills; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26416207) 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 PYREXIA (Fever chills) in a 44-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included MORPHINE SULFATE (ZOMORPH) for Back injury. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID- 19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient says she also had chills, headache ,sickness and diarrhea.She says a lot of Lab tests were done , results were negative.Treatment information was not provided. The patient did not have any possible inflammation of the heart. 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 44-year-old female patient with no medical history reported who experienced the unexpected and serious event of pyrexia. The event occurred the following day a third dose of mRNA-1273 vaccine was administered. Patient experienced chills, headache ,sickness and diarrhoea. Several lab tests were done with negative results. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 44-year-old female patient with no medical history reported who experienced the unexpected and serious event of pyrexia. The event occurred the following day a third dose of mRNA-1273 vaccine was administered. Patient experienced chills, headache ,sickness and diarrhoea. Several lab tests were done with negative results. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023413 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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: SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

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

Write-up: Fainting; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26416477) 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 SYNCOPE (Fainting) in a 47-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). On 30-Dec-2021, SYNCOPE (Fainting) 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. No Concomitant medication provided. No treatment medication reported. Patient had not had symptoms associated with COVID-19. Patient had shivers in the night. Woke up feeling awful. Fainted in the bathroom. Went back to bed and have horrible headache and feeling fragile. Patient has 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. This is a regulatory case concerning a 47-year-old female patient with no reported medical history, who experienced the serious per reported severity expected event of syncope. The event occurred on the same day after the third dose of mRNA-1273 vaccine administration. The event was assessed as related, per temporal association with the product administration. The rechallenge was reported as unknown; however, could be considered as not applicable since the event occurred after the third dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 47-year-old female patient with no reported medical history, who experienced the serious per reported severity expected event of syncope. The event occurred on the same day after the third dose of mRNA-1273 vaccine administration. The event was assessed as related, per temporal association with the product administration. The rechallenge was reported as unknown; however, could be considered as not applicable since the event occurred after the third dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023419 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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: Fatigue, 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: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fatigue; This case was received via Regulatory authority. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped). Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 06-Jun-2021 to an unknown date for COVID-19 vaccination. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, FATIGUE (Fatigue) 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 treatment medication reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). Re-challenge was reported as unknown. Patient was not pregnant, Patient was not currently breastfeeding. Last menstrual period date was 06-Dec-2021. Company comment: This Regulatory Authority case concerns a 42-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) event of fatigue. The event occurred 1 day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. The patient received as first and second dose of his COVID-19 vaccination schedule two doses AstraZeneca''s COVID-19 vaccine. Regulatory authority captured the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.; Sender''s Comments: This Regulatory Authority case concerns a 42-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) event of fatigue. The event occurred 1 day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. The patient received as first and second dose of his COVID-19 vaccination schedule two doses AstraZeneca''s COVID-19 vaccine. Regulatory authority captured the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.


VAERS ID: 2023430 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
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: Headache, Lip swelling, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BOTOX
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.MOD20214

Write-up: headache; Swollen lips; This case was received (Reference number: GB-RA-ADR 26417272) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of HEADACHE (headache) and LIP SWELLING (Swollen lips) in a 44-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005686) for an unknown indication. Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) from 01-Dec-2021 to an unknown date for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced LIP SWELLING (Swollen lips) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant). At the time of the report, HEADACHE (headache) outcome was unknown and LIP SWELLING (Swollen lips) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment drug information provided. Patient suffered from swelling to the lips with onset occurring around 15 hours after vaccination. She was also noted that she had feverish symptoms and headache. advised her to take loratadine along with some paracetamol for her fevers. 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 44-year-old female patient with no clinical history who experienced the unexpected events of HEADACHE, LIP SWELLING 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 44-year-old female patient with no clinical history who experienced the unexpected events of HEADACHE, LIP SWELLING 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: 2023431 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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: Maternal exposure during breast feeding, Migraine, SARS-CoV-2 test
SMQs:, Neonatal exposures via breast milk (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: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210228; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Maternal exposure during breast feeding; Migraine; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26417278) 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 MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and MIGRAINE (Migraine) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped). Concurrent medical conditions included Breast feeding. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). On 30-Dec-2021, MIGRAINE (Migraine) had resolved with sequelae. At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided by reporter. No treatment was provided. After having the vaccine, the patient was severely unwell for about 24 hours. Patient had constant chills and sweats, high temperature, pain everywhere in her body, migraine and extreme sensitivity to light. Patient felt generally uncomfortable after her first and second Pfizer vaccines but nothing like her reaction to the Moderna booster. Patient was unable to even look after her children. Company comment: This regulatory authority case concerns a 28-year-old female patient with no relevant medical history, who experienced Maternal exposure during breastfeeding and the unexpected serious (medically significant) event of Migraine after mRNA- 1273 vaccine, booster dose of the vaccination schedule. The patient had received initial schedule of vaccination with Pfizer BioNTech COVID-19 Vaccine. The onset of the event occurred approximately 1 day after the booster dose of mRNA- 1273 vaccine. Photosensitivity was also reported and could be in connection with Migraine. Additionally, the expected events of chills, pyrexia and myalgia were mentioned. The events resolved after approximately 24 hours. The seriousness criteria of the events was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial.; Sender''s Comments: This regulatory authority case concerns a 28-year-old female patient with no relevant medical history, who experienced Maternal exposure during breastfeeding and the unexpected serious (medically significant) event of Migraine after mRNA- 1273 vaccine, booster dose of the vaccination schedule. The patient had received initial schedule of vaccination with Pfizer BioNTech COVID-19 Vaccine. The onset of the event occurred approximately 1 day after the booster dose of mRNA- 1273 vaccine. Photosensitivity was also reported and could be in connection with Migraine. Additionally, the expected events of chills, pyrexia and myalgia were mentioned. The events resolved after approximately 24 hours. The seriousness criteria of the events was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 2023433 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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: Dizziness, Headache, Myalgia, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA
Current Illness: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef); Osteoarthritis; Rheumatoid arthritis
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Dizziness; Painful arm; Muscle pain; Headache; High temperature; This case was received (Reference number: GB-RA-ADR 26417538) 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 HEADACHE (Headache), PYREXIA (High temperature), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Painful arm) and MYALGIA (Muscle pain) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 10-Nov-2021 to 15-Nov-2021. Concurrent medical conditions included Rheumatoid arthritis, Osteoarthritis 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 COVID-19 vaccination. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and MYALGIA (Muscle pain) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) and DIZZINESS (Dizziness) was resolving and PYREXIA (High temperature), PAIN IN EXTREMITY (Painful arm) and MYALGIA (Muscle pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Patient had received vaccine at 6pm on the 29th. Woke up on the 30th with a very high temperature, the lowest could get it to with paracetamol and Ibuprofen was 38.4 degrees. Very ache all over and bad headache. Very tired. Sore eyes. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). Company Comment: This case concerns a 24-year-old female patient, with medical history or rheumatoid arthritis, osteoarthritis, and immunodeficiency, who experienced the unexpected and serious events of Myalgia, pain in extremity, Pyrexia, Headache, and Dizziness. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The events occurred the first day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. Previous doses of COVID-19 vaccine given with Chadox 1 NCOV-19 (Interchange of vaccine products). The medical history remains confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 24-year-old female patient, with medical history or rheumatoid arthritis, osteoarthritis, and immunodeficiency, who experienced the unexpected and serious events of Myalgia, pain in extremity, Pyrexia, Headache, and Dizziness. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The events occurred the first day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. Previous doses of COVID-19 vaccine given with Chadox 1 NCOV-19 (Interchange of vaccine products). The medical history remains confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023445 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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: Fatigue, Headache, Myalgia, Nausea, Peripheral swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Swollen arm; Headache; Generalized muscle aches; Fatigue; Nausea; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26418144) 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 PERIPHERAL SWELLING (Swollen arm), HEADACHE (Headache), MYALGIA (Generalized muscle aches), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Generalized muscle aches) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swollen arm), HEADACHE (Headache), MYALGIA (Generalized muscle aches) and FATIGUE (Fatigue) had not resolved and NAUSEA (Nausea) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. It was stated that the patient woke up, felt nauseated began to subside throughout the day, had a headache all day. Patient felt very tired and achy all over, sore and swollen at point of injection with red blotch that grew. Patient last menstrual period date was reported as 20-NOV-2021. Treatment information was not provided. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Report was not related to possible inflammation of the heart (myocarditis or pericarditis). Company Comment: This case concerns a 24-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Peripheral swelling, Headache, Myalgia, Fatigue and Nausea. The events occurred on the day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). Events seriousness assessed as per Regulatory Authority report and retained for consistency. Concomitant medications were provided by the reporter. Treatment information was not provided.. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender''s Comments: This case concerns a 24-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Peripheral swelling, Headache, Myalgia, Fatigue and Nausea. The events occurred on the day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). Events seriousness assessed as per Regulatory Authority report and retained for consistency. Concomitant medications were not provided by the reporter. Treatment information was not provided.. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.


VAERS ID: 2023446 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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: Chills, Ear pain, Fatigue, Headache, Muscle spasms, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; 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: Feverish; Foot pain; Muscle cramp; Earache; Headache; Shivers; Tiredness; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26418157) 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 HEADACHE (Headache), CHILLS (Shivers), FATIGUE (Tiredness), PYREXIA (Feverish), PAIN IN EXTREMITY (Foot pain), MUSCLE SPASMS (Muscle cramp) and EAR PAIN (Earache) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 20-May-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 17-Jul-2021 to an unknown date for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), PAIN IN EXTREMITY (Foot pain) (seriousness criterion medically significant), MUSCLE SPASMS (Muscle cramp) (seriousness criterion medically significant) and EAR PAIN (Earache) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant). On 30-Dec-2021, PYREXIA (Feverish) had not resolved, MUSCLE SPASMS (Muscle cramp) had resolved. At the time of the report, HEADACHE (Headache), CHILLS (Shivers) and FATIGUE (Tiredness) had not resolved and PAIN IN EXTREMITY (Foot pain) and EAR PAIN (Earache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-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. Symptoms came on suddenly and without warning. Muscle cramp was down left hand side rib cage. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided. Company comment: This case concerns a 38-year-old male patient with no medical history provided who experienced serious unexpected events of Headache, Chills, Fatigue, Pain in extremity, Muscle spasms, Ear pain and Pyrexia. Majority of the events occurred one day after the third, booster dose of mRNA-1273. The precise temporal relationship for the event Pyrexia cannot be determined, having in mind that the exact start date of the reported event was not provided. It was reported that the patient experienced muscle cramp in the left rib cage. At the time of the report, Pyrexia, Headache, Chills and Fatigue were still ongoing whereas Muscle spasms had resolved while Pain in extremity and Ear pain were resolving. No further information regarding clinical course of the events was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per RA and kept as such. Event terms, onset dates and outcomes captured per Regulatory Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Having in mind that the patient received Tozinameran prior to Company product Interchange of vaccine products should have been considered in this particular case.; Sender''s Comments: This case concerns a 38-year-old male patient with no medical history provided who experienced serious unexpected events of Headache, Chills, Fatigue, Pain in extremity, Muscle spasms, Ear pain and Pyrexia. Majority of the events occurred one day after the third, booster dose of mRNA-1273. The precise temporal relationship for the event Pyrexia cannot be determined, having in mind that the exact start date of the reported event was not provided. It was reported that the patient experienced muscle cramp in the left rib cage. At the time of the report, Pyrexia, Headache, Chills and Fatigue were still ongoing whereas Muscle spasms had resolved while Pain in extremity and Ear pain were resolving. No further information regarding clinical course of the events was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per RA and kept as such. Event terms, onset dates and outcomes captured per Regulatory Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Having in mind that the patient received Tozinameran prior to Company product Interchange of vaccine products should have been considered in this particular case.


VAERS ID: 2023448 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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: Arthralgia, Fatigue, Headache, Insomnia, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Arthritis (broad), COVID-19 (broad)

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

Write-up: Headache; Sore throat; Joint ache; Tiredness; Insomnia; This case was received via the RA (Reference number: GB-MHRA-ADR 26418188) 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 HEADACHE (Headache), OROPHARYNGEAL PAIN (Sore throat), ARTHRALGIA (Joint ache), FATIGUE (Tiredness) and INSOMNIA (Insomnia) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and INSOMNIA (Insomnia) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), ARTHRALGIA (Joint ache), FATIGUE (Tiredness) and INSOMNIA (Insomnia) had not resolved and OROPHARYNGEAL PAIN (Sore throat) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. No medical history was reported. Company comment: This case concerns a 29-year-old female patient with no medical history provided who experienced serious unexpected events of Headache, Arthralgia, Fatigue, Insomnia and Oropharyngeal pain. The events occurred one day after the third dose of mRNA-1273. At the time of the report, Oropharyngeal pain was resolving whereas all the other events were still ongoing. No further information regarding clinical course of the events was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. Event terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Having in mind that the patient also received Tozinameran, Interchange of vaccine products should have been considered in this particular case.; Sender''s Comments: This case concerns a 29-year-old female patient with no medical history provided who experienced serious unexpected events of Headache, Arthralgia, Fatigue, Insomnia and Oropharyngeal pain. The events occurred one day after the third dose of mRNA-1273. At the time of the report, Oropharyngeal pain was resolving whereas all the other events were still ongoing. No further information regarding clinical course of the events was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. Event terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Having in mind that the patient also received Tozinameran, Interchange of vaccine products should have been considered in this particular case.


VAERS ID: 2023474 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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: Axillary pain, Chills, Diarrhoea, Illness, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211225; 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: chills; Sickness; Diarrhoea; Fever; Armpit pain; Generalised aching; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26418901) 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 CHILLS (chills), ILLNESS (Sickness), DIARRHOEA (Diarrhoea), PYREXIA (Fever), AXILLARY PAIN (Armpit pain) and PAIN (Generalised aching) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant) and PAIN (Generalised aching) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant). At the time of the report, CHILLS (chills), ILLNESS (Sickness), DIARRHOEA (Diarrhoea), PYREXIA (Fever), AXILLARY PAIN (Armpit pain) and PAIN (Generalised aching) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-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 concomitant medications reported by reporter. Patient was experienced sore arm, aching body, feeling like gold ball in armpit, very tender, fever chills, sickness and diarrhoea. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment medications provided by the reporter. Company Comment: This case concerns a 30-year-old male, with no reported relevant medical history in this case, who experienced the serious unexpected events of Chills, Illness, Diarrhoea, Pyrexia, Axillary pain and Pain. The event Chills occurred in an unknown date and the outcome was Not Recovered/Not Resolved. The events, Illness, Diarrhoea, Pyrexia, Axillary pain and Pain occurred approximately one day after the administration of the 3rd dose of mRNA-1273 vaccine and at the time of the report, the outcome for the event 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 mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 30-year-old male, with no reported relevant medical history in this case, who experienced the serious unexpected events of Chills, Illness, Diarrhoea, Pyrexia, Axillary pain and Pain. The event Chills occurred in an unknown date and the outcome was Not Recovered/Not Resolved. The events, Illness, Diarrhoea, Pyrexia, Axillary pain and Pain occurred approximately one day after the administration of the 3rd dose of mRNA-1273 vaccine and at the time of the report, the outcome for the event 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 mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023476 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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: Asthenia, Chills, Diarrhoea, Injection site pain, Injection site swelling, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; 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: severe pain on the arm with the injcetion site; Diarrhoea; Vomiting; Chills; Weakness; Injection site swelling; This case was received via Regulatory authority. This regulatory authority case was reported by an other health care professional and describes the occurrence of INJECTION SITE PAIN (severe pain on the arm with the injcetion site), DIARRHOEA (Diarrhoea), VOMITING (Vomiting), CHILLS (Chills), ASTHENIA (Weakness) and INJECTION SITE SWELLING (Injection site swelling) 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 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced DIARRHOEA (Diarrhoea) (seriousness criterion disability), VOMITING (Vomiting) (seriousness criterion disability), CHILLS (Chills) (seriousness criterion disability), ASTHENIA (Weakness) (seriousness criterion disability) and INJECTION SITE SWELLING (Injection site swelling) (seriousness criterion disability). On an unknown date, the patient experienced INJECTION SITE PAIN (severe pain on the arm with the injcetion site) (seriousness criterion disability). At the time of the report, INJECTION SITE PAIN (severe pain on the arm with the injcetion site), DIARRHOEA (Diarrhoea), VOMITING (Vomiting), ASTHENIA (Weakness) and INJECTION SITE SWELLING (Injection site swelling) was resolving and CHILLS (Chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-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. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant products were reported. No treatment drugs were reported. The patient had severe pain on the arm with the injcetion site, restricted movement due to pain and swelling (started morning of 30-Dec-3021). Diarrhoea (watery x5 episodes) and vomiting x3 episodes at 18:00 30-Dec-2021. Chills without fever few minutes after diarrhea and vomiting. Tiredness and weakness. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. No report related to possible blood clots or low platelet counts. No possible inflammation of the heart (myocarditis or pericarditis). Company comment: This regulatory case concerns a female patient of an unknown age, with no medical history reported, who experienced the serious unexpected events of INJECTION SITE PAIN, DIARRHOEA, VOMITING, CHILLS, ASTHENIA and INJECTION SITE SWELLING. The events DIARRHOEA, VOMITING, CHILLS, ASTHENIA and INJECTION SITE SWELLING occurred on the following day of the third dose of the mRNA-1273 vaccine. The event INJECTION SITE PAIN after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.; Sender''s Comments: This regulatory case concerns a female patient of an unknown age, with no medical history reported, who experienced the serious unexpected events of INJECTION SITE PAIN, DIARRHOEA, VOMITING, CHILLS, ASTHENIA and INJECTION SITE SWELLING. The events DIARRHOEA, VOMITING, CHILLS, ASTHENIA and INJECTION SITE SWELLING occurred on the following day of the third dose of the mRNA-1273 vaccine. The event INJECTION SITE PAIN after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.


VAERS ID: 2023477 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
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: Back pain, Chills, Dysgeusia, Fatigue, Headache, Maternal exposure during breast feeding, Myalgia, Nausea, Pain in jaw, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Neonatal exposures via breast milk (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding; Eating disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211231; 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: Maternal exposure during breast feeding; Vomiting; Headache; Taste metallic; Shivering; Fatigue; Backache; Jaw pain; Nausea; High temperature; Muscle ache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26419220) 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 VOMITING (Vomiting), HEADACHE (Headache), DYSGEUSIA (Taste metallic), CHILLS (Shivering), FATIGUE (Fatigue), BACK PAIN (Backache), PAIN IN JAW (Jaw pain), NAUSEA (Nausea), PYREXIA (High temperature), MYALGIA (Muscle ache) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 32-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concurrent medical conditions included Eating disorder and Breast feeding. On 30-Dec-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), DYSGEUSIA (Taste metallic) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), BACK PAIN (Backache) (seriousness criterion medically significant), PAIN IN JAW (Jaw pain) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). At the time of the report, VOMITING (Vomiting), HEADACHE (Headache), CHILLS (Shivering), FATIGUE (Fatigue), BACK PAIN (Backache), PAIN IN JAW (Jaw pain), NAUSEA (Nausea), PYREXIA (High temperature) and MYALGIA (Muscle ache) had not resolved, DYSGEUSIA (Taste metallic) was resolving and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication information was provided. No treatment medication were provided. Patient has not had symptoms associated with COVID-19.; Sender''s Comments: This case concerns a 32-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Vomiting, Headache, Dysgeusia, Chills, Fatigue, Back Pain, Pain In Jaw, Nausea, Pyrexia, Myalgia, and Maternal Exposure During Breast Feeding. The events occurred approximately 1 day after the third dose of mRNA-1273 (Moderna covid-19 vaccine; except maternal exposure during breast feeding which occurs at an unspecified interval. 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: 2023489 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Suspected COVID-19; Positive COVID-19 test); Menopause (Had not had any bleeding since Mar2021 as was starting the menopause)
Allergies:
Diagnostic Lab Data: Test Date: 20211130; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200009380

Write-up: menopause, Vaginal bleeding; Primary immunisation: COVID-19 vaccine ASTRAZENECA and COVID-19 vaccine (manufacturer unknown); Booster: COMIRNATY; Primary immunisation: COVID-19 vaccine ASTRAZENECA and COVID-19 vaccine (manufacturer unknown); Booster: COMIRNATY; The patient received third (booster) dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory authority. A 51 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Menopause" (unspecified if ongoing), notes: Had not had any bleeding since Mar2021 as was starting the menopause; "COVID-19", start date: 30Nov2021, stop date: 08Dec2021, notes: Suspected COVID-19; Positive COVID-19 test. The patient was not breast feeding at the time of this report. The patient was not enrolled in clinical trial. Last menstrual date of the patient was 06Mar2021. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE NUMBER UNKNOWN), administration date: 20Sep2021, for COVID-19 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "Primary immunisation: COVID-19 vaccine ASTRAZENECA and COVID-19 vaccine (manufacturer unknown); Booster: COMIRNATY"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "The patient received third (booster) dose."; POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "menopause, Vaginal bleeding". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Nov2021) yes - positive covid-19 test. 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.


VAERS ID: 2023810 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-21
Onset:2021-12-30
   Days after vaccination:9
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: Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20220108415

Write-up: DIARRHOEA; VOMITING; This spontaneous report received from a health care professional by a Regulatory Authority (PH-PHFDA-300130230) and concerned a 41 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 21-DEC-2021 for prophylactic vaccination (Dose number in series:1). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 30-DEC-2021, the patient experienced diarrhoea and vomiting. On an unspecified date the patient was hospitalized and the number of days hospitalized were unknown (Dose number in series:1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhoea and vomiting was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0:20220108415-COVID-19 VACCINE AD26.COV2.S-Diarrhoea,Vomiting. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 2024327 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-27
Onset:2021-12-30
   Days after vaccination:33
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: Chest pain, Dyspepsia, Dyspnoea, Fatigue, Myocarditis, Palpitations
SMQs:, Anaphylactic reaction (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), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Chest pain; Shortness of breath; Heart palpitations; Fatigue/unusual tiredness; myocarditis; Heartburn; This case was received via RA (Reference number: GB-MHRA-ADR 26418841) 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 MYOCARDITIS (myocarditis), DYSPEPSIA (Heartburn), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and FATIGUE (Fatigue/unusual tiredness) in a 35-year-old female patient 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) from 15-May-2021 to an unknown date for Vaccination. On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced DYSPEPSIA (Heartburn) (seriousness criterion medically significant). On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations) (seriousness criterion medically significant) and FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and FATIGUE (Fatigue/unusual tiredness) outcome was unknown and DYSPEPSIA (Heartburn) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. for the astra zeneca I ended up in emergency. it started as heartburn about 3 days after the injection and got worse over 24hrs i had pain in my chest and lower thorax area. in emergency they said they believed it was myocarditis. for the moderna after about 3 days I had bad heartburn. generally fit and well.Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test.Patient is not pregnant,Patient is not currently breastfeeding Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial This report related to a possible inflammation of the heart (myocarditis or pericarditis). Relevant investigations and tests conducted were chest x-rays, ECG and bloods taken at emergency. The symptoms did not lead to hospital stay. It was not known whether diagnosis was made by a medical professional since it was reported that it was verbally diagnosed by the doctor in the emergency. The patient was treated with painkillers. Company comment: This regulatory authority case concerns a 35-year-old female patient with no relevant medical history and previous administration of COVID-19 Vaccine AstraZeneca, who experienced serious unexpected events of dyspepsia, chest pain, dyspnoea, palpitations and fatigue, and expected event of myocarditis, that occurred after the third dose of the mRNA-1273 . Reportedly, the patient had heartburn 3 days after vaccination. The patient had chest X ray and ECG performed at emergency. It was reported that diagnosis of myocarditis was only made verbally by the emergency doctor and was not documented. The patient was treated with painkillers. The rechallenge was not applicable since due to occurrence after the third dose , no rechallenge was done and recurrence was not applicable. 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 35-year-old female patient with no relevant medical history and previous administration of COVID-19 Vaccine AstraZeneca, who experienced serious unexpected events of dyspepsia, chest pain, dyspnoea, palpitations and fatigue, and expected event of myocarditis, that occurred after the third dose of the mRNA-1273 . Reportedly, the patient had heartburn 3 days after vaccination. The patient had chest X ray and ECG performed at emergency. It was reported that diagnosis of myocarditis was only made verbally by the emergency doctor and was not documented. The patient was treated with painkillers. The rechallenge was not applicable since due to occurrence after the third dose , no rechallenge was done and recurrence was not applicable. 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: 2026058 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-30
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: COVID-19, Drug ineffective, Immunisation, 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: 20211230; Test Name: Corona test; Test Result: Positive
CDC Split Type: DKPFIZER INC202200003586

Write-up: Booster; got diagnosed with corona; got diagnosed with corona; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 47 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Dec2021 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single, (Batch/Lot number: unknown) 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: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "got diagnosed with corona". Patient was on 30Dec2021 tested positive for Corona. Patient had now ongoing her last day of the 48 hour symptom free days. Patient had experienced slight fever and headache for 1.5 days after diagnosis. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2026221 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-30
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Pain
SMQs:

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

Write-up: Ache; Chills; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26415225) 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 PAIN (Ache) and CHILLS (Chills) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Epileptic seizure (Epileptic). On an unknown date, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). At the time of the report, PAIN (Ache) had not resolved and CHILLS (Chills) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Paracetamol was taken 4hourly but to little effect . No concomitant product was provided. 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. Company comment: This regulatory authority case concerns a 37-year-old female patient with no relevant medical history who experienced serious unexpected event of pain and chills, that occurred after the 2nd dose of the mRNA-1273 however, the exact time to onset was not provided. The rechallenge was not applicable due to occurrence after the 2nd dose. 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 37-year-old female patient with no relevant medical history who experienced serious unexpected event of pain and chills, that occurred after the 2nd dose of the mRNA-1273 however, the exact time to onset was not provided. The rechallenge was not applicable due to occurrence after the 2nd dose. 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: 2026585 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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: Abdominal pain upper, Headache, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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.MOD20214

Write-up: Nausea; Headache; Stomach ache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26414153) 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 NAUSEA (Nausea), HEADACHE (Headache) and ABDOMINAL PAIN UPPER (Stomach ache) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and ABDOMINAL PAIN UPPER (Stomach ache) (seriousness criterion medically significant). At the time of the report, NAUSEA (Nausea), HEADACHE (Headache) and ABDOMINAL PAIN UPPER (Stomach ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Date of LMP was reported on 16-Dec-2021. No Concomitant medication details were provided. No Treatment medication details were provided. She woke up the morning after the Moderns booster felt nauseous and sharp headache around the front and towards her ears. Her stomach was upset and have got bad belly aches. She also felt very dehydrated and constantly thirsty. Patient was not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial Company comment: This case concerns a 24-year-old female patient , with no reported medical history, who experienced the serious (medically significant according to Authority report), unexpected events of nausea, headache and abdominal pain upper, 1 day after the third dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The patient felt nauseous and sharp frontal headache which extends towards her ears. Her stomach was upset and felt very dehydrated and thirsty. At the time of 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 24-year-old female patient , with no reported medical history, who experienced the serious (medically significant according to Authority report), unexpected events of nausea, headache and abdominal pain upper, 1 day after the third dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The patient felt nauseous and sharp frontal headache which extends towards her ears. Her stomach was upset and felt very dehydrated and thirsty. At the time of report, events had not resolved. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 2026595 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Headache, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
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: Nauseous; Diarrhea; Headache; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26414960) 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 NAUSEA (Nauseous), DIARRHOEA (Diarrhea) and HEADACHE (Headache) in a 46-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not known) for an unknown indication. Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced NAUSEA (Nauseous) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, NAUSEA (Nauseous), DIARRHOEA (Diarrhea) 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 medication information was provided. No treatment medication were provided. Patient last menstrual period date : 25-NOV-2021 Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Patient has not had symptoms associated with COVID-19 Patient is not pregnant ,Patient is not currently breastfeeding Company comment: This regulatory authority case concerns a 46-year-old female patient with no relevant medical history who experienced serious unexpected events of nausea, diarrhoea and headache, that occurred approximately 1 day after the third dose of the mRNA-1273 . The rechallenge was not applicable since due to occurrence after the third dose , no rechallenge was done and recurrence was not applicable. 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 46-year-old female patient with no relevant medical history who experienced serious unexpected events of nausea, diarrhoea and headache, that occurred approximately 1 day after the third dose of the mRNA-1273 . The rechallenge was not applicable since due to occurrence after the third dose , no rechallenge was done and recurrence was not applicable. 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: 2026603 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA BOOSTER / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started)
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Vomiting; This case was received(Reference number: GB-MHRA-ADR 26415690) 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 VOMITING (Vomiting) in a 46-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Booster) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started) on 09-Oct-2021. Concomitant products included CITALOPRAM for Bipolar depression. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). At the time of the report, VOMITING (Vomiting) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not tested positive for COVID-19 since having the vaccine, Patient was not enrolled in clinical trial. Treatment medication information was not provided by the reporter.; Sender''s Comments: This case concerns a patient, with medical history of Bipolar depression, who experienced the serious unexpected event(s) of Vomiting. 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: 2026615 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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: Cold-stimulus headache, Fatigue, Influenza like illness, Myalgia, Neck pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Ice cream headache; Neck pain; Flu like symptoms; Fever; Muscle pain; Tiredness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26417776) 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 COLD-STIMULUS HEADACHE (Ice cream headache), NECK PAIN (Neck pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), MYALGIA (Muscle pain) and FATIGUE (Tiredness) 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 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced COLD-STIMULUS HEADACHE (Ice cream headache) (seriousness criterion medically significant), NECK PAIN (Neck pain) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). At the time of the report, COLD-STIMULUS HEADACHE (Ice cream headache), NECK PAIN (Neck pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), MYALGIA (Muscle pain) and FATIGUE (Tiredness) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. It was reported that patient had no symptoms associated with COVID-19 and was not enrolled in any clinical trials. Patient had not tested for covid-19.It was reported that patient''s report was not related to possible inflammation of the heart (myocarditis or pericarditis). Company comment: This is a regulatory case concerning a female patient of an unknown age with no medical history reported who experienced the unexpected serious events of Cold-stimulus headache, Neck pain, Influenza like illness, Pyrexia, Myalgia and Fatigue. As reported, the patient experienced events one day after the third dose of mRNA-1273 vaccine. The rechallenge and action taken with the suspect product were kept as per SD. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a female patient of an unknown age with no medical history reported who experienced the unexpected serious events of Cold-stimulus headache, Neck pain, Influenza like illness, Pyrexia, Myalgia and Fatigue. As reported, the patient experienced events one day after the third dose of mRNA-1273 vaccine. The rechallenge and action taken with the suspect product were kept as per SD. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2026627 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
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: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: Vomiting; This case was received via RA (Reference number: GB-MHRA-ADR 26418594) 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 VOMITING (Vomiting) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). At the time of the report, VOMITING (Vomiting) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment medications was not reported Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant, Patient was not currently breastfeeding Company Comment: This case refers to a 34-year-old female patient with no known medical history who experienced the unexpected event of Vomiting on the same 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 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case refers to a 34-year-old female patient with no known medical history who experienced the unexpected event of Vomiting on the same 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 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2026636 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
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: Abdominal pain upper, Chills, Headache, Illness, Muscle spasms, Pain in extremity, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: fever; stomach cramps; Shivering; Fever chills; Headache; Sickness; Cramps leg; Stomach ache; Painful arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26418894) 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 PYREXIA (fever), ABDOMINAL PAIN UPPER (stomach cramps), CHILLS (Shivering), PYREXIA (Fever chills), HEADACHE (Headache), ILLNESS (Sickness), MUSCLE SPASMS (Cramps leg), ABDOMINAL PAIN UPPER (Stomach ache) and PAIN IN EXTREMITY (Painful arm) in a 41-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: FLUOXETINE (Patient takes regular fluoxetine but did not take it today in case it reacted with booster). Past adverse reactions to the above products included No adverse event with FLUOXETINE. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced MUSCLE SPASMS (Cramps leg) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach ache) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced CHILLS (Shivering) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and ILLNESS (Sickness) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (fever) (seriousness criterion medically significant) and ABDOMINAL PAIN UPPER (stomach cramps) (seriousness criterion medically significant). At the time of the report, PYREXIA (fever), ABDOMINAL PAIN UPPER (stomach cramps) and ILLNESS (Sickness) was resolving and CHILLS (Shivering), PYREXIA (Fever chills), HEADACHE (Headache), MUSCLE SPASMS (Cramps leg), ABDOMINAL PAIN UPPER (Stomach ache) and PAIN IN EXTREMITY (Painful arm) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Concomitant medications were provided. Treatment information was not provided Started with sore arm, then leg and stomach cramps, then fever, shivering and headache and then sickness. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial Company comment: This case concerns a 41-year-old, female patient with no medical history, who experienced the unexpected events of muscle spasms, abdominal pain upper(two events), pain in extremity, chills, pyrexia(two events), headache and illness. The events occurred on the same day or 1 day after the third dose of mRNA-1273. As reported the events started with sore arm, then leg and stomach cramps, then fever, shivering and headache and then sickness. 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 41-year-old, female patient with no medical history, who experienced the unexpected events of muscle spasms, abdominal pain upper(two events), pain in extremity, chills, pyrexia(two events), headache and illness. The events occurred on the same day or 1 day after the third dose of mRNA-1273. As reported the events started with sore arm, then leg and stomach cramps, then fever, shivering and headache and then sickness. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2026671 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest discomfort, Chest pain, Dyspnoea, Echocardiogram, Fatigue, Immunisation, Magnetic resonance imaging, Myocarditis, Pain in extremity, Palpitations, SARS-CoV-2 test, Tachycardia, Troponin
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), Tendinopathies and ligament disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Bloods; Result Unstructured Data: Test Result:being monitored in hospital; Test Name: Echocardiogram; Result Unstructured Data: Test Result:being monitored in hospital; Test Name: MRI; Result Unstructured Data: Test Result:being monitored in hospital; Test Date: 20220102; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: troponin; Result Unstructured Data: Test Result:Raised, peak troponin value: 670
CDC Split Type: GBPFIZER INC202200019384

Write-up: Fatigue/unusual tiredness; Chest pain; Shortness of breath; Heart palpitations; Racing heart (tachycardia); pain down left arm; heavy / tight feeling chest; Myocarditis; Primary immunisation: BNT162b2; Booster: COMIRNATY; 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-202201051608597410-YTLDL. Other Case identifier(s): GB-MHRA-ADR 26439832. A 32 year-old male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN3543) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2), for COVID-19 immunisation; Bnt162b2 (DOSE 1), for COVID-19 immunisation. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 30Dec2021, outcome "unknown", described as "Primary immunisation: BNT162b2; Booster: COMIRNATY"; CHEST DISCOMFORT (hospitalization, medically significant), outcome "recovering", described as "heavy / tight feeling chest"; MYOCARDITIS (hospitalization, medically significant) with onset 01Jan2022, outcome "not recovered", described as "Myocarditis"; FATIGUE (hospitalization, medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (hospitalization, medically significant), outcome "unknown", described as "Chest pain"; DYSPNOEA (hospitalization, medically significant), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (hospitalization, medically significant), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (hospitalization, medically significant), outcome "unknown", described as "Racing heart (tachycardia)"; PAIN IN EXTREMITY (hospitalization, medically significant), outcome "unknown", described as "pain down left arm". The patient was hospitalized for immunisation, chest discomfort, myocarditis, fatigue, chest pain, dyspnoea, palpitations, tachycardia, pain in extremity (start date: Jan2022). The patient was on day 3 of hospitalization at the time of this report and was still in hospital. The diagnosis was made by a medical professional, cardiologist. The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) being monitored in hospital; echocardiogram: (unspecified date) being monitored in hospital; magnetic resonance imaging: (unspecified date) being monitored in hospital; sars-cov-2 test: (02Jan2022) no - negative covid-19 test; troponin: (unspecified date) raised, peak troponin value: 670. The patient had not been tested positive for COVID-19 since having the vaccine. Therapeutic measures were taken as a result of chest discomfort, myocarditis, fatigue, chest pain, dyspnoea, palpitations, tachycardia, pain in extremity. The patient was unsure on the name of the treatment medication prescribed. No follow-up attempts are needed. No further information is expected.


VAERS ID: 2029512 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Immunisation, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202200002796

Write-up: uncontrollable and violent tremor; since then I''m feverish; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 18:00 (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, unknown manufacturer), for covid-19 immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021 18:00, outcome "unknown", described as "booster"; TREMOR (medically significant), outcome "recovered", described as "uncontrollable and violent tremor"; PYREXIA (non-serious) with onset 31Dec2021 05:00, outcome "not recovered", described as "since then I''m feverish". Therapeutic measures were taken as a result of tremor. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029527 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000059A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Chills, 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: INDAPAMIDE; METOPROLOL
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.MOD20224

Write-up: chills; Swollen armpit; This case was received via Regulatory authority. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (chills) and AXILLARY PAIN (Swollen armpit) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000059A) for an unknown indication. Concomitant products included INDAPAMIDE and METOPROLOL for Blood pressure. On 28-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced AXILLARY PAIN (Swollen armpit) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant). At the time of the report, CHILLS (chills) outcome was unknown and AXILLARY PAIN (Swollen armpit) 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. Treatment medications was not provided by the reporter. Patient was very tired and had muscle aches, painful arm, chills on day after booster and Two days after had swollen and painful glands under armpit. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient is not enrolled in clinical trial. Company comment: This is a regulatory authority case concerning a 38-year-old, female patient with no reported medical history, who experienced the unexpected serious events of chills and swollen armpit. The event chills occurred 1 day after the unknown dose number of mRNA-1273 vaccine administration and was accompanied by fatigue, myalgia and pain in the arm while the event swollen armpit occurred 2 days after the unknown dose number of mRNA-1273 vaccine administration and was accompanied by swollen and painful glands under armpit. No reported treatment information. The outcome of the event swollen armpit was not resolved while chills, fatigue, myalgia, pain in the arm and swollen and painful glands under armpit the outcome was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 38-year-old, female patient with no reported medical history, who experienced the unexpected serious events of chills and swollen armpit. The event chills occurred 1 day after the unknown dose number of mRNA-1273 vaccine administration and was accompanied by fatigue, myalgia and pain in the arm while the event swollen armpit occurred 2 days after the unknown dose number of mRNA-1273 vaccine administration and was accompanied by swollen and painful glands under armpit. No reported treatment information. The outcome of the event swollen armpit was not resolved while chills, fatigue, myalgia, pain in the arm and swollen and painful glands under armpit the outcome was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2029548 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-30
Submitted: 0000-00-00
Entered: 2022-01-12
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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THYROXINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: High temperature, aches, pains, chest pain, fatigue; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424042) 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 ADVERSE DRUG REACTION (High temperature, aches, pains, chest pain, fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for Ill-defined disorder. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for Ill-defined disorder. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced ADVERSE DRUG REACTION (High temperature, aches, pains, chest pain, fatigue) (seriousness criterion medically significant). At the time of the report, ADVERSE DRUG REACTION (High temperature, aches, pains, chest pain, fatigue) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No medical history was reported. Concomitant medication included: HRT used for Ill-defined disorder. It was reported that it was worse than COVID. She was in bed for two days so far. Too weak to do anything. It was the same with her first AZ vaccine back in April last year. The patient was very sceptical. The Patient thought the vaccines were probably destroying our natural immunity. But patient also stated that none of the statements above matches her situation. She was in bed felt very ill. She had not phoned the doctor. No treatment medication details was provided. company comment This regulatory case concerns a 58-year-old female patient with no relevant medical history reported, who experienced the unexpected serious events of adverse drug reaction (seriousness criteria- Medically significant) The event occurred unknown days after a dose of mRNA-1273 vaccine, given through an unknown route for an ill-defined disorder. Patient had High temperature, aches, pains, chest pain, fatigue. Concomitant medication included HRT (Thyroxine) used for an Ill-defined disorder. It was reported that it was worse than COVID. She was in bed for two days. She was too weak to do anything. It was the same with her first AZ vaccine back in April last year. The patient was very sceptical. The Patient thought the vaccines were probably destroying our natural immunity. She wished that she should have resisted the coercion to have the booster and it was a mistake.But patient also stated that none of the statements above matches her situation. She was in bed and felt very ill. She had not phoned the doctor. Treatment medication was not provided by the reporter. The event was not resolved 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 per Regulatory Authority?s report.; Sender''s Comments: This regulatory case concerns a 58-year-old female patient with no relevant medical history reported, who experienced the unexpected serious events of adverse drug reaction (seriousness criteria- Medically significant) The event occurred unknown days after a dose of mRNA-1273 vaccine, given through an unknown route for an ill-defined disorder. Patient had High temperature, aches, pains, chest pain, fatigue. Concomitant medication included HRT (Thyroxine) used for an Ill-defined disorder. It was reported that it was worse than COVID. She was in bed for two days. She was too weak to do anything. It was the same with her first AZ vaccine back in April last year. The patient was very sceptical. The Patient thought the vaccines were probably destroying our natural immunity. She wished that she should have resisted the coercion to have the booster and it was a mistake.But patient also stated that none of the statements above matches her situation. She was in bed and felt very ill. She had not phoned the doctor. Treatment medication was not provided by the reporter. The event was not resolved 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 per Regulatory Authority?s report.


VAERS ID: 2029549 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: GBMODERNATX, INC.MOD20224

Write-up: Pain and redness at injection site; Ongoing swollen lymph nodes in armpit.; Headache; Fever chills; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424736) 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 ADVERSE DRUG REACTION (Ongoing swollen lymph nodes in armpit.), HEADACHE (Headache), PYREXIA (Fever chills) and ADVERSE DRUG REACTION (Pain and redness at injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (Batch no. 3005688) for Booster. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Parenteral) 1 dosage form. On 30-Dec-2021, the patient experienced ADVERSE DRUG REACTION (Ongoing swollen lymph nodes in armpit.) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced ADVERSE DRUG REACTION (Pain and redness at injection site) (seriousness criterion medically significant). On 01-Jan-2022, HEADACHE (Headache) and PYREXIA (Fever chills) had resolved. At the time of the report, ADVERSE DRUG REACTION (Ongoing swollen lymph nodes in armpit.) and ADVERSE DRUG REACTION (Pain and redness at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) was unknown. The concomitant medications were not reported. The treatment information was not provided. The patient took Moderna booster vaccine. The outcome for swollen lymph nodes e in armpit ,pain and redness at injection site was reported as ongoing COMPANY COMMENT: This is a Regulatory case concerning a 45-old female patient with no clinical history who experienced the unexpected events of ADVERSE DRUG REACTION, HEADACHE, ADVERSE DRUG REACTION and PYREXIA The events occurred 1 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 45-old female patient with no clinical history who experienced the unexpected events of ADVERSE DRUG REACTION, HEADACHE, ADVERSE DRUG REACTION and PYREXIA The events occurred 1 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: 2029921 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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 - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101885677

Write-up: Flu symptoms; 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-202112301446472090-TPV3O (RA). Other Case identifier(s): GB-MHRA-ADR 26416493 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. It was unsure if patient had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The following information was reported: INFLUENZA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Flu symptoms". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. This report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029936 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211224; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101886023

Write-up: Fainting; 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-202112301532199950-KTLJZ (RA). Other Case identifier(s): GB-MHRA-ADR 26416912 (RA). A 17 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Batch/Lot number: Unknown) as dose 2, 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., Unknown manufacturer.), for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Fainting". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Dec2021) negative, notes: No - Negative COVID-19 test. Additional information: Unsure if patient has had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The 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: 2029968 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Heart rate, Heart rate increased, Immunisation, Interchange of vaccine products, Off label use, Panic attack, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: heart rate; Result Unstructured Data: Test Result:115 bpm; Comments: High heart rate; Test Date: 20211223; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101885681

Write-up: not previously received the full primary immunization series of BNT162b2; Booster: COMIRNATY; not previously received the full primary immunization series of BNT162b2; Booster: COMIRNATY; Patient received the third (booster) dose; Fainting; suffered panic attack; High heart rate 115bpm; This is a spontaneous report received from a contactable reporter(s) (Consumer) from the Regulatory Authority, number: GB-MHRA-WEBCOVID-202112301714088700-EKUQZ (MHRA). Other Case identifier(s): GB-MHRA-ADR 26417500 (MHRA). A 41-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 41 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 01; MANUFACTUERER UNKNOWN, not previously received the full primary immunization series of BNT162b2), for COVID-19 Immunization; Covid-19 vaccine (DOSE 02; MANUFACTUERER UNKNOWN, not previously received the full primary immunization series of BNT162b2), for COVID-19 Immunization. Patient last menstrual period date was 23Dec2021. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "not previously received the full primary immunization series of BNT162b2; Booster: COMIRNATY"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Patient received the third (booster) dose"; SYNCOPE (medically significant) with onset 30Dec2021, outcome "recovered" (30Dec2021), described as "Fainting"; PANIC ATTACK (medically significant) with onset 30Dec2021, outcome "not recovered", described as "suffered panic attack"; HEART RATE INCREASED (medically significant) with onset 30Dec2021, outcome "unknown", described as "High heart rate 115bpm". The patient suffered panic attack, High heart rate 115bpm and fainted within 10 minutes of vaccination. 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). The patient underwent the following laboratory tests and procedures: heart rate: (30Dec2021) 115 bpm, notes: High heart rate; sars-cov-2 test: (23Dec2021) negative, notes: 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: 2029990 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Amaurosis fugax, Nausea, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Retinal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101886044

Write-up: Nausea; faint for a moment; temporary loss of sight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). The reporter is the parent. Regulatory number: GB-MHRA-WEBCOVID-202112301931443260-50XNC (RA). Other Case identifier(s): GB-MHRA-ADR 26418158 (RA). A 14 year-old male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 14 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 27Sep2021, stop date: 08Oct2021. The patient''s concomitant medications were not reported. Other medical conditions were none. The following information was reported: NAUSEA (medically significant) with onset 30Dec2021, outcome "recovered" (30Dec2021), described as "Nausea"; SYNCOPE (medically significant) with onset 30Dec2021, outcome "recovered" (30Dec2021), described as "faint for a moment"; AMAUROSIS FUGAX (medically significant) with onset 30Dec2021, outcome "recovered" (30Dec2021), described as "temporary loss of sight". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Sep2021) yes - positive covid-19 test. Clinical course: 14yr old son experienced temporary loss of sight while resting in the waiting room after his 1st vaccine. He was taken to a quiet room and seemed to faint for a moment, then gradually felt better. He was able to walk away after 15 minutes or so of rest. 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; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029996 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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 FK9706 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, COVID-19, Hypoaesthesia, Myalgia, Pain in extremity, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Barrett''s esophagus; Paranoid schizophrenia; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101885683

Write-up: arm is burning and painfull; arm is burning and painfull; SARS-CoV-2 infection; Muscle burning sensation; Numbness; This is a spontaneous report received from a contactable reporter(s) (Consumer) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112301956138470-6KVS7 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26418214 (MHRA). A 39-year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: Fk9706) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally); "Barrett''s esophagus" (unspecified if ongoing); "Paranoid Schizophrenia" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 30Dec2021, outcome "not recovered", described as "SARS-CoV-2 infection"; MYALGIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Muscle burning sensation"; HYPOAESTHESIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Numbness"; PAIN IN EXTREMITY (medically significant), BURNING SENSATION (medically significant), outcome "unknown" and all described as "arm is burning and painful". Since having vaccine the patient arm is burning and painful. And going numb. Patient is not enrolled in clinical trial. Report relate to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) yes - positive covid-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2030054 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Chest pain, Fatigue, Immunisation, Interchange of vaccine products, Myocarditis, Off label use, Palpitations, Pericarditis, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), 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
CDC Split Type: GBPFIZER INC202101885588

Write-up: Fatigue/unusual tiredness; Chest pain; Heart palpitations; pericarditis; myocarditis; Off label use; Interchange of vaccine products; Booster; Chest pain; 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-202112310011264110-KKIWX (RA). Other Case identifier(s): GB-MHRA-ADR 26418727 (RA). A 34 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. 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) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; CHEST PAIN (medically significant) with onset 30Dec2021, outcome "not recovered", FATIGUE (medically significant), outcome "unknown" and all described as "Fatigue/unusual tiredness"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations"; PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis"; MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The reporter considered that this report related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay. There was no diagnosis made by a medical professional. None of the above symptoms were experienced, and cannot confirm that there were no symptoms. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2030057 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), COVID-19 (broad), Sexual dysfunction (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: AMITRIPTYLINE; NORVASC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high (which is being managed by medication); Hemiplegic migraine (which causes paralysis on one side of my body and I''m on medication to manage these); Paralysis one side of body
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101885783

Write-up: Facial palsy/my face dropped slightly on the right side; Numbness facial/20 minutes after the vaccine, my right side of the face became numb; Tingling/tingling all over the face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112310038045220-TSBNY Regulatory Authority. Other Case identifier(s): GB-MHRA-ADR 26418774 Regulatory Authority. A 39 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hemiplegic migraines which causes paralysis on one side of her body" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: which is being managed by medication; "Hemiplegic migraines" (unspecified if ongoing), notes: which causes paralysis on one side of her body and she was on medication to manage these. Patient had no symptoms associated with COVID-19, had not tested positive for COVID-19 since having the vaccine, was not enrolled in clinical trial and was not currently breastfeeding. Concomitant medication(s) included: AMITRIPTYLINE taken for hemiplegic migraine; NORVASC taken for hypertension. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: FACIAL PARALYSIS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Facial palsy/my face dropped slightly on the right side"; HYPOAESTHESIA (non-serious) with onset 30Dec2021, outcome "not recovered", described as "Numbness facial/20 minutes after the vaccine, my right side of the face became numb"; PARAESTHESIA (non-serious) with onset 30Dec2021, outcome "recovered" (30Dec2021), described as "Tingling/tingling all over the face". The events "facial palsy/my face dropped slightly on the right side", "numbness facial/20 minutes after the vaccine, my right side of the face became numb" and "tingling/tingling all over the face" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: Had the vaccine, within 5 to 10 minutes of receiving the vaccine she had tingling all over the face. It was more prominent on the right. 20 minutes after the vaccine, her right side of the face became numb. The tingling subsided on the left and continued on the right. She went home to rest and then around 4 hours later her face dropped slightly on the right side. The report of the patient was not related to possible inflammation of the heart (myocarditis or pericarditis). She contacted her General Practitioner and got an appointment. She was checked over and told to monitor. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2030074 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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 BN:FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101885569

Write-up: Fatigue/unusual tiredness; Chest pain; Shortness of breath; Chest pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Agency Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112310407219660-N3MSY Regulatory Authority. Other Case identifier(s): GB-MHRA-ADR 26418919 Regulatory Authority. A 40 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: BN:FN3543) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Last menstrual period was 09NOV2021. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 vaccination; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 vaccination. The following information was reported: CHEST PAIN (medically significant) with onset 30Dec2021, outcome "not recovered", FATIGUE (medically significant), outcome "unknown" and all described as "Fatigue/unusual tiredness"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath". Clinical course: Chest pain and shortness of breath. This occurred 1 day after having Pfizer booster. Patient has not tested positive for COVID-19 since having the vaccine. The reporter considered the report was relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2030075 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Headache, Immunisation, Interchange of vaccine products, Off label use, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101885564

Write-up: Fainting; Vomited; Headache; off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112310412184140-TSYES. Other Case identifier(s): GB-MHRA-ADR 26418920. A 31 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). Patient last menstrual period date: 27Nov2021. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test, Patient is not currently breastfeeding. Concomitant medication(s) included: CITALOPRAM taken for anxiety, start date: 12Apr2018. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for Covid-19 immunisation; Covid-19 vaccine (Dose 2, Unknown manufacturer), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; SYNCOPE (medically significant) with onset 31Dec2021, outcome "recovering", described as "Fainting"; VOMITING (medically significant) with onset 31Dec2021, outcome "recovering", described as "Vomited"; HEADACHE (medically significant) with onset 31Dec2021, outcome "recovering", described as "Headache". Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2030083 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Blindness, Feeling hot, Immunisation, Interchange of vaccine products, Off label use, Paraesthesia, Vision blurred
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Medication errors (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: GBPFIZER INC202101885700

Write-up: received COVID-19 VACCINE ASTRAZENECA; booster dose BNT162b2; received COVID-19 VACCINE ASTRAZENECA; booster dose BNT162b2; Booster; Loss of vision; Blurred vission; hot and prickly face; hot and prickly face; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112310656150640-GLZFT. Other Case identifier: GB-MHRA-ADR 26419650. A 49 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN5254) at the age of 49 years as dose 3, (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test.Patient has not tested positive for COVID-19 since having the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1), administration date: 21Mar2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 2), administration date: 05Jun2021, for COVID-19 immunisation. The following information was reported: the patient received COVID-19 VACCINE ASTRAZENECA; booster dose BNT162b2; BLINDNESS (medically significant) with onset 30Dec2021, outcome "recovered" (30Dec2021), described as "Loss of vision"; VISION BLURRED (medically significant) with onset 30Dec2021, outcome "unknown", described as "Blurred vission"; FEELING HOT (medically significant), PARAESTHESIA (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "hot and prickly face". It was reported that it was very hot and prickly face immediately after booster was administered. Vision started to blur approximately 30 minutes later leading to complete blueness in both of eyes progressing to no vision within 1 hour. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). And patient "Turned all lights out". No follow-up attempts are possible. No further information is expected.


VAERS ID: 2030090 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
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: Ageusia, Dizziness, Headache, SARS-CoV-2 test
SMQs:, Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211231; 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; Dizzy spells; Loss of taste; This case was received via RA (Reference number: GB-MHRA-ADR 26419843) 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), DIZZINESS (Dizzy spells) and AGEUSIA (Loss of taste) in a 35-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), DIZZINESS (Dizzy spells) (seriousness criterion medically significant) and AGEUSIA (Loss of taste) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), DIZZINESS (Dizzy spells) and AGEUSIA (Loss of taste) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-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. The concomitant medications were not reported. The treatment information was not provided. Patient had not tested positive for COVID-19 since having the vaccine. Patient had no symptoms associated with COVID-19.Also patient was not enrolled in any clinical trials. It was reported that patient''s report was not related to possible inflammation of the heart myocarditis or pericarditis. Company Comment This regulatory case concerns a 35-year-old male patient with no relevant medical history reported, who experienced the unexpected serious events of ageusia, dizziness and headache (seriousness criteria- Medically significant for all events). The event occurred on the same day (unknown time) after the third dose of mRNA-1273 vaccine, given through an unknown route for an unknown indication. On the next day, SARS-CoV-2 test was negative. Patient had not tested positive for COVID-19 since having the vaccine. Patient had no symptoms associated with COVID-19. It was reported that patient''s report was not related to possible inflammation of the heart myocarditis or pericarditis. The concomitant medications were not reported. The treatment information was not provided. The events were not resolved 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 per Regulatory Authority?s report.; Sender''s Comments: This regulatory case concerns a 35-year-old male patient with no relevant medical history reported, who experienced the unexpected serious events of ageusia, dizziness and headache (seriousness criteria- Medically significant for all events). The event occurred on the same day (unknown time) after the third dose of mRNA-1273 vaccine, given through an unknown route for an unknown indication. On the next day, SARS-CoV-2 test was negative. Patient had not tested positive for COVID-19 since having the vaccine. Patient had no symptoms associated with COVID-19. It was reported that patient''s report was not related to possible inflammation of the heart myocarditis or pericarditis. The concomitant medications were not reported. The treatment information was not provided. The events were not resolved 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 per Regulatory Authority?s report.


VAERS ID: 2030095 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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: Arthralgia, Dyspnoea, Erythema, Feeling cold, Malaise, Myalgia, SARS-CoV-2 test, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENDROFLUAZIDE; INFLUENZA VIRUS; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Feeling unwell; Muscle pain; Joint pain; Chilliness; Swelling; Redness; Breathlessness; This case was received via RA (Reference number: GB-MHRA-ADR 26420108) 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 MALAISE (Feeling unwell), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), FEELING COLD (Chilliness), SWELLING (Swelling), ERYTHEMA (Redness) and DYSPNOEA (Breathlessness) in a 50-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 25-Nov-2021. Concomitant products included RAMIPRIL from 20-May-2015 to an unknown date for Blood pH high, BENDROFLUMETHIAZIDE (BENDROFLUAZIDE) from 20-May-2021 to an unknown date for Retention water, INFLUENZA VACCINE (INFLUENZA VIRUS) from 01-Oct-2021 to an unknown date for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), FEELING COLD (Chilliness) (seriousness criterion medically significant), SWELLING (Swelling) (seriousness criterion medically significant), ERYTHEMA (Redness) (seriousness criterion medically significant) and DYSPNOEA (Breathlessness) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (Feeling unwell) (seriousness criterion medically significant). On 30-Dec-2021, DYSPNOEA (Breathlessness) was resolving. At the time of the report, MALAISE (Feeling unwell) was resolving and MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), FEELING COLD (Chilliness), SWELLING (Swelling) and ERYTHEMA (Redness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Nov-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. It was reported that it started with a sore arm , then the area started to swell and go red , patient woke the following morning feeling unwell with no energy , the same feeling patient had when she had COVID as the day progressed muscle and joint pain , and did not know what to go with them. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not currently breastfeeding. No treatment information reported. Company Comment: This case concerns a 50-year-old female patient, with reported history of Suspected COVID-19, who experience the serious unexpected events of Malaise, Myalgia, Arthralgia, Feeling Cold, Swelling, Erythema, Dyspnoea. The event Malaise occurred in an unknown date and the outcome at the time of the report was Recovering/Resolving. The events Myalgia, Arthralgia, Feeling Cold, Swelling and Erythema occurred 1 day 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 event Dyspnoea occurred 1 day after the administration of the 3rd dose of the mRNA-1273 vaccine and the outcome at the time of the report was Recovering/Resolving. The rechallenge could be considered not applicable since the event occurred after the 3rd dose and no additional dosing will be given. The reported history of Suspected COVID-19 remains as a confounder for the events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 50-year-old female patient, with reported history of Suspected COVID-19, who experience the serious unexpected events of Malaise, Myalgia, Arthralgia, Feeling Cold, Swelling, Erythema, Dyspnoea. The event Malaise occurred in an unknown date and the outcome at the time of the report was Recovering/Resolving. The events Myalgia, Arthralgia, Feeling Cold, Swelling and Erythema occurred 1 day 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 event Dyspnoea occurred 1 day after the administration of the 3rd dose of the mRNA-1273 vaccine and the outcome at the time of the report was Recovering/Resolving. The rechallenge could be considered not applicable since the event occurred after the 3rd dose and no additional dosing will be given. The reported history of Suspected COVID-19 remains as a confounder for the events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030097 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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, Headache, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE
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: Fever; Muscular pain; Shivers; Headache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26420104) 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 PYREXIA (Fever), MYALGIA (Muscular pain), CHILLS (Shivers) and HEADACHE (Headache) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 16-Jun-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), MYALGIA (Muscular pain) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 31-Dec-2021, PYREXIA (Fever), MYALGIA (Muscular pain), CHILLS (Shivers) and HEADACHE (Headache) had 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. Vaccine was given in the evening and the next day patient awoke with fever, headache, and muscular aches. Throughout the course of the day the fever alternated with feeling cold and shivery. Muscular aches and headache continued all day, as well as a sore arm at the injection site. patient also had little appetite and felt occasionally queasy. Pain was managed with Medication and patient was tried to sleep during the day to get through the worst of it. Symptoms only lasted a day, and the following day patient awoken and felt almost normal, still suffered with slight sore arm. Patient was not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. Patient was not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Treatment Medication use information was provided by reporter that includes pain was managed with ibuprofen and co-codamol. Company comment: This regulatory case concerns a 28-year-old female patient, with no medical history reported, who experienced the serious unexpected events of PYREXIA, MYALGIA, CHILLS and HEADACHE. The events occurred on the following day of the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable as no information about further dosing has been disclosed. A SARS-CoV-2 test: negative was performed on an unknown date. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.; Sender''s Comments: This regulatory case concerns a 28-year-old female patient, with no medical history reported, who experienced the serious unexpected events of PYREXIA, MYALGIA, CHILLS and HEADACHE. The events occurred on the following day of the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable as no information about further dosing has been disclosed. A SARS-CoV-2 test: negative was performed on an unknown date. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.


VAERS ID: 2030100 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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: Dysmenorrhoea, Heavy menstrual bleeding, Maternal exposure during breast feeding, Muscle spasms
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Neonatal exposures via breast milk (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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: cramps; Maternal exposure during breast feeding; Heavy periods; Painful periods; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26420263) 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 MUSCLE SPASMS (cramps), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding), HEAVY MENSTRUAL BLEEDING (Heavy periods) and DYSMENORRHOEA (Painful periods) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Breast feeding. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criterion medically significant) and DYSMENORRHOEA (Painful periods) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCLE SPASMS (cramps) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). At the time of the report, MUSCLE SPASMS (cramps) was resolving, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown and HEAVY MENSTRUAL BLEEDING (Heavy periods) and DYSMENORRHOEA (Painful periods) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant product reported. No treatment product reported. Company Comment: This case concerns a 34-year-old, female patient, with reported medical history of Breast feeding, who experienced the serious unexpected events of Muscle spasms, Heavy menstrual bleeding and Dysmenorrhoea. Additionally, the special situation of Maternal Exposure During Breast Feeding has been reported. The event of Muscle spasms occurred in an unknown date in relation with the administration of the third dose of the mRNA-1273 vaccine and the outcome at the time of the report was Recovering/Resolving. The event of Maternal exposure during breast feeding occurred in an unknown date in relation with the administration of the third dose of the mRNA-1273 vaccine and the outcome at the time of the report was unknown. The events of Heavy menstrual bleeding and Dysmenorrhoea exposure during breast feeding occurred 1 day after the administration of the third dose of the mRNA-1273 vaccine and the outcome at the time of the report was Not Recovered/Not Resolved. The rechallenge is not applicable since the events occurred after the third dose of the of the mRNA-1273 vaccine and another dose will not be administered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 34-year-old, female patient, with reported medical history of Breast feeding, who experienced the serious unexpected events of Muscle spasms, Heavy menstrual bleeding and Dysmenorrhoea. Additionally, the special situation of Maternal Exposure During Breast Feeding has been reported. The event of Muscle spasms occurred in an unknown date in relation with the administration of the third dose of the mRNA-1273 vaccine and the outcome at the time of the report was Recovering/Resolving. The event of Maternal exposure during breast feeding occurred in an unknown date in relation with the administration of the third dose of the mRNA-1273 vaccine and the outcome at the time of the report was unknown. The events of Heavy menstrual bleeding and Dysmenorrhoea exposure during breast feeding occurred 1 day after the administration of the third dose of the mRNA-1273 vaccine and the outcome at the time of the report was Not Recovered/Not Resolved. The rechallenge is not applicable since the events occurred after the third dose of the of the mRNA-1273 vaccine and another dose will not be administered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030112 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   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: Pain, 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:
Allergies:
Diagnostic Lab Data: Test Date: 20211231; 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: Rash; Pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26420566) 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 RASH (Rash) and PAIN (Pain) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PAIN (Pain) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). At the time of the report, RASH (Rash) had not resolved and PAIN (Pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-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 not had symptoms associated with COVID-19. Yesterday patient had aches all over and had pains in hands when trying to do things. Today her legs and feet were covered in a rash. Patient had not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial No concomitant medication was reported. No treatment information was provided. The last menstrual period date of the patient was reported to be on 30-NOV-2021. This report does not relate to possible inflammation of the heart (myocarditis or pericarditis) Company comment This is a regulatory case concerning a 37-year-old female patient with no medical history reported, who experienced the serious unexpected events of Pain and Rash. The event Pain occurred on the day after the third dose of mRNA-1273. The event Rash occurred approximately 2 days after the third dose of mRNA-1273. The rechallenge was assessed as unknown according to SD. 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 is a regulatory case concerning a 37-year-old female patient with no medical history reported, who experienced the serious unexpected events of Pain and Rash. The event Pain occurred on the day after the third dose of mRNA-1273. The event Rash occurred approximately 2 days after the third dose of mRNA-1273. The rechallenge was assessed as unknown according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030113 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Nausea, Pain in extremity, SARS-CoV-2 test, Somnolence, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: nauseous; groggy; shaking; Chills; Nausea; Groggy on awakening; Headache; Aching in limb; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26420750) 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 NAUSEA (nauseous), SOMNOLENCE (groggy), TREMOR (shaking), CHILLS (Chills), NAUSEA (Nausea), SOMNOLENCE (Groggy on awakening), HEADACHE (Headache) and PAIN IN EXTREMITY (Aching in limb) in a 19-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 11-May-2021 to an unknown date for Vaccination. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PAIN IN EXTREMITY (Aching in limb) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), SOMNOLENCE (Groggy on awakening) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (nauseous) (seriousness criterion medically significant), SOMNOLENCE (groggy) (seriousness criterion medically significant) and TREMOR (shaking) (seriousness criterion medically significant). On 31-Dec-2021, CHILLS (Chills) had resolved. At the time of the report, NAUSEA (nauseous), SOMNOLENCE (groggy), TREMOR (shaking), NAUSEA (Nausea), SOMNOLENCE (Groggy on awakening), HEADACHE (Headache) and PAIN IN EXTREMITY (Aching in limb) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Immediately after vaccination patient experienced ache in arm. At night, patient had uncontrollable shaking and could not get warm. Patient felt nauseous every time. Patient was groggy in the morning and had headache. Patient had not had symptoms associated with COVID-19 Patient had not tested positive for COVID-19 since vaccination. Patient was not enrolled in clinical trial. Company comment: This is a regulatory case concerning a 19 year-old, male patient with no reported medical history and Interchange of vaccine products (vaccination with a dose of COVID-19 vaccine BioNTech approximately 7 months prior), who experienced the serious (due to medically important condition) unexpected, according CCDS, events of nausea (reported twice), somnolence (reported twice), tremor, headache, pain in extremity and chills. Events were assessed as serious by the Regulatory Authority. The events nausea, somnolence, headache, pain in extremity and chills occurred the same day to 1 day after the booster dose of mRNA-1273 vaccine and the events nausea, somnolence and tremor on an unknown date. The outcome of the events was reported as recovering except for chills that was reported as 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 19 year-old, male patient with no reported medical history and Interchange of vaccine products (vaccination with a dose of COVID-19 vaccine BioNTech approximately 7 months prior), who experienced the serious (due to medically important condition) unexpected, according CCDS, events of nausea (reported twice), somnolence (reported twice), tremor, headache, pain in extremity and chills. Events were assessed as serious by the Regulatory Authority. The events nausea, somnolence, headache, pain in extremity and chills occurred the same day to 1 day after the booster dose of mRNA-1273 vaccine and the events nausea, somnolence and tremor on an unknown date. The outcome of the events was reported as recovering except for chills that was reported as 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: 2030114 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
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, Nausea, Pain, Pyrexia, SARS-CoV-2 test
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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE
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: Fever; Pain; Headache; Nausea; This case was received (Reference number: GB-MHRA-ADR 26420584) 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 PYREXIA (Fever), PAIN (Pain), HEADACHE (Headache) and NAUSEA (Nausea) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 13-Aug-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PAIN (Pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever) was resolving and PAIN (Pain), HEADACHE (Headache) and NAUSEA (Nausea) 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. It was reported that patient''s last menstrual period was on 13-Dec-2021. Historical condition was not reported. Treatment information was not provided. Company comment: This regulatory authority case concerns a 38-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Pyrexia, Pain, Headache and Nausea after mRNA- 1273 vaccine, third dose the vaccination schedule (reported as 3b dose). The patient had received initial schedule of vaccination with COVID-19 mRNA Vaccine BioNTech 2 months and 22 days before. The onset of the events Pain, Headache and Nausea occurred on the day after the 3b dose of mRNA- 1273 vaccine and Pyrexia developed on the following day. Headache, Nausea and Pyrexia are consistent with the known safety profile of the vaccine, but since they were reported with a seriousness criteria they are considered unexpected. Very limited information is available regarding clinical course of the events. The seriousness criteria of the events was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Patient not tested positive for COVID-19 since she had the vaccine. Patient not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial.; Sender''s Comments: This regulatory authority case concerns a 38-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Pyrexia, Pain, Headache and Nausea after mRNA- 1273 vaccine, third dose the vaccination schedule (reported as 3b dose). The patient had received initial schedule of vaccination with COVID-19 mRNA Vaccine BioNTech 2 months and 22 days before. The onset of the events Pain, Headache and Nausea occurred on the day after the 3b dose of mRNA- 1273 vaccine and Pyrexia developed on the following day. Headache, Nausea and Pyrexia are consistent with the known safety profile of the vaccine, but since they were reported with a seriousness criteria they are considered unexpected. Very limited information is available regarding clinical course of the events. The seriousness criteria of the events was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 2030118 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
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: SARS-CoV-2 test, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad), COVID-19 (broad)

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

Write-up: Shaking; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26420852) 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 TREMOR (Shaking) 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 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced TREMOR (Shaking) (seriousness criterion medically significant). On 31-Dec-2021, TREMOR (Shaking) 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. No concomitant drug information provided. No treatment drug information provided. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No possible inflammation of the heart (myocarditis or pericarditis). Company comment: This case concerns a female patient of an unknown age, with no medical history reported, who experienced the serious unexpected event of tremor after the third dose of mRNA-1273. The event occurred the same day after vaccination, lasted for a day and then resolved. The re-challenge was reported as unknown. 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 female patient of an unknown age, with no medical history reported, who experienced the serious unexpected event of tremor after the third dose of mRNA-1273. The event occurred the same day after vaccination, lasted for a day and then resolved. The re-challenge was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event assessed as serious by the Regulatory Authority.


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