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From the 1/7/2022 release of VAERS data:

Found 129 cases where Age is 12-or-more-and-under-18 and Vaccine is COVID19 and Manufacturer is MODERNA and Standard-MedDRA-Query broadly-matches 'Anaphylactic reaction'

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Case Details

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VAERS ID: 1819952 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-10-06
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Arthralgia, Back pain, Dyspnoea, Headache, Myalgia, Pyrexia, Vaccination site oedema, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Arrhythmia; Dyspnoea; Vaccination site oedema; Back pain; Headache; Vaccination site pain; Arthralgia; Pyrexia; Myalgia; This case was received via Regulatory Agency (Reference number: FI-FIMEA-20215551) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia), DYSPNOEA (Dyspnoea), VACCINATION SITE OEDEMA (Vaccination site oedema), BACK PAIN (Back pain), HEADACHE (Headache), VACCINATION SITE PAIN (Vaccination site pain), ARTHRALGIA (Arthralgia), PYREXIA (Pyrexia) and MYALGIA (Myalgia) in a 17-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Oct-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2021, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion disability), DYSPNOEA (Dyspnoea) (seriousness criterion disability), VACCINATION SITE OEDEMA (Vaccination site oedema) (seriousness criterion disability), BACK PAIN (Back pain) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability), VACCINATION SITE PAIN (Vaccination site pain) (seriousness criterion disability), ARTHRALGIA (Arthralgia) (seriousness criterion disability), PYREXIA (Pyrexia) (seriousness criterion disability) and MYALGIA (Myalgia) (seriousness criterion disability). At the time of the report, ARRHYTHMIA (Arrhythmia), DYSPNOEA (Dyspnoea), VACCINATION SITE OEDEMA (Vaccination site oedema), BACK PAIN (Back pain), HEADACHE (Headache), VACCINATION SITE PAIN (Vaccination site pain), ARTHRALGIA (Arthralgia), PYREXIA (Pyrexia) and MYALGIA (Myalgia) was resolving. Concomitant drugs were not reported. Treatment medications were not provided. Company''s comment: This case concerns a 17-year-old female patient with no previous relevant medical history, who experienced the unexpected serious events of Arrythmia, Dyspnoea, Vaccination site oedema, Back pain, Headache, Vaccination site pain, Arthralgia, Pyrexia and Myalgia after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The events occurred on the day after the second dose of Spikevax. No further information was provided. Headache, Vaccination site pain, Arthralgia, Pyrexia and Myalgia are consistent with the known safety profile of the vaccine for adults, but since the events were reported with a serious outcome and the patient is younger than 18 years old, they are considered unexpected. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of Spikevax vaccine is not affected by this report. The seriousness criteria of the events was assessed as per regulatory authority report. There is insufficient evidence to support Disability from a clinical or regulatory standpoint.; Sender''s Comments: This case concerns a 17-year-old female patient with no previous relevant medical history, who experienced the unexpected serious events of Arrythmia, Dyspnoea, Vaccination site oedema, Back pain, Headache, Vaccination site pain, Arthralgia, Pyrexia and Myalgia after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The events occurred on the day after the second dose of Spikevax. No further information was provided. Headache, Vaccination site pain, Arthralgia, Pyrexia and Myalgia are consistent with the known safety profile of the vaccine for adults, but since the events were reported with a serious outcome and the patient is younger than 18 years old, they are considered unexpected. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of Spikevax vaccine is not affected by this report. The seriousness criteria of the events was assessed as per regulatory authority report. There is insufficient evidence to support Disability from a clinical or regulatory standpoint.


VAERS ID: 1822467 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Cough, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

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

Write-up: Cough; Dyspnoea; Asthma; This case was received via regulatory authority (Reference number: FI-FIMEA-20215542) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COUGH (Cough), DYSPNOEA (Dyspnoea) and ASTHMA (Asthma) in a 15-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Aug-2021, the patient experienced COUGH (Cough) (seriousness criterion medically significant), DYSPNOEA (Dyspnoea) (seriousness criterion medically significant) and ASTHMA (Asthma) (seriousness criterion medically significant). At the time of the report, COUGH (Cough), DYSPNOEA (Dyspnoea) and ASTHMA (Asthma) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant medications were not provided. Treatment information was not provided. Company comment: This is a regulatory authority case concerning a 15-year-old male patient with no relevant medical history reported, who experienced serious unexpected events of Cough, Dyspnoea and Asthma. The events occurred 2 days after the first dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. 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 is a regulatory authority case concerning a 15-year-old male patient with no relevant medical history reported, who experienced serious unexpected events of Cough, Dyspnoea and Asthma. The events occurred 2 days after the first dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1822700 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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.MOD20213

Write-up: Syncope; Jumais vu; Chest Pain; Dyspnoea; Palpitations; Tachycardia; Fever; Fatigue; This case was received via Regulatory Authority RA (Reference number: GB-MHRA-ADR 26086026) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope) in a 16-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), JAMAIS VU (Jamais vu), CHEST PAIN (Chest Pain), DYSPNOEA (Dyspnoea), PALPITATIONS (Palpitations), TACHYCARDIA (Tachycardia), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, SYNCOPE (Syncope), CHEST PAIN (Chest Pain), DYSPNOEA (Dyspnoea), PALPITATIONS (Palpitations), TACHYCARDIA (Tachycardia), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown and JAMAIS VU (Jamais vu) 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. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant information was not provided. Treatment information was not provided. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient reported to have possible Myocarditis and Pericarditis also patient saw cardiologist. It was reported that there was presence of pericardial rub, or changes in heart sounds. Patient was asymptomatic. Patient laboratory data included ECG, CHEST X-RAY, Echocardiogram, chest CT, Chest MRI, Cardiac Biopsy, Coronary Angiography with unknown dates and results. Company Comment: This case concerns a 16-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of syncope. The events occurred approximately on an unknown day after the unknown dose of Moderna CoviD-19 Vaccine. The rechallenge was not applicable, as the events happened after the unknonw dose. The benefit-risk relationship of Moderna CoviD-19 Vaccine, is not affected by this report.; Sender''s Comments: This case concerns a 16-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of syncope. The events occurred approximately on an unknown day after the unknown dose of Moderna CoviD-19 Vaccine. The rechallenge was not applicable, as the events happened after the unknonw dose. The benefit-risk relationship of Moderna CoviD-19 Vaccine, is not affected by this report.


VAERS ID: 1824111 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-03
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004731 / UNK - / OT

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

Life Threatening? Yes
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: DEMODERNATX, INC.MOD20213

Write-up: Anaphylactic reaction; This case was received via Regulatory Agency (Reference number: DE-PEI-202100205347) on 20-Oct-2021 and was forwarded to Moderna on 20-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 12-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004731) for COVID-19 vaccination. No Medical History information was reported. On 03-Oct-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criteria medically significant and life threatening). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant product use was not provided by reporter. Treatment information was not provided. Patient reported that Initials: (Last name, first name) After the intramuscular injection, the vaccine recipient developed an anaphylactic reaction at approximately 11:30 a.m. Outpatient treatment was required. Vaccination took place at the vaccination center. Company Comment: This case concerns a 12-year-old male patient with no previous relevant medical history, who experienced the unexpected serious event of Anaphylactic reaction after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred immediately after the dose of Spikevax, dose number unknown. Outpatient treatment was required, but not specified. No further information was provided. The rechallenge is not applicable, since no further doses should be expected. Anaphylactic reaction is consistent with the known safety profile of the vaccine in adults, but since the event was reported in an adolescent, it is currently considered unexpected. The benefit-risk relationship of Spikevax vaccine is not affected by this report. The event was assessed as Life-threatening as per regulatory authority report. There is insufficient evidence to support this seriousness assessment from a clinical or regulatory standpoint. Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Translation received on 21-OCT-2021 is significant. Sender''s comment is updated and added in inarrative.; Sender''s Comments: This case concerns a 12-year-old male patient with no previous relevant medical history, who experienced the unexpected serious event of Anaphylactic reaction after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred immediately after the dose of Spikevax, dose number unknown. Outpatient treatment was required, but not specified. No further information was provided. The rechallenge is not applicable, since no further doses should be expected. Anaphylactic reaction is consistent with the known safety profile of the vaccine in adults, but since the event was reported in an adolescent, it is currently considered unexpected. The benefit-risk relationship of Spikevax vaccine is not affected by this report. The event was assessed as Life-threatening as per regulatory authority report. There is insufficient evidence to support this seriousness assessment from a clinical or regulatory standpoint.


VAERS ID: 1826891 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-16
Onset:2021-10-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005890 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.3 degree Celsius
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; This case was received via regulatory authority (Reference number: 2021TJP110999) on 20-Oct-2021 and was forwarded to Moderna on 28-Oct-2021. This case, initially reported to the regulatory authority by a (physician), was received via the regulatory authority (Ref, v21129600). Anaphylaxis was assessed as serious by the MAH. The patient visited a hospital regularly for allergy. On an unknown date, body temperature before the vaccination: 36.3 degrees Celsius. On 16-Oct-2021, around 09:30, the patient received this vaccine (unknown number of doses). At 10:00, anaphylaxis developed. About 30 minutes after the vaccination, skin rash gradually developed. Vital signs showed stable respiratory symptoms. Redness and wheals spread from the limbs to the trunk. The symptoms tended to improve by administration of d-chlorpheniramine maleate, but skin rash increased. Hydrocortisone sodium succinate was administered. The patient was instructed to visit a medical institution. Afterwards, the symptoms were resolving. The outcome of anaphylaxis was reported as resolving. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Mild anaphylaxis was suspected. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 16 year old female patient with medical history of hospital visits for allergy, who experienced the expected event of anaphylactic reaction. The event occurred approximately 30 minutes after a dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1828100 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003652 / UNK - / OT

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

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

Write-up: Angioedema; Acute urticaria; This case was received via regulatory authority (Reference number: CY-CYPPVPR-200921KK2) on 22-Oct-2021 and was forwarded to Moderna on 22-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of ANGIOEDEMA (Angioedema) in a 14-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3003652) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Sep-2021 at 8:00 AM, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 01-Sep-2021 at 8:00 PM, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant) and URTICARIA (Acute urticaria). On 01-Sep-2021 at 11:00 PM, ANGIOEDEMA (Angioedema) and URTICARIA (Acute urticaria) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Company Comment: This case concerns a 14-year-old male subject, with no relevant medical history, who experienced the unexpected and serious event of Angioedema. The event occurred 12 hours after an unkown dose of Spikevax. The rechallenge is not applicable, as it cannot be assessed. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 14-year-old male subject, with no relevant medical history, who experienced the unexpected and serious event of Angioedema. The event occurred 12 hours after an unkown dose of Spikevax. The rechallenge is not applicable, as it cannot be assessed. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1828187 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-02
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Ageusia, Dyspnoea, Headache, Muscle spasms, Nasal congestion, Nausea, Pyrexia, Rash
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: This case was initially received via regulatory authority (Reference number: SE-MPA-2021-087714) on 21-Oct-2021. The most recent information was received on 21-Oct-2021 and was forwarded to Moderna on 21-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA, MUSCLE SPASMS, HEADACHE, ABDOMINAL PAIN, RASH and PYREXIA in a 16-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma and Endometriosis. In 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In October 2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced AGEUSIA. On 02-Sep-2021, the patient experienced NASAL CONGESTION and DYSPNOEA. In October 2021, the patient experienced NAUSEA (seriousness criterion hospitalization), MUSCLE SPASMS (seriousness criterion hospitalization), HEADACHE (seriousness criterion hospitalization), ABDOMINAL PAIN (seriousness criterion hospitalization), RASH (seriousness criterion hospitalization) and PYREXIA (seriousness criterion hospitalization). In 2021, AGEUSIA outcome was unknown. On 12-Sep-2021, NASAL CONGESTION and DYSPNOEA had resolved. At the time of the report, NAUSEA, MUSCLE SPASMS, HEADACHE, ABDOMINAL PAIN, RASH and PYREXIA was resolving. No concomitant medications were reported. No treatment medications were reported. Company comment: This case concerns a 16-year-old female patient with medical history of asthma and endometriosis who experienced the unexpected events of nausea, muscle spasms, headache, abdominal pain, rash, and pyrexia. The events occurred following an unspecified period after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as details pertaining to dates administered dose was not disclosed. Causality assessment with product use was not provided by the reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event was assessed as serious per regulatory authority reporting as events resulted in hospitalization. This case was linked to SE-MPA-2021-088283, SE-MPA-2021-087714 (Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Follow up document received includes new events, medical history, product start date and case was upgraded; Sender''s Comments: This case concerns a 16-year-old female patient with medical history of asthma and endometriosis who experienced the unexpected events of nausea, muscle spasms, headache, abdominal pain, rash, and pyrexia. The events occurred following an unspecified period after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as details pertaining to dates administered dose was not disclosed. Causality assessment with product use was not provided by the reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event was assessed as serious per regulatory authority reporting as events resulted in hospitalization. SE-MPA-2021-088283: SE-MPA-2021-087714:


VAERS ID: 1835032 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-16
Onset:2021-10-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic to cats; Allergic to dogs; Food allergy (sesame); Food allergy (pork); Food allergy (beef); House dust allergy (House dust); Pollen allergy (hinoki cypress); Pollen allergy (cedar); Seafood allergy (shrimp); Seafood allergy (crab)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP112091) on 23-Oct-2021 and was forwarded to Moderna on 29-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 16-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included House dust allergy (House dust), Allergic to cats, Allergic to dogs, Pollen allergy (cedar), Pollen allergy (hinoki cypress), Seafood allergy (shrimp), Seafood allergy (crab), Food allergy (pork), Food allergy (beef) and Food allergy (sesame). On 16-Oct-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Oct-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criteria hospitalization and medically significant). On 17-Oct-2021, ANAPHYLACTIC REACTION (Anaphylaxis) had resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) to be possibly related.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 16-year-old female patient with a history of multiple allergies, who experienced the serious unexpected event of ANAPHYLAXIS. The event occurred the same day of the first dose of Spikevax. The rechallenge was not applicable as no information about additional dosing was disclosed. The medical history of multiple allergies remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1835853 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-21
Onset:2021-09-27
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005285 / 1 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (broad)

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

Write-up: Dyspnoea; Tachycardia; This case was received via regulatory authority (Reference number: FR-AFSSAPS-NY20214729) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of in a 17-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005285) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication. Concurrent medical conditions included Migraine (Prone to migraines). On 21-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications reported. No treatment medications reported. Rechallenge was done and outcome was unknown. Company comment: This case concerns a 17-year-old, female patient with no relevant medical history, who experienced the unexpected events of dyspnoea and tachycardia. The events dyspnoea and tachycardia occurred 6 days after the first dose of Spikevax. The rechallenge was not applicable as no information about additional dosing was disclosed. Vaccination with Pfizer''s Cominarty COVID-19 vaccine could be potentially confounder. The benefit-risk relationship of Spikevax is not affected by this report. The regulatory authority reported the same events associated with Spikevax and Comirnaty vaccination, without specifying the application date of Pfizer?s product, hence it is not possible to determine whether the adverse event could be related to one or the other vaccine. Dyspnea and tachycardia in a 17-year-old woman 6 days after the first injection of the COMIRNATY vaccine. Recovered 2 days later. Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Translation document received on 27 Oct 2021. Other relevant history is updated. Reporter''s comments is updated.; Sender''s Comments: This case concerns a 17-year-old, female patient with no relevant medical history, who experienced the unexpected events of dyspnoea and tachycardia. The events dyspnoea and tachycardia occurred 6 days after the first dose of Spikevax. The rechallenge was not applicable as no information about additional dosing was disclosed. Vaccination with Pfizer''s Cominarty COVID-19 vaccine could be potentially confounder. The benefit-risk relationship of Spikevax is not affected by this report. The regulatory authority reported the same events associated with Spikevax and Comirnaty vaccination, without specifying the application date of Pfizer?s product, hence it is not possible to determine whether the adverse event could be related to one or the other vaccine.


VAERS ID: 1835873 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005238 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chest discomfort, Dizziness, Fatigue, Headache, Heart rate increased, Myalgia, Nausea, Pyrexia, Vaccination site pain, Vaccination site swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

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

Write-up: Significant pulse increase upon slighetes exertion; Pressure on chest; Dizziness; Headache; Vaccination site swelling; Pain at the Vaccination site; Joint pain; Muscle pain; Fever; Tiredness; Nausea; This case was received via regulatory authority (Reference number: SE-MPA-2021-089365) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Pressure on chest), HEART RATE INCREASED (Significant pulse increase upon slighetes exertion), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Fever), FATIGUE (Tiredness), NAUSEA (Nausea), DIZZINESS (Dizziness), HEADACHE (Headache), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Pain at the Vaccination site) in a 17-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3005835 and 3005238) for COVID-19 vaccination. No Medical History information was reported. On 19-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion hospitalization), MYALGIA (Muscle pain) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization), FATIGUE (Tiredness) (seriousness criterion hospitalization), NAUSEA (Nausea) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), VACCINATION SITE SWELLING (Vaccination site swelling) (seriousness criterion hospitalization) and VACCINATION SITE PAIN (Pain at the Vaccination site) (seriousness criterion hospitalization). On 29-Aug-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion hospitalization). On 15-Sep-2021, the patient experienced CHEST DISCOMFORT (Pressure on chest) (seriousness criterion hospitalization). On 16-Sep-2021, the patient experienced HEART RATE INCREASED (Significant pulse increase upon slighetes exertion) (seriousness criterion hospitalization). On 19-Sep-2021, VACCINATION SITE SWELLING (Vaccination site swelling) had resolved. On 20-Sep-2021, VACCINATION SITE PAIN (Pain at the Vaccination site) had resolved. At the time of the report, CHEST DISCOMFORT (Pressure on chest), HEART RATE INCREASED (Significant pulse increase upon slighetes exertion), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Fever), FATIGUE (Tiredness), NAUSEA (Nausea), DIZZINESS (Dizziness) and HEADACHE (Headache) had not resolved. No concomitant medication provided. No treatment information mentioned. Company Comment: This case concerns a 17-year-old female patient with no relevant medical history, who experienced the unexpected serious events of Myalgia, Fatigue, Nausea, Arthralgia, Pyrexia, Headache, Vaccination site pain and swelling (developed on the same day after the administration of the first dose of Spikevax), Dizziness (developed 10 days after the first dose of Spikevax), Chest discomfort and Heart rate increased (which developed 27 and 28 days after the first dose, respectively). At the time of the report, only Vaccination site swelling and Vaccination site pain resolved, while the remaining reported events did not resolve. Having in mind that there is provided information regarding the second dose and as the events Vaccination site swelling and Vaccination site pain did not re-occur, rechallenge is considered negative for these. However, the rechallenge is not applicable for the remaining events as these events did not resolve at the time of the report. The benefit risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Translation document received on 27-OCT-2021. Event verbatim updated.; Sender''s Comments: This case concerns a 17-year-old female patient with no relevant medical history, who experienced the unexpected serious events of Myalgia, Fatigue, Nausea, Arthralgia, Pyrexia, Headache, Vaccination site pain and swelling (developed on the same day after the administration of the first dose of Spikevax), Dizziness (developed 10 days after the first dose of Spikevax), Chest discomfort and Heart rate increased (which developed 27 and 28 days after the first dose, respectively). At the time of the report, only Vaccination site swelling and Vaccination site pain resolved, while the remaining reported events did not resolve. Having in mind that there is provided information regarding the second dose and as the events Vaccination site swelling and Vaccination site pain did not re-occur, rechallenge is considered negative for these. However, the rechallenge is not applicable for the remaining events as these events did not resolve at the time of the report. The benefit risk relationship of Spikevax is not affected by this report.


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