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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: 1787622 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Dyspnoea, Erythema, Lip discolouration, Pallor, Panic reaction, Productive cough
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

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

Write-up: Pallor facial; Erythema facial; Lip discolouration; Panic reaction; Phlegm; Cough; Breathing difficult; This case was received via Regulatory Agency (Reference number: FI-FIMEA-20215099) on 06-Oct-2021 and was forwarded to Moderna on 06-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of in a 14-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 23-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided Treatment information was not provided Company comment: This case concerns a 14-year-old, female patient with no relevant medical history, who experienced the unexpected events of pallor, erythema, lip discolouration, panic reaction, productive cough, cough and dyspnea. The events of pallor, erythema, lip discolouration, panic reaction, productive cough, cough and dyspnea occurred within the same day of the first dose of mRNA-1273 vaccine administration. The rechallenge was not applicable, as the event occurred within the same day of the first dose of mRNA-1273 vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 14-year-old, female patient with no relevant medical history, who experienced the unexpected events of pallor, erythema, lip discolouration, panic reaction, productive cough, cough and dyspnea. The events of pallor, erythema, lip discolouration, panic reaction, productive cough, cough and dyspnea occurred within the same day of the first dose of mRNA-1273 vaccine administration. The rechallenge was not applicable, as the event occurred within the same day of the first dose of mRNA-1273 vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1788766 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001943 / 2 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Angioedema, Bronchial disorder, Bronchitis, Bronchospasm, Chills, Cough, Diarrhoea, Dyspnoea, Lung disorder, Nausea, Pain in extremity, Pneumonia, Product administered to patient of inappropriate age, Pyrexia, Respiratory disorder, Rhinorrhoea, Sneezing, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: Anaphylaxis; Hypersensitivity reaction; Immunodeficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: Bronchitis; Problems with bronchi; Problems with lungs; respiratory diseases; Inappropriate age at vaccine administration; vomiting; Nausea; Fever; Chills; Angioedema; Difficulty breathing; Abdominal cramps; Pain in the hand; Diarrhea; Sneezing; runny nose; Bronchospasm; wheezing; Cough; Difficulty breathing (repeatedly); Cough; Budding pneumonia; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Sep-2021. The most recent information was received on 07-Oct-2021 and was forwarded to Moderna on 07-Oct-2021. This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Budding pneumonia) and ANGIOEDEMA (Angioedema) in a 17-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3001943 and 214001) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anaphylaxis, Hypersensitivity reaction and Immunodeficiency. On 18-May-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Jun-2021 at 12:00 PM, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PNEUMONIA (Budding pneumonia) (seriousness criterion medically significant), DYSPNOEA (Difficulty breathing (repeatedly)) and the first episode of COUGH (Cough). On 18-May-2021, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), DYSPNOEA (Difficulty breathing), ABDOMINAL PAIN (Abdominal cramps), PAIN IN EXTREMITY (Pain in the hand), DIARRHOEA (Diarrhea), SNEEZING (Sneezing), RHINORRHOEA (runny nose), BRONCHOSPASM (Bronchospasm), WHEEZING (wheezing), the second episode of COUGH (Cough), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration), VOMITING (vomiting), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced BRONCHITIS (Bronchitis), BRONCHIAL DISORDER (Problems with bronchi), LUNG DISORDER (Problems with lungs) and RESPIRATORY DISORDER (respiratory diseases). The patient was treated with FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (SALMECOMP) on 28-Sep-2021 for Adverse event, at an unspecified dose and frequency; AZITHROMYCIN from 28-Sep-2021 to 30-Sep-2021 for Adverse event, at an unspecified dose and frequency and PREDNISOLONE on 28-Sep-2021 for Adverse event, at an unspecified dose and frequency. On 18-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved. At the time of the report, PNEUMONIA (Budding pneumonia), DYSPNOEA (Difficulty breathing (repeatedly)), BRONCHITIS (Bronchitis), BRONCHIAL DISORDER (Problems with bronchi), LUNG DISORDER (Problems with lungs) and RESPIRATORY DISORDER (respiratory diseases) outcome was unknown and ANGIOEDEMA (Angioedema), DYSPNOEA (Difficulty breathing), ABDOMINAL PAIN (Abdominal cramps), PAIN IN EXTREMITY (Pain in the hand), DIARRHOEA (Diarrhea), SNEEZING (Sneezing), RHINORRHOEA (runny nose), BRONCHOSPASM (Bronchospasm), WHEEZING (wheezing), the last episode of COUGH (Cough), VOMITING (vomiting), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) had not resolved. Concomitant medication use information was not provided by reporter. Treatment medications included antibiotics for bronchitis started on 19-may-2021 and stopped on 26-may-2021. Treatment medication included Nasal drops, Antibiotics since 19-May taken 4x. Patient was still sick since the first vaccination, was never really healthy.Loads of antibiotics, cough syrup, pills, etc. There were also severe obstructive [rales] bilaterally,immunoglobulins, and sub-groups. Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow up received on 07-oct-2021 vaccine information added and treatment medication added. On 07-Oct-2021: Translation document received on 12-Oct-2021.Patient''s Demographic updated. Pregnancy Status updated. Current condition added. Vaccine facility , Treatment medication and Events added. On 12-Oct-2021: Follow up received contains no new information.; Sender''s Comments: This case concerns a 17 year-old, female patient with relevant medical history of Anaphylaxis, Hypersensitivity reaction and Immunodeficiency, who experienced the serious unexpected events of pneumonia and angioedema. The event of pneumonia reported to have occurred at an unknown date prior to the Moderna COVID-19 vaccine. The event of angioedema occurred on the same day after the first dose of Moderna COVID-19 vaccine. The rechallenge was unknown. Product administered to patient of inappropriate age was considered as an additional event. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Events assessed as serious as per IME list.


VAERS ID: 1796798 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-24
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004731 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angioedema, Influenza like illness
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: FRMODERNATX, INC.MOD20213

Write-up: Giant urticaria; Influenza like illness; This case was received via Regulatory Agency (Reference number: FR-AFSSAPS-LY202111406) on 11-Oct-2021 and was forwarded to Moderna on 11-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of ANGIOEDEMA (Giant urticaria) in a 17-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3004234 and 3004731) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced ANGIOEDEMA (Giant urticaria) (seriousness criterion medically significant) and INFLUENZA LIKE ILLNESS (Influenza like illness). At the time of the report, ANGIOEDEMA (Giant urticaria) and INFLUENZA LIKE ILLNESS (Influenza like illness) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment medication was not provided. Company comment: This case concerns a 27-year-old female patient with no reported medical history, who experienced the unexpected event of angioedema. The event occurred on the same day after the administration of the second dose of mRNA-1273 (Spikevax). The rechallenge was not applicable as the event occurred after the second vaccine dosing. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report. Event assessed as serious per Regulatory authority as the events were noted as medically significant and is an important medical event. Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Translation received on 13-Oct-2021 contain Dose 1 details was updated.; Sender''s Comments: This case concerns a 27-year-old female patient with no reported medical history, who experienced the unexpected event of angioedema. The event occurred on the same day after the administration of the second dose of mRNA-1273 (Spikevax). The rechallenge was not applicable as the event occurred after the second vaccine dosing. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report. Event assessed as serious per Regulatory authority as the events were noted as medically significant and is an important medical event.


VAERS ID: 1806479 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Hepatic cytolysis, Hyperleukocytosis, Inflammatory marker increased, Inflammatory marker test, Microcytic anaemia, Rash, Thrombocytosis
SMQs:, Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Haematopoietic erythropenia (narrow), Malignancy related conditions (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210813; Test Name: INFLAMMATORY MARKER; Result Unstructured Data: Inflammatory marker increased.
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: HEPATIC CYTOLYSIS; THROMBOCYTOSIS; microcytic anemia; increased inflammatory markers; HYPERLEUCOCYTOSE; JOINT PAIN; generalized rash; This case was received via regulatory authority (Reference number: FR-AFSSAPS-PS20212308) on 15-Oct-2021 and was forwarded to Moderna on 15-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of INFLAMMATORY MARKER INCREASED (increased inflammatory markers), HYPERLEUKOCYTOSIS (HYPERLEUCOCYTOSE), HEPATIC CYTOLYSIS (HEPATIC CYTOLYSIS), THROMBOCYTOSIS (THROMBOCYTOSIS), MICROCYTIC ANAEMIA (microcytic anemia) and ARTHRALGIA (JOINT PAIN) in a 15-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced ARTHRALGIA (JOINT PAIN) (seriousness criterion hospitalization) and RASH (generalized rash). On 13-Aug-2021, the patient experienced INFLAMMATORY MARKER INCREASED (increased inflammatory markers) (seriousness criterion hospitalization), HYPERLEUKOCYTOSIS (HYPERLEUCOCYTOSE) (seriousness criteria hospitalization and medically significant), THROMBOCYTOSIS (THROMBOCYTOSIS) (seriousness criterion hospitalization) and MICROCYTIC ANAEMIA (microcytic anemia) (seriousness criterion hospitalization). On 30-Aug-2021, the patient experienced HEPATIC CYTOLYSIS (HEPATIC CYTOLYSIS) (seriousness criteria hospitalization and medically significant). On 08-Sep-2021, ARTHRALGIA (JOINT PAIN) had resolved. At the time of the report, INFLAMMATORY MARKER INCREASED (increased inflammatory markers), HYPERLEUKOCYTOSIS (HYPERLEUCOCYTOSE), HEPATIC CYTOLYSIS (HEPATIC CYTOLYSIS), THROMBOCYTOSIS (THROMBOCYTOSIS) and MICROCYTIC ANAEMIA (microcytic anemia) was resolving and RASH (generalized rash) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Aug-2021, Inflammatory marker test: increased (High) Inflammatory marker increased.. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Translation received on 16-Oct-21 includes event verbatim updated.; Sender''s Comments: This is a regulatory case concerning a 15 year-old male patient with no relevant medical history reported who experienced the serious unexpected events of INFLAMMATORY MARKER INCREASED, HYPERLEUKOCYTOSIS, HEPATIC CYTOLYSIS, THROMBOCYTOSIS, MICROCYTIC ANAEMIA and ARTHRALGIA leading to hospitalization. The events occurred between one and 19 days after a dose of Spikevax. Rechallenge is not applicable. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1809273 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214018 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Malaise, Respiratory distress, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

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

Write-up: malaise with tachycardia and respiratory distress; respiratory distress; Malaise; tachycardia; This case was received via regulatory authority (Reference number: FR-AFSSAPS-CN20213066) on 14-Oct-2021 and was forwarded to Moderna on 14-Oct-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of CHEST PAIN (malaise with tachycardia and respiratory distress), RESPIRATORY DISTRESS (respiratory distress), MALAISE (Malaise) and TACHYCARDIA (tachycardia) in a 15-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214018) for COVID-19 vaccination. No Medical History information was reported. On 11-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced CHEST PAIN (malaise with tachycardia and respiratory distress) (seriousness criterion medically significant). 15-Sep-2021, the patient experienced RESPIRATORY DISTRESS (respiratory distress) (seriousness criterion medically significant), MALAISE (Malaise) (seriousness criterion medically significant) and TACHYCARDIA (tachycardia) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (malaise with tachycardia and respiratory distress), RESPIRATORY DISTRESS (respiratory distress), MALAISE (Malaise) and TACHYCARDIA (tachycardia) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided. Company Comment This case concerns a 15-year-old male patient with no relevant medical history who experienced serious unexpected events of chest pain, malaise with tachycardia and respiratory distress. The events occurred four days following the second dose of the Spikevax. The rechallenge was not applicable as the event occurred following the second dose. causality for the reported event was not provided by the reporter.Very limited information regarding clinical course of the event has been provided at this time. The benefit-risk relationship of Spikevax is not affected by this report.,.Event seriousness assessed as per Regulatory Authority reporting as medically significant. Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Translation received on 15-Oct-2021 contains event verbatim in English language were updated. Added events: malaise, tachycardia and respiratory distress.; Sender''s Comments: This case concerns a 15-year-old male patient with no relevant medical history who experienced serious unexpected events of chest pain, malaise with tachycardia and respiratory distress. The events occurred four days following the second dose of the Spikevax. The rechallenge was not applicable as the event occurred following the second dose. causality for the reported event was not provided by the reporter.Very limited information regarding clinical course of the event has been provided at this time. The benefit-risk relationship of Spikevax is not affected by this report.,.Event seriousness assessed as per Regulatory Authority reporting as medically significant.


VAERS ID: 1809380 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Dyspnoea, Headache, Pulmonary pain
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: FRMODERNATX, INC.MOD20213

Write-up: Pain abdominal; Headache; Difficulty breathing; Pulmonary pain; This case was received via regulatory authority (Reference number: FR-AFSSAPS-ST20213666) on 14-Oct-2021 and was forwarded to Moderna on 14-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), PULMONARY PAIN (Pulmonary pain), ABDOMINAL PAIN (Pain abdominal) and HEADACHE (Headache) in a 16-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 31-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 01-Sep-2021, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion medically significant), PULMONARY PAIN (Pulmonary pain) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 07-Sep-2021, the patient experienced ABDOMINAL PAIN (Pain abdominal) (seriousness criterion medically significant). On 14-Sep-2021, HEADACHE (Headache) had resolved. In September 2021, ABDOMINAL PAIN (Pain abdominal) had resolved. At the time of the report, DYSPNOEA (Difficulty breathing) and PULMONARY PAIN (Pulmonary pain) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Patient medical history reported as NTR. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company comment -This case concerns a 16-year-old female patient with no relevant medical history who experienced serious unexpected events of Dyspnoea, Pulmonary pain, Headache and Abdominal pain. The events Dyspnoea, Pulmonary pain and Headache occurred one day after the first dose of Spikevax whereas the event Abdominal pain occurred seven days after the dose of Spikevax. The benefit-risk relationship of Spikevax is not affected by this report. Seriousness criteria of Medically significant is maintained for all events for consistency with RA report, however the source document does not include information that supports the seriousness criteria. Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Translation document received on 15 Oct 2021 contain dosage text translated.; Sender''s Comments: This case concerns a 16-year-old female patient with no relevant medical history who experienced serious unexpected events of Dyspnoea, Pulmonary pain, Headache and Abdominal pain. The events Dyspnoea, Pulmonary pain and Headache occurred one day after the first dose of Spikevax whereas the event Abdominal pain occurred seven days after the dose of Spikevax. The benefit-risk relationship of Spikevax is not affected by this report. Seriousness criteria of Medically significant is maintained for all events for consistency with RA report, however the source document does not include information that supports the seriousness criteria.


VAERS ID: 1809730 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-22
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 049283017 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Flushing, Headache, Heat oedema, Local reaction, Lymphadenopathy, Vaccination site reaction
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (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: CINAZYN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine with aura
Allergies:
Diagnostic Lab Data: Test Date: 20210922; Test Name: Body temperature; Result Unstructured Data: Temperature elevated
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat; headache and alternating body temperature in a patient monitored at the Migraines and Headaches Center.; Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat; headache and alternating body temperature in a patient monitored at the Migraines and Headaches Center.; Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat; headache and alternating body temperature in a patient monitored at the Migraines and Headaches Center.; Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat; headache and alternating body temperature in a patient monitored at the Migraines and Headaches Center.; Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat;headache and alteration of body temperature in patient follow-up at the Headache Cente.; Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat;headache and alteration of body temperature in patient follow-up at the Headache Center.; Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat;headache and alteration of body temperature in patient follow-up at the Headache Center.; This case was initially received via Regulatory Agency (Reference number: IT-MINISAL02-794052) on 08-Oct-2021. The most recent information was received on 14-Oct-2021 and was forwarded to Moderna on 14-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of LYMPHADENOPATHY (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat; headache and alternating body temperature in a patient monitored at the Migraines and Headaches Center.), VACCINATION SITE REACTION (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat; headache and alternating body temperature in a patient monitored at the Migraines and Headaches Center.), HEADACHE (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat; headache and alternating body temperature in a patient monitored at the Migraines and Headaches Center.), BODY TEMPERATURE INCREASED (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat; headache and alternating body temperature in a patient monitored at the Migraines and Headaches Center.), LOCAL REACTION (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat;headache and alteration of body temperature in patient follow-up at the Headache Center.), FLUSHING (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat;headache and alteration of body temperature in patient follow-up at the Headache Center.) and HEAT OEDEMA (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat;headache and alteration of body temperature in patient follow-up at the Headache Center.) in a 12-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 049283017) for COVID-19 immunisation. The patient''s past medical history included Migraine with aura. Concomitant products included CINNARIZINE (CINAZYN) from 08-Sep-2021 to an unknown date for an unknown indication. On 15-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced LYMPHADENOPATHY (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat; headache and alternating body temperature in a patient monitored at the Migraines and Headaches Center.) (seriousness criterion medically significant), VACCINATION SITE REACTION (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat; headache and alternating body temperature in a patient monitored at the Migraines and Headaches Center.) (seriousness criterion medically significant), HEADACHE (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat; headache and alternating body temperature in a patient monitored at the Migraines and Headaches Center.) (seriousness criterion medically significant), BODY TEMPERATURE INCREASED (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat; headache and alternating body temperature in a patient monitored at the Migraines and Headaches Center.) (seriousness criterion medically significant), LOCAL REACTION (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat;headache and alteration of body temperature in patient follow-up at the Headache Center.) (seriousness criterion medically significant), FLUSHING (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat;headache and alteration of body temperature in patient follow-up at the Headache Center.) (seriousness criterion medically significant) and HEAT OEDEMA (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat;headache and alteration of body temperature in patient follow-up at the Headache Center.) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat; headache and alternating body temperature in a patient monitored at the Migraines and Headaches Center.), VACCINATION SITE REACTION (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat; headache and alternating body temperature in a patient monitored at the Migraines and Headaches Center.), HEADACHE (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat; headache and alternating body temperature in a patient monitored at the Migraines and Headaches Center.), BODY TEMPERATURE INCREASED (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat; headache and alternating body temperature in a patient monitored at the Migraines and Headaches Center.), LOCAL REACTION (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat;headache and alteration of body temperature in patient follow-up at the Headache Center.), FLUSHING (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat;headache and alteration of body temperature in patient follow-up at the Headache Center) and HEAT OEDEMA (Reactive axillary lymphadenopathy, local reaction at the injection site with redness, edema and heat;headache and alteration of body temperature in patient follow-up at the Headache Center.) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2021, Body temperature: high (High) Temperature elevated. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No treatment medications were reported. Company Comment: This is a regulatory case concerning a 12 year-old female patient with medical history of migraine who experienced the serious unexpected events of LYMPHADENOPATHY, VACCINATION SITE REACTION,HEADACHE, BODY TEMPERATURE INCREASED, LOCAL REACTION and HEAT OEDEMA approximately 8 days after receiving a dose of Spikevax.. The rechallenge cannot be assessed since there?s no information of dose number or previous or further doses. Patient medical history of migraine remains as a confounder for the event headache. The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness was captured as per Regulatory Authority assessment in Source Document. Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Significant follow up received and contains: Added new event Vaccination site reaction, Date of Lab investigation "Body Temperature" updated from initial Source document and narrative was updated accordingly. On 14-Oct-2021: Translated doc received on 18-OCT-2021 and added event Verbatim.; Sender''s Comments: This is a regulatory case concerning a 12 year-old female patient with medical history of migraine who experienced the serious unexpected events of LYMPHADENOPATHY, VACCINATION SITE REACTION,HEADACHE, BODY TEMPERATURE INCREASED, LOCAL REACTION and HEAT OEDEMA approximately 8 days after receiving a dose of Spikevax.. The rechallenge cannot be assessed since there?s no information of dose number or previous or further doses. Patient medical history of migraine remains as a confounder for the event headache. The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness was captured as per Regulatory Authority assessment in Source Document.


VAERS ID: 1816717 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-06
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Burning sensation, Delirium, Dyspnoea, Fatigue, Nausea, Night sweats, Pain in extremity, Pyrexia, Taste disorder, Tremor, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: Fatigue; Tremor; Taste disorder; Pyrexia; Nausea; Vaccination site pain; Pain in fingers; Delirious; Night sweat; Burning sensation; Breathing difficult; This case was received via regulatory authority (Reference number: FI-FIMEA-20215466) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), TREMOR (Tremor), TASTE DISORDER (Taste disorder), PYREXIA (Pyrexia), NAUSEA (Nausea), VACCINATION SITE PAIN (Vaccination site pain), PAIN IN EXTREMITY (Pain in fingers), DELIRIUM (Delirious), NIGHT SWEATS (Night sweat), BURNING SENSATION (Burning sensation) and DYSPNOEA (Breathing difficult) in a 12-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion life threatening), TREMOR (Tremor) (seriousness criterion life threatening), TASTE DISORDER (Taste disorder) (seriousness criterion life threatening), PYREXIA (Pyrexia) (seriousness criterion life threatening), NAUSEA (Nausea) (seriousness criterion life threatening), VACCINATION SITE PAIN (Vaccination site pain) (seriousness criterion life threatening), PAIN IN EXTREMITY (Pain in fingers) (seriousness criterion life threatening), DELIRIUM (Delirious) (seriousness criteria medically significant and life threatening), NIGHT SWEATS (Night sweat) (seriousness criterion life threatening), BURNING SENSATION (Burning sensation) (seriousness criterion life threatening) and DYSPNOEA (Breathing difficult) (seriousness criterion life threatening). At the time of the report, FATIGUE (Fatigue), TREMOR (Tremor), TASTE DISORDER (Taste disorder), PYREXIA (Pyrexia), NAUSEA (Nausea), VACCINATION SITE PAIN (Vaccination site pain), PAIN IN EXTREMITY (Pain in fingers), DELIRIUM (Delirious), NIGHT SWEATS (Night sweat), BURNING SENSATION (Burning sensation) and DYSPNOEA (Breathing difficult) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: This case concerns a 12-year-old, male patient with no relevant medical history, who experienced the serious unexpected event of Dyspnoea. Event seriousness for the events Fatigue, Tremor, Taste disorder, Pyrexia, Nausea, Vaccination site pain, Pain in extremity, Delirium, Night sweats, Burning sensation, assessed as per Regulatory Authority reporting, however there was no information in the source document supporting the life-threatening seriousness criteria. The events occurred after unknown dose number and unspecified lapse of time after Spikevax. The rechallenge was not applicable as the dose numbers not reported. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 12-year-old, male patient with no relevant medical history, who experienced the serious unexpected event of Dyspnoea. Event seriousness for the events Fatigue, Tremor, Taste disorder, Pyrexia, Nausea, Vaccination site pain, Pain in extremity, Delirium, Night sweats, Burning sensation, assessed as per Regulatory Authority reporting, however there was no information in the source document supporting the life-threatening seriousness criteria. The events occurred after unknown dose number and unspecified lapse of time after Spikevax. The rechallenge was not applicable as the dose numbers not reported. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1817450 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-09-10
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Face oedema, Headache, Localised infection, Localised oedema, Pyrexia, Respiratory tract oedema, Sialoadenitis
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20213

Write-up: Neck oedema; Pyrexia; Face oedema; Breathing difficult; Headache; Sialoadenitis; Localised infection; Respiratory tract oedema; This case was received via regulatory authority (Reference number: FI-FIMEA-20215451) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOCALISED OEDEMA (Neck oedema), PYREXIA (Pyrexia), FACE OEDEMA (Face oedema), DYSPNOEA (Breathing difficult), HEADACHE (Headache), SIALOADENITIS (Sialoadenitis), LOCALISED INFECTION (Localised infection) and RESPIRATORY TRACT OEDEMA (Respiratory tract oedema) in a 15-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced LOCALISED OEDEMA (Neck oedema) (seriousness criterion hospitalization), PYREXIA (Pyrexia) (seriousness criterion hospitalization), FACE OEDEMA (Face oedema) (seriousness criterion hospitalization), DYSPNOEA (Breathing difficult) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), SIALOADENITIS (Sialoadenitis) (seriousness criteria hospitalization and medically significant), LOCALISED INFECTION (Localised infection) (seriousness criterion hospitalization) and RESPIRATORY TRACT OEDEMA (Respiratory tract oedema) (seriousness criteria hospitalization and medically significant). At the time of the report, LOCALISED OEDEMA (Neck oedema), PYREXIA (Pyrexia), FACE OEDEMA (Face oedema), DYSPNOEA (Breathing difficult), HEADACHE (Headache), SIALOADENITIS (Sialoadenitis), LOCALISED INFECTION (Localised infection) and RESPIRATORY TRACT OEDEMA (Respiratory tract oedema) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant drug details were reported. No treatment details were reported. Company Comment: This case concerns a 15-year-old, female with no reported medical history, who experienced the serious, unexpected events of localized oedema, pyrexia, face oedema, dyspnoea, headache, sialoadenitis, localized infection and respiratory tract oedema. The events occurred approximately 15 days after first dose of Spikevax. The rechallenge was not applicable, as no information about second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event terms, onset dates, outcomes and seriousness captured per SD from Regulatory Authority reporting.; Sender''s Comments: This case concerns a 15-year-old, female with no reported medical history, who experienced the serious, unexpected events of localized oedema, pyrexia, face oedema, dyspnoea, headache, sialoadenitis, localized infection and respiratory tract oedema. The events occurred approximately 15 days after first dose of Spikevax. The rechallenge was not applicable, as no information about second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event terms, onset dates, outcomes and seriousness captured per SD from Regulatory Authority reporting.


VAERS ID: 1817451 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-30
Onset:2021-09-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004494 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure decreased, Fatigue, Feeling cold, Headache, Lymphadenopathy, Malaise, Muscular weakness, Pain in extremity, Pallor, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: Fainting; Lower extremities weakness of; Blood pressure decreased; Pallor of skin; Malaise; Feeling cold; Pain in extremity; Lymphadenopathy; Headache; Fatigue; Pyrexia; This case was received via regulatory authority (Reference number: FI-FIMEA-20215454) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting) in a 12-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004494) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), MUSCULAR WEAKNESS (Lower extremities weakness of), BLOOD PRESSURE DECREASED (Blood pressure decreased), PALLOR (Pallor of skin), MALAISE (Malaise), FEELING COLD (Feeling cold), PAIN IN EXTREMITY (Pain in extremity), LYMPHADENOPATHY (Lymphadenopathy), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Pyrexia). At the time of the report, SYNCOPE (Fainting), MUSCULAR WEAKNESS (Lower extremities weakness of), BLOOD PRESSURE DECREASED (Blood pressure decreased), PALLOR (Pallor of skin), MALAISE (Malaise), FEELING COLD (Feeling cold), PAIN IN EXTREMITY (Pain in extremity), LYMPHADENOPATHY (Lymphadenopathy), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Pyrexia) had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications provided. No treatment medications provided. Company Comment: This case concerns a 12 year old female patient, with no medical history reported who experienced non serious unexpected events of syncope, blood pressure decreased, muscular weakness, pallor, feeling cold and fatigue after first dose of mRNA-1273. The events occurred the same day after first dose. The re-challenge is unknown as there is no information regarding second dose. The benefit-risk relationship of Spikevax in not affected by this report. Event syncope was automatically upgraded as serious as per regulatory authority list. However, based on information available and as per medical judgement was assessed as non-serious.; Sender''s Comments: This case concerns a 12 year old female patient, with no medical history reported who experienced non serious unexpected events of syncope, blood pressure decreased, muscular weakness, pallor, feeling cold and fatigue after first dose of mRNA-1273. The events occurred the same day after first dose. The re-challenge is unknown as there is no information regarding second dose. The benefit-risk relationship of Spikevax in not affected by this report. Event syncope was automatically upgraded as serious as per regulatory authority list. However, based on information available and as per medical judgement was assessed as non-serious.


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