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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: 1841843 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-23
Onset:2021-10-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005694 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Pruritus, Rash
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; Skin eruption; Pruritus; This case was received via regulatory authority (Reference number: 2021TJP112372) on 26-Oct-2021 and was forwarded to Moderna on 01-Nov-2021. This case, initially reported to the regulatory authority by a physician, was received via the regulatory authority (Ref, v21129961). On an unknown date, the patient received the 1st dose of this vaccine. Skin eruption and pruritus developed. On 23-Oct-2021, at 14:58, the patient received the 2nd dose of this vaccine. At 15:12, pruritus, abdominal pain, and queasy developed. The patient moved to an emergency outpatient department. At 15:30, the patient was examined and diagnosed with mild anaphylaxis. Famotidine, d-chlorpheniramine maleate, and methylprednisolone sodium succinate were administered. The patient was admitted to the pediatrics department in the reporting hospital for follow-up. On 24-Oct-2021, the symptoms were resolving, and the patient was discharged from the hospital. Outpatient follow-up was made. The outcome of skin eruption and pruritus was unknown. The outcome of anaphylaxis was reported as resolving. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 14 year old male patient with no relevant medical history, who experienced the unexpected event of anaphylactic reaction. The event occurred approximately 14 minutes after the second 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: 1842506 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005696 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature decreased, Cyanosis, Dizziness, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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: Body temperature decreased; Lower extremities weakness of; Dizziness; Cyanosis peripheral; This case was received via regulatory authority (Reference number: FI-FIMEA-20215742) on 27-Oct-2021 and was forwarded to Moderna on 27-Oct-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of BODY TEMPERATURE DECREASED (Body temperature decreased), MUSCULAR WEAKNESS (Lower extremities weakness of), DIZZINESS (Dizziness) and CYANOSIS (Cyanosis peripheral) in a 15-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005696) for COVID-19 vaccination. No Medical History information was reported. On 06-Oct-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 06-Oct-2021, the patient experienced BODY TEMPERATURE DECREASED (Body temperature decreased) (seriousness criterion disability), MUSCULAR WEAKNESS (Lower extremities weakness of) (seriousness criterion disability), DIZZINESS (Dizziness) (seriousness criterion disability) and CYANOSIS (Cyanosis peripheral) (seriousness criterion disability). At the time of the report, BODY TEMPERATURE DECREASED (Body temperature decreased), MUSCULAR WEAKNESS (Lower extremities weakness of), DIZZINESS (Dizziness) and CYANOSIS (Cyanosis peripheral) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Company comment: This is a regulatory case concerning a 15 year-old, female patient with no relevant history, who experienced the unexpected serious events of BODY TEMPERATURE DECREASED, MUSCULAR WEAKNESS, DIZZINESS and CYANOSIS. The event soccurred approximately 1 days after the 1st dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable (information about 2nd dose was not provided). Events were classified as serious by regulatory authority The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 15 year-old, female patient with no relevant history, who experienced the unexpected serious events of BODY TEMPERATURE DECREASED, MUSCULAR WEAKNESS, DIZZINESS and CYANOSIS. The event soccurred approximately 1 days after the 1st dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable (information about 2nd dose was not provided). Events were classified as serious by regulatory authority The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.


VAERS ID: 1855733 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Chest pain, Dyspnoea, Fatigue, Heart rate increased, Pain, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant 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), Cardiac arrhythmia terms, nonspecific (narrow), Tendinopathies and ligament disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MEDIKINET
Current Illness:
Preexisting Conditions: Comments: No relevant medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20213

Write-up: Arrhythmia; Chest pain; Pain in hand; Heart rate increased; Shortness of breath; Referred pain; Fatigue; This case was received via Regulatory Agency (Reference number: FI-FIMEA-20215953) on 01-Nov-2021 and was forwarded to Moderna on 01-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia) 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 relevant medical history was provided by the reporter. Concomitant products included METHYLPHENIDATE HYDROCHLORIDE (MEDIKINET) for ADHD. On 27-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Pain in hand), HEART RATE INCREASED (Heart rate increased), DYSPNOEA (Shortness of breath), PAIN (Referred pain) and FATIGUE (Fatigue). At the time of the report, ARRHYTHMIA (Arrhythmia), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Pain in hand), HEART RATE INCREASED (Heart rate increased), DYSPNOEA (Shortness of breath), PAIN (Referred pain) and FATIGUE (Fatigue) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No Treatment medication was reported. Company comment: This case concerns a 15-year-old male patient with no relevant medical history, who experienced the serious unexpected event of Arrhythmia (AESI), non-serious unexpected events of chest pain, pain in extremity, heart rate increased, dyspnoea, pain, non-serious expected event of fatigue. The events occurred the day after the first dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 15-year-old male patient with no relevant medical history, who experienced the serious unexpected event of Arrhythmia (AESI), non-serious unexpected events of chest pain, pain in extremity, heart rate increased, dyspnoea, pain, non-serious expected event of fatigue. The events occurred the day after the first dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1858928 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-09-17
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Circulatory collapse, Dizziness, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Circulatory collapse; Dizziness; Vomiting; Fever; This regulatory authority case was reported by a consumer and describes the occurrence of CIRCULATORY COLLAPSE (Circulatory collapse) in a 14-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3004215) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Aug-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced CIRCULATORY COLLAPSE (Circulatory collapse) (seriousness criterion medically significant), DIZZINESS (Dizziness), VOMITING (Vomiting) and PYREXIA (Fever). On 18-Sep-2021, CIRCULATORY COLLAPSE (Circulatory collapse), DIZZINESS (Dizziness), VOMITING (Vomiting) and PYREXIA (Fever) was resolving. Concomitant medication were not provided. Treatment medication were not reported. Company comment: This case concerns a 14-year-old, female patient with no relevant medical historyreported, who experienced the unexpected event of CIRCULATORY COLLAPSE. The event occurred the following day of the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable as no information about additional dosing was disclosed. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Reporter''s Comments: The case is non-serious and un labelled. Due to temporal relationship and the known safety profile of the vaccine, the causality is assessed as probable.; Sender''s Comments: This case concerns a 14-year-old, female patient with no relevant medical historyreported, who experienced the unexpected event of CIRCULATORY COLLAPSE. The event occurred the following day of the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable as no information about additional dosing was disclosed. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1868719 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-25
Onset:2021-10-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Thrombosis with thrombocytopenia syndrome
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (narrow)

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

Write-up: Thrombosis with thrombocytopenia; Respiratory discomfort; This case was received via Regulatory Authority (Reference number: 2021TJP116388) on 03-Nov-2021 and was forwarded to Moderna on 08-Nov-2021. This case, initially reported to the Regulatory Authority by a pharmacist, was received via the Regulatory Authority (Ref, v21130579). The patient was taking epinastine hydrochloride, l-carbocisteine, and montelukast sodium. On an unknown date, the patient received the 1st dose of this vaccine. On 25-Oct-2021, at 20:00, the patient received the 2nd dose of this vaccine. On 26-Oct-2021, in the morning, thrombosis with thrombocytopenia and respiratory discomfort developed. The patient was aware of difficulty breathing. On 27-Oct-2021, the patient was hospitalized. On 31-Oct-2021, the symptoms resolved, and the patient was discharged from the hospital. The outcome of thrombosis with thrombocytopenia and respiratory discomfort was reported as resolved. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 15-year-old female patient with relevant medical history of Bronchial asthma who experienced serious unexpected events of Thrombosis with thrombocytopenia syndrome and Dyspnoea. The events occurred one day after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable as the events occurred following the second dose. The events were considered related to the product per the reporter''s assessment. Causality for the event Dyspnoea is confounded with patient''s reported medical history of Bronchial asthma. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1872432 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-09-09
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005695 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Nodular rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)

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

Write-up: Nodular rash; This case was received via Regulatory Agency (Reference number: ES-AEMPS-1039810) on 08-Nov-2021 and was forwarded to Moderna on 08-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of NODULAR RASH (Nodular rash) in a 15-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3005790 and 3005695) for COVID-19 vaccination. No Medical History information was reported. On 19-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 16-Sep-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On 09-Sep-2021, the patient experienced NODULAR RASH (Nodular rash) (seriousness criterion medically significant). At the time of the report, NODULAR RASH (Nodular rash) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: This case concerns a 15 year old male patient with no relevant medical history, who experienced the unexpected event of nodular rash. The event nodular rash occurred approximately 3 weeks after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable as this is the first dose. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Translated document received on 08-Nov-2021, included No New Information.; Sender''s Comments: This case concerns a 15 year old male patient with no relevant medical history, who experienced the unexpected event of nodular rash. The event nodular rash occurred approximately 3 weeks after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable as this is the first dose. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1883873 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-10-10
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004493 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Heart rate increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant 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), 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: SHORTNESS OF BREATH; HEAVY CHEST PAIN; FAST PULSE UPON EXERTION; This case was received via regulatory authority (Reference number: SE-MPA-2021-091485) on 10-Nov-2021 and was forwarded to Moderna on 10-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of DYSPNOEA (SHORTNESS OF BREATH), CHEST PAIN (HEAVY CHEST PAIN) and HEART RATE INCREASED (FAST PULSE UPON EXERTION) in a 17-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3005835 and 3004493) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 10-Oct-2021, the patient experienced DYSPNOEA (SHORTNESS OF BREATH) (seriousness criterion hospitalization), CHEST PAIN (HEAVY CHEST PAIN) (seriousness criterion hospitalization) and HEART RATE INCREASED (FAST PULSE UPON EXERTION) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (SHORTNESS OF BREATH), CHEST PAIN (HEAVY CHEST PAIN) and HEART RATE INCREASED (FAST PULSE UPON EXERTION) was resolving. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant or treatment medications were reported. Company comment: This case concerns a 17-year-old female patient with no medical history, who experienced the serious unexpected events of Dyspnoea, Chest pain and heart rate increase. The events occurred 12 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report. However the second dose of mRNA-1273 vaccine was given more than 35 days after the first dose.(47days interval) Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Translation received on 12-Nov-21 includes event verbatim translated.; Sender''s Comments: This case concerns a 17-year-old female patient with no medical history, who experienced the serious unexpected events of Dyspnoea, Chest pain and heart rate increase. The events occurred 12 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report. However the second dose of mRNA-1273 vaccine was given more than 35 days after the first dose.(47days interval)


VAERS ID: 1891086 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004219 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Affect lability, Asthenia, Chest discomfort, Diarrhoea, Dizziness, Eye swelling, Fatigue, Headache, Influenza, Pain in extremity, Palpitations, Rash, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Pseudomembranous colitis (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

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

Write-up: A restrictive feeling; Swollen eyes; Psyche is a pure roller coaster ride; Dizziness; Diarrhoea; No strength to stand up or climb stairs; Severe aching limbs; Heart racing; Vomiting; Suddenly and severely changed skin complexion (pimple-like impurities); Fatigue is very present and leads to limitations.; Headache; 3 hours after the first vaccination, our daughter had severe flu symptoms; Dizziness; This regulatory authority case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (A restrictive feeling), EYE SWELLING (Swollen eyes), AFFECT LABILITY (Psyche is a pure roller coaster ride), the second episode of DIZZINESS (Dizziness), DIARRHOEA (Diarrhoea), ASTHENIA (No strength to stand up or climb stairs), PAIN IN EXTREMITY (Severe aching limbs), PALPITATIONS (Heart racing), VOMITING (Vomiting), RASH (Suddenly and severely changed skin complexion (pimple-like impurities)), FATIGUE (Fatigue is very present and leads to limitations.), HEADACHE (Headache), INFLUENZA (3 hours after the first vaccination, our daughter had severe flu symptoms) and the first episode of DIZZINESS (Dizziness) in a 15-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3004219) for COVID-19 vaccination. No Medical History information was reported. On 16-Sep-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced INFLUENZA (3 hours after the first vaccination, our daughter had severe flu symptoms) (seriousness criterion medically significant) and the first episode of DIZZINESS (Dizziness) (seriousness criterion medically significant). On 18-Oct-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced CHEST DISCOMFORT (A restrictive feeling) (seriousness criterion medically significant), EYE SWELLING (Swollen eyes) (seriousness criterion medically significant), AFFECT LABILITY (Psyche is a pure roller coaster ride) (seriousness criterion medically significant), the second episode of DIZZINESS (Dizziness) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea) (seriousness criterion medically significant), ASTHENIA (No strength to stand up or climb stairs) (seriousness criterion medically significant), PAIN IN EXTREMITY (Severe aching limbs) (seriousness criterion medically significant), PALPITATIONS (Heart racing) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant), RASH (Suddenly and severely changed skin complexion (pimple-like impurities)) (seriousness criterion medically significant), FATIGUE (Fatigue is very present and leads to limitations.) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 18-Sep-2021, INFLUENZA (3 hours after the first vaccination, our daughter had severe flu symptoms) had resolved. On 24-Oct-2021, CHEST DISCOMFORT (A restrictive feeling), EYE SWELLING (Swollen eyes), AFFECT LABILITY (Psyche is a pure roller coaster ride), the last episode of DIZZINESS (Dizziness), DIARRHOEA (Diarrhoea), ASTHENIA (No strength to stand up or climb stairs), PAIN IN EXTREMITY (Severe aching limbs), PALPITATIONS (Heart racing), VOMITING (Vomiting), RASH (Suddenly and severely changed skin complexion (pimple-like impurities)), FATIGUE (Fatigue is very present and leads to limitations.) and HEADACHE (Headache) had not resolved. Concomitant products were not provided. Treatment medication were not reported. Company''s comment: This case concerns a 15-year-old male patient with no relevant medical history reported who experienced the unexpected and serious events of influenza, first episode of dizziness, pain in extremity, second episode of dizziness, headache, diarrhoea, vomiting, asthenia, palpitations, chest discomfort, affect lability, fatigue, eye swelling and rash. The events influenza and first episode of dizziness occurred the same day after the first dose of mRNA-1273 vaccine was administered and the rest of the events occurred the same day after the second dose was given. The rechallenge was positive as the first episode of dizziness had resolved before the second dose and re-appear after the second dose was given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Translated document received on 13-Nov-2021, included event verbatim translated. Sender''s comments translated.; Reporter''s Comments: The case is serious and unlabelled. Due to temporal relationship and the known safety profile of the vaccine the causality is assessed as possible.; Sender''s Comments: This case concerns a 15-year-old male patient with no relevant medical history reported who experienced the unexpected and serious events of influenza, first episode of dizziness, pain in extremity, second episode of dizziness, headache, diarrhoea, vomiting, asthenia, palpitations, chest discomfort, affect lability, fatigue, eye swelling and rash. The events influenza and first episode of dizziness occurred the same day after the first dose of mRNA-1273 vaccine was administered and the rest of the events occurred the same day after the second dose was given. The rechallenge was positive as the first episode of dizziness had resolved before the second dose and re-appear after the second dose was given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1892312 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-20
Onset:2021-11-01
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005685 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chest pain, Dyspnoea, Electrocardiogram, Myocarditis, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.6 degree Celsius; Test Date: 20211102; Test Name: Electrocardiogram; Result Unstructured Data: Suspected myocarditis that was indicate.
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Chest pain; Mild breathlessness; Suspected myocarditis; Generalized aching; Pyrexia; This case was received via the regulatory authority (Reference number: 2021TJP120534) on 12-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This case, reported by a physician, was received by the RA via Moderna''s adverse reaction reporting site (TASK0022420). On 20-Sep-2021, at 14:00, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: 36.6 degrees Celsius. On 31-Oct-2021, at 14:00, the patient received the 2nd dose of this vaccine. On 01-Nov-2021, the patient experienced generalized aching and pyrexia. On 02-Nov-2021, at 08:00, the patient experienced chest pain during deep inspiration and mild breathlessness from early morning. Because chest pain at rest was noted, the patient saw a nearby physician. The patient was hospitalized for suspected myocarditis that was indicated by electrocardiogram. On 06-Nov-2021, the symptoms were resolving, and the patient was discharged from the hospital. The outcome of generalized aching, pyrexia, chest pain, mild breathlessness, and suspected myocarditis was reported as resolving. Follow-up investigation will be not possible due to lack of cooperation of the reporter. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported.; Sender''s Comments: This case concerns a 16 year-old male patient with no reported medical history who experienced the expected serious adverse event of special interest of myocarditis and the unexpected serious events of chest pain, pyrexia, and dyspnea. The event occurred approximately 2 to 3 days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1896579 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004959 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Chest discomfort, Chills, Cold sweat, Dizziness, Dyspnoea, Pain in extremity, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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; Dyspnoea; Dizziness; Chest pressure; Cold sweat; Asthenia; Pain in arm; Chills; Pyrexia; This case was received via Regulatory Agency (Reference number: FI-FIMEA-20216377) on 16-Nov-2021 and was forwarded to Moderna on 16-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting) in a 15-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004959) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Oct-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 16-Oct-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), DYSPNOEA (Dyspnoea), DIZZINESS (Dizziness), CHEST DISCOMFORT (Chest pressure), COLD SWEAT (Cold sweat), ASTHENIA (Asthenia), PAIN IN EXTREMITY (Pain in arm), CHILLS (Chills) and PYREXIA (Pyrexia). At the time of the report, SYNCOPE (Fainting), DYSPNOEA (Dyspnoea), DIZZINESS (Dizziness), CHEST DISCOMFORT (Chest pressure), COLD SWEAT (Cold sweat), ASTHENIA (Asthenia), PAIN IN EXTREMITY (Pain in arm), CHILLS (Chills) and PYREXIA (Pyrexia) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medications were provided. No treatment medications were provided. Company Comment: This case concerns a 15-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of syncope. The event occurred 1 day after the first dose of mRNA-1273. The rechallenge was unknown since no information regarding dose number two was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 15-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of syncope. The event occurred 1 day after the first dose of mRNA-1273. The rechallenge was unknown since no information regarding dose number two was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.


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