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From the 11/26/2021 release of VAERS data:

Found 107 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: 1771021 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Influenza, Oropharyngeal pain, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: sore throat; dizzy; flu; Rash; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26008838) on 30-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Rash), OROPHARYNGEAL PAIN (sore throat), DIZZINESS (dizzy) and INFLUENZA (flu) in a 14-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). Concurrent medical conditions included Asthma and Suspected COVID-19 since 27-Sep-2021. On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) (seriousness criterion medically significant), DIZZINESS (dizzy) (seriousness criterion medically significant) and INFLUENZA (flu) (seriousness criterion medically significant). On 29-Sep-2021, RASH (Rash) had not resolved. At the time of the report, OROPHARYNGEAL PAIN (sore throat), DIZZINESS (dizzy) and INFLUENZA (flu) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: not provided (Inconclusive) Inconclusive test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient waiting on PCR as sons has asthma and I has to multi-dose him as coughing non stop, rash spreading daily, sore throat, flu, dizzy etc was fit n well before 1st vaccine n a complete state. Company comment: This case concerns a 14 year-old male patient with history of asthma, suspected COVID-19, and immunodeficiency, who experienced the unexpected serious events of Oropharyngeal pain, Dizziness, Influenza, and Rash. The events occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The history of asthma, suspected COVID-19 and immunodeficiency may have contributed to the events. Seriousness criteria of Medically significant maintained for events for consistency with RA report, however the source document does not include information that supports seriousness criteria.; Sender''s Comments: This case concerns a 14 year-old male patient with history of asthma, suspected COVID-19, and immunodeficiency, who experienced the unexpected serious events of Oropharyngeal pain, Dizziness, Influenza, and Rash. The events occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The history of asthma, suspected COVID-19 and immunodeficiency may have contributed to the events. Seriousness criteria of Medically significant maintained for events for consistency with RA report, however the source document does not include information that supports seriousness criteria.


VAERS ID: 1772492 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005695 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angioedema
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: ESMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: ES-AEMPS-1009414) on 30-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of ANGIOEDEMA in a 14-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005695) for SARS-CoV-2 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced ANGIOEDEMA (seriousness criterion medically significant). On 16-Aug-2021, ANGIOEDEMA had resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications provided. No treatment medications provided. Patient experienced lips and hands angioedema. Company Comment: This case concerns a 14 year old female patient with no relevant medical history, who experienced the unexpected event of angioedema. The event occurred on the same day 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. Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Translation received on 04 Oct 2021, expiry date of vaccine added and translated verbatim added in narrative.; Sender''s Comments: This case concerns a 14 year old female patient with no relevant medical history, who experienced the unexpected event of angioedema. The event occurred on the same day 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: 1773213 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-22
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / 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? 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: Anaphylactic reaction; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP100278) on 30-Sep-2021 and was forwarded to Moderna on 06-Oct-2021. This case, reported by a health care worker, was received by regulatory authority via Moderna''s adverse reaction reporting site (TASK0021967), and this case, initially reported to the regulatory authority by a physician, was received via the regulatory authority (Ref,v21128310). The patient had an allergic history of house dust. The patient underwent surgery for endocardial defect at the age of 4 years. On an unknown date, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: 35.6 degrees Celsius. On 22-Sep-2021, at 16:44, the patient received the 2nd dose of this vaccine. Immediately after the vaccination, pruritus in the pharynx developed. At 16:59, anaphylaxis developed. The onset was sudden and the symptoms were rapidly progressive. Within several minutes, right chest pain, mild queasy, and abdominal pain developed. Vital signs showed only mild hypertension (BP: 169/81 and P: 62). BP was usually the 120s. The primary care clinic got contacted and ordered an emergency transportation. The patient waited in a first-aid room until transportation. The patient was awake and alert, and there were no agony-like symptoms. At 17:40, the patient was able to transfer alone. The outcome of anaphylaxis was unknown. 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: Not reported. 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 no previous relevant medical history , who experienced the expected event of Anaphylactic reaction. The event occurred on the same day after the second dose of Spikevax. The rechallenge was not applicable since the event occurred after the second dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1783264 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-19
Onset:2021-09-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214008 / UNK - / 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: This case was received via a regulatory authority (Reference number: DE-PEI-202100199425) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION in a 16-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214008) for COVID-19 vaccination. No Medical History information was reported. On 19-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced ANAPHYLACTIC REACTION (seriousness criteria hospitalization and medically significant). On 19-Sep-2021, ANAPHYLACTIC REACTION had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant medication was not provided. Treatment medication was not provided. Patient had experienced questionable anaphylactic reaction which started at 8.15 am and lasted until 8.54 am. Patient had also experienced hemodynamic instability and vomiting and no medication was taken for that. Company Comment: This case concerns a 16-year-old, male patient with no previous relevant medical history, who experienced the expected event of Anaphylactic reaction. The event occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Translation received on 07-OCT-2021: No new information was upadated; Sender''s Comments: This case concerns a 16-year-old, male patient with no previous relevant medical history, who experienced the expected event of Anaphylactic reaction. The event occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1783376 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-09-14
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004954 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, C-reactive protein, Chest discomfort, Chest pain, Echocardiogram, Ejection fraction, Electrocardiogram, Malaise, Myocarditis, Troponin T, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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 Date: 202109; Test Name: C-reactive protein; Result Unstructured Data: 68 (increased) mg/mL; Test Date: 202109; Test Name: Echocardiography; Result Unstructured Data: OBS slightly decreased left ventricle function; Test Date: 202109; Test Name: Ejection fraction; Result Unstructured Data: 45 (%percent); Test Date: 202109; Test Name: EKG; Result Unstructured Data: Monstrous ST-elevations; Test Date: 202109; Test Name: Troponin T; Result Unstructured Data: 2289.3 (increased) ng/L
CDC Split Type: DKMODERNATX, INC.MOD20213

Write-up: Chest pressure; Chest pain; General malaise; Vomiting; Weakness; Perimyocarditis; This case was received via a regulatory authority (Reference number: DK-DKMA-ADR 25984621) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of CHEST DISCOMFORT (Chest pressure), CHEST PAIN (Chest pain), MALAISE (General malaise), VOMITING (Vomiting), ASTHENIA (Weakness) and MYOCARDITIS (Perimyocarditis) in a 15-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3004954 and 3004954) for COVID-19 immunisation. No Medical History information was reported. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced CHEST DISCOMFORT (Chest pressure) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization), MALAISE (General malaise) (seriousness criterion hospitalization), VOMITING (Vomiting) (seriousness criterion hospitalization), ASTHENIA (Weakness) (seriousness criterion hospitalization) and MYOCARDITIS (Perimyocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, CHEST DISCOMFORT (Chest pressure), CHEST PAIN (Chest pain), MALAISE (General malaise), VOMITING (Vomiting), ASTHENIA (Weakness) and MYOCARDITIS (Perimyocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, C-reactive protein: high (High) 68 (increased) mg/mL. In September 2021, Echocardiogram: abnormal (abnormal) OBS slightly decreased left ventricle function. In September 2021, Ejection fraction: 45 (abnormal) 45 (%percent). In September 2021, Electrocardiogram: abnormal (abnormal) Monstrous ST-elevations. In September 2021, Troponin T: 2289.3 (High) 2289.3 (increased) ng/L. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not reported. Treatment history was not reported. Company Comment: This case concerns a 15 year old male with no reported medical history , who experienced expected event of myocarditis and other unexpected events of chest pain, chest pressure, weakness , asthenia and malaise . These events occurred 2 days after vaccination with the 2nd dose of mRNA-1273 (Spikevax) and 1 month and 2 days post vaccination with the 1st dose. The rechallenge for this case is not applicable. The benefit risk relationship of mRNA-1273 ( Spikevax) is not affected by this report.; Sender''s Comments: This case concerns a 15 year old male with no reported medical history , who experienced expected event of myocarditis and other unexpected events of chest pain, chest pressure, weakness , asthenia and malaise . These events occurred 2 days after vaccination with the 2nd dose of mRNA-1273 (Spikevax) and 1 month and 2 days post vaccination with the 1st dose. The rechallenge for this case is not applicable. The benefit risk relationship of mRNA-1273 ( Spikevax) is not affected by this report.


VAERS ID: 1784535 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-10-03
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005235 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic shock, Blood pressure decreased, Depressed level of consciousness, Dyspnoea, Eyelid oedema, Malaise, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Periorbital and eyelid disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), 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? 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: Depressed level of consciousness; Anaphylactic shock; Eyelid oedema; Malaise; Urticaria; Dyspnoea; Blood pressure decreased; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP103648) on 06-Oct-2021 and was forwarded to Moderna on 11-Oct-2021. This case, initially reported to the regulatory authority by a physician, was received via the regulatory authority (Ref, v21128732). On 04-Sep-2021, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before vaccination: 36.1 degrees Celsius. On 02-Oct-2021, at 16:00, the patient received the 2nd dose of this vaccine. At 22:00, the patient felt an irritated sensation in the extremities that wheal could occur. The patient went to bed with doing nothing. On 03-Oct-2021, at 07:00, on awakening, the patient experienced eyelid oedema and intense malaise. Around 12:00, rash developed on the extremities, face, and abdomen with itchy. At 13:00, the patient was transferred to a medical institution because dyspnoea also developed. On arrival, decreased level of consciousness was noted, blood pressure could not be measured, and the radial artery was not palpable. The patient was diagnosed with anaphylactic shock, and adrenaline was injected intramuscularly. The skin eruption remained afterwards, but blood pressure and consciousness level recovered. The patient was transported to the reporting hospital. There was no digestive symptom. After admission to the hospital, the patient was treated with antihistamines and steroids, and the symptoms were resolving. On 05-Oct-2021, recovery of symptoms was confirmed. The patient was discharged from the hospital. The outcome of eyelid oedema, malaise, urticaria, dyspnoea, depressed level of consciousness, blood pressure decreased, and anaphylactic shock 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 timing of onset was late, but the symptoms were severe, so this case was reported.; Sender''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. This case involves a 14year-old female subject with no known medical history or concurrent medical conditions who one day after her second vaccination developed the serious unlisted adverse events of depressed level of consciousness, eye lid oedema, malaise, urticaria, blood pressure decreased, dyspnoea and anaphylactic shock. 2 days after treatment in the hospital with antihistamines and steroids, all symptoms resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1786707 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-21
Onset:2021-09-25
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Myocarditis
SMQs:, Anaphylactic reaction (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: Medical History/Concurrent Conditions: Protein C increased; Troponin I increased
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: Sep 21, 2nd dose of the Moderna Covid-19 vaccine; Sep 25, chest tightness and pain, troponin I elevation up to 4561 ng/L and CRP, waiting to perform cardiac MRI, suspected myocarditis; 21/9 2a dose Covid19 Moderna, 25/9, a 4561 ng/L e PCR, chest tightness; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Sep 21, 2nd dose of the Moderna Covid-19 vaccine; Sep 25, chest tightness and pain, troponin I elevation up to 4561 ng/L and CRP, waiting to perform cardiac MRI, suspected myocarditis) and CHEST PAIN (21/9 2a dose Covid19 Moderna, 25/9 a 4561 ng/L e PCR, in a 15-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Troponin I increased on 25-Sep-2021 and Protein C increased on 25-Sep-2021. On 21-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Sep-2021, the patient experienced MYOCARDITIS (Sep 21, 2nd dose of the Moderna Covid-19 vaccine; Sep 25, chest tightness and pain, troponin I elevation up to 4561 ng/L and CRP, waiting to perform cardiac MRI, suspected myocarditis) (seriousness criteria hospitalization and medically significant), CHEST PAIN (21/9 2a dose Covid19 Moderna, 25/9 a 4561 ng/L e PCR, (seriousness criterion hospitalization) and CHEST DISCOMFORT (chest tightness). At the time of the report, MYOCARDITIS (Sep 21, 2nd dose of the Moderna Covid-19 vaccine; Sep 25, chest tightness and pain, troponin I elevation up to 4561 ng/L and CRP, waiting to perform cardiac MRI, suspected myocarditis), CHEST PAIN (21/9 2a dose Covid19 Moderna, 25/9 a 4561 ng/L e PCR, and CHEST DISCOMFORT (chest tightness) was resolving. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. On 25-SEP-2021 the patient had an Echocardiogram and Troponin I done, Troponin was elevated to 4561 ng/L and CRP was done. Patient was waiting to perform Cardiac MRI which resulted in myocarditis. Patient was suspected to myocarditis with a peak TNL 4500 ng/ml and chest pain in remission and TNL declining and after few days of second vaccination patient had preserved cardiac function and was awaiting for Cardiac MRI. Concomitant medications and treatment information was not provided. Patient had took the second dose on 21-SEP-2021 and on 25-SEP-2021 experienced chest tightness and pain. Lab data: On unknown date Echocardiogram was done with unknown results. On 25 Sep 2021: MRI, Troponin I, Blood test was done with unknown results. Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Translation received on 12-OCT-2021 contains: Event Verbatim Updated and Reporter''s comment updated in narrative. On 12-Oct-2021: Significant follow up received lab data and events were added.; Sender''s Comments: This case concerns a 15-year-old male patient with no relevant medical history, who experienced the unexpected serious AESI event of Myocarditis with unexpected serious event of Chest pain. The events occurred approximately 5 days after the second dose of Spikevax administration. The rechallenge was not applicable since no events were reported after the first dose and no additional dosing was expected. The benefit-risk relationship is not affected by this report. The event Myocarditis was assessed as UNEXPECTED per current guidance, since it occurred in a 15-year-old patient.


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.


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