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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: 1736239 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (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: ITMODERNATX, INC.MOD20213

Write-up: Cardiac arrest; This case was received via regulatory authority (Reference number: IT-MINISAL02-784178) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CARDIAC ARREST (Cardiac arrest) in a 14-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On an unknown date, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criteria hospitalization and medically significant). At the time of the report, CARDIAC ARREST (Cardiac arrest) outcome was unknown. 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 14-year-old, male patient with no relevant medical history, who experienced the unexpected event of Cardiac arrest. Very limited information was provided regarding the event. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translated document received on 21-Sep-2021 and contains no new information.; Sender''s Comments: This case concerns a 14-year-old, male patient with no relevant medical history, who experienced the unexpected event of Cardiac arrest. Very limited information was provided regarding the event. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.


VAERS ID: 1739297 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214024 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Palpitations
SMQs:, Anaphylactic reaction (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)

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 bronchial
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-782312) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of CHEST PAIN, PALPITATIONS and DYSPNOEA in a 16-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214024) for COVID-19 vaccination. The patient''s past medical history included Anxiety. Concurrent medical conditions included Asthma bronchial. On 27-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 31-Aug-2021, the patient experienced CHEST PAIN (seriousness criterion medically significant), PALPITATIONS (seriousness criterion medically significant) and DYSPNOEA (seriousness criterion medically significant). At the time of the report, CHEST PAIN, PALPITATIONS and DYSPNOEA was resolving. 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 medication details was provided. No treatment medication details was provided. Patient had shortness of breath. Company comment: This regulatory authority case concerns a 16-year-old female patient with relevant medical history of anxiety and concurrent medical condition of asthma bronchial, who experienced serious unexpected events of chest pain, palpitations and dyspnea. The events occurred approximately 4 days after the first dose of Spikevax. Rechallenge was not applicable since action taken was uknown and there is llack of information regarding the second dose. Patient''s medical history of anxiety and concurrent condition of bronchial asthma are possible confounders. The benefit-risk relationship of drug is not affected by this report. The RA assessed the events as serious with seriousness criterion of medically significant. Per medical judgement, based on the information provided and patient''s age, the events should be considered as medically significant. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation Received on 23-Sep-2021 contains translated verbatim.; Sender''s Comments: This regulatory authority case concerns a 16-year-old female patient with relevant medical history of anxiety and concurrent medical condition of asthma bronchial, who experienced serious unexpected events of chest pain, palpitations and dyspnea. The events occurred approximately 4 days after the first dose of Spikevax. Rechallenge was not applicable since action taken was uknown and there is llack of information regarding the second dose. Patient''s medical history of anxiety and concurrent condition of bronchial asthma are possible confounders. The benefit-risk relationship of drug is not affected by this report. The RA assessed the events as serious with seriousness criterion of medically significant. Per medical judgement, based on the information provided and patient''s age, the events should be considered as medically significant.


VAERS ID: 1747026 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 049283017 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental overdose, Erythema, Maternal exposure during pregnancy
SMQs:, Anaphylactic reaction (broad), Drug abuse and dependence (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypersensitivity (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Maternal exposure during pregnancy; accidental overdose; This case was received via regulatory authority (Reference number: IT-MINISAL02-785232) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ERYTHEMA in a 12-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 049283017) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 milliliter. Last menstrual period and estimated date of delivery were not provided. On 26-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and ACCIDENTAL OVERDOSE (accidental overdose). On 09-Sep-2021, the patient experienced ERYTHEMA (seriousness criterion disability). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 26-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and ACCIDENTAL OVERDOSE (accidental overdose) had resolved. At the time of the report, ERYTHEMA had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant and treatment medications were not provided. This case concerns a 12-year-old, female subject with no relevant history reported, who experienced the unexpected events of vaccine exposure during pregnancy and ERYTHEMA. The patient received the first dose of vaccine at 28 weeks of gestation and erythema occurred fourteen days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation received on 24-sep-21 and contains no new information.; Sender''s Comments: This case concerns a 12-year-old, female subject with no relevant history reported, who experienced the unexpected events of vaccine exposure during pregnancy and ERYTHEMA. The patient received the first dose of vaccine at 28 weeks of gestation and erythema occurred fourteen days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1747201 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005691 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Feeling cold, Nausea, Oropharyngeal discomfort, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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? 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: Fruit allergy (Allergy (raw fruit))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Pharynx strange sensation; Dizziness; Nausea; Chills; Skin rash on the neck and abdomen; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP095077) on 15-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, initially reported to the regulatory authority by a physician, was received via the regulatory authority (Ref, v21126785). On an unknown date, body temperature before vaccination: 37.0 degrees Celsius. On 12-Sep-2021, at 17:23, the patient received the 1st dose of this vaccine. At 17:33, pharynx strange sensation, dizziness, nausea, chills, and skin rash on the neck and abdomen developed. There were no abnormalities in vital signs. Oral antiallergic medication and adrenaline were administered, and the patient was transported to the reporting hospital. Pharyngeal discomfort, dizziness, and nausea remained slightly on arrival, but these symptoms tended to improve. The patient was admitted to the hospital for follow-up. On 13-Sep-2021, recovery of the symptoms was confirmed, and the patient was discharged from the hospital. The outcome of pharynx strange sensation, dizziness, nausea, chills, and skin rash on the neck and abdomen was reported as recovered. 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 patient''s conditions at the peak of the symptoms and at the time of the onset are unknown, but the symptoms were mild on arrival at the hospital. Hospitalization was aimed just for follow-up. Allergen contamination or somatoform disorders are considered to be other factors.; Sender''s Comments: This case concerns a 15-year-old female patient with a history of food allergy, who experienced the unexpected, serious (hospitalization) events of oropharyngeal discomfort, dizziness, nausea, feeling cold and rash. Events nausea and rash are considered unexpected due to seriousness assessment by reporter. The event occurred approximately 10 minutes after the first dose of mRNA-1273. The rechallenge was not applicable according to source document. The medical history of food allergy is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1751370 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 049283017/21402 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Injection site erythema, Injection site oedema, Pruritus, Throat tightness, Venous pressure jugular, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIRAHIST [CHLORPHENAMINE MALEATE;TRIAMCINOLONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-786073) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of DYSPNOEA, WHEEZING, VENOUS PRESSURE JUGULAR, PRURITUS, INJECTION SITE OEDEMA, THROAT TIGHTNESS and INJECTION SITE ERYTHEMA in a 17-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 049283017/214024) for COVID-19 immunisation. The patient''s past medical history included Allergic asthma. Concomitant products included CHLORPHENAMINE MALEATE, TRIAMCINOLONE for an unknown indication. On 13-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 milliliter. On 13-Sep-2021, the patient experienced DYSPNOEA (seriousness criterion medically significant), WHEEZING (seriousness criterion medically significant), VENOUS PRESSURE JUGULAR (seriousness criterion medically significant), PRURITUS (seriousness criterion medically significant), INJECTION SITE OEDEMA (seriousness criterion medically significant), THROAT TIGHTNESS (seriousness criterion medically significant) and INJECTION SITE ERYTHEMA (seriousness criterion medically significant). On 13-Sep-2021, DYSPNOEA, WHEEZING, VENOUS PRESSURE JUGULAR, PRURITUS, INJECTION SITE OEDEMA, THROAT TIGHTNESS and INJECTION SITE ERYTHEMA had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication was not provided Patient underwent complete blood count test on 13-SEP-2021 and the results were not provided. Company Comment: This case concers a 17-year old female patient, with medical history of allergic asthma who experienced the unexpected events of dyspnoea, wheezing, throat tightness and pruritus. Additionally, venous pressure jugular was also reported. The events occurred the same day after dose of mRNA-1273. The rechallange is unknown, since it is not clear in the SD if the dose received is the first or second one (awaiting for translation). Patient?s history of allergic asthma remain a confounder. The benefit-risk relationship of Spikevax in not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Significant Follow-Up Appended : Events (Throat constriction, Injection site erythema, Injection site oedema) & Concomitant were added.; Sender''s Comments: This case concers a 17-year old female patient, with medical history of allergic asthma who experienced the unexpected events of dyspnoea, wheezing, throat tightness and pruritus. Additionally, venous pressure jugular was also reported. The events occurred the same day after dose of mRNA-1273. The rechallange is unknown, since it is not clear in the SD if the dose received is the first or second one (awaiting for translation). Patient?s history of allergic asthma remain a confounder. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1752939 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-09-06
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Body temperature, Chest discomfort, Chest pain, Chills, Headache, Hypothermia, Nausea, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, Sinusitis
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Body temperature; Result Unstructured Data: 39.8; Test Date: 20210920; Test Name: Body temperature; Result Unstructured Data: 35 and 37; Test Date: 20210909; Test Name: SARS COV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Hypothermia; Chest distress; Nausea; Sinusitis; Throat pain; Chest pain; Back pain; Pyrexia; Chills; Headache; This case was received via regulatory authority (Reference number: 2021TJP095040) on 21-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This case was reported by the family member of a vaccine recipient via the Drug Information Center. Hypothermia was assessed as serious by the MAH. On Aug-2021, the patient received the 1st dose of the vaccine. On 06-Sep-2021, around 13:00, the patient received 2nd dose of the vaccine. In the middle of the night, the patient experienced pyrexia of 39.8 degrees Celsius and took antipyretic. The patient experienced chills, headache, chest pain, and back pain. On an unknown date, the patient experienced throat pain. On 09-Sep-2021, the patient visited an internal medicine department and an ophthalmology department. The patient was diagnosed with sinusitis. Due to throat pain, a test for coronavirus infection was performed, and the result was negative. On 20-Sep-2021, the patient experienced nausea, chest pain, hypothermia (35-degree level in Celsius), chills, low-grade fever (37 degrees in Celsius), and chest distress. The outcome of pyrexia, chills, headache, chest pain, back pain, sinusitis, throat pain, nausea, hypothermia, and chest distress was not resolved. Follow-up investigation is impossible due to lack of cooperation from the reporter. Company Comment: 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 13-year-old male patient with no medical history reported, who experienced the serious (medically significant) unexpected event of Hypothermia and other non-serious events. The events occurred approximately 14 days after the second dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered unknown because it was not reported whether the same/similar events had occurred after the first dose. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1757800 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-28
Onset:2021-08-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005294 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Dysentery, Dyspnoea, Headache, Lymphadenopathy, Pain in extremity, Peripheral swelling, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-787453) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of LYMPHADENOPATHY, DYSPNOEA, HEADACHE, PERIPHERAL SWELLING, ARTHRALGIA, PYREXIA, PAIN IN EXTREMITY and DYSENTERY in a 15-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 immunization. The patient''s past medical history included COVID-19 in March 2021. On 28-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On 28-Aug-2021, the patient experienced LYMPHADENOPATHY (seriousness criterion medically significant), DYSPNOEA (seriousness criterion medically significant), HEADACHE (seriousness criterion medically significant), PERIPHERAL SWELLING (seriousness criterion medically significant), ARTHRALGIA (seriousness criterion medically significant), PYREXIA (seriousness criterion medically significant), PAIN IN EXTREMITY (seriousness criterion medically significant) and DYSENTERY (seriousness criterion medically significant). On 04-Sep-2021, LYMPHADENOPATHY, DYSPNOEA, HEADACHE, PERIPHERAL SWELLING, ARTHRALGIA, PYREXIA, PAIN IN EXTREMITY and DYSENTERY had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication information was reported. No treatment medications were provided. It was reported that after the vaccination, the patient had a fever of 38?, arm pain and swelling, swollen lymph nodes, dysentery, headache, joint pain, difficulty breathing (lasting 4 hours, starting 12 hours after the vaccination Company Comment: This case concerns a 15-year-old, female patient with relevant medical history of COVID 19, who experienced the unexpected events of lymphadenopathy, dyspnoea, headache, peripheral swelling, arthralgia, pyrexia, pain in extremity and dysentery. The events occurred on the same day after the first dose of Moderna COVID-19 Vaccine. The rechallenge was unknown since events occurred after first dose and no information about the second dose was disclosed.The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a serious medical condition. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received on 29-Sep-21, Medical history start date was added and narrative was updated accodingly; Sender''s Comments: This case concerns a 15-year-old, female patient with relevant medical history of COVID 19, who experienced the unexpected events of lymphadenopathy, dyspnoea, headache, peripheral swelling, arthralgia, pyrexia, pain in extremity and dysentery. The events occurred on the same day after the first dose of Moderna COVID-19 Vaccine. The rechallenge was unknown since events occurred after first dose and no information about the second dose was disclosed.The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a serious medical condition.


VAERS ID: 1765831 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214016 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Conjunctival hyperaemia, Dyspnoea, Erythema
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Conjunctival disorders (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Conjunctival hyperaemia; Acute dyspnea; This case was received via regulatory authority (Reference number: ES-AEMPS-1004222) on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CONJUNCTIVAL HYPERAEMIA (Conjunctival hyperaemia), DYSPNOEA (Acute dyspnea) and ERYTHEMA in a 16-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214016) for COVID-19 vaccination. Co-suspect product included non-company product ASCORBIC ACID, MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM ASCORBATE, SODIUM CHLORIDE, SODIUM SULFATE (PLEINVUE) powder for oral solution for Constipation. No Medical History information was reported. On 05-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ASCORBIC ACID, MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM ASCORBATE, SODIUM CHLORIDE, SODIUM SULFATE (PLEINVUE) (unknown route) at an unspecified dose. On 06-Aug-2021, the patient experienced CONJUNCTIVAL HYPERAEMIA (Conjunctival hyperaemia) (seriousness criterion medically significant), DYSPNOEA (Acute dyspnea) (seriousness criterion medically significant) and ERYTHEMA (seriousness criterion medically significant). On 06-Aug-2021, CONJUNCTIVAL HYPERAEMIA (Conjunctival hyperaemia), DYSPNOEA (Acute dyspnea) and ERYTHEMA had resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 05-Aug-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided. Company Comment: This case concerns a 16 year old female with no reported history who experienced the serious, unlisted events of Dysponea, Conjunctival hyperemia and Erythema one day after the first dose of Spikevax. Re-challenge is not applicable as this is the first dose. Benefit-risk relationship of Spikevax is not affected by this report. Events assessed as serious by the RA; however, there is no information in the source documents to support that the events were medically significant and serious. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Translation received on 30 Sep 2021 in which event verbatim, drug information were translated.; Sender''s Comments: This case concerns a 16 year old female with no reported history who experienced the serious, unlisted events of Dysponea, Conjunctival hyperemia and Erythema one day after the first dose of Spikevax. Re-challenge is not applicable as this is the first dose. Benefit-risk relationship of Spikevax is not affected by this report. Events assessed as serious by the RA; however, there is no information in the source documents to support that the events were medically significant and serious.


VAERS ID: 1769904 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-24
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004669 / UNK RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Cerebral haemorrhage, Coma, Vaccination site erythema, Vaccination site oedema
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (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: VIGABATRIN; POTASSIUM CITRATE; BECLOMETASONE DIPROPIONATE; LANSOPRAZOLE; LEVETIRACETAM; CLOBAZAM; CLONAZEPAM; OXYGEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Encephalitis herpes (Herpetic encephalitis since birth)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-789892) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE, VACCINATION SITE OEDEMA, COMA and CARDIAC ARREST in a 17-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004669) for SARS-CoV-2 immunisation. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Encephalitis herpes (Herpetic encephalitis since birth). Previously administered products included for Product used for unknown indication: LEVETIRACETAM, BECLOMETHASONE DIPROPIONATE and CLOBAZAM. Past adverse reactions to the above products included No adverse event with BECLOMETHASONE DIPROPIONATE, CLOBAZAM and LEVETIRACETAM. Concomitant products included VIGABATRIN, POTASSIUM CITRATE, BECLOMETASONE DIPROPIONATE, LANSOPRAZOLE, LEVETIRACETAM, CLOBAZAM, IPRATROPIUM BROMIDE, SALBUTAMOL, CLONAZEPAM and OXYGEN for an unknown indication. On 03-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 24-Aug-2021, the patient experienced CEREBRAL HAEMORRHAGE (seriousness criteria medically significant and life threatening), VACCINATION SITE OEDEMA (seriousness criterion life threatening), COMA (seriousness criteria medically significant and life threatening), CARDIAC ARREST (seriousness criteria medically significant and life threatening) and VACCINATION SITE ERYTHEMA (Redness in right arm). At the time of the report, CEREBRAL HAEMORRHAGE, VACCINATION SITE OEDEMA, COMA, CARDIAC ARREST and VACCINATION SITE ERYTHEMA (Redness in right arm) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. The patient experienced swelling and redness in the right arm, cardiac arrest, brain hemorrhage, and coma. The patient was currently hospitalized. No treatment medication was provided. Company Comment:This case concerns a 17 year old male patient with medical history of encephalitis herpetic, who experienced serious unexpected events of cerebral haemorrhage, cardiac arrest and coma after dose of mRNA-1273. The events occurred 22 days after dose of mRNA-1273.The re-challenge is unknown. Patient?s history of herpetic encephalitis and polypharmacy remain confounders. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Translation received on 01-Oct-2021 contains translated event verbatim and sender''s comment.; Sender''s Comments: This case concerns a 17 year old male patient with medical history of encephalitis herpetic, who experienced serious unexpected events of cerebral haemorrhage, cardiac arrest and coma after dose of mRNA-1273. The events occurred 22 days after dose of mRNA-1273.The re-challenge is unknown. Patient?s history of herpetic encephalitis and polypharmacy remain confounders. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1770990 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-13
   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? 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: This case was received via regulatory authority (Reference number: ES-AEMPS-1009440) 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 13-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced ANGIOEDEMA (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA had not resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient had Lip and hand angioedema. It was reported that rechallenge was done and reaction reoccurred. Treatment medication was not provided by the reporter. Company Comment: This case concerns a 14-year-old female patient with no relevant medical history, who experienced the serious unexpected event of Angioedema. The event occurred 1 day after the unspecified dose of Spikevax. The re-challenge was reported as positive; however no additional information regarding the doses. The benefit-risk relationship of Spikevax is not affected by this report. This case was linked to ES-AEMPS-1009414 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Translation Received on 02-Oct-2021: Event details added to the narrative.; Sender''s Comments: This case concerns a 14-year-old female patient with no relevant medical history, who experienced the serious unexpected event of Angioedema. The event occurred 1 day after the unspecified dose of Spikevax. The re-challenge was reported as positive; however no additional information regarding the doses. The benefit-risk relationship of Spikevax is not affected by this report. ES-AEMPS-1009414:


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