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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'

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1703853 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004952 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Dyspnoea, Erythema, Malaise, Sensation of foreign body, Vision blurred, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20213

Write-up: Wheezing; Localised erythema; Vision blurred; Asthenia; Lump feeling in throat; Dyspnoea; Malaise; This case was received via (Reference number: FI-FIMEA-20214214) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of WHEEZING (Wheezing), ERYTHEMA (Localised erythema), VISION BLURRED (Vision blurred), ASTHENIA (Asthenia), SENSATION OF FOREIGN BODY (Lump feeling in throat), DYSPNOEA (Dyspnoea) and MALAISE (Malaise) in a 15-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004952) for COVID-19 vaccination. No Medical History information was reported. On 17-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced WHEEZING (Wheezing) (seriousness criterion life threatening), ERYTHEMA (Localised erythema) (seriousness criterion life threatening), VISION BLURRED (Vision blurred) (seriousness criterion life threatening), ASTHENIA (Asthenia) (seriousness criterion life threatening), SENSATION OF FOREIGN BODY (Lump feeling in throat) (seriousness criterion life threatening), DYSPNOEA (Dyspnoea) (seriousness criterion life threatening) and MALAISE (Malaise) (seriousness criterion life threatening). At the time of the report, WHEEZING (Wheezing), ERYTHEMA (Localised erythema), VISION BLURRED (Vision blurred), ASTHENIA (Asthenia), SENSATION OF FOREIGN BODY (Lump feeling in throat), DYSPNOEA (Dyspnoea) and MALAISE (Malaise) 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. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The seriousness criteria are maintained for consistency with the RA report.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The seriousness criteria are maintained for consistency with the RA report.


VAERS ID: 1703854 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Hypoaesthesia, Nausea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

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

Write-up: Nausea; Dizziness; Breathing difficult; Numbness of extremities; Pyrexia; This case was received via (Reference number: FI-FIMEA-20214222) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), DIZZINESS (Dizziness), DYSPNOEA (Breathing difficult), HYPOAESTHESIA (Numbness of extremities) and PYREXIA (Pyrexia) in a 14-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion life threatening), DIZZINESS (Dizziness) (seriousness criterion life threatening), DYSPNOEA (Breathing difficult) (seriousness criterion life threatening), HYPOAESTHESIA (Numbness of extremities) (seriousness criterion life threatening) and PYREXIA (Pyrexia) (seriousness criterion life threatening). At the time of the report, NAUSEA (Nausea), DIZZINESS (Dizziness), DYSPNOEA (Breathing difficult), HYPOAESTHESIA (Numbness of extremities) and PYREXIA (Pyrexia) was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1709547 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anosmia, Cough, Headache, Impaired work ability, Nasal congestion, Nasopharyngitis, Neck pain, Oropharyngeal pain, Pyrexia, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Arthritis (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? 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: Neck pain; Pyrexia; Headache; Vaccination site pain; Cough; Common cold; Nasal stuffiness; Anosmia; Impaired work ability; Throat pain; This case was received via Medicines Agency (Reference number: FI-FIMEA-20214380) on 11-Sep-2021 and was forwarded to Moderna on 11-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), PYREXIA (Pyrexia), HEADACHE (Headache), VACCINATION SITE PAIN (Vaccination site pain), COUGH (Cough), NASOPHARYNGITIS (Common cold), NASAL CONGESTION (Nasal stuffiness), ANOSMIA (Anosmia), IMPAIRED WORK ABILITY (Impaired work ability) and OROPHARYNGEAL PAIN (Throat pain) in a 15-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 19-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced NECK PAIN (Neck pain) (seriousness criterion disability), PYREXIA (Pyrexia) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability), VACCINATION SITE PAIN (Vaccination site pain) (seriousness criterion disability), COUGH (Cough) (seriousness criterion disability), NASOPHARYNGITIS (Common cold) (seriousness criterion disability), NASAL CONGESTION (Nasal stuffiness) (seriousness criterion disability), ANOSMIA (Anosmia) (seriousness criterion disability), IMPAIRED WORK ABILITY (Impaired work ability) (seriousness criterion disability) and OROPHARYNGEAL PAIN (Throat pain) (seriousness criterion disability). At the time of the report, NECK PAIN (Neck pain), PYREXIA (Pyrexia), HEADACHE (Headache), VACCINATION SITE PAIN (Vaccination site pain), COUGH (Cough), NASOPHARYNGITIS (Common cold), NASAL CONGESTION (Nasal stuffiness), ANOSMIA (Anosmia), IMPAIRED WORK ABILITY (Impaired work ability) and OROPHARYNGEAL PAIN (Throat pain) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment product information was not provided. Company Comment: This case concerns a 15 year-old, female subject with no reported medical history, who experienced the unexpected events of neck pain, pyrexia, headache, vaccination site pain, cough, nasopharyngitis, nasal congestion, anosmia, impaired work ability, oropharyngeal pain. The events occurred approximately 2 days after the first dose of Spikevax. The rechallenge was not applicable as the events occurred after the first dose. The events pyrexia, headache and vaccination site pain are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 15 year-old, female subject with no reported medical history, who experienced the unexpected events of neck pain, pyrexia, headache, vaccination site pain, cough, nasopharyngitis, nasal congestion, anosmia, impaired work ability, oropharyngeal pain. The events occurred approximately 2 days after the first dose of Spikevax. The rechallenge was not applicable as the events occurred after the first dose. The events pyrexia, headache and vaccination site pain are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1719213 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-06
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027D21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Antineutrophil cytoplasmic antibody negative, Antinuclear antibody, Blood creatinine, Blood culture, Blood glucose, Blood potassium, Blood sodium, Bronchoscopy abnormal, C-reactive protein, Chest discomfort, Computerised tomogram thorax, Cough, Endotracheal intubation, Fatigue, Full blood count, Gram stain, Haemoptysis, Mycobacterium tuberculosis complex test negative, Platelet count, Potassium hydroxide preparation, Procalcitonin, Productive cough, Prothrombin time, Pulmonary thrombosis, Pyrexia, Red blood cell sedimentation rate, SARS-CoV-2 test, Urine analysis
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: 24th August: CEFTRIAXONA MK 1 GM, PULMICORT 0.5 MG (NEBULIZAR), ALBUGENOL SO/RESP 10 ML. TROPIUM SOLUC P/RESP 10 ML. 26th August: CEFTRIAXONA MK 1 GM, AZTHOMAC 500 MG, PULMICORT 0.5 MG (NEBULIZAR), 27th August: DICYNONE AMPOLLA, PARACONY
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 24th august torax RX, COVID, PCR, c-reactive protein, blood glucose, blood creatinine, 25th august TAC TORAX 29th august torax RX 24th August: sodium, potassium, Baar Direct, 25th August: baar Direct, 26th August: Baar Direct, Latex R.A, c-reactive protein, general urine, ANA, KOH (fungus) 27th August: MTB RIF (tuberculosis), KOH (fungus), GRAM, BAAR direct, 29th August: hemogram blood, c-reactive protein, 31th August: hemogram blood, c-reactive protein, 6th Sept: ANCA 11th Sept: RxTorax AP o PA. 14th Sept: ANCA (negatives)
CDC Split Type:

Write-up: 06-August - 15 August: low fever, fatigue and chest pressure 16 August - 21 August: dry cough and finally with phlegm on 21th August. 22th August - : coughing up blood (profuse blood sputum) 24th August: Hospitalization (Hospital) Diagnostic: Study for "Tuberculosis or fungus". Test for COVID19 Antigens and PCR : NEGATIVES 27th August: MTB NOT DETECTED on fiberoptic bronchoscopy with this treatment the fevers disappeared, during the fiberoptic bronchoscopy the the pulmonologist locates a clot in the upper posterior lobe on the left lung, but leaves it because it risks filling the entire lung with blood with danger requiring intubation. 28th August: changed the antibiotic


VAERS ID: 1720572 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214016 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental underdose, Angioedema, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Medication errors (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: Angioedema; Urticaria; Accidental underdose; This case was received via Medicines Agency (Reference number: ES-AEMPS-992998 ) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of ANGIOEDEMA (Angioedema) and URTICARIA (Urticaria) in a 13-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214016) 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 dose of mRNA-1273 (Spikevax) (Intramuscular) .3 milliliter. On 19-Aug-2021, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), URTICARIA (Urticaria) (seriousness criterion medically significant) and ACCIDENTAL UNDERDOSE (Accidental underdose). On 19-Aug-2021, ACCIDENTAL UNDERDOSE (Accidental underdose) had resolved. At the time of the report, ANGIOEDEMA (Angioedema) and URTICARIA (Urticaria) outcome was unknown. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 19-Aug-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No Treatment medication was provided by the reporter. No Concomitant medication was provided by the reporter. Company Comment: This case involves a 13-year-old female (adolescent) patient with unknown medical history who experienced the unexpected serious AEs Angioedema and Urticaria (both medically significant) on the same day she received her first dose of Spikevax(19-August-2021). As a result, the drug was withdrawn. No reporter causality was provided. The benefit risk relationship of the drug.mRNA-1273 is not affected by this report. this case also reports an "accidental underdose". Sender''s Comments: This case involves a 13-year-old female (adolescent) patient with unknown medical history who experienced the unexpected serious AEs Angioedema and Urticaria (both medically significant) on the same day she received her first dose of Spikevax(19-August-2021). As a result, the drug was withdrawn. No reporter causality was provided. The benefit risk relationship of the drug.mRNA-1273 is not affected by this report. this case also reports an "accidental underdose"


VAERS ID: 1729740 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Presyncope, Visual impairment
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (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: Vasovagal reflex; Dimmed vision; Possibility of anaphylaxis; This case was received via regulatory authority (Reference number: 2021TJP093278) on 13-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This case, reported by a vaccinator (other than a physician), was received by regulatory authority via Moderna''s adverse reaction reporting site (TASK0021689), and reported to the regulatory authority by a vaccinator (other than a physician), was received via the regulatory authority (Ref, v21126586). On 11-Sep-2021, at 11:00, the patient received the 1st dose of this vaccine. At 11:05, anaphylaxis possibly developed suddenly. At 11:30, vasovagal reflex developed. Queasy and dimmed vision were noted. Lactated ringer''s solution 500 mL, d-chlorpheniramine maleate 1A, and famotidine 1A were administered in bed. Improvement was confirmed, and when the patient walked home, queasy developed again. Adrenaline 0.3 mg was injected intramuscularly in bed, but the symptoms did not improve. The patient was raced to a hospital and was hospitalized. On 12-Sep-2021, the patient had queasy but was discharged from the hospital at the patient''s request. On 13-Sep-2021, it was confirmed that the symptoms were resolving. The outcome of possibility of anaphylaxis, vasovagal reflex, and dimmed vision 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. Company Comment: This case concerns a 16-year-old, male patient with no medical history, who experienced the expected event of Anaphylactic reaction. The event occurred immediately within 30 minutes after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient also experienced serious events of Presyncope and Visual impairment. Event seriousness assessed as per Regulatory Authority reporting. The rechallenge was not applicable. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender''s Comments: This case concerns a 16-year-old, male patient with no medical history, who experienced the expected event of Anaphylactic reaction. The event occurred immediately within 30 minutes after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient also experienced serious events of Presyncope and Visual impairment. Event seriousness assessed as per Regulatory Authority reporting. The rechallenge was not applicable. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1730636 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Headache, Malaise
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: Dyspnoea; Malaise; Headache; This case was received via regulatory authority (Reference number: ES-AEMPS-998365) 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 MALAISE (Malaise), HEADACHE (Headache) and DYSPNOEA (Dyspnoea) in a 13-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 02-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 02-Sep-2021, the patient experienced MALAISE (Malaise) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 03-Sep-2021, the patient experienced DYSPNOEA (Dyspnoea) (seriousness criterion medically significant). On 03-Sep-2021, DYSPNOEA (Dyspnoea) had resolved. At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) was resolving. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 02-Sep-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported by reporter. Treatment information was not provided by reporter. Batch number of the suspect product was unknown. Company Comment: This case concerns a 13-year-old, female patient with no relevant medical history, who experienced the serious unexpected events of malaise, headache and dyspnoea. The events of malaise and headache occurred during the same day after the second dose of Spikevax, and the event of dyspnoea occurred one day after the second dose was given. The event dyspnoea resolved, and malaise and headache were resolving at the time of the report. It should be noted that action taken was reported as drug withdrawn per RA source document, and taking into consideration that the events resolved/were resolving, dechallenge was considered as positive, and rechallenge was considered as not applicable taking into consideration action taken with the suspect drug. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation received on 21-Sep-2021 - Suspect product details updated.; Sender''s Comments: This case concerns a 13-year-old, female patient with no relevant medical history, who experienced the serious unexpected events of malaise, headache and dyspnoea. The events of malaise and headache occurred during the same day after the second dose of Spikevax, and the event of dyspnoea occurred one day after the second dose was given. The event dyspnoea resolved, and malaise and headache were resolving at the time of the report. It should be noted that action taken was reported as drug withdrawn per RA source document, and taking into consideration that the events resolved/were resolving, dechallenge was considered as positive, and rechallenge was considered as not applicable taking into consideration action taken with the suspect drug. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1730639 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214018 / 1 - / OT

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

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

Write-up: Anaphylactic reaction; This case was received via regulatory authority (Reference number: BX20218022) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 12-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214018) for COVID-19 vaccination. The patient''s past medical history included Allergic asthma since an unknown date. Concomitant products included SALBUTAMOL (VENTOLINE [SALBUTAMOL]) for an unknown indication. On 23-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. The treatment information was not provided. This case concerns a 12-year-old, female with a history of asthma , who experienced the expected event Anaphylactic reaction . The event occurred on the same day after the first dose of mRNA-1273 Moderna vaccine (Spikevax). The rechallenge was not applicable since this is the case for the first dose. The event is consistent with the current understanding of the mechanism of action of the study medication . The medical history of could be a potentially confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.; Sender''s Comments: This case concerns a 12-year-old, female with a history of asthma , who experienced the expected event Anaphylactic reaction . The event occurred on the same day after the first dose of mRNA-1273 Moderna vaccine (Spikevax). The rechallenge was not applicable since this is the case for the first dose. The event is consistent with the current understanding of the mechanism of action of the study medication . The medical history of could be a potentially confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.


VAERS ID: 1730831 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214021 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Pain in extremity, Type I hypersensitivity
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Tendinopathies and ligament 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:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Immediate hypersensitivity reaction; Pain in arm; Asthenia; This case was received via regulatory authority (Reference number: FR-AFSSAPS-NT20213819) 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 TYPE I HYPERSENSITIVITY (Immediate hypersensitivity reaction) in a 13-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214021) for SARS-CoV-2 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced TYPE I HYPERSENSITIVITY (Immediate hypersensitivity reaction) (seriousness criteria hospitalization and medically significant), PAIN IN EXTREMITY (Pain in arm) and ASTHENIA (Asthenia). At the time of the report, TYPE I HYPERSENSITIVITY (Immediate hypersensitivity reaction) had resolved and PAIN IN EXTREMITY (Pain in arm) and ASTHENIA (Asthenia) 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 reported by reporter. No treatment medications provided by the reporter. Company Comment: This case concerns a 13 year-old, male patient with no relevant medical history, who experienced the unexpected event of Type I hypersensitivity reaction. The event occurred on the same day after the first dose of Spikevax (Moderna COVID-19 vaccine) requiring hospitalization. The rechallenge was not applicable since the event occurred after the first dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation received on 21-Sep-2021 and contain no new information.; Sender''s Comments: This case concerns a 13 year-old, male patient with no relevant medical history, who experienced the unexpected event of Type I hypersensitivity reaction. The event occurred on the same day after the first dose of Spikevax (Moderna COVID-19 vaccine) requiring hospitalization. The rechallenge was not applicable since the event occurred after the first dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.


VAERS ID: 1736221 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-31
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003659 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Injection site reaction, Lymphadenopathy, Skin disorder
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: This case was received via regulatory authority (Reference number: BE-FAMHP-DHH-N2021-106305) 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 ERYTHEMA, SKIN DISORDER, INJECTION SITE REACTION and LYMPHADENOPATHY in a 13-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3003659) for COVID-19 vaccination. No Medical History information was reported. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced ERYTHEMA, SKIN DISORDER, INJECTION SITE REACTION and LYMPHADENOPATHY. At the time of the report, ERYTHEMA, SKIN DISORDER, INJECTION SITE REACTION and LYMPHADENOPATHY outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: The translation document received contains no new information.


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