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From the 1/7/2022 release of VAERS data:

Found 129 cases where Age is 12-or-more-and-under-18 and Vaccine is COVID19 and Manufacturer is MODERNA and Standard-MedDRA-Query broadly-matches 'Anaphylactic reaction'

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Case Details

This is page 5 out of 13

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VAERS ID: 1924962 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-11-30
Onset:2021-12-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013F21A / 3 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Erythema, Muscle twitching
SMQs:, Anaphylactic reaction (broad), Dyskinesia (broad), Dystonia (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NA
Current Illness:
Preexisting Conditions: Epileptic
Allergies: NA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Muscle Twitch, Redness in arm


VAERS ID: 1957922 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Menstrual disorder, Product administered to patient of inappropriate age, Pruritus, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (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? 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: USMODERNATX, INC.MOD20214

Write-up: Sometimes it itches on the body; Like red spots; Swollen; Inappropriate age at vaccine administration; Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose), PRURITUS (Sometimes it itches on the body), ERYTHEMA (Like red spots), SWELLING (Swollen) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). In 2021, the patient experienced MENSTRUAL DISORDER (Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose). On an unknown date, the patient experienced PRURITUS (Sometimes it itches on the body), ERYTHEMA (Like red spots) and SWELLING (Swollen). In May 2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved. At the time of the report, MENSTRUAL DISORDER (Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose), PRURITUS (Sometimes it itches on the body), ERYTHEMA (Like red spots) and SWELLING (Swollen) outcome was unknown. No concomitant medications information was reported. No treatment medications were provided. It was reported sometimes it itches on the body, like red spots and was swollen and that sometimes it goes and come. The menstruation problems appeared after 15 days from the second dose. Reporter did not allow further contact


VAERS ID: 1984811 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-10-24
Onset:2021-10-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027C21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Malaise, Peripheral swelling, Product administered to patient of inappropriate age, Pyrexia, Sneezing
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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? 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:

Write-up: Moderna adult vaccine given to minor. Mother states individual showed signs of fever for 3 days, feeling sick - sneezing, and swollen arm.


VAERS ID: 1398305 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002184 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Product administered to patient of inappropriate age
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow), Medication errors (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20212

Write-up: Anaphylactic reaction; Inappropriate age at vaccine administration; This regulatory authority case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 17-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002184) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-May-2021 at 1:35 PM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 10-May-2021 at 1:50 PM, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). On 10-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylactic reaction) to be probably related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). Concomitant medication use was not provided. No Treatment information was provided. Based on the current available information and temporal association between the use of the product and the anaphylactic reaction, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per assessment by Authority and per IME list; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the anaphylactic reaction, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per assessment by Authority and per IME list


VAERS ID: 1450821 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000495 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Headache, Injection site pain, Paraesthesia, Peripheral circulatory failure
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN HEADACHE , PARAESTHESIA , PERIPHERAL CIRCULATORY FAILURE and DYSPNOEA in a 17-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000495) for COVID-19 vaccination. No Medical History information was reported. On 02-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced INJECTION SITE PAIN (seriousness criterion hospitalization prolonged), HEADACHE (seriousness criterion hospitalization prolonged), PARAESTHESIA (seriousness criterion hospitalization prolonged), PERIPHERAL CIRCULATORY FAILURE (seriousness criterion hospitalization prolonged) and DYSPNOEA (seriousness criterion hospitalization prolonged). At the time of the report, INJECTION SITE PAIN , HEADACHE PARAESTHESIA PERIPHERAL CIRCULATORY FAILURE and DYSPNOEA was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. 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: 1473541 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-06-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angina pectoris, Blood glucose, Dyspnoea, Electroencephalogram, Heart rate, Urine analysis
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Other ischaemic heart disease (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: Medical History/Concurrent Conditions: Clinical trial participant; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: blood sugar; Test Result: Inconclusive ; Result Unstructured Data: Low; Test Date: 20210701; Test Name: EEG; Test Result: Inconclusive ; Result Unstructured Data: no result reported.; Test Date: 20210630; Test Name: heart rate; Test Result: Inconclusive ; Result Unstructured Data: irregular heartbeats; Test Date: 20210701; Test Name: heart rate; Test Result: Inconclusive ; Result Unstructured Data: fast heart rate of 120beats per minute; Test Date: 20210701; Test Name: Urine Test; Result Unstructured Data: found in urine all tests returned clear.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Chest pain - cardiac; Labored breathing; This regulatory authority case was reported by an other health care professional and describes the occurrence of ANGINA PECTORIS (Chest pain - cardiac) and DYSPNOEA (Labored breathing) in a 15-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Clinical trial participant. On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced ANGINA PECTORIS (Chest pain - cardiac) (seriousness criterion hospitalization) and DYSPNOEA (Labored breathing) (seriousness criterion hospitalization). At the time of the report, ANGINA PECTORIS (Chest pain - cardiac) and DYSPNOEA (Labored breathing) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jun-2021, Blood glucose: low (Inconclusive) Low. On 30-Jun-2021, Heart rate: irregular (Inconclusive) irregular heartbeats. On 01-Jul-2021, Electroencephalogram: inconclusive (Inconclusive) no result reported.. On 01-Jul-2021, Heart rate: increased (Inconclusive) fast heart rate of 120beats per minute. On 01-Jul-2021, Urine analysis: normal (normal) found in urine all tests returned clear.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter. Very limited information regarding these events have been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected.


VAERS ID: 1634439 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 304492 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dermatitis bullous, Urticaria
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: ; This case was received (Reference number: IT-MINISAL02-769637) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of DERMATITIS BULLOUS in a 14-year-old female patient who received mRNA-1273 (batch no. 304492) for Immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Jul-2021, the patient received dose of mRNA-1273 (Intramuscular) .5 milliliter. On 02-Aug-2021, the patient experienced DERMATITIS BULLOUS (seriousness criterion medically significant) and URTICARIA. At the time of the report, DERMATITIS BULLOUS and URTICARIA had not resolved. The action taken with mRNA-1273 (Intramuscular) was unknown. For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were 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: 1636074 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-08-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214019 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (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: ITMODERNATX, INC.MOD20212

Write-up: POMFI FRONTALI; This case was received (Reference number: IT-MINISAL02-770150) on 18-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of URTICARIA in a 17-year-old female patient who received mRNA-1273 (batch no. 214019) for COVID-19 vaccination. No Medical History information was reported. On 09-Aug-2021, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form in total. On 09-Aug-2021, after starting mRNA-1273, the patient experienced URTICARIA (seriousness criterion medically significant). At the time of the report, URTICARIA was resolving. For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments. Company comment- Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.


VAERS ID: 1640569 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214016 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypersensitivity, Pharyngeal swelling, Tachycardia
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Tachycardia; Allergic reaction; Inflamaci?n; This case was received via (Reference number: ES-AEMPS-973509) on 19-Aug-2021 and was forwarded to Moderna on 19-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia), HYPERSENSITIVITY (Allergic reaction) and PHARYNGEAL SWELLING (Inflamaci?n) in a 17-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214016) for COVID-19 vaccination. No Medical History information was reported. On 11-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced TACHYCARDIA (Tachycardia) (seriousness criterion medically significant), HYPERSENSITIVITY (Allergic reaction) (seriousness criterion medically significant) and PHARYNGEAL SWELLING (Inflamaci?n) (seriousness criterion medically significant). On 11-Aug-2021, TACHYCARDIA (Tachycardia), HYPERSENSITIVITY (Allergic reaction) and PHARYNGEAL SWELLING (Inflamaci?n) had resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 11-Aug-2021. No concomitant and treatment information was provided. 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: 1642124 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004234 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic shock
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: FRMODERNATX, INC.MOD20212

Write-up: Anaphylactic shock; This case was received via regulatory authority (Reference number: FR-AFSSAPS-BX20217307) on 19-Aug-2021 and was forwarded to Moderna on 19-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in a 16-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004234) for COVID-19 vaccination. No Medical History information was reported. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria hospitalization and medically significant). At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant and treatment medications were reported Company Comment Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.


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