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This is VAERS ID 522465

History of Changes from the VAERS Wayback Machine

First Appeared on 3/14/2014

VAERS ID: 522465
VAERS Form:
Age:0.5
Sex:Male
Location:Foreign
Vaccinated:2014-02-05
Onset:2014-02-06
Submitted:2014-02-11
Entered:2014-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER KH189 / 0 UN / UN
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER A007A / 2 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER Y7SC / 1 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H021856 / 1 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Cardio-respiratory arrest, Death, Respiratory arrest, Sudden infant death syndrome

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2014-02-06
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BESOFTEN; KINDAVATE; PROPETO
Current Illness: Asteatosis; Eczema; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 02/05/2014, Body temperature, 36.6 degrees C
CDC 'Split Type': WAES1402JPN004065

Write-up: Initial information has been received from a physician via the Agency concerning a 6-month-old male patient with eczema and asteatosis who on 05-FEB-2014 was vaccinated orally with ROTATEQ mixture for internal use (Lot No. H021856, exp. 01-OCT-2014, dose and indication not reported) for the second time. There was a specific note on the Medical Questionnaire for Vaccination indicating that the patient had received application of BESOFTEN cream, KINDAVATE ointment and PROPETO for the treatment of eczema and asteatosis. The patient''s birth weight was 2710 g. Other suspect drugs included DTaP-IPV (manufacturer unknown) injection drug (third time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. A007 A), BCG vaccine (manufacturer unknown) (first time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. KH189) and Hep B vaccine (manufacturer unknown) injection drug (second time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. Y7SC). On 05-FEB-2014, the patient was vaccinated with ROTATEQ (second time), DTaP-IPV (manufacturer unknown) (third time), BCG vaccine (manufacturer unknown) (first time) and Hep B vaccine (manufacturer unknown) (second time). The patient''s body temperature before the vaccination was 36.6 degrees C. On 06-FEB-2014, at 9:00 a.m. the patient was fed milk and baby food. At around 10:00 a.m., his mother got him to sleep in a supine position. At around 11:30 a.m., the patient developed cardio-respiratory arrest. His mother noticed that the patient was in a prone position and was no breathing. The patient''s mother made an emergency call and the patient was transferred to the reporting hospital, where resuscitation was performed but there was no response to treatment. At 13:00, the patient was confirmed dead. It was reported that the cause of death was cardio-respiratory arrest. Postmortem was to be performed. Reporter''s comment: Not provided. The reporting physician considered that cardio-respiratory arrest was serious due to death. The reporting physician felt that the causal relationship of cardio-respiratory arrest to ROTATEQ, BCG vaccine (manufacturer unknown), Hep B vaccine (manufacturer unknown) and cardio-respiratory arrest was unknown. The reporting physician considered that sudden infant death syndrome (SIDS) was the other possible causative factor for cardio-respiratory arrest. Per internal review cardio-respiratory arrest was considered as other important medical event. No further information is available.


Changed on 6/14/2014

VAERS ID: 522465 Before After
VAERS Form:
Age:0.5
Sex:Male
Location:Foreign
Vaccinated:2014-02-05
Onset:2014-02-06
Submitted:2014-02-11
Entered:2014-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER KH189 / 0 UN / UN
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER A007A / 2 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER Y7SC / 1 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H021856 / 1 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Cardio-respiratory arrest, Death, Respiratory arrest, Sudden infant death syndrome

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2014-02-06
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BESOFTEN; KINDAVATE; PROPETO
Current Illness: Asteatosis; Eczema; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 02/05/2014, Body temperature, 36.6 degrees C
CDC 'Split Type': WAES1402JPN004065

Write-up: Initial information has been received from a physician via the Agency concerning a 6-month-old male patient with eczema and asteatosis who on 05-FEB-2014 was vaccinated orally with ROTATEQ mixture for internal use (Lot No. H021856, exp. 01-OCT-2014, dose and indication not reported) for the second time. There was a specific note on the Medical Questionnaire for Vaccination indicating that the patient had received application of BESOFTEN cream, KINDAVATE ointment and PROPETO for the treatment of eczema and asteatosis. The patient''s birth weight was 2710 g. Other suspect drugs included DTaP-IPV (manufacturer unknown) injection drug (third time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. A007 A), BCG vaccine (manufacturer unknown) (first time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. KH189) and Hep B vaccine (manufacturer unknown) injection drug (second time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. Y7SC). On 05-FEB-2014, the patient was vaccinated with ROTATEQ (second time), DTaP-IPV (manufacturer unknown) (third time), BCG vaccine (manufacturer unknown) (first time) and Hep B vaccine (manufacturer unknown) (second time). The patient''s body temperature before the vaccination was 36.6 degrees C. On 06-FEB-2014, at 9:00 a.m. the patient was fed milk and baby food. At around 10:00 a.m., his mother got him to sleep in a supine position. At around 11:30 a.m., the patient developed cardio-respiratory arrest. His mother noticed that the patient was in a prone position and was no breathing. The patient''s mother made an emergency call and the patient was transferred to the reporting hospital, where resuscitation was performed but there was no response to treatment. At 13:00, the patient was confirmed dead. It was reported that the cause of death was cardio-respiratory arrest. Postmortem was to be performed. Reporter''s comment: Not provided. The reporting physician considered that cardio-respiratory arrest was serious due to death. The reporting physician felt that the causal relationship of cardio-respiratory arrest to ROTATEQ, BCG vaccine (manufacturer unknown), Hep B vaccine (manufacturer unknown) and cardio-respiratory arrest was unknown. The reporting physician considered that sudden infant death syndrome (SIDS) was the other possible causative factor for cardio-respiratory arrest. Per internal review cardio-respiratory arrest was considered as other important medical event. No further information is available.


Changed on 3/14/2015

VAERS ID: 522465 Before After
VAERS Form:
Age:0.5
Sex:Male
Location:Foreign
Vaccinated:2014-02-05
Onset:2014-02-06
Submitted:2014-02-11
Entered:2014-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER KH189 / 0 UN / UN
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER A007A / 2 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER Y7SC / 1 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H021856 / 1 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Cardio-respiratory arrest, Death, Respiratory arrest, Sudden infant death syndrome

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2014-02-06
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BESOFTEN; KINDAVATE; PROPETO
Current Illness: Asteatosis; Eczema; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 02/05/2014, Body temperature, 36.6 degrees C
CDC 'Split Type': WAES1402JPN004065

Write-up: Initial information has been received from a physician via the Agency concerning a 6-month-old male patient with eczema and asteatosis who on 05-FEB-2014 was vaccinated orally with ROTATEQ mixture for internal use (Lot No. H021856, exp. 01-OCT-2014, dose and indication not reported) for the second time. There was a specific note on the Medical Questionnaire for Vaccination indicating that the patient had received application of BESOFTEN cream, KINDAVATE ointment and PROPETO for the treatment of eczema and asteatosis. The patient''s birth weight was 2710 g. Other suspect drugs included DTaP-IPV (manufacturer unknown) injection drug (third time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. A007 A), BCG vaccine (manufacturer unknown) (first time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. KH189) and Hep B vaccine (manufacturer unknown) injection drug (second time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. Y7SC). On 05-FEB-2014, the patient was vaccinated with ROTATEQ (second time), DTaP-IPV (manufacturer unknown) (third time), BCG vaccine (manufacturer unknown) (first time) and Hep B vaccine (manufacturer unknown) (second time). The patient''s body temperature before the vaccination was 36.6 degrees C. On 06-FEB-2014, at 9:00 a.m. the patient was fed milk and baby food. At around 10:00 a.m., his mother got him to sleep in a supine position. At around 11:30 a.m., the patient developed cardio-respiratory arrest. His mother noticed that the patient was in a prone position and was no breathing. The patient''s mother made an emergency call and the patient was transferred to the reporting hospital, where resuscitation was performed but there was no response to treatment. At 13:00, the patient was confirmed dead. It was reported that the cause of death was cardio-respiratory arrest. Postmortem was to be performed. Reporter''s comment: Not provided. The reporting physician considered that cardio-respiratory arrest was serious due to death. The reporting physician felt that the causal relationship of cardio-respiratory arrest to ROTATEQ, BCG vaccine (manufacturer unknown), Hep B vaccine (manufacturer unknown) and cardio-respiratory arrest was unknown. The reporting physician considered that sudden infant death syndrome (SIDS) was the other possible causative factor for cardio-respiratory arrest. Per internal review cardio-respiratory arrest was considered as other important medical event. No further information is available.


Changed on 9/14/2017

VAERS ID: 522465 Before After
VAERS Form:(blank) 1
Age:0.5
Sex:Male
Location:Foreign
Vaccinated:2014-02-05
Onset:2014-02-06
Submitted:2014-02-11
Entered:2014-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER KH189 / 0 1 UN / UN
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER A007A / 2 3 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER Y7SC / 1 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H021856 / 1 2 - MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Cardio-respiratory arrest, Death, Respiratory arrest, Sudden infant death syndrome

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2014-02-06
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BESOFTEN; KINDAVATE; PROPETO
Current Illness: Asteatosis; Eczema; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 02/05/2014, Body temperature, 36.6 degrees C
CDC 'Split Type': WAES1402JPN004065

Write-up: Initial information has been received from a physician via the Agency concerning a 6-month-old male patient with eczema and asteatosis who on 05-FEB-2014 was vaccinated orally with ROTATEQ mixture for internal use (Lot No. H021856, exp. 01-OCT-2014, dose and indication not reported) for the second time. There was a specific note on the Medical Questionnaire for Vaccination indicating that the patient had received application of BESOFTEN cream, KINDAVATE ointment and PROPETO for the treatment of eczema and asteatosis. The patient''s birth weight was 2710 g. Other suspect drugs included DTaP-IPV (manufacturer unknown) injection drug (third time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. A007 A), BCG vaccine (manufacturer unknown) (first time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. KH189) and Hep B vaccine (manufacturer unknown) injection drug (second time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. Y7SC). On 05-FEB-2014, the patient was vaccinated with ROTATEQ (second time), DTaP-IPV (manufacturer unknown) (third time), BCG vaccine (manufacturer unknown) (first time) and Hep B vaccine (manufacturer unknown) (second time). The patient''s body temperature before the vaccination was 36.6 degrees C. On 06-FEB-2014, at 9:00 a.m. the patient was fed milk and baby food. At around 10:00 a.m., his mother got him to sleep in a supine position. At around 11:30 a.m., the patient developed cardio-respiratory arrest. His mother noticed that the patient was in a prone position and was no breathing. The patient''s mother made an emergency call and the patient was transferred to the reporting hospital, where resuscitation was performed but there was no response to treatment. At 13:00, the patient was confirmed dead. It was reported that the cause of death was cardio-respiratory arrest. Postmortem was to be performed. Reporter''s comment: Not provided. The reporting physician considered that cardio-respiratory arrest was serious due to death. The reporting physician felt that the causal relationship of cardio-respiratory arrest to ROTATEQ, BCG vaccine (manufacturer unknown), Hep B vaccine (manufacturer unknown) and cardio-respiratory arrest was unknown. The reporting physician considered that sudden infant death syndrome (SIDS) was the other possible causative factor for cardio-respiratory arrest. Per internal review cardio-respiratory arrest was considered as other important medical event. No further information is available.


Changed on 2/14/2018

VAERS ID: 522465 Before After
VAERS Form:1
Age:0.5
Sex:Male
Location:Foreign
Vaccinated:2014-02-05
Onset:2014-02-06
Submitted:2014-02-11
Entered:2014-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER KH189 / 1 UN / UN
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER A007A / 3 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER Y7SC / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H021856 / 2 MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Cardio-respiratory arrest, Death, Respiratory arrest, Sudden infant death syndrome

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2014-02-06
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BESOFTEN; KINDAVATE; PROPETO
Current Illness: Asteatosis; Eczema; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 02/05/2014, Body temperature, 36.6 degrees C
CDC 'Split Type': WAES1402JPN004065

Write-up: Initial information has been received from a physician via the Agency concerning a 6-month-old male patient with eczema and asteatosis who on 05-FEB-2014 was vaccinated orally with ROTATEQ mixture for internal use (Lot No. H021856, exp. 01-OCT-2014, dose and indication not reported) for the second time. There was a specific note on the Medical Questionnaire for Vaccination indicating that the patient had received application of BESOFTEN cream, KINDAVATE ointment and PROPETO for the treatment of eczema and asteatosis. The patient''s birth weight was 2710 g. Other suspect drugs included DTaP-IPV (manufacturer unknown) injection drug (third time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. A007 A), BCG vaccine (manufacturer unknown) (first time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. KH189) and Hep B vaccine (manufacturer unknown) injection drug (second time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. Y7SC). On 05-FEB-2014, the patient was vaccinated with ROTATEQ (second time), DTaP-IPV (manufacturer unknown) (third time), BCG vaccine (manufacturer unknown) (first time) and Hep B vaccine (manufacturer unknown) (second time). The patient''s body temperature before the vaccination was 36.6 degrees C. On 06-FEB-2014, at 9:00 a.m. the patient was fed milk and baby food. At around 10:00 a.m., his mother got him to sleep in a supine position. At around 11:30 a.m., the patient developed cardio-respiratory arrest. His mother noticed that the patient was in a prone position and was no breathing. The patient''s mother made an emergency call and the patient was transferred to the reporting hospital, where resuscitation was performed but there was no response to treatment. At 13:00, the patient was confirmed dead. It was reported that the cause of death was cardio-respiratory arrest. Postmortem was to be performed. Reporter''s comment: Not provided. The reporting physician considered that cardio-respiratory arrest was serious due to death. The reporting physician felt that the causal relationship of cardio-respiratory arrest to ROTATEQ, BCG vaccine (manufacturer unknown), Hep B vaccine (manufacturer unknown) and cardio-respiratory arrest was unknown. The reporting physician considered that sudden infant death syndrome (SIDS) was the other possible causative factor for cardio-respiratory arrest. Per internal review cardio-respiratory arrest was considered as other important medical event. No further information is available.


Changed on 6/14/2018

VAERS ID: 522465 Before After
VAERS Form:1
Age:0.5
Sex:Male
Location:Foreign
Vaccinated:2014-02-05
Onset:2014-02-06
Submitted:2014-02-11
Entered:2014-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER KH189 / 1 UN / UN
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER A007A / 3 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER Y7SC / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H021856 / 2 MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Cardio-respiratory arrest, Death, Respiratory arrest, Sudden infant death syndrome

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2014-02-06
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BESOFTEN; KINDAVATE; PROPETO
Current Illness: Asteatosis; Eczema; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 02/05/2014, Body temperature, 36.6 degrees C
CDC 'Split Type': WAES1402JPN004065

Write-up: Initial information has been received from a physician via the Agency concerning a 6-month-old male patient with eczema and asteatosis who on 05-FEB-2014 was vaccinated orally with ROTATEQ mixture for internal use (Lot No. H021856, exp. 01-OCT-2014, dose and indication not reported) for the second time. There was a specific note on the Medical Questionnaire for Vaccination indicating that the patient had received application of BESOFTEN cream, KINDAVATE ointment and PROPETO for the treatment of eczema and asteatosis. The patient''s birth weight was 2710 g. Other suspect drugs included DTaP-IPV (manufacturer unknown) injection drug (third time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. A007 A), BCG vaccine (manufacturer unknown) (first time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. KH189) and Hep B vaccine (manufacturer unknown) injection drug (second time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. Y7SC). On 05-FEB-2014, the patient was vaccinated with ROTATEQ (second time), DTaP-IPV (manufacturer unknown) (third time), BCG vaccine (manufacturer unknown) (first time) and Hep B vaccine (manufacturer unknown) (second time). The patient''s body temperature before the vaccination was 36.6 degrees C. On 06-FEB-2014, at 9:00 a.m. the patient was fed milk and baby food. At around 10:00 a.m., his mother got him to sleep in a supine position. At around 11:30 a.m., the patient developed cardio-respiratory arrest. His mother noticed that the patient was in a prone position and was no breathing. The patient''s mother made an emergency call and the patient was transferred to the reporting hospital, where resuscitation was performed but there was no response to treatment. At 13:00, the patient was confirmed dead. It was reported that the cause of death was cardio-respiratory arrest. Postmortem was to be performed. Reporter''s comment: Not provided. The reporting physician considered that cardio-respiratory arrest was serious due to death. The reporting physician felt that the causal relationship of cardio-respiratory arrest to ROTATEQ, BCG vaccine (manufacturer unknown), Hep B vaccine (manufacturer unknown) and cardio-respiratory arrest was unknown. The reporting physician considered that sudden infant death syndrome (SIDS) was the other possible causative factor for cardio-respiratory arrest. Per internal review cardio-respiratory arrest was considered as other important medical event. No further information is available.


Changed on 8/14/2018

VAERS ID: 522465 Before After
VAERS Form:1
Age:0.5
Sex:Male
Location:Foreign
Vaccinated:2014-02-05
Onset:2014-02-06
Submitted:2014-02-11
Entered:2014-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER KH189 / 1 UN / UN
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER A007A / 3 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER Y7SC / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H021856 / 2 MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Cardio-respiratory arrest, Death, Respiratory arrest, Sudden infant death syndrome

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2014-02-06
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BESOFTEN; KINDAVATE; PROPETO
Current Illness: Asteatosis; Eczema; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 02/05/2014, Body temperature, 36.6 degrees C
CDC 'Split Type': WAES1402JPN004065

Write-up: Initial information has been received from a physician via the Agency concerning a 6-month-old male patient with eczema and asteatosis who on 05-FEB-2014 was vaccinated orally with ROTATEQ mixture for internal use (Lot No. H021856, exp. 01-OCT-2014, dose and indication not reported) for the second time. There was a specific note on the Medical Questionnaire for Vaccination indicating that the patient had received application of BESOFTEN cream, KINDAVATE ointment and PROPETO for the treatment of eczema and asteatosis. The patient''s birth weight was 2710 g. Other suspect drugs included DTaP-IPV (manufacturer unknown) injection drug (third time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. A007 A), BCG vaccine (manufacturer unknown) (first time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. KH189) and Hep B vaccine (manufacturer unknown) injection drug (second time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. Y7SC). On 05-FEB-2014, the patient was vaccinated with ROTATEQ (second time), DTaP-IPV (manufacturer unknown) (third time), BCG vaccine (manufacturer unknown) (first time) and Hep B vaccine (manufacturer unknown) (second time). The patient''s body temperature before the vaccination was 36.6 degrees C. On 06-FEB-2014, at 9:00 a.m. the patient was fed milk and baby food. At around 10:00 a.m., his mother got him to sleep in a supine position. At around 11:30 a.m., the patient developed cardio-respiratory arrest. His mother noticed that the patient was in a prone position and was no breathing. The patient''s mother made an emergency call and the patient was transferred to the reporting hospital, where resuscitation was performed but there was no response to treatment. At 13:00, the patient was confirmed dead. It was reported that the cause of death was cardio-respiratory arrest. Postmortem was to be performed. Reporter''s comment: Not provided. The reporting physician considered that cardio-respiratory arrest was serious due to death. The reporting physician felt that the causal relationship of cardio-respiratory arrest to ROTATEQ, BCG vaccine (manufacturer unknown), Hep B vaccine (manufacturer unknown) and cardio-respiratory arrest was unknown. The reporting physician considered that sudden infant death syndrome (SIDS) was the other possible causative factor for cardio-respiratory arrest. Per internal review cardio-respiratory arrest was considered as other important medical event. No further information is available.


Changed on 9/14/2018

VAERS ID: 522465 Before After
VAERS Form:1
Age:0.5
Sex:Male
Location:Foreign
Vaccinated:2014-02-05
Onset:2014-02-06
Submitted:2014-02-11
Entered:2014-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER KH189 / 1 UN / UN
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER A007A / 3 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER Y7SC / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H021856 / 2 MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Cardio-respiratory arrest, Death, Respiratory arrest, Sudden infant death syndrome

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2014-02-06
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BESOFTEN; KINDAVATE; PROPETO
Current Illness: Asteatosis; Eczema; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 02/05/2014, Body temperature, 36.6 degrees C
CDC 'Split Type': WAES1402JPN004065

Write-up: Initial information has been received from a physician via the Agency concerning a 6-month-old male patient with eczema and asteatosis who on 05-FEB-2014 was vaccinated orally with ROTATEQ mixture for internal use (Lot No. H021856, exp. 01-OCT-2014, dose and indication not reported) for the second time. There was a specific note on the Medical Questionnaire for Vaccination indicating that the patient had received application of BESOFTEN cream, KINDAVATE ointment and PROPETO for the treatment of eczema and asteatosis. The patient''s birth weight was 2710 g. Other suspect drugs included DTaP-IPV (manufacturer unknown) injection drug (third time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. A007 A), BCG vaccine (manufacturer unknown) (first time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. KH189) and Hep B vaccine (manufacturer unknown) injection drug (second time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. Y7SC). On 05-FEB-2014, the patient was vaccinated with ROTATEQ (second time), DTaP-IPV (manufacturer unknown) (third time), BCG vaccine (manufacturer unknown) (first time) and Hep B vaccine (manufacturer unknown) (second time). The patient''s body temperature before the vaccination was 36.6 degrees C. On 06-FEB-2014, at 9:00 a.m. the patient was fed milk and baby food. At around 10:00 a.m., his mother got him to sleep in a supine position. At around 11:30 a.m., the patient developed cardio-respiratory arrest. His mother noticed that the patient was in a prone position and was no breathing. The patient''s mother made an emergency call and the patient was transferred to the reporting hospital, where resuscitation was performed but there was no response to treatment. At 13:00, the patient was confirmed dead. It was reported that the cause of death was cardio-respiratory arrest. Postmortem was to be performed. Reporter''s comment: Not provided. The reporting physician considered that cardio-respiratory arrest was serious due to death. The reporting physician felt that the causal relationship of cardio-respiratory arrest to ROTATEQ, BCG vaccine (manufacturer unknown), Hep B vaccine (manufacturer unknown) and cardio-respiratory arrest was unknown. The reporting physician considered that sudden infant death syndrome (SIDS) was the other possible causative factor for cardio-respiratory arrest. Per internal review cardio-respiratory arrest was considered as other important medical event. No further information is available.


Changed on 10/14/2018

VAERS ID: 522465 Before After
VAERS Form:1
Age:0.5
Sex:Male
Location:Foreign
Vaccinated:2014-02-05
Onset:2014-02-06
Submitted:2014-02-11
Entered:2014-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER KH189 / 1 UN / UN
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER A007A / 3 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER Y7SC / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H021856 / 2 MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Cardio-respiratory arrest, Death, Respiratory arrest, Sudden infant death syndrome

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2014-02-06
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BESOFTEN; KINDAVATE; PROPETO
Current Illness: Asteatosis; Eczema; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 02/05/2014, Body temperature, 36.6 degrees C
CDC 'Split Type': WAES1402JPN004065

Write-up: Initial information has been received from a physician via the Agency concerning a 6-month-old male patient with eczema and asteatosis who on 05-FEB-2014 was vaccinated orally with ROTATEQ mixture for internal use (Lot No. H021856, exp. 01-OCT-2014, dose and indication not reported) for the second time. There was a specific note on the Medical Questionnaire for Vaccination indicating that the patient had received application of BESOFTEN cream, KINDAVATE ointment and PROPETO for the treatment of eczema and asteatosis. The patient''s birth weight was 2710 g. Other suspect drugs included DTaP-IPV (manufacturer unknown) injection drug (third time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. A007 A), BCG vaccine (manufacturer unknown) (first time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. KH189) and Hep B vaccine (manufacturer unknown) injection drug (second time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. Y7SC). On 05-FEB-2014, the patient was vaccinated with ROTATEQ (second time), DTaP-IPV (manufacturer unknown) (third time), BCG vaccine (manufacturer unknown) (first time) and Hep B vaccine (manufacturer unknown) (second time). The patient''s body temperature before the vaccination was 36.6 degrees C. On 06-FEB-2014, at 9:00 a.m. the patient was fed milk and baby food. At around 10:00 a.m., his mother got him to sleep in a supine position. At around 11:30 a.m., the patient developed cardio-respiratory arrest. His mother noticed that the patient was in a prone position and was no breathing. The patient''s mother made an emergency call and the patient was transferred to the reporting hospital, where resuscitation was performed but there was no response to treatment. At 13:00, the patient was confirmed dead. It was reported that the cause of death was cardio-respiratory arrest. Postmortem was to be performed. Reporter''s comment: Not provided. The reporting physician considered that cardio-respiratory arrest was serious due to death. The reporting physician felt that the causal relationship of cardio-respiratory arrest to ROTATEQ, BCG vaccine (manufacturer unknown), Hep B vaccine (manufacturer unknown) and cardio-respiratory arrest was unknown. The reporting physician considered that sudden infant death syndrome (SIDS) was the other possible causative factor for cardio-respiratory arrest. Per internal review cardio-respiratory arrest was considered as other important medical event. No further information is available.

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