chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 year old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 14-NOV-2016, the patient was vaccinated with a dose of improperly stored VAQTA with lot number M027879 and expiration date of 24-JAN-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA007912:Original Case : 1701USA003168 US-009507513-1701USA007922:Original Case : 1701USA003168 US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18 year old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 29-NOV-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 with lot number M028323 and expiration date of 26-SEP-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168:Original Case : 1701USA004150; US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a pharmacist who reported that multiple "newborn unknown patients" were administered improperly stored pediatric RECOMBIVAX HB ("2.5/0.5") on 13-JAN-2017 (lot number and route of administration not provided). No adverse effects reported. Temperature range/time frame reported as: > 32F but < 36F for 2 hours, and 1 cycle below 32F for 30 to 45 minutes. No further information provided. This is one of two cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009402.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 30-NOV-2016, the patient was vaccinated with a dose of improperly stored VAQTA with lot number M027879 and expiration date of 24-JAN-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168:Original Case : 1701USA003168; US-009507513-1701USA007912:Original Case : 1701USA003168; US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 30-NOV-2016, the patient was vaccinated with a dose of improperly stored VAQTA with lot number M027879 and expiration date of 24-JAN-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910:US-009507513-1701USA004148: US-009507513-1701USA003168: Original Case : 1701USA003168 US-009507513-1701USA007912: Original Case : 1701USA003168 US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 06-DEC-2016, the patient was vaccinated with a dose of improperly stored VAQTA with lot number M027879 and expiration date of 24-JAN-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 19-DEC-2016, the patient was vaccinated with a dose of improperly stored VAQTA with lot number M027879 and expiration date of 24-JAN-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 year old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 06-DEC-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 with lot number M028323 and expiration date of 26-SEP-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (C) for 27 minutes, 0.7 degrees C for 19 minutes, 1.1 degrees C for 36 minutes, 0.7 degrees C for 29 minutes, 1.3 degrees C for 17 minutes, 1.1 degrees C for 20 minutes, 0.9 degrees C for 26 minutes, 0.7 degrees C for 31 minutes and 1.2 degrees C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 3 year old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 30-NOV-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168:Original Case : 1701USA004150 US-009507513-1701USA007912: Original Case : 1701USA007906 US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Age: 1.25
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 06-DEC-2016, the patient was vaccinated with a dose of improperly stored MMRII (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 year old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 07-DEC-2016, the patient was vaccinated with a dose of improperly stored MMRII (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB injection (lot # L038018, expiration date 13-SEP-2017 and lot # L016427, expiration date 13-APR-2017) for prophylaxis (strength, dose and route were unknown). On unknown dates, the following temperature excursions were registered : between 46 Farenheit degrees and 77 Farenheit degrees for 20 minutes and between 46°F and 77°F for 10 minutes. There were no previous temperature excursions. Digital Data Logger was involved. No adverse symptoms were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008578: US-009507513-1701USA008577: US-009507513-1701USA008576: US-009507513-1701USA002579: US-009507513-1701USA008579:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L048848 with expiration date on 09-AUG-2018; lot # M032649 with expiration date on 11-NOV-2018; lot # M006708 with expiration date on 02-JUN-2018; lot # L033343 with expiration date on 13-SEP-2017; lot # reported as M035487 with expiration date on 23-FEB-2019; lot # M034894 with expiration date on 11-NOV-2018 and lot # M020926 with expiration date on 11-AUG-2018; dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 33 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005323: US-009507513-1701USA009359: US-009507513-1701USA009357:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M018810 with expiration date on 18-MAY-2018; lot # M024261 with expiration date on 30-JUL-2018; lot # M016193 with expiration date on 24-APR-2018; lot # M023169 with expiration date on 13-JUN-2018; lot # M028323 with expiration date on 26-SEP-2018; lot # M030380 with expiration date on 01-FEB-2019; lot # L036301 with expiration date on 20-DEC-2017; dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 33 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009358: US-009507513-1701USA005323: US-009507513-1701USA009357.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a pharmacist who reported that two unknown patients (demographics not provided) were administered M-M-R II (albumin status unknown; lot number, dosage and route of administration not reported) that had been reconstituted with sterile diluent MRK on an unknown date that was improperly stored. No adverse effects reported. Temperature range/time frame reported as: > 32F but < 36F for 2 hours, and 1 cycle below 32F for 30 to 45 minutes. No further information provided. The is one of two cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA006765.
Sex: F
Vaccine: PNC13
Symptoms: Streptococcus test positive
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's mother). This mother reported for her 2 daughters. This is the 2nd case (younger daughter) out of the 2 cases. A female patient of an unspecified age (going to be 2) and ethnicity received PREVNAR 13 (Lot # not available) via an unspecified route of administration at single on an unspecified date for immunization, following the CDC schedule for vaccination. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced persistent sinus infections with outcome of not recovered, strep 2 infection with outcome of unknown, they were vaccinated but yet she was not having immunity with outcome of unknown, persistent problems with illness with outcome of not recovered. Therapeutic measures were taken as a result of persistent sinus infections, strep 2 infection. Course of events: After the vaccinations, the child was fine but fast forward a year or so later she was having persistent problems with illness with recurrent infections. Heavy growth strep was diagnosed at the end of Nov2016. Nasal swab test turned out that it was a Strep in the category of 2 which was puzzling to the paediatrician because she had been vaccinated for the strains that are covered in that type 2 category. The Pneumo titers were done and has immunity for 4 out of the 13 and actually that was not true, it was 4 out of the 23. [not reported clearly that out of the two children which child has immunity of 1 out of 13 and which child has immunity of 4 out of 2]. So the mother did not know if it was the 13 or if there was some that were outside of that has been vaccinated, she did not know but next one will be 4th. There was improvement for her and her younger sister for a few days while she was taking an antibiotic and then they had infections again. A pneumonia titer was done 22Dec2016 and it came back that the older child did not have immunity to any of the 13; she only had immunity to 19F. For the rest of the serotypes, the immunity was all under 2. Nasal Swab Test (Date unspecified): Strep type 2 infection. The family actually had different paediatrician during that time because they moved from one state to another but they were right on time with vaccinations, like within a day of the next eligible time period and the mother was calling about PREVNAR 13. The mother called since she was not sure but the children were vaccinated but then they found that they are having some repeated continual sinus infection problems. Her younger sibling has persistent sinus infections and there is the same situation with the younger sibling as with the oldest daughter. The mother concern was the fact the child was vaccinated but yet she was not having immunity towards she was vaccinated for and as a result have become quite ill. There is  a very resistant form of Strep and so the mother was wondering what was the percentage of efficacy when you go through the CDC recommended schedule of the 2 month, 4 month, 6 month and then between 12 and 15 month schedule. A Product Complaint was filed.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US024822, is an initial spontaneous report received from a healthcare professional on 23 Nov 2015. This report refers to a 48 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) multi dose vial (MDV) into left deltoid, intramuscularly, at a dose of 0.5 ml on 23 Nov 2015 at 09:46 am. It was reported that the vaccine administered was out of temperature range at 46.8 degree Fahrenheit for 24 hours. The case was reported as non-serious. No adverse event was reported following this medication error. Follow up report received from a healthcare professional on 21 Jan 2016: Added suspect drug information (batch number, vaccination site and time).
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Computerised tomogram normal, Mobility decreased, Neck pain, Pain in extremity, X-ray normal
Clinical narrative: Four hours after receiving the PPSV23 in her right deltoid and 2016 annual influenza shot in the left deltoid patient began having pain from neck on right side to below the elbow on the right side and pain has not subsided. She has difficulty with moving the arm without pain.
Age: 59.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Headache, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Fever/chills, headache, cold over kidneys, pain torso and head, fever wo chills, chills wo fever.  Very strong and relentless sx for 12 hours. Injection site swelling/inflam/heat larger than flat hand with fingers close together.
Age: 59.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Peripheral coldness, Pyrexia
Clinical narrative: Fever/chills, headache, cold over kidneys, pain torso and head, fever wo chills, chills wo fever.  Very strong and relentless sx for 12 hours. Injection site swelling/inflam/heat larger than flat hand with fingers close together.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Dehydration, Diarrhoea, Pain
Clinical narrative: Aches, pains, stomach pains, and diarrhea, dehydration.
Age: 66.0
Sex: F
Vaccine: FLUX, HEPAB, MMR
Symptoms: Antibody test positive
Clinical narrative: This literature marketed report was received from the authors in a published literature abstract title as stated below, concerning a 66 year old female patient (typed B*39:01, 44:02). The aim of this study was to analyze the reasons of fast (10 days) development of strong DSA in the recipient after single lung transplantation. The patient had two children. (typed 8*07:02, 44:02) and 1983 (typed 8*27:03, 39:01). The patient received pneumococcal (P) (manufacturer unknown) and shingle vaccinations zoster vaccine live (manufacturer unknown) in August 2008 and September 2009, respectively. In October 2014 the patient received pneumococcal (P) (manufacturer unknown) vaccination followed by two hepatitis a hepatitis a virus vaccine (manufacturer unknown) and hepatitis b virus vaccine (in September 2015 and in October 2015), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) in September 2015, influenza virus vaccine  and M-M-R II (dose, route, lot# and the expiration date were not reported)for prophylaxis in October 2015. There was no concomitant medication provided. It was reported that hepatitis a hepatitis a virus vaccine (manufacturer unknown), zoster vaccine live (manufacturer unknown) and M-M-R II vaccines contain viruses grown on live human lung fibroblasts (HLF) (MRC-5, typed 8*07:02, 44:02, and WI-38, typed 8*08:01, 58:01). Each dose of vaccine used for injection was known to contain protein components of hepatic leukemia factor (HLF) including Human leukocyte antigen (HLA). On 07-FEB-2016, the patient underwent single lung transplant (typed 8*81:01,15:17)  with negative Donor specific antibodies (DSA) and flow cytometry cross match (FC XM).Historical samples did not have any DSA and were FC XM negative. On 17-FEB-2016, a strong donor specific antibodies to B81 were detected in the patient. At the time of reporting, the outcome of donor specific antibody present was unknown.  Conclusions: Most likely fast de novo DSA development was due to immunological memory booster effect produced by five exposures to MM B locus alleles which share the following Es: 70IAQ. 65QIA, 65QIA+76esn, 69aa+80n, and 163ew+73te. The later three consist of paired non-self and self Es. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site irritation
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 63 year old male patient with no medical history, concurrent conditions and concomitant therapy. On 15-DEC-2016, the patient was vaccinated with ZOSTAVAX Injection for prophylaxis (strength, route, dose, lot number and expiration date were not provided). On 15-DEC-2016 (reported as since receipt of the vaccine), the patient had complained of irritation at the injection site, "almost like a bee sting". However, this was not described as a rash in any way. None lab diagnostic test were performed. The outcome of injection site irritation was reported as not recovered/not resolved. The causal relationship between the event and therapy with ZOSTAVAX was not assessed. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: MMR
Symptoms: Mumps, Mumps antibody test positive
Clinical narrative: Information has been received from a physician concerning to a 38 year old male patient with no pertinent medical history nor drug allergies. On 02-DEC-2016, was vaccinated with a dose of M-M-R II (Lot number not reported), subcutaneous for prophylaxis. No concomitant medications reported. On 19-DEC-2016, the patient was diagnosed with mumps, at an emergency room, but he was not admitted. The mumps titer was elevated. The patient did not receive treatment for the mumps. There was no intervention to prevent serious criteria, no disability, cancer, life threatening, overdose nor death were reported. On an unknown date the patient recovered from mumps. No product quality complaint was reported. The relationship between mumps and vaccination with M-M-R II was not reported. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 07-DEC-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: Original Case : 1701USA004150 US-009507513-1701USA007912: Original Case : 1701USA007906 US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site urticaria
Clinical narrative: Hives around injection site.
Age: 12.0
Sex: F
Vaccine: FLUX, HEPA, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Itchy at site of injection, red inflamed area.  Patient is now Dx w/cellulitis. As a note, RN providing immunization was not observed wearing gloves when administering immunization.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash with bumps on chest and back. No associated fever or difficulty breathing. Self resolved in 2-3 days.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives all over body + itchiness from hives. Patient came to me at the pharmacy today (1/20/17) stating he has had hives since 1/15/17. He has been taking Benadryl but once the Benadryl wears off he feels itchy again. This is his first time taking the Fluzone HD he normally always gets Fluvirin without any adverse reactions.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site which was about 3x2. Pt feels fine but was instructed by another RPh to go report it at the pharmacy where she got her immunization. Pt just wanted to let us know and I advised her to put a cold compress on it.
Age: 11.0
Sex: M
Vaccine: HPVX, MEN, TDAP
Symptoms: Dizziness, Headache, Hypoaesthesia, Nausea, Pain
Clinical narrative: Patient complained of pain, numbness in entire arm, large raised circular reaction, hot to touch, headache, nausea and felt faint. This lasted through Friday 7:00 AM. Treated with Aleve, and benadryl.
Age: 11.0
Sex: M
Vaccine: HPVX, MEN, TDAP
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient complained of pain, numbness in entire arm, large raised circular reaction, hot to touch, headache, nausea and felt faint. This lasted through Friday 7:00 AM. Treated with Aleve, and benadryl.
Age: 62.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arm got sore with swelling to the point I could pick up my arm. Used ice pack but did no good. It's been three days and now just getting my arm to move but still a bit sore.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Patient received FLUVIRIN vaccine in left deltoid muscle. Almost immediately the area swelled to about the size of a quarter. Patient was advised to stay in waiting room and to take diphenhydramine 50mg which he did. Swelling decreased within a 30 min time period of observation. Patient was advised to go to a walk-in clinic or ER if symptoms worsened or persisted. Patient did not feel need to go immediately and had no further symptoms. When contacted 2 hours later the swelling was significantly decreased with no further complications.
Age: 42.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pain, Pyrexia
Clinical narrative: She reported: severe hives, severe pain, golf size red raised area at injection site, fever, and feeling very sick for over a week.
Age: 42.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: She reported: severe hives, severe pain, golf size red raised area at injection site, fever, and feeling very sick for over a week.
Age: 12.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Erythema, Nausea, Paraesthesia, Peripheral swelling, Skin warm
Clinical narrative: Red, hot to touch, swollen from elbow to over shoulder, nausea, tingling in fingers.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyskinesia, Hypotonia, Musculoskeletal stiffness, Unresponsive to stimuli
Clinical narrative: Body went stiff and then went limp, he was unresponsive for about 10 minutes, during which time his limbs were also jerking.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Blood pressure increased, Dizziness, Lethargy
Clinical narrative: BP 215/114, pulse 114, week, dizzy, lethargic, BP continued to be above 100 bottom until 3:00 pm and then was 186/96, pulse 102 4:30 pm BP 178/78, pulse 83.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Pt experienced soreness on underside of right arm where ZOSTAVAX was given, as well as an itchy, red, circular rash. Pt was advised to use ice, topical steroid cream and topical BENADRYL.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Diagnostic procedure, Erythema, Pruritus
Clinical narrative: Red, itchy hives started on my bilateral lower legs. It progressed in distribution (to involve my entire body) and severity over the next several weeks.
Age: 24.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Anorectal manometry, Full blood count, Gastrointestinal disorder, Muscle twitching
Clinical narrative: About an hour after I received the HPV vaccine and Hep B vaccine administered at the same time together, I started getting twitching in my legs and calves. It soon spread to my arms and other areas of my body. Then months later, I started getting digestive problems that I'd never had before. I have seen various doctors and no one can figure it out as of yet.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: Tired, hard to breath, heart raise over normal. Nebulizer treatment, rest and observation for 3 and a half hours until heart came down to normal rate.
Age: 56.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Herpes zoster, Laboratory test, Neuralgia, Rash
Clinical narrative: HERPES ZOSTER, RASH, SHINGLES AND NEURALGIA.
Age: 56.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: HERPES ZOSTER, RASH, SHINGLES AND NEURALGIA.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Fever, redness, itching, swelling on the upper part of the arm to shoulder joint and top of clavicle, soreness.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Altered state of consciousness, Back pain, Chest pain, Cough, Erythema
Clinical narrative: Patient had redness, swelling, pain on arm of injection. Redness and swelling from shoulder down to elbows. (Left arm) Pain radiates to chest and jaws. Patient had fever on first night. Doctors visit recommended monitoring and follow-up if no improvement.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hyperhidrosis, Malaise, Nausea, Pain in extremity, Pain in jaw
Clinical narrative: Patient had redness, swelling, pain on arm of injection. Redness and swelling from shoulder down to elbows. (Left arm) Pain radiates to chest and jaws. Patient had fever on first night. Doctors visit recommended monitoring and follow-up if no improvement.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Peripheral swelling, Pyrexia, Wheezing
Clinical narrative: Patient had redness, swelling, pain on arm of injection. Redness and swelling from shoulder down to elbows. (Left arm) Pain radiates to chest and jaws. Patient had fever on first night. Doctors visit recommended monitoring and follow-up if no improvement.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chest pain, Injection site erythema, Injection site swelling, Pain in jaw, Pyrexia
Clinical narrative: Patient had redness, swelling, pain on arm of injection. Redness and swelling from shoulder down to elbows. (Left arm) Pain radiates to chest and jaws. Patient had fever on first night. Doctors visit recommended monitoring and follow-up if no improvement.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hypotonia
Clinical narrative: Baby went limp and quiet after getting the shots. Examined vital signs are good. After 5 minutes became reactive to external stimuli such as flicking of toes, cool water to face.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Rash pruritic, Scab, Skin lesion
Clinical narrative: Rash first showed on back, pruritic spread to chest, face, arms and scalp. Lesions different stages of development, occasional shell vesicles, redness to crusted over.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test
Clinical narrative: Rash first showed on back, pruritic spread to chest, face, arms and scalp. Lesions different stages of development, occasional shell vesicles, redness to crusted over.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose of Hepatitis A vaccine given instead of pediatric dose.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injected limb mobility decreased, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Immediate pain post injection lasting until present. Limited range of motion in left shoulder, severe pain with ROM, unable to sleep at night, unable to dress without pain, unable to exercise, tenderness to touch.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder, Tenderness, X-ray limb
Clinical narrative: Immediate pain post injection lasting until present. Limited range of motion in left shoulder, severe pain with ROM, unable to sleep at night, unable to dress without pain, unable to exercise, tenderness to touch.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV1
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Adrenal suppression, Blood cortisol decreased, Dyspnoea, Goitre, Pharyngeal oedema
Clinical narrative: Evolving rash/hives over the body with shortness of breath and airway swelling. Intervention with IV Steroids. Prolonged course requiring steroids subsequent. PE steroid induced thyroid swelling thyroidectomy. Adrenal suppression.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised, Thyroidectomy, Urticaria
Clinical narrative: Evolving rash/hives over the body with shortness of breath and airway swelling. Intervention with IV Steroids. Prolonged course requiring steroids subsequent. PE steroid induced thyroid swelling thyroidectomy. Adrenal suppression.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Arthralgia, Urticaria
Clinical narrative: Hives all over body. Severe joint pain.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling of the arm; improved in 2-3 days.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Severe pain of (L) upper arm that lasted 3-4 days after vaccination.
Age: 19.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: 1/6/17 spoke with patient. Informed of fever, redness, warmth at site. Arm sore. Encouraged ice packs, MOTRIN, and to see MD. 1/19/17 spoke with patient. Saw MD treated for cellulitis, BACTRIM X 10 days. Condition has improved.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Erythema, Joint swelling, Peripheral swelling, Pruritus, Sensation of foreign body
Clinical narrative: Extreme joint pain, Dysautonomia-POTS, chronic fatigue, daily debilitating headaches, constant shaking, chills, fever. Has not gotten better-still has all symptoms.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Antinuclear antibody positive, Arthralgia, Autonomic nervous system imbalance, Chills, Fatigue
Clinical narrative: Extreme joint pain, Dysautonomia-POTS, chronic fatigue, daily debilitating headaches, constant shaking, chills, fever. Has not gotten better-still has all symptoms.