chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 year old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 17-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868 US-009507513-1902USA009324:Original Case : 1902USA009323 US-009507513-1902USA009325:Original Case : 1902USA009323 US-009507513-1902USA009326:Original Case : 1902USA009323.
Age: 1.08
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13 month old Child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 17-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009325: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Age: 1.58
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 19 month old Child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 13-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009325: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old infant patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 13-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009325: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 05-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868 US-009507513-1902USA009324:Original Case : 1902USA009323US-009507513-1902USA009323:Original Case : 1902USA009323 US-009507513-1902USA009326:Original Case : 1902USA009323.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 05-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009323: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 03-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009323: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 02-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009323: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 9 weeks old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 28-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868 US-009507513-1902USA009324:Original Case : 1902USA009323 US-009507513-1902USA009323:Original Case : 1902USA009323 .-009507513-1902USA009326:Original Case : 1902USA009323.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 28-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009323: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 28-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009323: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 26-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009323: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 7 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 25-SEP-2018, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868 US-009507513-1902USA009324:Original Case : 1902USA009323 US-009507513-1902USA009323:Original Case : 1902USA009323 US-009507513-1902USA009326:Original Case : 1902USA009323.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 3 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 25-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009323: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 24-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009323: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 8 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 24-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009323: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 7 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 21-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868 US-009507513-1902USA009324:Original Case : 1902USA009323 US-009507513-1902USA009323:Original Case : 1902USA009323 US-009507513-1902USA009326:Original Case : 1902USA009323.
Age: 0.75
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 9 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 17-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009323: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 7 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 14-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323. US-009507513-1902USA009323:Original Case : 1902USA009323 US-009507513-1902USA009326:Original Case : 1902USA009323
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 10 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 14-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009323:Original Case : 1902USA009323; US-009507513-1902USA009326:Original Case : 1902USA009323.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 14-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323 US-009507513-1902USA009326: Original Case : 1902USA009323.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 3 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 12-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323 US-009507513-1902USA009326: Original Case : 1902USA009323.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 10-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323 US-009507513-1902USA009326: Original Case : 1902USA009323.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a 68 year old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 22-FEB-2019, the patient was vaccinated with an expired dose of ZOSTAVAX lot # N032103 with expiration date of 11-FEB-2019 for prophylaxis (dose, route of administration and anatomical location were not reported). No  adverse effects were reported.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 16-NOV-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 7 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 13-NOV-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 06-NOV-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009323:Original Case : 1902USA009323.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 05-NOV-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323  US-009507513-1902USA009323: Original Case : 1902USA009323.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 7 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 05-NOV-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 31-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 29-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 8 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 25-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 7 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 23-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 23-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient experienced flu like symptoms. The reporter did not have any additional information regarding the patient or event. This case was one of the 5 cases, reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site swelling, Lymph node pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 12th February 2019, the patient received the 2nd dose of SHINGRIX. On 14th February 2019, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and lymph node pain. On 15th February 2019, the patient experienced burning sensation and pain. On an unknown date, the outcome of the burning sensation, injection site erythema, injection site swelling, lymph node pain and pain were unknown. It was unknown if the reporter considered the burning sensation, injection site erythema, injection site swelling, lymph node pain and pain to be related to SHINGRIX. Additional details were provided as follows: On Tuesday, the patient received SHINGRIX. A day before reporting, the patient experienced that injection site was red and swollen, and her lymph nodes under her arm were painful. On the day of reporting, the patient had painful burning type of sensation all along the outer edge of her arm, armpit, and part ways down her left side. So far it was not a severe pain, but it was something that the patient had never experienced before, and since it happened after shot, the patient was a little concerned and just need some confirmation that she was okay. There was no rash along the site. The patient wondered if she was actually getting shingles due to the vaccine. The patient has not contacted her physician till the time of reporting. The patient asked if this was a reaction to the vaccine. she have not read about this reaction in the patient leaflet or on the medical websites. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever, headache, muscle pain, pain in arm and stomach discomfort. On an unknown date, the outcome of the fever, headache, muscle pain, pain in arm and stomach discomfort were unknown. It was unknown if the reporter considered the fever, headache, muscle pain, pain in arm and stomach discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient said she experienced all of the side effects listed plus a temperature of 101 and wanted to know whether it was normal. The patient experienced side effects like headache, muscle aches, fever of 101, whole arm pain and also mild stomach discomfort. Lab Comments: On unknown date, the body temperature was recorded.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Blister, Herpes zoster, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 63-year-old female patient who received SHINGRIX (batch number G72ZD, expiry date 24th November 2020) for prophylaxis. The patient's past medical history included rheumatoid arthritis.  On 5th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th February 2019, less than a day after receiving SHINGRIX, the patient experienced feeling unwell, injection site pain, upset stomach and weakness. On 14th February 2019, the patient experienced shingles and blister. In February 2019, the patient experienced pain. On an unknown date, the outcome of the shingles, feeling unwell, injection site pain, upset stomach, weakness, pain and blister were unknown. It was unknown if the reporter considered the shingles, feeling unwell, injection site pain, upset stomach, weakness, pain and blister to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. On the day of vaccination, the patient felt a little sick, complained of soreness at the injection site, upset stomach and weakness. Less than a month after receiving SHINGRIX, the symptoms started to get worse and she began to experience a lot of pain. Nine days after receiving SHINGRIX, the patient broke out in blisters. The next day, the patient was diagnosed by her physician. The shingles was on the right side of her body.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 63-year-old female patient who received SHINGRIX (batch number G72ZD, expiry date 24th November 2020) for prophylaxis. The patient's past medical history included rheumatoid arthritis.  On 5th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th February 2019, less than a day after receiving SHINGRIX, the patient experienced feeling unwell, injection site pain, upset stomach and weakness. On 14th February 2019, the patient experienced shingles and blister. In February 2019, the patient experienced pain. On an unknown date, the outcome of the shingles, feeling unwell, injection site pain, upset stomach, weakness, pain and blister were unknown. It was unknown if the reporter considered the shingles, feeling unwell, injection site pain, upset stomach, weakness, pain and blister to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. On the day of vaccination, the patient felt a little sick, complained of soreness at the injection site, upset stomach and weakness. Less than a month after receiving SHINGRIX, the symptoms started to get worse and she began to experience a lot of pain. Nine days after receiving SHINGRIX, the patient broke out in blisters. The next day, the patient was diagnosed by her physician. The shingles was on the right side of her body.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a adult female patient who received SHINGRIX for prophylaxis. On 14th February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, 18 hrs after receiving SHINGRIX, the patient experienced chills, tiredness and headache. The patient was treated with paracetamol (Acetaminophen). On an unknown date, the outcome of the chills, tiredness and headache were not recovered/not resolved. It was unknown if the reporter considered the chills, tiredness and headache to be related to SHINGRIX. Additional details were provided as follows: Age at vaccination was not reported however patient could be adult at time of vaccination. On 14th February 2019, the patient received her 2nd dose. About 18 hours later on 15th February 2019, she started to experience chills, felt tired and a little headache. She did not experienced these symptoms after the first dose of series. No further information provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a adult female patient who received SHINGRIX for prophylaxis. On 14th February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, 18 hrs after receiving SHINGRIX, the patient experienced chills, tiredness and headache. The patient was treated with paracetamol (Acetaminophen). On an unknown date, the outcome of the chills, tiredness and headache were not recovered/not resolved. It was unknown if the reporter considered the chills, tiredness and headache to be related to SHINGRIX. Additional details were provided as follows: Age at vaccination was not reported however patient could be adult at time of vaccination. On 14th February 2019, the patient received her 2nd dose. About 18 hours later on 15th February 2019, she started to experience chills, felt tired and a little headache. She did not experienced these symptoms after the first dose of series. No further information provided.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, 14 hrs after receiving SHINGRIX, the patient experienced sickness, nausea, pain, headache and fatigue. On an unknown date, the outcome of the sickness was unknown and the outcome of the nausea, pain, headache and fatigue were not recovered/not resolved. It was unknown if the reporter considered the sickness, nausea, pain, headache and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was very sick 14 hours after receiving vaccine and asked how long it would last. The patient also experiencing nausea, aches with a headache, fatigue and was on bed most of the day.