chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 30-APR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.8
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 months 13 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 1.76
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (immunization official) referring to a 21 month old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 10-JUNJ-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIBVAX, lot # K010440 (expiration date, dose and route not reported) which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months 11 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.5
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months 11 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (immunization official) referring to a 4 year old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 10-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K015970(expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.7
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months 28 days old male patient. No concurrent condition, medical history of allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.8
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months 15 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.7
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months and 30 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.7
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months 8 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (immunization official) referring to a 4 year old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 10-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K015970 (expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.7
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months and 30 dyas old male patient. No concurrent condition, medical histtory or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product qualitty complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 12 year old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 18-AUG-2014, the patient was vaccinated with a dose of GARDASIL (dose and route were not reported, lot # K005083, expiration date 04-NOV-2016). On 27-AUG-2015, the patient was vaccinated with a dose of GARDASIL 9 (dose and route were not reported, lot # K026247). There was no adverse experience reported. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Influenza
Clinical narrative: Information has been received from a pharmacist referring to her son of unknown age. No concurrent, historical conditions or drug reactions/allergies were reported. On an unknown date, the patient was vaccinated with unspecified doses of (Oka/Merck) VARIVAX (dose, route, lot # and expiration date unknown)as a child. There was no concomitant medication reported. On an unknown date, the patient was vaccinated with unspecified does of (Oka/Merck) VARIVAX (dose, route, lot # and expiration date unknown) as a child. There was no concomitant medication reported. In December 2014, the patient developed the flu. The outcome of the event was unknown. Causality between the event and (Oka/Merck) VARIVAX was not reported. This is one of the reports front the same reporter. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months 1 day old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to 10 unspecified patients of unknown age and gender. No concurrent conditions and medical history were reported. On an unknown date (also reported as on either 14-AUG-2015 or 15-AUG-2015) the patients were vaccinated with improperly stored GARDASIL (Lot Number L020162, expiry date 23-JUL-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with GARDASIL was unknown. The outcome of events was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. No product quality complaint was reported. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 months 26 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K0116633, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (immunization official) referring to a 4 year old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 05-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K015970 (expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months 21 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.9
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 months 3 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.9
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 months 3 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.7
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months 4 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 1.6
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 months 19 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (immunization official) referring to a 5 year old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 10-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K015970 (expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to three patients of unknown age and gender. There was no medical history or concurrent condition reported. On unknown dates, 3 doses of improperly stored LIQUID PEDVAXHIB (lot # J016185 with expired date 02-OCT-2016, dose and route were unknown) were administered to the patients. No concomitant medication was provided. No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old male patient. The patient's medical history and concurrent conditions were not reported. On 10-SEP-2012, the patient was vaccinated   with the first dose of (Oka/Merck) VARIVAX (strength, route, anatomical location, lot number and expiration date were not reported). There was no concomitant therapies described On 02-AUG-2015, a second dose of (Oka/Merck) VARIVAX (lot reported L008969, exp date 11-MAR-2017) was administered to the patient. On 14-AUG-2014, reported as 10 days after the vaccination with (Oka/Merck) VARIVAX, the patient experienced rash, which outcome was unknown. The patient contacted the nurse. It was reported that the patient sought medical attention, but he did not receive treatment for the above event. There were not labs performed for this event. The nurse did not assess the rash with (Oka/Merck) VARIVAX. Additional information has been requested. The lot number L008969 is not valid for (Oka/Merck) VARIVAX.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site nodule
Clinical narrative: Information was received from a pharmacist via a company representative referring to a 54 years old female patient. There was no information about the patients medical history and concurrent condition. On 05-AUG-2015 the patient was vaccinated with ZOSTAVAX vial subcutaneously (strength, dose, and lot number unknown). Concomitant therapy was unknown. On 08-AUG-2015 the patient returned to the pharmacy and the patient had a hard knot the size of a quarter under her skin where the shot was received (the onset date of the adverse event was on an unspecified date in AUGUST 2015). The patient did not seek medical attention and no treatment was given to her. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to 3 unspecified patients. On 18-AUG-2015 the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L002419, expiration date 23-JUL-2016) (lot # L013545, expiration date 17-OCT-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # L006386; expiration date 25-FEB-2017), dose and route of administration were not reported. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.7
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months 18 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.8
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 months 24 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a child patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. On 06-AUG-2015 the patient was vaccinated with improperly stored PROQUAD (Merck) lot # L011079, expiry date 01-OCT-2016 (route of administration and dose not reported). The reporter stated she did not have the medical record at the time of the call. No adverse effects were reported. Additional information has been requested.
Age: 0.7
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months 16 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (immunization official) referring to a 4 year old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 10-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K026387(expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.8
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 21 months 26 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months 10 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This si one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 3 patients of unknown age and gender. The patients' concurrent condition, medical history or concomitant medications were not reported. On 14-AUG-2015 RECOMBIVAX HB lot # L001456; expiration date 22-OCT-2016 and lot # L003192; expiration date 22-OCT-2016 were improperly exposed to 70 degrees Fahrenheit for 2 minutes and to 28 degrees Fahrenheit for 10 minutes. Then on unspecified dates in AUGUST 2015, 3 patients received the improperly stored dose of RECOMBIVAX HB, dose and route of administration were unspecified. It was unspecified which patient received which   lot number. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: This spontaneous report as received from a consumer (also reported as patient's father) refers to a 19 year old female patient. No concurrent conditions and medical history were reported. On an unknown date approximately in August 2015 the patient was vaccinated with GARDASIL (dose 3), intramuscularly (lot number and expiry date unknown) (dosing regimen and frequency unknown) or GARDASIL 9 (dose 3), intramuscularly (lot number and expiry date unknown) (dose regimen and frequency unknown). No concomitant medications were reported. On 18-AUG-2015 (also reported as 6 hours after receiving an injection) the patient experienced muscle pain in the stomach. It was reported that the patient did not seek medical attention. It was reported that this was the final injection of GARDASIL or GARDASIL 9. The action taken with the therapy with GARDASIL or GARDASIL 9 was unknown. The outcome of myalgia was unknown. The relatedness of the events to the therapy with GARDASIL or GARDASIL 9 was unknown. There was no product quality issue reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. On 14-AUG-2015, ROTATEQ lot# L008034; expiration date 05-AUG-2016 was improperly exposed to 70 degrees Fahrenheit for 2 minutes and to 28 degrees Fahrenheit for 10 minutes. Then on unspecified date in August 2015, a patient received orally the improperly stored dose of ROTATEQ, dose was not specified. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist referring to her son of unknown age. There was no concurrent historical conditions or drug reactions/allergies. On an unknown date, the patient was vaccinated with unspecified doses of (Oka/Merck) VARIVAX injection (dose, route, lot# and expiration date unknown) as a child. There was no concomitant medication. In December 2014, the patient was diagnosed with shingles. The patient was seen by an unspecified nurse practitioner on an unspecified date. No lab diagnostics studies were performed to the patient. The patient was treated with VALTREX 1 gram "three times a day for a week" on an unspecified date. The outcome of the event was reported as recovered on unspecified date. Causality between the event and (Oka/Merck) VARIVAX was not reported. This is one of the reports from the same reporter. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months 10 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 6 months 1 day old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.9
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 months 8 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from   a nurse referring to two unspecified patients. On 188-AUG-2015 the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L001335, expiration date 13-JUL-2017) (dose and route unspecified) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Malaise, Pain
Clinical narrative: Redness at injection site and extending above and below. (L deltoid) body aches, chills, general malaise.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Rash, Rash erythematous, Rash pruritic, Ultrasound antenatal screen
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 17 year old female patient. The patient had no pertinent medical history, drug reactions or allergies nor concomitant medications. On 24-MAR-2011, the patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL lot # 0786Z and expiration date 18-OCT-2012 as her physician recommended. Then on 18-MAR-2014, she received the second intramuscular 0.5 ml dose of GARDASIL lot # J011272 and expiration date 21-APR-2016 as her physician recommended. The patient became pregnant with estimated last menstrual period (LMP) of 19-MAR-2015 (based on number of weeks of the pregnancy) and estimated delivery date (EDD) of 24-DEC-2015 (based on LMP). The patient finished the series of vaccinations on 21-JUL-2015 with the third 0.5 ml dose of GARDASIL 9 lot #K026246, expiration date 21-JAN-2017 administered intramuscularly per the physician's recommendation. Other suspect therapies included MENACTRA administered on the same day (dose, frequency, lot #, expiration date, route of administration not reported). On unspecified date in 2015, the patient experienced rash on her torso and both arms. The nurse stated the rash was present for over a month and it was raised, red, very itchy and painful after scratching. The patient was prescribed with prednisone (manufacturer unknown) but the rash got worse after she took the medication. The nurse stated the patient was seen at an unspecified clinic on 27-JUL-2015 (reported as 2 weeks ago) due to the rash. The patient was seen at an unspecified women's clinic on 06-AUG-2015 and had an ultrasound performed, which showed she was 20 weeks pregnant. The nurse stated the patient was also seen in their office on 06-AUG-2015 due to the rash. The nurse stated the patient was prescribed WESTCORT cream for the rash. The outcome of the event was unknown. The pregnancy outcome was pending and fetal outcome was unknown. The relatedness between the event and GARDASIL, GARDASIL 9 and MENACTRA was unknown. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 1 year old patient of unknown gender. The patient's concurrent condition, medical history or concomitant medications were not reported. On 11-AUG-2015, the patient was inadvertently vaccinated with PNEUMOVAX 23 (dose, lot #, expiration date and route of administration not reported) instead of PREVNAR 13. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 4 patients of unknown age and gender. The patients' concurrent condition, medical history or concomitant medications were not reported. On 14-AUG-2015, VAQTA lot # L00271; expiration date 02-JUN-2017 and lot # L009445; expiration: 01-JUN-2017 were improperly exposed to 70 degrees Fahrenheit for 2 minutes and to 28 degrees Fahrenheit for 10 minutes. Then no unspecified dates in August 2015, 4 patients received the improperly stored doses of VAQTA, dose and route of administration were unspecified. It was unspecified which patient received which lot number. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Syncope, Throat tightness
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. Concurrent or medical conditions were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route and lot number were not reported). Secondary suspects and concomitant therapies were not reported. The physician reported that on an unknown date, the patient experienced syncope past the 15 minute observation time and a tightening in her throat while on therapy with GARDASIL 9. On an unknown date, the patient recovered from syncope and tightening in her throat. The patient did not sought medical attention. No treatment was given for the events. The events did not required intervention to prevent serious criteria, did not produce significant disability or incapacity, did not required hospitalization and there were not life threatening for the patient. No product quality complaint was reported. Additional information is not expected as the reporter did not wish further contact.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of hepatitis B surface antigen positive in a male patient who received ENGERIX B. Concurrent medical conditions included liver transplant (did not collect dates) and hemodialysis (did not collect dates). On 3rd January 2015, the patient received ENGERIX B. On 5th January 2015, 2 days after receiving ENGERIX B, the patient experienced hepatitis B surface antigen positive. On an unknown, the outcome of the hepatitis B surface antigen positive was not recovered/not resolved. It was unknown if the reporter considered the hepatitis B surface antigen positive to be related to ENGERIX B. Additional information: On 3 January 2015 a patient received a dose of ENGERIX B. Five days before the patient received the dose they had blood work pulled that showed that the patient was HBsAg negative. Forty-eight hours after receiving the ENGERIX B dose the patient had blood work pulled again showing that they were HBsAg positive. They pulled blood work again for a 2nd time on 10 January 2015 and the patient is still showing positive for HBsAg.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. There was no concurrent condition, medical history or concomitant medication reported. The pharmacist stated, that an unspecified female patient was vaccinated with the first dose of GARDSAIL (batch #; lot #, dose and route of administration were not reported) on an unspecified date in November 2012. The patient received the second and third doses of GARDASIL (batch #; lot #, dose and route of administration were not reported) on an unspecified date in January 2015, and on an unspecified date in February 2015, respectively. No adverse effect was reported. PQC (product quality complaint) was not involved. Additional information has been requested.
Age: 0.8
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 9 months 13 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot# L006386, expiration date 25-FEB-2017), dose and route of administration were not reported. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter.  Additional information has been requested.
Age: 1.8
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 22 months 16 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 1.9
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 23 months 16 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of unspecified patients of unknown age and unknown gender. From 16-JUN-2015, the unspecified number of unspecified patients were vaccinated with improperly stored doses of ROTATEQ (lot # K013861 and expiry date: 18-MAY-2016). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.7
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months 7 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: VARCEL
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. On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX lot # L015046, expiry date 29-APR-2017 that may have been exposed to temperatures outside of the recommended range and no adverse experiences were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 1.6
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 months 8 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.