chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Follow-up information received from the licensed practical nurse on 28-APR-2017 refers to a 9-week-old patient of unknown gender. On 15-AUG-2016, the patient received an improperly stored dose of RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported). Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1705USA004894: US-009507513-1705USA004895: US-009507513-1705USA004896: US-009507513-1705USA004897: US-009507513-1705USA004898: US-009507513-1705USA004899: US-009507513-1705USA004893: US-009507513-1705USA004892: US-009507513-1705USA004890: US-009507513-1705USA004889: US-009507513-1705USA004888: US-009507513-1705USA004887: US-009507513-1705USA004891: US-009507513-1705USA005004: US-009507513-1705USA005005: US-009507513-1705USA005006: US-009507513-1705USA005007: US-009507513-1705USA004976: US-009507513-1705USA004977: US-009507513-1705USA004978: US-009507513-1705USA004979: US-009507513-1705USA004980: US-009507513-1705USA004981: US-009507513-1705USA004982: US-009507513-1705USA004983: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA004942: US-009507513-1705USA004944: US-009507513-1705USA004945: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004949: US-009507513-1705USA004950: US-009507513-1705USA004951: US-009507513-1705USA004952: US-009507513-1705USA004953: US-009507513-1705USA004954: US-009507513-1705USA004955: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: US-009507513-1705USA004960: US-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004963: US-009507513-1705USA004964: US-009507513-1705USA004965: US-009507513-1705USA004966: US-009507513-1705USA004967: US-009507513-1705USA004968: US-009507513-1705USA004969: US-009507513-1705USA004975: US-009507513-1705USA004974: US-009507513-1705USA004973: US-009507513-1705USA004972: US-009507513-1705USA004971: US-009507513-1705USA004970: US-009507513-1705USA004946: MERCK 1608USA012916: Mfr number.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant (also reported as a nurse) referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot# M025865, expiration date 24-MAY-2018; dose and route unknown) for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Telephone call attempt on 16-MAY-2016 to obtain follow-up information was unsuccessful. Additional information has been requested.; Sender's Comments:  US-009507513-1610USA011727:, MERCK 1610USA011945:Mfr number.
Sex: F
Vaccine: HPV9
Symptoms: Back pain
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 14 year old female patient. The patient had no medical history and current illnesses. The patient's other medications and prior vaccinations were not reported. On 09-MAY-2016, the patient was vaccinated with third dose of GARDASIL 9, route of administration: through needle and syringe (not specified), in the right arm (dose, frequency, lot number and lot expiration date were not reported) for prophylaxis. On 10-MAY-2016, the patient experienced severe pain throughout back. The outcome of back pain was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M041213 with expiration date 22-JUN-2019 and lot # M037770 with expiration date 01-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 13.1 degrees Celsius for 7 hours and 50 minutes. A Digital Data Logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007303: US-009507513-1705USA007304: US-009507513-1705USA007305: US-009507513-1705USA007306: US-009507513-1705USA007307: US-009507513-1705USA007308.
Sex: U
Vaccine: VARCEL
Symptoms: Accidental exposure to product, Exposure via eye contact, Exposure via skin contact, No adverse event
Clinical narrative: This spontaneous report was received from an office manager, concerning a patient of an unknown age and gender who was also a medical assistant. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 27-APR-2017, the medical assistant was topically exposed to VARIVAX reconstituted with sterile diluent (manufacturer unknown) (lot # and expiration date were not reported for neither of them), during the vaccine preparation (Occupational exposure to product). The vaccine came into contact with the medical assistant's eye, mouth and skin. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site extravasation, Overdose
Clinical narrative: This spontaneous report was received from a pharmacist , concerning a 1 year old female patient. The patient's concurrent conditions and pertinent medical history were not mentioned. On 28-APR-2017, the patient was vaccinated with VAQTA 25/0.5 (units not provided) 2 doses, given intramuscularly, which had lot # N005605 with expiry date on 08-APR-2018 prophylaxis. Concomitant therapies included PROQUAD. The reporting pharmacist stated that the patient received an adult dose and some of the vaccine leaked out of thigh; the patient experienced an overdose; however no adverse effects were noted. She did not seek medical attention and no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 06-APR-2017 and 01-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M016193, expiration date 24-APR-2018, intramuscularly (dose was not reported) in immunization series. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 1 hour and 53 minute and of 34.7 degrees Fahrenheit for 1 hour and 25 minutes. There were no previous temperature excursions reported. A Digital Data Logger was involved. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1705USA007706: US-009507513-1705USA007707: US-009507513-1705USA007708: US-009507513-1705USA007710: US-009507513-1705USA007711: US-009507513-1705USA007712: US-009507513-1705USA007705: US-009507513-1705USA007709.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker (reported also as immunization official) and refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M031557 with an expiration date 07-APR-2019 for prophylaxis (doses, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered doses of GARDASIL 9 experienced the temperature excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 hour. There was no previous temperature excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact with the physician. Sender's Comments: US-009507513-1705USA008192.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unknown number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions or concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M023932 with an expiration date in 24-DEC-2017 and Lot # M023932 with an expiration date 09-NOV-2017), for prophylaxis, that underwent a temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit, for a time frame of 32 hours and 13 minutes. The vaccines had a previous temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for a time frame of 14 hours. No digital data logger was involved, no adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of an unknown gender and age. There was no information about the patient's concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date in 2016 (reported as between May 2016 and December 2016), the patient was vaccinated with improperly stored VARIVAX lot # L021214 with expiration date of 10-JUN-2017, for prophylaxis (dose and route of administration were not reported), diluted in properly stored sterile diluent (dose, lot number and expiration date were not reported). Administered dose of vaccine experienced the temperature excursion of 15-46 degrees Fahrenheit (°F) for 12 hours. There were previous excursions of 15-46 degrees Fahrenheit (°F) for 29 hours.  There was not data logger involved. No adverse symptoms were reported. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001690: US-009507513-1705USA001692:
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-MAY-2017, the 13 year old patient was inadvertently vaccinated with a dose of PROQUAD (formulation, dose, frequency, route of administration and anatomical location of administration were not reported) lot # M043310, expiration date 24-APR-2018 for prophylaxis. Other suspect therapies included STERILE DILUENT used to reconstitute the dose of PROQUAD (lot # and expiration date were not provided). No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. The patient did not have concurrent conditions, any known allergies or reactions, medical history or concomitant medications. On an unknown date, the patient was vaccinated with ZOSTAVAX, for prophylaxis (dose, route of administration, lot number and expiration date were not reported) diluted with sterile diluent (DILUENT MRK INJECTION) (dose, route of administration, lot number and expiration date were not reported).     The patient had rheumatoid arthritis diagnosed on an unspecified date and was currently taking unspecified immunosuppressive medications. On an unknown date (reported as an unspecified amount of time later) the patient "got shingles" (herpes zoster). Therefore, she sought medical attention and received unspecified treatment. No laboratory tests were performed. The outcome of rheumatoid arthritis and shingles (herpes zoster) was unknown. No product quality complaint was involved. The causal relationship between the events and the suspect therapies ZOSTAVAX and sterile diluent (DILUENT MRK INJECTION) was unknown. Upon internal review the event rheumatoid arthritis was considered to be medically significant. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 9-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 15-AUG-2016, the patient was vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported) and ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012916.
Age: 0.17
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an 8-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-AUG-2016, the patient was vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported) and ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012916.
Age: 12.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 month old patient. The patient's medical history and concurrent conditions were not provided. On 11-MAY-2017 the patient was vaccinated with M-M-R II (dose and route of administration were not reported, lot # L026551 with expiration date: 16-JUL-2017). Other suspect therapies included STERILE DILUENT and PROQUAD (dose and route of administration were not reported, lot # L050910 with expiration date: 14-JUN-2017). Concomitant medications were not reported. The nurse reported patient received a simultaneous administration of M-M-R II and PROQUAD both reconstituted with STERILE DILUENT. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from an unspecified reporter and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown dates, the patient was intramuscularly vaccinated with 4 doses of LIQUID PEDVAXHIB (dose was not reported,lot # M045206 with expiration date: 27-APR-2019). Concomitant medications were not reported. No side effects reported. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 22-MAR-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (which had the lot # M030138, expiration date 15-JUN-2018) dosage information, route and anatomical site of vaccination were not informed, for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse effects were reported. The vaccine experienced temperatures from 15°F to 46°F (28.4F). Time: for 75 hours. There was no previous temperature excursion. The call was not because of a "data logger". Outcome: Supported for 1 month. It was also exposed to temperatures of 6°F to 14°F for 50 hours. There was no product quality complaint involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report has been received from a medical assistant concerning a 26 year old female patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 16-JUL-2007, the patient was vaccinated with the first dose of GARDASIL (dose, strength, route of administration, anatomical location, lot# and expiration date were not provided), for prophylaxis. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (dose, strength, route of administration, anatomical location, lot# and expiration date were not provided), for prophylaxis. On 07-APR-2017, the patient was vaccinated with the third dose of GARDASIL 9, 0.5 ml, one dose, intramuscularly (lot # M035486 with expiration date 05-JUN-2019), for prophylaxis. On 20-APR-2017, the patient contacted her physician, when she learned that she was pregnant. It was determined that the patient was four weeks pregnant at the time of the third vaccination. No adverse effects were reported. The patient's last menstrual period was on 10-MAR-2017 and estimated date of delivery was 15-DEC-2017. Additional information has been requested.
Age: 55.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers a 55 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions and concomitant medication were not reported. It was stated that the pharmacy received the ZOSTAVAX on 15-JUL-2016. On 29-JAN-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque-forming unit (PFU) injection, subcutaneously, 0.65 ml, lot # M014310, expiry date 26-MAY-2017 (anatomical location was not specified) for prophylaxis. On 22-MAR-2017, the pharmacy was audited by The Board of Pharmacy. The freezer temperature where ZOSTAVAX was stored was registered by the pharmacy thermometer as 2 Fahrenheit degrees, however the auditor's thermometer registered the temperature as 9 Fahrenheit degrees which was considered as a temperature excursion. The Board of Pharmacy auditor determined that the pharmacy's freezer thermometer should have been calibrated. Seven of the 10 doses of ZOSTAVAX that had undergone the temperature excursion had been administered to 7 patients between July 2016 and January 2017 (also reported as "over an 11 months period"). The remaining 3 doses were sent back for disposal. There was no previous temperature excursion. No adverse effect were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments: US-009507513-1705USA006382: US-009507513-1705USA006383: US-009507513-1705USA006384: US-009507513-1705USA006385: US-009507513-1705USA006380: US-009507513-1703USA010654:
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers a 64 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions and concomitant medication were not reported. It was stated that the pharmacy received the ZOSTAVAX on 15-JUL-2016. On 16-OCT-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque-forming unit (PFU) injection, subcutaneously, 0.65 ml, lot # M014310, expiry date 26-MAY-2017 (anatomical location was not specified) for prophylaxis. On 22-MAR-2017, the pharmacy was audited by The Board of Pharmacy. The freezer temperature where ZOSTAVAX was stored was registered by the pharmacy thermometer as 2 Fahrenheit degrees, however the auditor's thermometer registered the temperature as 9 Fahrenheit degrees which was considered as a temperature excursion. The Board of Pharmacy auditor determined that the pharmacy's freezer thermometer should have been calibrated. Seven of the 10 doses of ZOSTAVAX that had undergone the temperature excursion had been administered to 7 patients between July 2016 and January 2017 (also reported as "over an 11 months period"). The remaining 3 doses were sent back for disposal. There was no previous temperature excursion. No adverse effect were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments: US-009507513-1703USA010654: US-009507513-1705USA006383: US-009507513-1705USA006384: US-009507513-1705USA006385: US-009507513-1705USA006380: US-009507513-1705USA006381:
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers a 61 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions and concomitant medication were not reported. It was stated that the pharmacy received the ZOSTAVAX on 15-JUL-2016. On 14-NOV-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque-forming unit (PFU) injection, subcutaneously, 0.65 ml, lot # M014310, expiry date 26-MAY-2017 (anatomical location was not specified) for prophylaxis. On 22-MAR-2017, the pharmacy was audited by The Board of Pharmacy. The freezer temperature where ZOSTAVAX was stored was registered by the pharmacy thermometer as 2 Fahrenheit degrees, however the auditor's thermometer registered the temperature as 9 Fahrenheit degrees which was considered as a temperature excursion. The Board of Pharmacy auditor determined that the pharmacy's freezer thermometer should have been calibrated. Seven of the 10 doses of ZOSTAVAX that had undergone the temperature excursion had been administered to 7 patients between July 2016 and January 2017 (also reported as "over an 11 months period"). The remaining 3 doses were sent back for disposal. There was no previous temperature excursion. No adverse effect were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1705USA006382: US-009507513-1703USA010654: US-009507513-1705USA006384: US-009507513-1705USA006385: US-009507513-1705USA006380: US-009507513-1705USA006381.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers a 60 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions and concomitant medication were not reported. It was stated that the pharmacy received the ZOSTAVAX on 15-JUL-2016. On 02-DEC-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque-forming unit (PFU) injection, subcutaneously, 0.65 ml, lot # M014310, expiry date 26-MAY-2017 (anatomical location was not specified) for prophylaxis. On 22-MAR-2017, the pharmacy was audited by The Board of Pharmacy. The freezer temperature where ZOSTAVAX was stored was registered by the pharmacy thermometer as 2 Fahrenheit degrees, however the auditor's thermometer registered the temperature as 9 Fahrenheit degrees which was considered as a temperature excursion. The Board of Pharmacy auditor determined that the pharmacy's freezer thermometer should have been calibrated. Seven of the 10 doses of ZOSTAVAX that had undergone the temperature excursion had been administered to 7 patients between July 2016 and January 2017 (also reported as "over an 11 months period"). The remaining 3 doses were sent back for disposal. There was no previous temperature excursion. No adverse effect were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1705USA006382: US-009507513-1705USA006383: US-009507513-1703USA010654: US-009507513-1705USA006385: US-009507513-1705USA006380: US-009507513-1705USA006381.
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers a 53 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions and concomitant medication were not reported. It was stated that the pharmacy received the ZOSTAVAX on 15-JUL-2016. On 29-JAN-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque-forming unit (PFU) injection, subcutaneously, 0.65 ml, lot # M014310, expiry date 26-MAY-2017 (anatomical location was not specified) for prophylaxis. On 22-MAR-2017, the pharmacy was audited by The Board of Pharmacy. The freezer temperature where ZOSTAVAX was stored was registered by the pharmacy thermometer as 2 Fahrenheit degrees, however the auditor's thermometer registered the temperature as 9 Fahrenheit degrees which was considered as a temperature excursion. The Board of Pharmacy auditor determined that the pharmacy's freezer thermometer should have been calibrated. Seven of the 10 doses of ZOSTAVAX that had undergone the temperature excursion had been administered to 7 patients between July 2016 and January 2017 (also reported as "over an 11 months period"). The remaining 3 doses were sent back for disposal. There was no previous temperature excursion. No adverse effect were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments: US-009507513-1705USA006382: US-009507513-1705USA006383: US-009507513-1705USA006384: US-009507513-1703USA010654: US-009507513-1705USA006380: US-009507513-1705USA006381:
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On 11-MAY-2017, the patient inadvertently received an expired dose of GARDASIL 9 lot # L045711 and expiration date 08-MAY-2017 (route of administration, dose and anatomical location were not provided) for prophylaxis. No adverse effects reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Nausea, Neck pain, Pain, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 12 year old male patient. On 01-FEB-2017, the patient was vaccinated with GARDASIL 9 (lot # M024261), (route: intramuscular) in the right arm. On 02-FEB-2017 (with in 24 hours of vaccine administration), the patient experienced headache, vomiting, pyrexia, pain, neck pain and nausea. The patient seen in clinic on 02-FEB-2017 and symptoms had improved at the time of the visit. It was also reported that, patient's exam was reassuring. The patient scheduled for follow up on 03-FEB-2017 for re-evaluation. The causality of the events was unknown. Additional information is not expected because no further information could be obtained from the regulatory authority.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 12 year old male patient. On 01-FEB-2017, the patient was vaccinated with GARDASIL 9 (lot # M024261), (route: intramuscular) in the right arm. On 02-FEB-2017 (with in 24 hours of vaccine administration), the patient experienced headache, vomiting, pyrexia, pain, neck pain and nausea. The patient seen in clinic on 02-FEB-2017 and symptoms had improved at the time of the visit. It was also reported that, patient's exam was reassuring. The patient scheduled for follow up on 03-FEB-2017 for re-evaluation. The causality of the events was unknown. Additional information is not expected because no further information could be obtained from the regulatory authority.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies provided. On unknown dates, from 01-FEB-2017 to 28-FEB-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot# M028323, expiration date: 26-SEP-2018; lot# M017983, expiration date: 30-MAY-2018; lot# M041212, expiration date: 21-JUN-2019; lot# M041990, expiration date: 28-JUN-2019 (dose and route of administration were not provided). There were no adverse events. Administered doses of vaccines were stored in temperature between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 2 hours. Digital Data logger was used to capture temperature excursions. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. The nurse stated that the reason for temperature excursion was the refrigerator needing service. It was also added that there were no other temperature excursions once the service was completed. Reporter also stated that she would call back with the information regarding patients who received improperly stored vaccines. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007278: US-009507513-1705USA007279: US-009507513-1703USA005900.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies provided. On unknown dates, from 01-FEB-2017 to 28-FEB-2017, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot# M036058, expiration date: 19-MAY-2019; lot# M046133, expiration date: 26-SEP-2019; lot# M046134, expiration date: 27-SEP-2019 (dose and route of administration were not reported). There were no adverse effects. Administered doses of vaccines were stored in temperature between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 2 hours. Digital Data logger was used to capture temperature excursions. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. The nurse stated that the reason for temperature excursion was the refrigerator needing service. It was also added that there were no other temperature excursions once the service was completed. Reporter also stated that she would call back with the information regarding patients who received improperly stored vaccines. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007277: US-009507513-1705USA007279: US-009507513-1703USA005900.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported. Administered vaccines experienced a temperature of -4.4 degrees Celsius for undetermined time. There was no previous temperature of excursion. Data logger was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA007967.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported. Administered vaccines experienced a temperature of -4.4 degrees Celsius for undetermined time. There was no previous temperature of excursion. Data logger was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA007838.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from healthcare worker (reported also as immunization official) and refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot#M036056 with an expiration date 18-MAY-2019 for prophylaxis. There was no adverse effect reported. Administered doses of PEDVAXHIB experienced the temperature excursion form 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. A digital data logger was involved. This is one of several reports from the same reporter. Additional information is not expected as there was no consent to contact with the physician. Sender's Comments: US-009507513-1705USA000815.
Age: 1.92
Sex: M
Vaccine: PNC13
Symptoms: Cerebrospinal fluid leakage, Cochlea implant, Complication associated with device, Dehydration, Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's parent). A 23-month-old male patient received PREVNAR 13, via an unspecified route of administration in the thigh, on 02May2017 afternoon, at single dose, for immunisation. Medical history included deaf, pectus excavatum, cochlear function disorder, cortical dysplasia and latent tuberculosis. There were no concomitant medications. The patient had cochlea implant surgery on 04May2017. The patient experienced fever of 102 F on 06May2017 with outcome of recovering, UTI (urinary tract infection) on an unspecified date with outcome of not recovered, leg of vaccination site became really red and a swollen lump like a small egg on 02May2017 with outcome of recovered between 04May2017 and 09May2017 and dehydration on 07May2017 with outcome of unknown. The patient was hospitalized due to fever of 102 F from 07May2017 to 08May2017. The patient underwent lab tests and procedures which included body temperature: 102 F (Fahrenheit) on 06May2017, 103.5 F on 07May2017, 101.5 F on 07May2017, 99 F on 08May2017. Therapeutic measures were taken as a result of fever of 102 F and included treatment with TYLENOL. Clinical course: on 07May2017 they had to go to the doctor because the patient was leaking spinal fluid. The same day the patient had a second surgery because there was a complication with the seal and they had to go back in and reseal it. When he came out of surgery he had a fever of 103.5 F but they believed it was due to dehydration and UTI that was brewing. They brought the fever down but he was admitted to the hospital on 07May2017 and late that evening his fever was back up to 101.5 F. On 08May2017 his temperature reached only 99 F and in the evening the patient was released from the hospital. The reporter thought that maybe UTI was due to the anesthesia from the first surgery because heard that it could cause this because of urine retention, patient's doctor felt like the UTI was brewing before the first surgery.
Age: 1.92
Sex: M
Vaccine: PNC13
Symptoms: Laboratory test, Post procedural complication, Pyrexia, Urinary tract infection, Vaccination site mass
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's parent). A 23-month-old male patient received PREVNAR 13, via an unspecified route of administration in the thigh, on 02May2017 afternoon, at single dose, for immunisation. Medical history included deaf, pectus excavatum, cochlear function disorder, cortical dysplasia and latent tuberculosis. There were no concomitant medications. The patient had cochlea implant surgery on 04May2017. The patient experienced fever of 102 F on 06May2017 with outcome of recovering, UTI (urinary tract infection) on an unspecified date with outcome of not recovered, leg of vaccination site became really red and a swollen lump like a small egg on 02May2017 with outcome of recovered between 04May2017 and 09May2017 and dehydration on 07May2017 with outcome of unknown. The patient was hospitalized due to fever of 102 F from 07May2017 to 08May2017. The patient underwent lab tests and procedures which included body temperature: 102 F (Fahrenheit) on 06May2017, 103.5 F on 07May2017, 101.5 F on 07May2017, 99 F on 08May2017. Therapeutic measures were taken as a result of fever of 102 F and included treatment with TYLENOL. Clinical course: on 07May2017 they had to go to the doctor because the patient was leaking spinal fluid. The same day the patient had a second surgery because there was a complication with the seal and they had to go back in and reseal it. When he came out of surgery he had a fever of 103.5 F but they believed it was due to dehydration and UTI that was brewing. They brought the fever down but he was admitted to the hospital on 07May2017 and late that evening his fever was back up to 101.5 F. On 08May2017 his temperature reached only 99 F and in the evening the patient was released from the hospital. The reporter thought that maybe UTI was due to the anesthesia from the first surgery because heard that it could cause this because of urine retention, patient's doctor felt like the UTI was brewing before the first surgery.
Age: 1.92
Sex: M
Vaccine: PNC13
Symptoms: Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's parent). A 23-month-old male patient received PREVNAR 13, via an unspecified route of administration in the thigh, on 02May2017 afternoon, at single dose, for immunisation. Medical history included deaf, pectus excavatum, cochlear function disorder, cortical dysplasia and latent tuberculosis. There were no concomitant medications. The patient had cochlea implant surgery on 04May2017. The patient experienced fever of 102 F on 06May2017 with outcome of recovering, UTI (urinary tract infection) on an unspecified date with outcome of not recovered, leg of vaccination site became really red and a swollen lump like a small egg on 02May2017 with outcome of recovered between 04May2017 and 09May2017 and dehydration on 07May2017 with outcome of unknown. The patient was hospitalized due to fever of 102 F from 07May2017 to 08May2017. The patient underwent lab tests and procedures which included body temperature: 102 F (Fahrenheit) on 06May2017, 103.5 F on 07May2017, 101.5 F on 07May2017, 99 F on 08May2017. Therapeutic measures were taken as a result of fever of 102 F and included treatment with TYLENOL. Clinical course: on 07May2017 they had to go to the doctor because the patient was leaking spinal fluid. The same day the patient had a second surgery because there was a complication with the seal and they had to go back in and reseal it. When he came out of surgery he had a fever of 103.5 F but they believed it was due to dehydration and UTI that was brewing. They brought the fever down but he was admitted to the hospital on 07May2017 and late that evening his fever was back up to 101.5 F. On 08May2017 his temperature reached only 99 F and in the evening the patient was released from the hospital. The reporter thought that maybe UTI was due to the anesthesia from the first surgery because heard that it could cause this because of urine retention, patient's doctor felt like the UTI was brewing before the first surgery.
Sex: U
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unknown age, gender and race/ethnicity received a single dose of PREVNAR 13 for immunization on an unknown date. Medical history and concomitant medications were not reported. On an unknown date, the patient had cellulitis at injection site. Outcome was unknown.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Skin warm
Clinical narrative: This is a spontaneous report obtained from a contactable consumer (patient). A 71 year old female patient received, on 08May2017, PREVNAR 13 in the left deltoid, single dose, for immunization. Relevant medical history included depression. No illness at time of vaccination were noted. Concomitant medications included citalopram hydrobromide 20 mg, once daily, for depression (ongoing), bupropion Hcl 300 mg, once daily, for depression (ongoing), ASPIRIN once daily (ongoing), B12 from May2017 (ongoing) and hepatitis C vaccine (within 4 weeks) in the left arm, for immunization. On 08May2017, the patient's left upper arm was sore. On 09May2017, the patient's large area was red and was very, very hot and on 10May2017 was probably covering one fourth if not one third of her arm. The patient was recovering from the events at time of this report.
Age: 0.33
Sex: F
Vaccine: 6VAX-F, PNC13, RV1
Symptoms: Rash, Rash generalised
Clinical narrative: Mother stated that the day of administration a skin eruption appeared near the belly button.  Next day the child had a generalized rash.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Blood test, CSF culture, Computerised tomogram head, Ear infection, Lumbar puncture
Clinical narrative: Child began having seizures, started as twitching of right leg for about 4 minutes, then extended to include right arm and right side of face for another 5 minutes, finally generalized to all of her body for another 10 minutes. EMS arrived during that time and gave Diastat, which immediately stopped seizures. Transported to Hospital ED, where bloodwork, CSF cultures, and head CT performed. Gave patient prescription for Clindamycin because she also had otitis. Patient discharged home from ED.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Muscle twitching, Seizure
Clinical narrative: Child began having seizures, started as twitching of right leg for about 4 minutes, then extended to include right arm and right side of face for another 5 minutes, finally generalized to all of her body for another 10 minutes. EMS arrived during that time and gave Diastat, which immediately stopped seizures. Transported to Hospital ED, where bloodwork, CSF cultures, and head CT performed. Gave patient prescription for Clindamycin because she also had otitis. Patient discharged home from ED.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Oropharyngeal pain, Pain, Pyrexia, Vomiting
Clinical narrative: BODY ACHES,FEVER, NAUSEA/VOMITTING AND SORE THROAT.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Decreased appetite, Nasal congestion, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: BODY ACHES, STUFF NOSE, SORE THROAT, FEVER, HIVES, LOSS OF APPETITE.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: BODY ACHES, STUFF NOSE, SORE THROAT, FEVER, HIVES, LOSS OF APPETITE.
Age: 0.5
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 6-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 22-AUG-2016, the patient was vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported) and ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012916.