chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site paraesthesia, Injection site reaction
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. On 06-OCT-2016 the patient was vaccinated with GARDASIL 9 lot # M023169, 13-JUN-2018 intramuscular. On an unknown date the patient experienced tingling from injection site radiating up the arm to the neck immediately after the injection while still in the office. The medical assistant requested as lot check. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with doses of VAQTA 50/1.0 U/ml (lot # M001815, expiration date 20-SEP-2017, dose and route not reported). The doses of vaccine were improperly stored at 1.7 Celsius degree for 32 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This solicited report has been received from an unknown source via the company representative and refers to a patient (unknown age) of unknown demographics who participated in a patient support program. The patient's concomitant medications, concurrent conditions, medical history and past drugs were not reported. On 27-SEP-2016, the patient was vaccinated with ZOSTAVAX (dose, frequency, route of administration was unknown) (however indication was unspecified). On 28-SEP-2016, the program received paper work regarding this vaccine that was administered on the previous day (27-SEP-2016) to the patient. The program did a check for the expiration date of the lot number (lot number was not reported), and saw that the vaccine had expired "in February 2016". No AE (no adverse event) reported. No product quality complaint was reported. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot # L027431, expiry date: 22-JUL-2017). No adverse effects were reported. Excursion information: Time: 30 Minutes, Temperature 9C and Time: 30 Minutes, Temperature: 11C. The call was because of a data logger. The improperly stored doses were administered. There were no previous excursions. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition, historical medication and concomitant medication. On an unknown date the patients were vaccinated with improperly stored VAQTA, lot # M017982/expiration date- 13-SEP-2017, lot # L027735/expiration date- 12-JAN-2017, lot # M009786/expiration date- 26-MAY-2017, lot # L036449/expiration date- 26-MAY-2017 and lot # M027879/expiration date- 24-JAN-2018, lot # M032492/expiration date- 02-MAR-2018. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition, historical medication and concomitant medication. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB, lot # M010671/expiration date-02-JUN-2018, lot no. M026309/expiration date- 11-NOV-2018, lot # M018625/ expiration date- 11-AUG-2018, lot # M023892/expiration date- 15-SEP-2017 and lot no. M028322/expiration date- MAY-2018. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product use issue
Clinical narrative: Information has been received from a medical assistant via a company representative concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with the first doses of GARDASIL 9 (lot #, expiration date, dose and route were unknown). The patients did not come back on time for their follow up doses of HPV product. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not want to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 47 year old patient of unknown gender. No information on patient's pertinent medical history or drug reactions/allergies was reported. On an unknown date, the patient was vaccinated with dose of ZOSTAVAX (dose, route, lot # and expiry date were not provided). Concomitant medications were not reported. No known adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 21 years old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date in 2005 (when she was 10 years old), the patent was vaccinated with GARDASIL, (route: intramuscular). The patient came to the hospital on 17-OCT-2016, to receive additional dose of GARDASIL 9 to complete the series. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 28-JUL-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration 05-JUN-2017). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time of the first time was 1008 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site haemorrhage
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information on patient's pertinent medical history and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with an intramuscular injection of ZOSTAVAX (dose, frequency, lot # and expiry date were not provided) rather than subcutaneous injection, at her physician's office. On an unknown date, the patient experienced reddened area around the injection site and felt that the injection was bleeding a little more than she had expected. The outcome of events was unknown. The causality between the events and ZOSTAVAX was not provided. Additional information is not expected, as there was no consent to contact the physician.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via a company representative referring to two patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with ZOSTAVAX (strength, frequency, lot number and expiration date were unknown), 0.65 ml, subcutaneously. On unknown dates, the patients developed shingles after being vaccinated with ZOSTAVAX. The outcome of the event was unknown. The causal relationship between ZOSTAVAX and the event was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant regarding unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with unknown number of doses of ROTATEQ (lot # L039141 with expiry date 16-AUG-2016; lot# M004883 with expiry date 02-OCT-2017; lot# M025568 with expiry date 07-NOV-2016 and dosing details not known) that were improperly stored. The administered doses experienced a temperature excursion of 32.1 F(Fahrenheit) for 5 hours 10 minutes and 51.6 F(Fahrenheit) for 1 hour 4 minutes. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter denied consent to be contacted for further information.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant regarding unknown number of patients and age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with unknown number of doses of GARDASIL 9 (lot # L036301 with expiry date 20-DEC-2016, lot# L038503 with expiry date 18-DEC-2017 and dosing details not known) that improperly stored. The administered doses experienced a temperature excursion of 32.1 F(Fahrenheit) for 5 hours 10 minutes. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter denied consent to be contacted for further information.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 12-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L048464 with expiry date 06-DEC-2017 and dosing details not known). The administered doses experienced a temperature excursion of 6.8  F(fahrenheit) for a time frame of 26 minutes. The vaccine underwent a previous temperature excursion of 6.6 F(fahrenheit) for 25 minutes. The call was because of a "data logger". No adverse effect was reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unknown patients. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On multiple unspecified dates these patients were administered improperly stored GARDASIL 9 (lot # M021407, expired date 30-APR-2018) (dose and frequency were unknown). The GARDASIL 9 was exposed to 31F for a time frame of 15 minutes to less than 1 hours. It was unspecified if data logger was involved. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown date (within an 18-month period), the patients were vaccinated with improperly stored doses of GARDASIL (dose, route of administration, lot# and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 52 degrees Fahrenheit (the highest temperature) and 29 degrees Fahrenheit (the lowest temperature), for an unspecified period of time. It was unspecified, if the data logger was involved. Product quality complaint (PQC) was not involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple 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 (within an 18-month period), the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot# and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 52 degrees Fahrenheit (the highest temperature) and 29 degrees Fahrenheit (the lowest temperature), for an unspecified period of time. It was unspecified, if the data logger was involved. Product quality complaint (PQC) was not involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On an unspecified dates in 2012, the patient was vaccinated with the first and the second (0.5 ml each) dose of GARDASIL (route of administration, lot number and expiration dates were not reported). On the day of the report (26-SEP-2016), the patient visited the physician's office to receive the 3rd dose of GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date, the patient vaccinated with the first dose of GARDASIL 9 (lot #, expiration date, dose and route were unknown). On an unknown date, 1 year after the first dose, the patient was vaccinated with the second dose of GARDASIL 9 (lot #, expiration date, dose and route were unknown). (Drug use for unapproved schedule). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not want to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 10-OCT-2016, the patient was vaccinated with the expired dose of PROQUAD, lot # K025765 with expiration date on 08-JUN-2016, albumin status: human serum albumin (HSA), (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 06-MAR-2014, the patient was vaccinated with an improperly stored dose of GARDASIL 5 mg/0.5 ml injection, lot # J013777, expiration date 11-AUG-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two separate temperature excursions (dates unspecified): one lasting for 220 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius) and another lasting for 244 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.555555556 degrees Celsius). The vaccine was stored in a refrigerator. 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.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 06-MAR-2014, the patient was vaccinated with an improperly stored dose of GARDASIL 5 mg/0.5 ml injection, lot # J013777, expiration date 11-AUG-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two separate temperature excursions (dates unspecified): one lasting for 220 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. 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.
Sex: M
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient's pertinent medical history, drug reactions and allergies and concomitant medications were not reported. On 04-OCT-2016 the patient was vaccinated with a dose of GARDASIL lot # M014929, expiration date 27-MAY-2017, subcutaneous (dose was not reported). The nurse reported that GARDASIL was administered subcutaneously instead of intramuscularly. On an unknown date in October 2016, the patient experienced burning in the area of injection. No lab diagnostic studies were performed. The outcome of burning in the area of injection was unknown. The relatedness between burning in the area of injection and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 29-MAY-2014, the patient was vaccinated with an improperly stored dose of GARDASIL 5 mg/0.5 ml injection, lot # J013777, expiration date 11-AUG-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to four separate temperature excursions (dates unspecified): the first lasting for 32 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.555555556 degrees Celsius), the second lasting for 260 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius), the third lasting for 152 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius) and the fourth lasting for 492 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.555555556 degrees Celsius). The vaccine was stored in a refrigerator. 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.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 09-JUN-2014, the patient was vaccinated with an improperly stored dose of GARDASIL  5 mg/0.5 ml injection, lot # J013777, expiration date 11-AUG-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to four separate temperature excursions (dates unspecified): the first lasting for 260 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius), the second lasting for 492 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.555555556 degrees Celsius), the third lasting for 152 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius) and the fourth lasting for 32 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.555555556 degrees Celsius). The vaccine was stored in a refrigerator. 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.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 08-APR-2014, the patient was vaccinated with an improperly stored dose of GARDASIL 5 mg/0.5 ml injection, lot # J013777, expiration date 11-AUG-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two separate temperature excursions (dates unspecified): one lasting for 316 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.555555556 degrees Celsius) and another lasting for 220 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. 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.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 18-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml injection, lot # L044917, expiration date 05-OCT-2018 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. 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.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 25-MAY-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml injection, lot # L044917, expiration date 05-OCT-2018 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. 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.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 micrograms/1 ml injection, lot # L044917, expiration date 12-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. 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.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 30-JUN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml injection, lot # L044917, expiration date 05-OCT-2018 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. 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.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-SEP-2016, the patient was vaccinated with VARIVAX (lot: K018961, Expiry date: 15-OCT-2016, dose, frequency, route were not reported) which was improperly stored. No adverse effects reported. The temperature excursions were reported as 44 Fahrenheit (F) for 1 hour, -14.8 Celsius (C) for 1 minute, 8.36 F for 1 hour and -14.23 C for 1 hour. There were no previous excursions reported. Additional information was requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 06-MAY-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml injection, lot # L044917, expiration date 05-OCT-2018 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to three temperature excursions (dates unspecified): the first lasting for 80 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius), the second lasting for 144 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius) and the third lasting for 24 hours, with the lowest recorded temperature of 30 degrees Fahrenheit(-1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. 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.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 22-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml injection, lot # L044917, expiration date 05-OCT-2018 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to three temperature excursions (dates unspecified): the first lasting for 192 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius), the second lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius) and the third lasting for 24 hours, with the lowest recorded temperature of 30 degrees Fahrenheit (-1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. 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.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 22-JUN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml injection, lot # L044917, expiration date 05-OCT-2018 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to three temperature excursions (dates unspecified): the first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius), the second lasting for 192 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius) and the third lasting for 24 hours, with the lowest recorded temperature of 30 degrees Fahrenheit (-1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. 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.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-MAY-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml injection, lot # L044917, expiration date 05-OCT-2018 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two temperature excursions (dates unspecified): one lasting for 144 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.1111111111 degrees Celsius) and another lasting for 72 hours, with lowest recorded temperature of 31 degrees Fahrenheit (-0.555555556 degree Celsius) The vaccine was stored in a refrigerator. 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.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 14-JUN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml injection, lot # L044917, expiration date 05-OCT-2018 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two temperature excursions (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.555555556 degrees Celsius) and another lasting for 144 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. 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.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. Information regarding the patient's concurrent conditions and medical history was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 intramuscularly (anatomical location was not reported) which had a lot number of L026602 and expiration date on 19-OCT-2017. There were no concomitant medications provided. No adverse effects reported. At the reporting time, the GARDASIL 9 experienced a temperature excursion of 32.5 F for 3 hours and 50 minutes (1 cycle). Also, on an unspecified dates, there had been previous temperature excursions, one of 34.3F for 40 minutes and the other one of 34.9F for 10 minutes. The total cumulative excursion details were reported as "4 hour and 40 minutes; 34.4F with 3 total cycles". Furthermore, no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 13-MAY-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml injection, lot # L044917, expiration date 05-OCT-2018 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two temperature excursions (dates unspecified): one lasting for 144 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius) and another lasting for 72 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.555555556 degrees Celsius). The vaccine was stored in a refrigerator. 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.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 31-MAY-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml injection, lot # L044917, expiration date 05-OCT-2018 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two temperature excursions (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.555555556 degrees Celsius) and another lasting for 144 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. 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.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 16-JUN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml injection, lot # L044917, expiration date 05-OCT-2018 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two temperature excursions (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.555555556 degrees Celsius) and another lasting for 144 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. 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: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Injection site vesicles
Clinical narrative: Blister to left thigh.
Age: 17.0
Sex: M
Vaccine: MENB, VARCEL
Symptoms: Varicella
Clinical narrative: Pt received VARICELLA vaccine 10/4/16 - mom called on 10/14/16 - child developed chickenpox on face. Spoke with mom - taking child to MD today - advised her to call MD for FMD visit - T.C. to Dr re: vaccines, child received on 10/4/16 TC tomm 10/17/16 -  Child saw MD - dx with VARICELLA - Ok to got to school once they clear up 0n face. Child doing well.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 01-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml injection, lot # L044917, expiration date 05-OCT-2018 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to three temperature excursions (dates unspecified): one lasting for 24 hours, with the lowest recorded temperature of 30 degrees Fahrenheit (-1.111111111 degrees Celsius), the second lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius) and the third lasting for 192 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. 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.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant refers to a patient of unknown gender and age. There was no information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy. On 29-JUN-2016, the patient was vaccinated with first dose of GARDASIL 9 (dosing details were not provided). Physician assistant reported that at the time of this report on 14-OCT-2016, the patient visited the office to receive the second vaccine dose. It was unspecified if the patient was vaccinated with the second dose or not. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history and drug reactions/Allergies were reported. On an unspecified dates, the unspecified patient were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M001579 and expiry date 05-OCT-2018) (dosing regimen was unknown by the reporter). No concomitant medications were reported. The vaccine was exposed to temperature of 30 Fahrenheit for 12 hours. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history and drug reactions/Allergies were reported. On an unspecified dates, the unspecified patients were vaccinated with improperly stored doses of VAQTA (lot #L048222 and expiry date 19-DEC-2016) (dosing regimen was unknown by the reporter). No concomitant medications were reported. The vaccine was exposed to temperature of 30 Fahrenheit for 12 hours. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history and drug reactions/Allergies were reported. On an unspecified dates, the unspecified patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot #L022795 and expiry date 05-NOV-2016) (dosing regimen was unknown by the reporter). No concomitant medications were reported. The vaccine was exposed to temperature of 30 Fahrenheit for 12 hours. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Vaccine administered 10/13/16. On 10/19/16, Pt. came and reported a local reaction: redness on injection site and surrounding area.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Local reaction
Clinical narrative: Rec'd injections 10/14/16; Seen in office 10/17/16 for c/o (R) arm injection site redness, edema and mild increased warmth. Area approximately 13 x 13 cm. Dx as mild local reaction to vaccine (KINRIX) tx with ibuprofen and ice packs. Advised to return if S/s increased.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Abdominal discomfort, Injection site erythema, Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Mother called to report child has red welt - size of 50 cent piece over injection site with tenderness. Mother denies any other issues/concerns. Instructed to notify Dr. if S/S worsen. (Mother then stated child had upset stomach last night 10-18-16).
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 48 hours post administration patient experienced a shingles rash on read end. (Pt. said he had hx of chicken pox as child). Currently taking acyclovir expected to recover.
Age: 21.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient received BOOSTRIX in error. Gave patient VARIVAX afterwards.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-SEP-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 2544 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.