chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients might have received doses of improperly stored PNEUMOVAX 23 (single-dose vial) (lot # L027732 with expiration date 23-FEB-2017; dose and route were not reported). The vaccine was exposed to 31 Fahrenheit for 40 minutes. There was no prior excursion. Data logger was unknown. No adverse effects were reported. At the reporting time, the reporter did not sure if the vaccine was administered. This is one of several reports received from the same reporter. Additional has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On 17-SEP-2016 and 20-SEP-2016, the patients were vaccinated with improperly stored (wistar ra 27-3) M-M-R II lot # L036851/expiration date- 23-SEP-2019, subcutaneous (incorrect product storage). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information is not expected as reporter does not wants to get contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients might have received doses of improperly stored GARDASIL 9 (lot # M018819 with expiration date 28-MAY-2018; dose and route were not reported). The vaccine was exposed to 31 Fahrenheit for 40 minutes. There was no prior excursion. Data logger was unknown. NO adverse effects were reported. At the reporting time, the reporter did not sure if the vaccine was administered. This is one of several received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients might have received doses of improperly stored RECOMBIVAX HB (lot # L038018 with expiration date 13-SEP-2017; dose and route were not reported). The vaccine was exposed to 31 Fahrenheit for 40 minutes. There was no prior excursion. Data logger was unknown. No adverse effects were reported. At the reporting time, the reporter did not sure if the vaccine was administered. 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: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients might have received doses of improperly stored VAQTA (lot # L015460 with expiration date 20-JUL-2017; dose and route were not reported). The vaccine was exposed to 31 Fahrenheit for 40 minutes. There was no prior excursion. Data logger was unknown. No adverse effects were reported. At the reporting time, the reporter did not sure if the vaccine was administered. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Adverse event, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from patient's father regarding his 12 years old son. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with 1st dose of GARDASIL 9, intramuscularly, dose; unknown. It was followed by 2nd dose in the series (intramuscularly, dose: unknown), on an unknown date 30 days after the 1st dose. Subsequently on an unknown date, the patient experienced unspecified adverse event. The outcome of the adverse event and causality was not reported. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an unknown date of March 2015 the patient was vaccinated with first dose of GARDASIL (lot, expiration date, dosage regimen were unknown). It was reported that, the patient was vaccinated her second dose with GARDASIL 9 (lot, expiration date, dosage regiment were unknown). The reporter stated that, this time (exact date not reported), the patient is going to take her third dose in series with GARDASIL 9. No adverse effects reported. No product quality complaint (PQC) was filed. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients might have received doses of improperly stored ROTATEQ (lot # L027070 with expiration date 30-APR-2017; lot # L033548 with expiration date 14-MAY-2017; dose unknown; oral). The vaccine was exposed to 31 Fahrenheit for 40 minutes (incorrect product storage). There was no prior excursion. Data logger was unknown. No adverse effects were reported. At the reporting time, the reporter did not sure if the vaccine was administered. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Skin reaction
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were unknown. On an unknown date, the patient was administered ZOSTAVAX 19400 PFU (lot#, expiration date, dose and route were not reported). On an unknown date, the patient had a nickel sized skin reaction at the injection site. The pharmacist did not recommend any treatment, but the patient applied NEOSPORIN on her own. The outcome of injection site reaction was unknown. The causality assessment between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Emotional distress, Sleep terror, Somnambulism
Clinical narrative: This spontaneous report was received from a consumer refers to his son as approximately 12 year old male patient. Medical history and concomitant medications were not reported. On an unknown date in March 2016 the patient was vaccinated with first dose of GARDASIL (Lot, dose and route were not reported). On an unknown date in 2016, the patient experienced night terrors, sleepwalking an hour into each night and no awareness of why he was upset. On an unknown date, the patient sought medical attention. The patient did not had any laboratory tests performed. The patient did not received any treatment for the events. The outcome of the events was reported as not recovered. The reporter did not provide the causality between the events and the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician 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 history provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L033697, expiration date: 28-FEB-2017) (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 15.9 degrees Fahrenheit for 565 minutes. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of improperly stored ROTATEQ lot #M01969 with expiration date: 02-NOV-2017 and lot# M019707 with expiration date: 25-OCT-2017, orally (dose was not reported). Administered doses of ROTATEQ were exposed to 35 Fahrenheit degrees for 1 hour and 30 minutes. Data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with all three doses of GARDASIL or GARDASIL 9. On an unknown date, the patient reported that she had unspecified health issues ever since being administered the GARDASIL series of vaccines. The outcome of the events were unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were unknown. On an unknown date, the patient started therapy with GARDASIL 9 (lot# reported 36301, expiration date December 2017; dose, frequency and route were unknown). On an unknown date, the patient was given a dose of GARDASIL 9 that underwent a temperature excursion. The vaccine had been exposed to a temperature of 32.1 Fahrenheit degree for 7 hours. The patient did not experience any adverse event. It is unknown if any relevant tests were done. At the time of the report, it was unknown if the therapy was continued. This is one of the several reports received from the same reporter. Additional information is not expected as the physician did not have time to provide further information.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Feeling cold, Feeling of body temperature change, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old male patient. The patient penicillin allergy. On 27-SEP-2016, the patient was vaccinated with first dose of PNEUMOVAX 23 lot # L019835, 23-MAR-2017 intramuscular in the left deltoid. On 27-SEP-2016, the patient experienced swelling, redness and pain at his injection site the same evening that he received the dose. The patient also reported of experiencing chills, sweating and feeling hot and cold. The patient consulted his primary care physician who prescribed doxycycline for treatment of the patient's adverse experience. The outcome of the events were reported as unknown. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old male patient. The patient penicillin allergy. On 27-SEP-2016, the patient was vaccinated with first dose of PNEUMOVAX 23 lot # L019835, 23-MAR-2017 intramuscular in the left deltoid. On 27-SEP-2016, the patient experienced swelling, redness and pain at his injection site the same evening that he received the dose. The patient also reported of experiencing chills, sweating and feeling hot and cold. The patient consulted his primary care physician who prescribed doxycycline for treatment of the patient's adverse experience. The outcome of the events were reported as unknown. 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 nurse and refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On 29-SEP-2016, the patients were vaccinated with improperly stored GARDASIL 9 lot # M023169, expiry date 13-JUN-2018 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines were exposed to 40 to 50 degrees Fahrenheit for 24 hours. There were no previous excursions reported. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Fatigue, Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 80-year-old female patient. No information regarding the patient's medical history or concurrent conditions was provided. The patient had no known drug reactions or allergies. On 02-JUL-2007, the patient was vaccinated with the first dose of PNEUMOVAX 23 injection (dose, route of administration, lot# and expiry date were not reported). On 20-OCT-2015, the patient was vaccinated with a dose of PREVNAR 13 (formulation, dose, route of administration, lot# and expiry date were not reported). On 27-SEP-2016, she received another dose of PNEUMOVAX 23 injection (dose, route of administration, lot# and expiry date were not reported), along with a dose of an unspecified flu vaccine (formulation, dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. On 27-SEP-2016, reported as since receiving her second dose of PNEUMOVAX 23 concomitantly with the flu vaccine, the patient experienced extreme fatigue and malaise. No treatment was given for the events and no diagnostic lab studies were performed. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and the suspect vaccines was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number if patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose: unknown) which had lot # M007287 with expiry: 12-FEB-2018, lot # M020899 with expiry: 27-APR-2018, lot # M024683 with expiry: 18-MAY-2018, exposed to a temperature of -11.2 degree Celsius for 1 hour 18 minutes. A second freezer containing different lots, such as lot @ M006726 with expiry: 08-FEB-2018, lot # M004328 with expiry: 26-JAN-2018 and lot # L043622 with expiry: 03-NOV-2017, lot # M024683 with expiry: 30-SEP-2017, had a temperature excursion of -12.9 degree Celsius for 48 minutes. Also, one lot of VARIVAX (lot # M007287 and expiry: 12-FEB-2018) had an additional excursion of -9C for 2 hours. No adverse effects reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a physician via company representative concerning a 55 year old patient of unknown gender. who had not history of chicken pox. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In 1997, the patient received two doses of (Oka/Merck) VARIVAX 0.5ml (lot number, expiration date and route of administration were not reported). On an unspecified a titer was done and the titer was negative for varicella. At the time of the report the outcome of the event was unknown. A product quality complaint was not involved. The causal relationship between the event and (Oka/Merck) VARIVAX was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to her 32-year-old non-pregnant female patient. The patient's medical history included twin pregnancy. On an unknown date, the patient's twin sons were vaccinated with varicella virus vaccine live (manufacturer unknown) (reported as an unspecified chicken pox vaccine) (lot #, dose, route and site of administration were not reported). On an unknown date, the patient developed shingles after nursing her twin boys. She did not seek medical attention. The outcome of shingles and secondary transmission was reported as recovered/resolved on an unspecified date. The relatedness between the events and varicella virus vaccine live (manufacturer unknown) was not reported. This is one of several reports 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 as received from a pharmacy technician refers to unspecified number of patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (lot# L004651, expiration data: 11-FEB-2017) (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 15.9 degrees Fahrenheit for 565 minutes. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, refers to a 8 month old patient of unknown gender. Patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 21-SEP-2016, the child patient was inadvertently vaccinated with PROQUAD, rHA, lot # M017334, expiry date 05-OCT-2017, (dose, frequency and route of administration were not reported). No adverse effect reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information available. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a currently 26 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date (reported as when the patient was an infant), the patient received an initial dose of VARIVAX (dose, route, lot # and expiration date were unknown). On 27-SEP-2016, when the patient was 26 years old, the patient was vaccinated with a second dose of VARIVAX (dose, route, lot # and expiration date were unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
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 condition and concomitant medication were unknown. On 08-SEP-2016, the patient was inadvertently vaccinated with a dose of expired M-M-R II (dose and route unknown, lot# reported as M001200, expiration date: 28-AUG-2016). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient previously received a dose of M-M-R II (dose, frequency and lot # not reported) on 01-MAY-2012 and a dose of PROQUAD (dose, frequency and lot# not reported) on 17-MAR-2015. On 19-SEP-2016 the patient was inadvertently vaccinated a dose with M-M-R II (dose, frequency and lot# not reported) (extra dose administered). No symptoms reported. 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 number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA, strength: 25/0.5 (units unspecified), which had lot # M015290 with expiry: 20-SEP-2017 and lot # M022924 with expiry: 24-JAN-2018 (dose and route not reported). The vaccines were exposed to a temperature excursion of 9 degree Celsius for 1 hour 24 minutes. No adverse effects reported. No further information provided. 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: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. Since 11-JUL-2016, the patients had been administered doses of improperly stored GARDASIL 9 (lot # L024993, expiration date 17-OCT-2017; dose, frequency and route were unknown). No adverse effect was reported. It was reported that GARDASIL 9 was not supported, the product was not suitable for use. 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 nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # M016193 with expiry date: 24-APR-2018 and lot # L036301 with expiry: 20-DEC-2017 (dose and route were not reported). The vaccines underwent a temperature excursion of 9 degrees Celsius for 1 hour 24 minutes. No adverse effects were reported. No further information provided. This is one of several reports received from the same reporter. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patient were vaccinated with improperly stored doses of ROTATEQ (dose and route not reported) which had lot # M007125 with expiry: 06-OCT-2017 and lot # M004542 with expiry: 07-OCT-2017. The vaccines were exposed to a temperature excursion of 9 degree Celsius for 1 hour 24 minutes, with an additional excursion of 10 degree Celsius for 2 hours for lot # M007125 with expiry: 06-OCT-2017. No adverse effects reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to multiple patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored M-M-R II (lot # M002419, expiration date: 12-JAN-2018; dose and route were not provided). The vaccine underwent a temperature excursion of 29.7 degrees Fahrenheit for 5 hours, which was detected by a data logger. There was also previous temperature excursion, but more details were not available. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to multiple patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # M011117, expiration date: 07-DEC-2017; dose and route were not provided). The vaccine underwent a temperature excursion of 29.7 degrees Fahrenheit for 5 hours, which was detected by a data logger. There was also previous temperature excursion, but more details were not available. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to multiple patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with doses of improperly stored PEDVAXHIB (lot # L042257, expiration date: 17-AUG-2018; dose and route were not provided). The vaccine underwent a temperature excursion of 29.7 degrees Fahrenheit for 5 hours, which was detected by a data logger. There was also previous temperature excursion, but more details were not available. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Expired product administered, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information regarding the patient's medical history and concurrent conditions was provided. On 04-OCT-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23, lot # K010465, expiration date: 23-MAR-2016, intramuscularly, (dose, dose number and injection site were not provided). There were no concomitant medications reported. The pharmacist also stated that the patient reported vaccine "stung" at the time of vaccination. The patient did not seek medical attention. No laboratory diagnostic studies were performed. No treatment was given for the adverse event. No product quality complaint (PQC) was involved. The outcome of vaccine "stung" at the time of vaccination was unknown. The relatedness between the event and PNEUMOVAX 23 was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Information has been received from a clinical medical assistant referring to a patient of  unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 04-OCT-216 , the patient received a partial dose of GARDASIL 9 (lot # L040054, expiration date 26-DEC-2017, dose and route unknown), as a result of a defective administration syringe. About a third of the dose leaked out of the syringe and didn't get injected into the patient. The dose of GARDASIL 9 was aspirated from the vial it was supplied in, so there was no product quality complaint (PQC). No adverse effect had been reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Pharmacist 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. On unknown dates, the patients were vaccinated with 8 improperly stored vials of GARDASIL 9, (dose and route of administration were not provided; lot # reported as 36301 expiration date of December-2017). It was also reported that the administered doses experienced a temperature excursion during 7 hours at a temperature of 32.1 degrees Fahrenheit on unspecified date. No previous temperature excursion was reported. Lot number 36301 is an invalid lot number for GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unspecified dates since 29-AUG-2016, improperly stored PEDVAXHIB (lot # M010440, expiration date 09-DEC-2018, lot # M001813, expiration date 14-OCT-2018; dose and route were unknown) were administered to unspecified patients. No adverse experiences have been reported. The vaccines were exposure at 52 Fahrenheit degree for 35 degrees. There was no previous temperature excursion. Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number patient of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # M026876 with an expiration date on 26-JUL-2017) (dose, route and . No adverse events were reported and frequency were not reported). No adverse events were reported and no product quality complaint (PQC) was involved. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unspecified dates since 29-AUG-2016, improperly stored ROTATEQ (lot # L039141, expiration date 16-AUG-2017, oral; dose was unknown) were administered to unspecified patients. No adverse experiences have been reported. The vaccines were exposure at 52 Fahrenheit degree for 35 minutes. There was no previous temperature excursion. Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unspecified dates since 29-AUG-2016, improperly stored M-M-R II (rHA, lot # L036851, expiration date 23-SEP-2017, rHA, lot # L049316, expiration date 03-DEC-2017; dose and route were unknown) were administered to unspecified patients. No adverse experiences have been reported. The vaccines were exposure at 52 Fahrenheit degree for 35 minutes. There was no previous temperature excursion. Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager, referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (lot # K011562 and expiration date 08-APR-2017) (lot # L040460 and expiration date 27-MAY-2017) dose, anatomical location and administration route were not reported. The reporter stated that she was not aware of any adverse effects and no product quality complaint was involved. Temperature: 19.9 Fahrenheit degrees. 4 cycles below 24F. Time Frame: unspecified at the time of his reporting. Temperature excursion (cumulative time): 255 hours. Was a data logger involved: Yes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager, was received to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ (lot # L037924 and expiration date 22-JUN-2017) (lot # L039638 and expiration date 23-AUG-2017) orally, dose was not reported. The reporter stated that she was not aware of any adverse effects and no product quality complaint was involved. Temperature: 19.9 Fahrenheit degrees. 4 cycles below 24F. Time Frame: unspecified at the time of his reporting. Temperature excursion (cumulative time): 255 hours. Was a data logger involved. Yes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L024253 with an expiration date on 01-JUL-2017) (route, dose and frequency were not reported). No adverse events were reported and no product quality complaint (PQC) was involved. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX, (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. On an unknown date, the patient developed shingles. At the time of the reporting, the outcome of the herpes zoster was unknown. The relatedness between the event and therapy with VARIVAX was not reported. 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 certified medical assistant referring to an unspecified number of patients of unknown age and gender. Medical history, concomitant medications and concurrent conditions were not reported. On an unspecified dates, the patients were vaccinated with an improperly stored doses of PNEUMOVAX 23 (dosage and route administration were not provided; lot number L018503 expiration date 16-MAR-2017. No adverse effects were reported. The administered vaccines experienced a temperature excursion of 15 degrees C for 9 hours on an unspecified date. Data logger was not involved. Previous temperature excursion was 0 degrees C for 24 hours on an unspecified date. A product quality complain was not involved. This is one of three reports from the same source. 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 medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and concomitant therapies were reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (dose and route of administration were not reported) (lot number L043622, expiration date 03-NOV-2017; lot number L031066, expiration date 18-AUG-2017; lot number L035124, expiration date 14-SEP-2017). No adverse effects were reported. Additional information has been requested. This is one of the several reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and concomitant therapies were reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (dose and route of administration were not reported) (lot number M004895, expiration date 26-JUL-2017; lot number L051095, expiration date 17-JUN-2017). No adverse effects were reported. Additional information has been requested. This is one of the several reports received from the same reporter.
Sex: F
Vaccine: DTAP
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received DTPA vaccine. On 21st September 2016, the patient received DTPA (intramuscular). In September, less than a week after receiving DTPA vaccine the patient experienced pain in arm, injection site redness, injection site swelling, injection site induration, injection site itching, injection site warmth, headache and influenza-like symptoms. The patient was treated with hydrocortisone and medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the pain in arm, injection site redness, injection site swelling, injection site induration, injection site itching, injection site warmth, headache and influenza-like symptoms were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, injection site redness, injection site swelling, injection site induration, injection site itching, injection site warmth, headache and influenza-like symptoms to be related to DTPA vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of TDAP vaccine (not specified) in her right deltoid through my employer. The injection site was very painful, but now it was very red, swollen (7 cm in circumference), hard, very hot and it itches tremendously. Her entire right arm hurts. She also had headache and flu like symptoms. The next day of the reporting date, it was going to be 7 days since the vaccination. On the night before reporting, the patient had applied ice, but it did not help. She has also applied hydrocortisone cream for the itchiness. The patient was asking whether this was normal or she should go to her primary physician.
Sex: F
Vaccine: DTAP
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received DTPA vaccine. On 21st September 2016, the patient received DTPA (intramuscular). In September, less than a week after receiving DTPA vaccine the patient experienced pain in arm, injection site redness, injection site swelling, injection site induration, injection site itching, injection site warmth, headache and influenza-like symptoms. The patient was treated with hydrocortisone and medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the pain in arm, injection site redness, injection site swelling, injection site induration, injection site itching, injection site warmth, headache and influenza-like symptoms were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, injection site redness, injection site swelling, injection site induration, injection site itching, injection site warmth, headache and influenza-like symptoms to be related to DTPA vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of TDAP vaccine (not specified) in her right deltoid through my employer. The injection site was very painful, but now it was very red, swollen (7 cm in circumference), hard, very hot and it itches tremendously. Her entire right arm hurts. She also had headache and flu like symptoms. The next day of the reporting date, it was going to be 7 days since the vaccination. On the night before reporting, the patient had applied ice, but it did not help. She has also applied hydrocortisone cream for the itchiness. The patient was asking whether this was normal or she should go to her primary physician.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certificate medical assistant referring to an unspecified number of patients of unknown age and gender. Medical history, concomitant medications and concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (dosage and route of administration were not provided; lot number M00986 expiration 26-MAY-2017). No adverse effects were reported. The administered vaccines experienced a temperature excursion of 15degreesC for 9 hours on an unspecified date. Data logger was not involved. Previous temperature excursion was 0degreesC for 24 hours on an unspecified date. A product quality complain was not involved. This is one of three reports from the same source. 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 pharmacy technician referring to an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, intramuscularly, (lot # L040458, expiration date 04-FEB-2018), (dose was not reported). Concomitant medication information was not provided. Moreover, it was reported that the unspecified number of doses of RECOMBIVAX HB were exposed to a temperature excursion of 48.7 Fahrenheit degrees for 24 hours. However, no adverse events were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 53 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX, 0.65 ml (one dose), subcutaneous. On an unknown date, the patient experienced bruising and rash at the injection site after receiving ZOSTAVAX. The patient visited a physician however she did not received any treatment for the events. The outcome of bruising and rash at the injection site was reported as recovered. The causal assessment was not provided by the reporter. Product quality complaint was not involved. Additional information is not expected as consent to contact was not provided by the reporter.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain
Clinical narrative: 3 days later after receiving vaccine developed redness, pain, on 10/4/16 was seen in our office given KEFLEX 500 mg TID for 7 days and BENADRYL. Called patient on 10/6 patient says is much better.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Was given BEXSERO in L arm on 09/27/16. C/O L arm pain - that got worse. Using ibuprofen and applying ice packs as reported by mom on 09/29/16. Mom reports doing better 9/30/16 - moving L arm again.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Injection site rash, Type III immune complex mediated reaction
Clinical narrative: PREVNAR 13 given IM Into right thigh 10/4/16, rash developed the next day at the site, increased in size, given BENADRYL, brought back to our office 10/6/16, diagnosed with Arthus reaction, given CLARITIN.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Erythema, Injection site pain, Pyrexia
Clinical narrative: 10/4/16-Right leg pain after immunization. 10/3/16-minimal erythema, fever.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Fatigue, Local reaction, Malaise, Mass
Clinical narrative: Nausea, vomit x 2, overall fatigue/malaise} 10 hours after injection. Diarrhea 2 days after injection. Tenderness to right arm from elbow to armpit/shoulder-since injection given Monday 9-19-16. Localized reaction: hot to touch, tight skin, swelling, lumpiness.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Skin tightness, Skin warm, Swelling, Tenderness
Clinical narrative: Nausea, vomit x 2, overall fatigue/malaise} 10 hours after injection. Diarrhea 2 days after injection. Tenderness to right arm from elbow to armpit/shoulder-since injection given Monday 9-19-16. Localized reaction: hot to touch, tight skin, swelling, lumpiness.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Nausea, vomit x 2, overall fatigue/malaise} 10 hours after injection. Diarrhea 2 days after injection. Tenderness to right arm from elbow to armpit/shoulder-since injection given Monday 9-19-16. Localized reaction: hot to touch, tight skin, swelling, lumpiness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pruritus, Rash, Secretion discharge
Clinical narrative: Rash on left shoulder blade near injection site, pain, severe headache itching, pain, oozing fluid.
Age: 65.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Blister, Rash vesicular
Clinical narrative: Blistering/vesicular rash on (R) anterior wrist and posterior 3rd-5th digits. Rash also noted on (R) upper thigh.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth, Pain, Pruritus
Clinical narrative: Warm and redness around injection site 6 days after administration. Hurt day after injection and now itchy. Told pt to consult physician on Friday 10-7-16 because MD out on Thursday.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Hypersensitivity, Local swelling, Pruritus, Rash, Swelling face
Clinical narrative: Mother says child developed a rash and started swelling (face and neck). Itching, but no SOB. Took to ER the next day and treated for allergic reaction.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Left deltoid red, radiated down left upper arm.