chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in 5-year-old male patient who received KINRIX (batch number C5222AA ?, expiry date 20th June 2019) (GSK note: The reported lot number did not match any GSK lot number). Concomitant products included PROQUAD and VAQTA. On 11th May 2017, the patient received KINRIX (intramuscular) .5 ml. In May 2017, less a week after receiving KINRIX, the patient experienced extensive swelling of vaccinated limb and injection site erythema. In May 2017, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved. The reporter considered the extensive swelling vaccinated limb injection site erythema to be almost certainly related to KINRIX. Additional details were provided as follows: The patient's concomitant medication included multivitamin. On 11th May 2017, the patient received 2nd dose of subcutaneous PROQUAD vaccine (batch number M041507, expiry date 9th April 2018) in the right thigh and 3rd dose of intramuscular VAQTA vaccine (batch number M047658, expiry date 28th October 2017) in right thigh. The medical assistant reported that the patient received KINRIX in the left thigh as 5th DTaP and 4th Polio vaccine. Over the weekend, the patient's mother reported that the patient had swelling and redness in the left thigh starting 1 in above the knee and going up through the groin area. The patient's mother reported it was 5 to 7 inches in diameter. The reaction resolved before the patient could be seen at the office.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a multiple, unknown patients of unknown age and gender.  The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.   In April 2017, reported as between 18-APR-2017 and 26-APR-2017,  the patients received multiple doses of improperly stored VAQTA invalid Lot #M005274 with and expiration date on 03-APR-2018 and Lot #M039202 with an expiration date on 11-MAR-2018 (strength, dose, and route of administration were not reported) for prophylaxis. The vaccines were stored at a Temperature of 47°F to 77°F during 84 hours. There was no previous temperature excursions and the call was not because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015668: US-009507513-1705USA015670:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a family nurse practitioner via a company representative and refer to three one-year-old patients of unknown gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On an unknown date in May 2017, the patients were vaccinated with an expired dose of M-M-R II which expiration date was in April 2017 (strength, dose, frequency, route of administration, anatomical location, and lot number were not provided) for prophylaxis. No adverse events were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concurrent conditions was reported. On unknown dates, the unspecified patients were vaccinated with an improperly stored doses of GARDASIL 9 (lot number # M037770, expiration date 01-JUN-2019, dose and route of administration were not provided) reconstituted with properly stored sterile diluent. The vaccines were stored in the temperature between 47 and 77 degrees Fahrenheit for 42 minutes. There was unspecified previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA002252: US-009507513-1706USA002251.
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass
Clinical narrative: This spontaneous report was received from a a registered nurse referring to a female patient of unknown age. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On approximately 27-MAR-2017 (reported as 8 weeks ago), the patient was vaccinated with a dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not provided). In approximately March 2017, the patient developed a lump which could be felt under the injection site. No product quality complaint was involved. The outcome of the lump under injection site was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from an office manager via a company representative and refers to a 26 year old female patient. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 11-JAN-2017, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not not reported). On 13-MAR-2017, the patient was vaccinated with the second dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not not reported). On 15-MAY-2017, the patient was vaccinated with the third dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not not reported) (reported as early dose). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to multiple unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patients were vaccinated with a dose of ZOSTAVAX injection (lot#, expiration date, dose and route of administration were not reported) for shingles prevention, reconstituted with sterile diluent (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported). On unknown dates, the patients experienced shingles.     The outcome of the event and the causality between the event and suspect therapies were unknown. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant, concerning to a multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were provided.  On an unknown date, the reporter stated that multiple unspecified patients were vaccinated with an improperly stored dose of VARIVAX lot # L034368 and expiration date 08-SEP-2017 (dose and route of administration were not provided) for prophylaxis and was reconstituted with an sterile diluent which did not undergo a temperature excursion. No adverse effects was reported. The vaccine was stored at a total time in the range of temperature -9°Centigrade to 8° Centigrade, time frame of 37 minutes, no previous temperature excursion was reported. The call was placed because of a Digital Data logger report. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of 30 year old patients. The patients' had no medical history, concurrent condition, drug and allergy history to be reported. On an unspecified date, an unspecified number of patients were vaccinated with GARDASIL 9 (strength, dose, lot #, expiration date were not reported) for prophylaxis. No adverse effects reported. 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 referring to a multiple, unknown patients of unknown age and gender.  The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.   In April 2017, reported as between 18-APR-2017 and 26-APR-2017,  the patients received multiple doses of improperly stored ROTATEQ Lot #M040269 with an expiration date on 28-APR-2018 (strength, dose, and route of administration were not reported) for prophylaxis. The vaccines were stored at a Temperature of 47°F to 77°F during 84 hours. There was no previous temperature excursions and the call was not because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007430: US-009507513-1705USA015670:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a multiple, unknown patients of unknown age and gender.  The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.   In April 2017, reported as between 18-APR-2017 and 26-APR-2017,  the patients received multiple doses of improperly stored PNEUMOVAX 23 Lot #M043424 with an expiration date on 06-JUN-2018 (strength, dose, and route of administration were not reported) for prophylaxis.  The vaccines were stored at a Temperature of 47°F to 77°F during 84 hours. There was no previous temperature excursions and the call was not because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007430: US-009507513-1705USA015668:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 18 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 31-MAY-2017, the patient was vaccinated with a dose of GARDASIL (strength, dose, route, frequency were not provided) for prophylaxis. The lot number was M014929, with an expiration date of 27-MAY-2017. The nurse reported that the vaccine was expired when it was administered and no adverse effects were reported. No further information available and no product quality complain was reported. 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 healthcare worker referring to an unspecified number of unspecified patients of unknown age and gender. The patients' had no medical history, concurrent condition, drug and allergy history to be reported. On 12-JAN-2017, an unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ lot # M016238 expiration date  07-DIC-2017, (strength, dose were not provided) for prophylaxis. The patients' concomitant medications were not reported. On an unspecified date ROTATEQ was exposed to a temperature excursion of 32° Fahrenheit (°F) to 35°F (31°F) during a time frame of 1 hour, with no previous temperature excursion (incorrect product storage). No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested; Sender's Comments:  US-009507513-1706USA000994:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 31-MAY-2017, the patient was vaccinated with an expired dose of M-M-R II, therapy type (rHA), ( (lot # L015281 with an expiration date in 30-APR-2017), for prophylaxis (dose, frequency, route and strength were not provided), that was reconstituted with sterile diluent. No adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product quality issue
Clinical narrative: Information has been received from a licensed nurse practitioner (LPN) regarding two patients of unknown ages and genders. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients received an unspecified dose of GARDASIL 9 lot # L043214,, expiration date 30-AUG-2017, intramuscular for prophylaxis (dose number was not reported). The LPN reported a possible quality issue regarding the appearance of the vaccine in vials of GARDASIL 9. A product quality complaint has been filled. Additional information has been requested.
Sex: U
Vaccine: HPV9, MEN, TDAP
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a nurse from the physician's office via a Company representative, referring to a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (lot#, dose, frequency and route of administration were unspecified) for prophylaxis. Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and meningococcal vaccine (unspecified). On an unknown date after receiving GARDASIL 9, the patient became lightheaded but did not pass out while she was at the physician office. It was reported that no intervention to prevent serious criteria was necessary, that dizziness was not significant disability or incapacity or life threatening, and that the patient was not hospitalized. No product quality complaint was involved. At the time of the report, the outcome of dizziness was reported as recovered on an unspecified date. The relatedness assessment between GARDASIL 9 and dizziness was not provided. Additional information is not expected since there is no consent from the physician to be contacted.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report received from a pharmacist referred to a currently 51 year old female patient. The patient did not have any medical history or allergies. Concurrent conditions and concomitant medications were not reported. On an unknown date, the patient received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (lot and expiry date not reported). Pharmacist reported that the patient recently on an unknown date, had blood work as a prerequisite for employment, and the blood work revealed negative titers for measles, mumps and rubella (Antibody test negative). The patient then received a dose of MMR II (unknown lot/expiry date) reconstituted with sterile water diluent (unknown lot/expiry date) on 02-JUN-2017 because she had negative titers from the first dose. Outcome and causality for the event was not reported.  Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Exposure via skin contact, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with M-M-R II (dosing details were not provided) for prophylaxis. Pharmacist reported that after vaccination, a small amount of the vaccine was observed on the patient's skin (incorrect dose administered and exposure via skin contact). The patient had not experienced any adverse effects at the time. 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 pharmacy technician refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. Pharmacy technician reported that on multiple unknown dates, the patients may have been vaccinated with improperly stored M-M-R II and properly stored sterile diluent (STERILE DILUENT) (dosing details, lot# and expiry date were not provided) for prophylaxis. She mentioned that M-M-R II underwent a temperature excursion at 72 degree F. No data logger was involved. No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. Approximately in May 2017 (reported as some time last week near 26-MAY-2017), the patient was vaccinated with an expired ZOSTAVAX vial 19400 PFU (plaque-forming units), lot # L032184, expiry date: 30-NOV-2016 (dosing details and route were not reported) (expired product administered) for prophylaxis. The outcome of the event was unknown. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported.  On 01-APR-2017, temperature excursions had started. On 25-MAY-2017, the patient was vaccinated with improperly stored ZOSTAVAX via 19400 PFU (plaque-forming units) lot # M033336, expiry date: 11-OCT-2017 (dosing details and route were not reported) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 6 F to 14 F for a duration of 660 hours. Previous temperature excursion was reported. Time frame was cumulative multiple excursions. No data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. 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 Certified Medical Assistant and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concurrent conditions was reported. On unknown dates, the unspecified patients were vaccinated with an improperly stored doses of ROTATEQ oral liquid (lot number # M038724, expiration date 24-APR-2018, exact dose was not reported) reconstituted with properly stored sterile diluent (STERILE DILUENT). The vaccines were stored in the temperature between 47 and 77 degrees Fahrenheit for 42 minutes. There was previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA011097: US-009507513-1706USA002252:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 19-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ with lot # M025568 and expiration date on 07-NOV-2017 (strength and dose were not reported) for prophylaxis. The storage temperature was reported as 47 to 77 degrees Fahrenheit (°F) for a time frame of 7 hours and 15 minutes; but there was a previous temperature excursion reported, with a temperature of 32°F to 35°F for 10 hours. No adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002269: US-009507513-1706USA002268: US-009507513-1706USA002266: US-009507513-1705USA011335:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 08-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ with lot # M040268 and expiration date on 31-MAY-2018 (strength and dose were not reported) for prophylaxis. The storage temperature was reported as 47 to 77 degrees Fahrenheit (°F) for a time frame of 7 hours and 15 minutes; but there was a previous temperature excursion reported, with a temperature of 32°F to 35°F for 10 hours. No adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002269: US-009507513-1705USA011335: US-009507513-1706USA002266: US-009507513-1706USA002267:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 02-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # M040412 and expiration date on 30-JUN-2019 (strength and dose were not reported) for prophylaxis. The storage temperature was reported as 47 to 77 degrees Fahrenheit (°F) for a time frame of 7 hours and 15 minutes; but there was a previous temperature excursion reported, with a temperature of 32°F to 35°F for 10 hours. No adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested. Sender's Comments: US-009507513-1705USA011335: US-009507513-1706USA002268: US-009507513-1706USA002266: US-009507513-1706USA002267.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old non-pregnant female patient with type 2 diabetes, hypertension and drug reaction/allergy to penicillin. The patient's medical history and concomitant therapies were not reported. On 01-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX with lot # M035691 and expiration date of 07-NOV-2017 (strength, dose and route of administration were unknown) as recommended for her age from her physician for prophylaxis, and which was reconstituted with sterile diluent (strength, dose, frequency, route of administration, lot number and expiration date were unknown). On 02-JUN-2017, the patient developed "shingles like rash"  on  an unknown location on the body. The patient went to a local hospital on 04-JUN-2017, where the shingles (herpes Zoster) was confirmed by an unspecified diagnostic test and a treatment was given for the adverse event. However, the pharmacist confirmed that the patient was not admitted to hospital.   The action taken with the sterile diluent  was unknown. At the time of reporting, the patient was not recovered from the event. The causality between ZOSTAVAX, sterile diluent  and the event was not provided. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Fever 99.1 degree F, gave TYLENOL. Right leg still sore at site of injection, claims hurts to walk.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 15-MAY-2017, the patient was vaccinated with an improperly stored dose of PROQUAD injection, lot # M044018 with expiration date 01-MAY-2018 (strength, dose and route of administration were not reported). The vaccine experienced temperature excursion of 30 degrees Fahrenheit for 64 hours. Digital data logger was involved and there were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved in this case. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. Between 10-MAY-2017 and 16-MAY-2017, the patients were vaccinated with improperly stored doses of VARIVAX with lot number M019641 and expiration date on 20-APR-2018 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis. It was reported that on an unspecified date, the vaccine was exposed to a temperature between 47 Fahrenheit degrees and 77 Fahrenheit degrees for 90 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported. This is one of several reports received from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1705USA014918: US-009507513-1705USA014919:
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to multiple unspecified patients of unknown age and gender. The patients concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, since approximately 2011 (reported as "over the past 6 years"), the patients were vaccinated with doses of GARDASIL (doses, routes of administration, lot numbers and expiration dates were not provided). On unknown dates, the patients experienced injection site hurt. Product quality complained was not involved. The outcome of the event was unknown. Causality assessment was not specified. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA014282: US-009507513-1705USA014280: US-009507513-1705USA014281:
Sex: U
Vaccine: HPV9, MNQ
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report has been received from registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On 18-MAY-2017, the patient may have inadvertently received a dose of GARDASIL 9 (route of administration, dose and anatomical location were not provided) lot # N002720 and expiration date of 12-MAY-2019 and MENACTRA (manufacturer unknown) (lot #, expiration date, route of administration, dose and anatomical location were not provided and route of administration was unknown by reporter) for prophylaxis, both given in the same syringe. No adverse event 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 and refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The reporter stated that doses of RECOMBIVAX HB (lot # M046373, expiry date: 04-NOV-2018) were improperly stored at temperature 47 Fahrenheit degrees to 77 F degrees, for 46 hours. The digital data logger was involved. This improperly stored RECOMBIVAX HB were administered to unspecified number of patients: one dose on 08-MAY-2017, and another dose on 10-MAY-2017. No adverse effects were reported. Product quality complained was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA014879:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unspecified demographics. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On unknown dates, the unspecified number of improperly stored doses of LIQUID PEDVAXHIB, lot # M014927 with expiration date on 18-FEB-2019 (dose, route of administration and anatomical location were not reported) were administered to the unspecified number of patients. The temperature excursion was recorded via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 29.7 degrees Fahrenheit for 60 days before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA009653: US-009507513-1705USA012911:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unspecified demographics. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On unknown dates, the unspecified number of improperly stored doses of GARDASIL 9, lot # M041990 with expiration date on 28-JUN-2019  (dose, route of administration and anatomical location were not reported) were administered to the unspecified number of patients. No adverse effects were reported. The temperature excursion was recorded via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 29.7 degrees Fahrenheit for 60 days before administration to the patients. No previous temperature excursion was reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA012910: US-009507513-1705USA009653:
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician (reported also as a health care professional) referring to a 6 month old patient of unknown gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On 19-MAY-2017, the patient was inadvertently vaccinated with a unspecified dose of VAQTA intramuscularly, lot # M022924 (dosage scheduled, expiration date, number and anatomical location were not provided) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to multiple unspecified patients of unknown age and gender. The patients concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, since 2011 (reported as "over the past 6 years"), the patients were vaccinated with GARDASIL 9 (doses, routes of administration, lot numbers and expiry dates were not provided). On unknown dates, the patients experienced injection site hurt. Product quality complained was not involved The outcome of the event was unknown. Causality assessment was not specified. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA008994: US-009507513-1705USA014281: US-009507513-1705USA014282:
Sex: U
Vaccine: VARCEL
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, since approximately 2011 (reported as "over the past 6 years"), the patients were vaccinated with doses of VARIVAX (doses, routes of administration, lot numbers and expiration dates were not provided) reconstituted with sterile diluent (manufacturer unknown)(doses, routes of administration, lot numbers and expiration dates were not provided). On unknown dates, the patients experienced injection site stinging. Product quality complained was not involved. The outcome of the event was unknown. Causality assessment was not specified. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA014280: US-009507513-1705USA014282: US-009507513-1705USA008994:
Sex: U
Vaccine: MMRV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to multiple unspecified patients of unknown age and gender. No information on patient's concurrent conditions, medical history and concomitant medications was reported. On unknown dates, since approximately 2011 (reported as "over the past 6 years"), the patients were vaccinated with PROQUAD (doses, routes of administration, lot numbers and expiry dates not provided) reconstituted with sterile diluent (manufacturer unknown) (doses, routes of administration, lot numbers and expiry dates not provided). On unknown dates, the patients experienced injection site stinging. No product quality complained was involved. The outcome of the event was unknown. Causality assessment was not specified. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA008994: US-009507513-1705USA014280: US-009507513-1705USA014281.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. The reporter stated that doses of GARDASIL 9 (lot # M041990 , expiry date: 28-JUN-2019) were improperly stored at temperature 47 Fahrenheit degrees to 77 F degrees, for 46 hours. The digital data logger was involved. This improperly stored doses of GARDASIL 9 were administered to unspecified number of patients: one dose on 10-MAY-2017, and another dose on 12-MAY-2017 (dose, route of administration not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Product quality complaint was not involved. Additional information has been requested.; Sender's Comments: US-009507513-1705USA011163:
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Chills, Body aches, headache, redness and swelling on right upper arm.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Patient was only administered the MenCYW-135 liquid conjugate component of the MENVEO vaccine.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Petechiae, Platelet count decreased, Thrombocytopenia
Clinical narrative: Transfer from outside hospital with  petechial rash. At ED, lab showed thrombocytopenia.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Decreased appetite, Erythema, Influenza, Pain
Clinical narrative: Flu symptoms - fever, achiness, loss of appetite , arm redness, swelling and heat - diagnosed with cellulitis made three trips to er before being admitted for observation and treatment with steroids and Iv antibiotics.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Flu symptoms - fever, achiness, loss of appetite , arm redness, swelling and heat - diagnosed with cellulitis made three trips to er before being admitted for observation and treatment with steroids and Iv antibiotics.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Administration site rash, Erythema
Clinical narrative: Rash at administration site and the redness of the left arm.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Headache, Immediate post-injection reaction
Clinical narrative: Gave meningococcal vaccine in Right Deltoid while patient seated without issues. Gave HPV vaccine in Left Deltoid and patient instantly complained of a headache. He stood up and became dizzy. I laid him down on his back and brought his legs up. He was given juice and was observed for about 15-20 minutes. A message was left with his father to check on him but have not heard back from him.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Nodule, Pain, Peripheral swelling
Clinical narrative: Extreme itchiness within minutes of injection, swelling from top of shoulder down to elbow, hot to touch, redness, hard knot, extreme soreness upon moving.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Skin warm
Clinical narrative: Extreme itchiness within minutes of injection, swelling from top of shoulder down to elbow, hot to touch, redness, hard knot, extreme soreness upon moving.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Hepatitis B pediatric dose given instead of adult. It was caught and second pediatric dose was given to equal adult dose.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Dyspnoea, Eye movement disorder, Skin discolouration, Unresponsive to stimuli
Clinical narrative: Mother states child was with the parents in the car when the father try to talk to her she did not respond, the cheeks change color (blue) rolled the eyes up and had difficult breathing all these happened for a lapse of Three to five minutes.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Peripheral swelling, Rash macular
Clinical narrative: Almost immediately after injection, right arm became immediately swollen and developed a red botchy rash. After sitting in the office for 10 minutes and removing the bandage, skin returned to normal; minimal swelling; arm had FROM.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 03-MAY-2017, the patient was vaccinated with an expired dose of M-M-R II (recombinant human albumin (rHA)), injection, subcutaneously in the left thigh, lot number M032153, expiration date: 22-APR-2017 (strength and dose were not reported) as a booster dose. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT) (lot number reported as M046372, expiration date: 08-JUL-2019). The patient did not experience any adverse effects. There was no product quality complaint involved in this case. 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 pharmacist and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant medications and concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M043424, expiration date 16-JUN-2018 (route of administration and anatomical location were not reported). No adverse effects were reported. The administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 8 hours which was recorded by a digital data logger. No previous temperature excursion was reported. 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 registered nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, between 17-APR-2017 and 11-MAY-2017, the patients were vaccinated with doses of improperly stored GARDASIL 9 lot # M037770 with expiration date 01-JUN-2019 and lot # M043731 with expiration date 22-JUN-2019 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 47 to 77 degrees Fahrenheit for 75 hours. Digital data logger was not involved. The vaccine did not undergo previous temperature excursion. No adverse events were reported. The excursion was not detected because of a "data logger". Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse and referred to a 4-year-old patient of an unknown gender.  The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. The patient historical drugs included VARIVAX and M-M-R II. On 06-APR-2016, the patient was vaccinated with PROQUAD subcutaneously (strength, dose, and frequency were not reported; lot number L030586 with an expiration date 10-FEB-2017) for prophylaxis that was reconstituted with sterile diluent (manufacturer unknown) (lot number and expiration date were not reported). On 15-MAY-2017, the patient received a second dose of PROQUAD subcutaneously (strength, dose, and frequency were not reported; lot number M038228 with an expiration date 06-MAR-2018) that was reconstituted with sterile diluent (manufacturer unknown) (lot number and expiration date were not reported). The patient did not experience any adverse effects. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report has been received from a Licensed Practical Nurse and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX 23 (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not provided) for prophylaxis (reported as vaccination). Subsequently, on an unknown date reported as following the vaccination with PNEUMOVAX 23, the patients experienced pain and severe arm swelling. It was reported that the patients sought medical attention through a call that they made to the physician who recommended ice, ibuprofen, and elevation of the affected arm as a treatment for the events. At the reporting time, it was unknown whether the patients recovered or not from the adverse events. The causal relationship between the therapy with PNEUMOVAX 23 and the adverse events was not reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse concerning an unknown number of patients, names and demographics were unknown to the reporter. The patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD for prophylaxis, of several lots (lot # N002915, expiration date: 24-JUL-2017; lot# M033215, expiration date: 09-JAN-2018; lot# N002915, expiration date: 24-JUL-2018; and lot# M039449, expiration date: 20-MAR-2018) (dose, frequency and route of administration were not reported). No adverse effect was reported in any of the patients. It was reported that on an unspecified date, the vaccines were exposed to a temperature of 8.6 Fahrenheit degrees for 45 minutes. A prior temperature excursion was not reported. The call was placed because of a Digital Data logger report. This is one of two reports received from the same reporter. Additional information is not expected as there was no consent to contact the physician. Sender's Comments: US-009507513-1705USA014042.
Sex: U
Vaccine: HPVX
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported. On an unknown date in November 2016, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot # and expiration date were not not reported). On an unknown date in January 2017, there was an interchange of vaccine and the patient was vaccinated with the second dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. 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 registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, and drug reactions or allergies provided. On 03-MAY-2017, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB injection (lot # M034189, expiry date 23-MAY-2019, dose, route and site of administration were not reported). The vaccine was stored over 32 but under 35 degrees Fahrenheit for 552 hours. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported. No product quality complain was involved. Additional information has been requested.