chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy was not provided. On 24-JUL-2017, the patient was vaccinated with a dose of GARDASIL 9 (dosing details were not provided) for prophylaxis (extra dose administered and inappropriate schedule of drug administration). Reporter mentioned that the patient already received 3 doses of GARDASIL on 24-JUL-2008, 10-OCT-2008 and 31-MAR-2009, respectively. No adverse symptoms were reported. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose and route were not reported), lot# M037533 with expiration date 31-MAY-2018, for prophylaxis. The vaccines were exposed to temperature excursion of 9 degrees Celsius to 25 degrees Celsius for 2 hours. Data logger was involved. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA000379: US-009507513-1707USA012435:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (dose was not reported) lot# M040267 with expiration date 14-MAY-2018, lot# M041184 with expiration date 31-MAY-2018, orally for prophylaxis. The vaccines were exposed to temperature excursion of 9 degrees Celsius to 25 degrees Celsius for 2 hours. Data logger was involved. There was no previous temperature excursion. No adverse effects reported. This is one of several report received from  the same source.; Sender's Comments: US-009507513-1708USA000378: US-009507513-1707USA012435:
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 83 year old male patient with hypertension, cardiac murmur, arthritis and dementia alzheimer's type. On 26-OCT-2016 the patient was vaccinated with ZOSTAVAX, subcutaneous for prophylaxis. On 10-JUL-2017, 8 months 15 days after onset of therapy the patient experienced herpes zoster. The outcome of herpes zoster was reported as recovering/resolving.; Sender's Comments: US-009507513-1708USA002305:
Sex: U
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This spontaneous report as received from a nurse via field representative refers to a patient of unknown age and gender. The patient's current conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ROTATEQ (strength, dose, frequency,lot/batch # and expiration date were not reported) by mouth for prophylaxis and shortly "threw it up" (underdose). On an unknown date(reported as"few days later", the patient was administered with second dose of ROTATEQ (strength, dose, frequency, lot/batch # and expiration date were not reported). No symptoms were reported. No additional adverse event information was provided. No product quality complaint (PQC) involved. The outcome of the events was unknown. The causality assessment of the ROTATEQ with the event "threw it up" was not provided by the reporter.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to an adult patient of unknown age and gender. The patient's current conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 01-AUG-2017 the patient was vaccinated with a pediatric dose of RECOMBIVAX HB (strength 2.5/0.5) (dose, lot/batch# and expiration date were not reported) by accident instead of an adult dose (drug administered to patient of inappropriate age) intramuscularly for prophylaxis. No adverse effects were reported. No product quality complaint(PQC) involved. The outcome of drug administered to patient of inappropriate age and no adverse effects was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist regarding 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 in between 22-MAR-2017 and 01-AUG-2017, the patients' received unspecified doses of improperly stored ZOSTAVAX 19400 PFU (lot #, expiration date, dose and route were not reported) (incorrect product storage) reconstituted with properly stored sterile diluent (Manufacturer unknown) for prophylaxis. The vaccinations were occurred from 22-MAR-2017 to 01-AUG-2017. The storage temperature was 13.3F and time frame was 2.5 hours. The previous temperature excursion was 14.4F for 2 hours. Data logger was not used. No adverse effects was reported. This is one of the report received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA002351:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 01-AUG-2017 the patient received an expired dose of ZOSTAVAX (lot # M041510, expired on 27-JUL-2017) (dose and route were unspecified). The diluent used to reconstituted ZOSTAVAX was not expired. No adverse effects were reported. The outcome was not reported.
Sex: U
Vaccine: HEP, HEPA, HIBV, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified patient. Information regarding medical history, concurrent condition or concomitant medication was not provided. The reporter stated on an unknown date the patient might receive an improperly stored dose of one of the following vaccines, but she was not sure which of the lots of the patient received. The vaccines were stored in the range of 47 Fahrenheit to 77 Fahrenheit for 35 minutes and they were previously stored in 47 Fahrenheit to 77 Fahrenheit for 56 minutes. No adverse effects reported. Names of vaccines involved, VAQTA (lot# N005274, expiration date 03-APR-2018, dose unspecified, data logger); GARDASIL 9 (lot# M041990, expiration date 28-JUN-2019 or lot# M040412, expiration date 30-JUN-2019; dose unspecified, data logger); ROTATEQ (lot # M042169, 08-JUN-2018 or lot# M042169, expiration date 22-JUN-2018; dose unspecified, data logger); LIQUID PEDVAXHIB (lot# N003698, expiration date 31-OCT-2019 or lot# N003701, expiration date 01-NOV-2019; dose unspecified, data logger); RECOMBIVAX HB (lot# M045654, expiration date 03-JUL-2019, dose unspecified, data logger) for prophylaxis.
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a 5 year old patient. On 09-MAY-2017 and 13-JUN-2017 the patient was vaccinated with the first dose and the second dose of PROQUAD (lot # M043307, Expiration date: 24-APR-2018, rHA) for prophylaxis respectively. No adverse effects were reported. No product quality complaint (PQC) was involved.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to a 50 year old female patient with immunology test normal. On 21-JUN-2017 the patient was vaccinated with ZOSTAVAX, .65 ml, subcutaneous for prophylaxis. On 2017 the patient experienced herpes zoster.  The outcome of herpes zoster was reported as not recovered/not resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pruritus, Vaccination site erythema, Vaccination site pain
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient. Medical history, current conditions and concomitant medications were not reported. On 27-JUL-2017 the patient was vaccinated with ZOSTAVAX,VIAL 19400 PFU, (unknown lot number) 0.65 ml, subcutaneous for prophylaxis. On 29-JUL-2017, the patient experienced vaccination site erythema, headache, nausea, pruritus, vaccination site pain and vaccination site swelling. On an unknown date (i.e 5 days later) the patient experienced injection site erythema. The outcome of vaccination site erythema, headache, nausea, pruritus, vaccination site pain and vaccination site swelling was reported as not resolved. No treatment was given for the treatment. Causality was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site swelling
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient. Medical history, current conditions and concomitant medications were not reported. On 27-JUL-2017 the patient was vaccinated with ZOSTAVAX,VIAL 19400 PFU, (unknown lot number) 0.65 ml, subcutaneous for prophylaxis. On 29-JUL-2017, the patient experienced vaccination site erythema, headache, nausea, pruritus, vaccination site pain and vaccination site swelling. On an unknown date (i.e 5 days later) the patient experienced injection site erythema. The outcome of vaccination site erythema, headache, nausea, pruritus, vaccination site pain and vaccination site swelling was reported as not resolved. No treatment was given for the treatment. Causality was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 25 year old female patient. Information on pertinent medical history and concurrent condition was not provided. On 21-OCT-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # M014929, expiry date: 27-MAY-2017 (dose and route not reported) for prophylaxis. On 31-JUL-2017, she was vaccinated second dose of GARDASIL 9 (inappropriate schedule of drug administration). No adverse effects. No product quality complaint (PQC) involved. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received from a medical assistant referring to an unknown number of unspecified patients of unknown demographics. The patients' medical history was not reported. On unspecified dates, the patients were administered dose of improperly stored VAQTA of Strength 25/0.5 (units unspecified), lot# M047658 with an expiry date of 28-OCT-2017 (Dose, frequency, and anatomical location were not reported) intramuscularly for prophylaxis. The vaccines were exposed to 27.3 Fahrenheit degree (F) for 16 minutes and 32 to 35 (31.6) Fahrenheit degree (F) for 15 minutes. There was previous temperature excursion involved which was at 32 to 35 (34.4) Fahrenheit degree (F) for 15 minutes. Digital data logger was involved. No adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA002347:
Age: 85.0
Sex: M
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 85 years old male patient. The patient's medical history, concurrent conditions, drug allergies and concomitant medications were not reported. The pharmacist reported that on 01-AUG-2017, a patient inadvertently received PREVNAR 13 (unknown lot number and expiration date) instead of intended dose of PNEUMOVAX 23 (wrong vaccine administered). No dose of PNEUMOVAX 23 was administered. No adverse effects reported. There was no product quality complaint involved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age.  Medical history, current conditions and concomitant medications were not reported.  On an unknown date the patients were vaccinated with improperly stored dose of GARDASIL 9 (lot # M007728, expiry date: 21-MAR-2018 and lot # M021407, expiry date: 30-APR-2018) (unknown dose) for prophylaxis. No adverse effects were reported. The product was stored at: 32 degree fahrenheit to 35 degree fahrenheit (34F) at 42 hours' time frame. There was no previous temperature excursion. Call was because of data logger. No product quality compliant. The outcome of incorrect  product storage and no adverse event was unknown.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Eye pruritus, Rash generalised, Rash pruritic, Rash vesicular
Clinical narrative: This spontaneous report was received from a physician regarding a 2 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUL-2017 the patient was vaccinated with VAQTA 25/0.5, lot # M036459 with expiration date 18-JAN-2018 (dose was not reported), intramuscularly for routine vaccine. On 31-JUL-2017, the patient experienced itchy rash like hives all over her body (rash generalized) and itchy eyes (eye pruritus). The patient received unspecified medication as a treatment for the events. The outcome of rash generalised and eye pruritus was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional and refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored ROTATEQ lot # M014318 for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA002611: US-009507513-1708USA002612:
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site joint pain, Injection site joint swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 03-MAR-2017 the patient was vaccinated with ZOSTAVAX lot # M034765, subcutaneous for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect route of drug administration, injection site joint erythema, injection site joint swelling and injection site joint pain. The outcome of injection site joint pain, injection site joint erythema and injection site joint swelling was reported as not recovered/not resolved. The outcome of incorrect route of drug administration is unknown. The reporter considered incorrect route of drug administration to be not related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On an unknown date the patient was vaccinated with GARDASIL 9 lot # M042853 and N009173 for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA002734: US-009507513-1708USA002735: US-009507513-1708USA002736: US-009507513-1708USA002737:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX lot # M027886 for prophylaxis.  Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. This was one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA002307: US-009507513-1708USA002306:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unknown age.    On an unknown date the patients were vaccinated with ZOSTAVAX for prophylaxis.  On an unknown date the patient developed herpes zoster. The outcome of herpes zoster was unknown.; Sender's Comments:  US-009507513-1708USA001049:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with PROQUAD lot # M042500 for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD.     This was one of several reports received from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1708USA002307: US-009507513-1708USA002271:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX lot # M035695 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown.  The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. This was one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1708USA002271: US-009507513-1708USA002306:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with one dose of improperly stored VARIVAX (lot # M041080, expiry date 06-OCT-2018) for prophylaxis at a temperature of 6 degree fahrenheit to 14 degree fahrenheit for a time frame of 4 hours 55 minutes (incorrect product stored). No adverse effects reported. The call was because of a data logger.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were unknown. On unknown dates, the patients were vaccinated with doses of improperly stored LIQUID PEDVAXHIB (lot # M027884, expiration date 19-APR-2019) (dose and route unknown) for prophylaxis (incorrect product storage). Concomitant therapies included sterile diluent (manufacturer unknown). The nurse confirmed that sterile diluent (manufacturer unknown) was properly stored. No adverse effects were reported. The temperature excursion was between 47 degrees Fahrenheit (F) to 77.4 degrees F (66.4 degrees F) for a time frame of 3 hours and 22 minutes. There was no previous temperature excursion. This report was because of data logger. This is one of several reports from the same reporter (1708USA002361, 1708USA002362 and 1708USA002363).; Sender's Comments:  US-009507513-1708USA002362: US-009507513-1708USA002363:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a non health care professional (office manager) refers to an unknown number of unspecified patients of unknown demographics. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9 of lot # M040412 with an expiry date of 30-JUN-2019, (Strength, dose, frequency, route, anatomical location, were not reported) for prophylaxis. There were no concomitant therapies reported. The vaccines were exposed to 47 to 77 Fahrenheit degree (F) for 9 hours; 32 to 35 Fahrenheit degree (F) for 168 hours and 31 or colder (30) Fahrenheit degree (F) for 96 hours. There was no previous temperature excursion. Digital data logger was not involved. There were no adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1707USA013353: US-009507513-1708USA002330:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a non health care professional (office manager) refers to a patients' of unknown demographics. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of M-M-R II recombinant human albumin (rHA) or human serum albumin (HSA) (Strength, dose, frequency, route, anatomical location, lot/batch # and expiration date were not reported) for prophylaxis. The concomitant therapy included sterile diluent which was used to reconstitute M-M-R II injection, which was stored properly. The vaccines were exposed to 47 to 77 Fahrenheit degree (F) for 9 hours; 32 to 35 Fahrenheit degree (F) for 168 hours and 31 or colder (30) Fahrenheit degree (F) for 96 hours. There was no previous temperature excursion. Digital data logger was not involved. There was no product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1707USA013353: US-009507513-1708USA002329:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 4 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 02-AUG-2017, the 4-month old patient was vaccinated with first dose of ROTATEQ (dose, route, lot# and expiration date unknown) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received from a medical assistant referring to an unknown number of unspecified patients of unknown demographics. The patients' medical history was not reported. On unspecified dates, the patients were administered improperly stored GARDASIL 9 of lot # M036059 with an expiry date of 03-JUN-2019 (Strength, dose, frequency, anatomical location and route were not reported) for prophylaxis. There were no concomitant therapies reported. The vaccines were exposed to 27.3 Fahrenheit degree (F) for 16 minutes and 32 to 35 (31.6) Fahrenheit degree (F) for 15 minutes. There was previous temperature excursion involved which was at 32 to 35 (34.4) Fahrenheit degree (F) for 15 minutes. Digital data logger was involved. No adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA001749:
Sex: U
Vaccine: HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In between 01-JUN-2017 and 31-JUL-2017, the patient was vaccinated with improperly doses of ROTATEQ, from lot # M045545, expiry date:10-JUN-2018, orally (dose unknown), and GARDASIL 9 from lot # M044717, expiry date: 19-JUL-2019 and lot # M036059, expiry date: 03-JUN-2019 (dose, dose #, route were unknown) for prophylaxis (incorrect product storage). No adverse effects were reported. The vaccines were exposed to a temperature of -2 degree Celsius for 10 hours. Data logger was involved. There were no previous temperature excursions. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist regarding 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 date in between 22-MAR-2017 to 01-AUG-2017, the patients' received unspecified doses of improperly stored VARIVAX (lot #, expiration date, dose and route were not reported) (incorrect product storage) reconstituted with properly stored sterile diluent (Manufacturer unknown) for prophylaxis. The vaccinations were occurred from 22-MAR-2017 to 01-AUG-2017. The storage temperature was 13.3F and time frame was 2.5 hours. The previous temperature excursion was 14.4F for 2 hours. Data logger was not used. No adverse effects was reported. This is one of the report received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA001247: US-009507513-1708USA001247:
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 02-AUG-2017 inadvertently the patient was vaccinated with expired dose of PROQUAD (lot # M006103, expiry date 01-AUG-2017) 1 DF, subcutaneously for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: HPVX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patient received first, second and third doses of vaccination with either GARDASIL or GARDASIL 9 (dose, route, lot # and expiry date unknown) for prophylaxis. On an unknown date, the patient had inadvertently received vaccination with fourth dose of either GARDASIL or GARDASIL 9 (dose, route, lot # and expiry date unknown) for prophylaxis (extra dose administered). No adverse effects were reported. The patient's father reported to the pharmacist that his son received the fourth dose in the physician's office however he could not specify which one of the above vaccines the patient was administered. No product quality complaint was involved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were unknown. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # M024261, expiration date 30-JUL-2018) (dose and route unknown) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). The nurse confirmed that sterile diluent (manufacturer unknown) was properly stored. No adverse effects were reported. The temperature excursion was between 47 degrees Fahrenheit (F) to 77.4 degrees F (66.4 degrees F) for a time frame of 3 hours and 22 minutes. There was no previous temperature excursion. This report was because of data logger. This is one of several reports from the same reporter (1708USA002328, 1708USA002362 and 1708USA002363). Sender's Comments: US-009507513-1708USA002362: US-009507513-1708USA002363: US-009507513-1708USA002328.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were unknown. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot # M047662 [expiration date 02-DEC-2018]) (dose and route unknown) for prophylaxis (incorrect product storage). Concomitant therapies included sterile diluent (manufacturer unknown). The nurse confirmed that sterile diluent (manufacturer unknown) was properly stored. No adverse effects were reported. The temperature excursion was between 47 degrees Fahrenheit (F) to 77.4 degrees F (66.4 degrees F) for a time frame of 3 hours and 22 minutes. There was no previous temperature excursion. This report was because of data logger. This is one of several reports from the same reporter (1708USA002328, 1708USA002361 and 1708USA002363).; Sender's Comments: US-009507513-1708USA002363: US-009507513-1708USA002328: US-009507513-1708USA002361:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were unknown. On unknown dates, the patients were vaccinated with doses of improperly stored M-M-R II (lot # M011666 [expiration date 08-MAR-2018] and lot# M040558 [expiration date 03-OCT-2018]) (dose and route unknown) for prophylaxis (incorrect product storage). Concomitant therapies included sterile diluent (manufacturer unknown). The nurse confirmed that sterile diluent (manufacturer unknown) was properly stored. No adverse effects were reported. The temperature excursion was between 47 degrees Fahrenheit (F) to 77.4 degrees F (66.4 degrees F) for a time frame of 3 hours and 22 minutes. There was no previous temperature excursion. This report was because of data logger. This is one of several reports from the same reporter (1708USA002328, 1708USA002361 and 1708USA002362).; Sender's Comments: US-009507513-1708USA002361: US-009507513-1708USA002328: US-009507513-1708USA002362:
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 17 year old Hispanic female patient. There was no information about patient's pertinent medical history reported and concurrent conditions. No concomitant medications were reported. On 12-APR-2017 at 9:37 am, the patient was vaccinated with improperly stored dose 2 of VARIVAX (lot # M037642) via subcutaneous route in the left arm, for prophylaxis. She received the first vaccine dose on an unknown date.    This is one of three reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA002753: US-009507513-1706USA002207:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional and refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with inproperly stored VAQTA lot # N012324 for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA002041: US-009507513-1708USA002612:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional and refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB lot # N002202 for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA002611: US-009507513-1708USA002041:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On an unknown date the patient was vaccinated with RECOMBIVAX HB lot # N009802 and M045653 for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA002736: US-009507513-1708USA002735: US-009507513-1708USA002737: US-009507513-1708USA002090:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On an unknown date the patient was vaccinated with VAQTA lot # N005274 and N012324 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA002090: US-009507513-1708USA002736: US-009507513-1708USA002734: US-009507513-1708USA002737:
Age: 19.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Chills, Dizziness, Liver function test, Metabolic function test, Muscle spasms
Clinical narrative: A few hours after the vaccine, patient began feeling nauseous, dizzy, vomiting, muscle cramping, and chills. Patient was seen in the ED and was sent home.
Age: 19.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Nausea, Vomiting
Clinical narrative: A few hours after the vaccine, patient began feeling nauseous, dizzy, vomiting, muscle cramping, and chills. Patient was seen in the ED and was sent home.
Age: 0.25
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Patient developed fever and chickenpox rash within 48 hours of receiving vaccination. Patient was sent to hospital and was diagnosed with chickenpox. The patient is being follow up by his physician.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (strength, dose, route, lot# and expiration date were not reported) for prophylaxis. The vaccines were exposed to temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 16 hours and 28 degrees Fahrenheit for 4 hours. Data logger was not involved. There was no previous temperature excursion. No adverse effect was reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a multiple unspecified patients of unknown ages. 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 # N016185, expiry date 31-JUL-2018).  Other suspect therapies included sterile diluent (manufacturer unknown). It was reported that the vaccines were improperly stored with a temperature excursions between -14°c to -10°c during 2.5 hours. It was reported because a data logger. The sterile diluent (manufacturer unknown) used to reconstituted all vaccines were properly stored. No adverse effects were reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of two reports from the same reporter source, (linked to MARRS # 1707USA011252). Additional information has been requested. Lot # N016185 is a valid lot # for ZOSTAVAX.; Sender's Comments:  US-009507513-1707USA011252:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant who was also the office manager and refers to an unknown number of patients of an unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL 9 lot number reported as M042859 and expiration date 17-JUL-2017 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA010395.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 14-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patient was vaccinated with an unidentified Merck Human Papillomavirus (HPV) vaccine (name, lot number, expiration date, dose and route of administration were not provided). It was unknown how many doses of HPV vaccine were received by the patient. On an unknown date, the patient experienced seizure. On an unknown date, the patient was admitted to the health facility and then she was referred to another health facility for a second opinion, for "specialized care". No product quality complaint was involved. The outcome of seizure was unknown. The relatedness between the adverse event and unidentified Merck HPV vaccine was not reported. Upon internal review, the event of seizure was determined to be medically significant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # N009173 intramuscular for prophylaxis. On an unknown date the patient experienced inappropriate schedule of drug administration, no adverse event and product quality issue. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to two patients of unknown age. On 03-AUG-2017 the patients were vaccinated with PROQUAD lot # M006107 for prophylaxis. On 03-AUG-2017, 1 day after onset of therapy the patients experienced expired product administered. On an unknown date the patients experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to PROQUAD. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On an unknown date the patient was vaccinated with ROTATEQ lot # M044396 and N003396, oral for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT).    On an unknown date the patient experienced incorrect product storage and no adverse event.     This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA002090: US-009507513-1708USA002734: US-009507513-1708USA002735: US-009507513-1708USA002737:
Age: 70.0
Sex: F
Vaccine: YF
Symptoms: Injection site swelling
Clinical narrative: Initial unsolicited case received from a nurse on 24-July-2017. This case involves a 70-year-old female patient who was vaccinated with a first dose (also reported as previous dose 0) of YF-VAX (Batch number, expiry date, dose were not reported) via intramuscularly in the left deltoid on 17-Jul-2017. Patient's medical history, pre-existing allergies, medical condition and illness at the time of vaccination was not reported. Any other vaccine within four weeks of vaccination was not reported. On 17-Jul-2017 since vaccination, the patient's arm at injection site had swollen to "size of baseball" and called for medical advice also did not want to see provider. Laboratory investigations and corrective treatment were not reported. The outcome of the event was reported as not recovered. List of documents held by sender: none.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Allergy test positive, Anaphylactic reaction, Cough, Eye swelling, Lip swelling
Clinical narrative: 30 min. after receiving 2 vaccines - PENTACEL  and Varicella - and eating box of raisins - pt. developed few hives on neck, lip and eye swelling, frequent cough and then stridor. To ER - IM SOLU-MEDROL, BENADRYL and racemic epi. Responded well, observed overnight - home on BENADRYL and prednisone and EPI PEN Jr. Dx: anaphylaxis.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Stridor, Urticaria
Clinical narrative: 30 min. after receiving 2 vaccines - PENTACEL  and Varicella - and eating box of raisins - pt. developed few hives on neck, lip and eye swelling, frequent cough and then stridor. To ER - IM SOLU-MEDROL, BENADRYL and racemic epi. Responded well, observed overnight - home on BENADRYL and prednisone and EPI PEN Jr. Dx: anaphylaxis.
Age: 14.0
Sex: F
Vaccine: HEPAB, HPV9
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after receiving vaccine. Patient was watched for a period of time and reexamined by provider.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS, SWELLING WITH SWELLING OF 10 CENTIMETERS BY 5.5 CENTIMETERS AT INJECTION SITE. WAS TREATED AT CLINIC WITH A SHOT OF BENADRYL AND TOPICAL HYDROCORTISONE CREAM. AT THIS TIME REACTION IS IN PROCESS OF RESOLVING. LINE WAS DRAWN AROUND AREA TO OBSERVE SIZE.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Aphonia
Clinical narrative: Patient lost voice the following day.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Dyskinesia, Fall, Head injury, Injury
Clinical narrative: Patient was administered vaccines in patient room. Parent and child opted to wait their 15 minutes in the lobby. Patient with episode of convulsive syncope about 2min after receiving vaccines. Patient  walked out to the waiting room after vaccines given & was standing in a busy waiting room, when he began to feel dizzy while looking at his injection sites and the "blacked out" patient fell to the ground, hitting his left flank and head on the wall. Mother notes 4 seconds of jerking of the extremities while on the floor. Within 20sec, pt was able to open his eyes, sit up and was oriented x3. Was able to get up and sit in a wheelchair. MD evaluated pt immediately after the event. No pallor to the face with good respirations. No jerking of extremities.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient was administered vaccines in patient room. Parent and child opted to wait their 15 minutes in the lobby. Patient with episode of convulsive syncope about 2min after receiving vaccines. Patient  walked out to the waiting room after vaccines given & was standing in a busy waiting room, when he began to feel dizzy while looking at his injection sites and the "blacked out" patient fell to the ground, hitting his left flank and head on the wall. Mother notes 4 seconds of jerking of the extremities while on the floor. Within 20sec, pt was able to open his eyes, sit up and was oriented x3. Was able to get up and sit in a wheelchair. MD evaluated pt immediately after the event. No pallor to the face with good respirations. No jerking of extremities.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: INJECTION SITE RED, WARM SWOLLEN.  HE WENT TO THE ER AND WAS GIVEN KEFLEX WITH A CELLULITIS DIAGNOSIS. TODAY IN THE OFFICE THE AREA IS 17CM X 11 CM.  IT IS LESS WARM AND LESS SWOLLEN AND LESS FIRM TODAY PER MOM.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Seizure, Vomiting
Clinical narrative: Patient came into health department for immunizations prior to school. Patient expressed being anxious about shots. Three immunizations were given. Following immunizations patient vomited passed out and had a very brief seizure. Patient woke up immediately alert and oriented. No shortness of breath, redness or itching observed, vital signs were normal. Patient observed for 60 min after incident no further adverse events observed. Patient was referred to his PCP at clinic for follow up.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Pain and swelling and redness and right upper arm, then fever 102 and body aches.
Age: 1.58
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Aggression, Asthenia, Dizziness, Ear infection
Clinical narrative: Fever started at 6th day after the shot fallowed by swelling of the face and throat, fast heartbeat, dizziness, weakness. Major behavior changes, tantrums, hurting himself, no contact, no response. Temperature of 102 F on and off everything until 14 days after the vaccine.
Age: 1.58
Sex: M
Vaccine: MMR
Symptoms: Ear swelling, Heart rate increased, Intentional self-injury, Pharyngeal oedema, Pyrexia
Clinical narrative: Fever started at 6th day after the shot fallowed by swelling of the face and throat, fast heartbeat, dizziness, weakness. Major behavior changes, tantrums, hurting himself, no contact, no response. Temperature of 102 F on and off everything until 14 days after the vaccine.
Age: 1.58
Sex: M
Vaccine: MMR
Symptoms: Swelling face
Clinical narrative: Fever started at 6th day after the shot fallowed by swelling of the face and throat, fast heartbeat, dizziness, weakness. Major behavior changes, tantrums, hurting himself, no contact, no response. Temperature of 102 F on and off everything until 14 days after the vaccine.