chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with GARDASIL. On an unknown date the patient experienced lightheadedness. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date 28-SEP-2017, dose was not provided) orally, which were exposed to 50 Fahrenheit (F) for 40 minutes. Previous temperature excursion: 50.2 F for 1 hour and 10 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M023169 with an expiration date: 13-JUN-2018 (dose, frequency and route of administration were not reported). Administered dose of GARDASIL 9 experienced temperature excursion of 48.4 degree Fahrenheit for 35 minutes, 48.9 degree Fahrenheit for 35 minutes, 46.2 degree Fahrenheit for 5 minutes on an unknown dates and back in range. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L037554, expiration date 25-DEC-2017; site, doses and route of administration were not reported). No adverse effect was reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9, HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a office manager regarding a 12 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The patient was vaccinated with GARDASIL 9 on 06-JUL-2016 (M007764, exp 01/30/2018); on 08-SEP-2016 (M021407, exp 30-APR-2018); and on 29-SEP-2016 (M024261, exp 30-JUL-2018) intramuscularly (dose, strength, indication were not reported) (inappropriate schedule of drug administration). It was reported that patient was not experiencing any adverse effects as result of the vaccination. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history stored (Oka/Merck) VARIVAX (lot # M012990, expiration date 14-MAR-2018, 0.5 ml, once, subcutaneous). The vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 25-SEP-2016, the patient was vaccinated with improperly stored VARIVAX (lot # M012990, expiration date 14-MAR-2018, 0.5 ml, once, subcutaneous). The vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # L040460, expiration date 27-MAY-2017; site, doses and route of administration were not reported). No adverse effect was reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 25-SEP-2016, the patient was vaccinated with improperly stored VARIVAX (lot # M012990, expiration date 14-MAR-2018, 0.5 ml, once, subcutaneous). The vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M006710 and expiration date 06-DEC-2018, lot # M025192 and expiration date 21-MAR-2019; site, doses and route of administration were not reported). No adverse effect was reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 25-SEP-2016, the patient was vaccinated with improperly stored VARIVAX (lot # M024681, expiration date 18-MAY-2018, 0.5 ml, once, subcutaneous). The vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius) for 56 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 25-SEP-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # M012990, expiration date 14-MAR-2018, 0.5 ml, once, subcutaneous). The vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia, Rash maculo-papular
Clinical narrative: Child developed generalized Maculopapular rash, low grade fever and has irritable.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema
Clinical narrative: Red around injection site
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: 6 month old male received PENTACEL, PREVNAR and ROTA (had received and done well with same vaccines at 2 and 4 months of age) child with eczema and allergy to egg, milk, peanut. Child went home and within hour after vaccines started with cough, wheezing, increased work of breathing.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to unknown age and gender patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications were not provided. On 01-AUG-2016 the patient was vaccinated with improperly stored GARDASIL 9 (dose and route of administration were not reported); lot no. M003659 EXP 20-SEP-2017 or lot no. L025737 EXP 28-JUL-2017. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored VAQTA lot # M002268 and expiration date: 20-SEP-2017; (route and dosage unspecified). No adverse effects were reported. It was reported that therapy was not discontinued. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored (wistar ra 27-3) M-M-R II lot # L041455 and expiration date: 30-NOV-2017; lot # L043703 and expiration date: 03-NOV-2017; (route, therapy type and dosage unspecified). No adverse effects were reported. It was reported that therapy was not discontinued. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ lot # M019690 and expiration date: 02-NOV-2017; via oral route (dosage unspecified). No adverse effects were reported. It was reported that therapy was not discontinued. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # M008551 and expiration date: 02-JUN-2018; (route, therapy type and dosage unspecified). No adverse effects were reported. It was reported that therapy was not discontinued. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a male patient of unknown age. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date in June 2016, the patient was vaccinated with M-M-R II injection, (dose, route of administration, lot # and expiration date were not reported). On the same day, immediately after the vaccination, the patient fainted. Following the patient's fainting, the reporting nurse requested the emergency service, however the patient stated that he was "fine" and declined to be transported to the hospital. There was no treatment given for the adverse event and the patient did not seek any medical attention. The outcome of the event of fainting was considered as recovered/resolved on an unknown date in June 2016, however the patient's present status was unknown for the reporting nurse. The relatedness between the event and M-M-R II was not 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 medical assistant and refers to unspecified patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with a dose of improperly store ROTATEQ, orally, lot number M025565, expiration date 06-NOV-2017, (dose was not reported) (incorrect product storage). There was no concomitant medication reported. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site papule, Injection site rash
Clinical narrative: Information has been received from a nurse practitioner referring to a 60 years old female patient. The patient had no medical history, concomitant medication, drug reactions or allergies. On approximately 26-SEP-2016 (reported as about a week ago), the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously. Following the administration of ZOSTAVAX (specific date unknown, approximately in September 2016), the patient developed an injection site rash "shingles" that consisted of papules. The patient sought medical attention by visiting the clinic. No treatment was given for the events and no lab was performed. The patient had not recovered from the events at the time of reporting. The causal relationship between the events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 24 unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX (lot # reported as M020900 with an expiration date: 27-APR-2018, subcutaneously (dose and frequency were not reported). Administered doses of VARIVAX experienced temperature excursion of 6.2 degree Fahrenheit for 14 hours and 28 minutes, on 02-AUG-2016; 6.2 degree Fahrenheit for 13 hours and 45 minutes on 05-AUG-2016l 6.2 degree Fahrenheit for 14 hours and 10 minutes on 11-AUG-2016, 6.2 degree Fahrenheit for 13 hours and 59 minutes on 22-AUG-2016, 6.2 degree Fahrenheit for 61 hours and 50 minutes on 29-AUG-2016. There was no previous temperature excursion. Digital data; logger was not involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Accidental underdose, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a non-pregnant female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date in 2016 (reported as "last week"), a medical assistant at the physician's office administered a dose of GARDASIL 9 intramuscularly (dose, lot# and expiration date were not reported) to the patient. The primary reporter stated that some of the vaccination ran down the patient's arm and onto her hand, and she was unsure if the patient had received the entire dose of GARDASIL 9. No treatment was given for the event. No adverse effects were reported regarding the patient's skin that came in contact with the vaccine. The primary reporter stated that none of the vaccine came in contact with the medical assistant administering the vaccine. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 56 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), second lasting for 24 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius), third lasting for 24 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.89 degrees Celsius), fourth lasting for 104 hours, with the lowest recorded temperature of 29 degrees Fahrenheit (-1.67 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 56 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), second lasting for 24 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius), third lasting for 24 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.89 degrees Celsius), fourth lasting for 120 hours, with the lowest recorded temperature of 29 degrees Fahrenheit (-1.67 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 56 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), second lasting for 24 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.89 degrees Celsius), fourth lasting for 120 hours, with the lowest recorded temperature of 29 degrees Fahrenheit (-1.67 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse via company representative referring to a patient of unknown age and gender. Information about concurrent condition, medical history or concomitant therapy was not reported. On an unknown date the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (0.5 ml, lot # J010396, expiration date: 16-FEB-2015). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 12-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 56 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), second lasting for 24 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (0.56 degrees Celsius), third lasting for 24 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.89 degrees Celsius), fourth lasting for 120 hours, with the lowest recorded temperature of 29 degrees Fahrenheit (-1.67 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapies were not reported. On 04-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date; 21-JAN-2017; dose and route were not provided). The vaccines underwent a temperature excursion of the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius) for 16 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius) for 32 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 01-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 56 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), second lasting for 24 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (0.56 degrees Celsius), third lasting for 24 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.89 degrees Celsius), fourth lasting for 120 hours, with the lowest recorded temperature of 29 degrees Fahrenheit (-1.67 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 56 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), second lasting for 24 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius), third lasting for 24 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.89 degrees Celsius), fourth lasting for 8 hours, with the lowest recorded temperature of 29 degrees Fahrenheit (-1.67 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site rash, Injection site swelling, Rash
Clinical narrative: Hive and rash from shingles injection (ZOSTAVAX). Red rash and swelling at injection site. Pt states took 1 day to develop and hives proceeded over entire body.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hive and rash from shingles injection (ZOSTAVAX). Red rash and swelling at injection site. Pt states took 1 day to develop and hives proceeded over entire body.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius) for 16 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 56 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), second lasting for 24 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Headache, Pain, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 female patients of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 22-SEP-2016, one patient was vaccinated with PNEUMOVAX 23 lot # L024132, expiry date: 21-JAN-2017 (dosing details were not reported) once subcutaneously/ intramuscularly. On 12-OCT-2016, the second female was vaccinated with PNEUMOVAX 23 lot#M000592, expiry date: 12-OCT-2017 (dosing details were not reported) once subcutaneously/ intramuscularly. Approximately in 2016, both the patients experienced redness, swelling, body aches, headache and tiredness after the vaccination. The patients did not seek any medical attention. No treatment was given for the events. The outcome of redness, swelling, body aches, headache and tiredness was reported as recovered/resolved. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L046897, expiration date 23-FEB-2017 (dose and route of administration were not reported). The vaccine was exposed to 9 degrees Fahrenheit for 4 minutes. A data logger was not used to log temperatures. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M010671, expiration date 02-JUN-2018, dose and route were not provided), which were exposed to 50 Fahrenheit (F) for 40 minutes. Previous temperature excursion: 50.2 F for 1 hour and 10 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Lot number M011671 is an invalid lot number for hepatitis b vaccine (recombinant). 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 an unknown date, the patient was vaccinated with ZOSTAVAX lot # M030139, expiry date: 18-AUG-2017 (route of administration and dosing details were not reported) following a temperature excursion of 18.9F for 12 hours. No adverse effects were observed. There were no product quality complaints (PQC) involved. Additional information is not expected as the reporter did not wish further contact.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 6 years old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately 2012, reported as 4 years ago, the patient was vaccinated with a first dose of VARIVAX, subcutaneously (strength, site of administration, lot # and expiry date were not reported) and she did not experience any adverse effects after that vaccination. On an unknown date, the patient received second dose of VARIVAX, subcutaneously (strength, site of administration, lot # and expiry date were not reported). On an unspecified date, reported as 2 years after receiving the second dose of VARIVAX, she broke out in chickenpox. The outcome of the event was reported as recovered. The relatedness between the event and VARIVAX was not provided. Additional information is not expected, as there was no consent given to contact healthcare professional.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 51 year old female consumer referring to herself. The patient's concomitant medication, medical history and drug reactions/Allergies were reported as none. In approximately October 2015, the patient was vaccinated with a dose of ZOSTAVAX (vial 19400 PFU) (lot number, expiration date and dose were not provided). The route of administration was reported as injection. On 06-OCT-2016, the patient was diagnosed with shingles. On 07-OCT-2016, the patient started the VALTREX medication prescribed by the physician. No laboratory diagnostic studies were performed. At the time of the report, the patient was not recovered. The causal relationship between the event and ZOSTAVAX (vial 19400 PFU) was unknown. Additional information is not expected because no consent for follow up has been provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored VARIVAX 0.5 ml, subcutaneously, lot# M027343 with expiration date: 01-JUN-2016. Administered doses of VARIVAX were exposed to 8.6 Fahrenheit degrees for 25 hours. Data logger was used. There were no previous excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. 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 physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 07-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 33 degree Fahrenheit (0.56 degrees Celsius) for 48 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Vaccine positive rechallenge
Clinical narrative: Symptoms began following injection which has worsened. Symptoms so far include red raised area where injection was given, 5" x 3" which is warm/hot to touch. Employee states this happens every time she takes flu shot. Has not yet resolved (visited employee health 10/13/2016).
Age: 13.0
Sex: F
Vaccine: DTAP, MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: None.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, soreness, warmth on upper 1/2 of injection arm.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Muscular weakness, Myalgia, Skin discolouration, Vaccination site rash
Clinical narrative: 5 Days after vaccine - red rash down arm site of vaccination. Severe muscle soreness weakness. Rash spread from upper arm down to hand. Turned colors lasted 2 more wks.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot, and swollen at the injection site.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Welt around upper arm, itching, swelling, bruising, extreme pain (not just at injection site), warm to touch.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Welt around upper arm, itching, swelling, bruising, extreme pain (not just at injection site), warm to touch.
Age: 17.0
Sex: F
Vaccine: HPV9, IPV, TD, VARCEL
Symptoms: Rash
Clinical narrative: Rash on (L) arm and neck - cannot be sure rash was present prior to vaccination, gave BENADRYL IM 25 mg, ZYRTEC PO 10 mg. 30 minutes later gave BENADRYL 12.5 mg IM, DEPO-MEDROL 40 mg IM. Pt in no distress. Pulse ox 99% on room air.
Age: 6.0
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient had no symptoms, patient was told to contact doctor if any symptoms occurred such as redness, pain, swelling, joint pain, body aches, drowsiness, diarrhea. Patient did not report any symptoms.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Papule, Pruritus
Clinical narrative: Circular, palpable papule. Slightly red in color. Patient states that it does itch. Located just on right arm and lower back. Started about 1 1/2 after injection. Papules on right arm are starting to disappear. Advised patient to call OB/GYN. Advised her to take BENADRYL. Denies any trouble breathing at any time or at present time.
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: This spontaneous report was received from a physician and refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. On an unknown date in approximately 2012, (reported as "four years ago") the patient was vaccinated with GARDASIL (strength, dosage, frequency, route, lot# and expiration date were not provided). Concomitant therapies were not provided. On an unknown date, the patient was diagnosed with Postural orthostatic tachycardia syndrome (POTS) and she frequently fainted. The outcome of postural orthostatic tachycardia syndrome was unknown. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 66 year old male patient. Patient had no pertinent medical history, drug reactions or allergies. No concomitant therapies were reported. On 07-JUL-2016, the patient was vaccinated with 0.65 ml dose of ZOSTAVAX 19400 PFU, subcutaneously, lot # M003487, expiration date: 21-APR-2017 (reported as Doctor recommended). Approximately on 23-SEP-2016 (reported as: two weeks ago), the patient experienced shingles (herpes zoster), located in the trunk and upper thigh area (unspecified if both thighs). He received treatment for the adverse event. At the time of the report the patient was recovering. The causal relationship between the event and ZOSTAVAX was unknown. There was no intervention to prevent serious criteria. Product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective report was received from a medical assistant and refers to a currently 16 year old female patient with none drug reactions or allergies. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, intramuscular, lot number K010215, expiration date 05-MAY-2017, (dose and frequency were not reported). There was no concomitant medication reported. On an unknown date, the patient had a positive pregnancy test result (exposure during pregnancy). The last menstrual period (LMP) was reported as February 2016, the estimated date of delivery and the estimated date of conception were unknown. At the time of reporting, the pregnancy outcome was pending and the fetal outcome was unknown. Additional information is not expected because there was no consent for follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product use issue
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant medications were reported. On 01-JUN-2016 the patient was vaccinated with a dose of ZOSTAVAX (dose and frequency not specified) (lot number and expiration date were not reported). The reporting pharmacist reported that the patient stated that the vaccine was administered "to his ear", however the pharmacist who administered ZOSTAVAX stated that the vaccine was administered subcutaneously to the deltoid area of the arm. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 156 hours with the lowest recorded temperature of -3 Fahrenheit degree. The total cumulative excursion time of the second time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 34 degrees Fahrenheit for 376 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site inflammation, Administration site pain, Feeling hot, Pain, Rash erythematous
Clinical narrative: Localized pain/inflammation at site of admin. Felt hot. Red rash about 3" by 3" - painful when touched. Ice, ADVIL and BENADRYL were used.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt has a 51/2 51/2 cm swollen, red, warm area to left deltoid where the TRUMEMBA was given on 10/11/16.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Injection site erythema, Injection site pain
Clinical narrative: Vaccine given on 10/11/16. Mother noted redness at injection site on 10/12/16. Redness on R thigh between hip and spreading down to knee. Pt states is sore and has a slight limp. Mother gave MOTRIN med.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse and refers to unspecified patients of unknown age and gender. The patient's concurrent or medical conditions were reported. On unspecified dates since 02-AUG-2016, improperly stored doses of RECOMBIVAX HB lot # L044694, expiration date 04-FEB-2016 (dose was not reported) were administered to unspecified patients. These vaccines were stored under 1 degree Celsius for 2 hours. There was no previous temperature excursion. No digital data logger was reported. No adverse effects were reported. No product quality complain was involved. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Cold sweat, Headache, Hyperhidrosis, Immediate post-injection reaction, Nausea
Clinical narrative: Sweaty and clammy immediately after vaccine on 10/7/16. 10/11/16 he developed nausea, headache, vomited x 1.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Sweaty and clammy immediately after vaccine on 10/7/16. 10/11/16 he developed nausea, headache, vomited x 1.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness around injection site. Pt went to ER and received steroids and antibiotic.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Pt developed rash on RUE where imm was given and a fever of 102.6.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Biopsy, Borrelia test negative, Pruritus, Rash
Clinical narrative: Severe rash within 24 hours of injection. Rash continues as of this date. Patient seen by 4 doctors. Latest dermatologist said PREVNAR 13. Triamcinolone acetonide cream prescribed 10/7. Itching subsided. Rash continues to appear.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: Child got hives on arms and legs next morning - hives were extremely hot, red, and extremely itchy - couple of hours later they went to face - brought child to Urgent Care. Given BENADRYL - had hives for 3 days.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: At 24hr after shots, patient began developing redness and swelling at shot sites. On day of exam (approximately 48hr after shots), she had a 10cm x 12cm area of induration and redness around (R) shot site and a 8.5cm x 10.25c, area of induration and redness around (L) shot site.