chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, Inflammation, Pain in extremity
Clinical narrative: Mother of the girl takes her to the ER since on June 8th the girl received some vaccines and a cellulitis developed on the right arm and where the doctor helped her due to complaints of pain and inflammation on the arm.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. It was reported that on an unspecified date, the patient received her first dose of VARIVAX (dose, route, lot # and its expiration date were not reported), and then on 25-MAY-2016, the patient was inadvertently administered a dose of ZOSTAVAX (lot # L046295, its expiration date was 17-FEB-2017) (dose and route were not provided), instead of the intended second dose of VARIVAX. No product confusion was reported; the pharmacist stated that the error occurred due to miscommunication between her and the patient's prescriber, and she thought the patient was supposed to received ZOSTAVAX. No adverse effect was reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Full blood count normal, Injection site pain, Nausea, Pain, Pain in extremity
Clinical narrative: Nausea, fever; Pain at injection site; Could not move arm without pain.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Nausea, fever; Pain at injection site; Could not move arm without pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site urticaria, Injection site vesicles
Clinical narrative: Fever, Redness at injection site, Chills, Blisters/Hives at injection site, body aches, Headaches,  Soreness in arms and swelling.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever, Redness at injection site, Chills, Blisters/Hives at injection site, body aches, Headaches,  Soreness in arms and swelling.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, hardness and redness way beyond the injection site as well as warmth to arm vaccine injected at with itchiness noticed at home 6-2-16 morning.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Arthralgia, Bone pain, Headache, Malaise, Nausea
Clinical narrative: Pt w/ fever up to 101. Associated symptoms also included bone pain, headache, malaise, nausea and pain in joints. Symptoms started 1 day ago.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Pt w/ fever up to 101. Associated symptoms also included bone pain, headache, malaise, nausea and pain in joints. Symptoms started 1 day ago.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A), regarding to multiple unspecified patients of unknown ages and gender. The patients' medical history or concurrent conditions were not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (therapy type: Digital Data Logger) (lot # L004649, expiration date 11-FEB-2017 and Lot # L044526, expiration date 09-NOV-2017) (dose, route of administration and anatomical location were not provided). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint was not filed. This is one of several reports from the same source (MARRS #1605USA012734, 1606USA005737, 1606USA005738, 1606USA005739, and 1606USA005741).
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to multiple unspecified patients of unknown age. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (dosing details were not reported) (lot # M000442 with expiry date 31-MAR-2018), was exposed to a temperature of 9.7 degree centigrade for a time frame of 1 hour, 22 minutes. There was no previous temperature excursion reported. The call was because of a date logger (therapy type: digital data logger) (Incorrect product stored). No adverse effects were reported. This is one of several reports 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 medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 27-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # L040459, expiration date 06-APR-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 27.7 degrees Fahrenheit for 10 hours and also at a temperature of 31.3 degrees Fahrenheit for 11.5 hours. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL lot # K023432 with expiry date on 18-JUN-2016, (strength, dose, route and anatomical location not reported). No adverse effect was reported and no product quality complaint was reported. Temperature: 9 Celsius degrees. Time frame: 40 hours. Was it administered (AE)? Yes. Previous temperature excursion? No. Was call because of a "data logger"? No. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of VAQTA which had a lot# of L023232, and an expiration date of 25-FEB-2017 (concentration, dose, route and anatomical place of vaccination were not provided). Which were exposed to a temperature of 32.7 F for 31 hours. There were no previous excursion and a data logger was involved. Information regarding concomitant therapies was not reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with a dose of improperly stored ROTATEQ (incorrect product storage) (lot number L033548, expiry date 14-MAY-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. It was reported that the ROTATEQ was exposed to a temperature of 33.8 degrees Fahrenheit for 16 hours, 51.6 degrees Fahrenheit for 16 hours, 33.6 degrees Fahrenheit for 16 hours and 34.1 degree Fahrenheit for 16 hours. There was no previous temperature excursions. It was reported that this case was reported due to a data logger. The action taken with the therapy with ROTATEQ was unknown. The outcome of events was unknown. There was no product quality complaint reported. This case number US-009507513-1606USA005776 via same reporter link. 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 medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 25-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # L040459, expiration date 06-APR-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 27.7 degrees Fahrenheit for 10 hours and also at a temperature of 31.3 degrees Fahrenheit for 11.5 hours. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a physician referring to an unspecified number of patients of unknown age and gender. On unspecified dates, an unspecified number of patients was vaccinated with GARDASIL (lot # L040459, expiration date 06-APR-2017, dose and route were not reported) which was improperly stored (incorrect product storage). There was no previous temperature excursion and the temperature of storage was 30.2 F, and the time frame was 41 hours. No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions and medical histories were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L016429, expiry date 09-AUG-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccines were stored at a temperature of 34.5 degrees Fahrenheit for 72.3 hours. There was no previous temperature excursion reported. No symptoms were reported. No product quality complains (PQC) were involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 24-MAY_2016, the patient was inadvertently vaccinated with 2 doses of GARDASIL 9 (lot # L044475 exp date 12-MAY-2017) (dose and route not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-APR-2016 the patient was vaccinated with an improperly dose of GARDASIL 9 lot # L011846 with expiration date on 16-JUN-2017, (strength, dose, frequency, route and anatomical location were not reported). No adverse effect was reported and no product quality complaint was involved. Temperature/Time frame: 50.5 Fahrenheit degrees for 1 hour. Back in range? Yes. No prior excursions. Call was because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient had been vaccinated with ZOSTAVAX (lot# and expiration date were not reported) on 24-JAN-2014. On 24-JAN-2014, the patient had been vaccinated with a dose of ZOSTAVAX (strength, dose, route, lot# and expiration date were not reported). On 31-MAY-2016 the patient received a second dose of ZOSTAVAX lot # L034727 (reported as 1034727), expiration date 09-DEC-2016 (extra dose administered). No adverse events reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report was received from a physician referring to a 15 year old female patient. Her pertinent medical history or concurrent conditions were not provided. Approximately, on 10-MAY-2016, reported as "three or four weeks ago", the patient was vaccinated with a first dose of GARDASIL 9, intramuscularly (lot # and expiration date were not reported). Information regarding concomitant therapy was not reported. Subsequently, the patient experienced extreme pain (injection site pain) and a knot formed (injection site nodule) on her arm at the injection site, approximately in May 2016. It was reported that the patient sought medical attention by contacting the physician. The outcome of injection site pain and injection site nodule was reported as still had not improved (not recovered). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A.), regarding to multiple unspecified patients of unknown ages and gender. The patients' medical history or concurrent conditions were not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (therapy type: Digital Data Logger) (lot # L044475, expiration date 12-MAY-2017) (dose, route of administration and anatomical location were not provided). The vaccines were subjected to temperature excursions of 23.3 degrees C for a time frame of 45 minutes. Back in range was reported as yes and there was no previous temperature excursion. Concomitant medications were not provided. No adverse effects were reported. Product quality complaint was not filed. This is one of several reports from the same source (MARRS #1605USA012734, 1606USA005737, 1606USA005738, 1606USA005740, and 1606USA005741). 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 Certified Medical Assistant (C.M.A), regarding to multiple unspecified patients of unknown ages and gender. The patients' medical history or concurrent conditions were not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (therapy type: Digital Data Logger) (lot # L030868, expiration date 09-JUN02018 and Lot # L038502, expiration date 16-AUG-2018) (dose, route of administration and anatomical location were not provided). Concomitant medications were not provided. No adverse effects were not reported. Product quality complaint was not filed. This is one of several reports from the same source (MARRS #1606USA005737, 1606USA005739, 1606USA005740, 1606USA005741 and 1605USA012734). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A), regarding to multiple unspecified patients of unknown ages and gender. The patients' medical history or concurrent conditions were not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (therapy type: Digital Data Logger) (lot # L012479, expiration date 10-APR-2017 and Lot # L027432, expiration date 22-JUL-2017) (dose, route of administration and anatomical location were not provided). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint was not filed. This is one of several reports from the same source (MARRS #1606USA005737, 1606USA005738, 1606USA005739, 1606USA005740, and 1606USA005741). Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Skin disorder
Clinical narrative: This spontaneous report was received from a healthcare worker, referring to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 17-MAY-2016, the patient was vaccinated with ZOSTAVAX lot # L044530 with expiration date on 06-AUG-2016, 0.65 ml, subcutaneous (anatomical location was not reported). Concomitant medications were not reported. Subsequently, on an unspecified date, the patient was prescribed to start Prednisone (manufacturer unknown), 40mg followed by decreasing doses daily for 16 days and apply Fluocinonide to the scalp, twice a day, for five days as needed, by an unspecified dermatologist, for an unspecified reason. At the time of reporting, the outcome of skin disorder and its causal relation with the vaccination were unknown. No product quality complaint was involved. 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 medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 28-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # L040459, expiration date 06-APR-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 27.7 degrees Fahrenheit for 10 hours. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Chills, Diarrhoea
Clinical narrative: Patient reported chills, stomach cramps and diarrhea, resolved by next day.
Sex: U
Vaccine: HPV4
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. The patient's concurrent conditions and medical history were not provided. On 25-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # L040459, expiration date 06-APR-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 27.7 degrees Fahrenheit for 10 hours. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an unknown number of patients of unknown gender and age. Concurrent conditions and medical history were not reported. On unknown dates the patients received an extra dose of hepatitis a vaccine, inactivated (manufacturer unknown) (dose, route, lot# and expiration date were not reported) of hepatitis A vaccine series. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A.), regarding to multiple unspecified patients of unknown ages and gender. The patient's medical history or concurrent conditions were not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (therapy type: Digital Data Logger) orally, (lot # L039297, expiration date 19-JUN-2017 and Lot # L035511, expiration date 21-MAY-2017) (dose was not provided). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint was not filed. This is one of several reports from the same source (MARRS #1605USA012734, 1606USA005738, 1606USA005739, 1606USA005740 and 1604USA005741). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Concurrent condition and medical history of the patient were not reported. On 01-JUN-2016 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L039298, expiration date: 27-JUN-2017) (dose unspecified). (Incorrect storage of drug). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A), regarding to multiple unspecified patients of unknown ages and gender. The patient's medical history or concurrent conditions were not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L032761, expiration date 24-FEB-2017 and Lot # L050910, expiration date 14-JUN-2017) (dose, route of administration and anatomical location were not provided). The vaccines were subjected to temperature excursion of 23.0 degrees C for a time frame of 1 hour and 29 minutes. Back in range was reported as yes and there was no previous temperature excursion. Concomitant medications were not provided. No adverse effects were reported. Product quality complaint was not filed. This is one of several reports from the same source (MARRS # 1605USA012734, 1606USA005737, 1606USA005738, 1606USA005739 and 1606USA005740). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-APR-2016 the patient was vaccinated with an improperly dose of GARDASIL 9 lot # L011846 with expiration date on 16-JUN-2017, (strength, dose, frequency, route and anatomical location were not reported). No adverse effect was reported and no product quality complaint was involved. Temperature/Time frame: 50.5 Fahrenheit degrees for 1 hour. Back in range? Yes. No prior excursions. Call was because of a data logger. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma excision, Skin papilloma
Clinical narrative: This spontaneous report was received from licensed practical nurse and refers to a 14 or 15 year-old female patient (currently 20 years old) via a company representative. The patient's concurrent conditions and medical history were not reported. On approximately 28-MAY-2010 (reported as "about 5 or 6 years ago"), the patient was vaccinated with her third dose of GARDASIL intramuscularly injection (concentration, dose, anatomical place of vaccination, lot # and expiration date were not provided). Information regarding concomitant therapies was not reported. On approximately May 2010 (reported as "following the third dose of GARDASIL"), the patient experienced warts on her feet (skin papilloma). Therefore, she was sent to a podiatrist and her warts were burned off on an unspecified date. At the time of reporting, the patient recovered from the skin papilloma and the reporter stated that it was determined that the skin papilloma was related to GARDASIL. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 22-DEC-2015 the patient was inadvertently vaccinated with an expired dose of ROTATEQ (lot # K007243, expiration date 13-DEC-2015; dose and dose number were not reported; oral). No adverse effect was reported. This is one of several reported received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a currently 18 year old patient of unknown gender. Information regarding relevant medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with improperly stored VARIVAX (lot # L049535, expiration date 08-DEC-2017, subcutaneous, dose not reported). The patient was concomitantly used unspecified diluent (manufacturer unknown) (lot # reported as L03598, expiration date 01-MAY-2018). It was reported that the vaccine was exposed to -3 C for 13 hours and 8 minutes. There was no previous excursion. The call was placed because of data logger. It was also reported that on an unknown date, the patient was vaccinated with another dose of VARIVAX (lot # reported as L77777, expiration date January 2017, subcutaneous, dose not reported). This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a 66 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (anatomical route of vaccination, dose number, lot number and expiration date were not provided). The patient's concomitant medications were not reported. On an unknown date, the patient had a significant swelling from her elbow to her shoulder, also described as "illness at the time of vaccination" (conflicting information). Due to it, the patient required medical intervention to prevent any serious outcome. It was also reported that the patient was not prescribed with drug treatment for peripheral swelling, that the patient was not hospitalized and that peripheral swelling was not life threatening or significant disability. At the time of the report, the outcome of peripheral swelling was reported as recovered on an unknown date. The relatedness between the adverse event and vaccination with PNEUMOVAX 23 was not provided. Additional information is not expected as all information has been received to complete the case.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age. Their pertinent medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with doses of GARDASIL 9, lot # L043213, expiration date: 28-AUG-2017 (routes, anatomical location and doses number were not reported) that were improperly stored. Information regarding concomitant therapy was not reported. 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: Syncope
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On an unknown date the patient was vaccinated with GARDASIL 9 (strength, dosing details, anatomical location, lot# and expiration date were unknown). On an unknown date, while on GARDASIL 9, the patient fainted (syncope). The outcome of syncope was unknown. Causality assessment was not provided. No product quality complaint was filed. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Information has been received from a physician via a company representative referring to a 60 year old female patient who was also a nurse practitioner. Concurrent condition and medical history of the patient were not reported. On 12-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J014566, expiration date: 18-FEB-2015) (dose and route unspecified). On 23-MAR-2016, the patient got shingles and was still experiencing nerve pain. The outcome of the events was reported as no recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Nurse Practitioner (L.N.P) via company representative referring to a patient of unknown age. Their pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was administered both: a dose of GARDASIL 9. intramuscularly (lot #, expiration date, anatomical location and dose number were not reported) and a dose of GARDASIL, intramuscularly (lot #, expiration date, anatomical location and dose number were not reported) as part of a patient's three dose series. The order, frequency and timing of the administered vaccines were unspecified. Information regarding concomitant therapy was not reported. No adverse experience 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 referring to multiple unspecified patients of unknown age. Their pertinent medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with doses of ROTATEQ, orally, lot # L027076, expiration date: 25-MAY-2017 (anatomical location and doses number were not reported) that were improperly stored. Information regarding concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with improperly stored PROQUAD (lot # L045676, expiration date 09-MAY_2017), (lot# L046509, expiration date 19-MAY-2018), (lot# L051100, expiration date 17-JUN-2017) (dose and route were not reported). Concomitant drug was not reported. No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot# L034369, expiration date 08-SEP-2017), (lot# L037561, expiration 29-SEP-2017). (lot# L034369, expiration date 08-SEP-2017), (lot# was reported as L041205, expiration date was reported as 20-OCT-2017) ( dose and route were not reported). Concomitant drug was not reported. No adverse effects were reported. This is one of the two reports 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 medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 24-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # L040459, expiration date 06-APR-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 27.7 degrees Fahrenheit for 10 hours. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 15 years old patient of unknown gender. Concurrent conditions and medical history were not reported. On 24-MAY-2016, one day before the patient turned 16 years old, the patient accidently received a dose of VAQTA (dose, route, lot# and expiration date were not reported) instead of GARDASIL. The reporter stated that the dose of VAQTA the patient received was an extra dose of Hepatitis A vaccine because the patient completed the series as a child. No adverse event was reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Concurrent condition and medical history of the patient were not reported. On 01-JUN-2016 the patient was vaccinated with a dose of improperly stored ROTATEQ orally (lot # L039298, expiration date: 27-JUN-2017) (dose unspecified) and a dose of improperly stored PEDVAXHIB (lot # L042258, expiration date: 18-AUG-2018 (dose and route unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report has been received from a nurse practitioner via a company representative, concerning a 14 year old female patient. The patient's concurrent conditions, pertinent medical history and drug reactions/allergies were unspecified by reporter. On an unspecified dates, the patient was vaccinated with 2 doses of GARDASIL 9 at unspecified intervals. Then, on 07-APR-2016, the patient received the third dose of GARDASIL 9 (lot #, expiration date, strength and dose were not provided for all of them), intramuscularly. There was no concomitant therapy reported. On an unknown date, the patient developed a "knot" on her arm at the injection site. The reporter stated that it was the first shot of GARDASIL 9, which resulted in a "knot" on her left arm. The treatment recommended was ibuprofen as needed and warm soap with Epsom salt. However, it was reported that there was no treatment given for the adverse event. On 26-APR-2016, the patient was seen again and there was no redness, no wart, no rash, no other symptoms. Nevertheless, the patient present status was unspecified by reporter. The causal assessment between injection site nodule and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. On 07-JUN-2016 the patient was administered an improperly stored (11.7 Fahrenheit (F) for 30 minutes) dose of VARIVAX (dose and frequency were unknown). There were four improperly stored lots of VARIVAX (lot L028277, expiration date 28-JUL-2017; lot L042264, expiration date 26-OCT-2017; lot L042267, expiration date 27-OCT-2017; lot M000762, expiration date 06-JAN-2018), but the reporter didn't known which dose was administered. No adverse effect was reported. No previous temperature was excursion. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Paraesthesia, Thyroid disorder, White blood cell count decreased
Clinical narrative: This spontaneous report as received from a female patient of unknown age regarding herself. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. in January 2016, the patient was vaccinated with ZOSTAVAX (strength, lot#, expiry were not reported) 1 shot subcutaneously. She stated that ever since she received the shot she, "hasn't felt right". She stated that she did not experience any of the most common listed side effects given in the Prescribing Information. But in January 2016, the patient has lowered WBC result when blood testing was done and had issues with her thyroid as well. She stated that she also felt a "pins and needles" sensation in her arm. The outcome of the events was reported as no recovered/not resolved. There were no product quality complaints (PCQ) involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with a dose of improperly stored VARIVAX (lot number L046884, expiry date 23-NOV-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. It was reported that the VARIVAX was exposed to a temperature of 19.1 degrees Fahrenheit for 156 hours. There was no previous temperature excursions. It was reported that this case was reported due to a data logger. The action taken with the therapy with VARIVAX was unknown. The outcome of events was unknown. There was no product quality complaint reported. This case is related case number US-009507513-1606USA005776 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9 lot # L024993 with expiration date of 17-OCT-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. It was reported by the nurse, that GARDASIL 9 was exposed to a temperature of 34 degrees F for 12 hours. The aforementioned vaccine had never been involved in any previous temperature excursion. Data logger was stated. Furthermore, no adverse event symptoms were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration
Clinical narrative: This solicited report was received from a consumer concerning a 27 year old female patient (currently 42 years old) enrolled in a patient support program. In approximately 2000, at the age of 26 years, the patient was vaccinated with the first dose of GARDASIL (dose, strength, route of administration and lot number were not provided). In approximately 2001, at the age of 27 years, the patient was vaccinated with the second dose of GARDASIL. In approximately 2008, at the age of 34 years, the patient was vaccinated with the third dose of GARDASIL. According to this information, the patent received the second and third dose at an inappropriate age and did not comply with the dosing schedule time. At the time of reporting, the outcome of inappropriate schedule of drug administration was unknown. The causal relationship between inappropriate schedule of drug administration and GARDASIL was not related. Additional information is not expected since no consent for follow up was given.
Sex: U
Vaccine: HIBV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Concurrent condition and medical history of the patient were not reported. On 01-JUN-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # L042265, expiration date: 26-OCT-2017) (dose and route unspecified) and a dose of improperly stored PEDVAXHIB (lot # L042258, expiration date: 18-AUG-2018) (dose and route unspecified). No adverse effects were reported. This is one of 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: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 31-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # reported as M000995, expiration date reported as 06-JAN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -8.4 degrees Celsius for 17.5 hours. There was previous excursion of -8.5 degrees Celsius for 37 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 27-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # reported as M000995, expiration date reported as 06-JAN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -8.4 degrees Celsius for 17.5 hours. There was previous excursion of -8.5 degrees Celsius for 37 hours. Data logger was involved. 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 health care worker referring to an unspecified number of patients of unknown ages and genders. Information regarding medical history or concurrent conditions was not informed. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (which had the lot # L040181, expiration date 18-AUG-2017, L035686, expiration date 16-FEB-2017) (dose, route and anatomical site of vaccination were not provided). Information regarding concomitant medication was not reported. No adverse effects were reported. There was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with unspecified improperly stored doses of GARDASIL which had a lot# reported as "K006962" and an expiration date of 19-FEB-2017 (concentration, dose, route, and anatomical place of vaccination were not provided). Which were exposed to a temperature of 32.7 F for 31 hours. There were no previous excursion and a data logger was involved. Information regarding concomitant therapies was not reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 31-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # reported as M000995, expiration date reported as 06-JAN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -8.4 degrees Celsius for 14.5 hours. There was previous excursion of -8.5 degrees Celsius for 37 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 18-FEB-2016 the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # K000737, expiration date 16-JAN-2016; dose, dose number and route not reported). No adverse effect was 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: This spontaneous report has been received from a nurse referring to 6 unspecified patients of unknown age and gender. On multiple unspecified dates, the 6 unspecified patients were vaccinated with 6 doses of VARIVAX (lot # L038132, expiration date 01-OCT-2017, dose and route were not reported) which was improperly stored. There was no previous temperature excursion and data logger. The vaccine has been stored under temperature of -8.38 C, degree for 17 hours and 46 minutes. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 02-JUN-2016 the patient was vaccinated with a dose of GARDASIL (dose, route, dose number, lot# and expiration date were not reported) that had been mixed with 1 whole vial of sterile diluent prior to administration. No adverse effects were reported. Additional information is not expected as no contact details were available.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 19-FEB-2016 the patient was inadvertently vaccinated with an expired dose of ROTATEQ (lot#, K007243, expiration date 13-DEC-2015; dose and dose number were not reported, oral). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.