chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Body temperature increased
Clinical narrative: This spontaneous report concerning a healthy adolescent female patient of unknown age, was received via a company representative from a nurse practitioner who is also the patient's mother. Information regarding the patient's drug reactions and allergies was not provided. On an unknown date, the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly (lot number, expiration date and anatomical location were not reported). There were no concomitant medications provided. On an unknown date, the following morning after vaccination, the patient awakened with an elevated temperature of 103F taken orally, so the nurse practitioner stayed at home from work to take care and monitored her daughter. The company representative stated that "no one went to a doctor's office" and it was unknown if the nurse practitioner provided any treatment to the patient. The following day, on an unspecified date, the patient had fully recovered from the event. There were no laboratory studies performed. No product quality complaint was involved. The causality assessment was not provided. Additional information is not expected because there was no consent for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered nurse, via Pfizer (manufacturer control number 2016496059), reporting on herself an approximately 74 year old white female patient. Medical history, concurrent conditions and concomitant therapies were not reported. In approximately 2011, reported as "about 5 years ago", the patient was vaccinated with a dose of ZOSTAVAX, strength, frequency, dose, route, lot/batch number and expiration date were not reported. The reporter referred that she had received the ZOSTAVAX, and it caused, on an unknown date, her arm to get red, swollen and hot at the injection site for about 7 to 10 days. She also reported that the vaccine did not work for her because she had shingles on her scalp and the back of the neck on approximately 2014, reported as "about 2 years ago". The outcome of the vaccine did not work for her was unknown, for the events shingles, her arm to get red, swollen and hot at the injection site and herpes zoster was reported as resolved. The reporter considered her arm to get red, swollen and hot at the injection site to be related to ZOSTAVAX. The relationship of herpes zoster and the vaccine did not work for her to ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to three unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. From 26-APR-2016 through 03-NOV-2016, the patients received improperly stored doses of VAQTA (lot # L023936 with expiration date 15-MAR-2017; dose and route were not reported. The temperature and time frame that the vaccine was improperly stored at were reported as below: On 26-APR-2016, 34 Fahrenheit (F) for 24 hours; On 22-JUL-2016, 34 F for 16 hours 40 minutes; On 27-JUL-2016, 34 F for 16 hours 30 minutes; On 28-JUL-2016, 33 F for 15 hours 33 minutes; On 01-AUG-2016, 33 F for 64 hours 3 minutes; On 02-AUG-2016, 32 F for 14 hours 56 minutes; On 03-AUG-2016, 35 F for 16 hours 37 minutes; On 04-AUG-2016, 33 F for 16 hours 10 minutes; On 08-AUG-2016, 35 F for 62 hours 52 minutes; On 08-AUG-2016, 35 F for 62 hours 52 minutes; On 09-AUG-2016, 35 F for 16 hours 1 minute; On 15-AUG-2016, 35 F for 65 hours 30 minutes; On 08-SEP-2016, 47 F for 17 hours 18 minutes ; On 09-SEP-2016, 47 F for 15 hours 42 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse referring to unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # M032635 with expiration date 05-MAY-2018, dosage and route of administration were not reported), which was exposed to temperature excursion (temperature: 51.3 degrees F, time frame: 1 hour) because of data logger. There was no previous temperature excursion. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received on 14-OCT-2016 from a nurse practitioner referring to a patient of unknown age and gender. The patient' s concurrent conditions, medical history and concomitant therapy were not reported. On 15-AUG-2016, the patient was vaccinated with the first dose in a series of three of GARDASIL (route, dose, lot number and expiration not reported). The nurse practitioner reported the patient was in the office to receive the second dose in the series of GARDASIL 9, (route, dose, lot number and expiration not reported) on 14-OCT-2016. No adverse effects reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 02-NOV-2016 from a nurse regarding multiple unspecified patients. On unspecified dates, multiple unspecified patients were vaccinated with improperly stored M-M-R II (lot # L039551, expiration 07-OCT-2017) or GARDASIL 9 (lot # M009378, expiration 23-APR-2018). Temperature and timeframe were unknown to reporter. No adverse effects were reported. No further information was provided. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning 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 an improperly stored dose of VAQTA 25/0.5 (units not provided), lot # M036459, expiration date: 18-JAN-2018, (dose number, route and anatomical location of administration were unknown). The temperature excursion reported was: 51.3 F for 40 minutes. There was no previous temperature excursion. The temperature excursion was detected by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV, MMR, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 02-NOV-2016 from a nurse regarding an unspecified number of patients. On unspecified dates, an unspecified number of patients may have received improperly stored M-M-R II, (lot # M004063, expiration 25-JAN-2018; lot # M010426, expiration 01-MAR-2018), PEDVAXHIB (lot # M020101, expiration 07-MAR-2019, lot # M025194, expiration 22-MAR-2019) and  RECOMIBVAX HB (lot # L045117, expiration 06-OCT-2018). Temperature: 9.3 degrees Celsius for 2 hours and 14 minutes. No adverse effects were reported. No previous temperature excursion was noted. No further information was provided. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified number of patients of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. On unspecified dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot # M027347 with expiration date 01-JUN-2018, lot # M024677 with expiration date 18-MAY-2018, lot # M027885 with expiration date 03-JUN-2018; dose and route unknown). No adverse effects were reported. Temperature Excursion Details were as below: -9.5 centigrade for 48 minutes, 4.6 centigrade for 31 hours and 8 minutes and -9.7 centigrade for 46 minutes. Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning 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 an improperly stored dose of GARDASIL 9, lot # M007764, expiration date: 30-JAN-2018, (dose number, route and anatomical location of administration were unknown). The temperature excursions reported were: 51.3 F for 40 minutes, and 50.2 F for 1 hour and 10 minutes. The temperature excursions were detected by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 13-OCT-2016 via telephone call from a registered nurse who reported that an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) was administered to 9 week old patient on 10-OCT-2016. The reported lot numbers are: # M014925, expiration date 16-FEB-2019 and Lot # M010439, expiration date 08-DEC-2018. It was not specified which lot # was administered to this patient. No adverse effects reported. This report was due to data logger. This is one of several reports 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 registered nurse refers to a multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored PROQUAD with lot # M001150 and expiration date: 05-JUL-2017; lot# M019233 and expiration date: 17-OCT-2017; strength, dosage and route unspecified. Temperature/time frame was 5.5 Fahrenheit (F) for 4 hours, 45 minutes. There was no previous excursions. No data logger involved. No adverse effects reported. No product quality complaint was involved. No additional information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 0.67
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 13-OCT-2016 via telephone call from a registered nurse who reported that an improperly stored dose of Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate) was administered to an 8 month old patient on 10-OCT-2016. The reported lot numbers are: # M014925, expiration date 16-FEB-2019 and Lot # M010439, expiration date 08-DEC-2018. It was not specified which lot # was administered to this patient. No adverse effects reported. This report was due to data logger. This is one of several reports from the same source. Additional information was requested.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 13-OCT-2016 via telephone call from a registered nurse who reported that an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) was administered to a 10 week old patient on 10-OCT-2016. The reported lot numbers are: # M014925, expiration date 16-FEB-2019 and Lot # M010439, expiration date 08-DEC-2018. It was not specified which lot # was administered to this patient. No adverse effects reported. This report was due to data logger. This is one of several reports from the same source. Additional information was requested.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 13-OCT-2016 via telephone call from a registered nurse who reported that an improperly stored dose of GARDASIL 9 was administered to a 15 year old patient on 10-OCT-2016. (Lot # L036301, expiration date 20-DEC-2017 and Lot # M018810, expiration date 28-MAY-2018). It was not specified which lot # was administered to this patient. No adverse effects reported. This report was due to data logger. This is one of several reports from the same source. Additional information was requested.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 13-OCT-2016 via telephone call from a registered nurse who reported that an improperly stored dose of GARDASIL 9 was administered to an 11 year old patient on 10-OCT-2016. (Lot # L036301, expiration date 20-DEC-2017 and Lot # M018810, expiration date 28-MAY-2018). It was not specified which lot # was administered to this patient. No adverse effects reported. This report was due to data logger. This is one of several reports from the same source. Additional information was requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to two unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. From 26-APR-2016 through 03-NOV-2016, the patients received improperly stored doses of VAQTA (lot # L009445 with expiration date 01-JUN-2017; dose and route were not reported). The temperature and time frame that the vaccine was improperly stored at were reported as below: On 26-APR-2016, 34 Fahrenheit (F) for 24 hours; On 22-JUL-2016, 34 F for 16 hours 40 minutes; On 27-JUL-2016, 34 F for 16 hours 30 minutes; On 28-JUL-2016, 33 F for 15 hours 33 minutes; On 01-AUG-2016, 33 F for 64 hours 3 minutes; On 02-AUG-2016, 32 F for 14 hours 56 minutes; On 03-AUG-2016., 35 F for 16 hours 37 minutes; On 04-AUG-2016, 33 F for 16 hours 10 minutes; On 08-AUG-2016, 35 F for 62 hours 52 minutes; on 09-AUG-2016, 35 F for 16 hours 1 minutes; On 15-AUG-2016, 35 F for 65 hours 30 minutes; On 08-SEP-2016, 47 F for 17 hours 18 minutes; On 09-SEP-2016, 47 F for 15 hours 42 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 13-OCT-2016 via telephone call from a registered nurse who reported that an improperly stored dose of GARDASIL 9 was administered to a 9 year old patient on 10-OCT-2016. (Lot # L036301, expiration date 20-DEC-2017 and Lot # M018810, expiration date 28-MAY-2018) It was not specified which lot # was administered to this patient. No adverse effects reported. This report was due to data logger. This is one of several reports from the same source. Additional information was requested.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 13-OCT-2016 via telephone call from a registered nurse who reported that an improperly stored dose of Meningococcal Protein Conjugate was administered to a 15 month old patient on 10-OCT-2016. The reported lot numbers are: # M014925, expiration date 16-FEB-2019 and Lot # M010439, expiration date 08-DEC-2018. It was not specified which lot # was administered to this patient. No adverse effects reported. This report was due to data logger. This is one of several reports from the same source. Additional information was requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information had been received on 21-OCT-2016 from a pharmacy technician who reported that on 17-OCT-2016 two unspecified patients (age and gender not reported) were administered PNEUMOVAX 23 pre-filled syringes (lot # M003616, expiration date 06-MAY-2018) (lot # M033086, expiration date 05-MAY-2018) intramuscular. The pharmacy technician stated the two patients called the pharmacy on 19-OCT-2016 experiencing redness and swelling at the injection sites. The patients stated their physician called the redness and swelling a cellulitis and prescribed unspecified antibiotics. Unspecified lab diagnostic studies were performed (results not provided). Present status of the patients was recovering. The pharmacy is requesting a lot check for both lots of PNEUMOVAX 23. No further information is available at this time. Lot # M003616, expiration date 06-MAY-2018 was found not to be valid for PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypoaesthesia, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a patient of unknown age and gender. The patient pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. The pharmacist reported that, on 14-OCT-2016, the patient received the PNEUMOVAX 23 (dose, strength, indication, route, expiry and lot# not reported). On the same day of the vaccination, the patient developed fever, it was not specified how high the fever was or how long it lasted, extreme pain (location of the pain was not specified), and lost feeling in the arm and it was not reported which arm. Patient sought medical attention by speaking to the pharmacist. Outcome of the events were unknown at the time of this report. No product quality complaint was involved. Causality assessment was not provided by the reporter. This case is linked to the case# 1610USA013658 (same reporter link). Additional information has been requested.
Age: 22.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 13-OCT-2016 via telephone call from a registered nurse who reported that an improperly stored dose of GARDASIL 9 was administered to a 22 year old patient on 10-OCT-2016. (Lot # L036301, expiration date 20-DEC-2017 and Lot # M018810, expiration date 28-MAY-2018). It was not specified which lot # was administered to this patient. No adverse effects reported. This report was due to data logger. This is one of several reports from the same source. Additional information was requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 13-OCT-2016 via telephone call from a registered nurse who reported that an improperly stored dose of GARDASIL 9 was administered to a 12 year old patient on 10-OCT-2016. (Lot # L036301, expiration date 20-DEC-2017 and Lot # M018810, expiration date 28-MAY-2018). It was not specified which lot # was administered to this patient. No adverse effects reported. This report was due to data logger. This is one of several reports from the same source. Additional information was requested.
Sex: U
Vaccine: HPV4
Symptoms: Gait disturbance
Clinical narrative: This spontaneous report as received from a consumer refers to her friend, a female patient of unknown age. Information on the patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with an unspecified HPV vaccine (also reported as miscellaneous because it is referencing adverse effects from an unspecified HPV vaccine, and a MSD product cannot be ruled out). Concomitant medication were not reported. The consumer reported, "The vaccine is a con. So many people have been injured by this vaccine! A friend of mine literally has trouble walking now and she's not even 25 years old. Totally fine before this." (See MARRS# 1610USA009450). The outcome of so many people being injured was not specified. This is one of two reports received from same reporter. Additional information is not expected.
Sex: F
Vaccine: HPVX
Symptoms: Gait disturbance
Clinical narrative: This spontaneous report as received from a consumer refers to her friend, a female patient of unknown age. Information on the patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with an unspecified HPV vaccine (also reported as miscellaneous because it is referencing adverse effects from an unspecified HPV vaccine, and a MSD product cannot be ruled out). Concomitant medication were not reported. The consumer reported, "The vaccine is a con. So many people have been injured by this vaccine! (see MARRS# 1611USA005445). A friend of mine literally has trouble walking now and she's not even 25 years old. Totally fine before this." The outcome of trouble walking is unknown. No further information was provided. This is one of two reports received from the same reporter. Additional information is not expected.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 13-OCT-2016 via telephone call from a registered nurse who reported that an improperly stored dose of GARDASIL 9 was administered to a 14 year old patient on 10-OCT-2016. (Lot # L036301, expiration date 20-DEC-2017 and Lot # M018810, expiration date 28-MAY-2018). It was not specified which lot # was administered to this patient. No adverse effects reported. This report was due to data logger. This is one of several reports from the same source. Additional information was requested.
Age: 21.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 13-OCT-2016 via telephone call from a registered nurse who reported that an improperly stored dose of GARDASIL 9 was administered to a 21 year old patient on 10-OCT-2016. (Lot # L036301, expiration date 20-DEC-2017 and Lot # M018810, expiration date 28-MAY-2018). It was not specified which lot # was administered to this patient. No adverse effects reported. This report was due to data logger. This is one of several reports from the same source. Additional information was requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX with lot # M023382 and expiration date: 11-MAY-2018; strength, dosage and route unspecified. Temperature/time frame was 5.5 Fahrenheit (F) for 4 hours, 45 minutes. There was no previous excursions. No data logger involved. No adverse effects reported. No product quality complaint was involved. No additional information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, MMRV, PPV, RV5, VARCEL, VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 24-OCT-2016 from a nurse who reported that improperly stored PNEUMOVAX 23 (lot # M005286, expiration 08-OCT-2017), VAQTA, (lot # M009377, expiration 17-JUN-2017; lot # M016191, expiration 26-MAY-2017; lot # M018644, expiration 20-SEP-2017; lot # L048460, expiration 14-JAN-2017), RECOMBIVAX HB (lot #M007763, expiration 15-SEP-2017), ROTATEQ (lot # M019706, expiration 24-OCT-2017), VARIVAX (lot # L000456, expiration 06-JAN-2017; lot # L008269, expiration 11-MAR-2017; lot # L015045, expiration 29-APR-2017), ZOSTAVAX (lot # L046899, expiration 23-FEB-2017), and PROQUAD (lot # L021599, expiration 10-DEC-2016) were administered in unspecified patients on unspecified dates. The number of doses administered was unspecified. The temperature for refrigerator was 60 degrees Fahrenheit for 11 hours, freezer was 30.9 degrees Fahrenheit for 11 hours and previous temperature excursion, refrigerator was 48 degrees Fahrenheit for 24 hours, 56 degrees Fahrenheit for 6 hours, freezer was 25 degrees Fahrenheit for six hours. No adverse effects were reported. No additional information was provided. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This solicited report has been received from a consumer (patient's mother) referring to her 15 year old son, who was enrolled in a Market Research. The patient's concurrent conditions, medical history and concomitant medication were unknown. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, dose and route were not reported). According to the reporter, the patient had had one shot of 3 and she was waiting to hear from the doctor if her son needed to have shot #3. The reporter also said there was a new study out that said 2 shots might be enough. Since it was a painful shot (injection site pain), the reporter didn't want her son to have more than he needed. The outcome of injection site pain was unknown. The causality was not reported. Additional information is not expected as there is no consent for follow up.
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This spontaneous report was received from a consumer reporting on her 14 year old son via company field employee. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were unknown by the reporter. On 23-SEP-2016, the patient was vaccinated with unidentified Merck HPV vaccine. On the same day, 2 minutes after vaccination the patient "passed out" (syncope). The reporter did not know if it was GARDASIL or GARDASIL 9. Lab diagnostics studies performed was unknown by the reporter. The patient did not seek medical attention. On an unknown date in September 2016, he recovered from the event. No product quality complaint (PQC) involved. The reporter did not provide relatedness between the events to the suspect therapy. Upon internal review "loss of consciousness" was considered to be serious due to medically significant. Follow up information has been received from the consumer on 08-NOV-2016. The consumer provided the physician's contact details. Upon internal review, the event coding of passed out has been corrected to syncope (previously coded to loss of consciousness). This case has been downgraded, since the event of syncope was not considered to be medically significant event. Additional information has been requested. Reporter details, event coding and narrative has been updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified patient of unknown age and gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 09-AUG-2016, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX subcutaneous injection (subcutaneously; lot # M006726, expiration date 08-FEB-2018 (strength and dose number were not reported), which was exposed to temperature excursion of 11.5 degrees Fahrenheit for 1 hour and 52 minutes. On an unknown date, there was a previous temperature excursion of 13.1 degrees Fahrenheit for 48 hours. Data logger was involved. No adverse effects were reported. Healthcare professional called and reported there was no further information to provide for this adverse event. The reporter requested no further follow-up from the company. This is one of several reports received from the same reporter. Additional information is not expected as the reporter requested no further follow-up.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse 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 PROQUAD (incorrect product storage) (lot # M015700, expiry date: 26-SEP-2017; lot # M017337, expiry date: 05-OCT-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of 9 degree Celsius (C) for 1 hour 1 minute. No previous temperature excursion was reported. It was also reported that this case was reported because of a data logger. No product quality complaint (PQC) was reported. This case is linked to case number 1611USA0048743 and 1611USA000386 via same reporter link. 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 nurse 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 M-M-R II (lot # L001336, expiry date: 13-JAN-2017; lot # L012482, expiry date: 24-AUG-2017; lot # L032044, expiry date: 24-AUG-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of 9 degree Celsius (C) for 1 hour 1 minute. No previous temperature excursion was reported. It was also reported that this case was reported because of a data logger. No product quality complaint (PQC) was reported. This case is linked to case number 1611USA004874 and 1611USA000386 via same reporter link. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Dyspnoea, Herpes zoster, Malaise, Rash
Clinical narrative: Information has been received from a 60 year old female consumer referring to herself. There was no concomitant medication, pertinent medical history or drug reactions or allergies. On 07-OCT-2016, the patient received a dose of ZOSTAVAX (dose, lot number and expiration date were unknown) injection subcutaneously. On 11-OCT-2016, the patient began to feel sick, and on 14-OCT-2016, the patient had severe breathing problems and chest pains. The patient went to an unspecified Emergency Room where they found bumps and a rash developing on the left side of her chest, and referred her to her primary physician for further evaluation. On 17-OCT-2016, the patient saw her physician who after seeing the rash and bumps diagnosed her with shingles. The physician prescribed prednisone (unspecified manufacturer) and valacyclovir hydrochloride (unspecified manufacturer). The patient has been using the medications for about 3 days and her symptoms seem to be worsening, and spreading over her entire chest and around to her back. No lab diagnostics was performed. The patient has not scheduled to see her provider again as of yet. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an x-ray technician concerning 3 unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 26-OCT-2016, the 3 patients were respectively vaccinated with a dose of improperly stored PEDVAXHIB (lot # M014927, expiration date 18-FEB-2019), dose and route unspecified. The vaccines were stored at 30 F for 9 hours. The date logger was involved in the report. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 14 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 22-SEP-2016, the patient was given a dose of PROQUAD (lot # L051098, expiration date 17-JUN-2017, rHA (recombinant human albumin); dose and route were unknown). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an x-ray technician concerning an unspecified patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 25-OCT-2016, the patient received 1 dose of improperly stored PEDVAXHIB (lot # M014927, expiration date 18-FEB-2019), dose and route were unspecified. The vaccine was stored at 30 F for 9 hours. The data logger was involved in the case. No adverse effects 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: Information has been received from an x-ray technician concerning 2 unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 26-OCT-2016, the two patients were respectively vaccinated with a dose of improperly stored GARDASIL 9 (lot # M013636, expiration date 15-FEB-2018), dose and route unspecified. The vaccines were stored at 30 F for 9 hours. Data logger was involved in the case. No adverse effects reported. 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: Information has been received from a medical assistant referring to seven unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. From 26-APR-2016 through 03-NOV-2016, the patients received improperly stored doses of GARDASIL (lot # L040459 with expiration date 06-APR-2017; dose and route were not reported). The temperature and time frame that the vaccine was improperly stored at were reported as below: On 26-APR-2016, 34 Fahrenheit (F) for 24 hours; On 22-JUL-2016, 34 F for 16 hours 40 minutes; On 27-JUL-2016, 34 F for 16 hours 30 minutes; On 28-JUL-2016, 33 F for 15 hours 33 minutes; On 01-AUG-2016, 33 F for 64 hours 3 minutes; On 02-AUG-2016, 32 F for 14 hours 56 minutes; On 03-AUG-2016, 35 F for 16 hours 37 minutes; On 04-AUG-2016, 33 F for 16 hours 10 minutes; On 08-AUG-2016, 35 F for 62 hours 52 minutes; On 09-AUG-2016, 35 F for 16 hours 1 minute; On 15-AUG-2016, 35 F for 65 hours 30 minutes On 08-SEP-2016, 47 F for 17 hours 18 minutes; On 09-SEP-2016, 47 F for 15 hours 42 minutes. There was no previous temperature excursion. Data logger was involved. 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: This spontaneous report as received from a certified medical assistant 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 # M017290, expiry date: 07-APR-2018). No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of 32.9 Fahrenheit (F) for 14 hours. No previous temperature excursion was reported. It was unspecified if the call was because of a data logger. No product quality complaint (PQC) was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning 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 an improperly stored dose of RECOMBIVAX HB, lot # L048848, expiration date: 09-AUG-2018, (dose number, route and anatomical location of administration were unknown). The temperature excursions reported were: 51.3 F for 40 minutes, and 50.2 F for 1 hour and 10 minutes. The temperature excursions were detected by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 86 year old female patient referring on herself. The patient's medical history and concurrent conditions were not reported. On an unspecified date in February 2016, the patient was vaccinated with ZOSTAVAX injection. The patient's concomitant therapies included ZOLOFT. On an unspecified date in September 2016, the patient experienced shingles for unspecified reason. The patient sought for medical attention in a visit to the physician and she was treated with valacyclovir. At the time of the report the outcome of the event was reported as not recovered. The causality between the event and the ZOSTAVAX was not reported. Additional information is not expected as the patient did not consent for a follow up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # M005733, expiration date: 01-OCT-2017, (dose number was unknown). The temperature excursions reported were: 51.3 F for 40 minutes, and 50.2 F for 1 hour and 10 minutes. The temperature excursions were detected by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient reports left arm pain days after receiving shot. Patient denies having previous history of left arm pain. Pain persists now greater than 7 mos. later.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 10cm x 10cm area of redness at injection site, warm to touch.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site extravasation
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (route, dosage schedule, lot # and expiration date were not reported). It was stated that a little liquid leaked from injection site post ZOSTAVAX vaccination (injection site extravasation). At the reporting time, the outcome of the event was unknown. The reporter did not assessed the causality between the event and the use of ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning 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 an improperly stored dose of PEDVAXHIB, lot # M025193, expiration date: 21-MAR-2019, (dose number, route and anatomical location of administration were unknown). The temperature excursion reported was: 51.3 F for 40 minutes. There was no previous temperature excursion. The temperature excursion was detected by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR
Symptoms: Electroencephalogram normal, Seizure
Clinical narrative: Seizure (afebrile) x 2 next day. Taken to ER via EMS. Fully recovered at ER. Neurologist recommended KEPPRA.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Flank pain, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 11/2/16-Pt reported site symptoms: (L) arm soreness, tender, hot to touch, pain radiating to shoulder, sign bicep swelling, temp 100.3F, (R) flank pain, urinary frequency.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pollakiuria
Clinical narrative: 11/2/16-Pt reported site symptoms: (L) arm soreness, tender, hot to touch, pain radiating to shoulder, sign bicep swelling, temp 100.3F, (R) flank pain, urinary frequency.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV9, MNQ
Symptoms: Abdominal pain, C-reactive protein increased, Nausea, Pain, Platelet count decreased
Clinical narrative: 5-6 hrs post injection, patient developed low grade fever, abdominal pain, nausea and body aches. She received 3rd HPV and MENVEO.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV9, MNQ
Symptoms: Pyrexia, White blood cell count normal
Clinical narrative: 5-6 hrs post injection, patient developed low grade fever, abdominal pain, nausea and body aches. She received 3rd HPV and MENVEO.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV9, MNQ
Symptoms: Abdominal pain, Chills, Full blood count normal, Nausea, Pain
Clinical narrative: 5-6 hrs post injection, patient developed low grade fever, abdominal pain, nausea and body aches. She received 3rd HPV and MENVEO.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV9, MNQ
Symptoms: Platelet count decreased, Pyrexia
Clinical narrative: 5-6 hrs post injection, patient developed low grade fever, abdominal pain, nausea and body aches. She received 3rd HPV and MENVEO.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Pyrexia, Vaccination site swelling
Clinical narrative: Fever max temp 101.0, redness at vaccine site slightly raised.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Skin at injection site dark pink and mild inflammation 2 inches.
Age: 1.42
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Chest X-ray normal, Culture urine negative, Cyanosis, Eye movement disorder, Febrile convulsion
Clinical narrative: Febrile seizure. 11/11/16 at 0100, tonic clonic-eyes rolled back in head, mild cyanosis at event per parents. Seizure lasted 10-20 minutes per parents. Fever was 104F.
Age: 1.42
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Influenza virus test negative, Pyrexia, Seizure, Tonic clonic movements, White blood cell count normal
Clinical narrative: Febrile seizure. 11/11/16 at 0100, tonic clonic-eyes rolled back in head, mild cyanosis at event per parents. Seizure lasted 10-20 minutes per parents. Fever was 104F.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Culture wound negative, Injection site reaction, Rash vesicular
Clinical narrative: Vesicular rash at site of PEDIARIX injection (DTaP/HBV/Polio).
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Mom called 11/9 that child fainted in car after immunization on 11/7. She took him to ER after. He was fine now per mother on 11/9. Per ER note - no tests done. Dx syncope vasovagal.
Age: 48.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Balance disorder, Dizziness, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Case number PHEH2016US025325, is an initial spontaneous report received from nurse on 29 Sep 2016. This report refers to a 48 years old male patient. Past medical history was not reported. Concomitant medications included as lisinopril and hydrochlorothiazide for hypertension (HTN) and ZYRTEC for allergies and hay fever. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185888) into left deltoid, at a dose of 0.5 ml, intramuscularly on 29 Sep 2016 at 07:15 AM. On the same day, the patient experienced dizziness, difficulty focusing, sweating increased, pale, severe nausea and vomiting after receiving vaccine. 30 minutes after receiving injection patient reported feeling dizzy, lightheadedness, sweaty, nauseous and vomited multiple times through day. By the next day felt off balance. The patient did vomit 1 day before injection but was not dizzy. Also had blurred vision plus double vision for 10 days after vaccination. The patient went to Ear Nose Throat specialist (ENT) and diagnosed with vestibular neuritis and prescribed with steroid VALIUM. It was reported that, 85 percent improved and he still felt off balance. The outcome of events was reported as condition unchanged. The seriousness of the events was reported as non-serious. The causality of the events was not reported. Seriousness of vestibular neuronitis was upgraded to serious (medically significant) based on the information available in the source document. Follow up report received from a nurse on 02 Nov 2016: Added patient demographics (Patient height and weight), concomitant medications, suspect drug information (batch number, vaccination site and time of vaccination), events (lightheadedness, felt off balance, blurred vision plus double vision and vestibular neuritis), treatment (steroid VALIUM) and reporter comments.
Age: 48.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Balance disorder, Diplopia, Disturbance in attention, Dizziness, Hyperhidrosis
Clinical narrative: Case number PHEH2016US025325, is an initial spontaneous report received from nurse on 29 Sep 2016. This report refers to a 48 years old male patient. Past medical history was not reported. Concomitant medications included as lisinopril and hydrochlorothiazide for hypertension (HTN) and ZYRTEC for allergies and hay fever. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185888) into left deltoid, at a dose of 0.5 ml, intramuscularly on 29 Sep 2016 at 07:15 AM. On the same day, the patient experienced dizziness, difficulty focusing, sweating increased, pale, severe nausea and vomiting after receiving vaccine. 30 minutes after receiving injection patient reported feeling dizzy, lightheadedness, sweaty, nauseous and vomited multiple times through day. By the next day felt off balance. The patient did vomit 1 day before injection but was not dizzy. Also had blurred vision plus double vision for 10 days after vaccination. The patient went to Ear Nose Throat specialist (ENT) and diagnosed with vestibular neuritis and prescribed with steroid VALIUM. It was reported that, 85 percent improved and he still felt off balance. The outcome of events was reported as condition unchanged. The seriousness of the events was reported as non-serious. The causality of the events was not reported. Seriousness of vestibular neuronitis was upgraded to serious (medically significant) based on the information available in the source document. Follow up report received from a nurse on 02 Nov 2016: Added patient demographics (Patient height and weight), concomitant medications, suspect drug information (batch number, vaccination site and time of vaccination), events (lightheadedness, felt off balance, blurred vision plus double vision and vestibular neuritis), treatment (steroid VALIUM) and reporter comments.