chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV9, MNQ, TDAP
Symptoms: Product reconstitution issue
Clinical narrative: Menveo was prescribed by physician but there is a possibility that patient only received the diluent and not the vaccine.
Age: 26.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Chills, Decreased appetite, Fatigue, Full blood count normal, Headache
Clinical narrative: FEVER, MALAISE, FATIGUE, HEADACHE, NAUSEA, CHILLS, DECREASED APPETITE.
Age: 26.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Influenza virus test negative, Malaise, Metabolic function test normal, Nausea, Pyrexia
Clinical narrative: FEVER, MALAISE, FATIGUE, HEADACHE, NAUSEA, CHILLS, DECREASED APPETITE.
Age: 26.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Chills, Dizziness, Full blood count normal, Headache, Hyperhidrosis
Clinical narrative: FEVER, MALAISE, FATIGUE, HEADACHE, NAUSEA, CHILLS, DECREASED APPETITE.
Age: 26.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Metabolic function test normal, Mononucleosis heterophile test negative, Nausea, Pyrexia, Streptococcus test negative
Clinical narrative: FEVER, MALAISE, FATIGUE, HEADACHE, NAUSEA, CHILLS, DECREASED APPETITE.
Age: 26.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: FEVER, MALAISE, FATIGUE, HEADACHE, NAUSEA, CHILLS, DECREASED APPETITE.
Age: 26.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Pyrexia
Clinical narrative: FEVER, MALAISE, FATIGUE, HEADACHE, NAUSEA, CHILLS, DECREASED APPETITE.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. In April 2016 (reported as between 05-APR-2016 and 14-APR-2016), the patients were vaccinated with improperly stored ROTATEQ (lot # L029617, expiration date reported as 19-MAY-2017, oral (dose was not reported). No adverse effects were reported. Administered doses of vaccines, experienced the temperature excursion of 53.2 degrees Fahrenheit for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. In April 2016 (reported as between 05-APR-2016 and 14-APR-2016), the patients was vaccinated with improperly stored RECOMBIVAX HB (lot # L038018, expiration date reported as 13-SEP-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 53.2 degrees Fahrenheit for 4 hours. Data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. In April 2016 (reported as between 05-APR-2016 and 14-APR-2016), the patients was vaccinated with improperly stored PNEUMOVAX 23 (lot # K020215, expiration date reported as 15-MAY-2016 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 53.2 degrees Fahrenheit for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. In April 2016 (reported as between 05-APR-2016 and 14-APR-2016), the patients were vaccinated with improperly stored VAQTA lot # L018499, expiration date reported as 25-FEB-2017 (dose, route and site of vaccination were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 53.2 degree Fahrenheit for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports 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 registered nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of PROQUAD (lot # L030591 with expiration date 10-FEB-2017, lot # L041629 with expiration date 22-APR-2017 and lot # L046507 with expiration date 17-MAY-2017; dose and route of administration were not reported). No adverse effects were reported. The call was made because of the data logger. PROQUAD (Merck) with lot # L030591 was stored in 7.6 degrees of Celsius for 49 hours. PROQUAD (Merck) with lot # L041629 and with lot # L046507 were stored in -12.2 degrees of Celsius for 1 hour. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: RV5
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. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (lot # reported as L033508, expiration date reported as 12-MAY-2017; lot # reported as L033543, expiration date reported as 30-MAY-2017, oral (dose was not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 56.8 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient medical history and concurrent conditions were not reported. On 12-APR-2016, the patient was vaccinated with expired dose of PNEUMOVAX 23 (25/0.5) (units not reported) (lot# K008927, expiry date: 17-MAR-2016, dose: 0.5 ml, intramuscularly). Concomitant therapy was not reported. No adverse effects was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, multiple unspecified patients were administered improperly stored VAQTA lot # L030442 expiration date: 19-FEB-2016 (dose, route and site of administration were not reported). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse efers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, multiple unspecified patients were administered improperly stored ROTATEQ, orally, lot # L020859, expiration date: 19-JAN-2017 (dose, route and site of administration were not reported). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, multiple unspecified patients were administered improperly stored RECOMBIVAX HB (lot # L020157,expiration date: 12-MAR-2018) (dose, route and site of administration were not reported). There were 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: This spontaneous report as received from a Licensed Practical Nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, multiple unspecified patients were administered improperly stored GARDASIL 9 lot # L020015 expiration date: 18-AUG-2017 (dose, route and site of administration were not reported). There was 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: This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown age and gender. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL lot # K016966, expiration date reported as 10-MAY-2017 (dose, route and site of vaccination were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 56.8 degrees Fahrenheit fro 12 hours. Data logger was involved. There were no previous excursions reported. 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 an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of (Merck) VARIVAX (lot # L034370 with expiration date 08-SEP-2017, lot # L038132 with expiration date 01-OCT-2017, lot # reported as L042266 with expiration date October 2017, lot # reported as L049532 with expiration date 08-DEC-2017; dose and route of administration were not reported). No adverse effects were reported. The call was made because of the data logger. (Merck) VARIVAX with lot # L034370 and with lot # reported a L042266 were stored in 7.6 degrees of Celsius for 49 hours. (Merck) VARIVAX with lot # L038132 and with lot # reported as L049532 were stored in -12.2 degrees of Celsius for 1 hour. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Blepharospasm
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a patient of unknown age and gender. The patient's medical history was not reported. In approximately April 2012 (reported as about 4 years ago), the patient as vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) and an unspecified flu vaccine. On an unknown date, the patient experienced a twitch in her eye. The outcome of twitch in eye was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Rash generalised, Streptococcus test, Urticaria
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an 11 year old male patient. The patient's medical history included hives as the reaction to unspecified penicillin. The patient did not have pertinent medical history. On 18-JAN-2016, the patient was vaccinated with a dos of GARDASIL 9 lot # L017407, expiration date 15-AUG-2017, intramuscularly (strength and dose were not provided). The patient did not take any concomitant medication. On 29-JAN-2016, the patient developed a rash and hives on the armpits and ankles that eventually spread over his entire body by an unspecified date in 2016. On an unspecified date in 2016, the patient received LOTRISONE cream as the treatment for the rash and hives. The patient recovered from the rash and hives on an unspecified date in 2016. Then, the treatment with LOTRISONE was discontinued on an unspecified date in 2016. On 25-MAR-2016, the patient was vaccinated with another dose of GARDASIL 9 lot # L024993, expiration date 17-OCT-2017, intramuscularly (strength and dose were not provided). On 28-MAR-2016, the patient developed a rash an hives on only the back of the arms and armpits. Then, on an unspecified date, the patient was started on LOTRISONE cream therapy for this new case of rash and hives. At the time of the reporting, the patient was recovering from the new rash and hive. On an unknown date, the patient underwent "strep test" but no result was provided. The patient sought medical attention via seeing the physician. The relatedness between the events and GARDASIL 9 was no reported.  Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Erythema multiforme, Oropharyngeal pain, Rash generalised, Rash macular, Skin test positive
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an 11 year old male patient. The patient's medical history included hives as the reaction to unspecified penicillin. The patient did not have pertinent medical history. On 18-JAN-2016, the patient was vaccinated with a dos of GARDASIL 9 lot # L017407, expiration date 15-AUG-2017, intramuscularly (strength and dose were not provided). The patient did not take any concomitant medication. On 29-JAN-2016, the patient developed a rash and hives on the armpits and ankles that eventually spread over his entire body by an unspecified date in 2016. On an unspecified date in 2016, the patient received LOTRISONE cream as the treatment for the rash and hives. The patient recovered from the rash and hives on an unspecified date in 2016. Then, the treatment with LOTRISONE was discontinued on an unspecified date in 2016. On 25-MAR-2016, the patient was vaccinated with another dose of GARDASIL 9 lot # L024993, expiration date 17-OCT-2017, intramuscularly (strength and dose were not provided). On 28-MAR-2016, the patient developed a rash an hives on only the back of the arms and armpits. Then, on an unspecified date, the patient was started on LOTRISONE cream therapy for this new case of rash and hives. At the time of the reporting, the patient was recovering from the new rash and hive. On an unknown date, the patient underwent "strep test" but no result was provided. The patient sought medical attention via seeing the physician. The relatedness between the events and GARDASIL 9 was no reported.  Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Skin warm, Streptococcus test, Urticaria
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an 11 year old male patient. The patient's medical history included hives as the reaction to unspecified penicillin. The patient did not have pertinent medical history. On 18-JAN-2016, the patient was vaccinated with a dos of GARDASIL 9 lot # L017407, expiration date 15-AUG-2017, intramuscularly (strength and dose were not provided). The patient did not take any concomitant medication. On 29-JAN-2016, the patient developed a rash and hives on the armpits and ankles that eventually spread over his entire body by an unspecified date in 2016. On an unspecified date in 2016, the patient received LOTRISONE cream as the treatment for the rash and hives. The patient recovered from the rash and hives on an unspecified date in 2016. Then, the treatment with LOTRISONE was discontinued on an unspecified date in 2016. On 25-MAR-2016, the patient was vaccinated with another dose of GARDASIL 9 lot # L024993, expiration date 17-OCT-2017, intramuscularly (strength and dose were not provided). On 28-MAR-2016, the patient developed a rash an hives on only the back of the arms and armpits. Then, on an unspecified date, the patient was started on LOTRISONE cream therapy for this new case of rash and hives. At the time of the reporting, the patient was recovering from the new rash and hive. On an unknown date, the patient underwent "strep test" but no result was provided. The patient sought medical attention via seeing the physician. The relatedness between the events and GARDASIL 9 was no reported.  Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a Registered Nurse via field representative regarding a 58 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date in 2013 (also reported as 3 years ago), the patient was vaccinated with ZOSTAVAX, one dose once, route unknown (also reported as injection). Concomitant thereapies included ZYRTEC. On an unspecified date after administration of ZOSTAVAZ the patient developed itchiness that started in her hands and ran throughout her arm. The patient sought medical attention and followed up with an unspecified Dermatologist who told her that the itching was non-vaccine related. The field representative could not confirm if there was a rash involved with the itching. The outcome of event was unknown. Product quality complaint (PQC) was not filed. The reporter's causality assessment to the event was not provided. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: This spontaneous report as received from a 79-year-old male patient with a pertinent history of atrial fibrillation. In approximately 2010 (reported as 6 years ago), the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml administered subcutaneously (strength, lot # and expiry date were unspecified). Concomitant therapies included warfarin and losartan potassium (manufacturer unknown). On 29-MAR-2016, the patient came down with a case of shingles and also nerve pain at night. The patient sought unspecified medical attention (however, he was not hospitalized), he was given VACLOVIR and gabapentin for the treatment of the events. No laboratory tests were performed. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported.  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 and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # K023363, expiration date: 20-MAY-2016 and lot# K023364, expiration date: 20-MAY-2016) (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of PROQUAD (Merck) experienced the temperature excursion of -6.5 degrees Celsius for 1 hour and 12 minutes. Data logger was involved. The previous temperature excursions were -7.4 degrees Celsius for 2 hours and 36 minutes. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding a 17 year old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not reported. On 13-APR-2016, the patient was vaccinated with VAQTA (50/1.0 U/ML (lot # L036449, expiry date 26-MAY-2017) 1 milliliter (ml)/once, intramuscular (Inappropriate schedule of vaccine administered). Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. 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 and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored PROQUAD (Merck) (lot # K007158, expiration date: 12-NOV-2015; lot # K018144, expiration date: 10-APR-2016) (dose and route of administration were not reported). No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of -6.5 degrees Celsius for 1 hour and 12 minutes. Data logger was involved. The previous temperature excursions were at -7.4 degrees Celsius for 2 hours and 36 minutes. Since dates of PROQUAD (Merck) administration were not known, it was unknown whether the vaccines that at the time of the report (also reported as currently) were expired, were administered to the patients prior to expire or after expire. Product quality complaint (PQC) was not 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 was received from a registered nurse and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored (Merck) VARIVAX (lot # K005427, expiration date: 15-APR-2016; lot # K018963, expiration date: 15-OCT-2106; lot # K015971, expiration date: 23-SEP-2016; lot # K005428, expiration date: 15-APR-2016) (dose and route of administration were not reported). No adverse effects were reported. Administered doses of (Merck) VARIVAX experienced the temperature excursion of -6.5 degrees Celsius for 1 hour and 12 minutes. Data logger was involved. The previous temperature excursions were at -7.4 degrees Celsius for 2 hours and 36 minutes. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored ZOSTAVAX (lot # K007985, expiration date: 03-SEP-2015, lot # K007987, expiration date: 03-SEP-2015) (dose and route of administration were not reported). No adverse effects were reported. Administered doses of ZOSTAVAX experienced the temperature excursion of -6.5 degrees Celsius for 1 hour and 12 minutes. Data logger was involved. The previous temperature excursions were at -7.4 degrees Celsius for 2 hours and 36 minutes. Since dates of ZOSTAVAX administration were not known, it was unknown whether the vaccines, that at the time of the report (also reported as currently) were expired, were administered to the patients prior to expiry or after expiry (considered as expired vaccine used). Product quality complaint (PQC) was not 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 was received from a registered nurse and refers to a multiple patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple patients received doses of improperly stored (Oka/Merck) VARIVAX (lot # K002917, expiration date: 26-FEB-2016) (dose and route of administration were not reported). No adverse effects were reported. Administered doses of (Oka/Merck) VARIVAX experienced the temperature excursion of -6.5 degrees Celsius for 1 hour and 12 minutes. Data logger was involved. The previous temperature excursions were at -7.4 degrees Celsius for 2 hours and 36 minutes. Since dates of (Oka/Merck) VARIVAX administration were not known, it was unknown whether the vaccines, that at the time of the report (also reported as currently) were expired, were administered to the patients prior to expiry or after expiry (considered as expired vaccine used). Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of an unknown age and gender. The patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified dates in April 2016, (reported as since 16-APR-2016), the patients might had been vaccinated with improperly stored PEDVAX HIB (lot # L042257, expiration date: 17-AUG-2018; dose and route of administration were not provided). The vaccine was exposed to temperature of 6 degrees Fahrenheit for 7 hours. No previous excursion was reported. No adverse effects were reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of an unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unspecified dates in April 2016, (reported as since 16-APR-2016), the patients might had been vaccinated with improperly stored GARDASIL 9 (lot # L043213, expiration date: 28-AUG-2017; dose and route of administration were not provided). The vaccine was exposed to temperature 6 degrees Fahrenheit for 7 hours. No previous excursion was reported. No adverse effects were reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (RN) refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On unspecified dates, the patients were vaccinated with an improperly stored (temperature: 21.6 degrees Fahrenheit (F), time frame: 1 hour and 55 minutes; previous temperature excursion: 28 F, time frame: 6 hours and 15 minutes; total cumulative temperature and time: 28 F for 8 hours and 10 minutes; the vaccine was back in range) doses of M-M-R II, lot # K024035, expiration date: 26-NOV-2016 (status albumin, dose and route of administration were not specified). No adverse effect was 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 registered nurse (R.N.) refers to multiple unspecified patients of unknown age and gender. The patients; medical history, concurrent conditions and concomitant medications were not provided. On unspecified dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) lot # L047305, expiration date: 23-MAY-2017 (dose and route of administration were not specified). 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 as received from a registered nurse (R.N) refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On unspecified dates, the patients were vaccinated with an improperly stored (temperature: 21.6 degrees Fahrenheit (F), time frame: 1 hour and 55 minutes; previous temperature excursion?: 28 F, time frame: 6 hours and 15 minutes; total cumulative temperature and time: 28 F for 8 hours and 10 minutes; the vaccine was back in range) doses of VARIVAX (Merck), lot # L006383, expiration date: 25-FEB-2017 (dose and route of administration were not specified). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (RN) refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On unspecified dates, the patients were vaccinated with an improperly stored temperature: 21.6 degrees Fahrenheit (F), time frame: 1 hour and 55 minutes previous temperature excursion: 28 F, time frame: 6 hours and 15 minutes; total cumulative temperature and time: 28 F for 8 hours and 10 minutes; the vaccine was back in range) doses of ZOSTAVAX lot # L011533, expiration date: 03-JUL-2016 (dose and route of administration were not specified). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On unspecified dates, the patients were vaccinated with an improperly stored doses of GARDASIL 9 lot # L043213, expiration date: 29-AUG-2017 (dose and route of administration were not specified). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L027067, expiration date: 06-APR-2017, orally (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 33 degrees Fahrenheit for 30 minutes daily for two weeks. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patient were vaccinated with improperly stored doses of VAQTA lot # L023936, expiration date: 15-MAR-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 33 degrees Fahrenheit for 30 minutes daily for two weeks. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L0140421, expiration date: 15-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 20 degrees Fahrenheit for 30 minutes daily for two weeks. Data logger was involved. There no previous excursions 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 an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # L047307, expiration date: 23-MAY-2017 (dose, therapy type and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 20 degrees Fahrenheit for 30 minutes daily for two weeks. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 66 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date in June 2015 (also reported as 10 months ago), the patient was vaccine with ZOSTAVAX 19400 PFU, dosage regiment and route unknown. Concomitant medications were not reported. On an unknown date the patient developed shingles. The patient sought medical attention by contacting pharmacist. The patient was treated with VALTREX. The outcome of shingles was reported to be recovered/resolved. Product quality complaint (PQC) was not filed. Causality assessment was not provided.  Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date, the patients were vaccinated improperly stored VAQTA lot # K005958, expiration date reported as 09-FEB-2017 (dose, route and site of vaccination were not reported). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 56.8 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot # L042257, expiration date reported as 17-AUG-2018 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 56.8 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. 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 was received from a registered nurse and refers to an unknown number of patients of an unknown age and gender. The patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified dates in April 2016, (reported as since 16-APR-2016), the patients might had been vaccinated with improperly stored ROTATEQ (lot # L029618, expiration date: 20-MAY-2017; dose was not provided) orally. The vaccine was exposed to temperature of 6 degrees Fahrenheit for 7 hours. No previous temperature excursion was reported. No adverse effects were reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of an unknown age and gender. The patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified dates in April 2016, reported as since 16-APR-2016), the patients might had been vaccinated with improperly stored VAQTA (lot # M003011, expiration date: 15-NOV-2017; dose and route of administration were not provided). The vaccine was exposed to temperature of 6 degrees Fahrenheit for 7 hours. No previous temperature excursion was reported. No adverse effects were reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. The primary reporter stated the patient was administered last in the series of GARDASIL (0.5 ml, intramuscularly) First and second dose of GARDASIL were given on 02-OCT-2015, and 04-OCT-2015 (unspecified lot/expiration date). Third dose in the series was GARDASIL 9 (0.5 ml, intramuscularly, unspecified lot/expiration date), which administered on 11-MAR-2016. No adverse effect was reported. Additional information is not expected as there was no consent for follow up.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen red spot at the point of vaccine approx. inch in diameter. By 4/24/2016 it was about 6.5 inches, bright red, swollen, hot.
Age: 63.0
Sex: F
Vaccine: PER, TD
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Pain from area of TDP shot, limited use of left arm due to high pain radiating from inside arm.
Age: 48.0
Sex: M
Vaccine: TYP
Symptoms: Chills, Diarrhoea, Pain
Clinical narrative: Chills, body aches, diarrhea.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dyskinesia, Electroencephalogram normal, Injection site pain, Myoclonus, Ultrasound scan normal
Clinical narrative: Whole body jerks resembling the startle reflex, as described by mother.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Ultrasound skull
Clinical narrative: Whole body jerks resembling the startle reflex, as described by mother.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Blood test, Chills, Contusion, Diarrhoea
Clinical narrative: FEVER/CHILLS/SINUSITIS/JOINT PAIN/HEADACHE/NAUSEA/DIARRHEA/SWOLLEN GLANDS BEHIND HEAD SIDES OF OCCIPITAL AREA/AND UNDER NECK/MUSCLE WEAKNESS/ERYTHEMA/BRUISING/3/24/2016-DIPLOPIA REQUIRING ER VISIT WHICH INCLUDE MRI/MRA/EMG NOW SCHEDULED-04/25/2016/ STILL HAVING SYMPTOMS.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Diplopia, Erythema, Headache, Lymphadenopathy, Muscular weakness
Clinical narrative: FEVER/CHILLS/SINUSITIS/JOINT PAIN/HEADACHE/NAUSEA/DIARRHEA/SWOLLEN GLANDS BEHIND HEAD SIDES OF OCCIPITAL AREA/AND UNDER NECK/MUSCLE WEAKNESS/ERYTHEMA/BRUISING/3/24/2016-DIPLOPIA REQUIRING ER VISIT WHICH INCLUDE MRI/MRA/EMG NOW SCHEDULED-04/25/2016/ STILL HAVING SYMPTOMS.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia, Sinusitis
Clinical narrative: FEVER/CHILLS/SINUSITIS/JOINT PAIN/HEADACHE/NAUSEA/DIARRHEA/SWOLLEN GLANDS BEHIND HEAD SIDES OF OCCIPITAL AREA/AND UNDER NECK/MUSCLE WEAKNESS/ERYTHEMA/BRUISING/3/24/2016-DIPLOPIA REQUIRING ER VISIT WHICH INCLUDE MRI/MRA/EMG NOW SCHEDULED-04/25/2016/ STILL HAVING SYMPTOMS.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Myalgia, Pain, Tenderness
Clinical narrative: Extreme soreness in all my muscles. Hurt all over. Flu-like symptoms for 2 days. Arm still very tender to touch on 3rd day.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Hot red reaction around injection site. A bit swollen. About a 2 inch circle.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Case of shingles.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Enlarged red circle around site of injection. Patient states area is very warm, and the area is also painful. Patient stated she did not feel any systemic effects and did not have a fever.
Age: 0.46
Sex: F
Vaccine: RV1
Symptoms: Haematochezia, Incomplete course of vaccination
Clinical narrative: Blood in diaper, took diaper and child to clinic, Dr immediately identified source as rotavirus vaccine, told us not to get next rotavirus vaccine and prescribed probiotics.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Itching and warmth at injection site 4/23/16. Patient consulted with a pediatric nurse that confirmed it looked like an injection site reaction. Patient took an antihistamine and ibuprofen and reports injection site has improved.
Age: 5.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding a 5 year old patient of unknown gender. There was no information about concurrent condition and historical medication. On 20-APR-2016, 5 year old patient was inadvertently administered a dose of ZOSTAVAX (lot # L036823, expiration date: 24-DEC-2016, instead of (Oka/Merck) VARIVAX) (wrong drug administered and inappropriate schedule of drug administration). No adverse effect was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with ZOSTAVAX. No concomitant medication was reported. On an unknown date "months after" receiving the vaccine the patient experienced shingles. The outcome of shingles was unknown. Causality between shingles and ZOSTAVAX was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received via a company representative from a 65 year old female patient, who was also a physician and was reporting on herself. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. In approximately 2011 (reported as about five years ago), the patient was vaccinated with a dose of ZOSTAVAX injection, 0.65 ml, subcutaneous (strength, site of administration, lot number and expiration date were not reported). In approximately 2013 (reported as 2 years later), the patient experienced shingles. It was not reported if the patient sought medical attention, if any lab diagnostic studies were performed or if any treatment was given for the event. Product quality complaint was not involved. The outcome of shingles was considered as recovered on an unknown date and the patient reported that she did not have any other episodes since that time. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Acupuncture, Injection site pain, Pain
Clinical narrative: Case number PHHY2016US041619, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 622219) website on 29 Mar 2016. This report refers to a 42-years-old female patient. Past medical history included acupuncture. Current conditions included cold and hurt with movement when trying to remove shirt/ cannot actually disrobe. Concomitant medications included SYNTHROID 0.05mg 4X per week. The patient was vaccinated with FLUVIRIN (batch number: 152805) intramuscularly in left arm on 01 Dec 2015. On 03 Dec 2015, the patient reported her arm and shoulder where the shot was administered began to hurt, pain became excruciating over next few weeks, could not move it without intense pain. The patient was treated with acupuncture, which decreased her pain from 10 to 3 (units unspecified), then it started to increase again over in next few days. It was reported that, after 2 and half months the pain had decreased although it hurt with number of movements including trying to remove shirt. The patient also reported that, she could barely put pressure from right arm to lift her left arm and felt that the pharmacist was not negligent while administering the flu shot. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as serious (reported as permanent disability). The causality of the events was not reported. Upon follow up, Quality Assurance department confirmed that reported batch number 152805 was not a valid batch number for FLUVIRIN, therefore the QA record for this batch number was cancelled. Follow up information report received from Quality Assurance department on 19 Apr 2016: Updated QA comments.