chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This solicited report was received from a physician referring to a 64 years old male patient enrolled in a marketing research program. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date in 2008, the patient was vaccinated with his first dose of ZOSTAVAX, one time injection, route of administration, lot# and expiry date were not reported). On an unknown date in March 2014, the patient went down with "mild case" of shingles that lasted approximately 3 days after receiving the ZOSTAVAX. The patient recovered with sequelae from the event on an unknown date, 3 days after the onset of shingles. Causality assessment was not provided. This is one of several cases from the same reporter. Additional information is not expected, as there was no consent for follow up.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site paraesthesia
Clinical narrative: Information has been received from a registered nurse referring to a 77 years old male patient with high blood pressure and sleep apnea. The patient had no drug reactions/allergies. Concomitant medication included PRADAXA (blood thinner). On 01-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX  23 (lot# M006139 with expiration date 13-MAY-2017, dose unknown, intramuscular). On the same date, the patient developed redness, tingling with severe pain at injection site and numbness to his forearm. The patient didn't sought medical attention. Pharmacist stated that the patient did not have symptoms treated and the symptoms slowly went away. At the reporting time, the patient was doing fine. The causality between the events and the vaccine was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified multiple patients with unknown demographics. Information on pertinent medical history, drug reaction/allergies and concomitant medications were not reported. On an unknown date, unspecified multiple patients were administered improperly stored PNEUMOVAX 23 (lot# L014458 with expiry date: 11-FEB-2017) on multiple unspecified dates. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 01-SEP-2016, the patient was vaccinated with improperly stored dose of VAQTA lot number reported as: LN749, expiry date: 26-AUG-2018 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. This is one of the 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 medical assistant refers to 3 unspecified patients of unknown gender and age. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # M014916, expiry date: 25-MAR-2018. A data logger was involved. Medical assistant reported that the vaccine underwent temperature excursion at 11 F for 70 minutes. She stated that the vaccine was exposed at 9 F for 90 minutes previously as well. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 07-SEP-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M007764, expiry date: 30-JAN-2018 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. This is one of the 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 a multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 10-JUL-2016 to 09-SEP-2016 the patients were vaccinated with improperly stored VAQTA (dosing details were not reported) lot # L036300, expiry date: 04-NOV-2016, which was stored at temperature of 25 degree Fahrenheit, for a time frame of 4 days 1 hour 45 minutes there was no previous temperature excursions reported, (lot # M002268, expiry date: 20-SEP-2017), which was stored at temperature of 25 degree Fahrenheit for a time frame of 15 minutes. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This solicited report was received from a physician referring to a 65 years old female patient enrolled in a marketing research program. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date in 2014, the patient was vaccinated with her first dose of ZOSTAVAX, one time injection (route of administration, lot# and expiry date were not reported). On an unknown date in January 2016, the patient went down with "mild case" of shingles that lasted approximately 3 days after receiving the ZOSTAVAX. The patient recovered with sequelae from the event on an unknown date, 3 days after the onset of shingles. Causality assessment was not provided. This is one of several cases from the same reporter. Additional information is not expected, as there was no consent for follow up.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-AUG-2016, the patient was vaccinated with improperly stored VAQTA, 25/0.5 injection, lot # L043209, expiry date 17-SEP-2017, 0.5 ml/once, intramuscularly. Temperature/time frame were 1.7C for 4 hours 10 minutes (on 26-AUG-2016), 1.7C for 2 hours 48 minutes (on 29-AUG-2016), 1.3C for 7 hours (on 30-AUG-2016) and 1.2C for 10 hours 14 minutes (on 31-AUG-2016), because of data logger. Prior excursion was 1.3C for 45 hours 18 minutes (on 07-JUL-2016). No adverse effects were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. This is one of three 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 was received from a medical assistant referring to 4 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # M002419, expiry date 12-JAN-2018) (dose and route not reported). The vaccine was exposed to temperature of 61 Fahrenheit for 3 hours. No previous temperature excursion was reported. No adverse effects and no product quality complaints (PQC) were reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to multiple unspecified patients of unknown age. 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 M-M-R II (lot # L036851, expiry date 23-SEP-2017, lot# L039551 expiry date 07-OCT-2017, lot# M004063 expiry date 25-JAN-2018). These vaccines were exposed to 46.8 F for 78 minutes. No adverse effects were reported. This is one of the several reports received from 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 a multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 10-JUL-2016 to 09-SEP-2016 the patients were vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M025563, expiry date: 06-NOV-2017), which was stored at temperature of 33 degree Fahrenheit, for a time frame of 4 days 1 hour 30 minutes there was a previous temperature excursion of 25 degree Fahrenheit for 15 minutes, orally. No adverse effects reported. There was no product quality complaint involved. This is one of the 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 as received from a nurse practitioner refers to multiple unspecified patients of unknown age. 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 PEDVAXHIB (lot# M007762 expiry date: 07-DEC-2018, lot# M020101 expiry date: 07-MAR-2019). These vaccines were exposed to 46.8 F for 78 minutes. No adverse effects were reported. This is one of the several reports received from 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 medical assistant refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, current conditions and concomitant medications were not reported. On 10-JUL-2016 to 09-SEP-2016 the patients were vaccinated with improperly stored RECOMBIVAX HB (dose details were not reported) lot # L040458, expiry date: 04-FEB-2018), which was stored at temperature of 25 degree Fahrenheit, for a time frame of 15 minutes, there was no previous temperature excursions reported. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified multiple patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, unspecified multiple patients were administered improperly stored GARDASIL 9 (lot# L0432123 with expiry date: 28-AUG-2017, lot # L043214 with expiry date: 30-AUG-2017 and lot# M005714 with expiry date: 03-OCT-2017) on multiple unspecified dates. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 06-SEP-2016, the patient received a dose of properly stored, expired M-M-R II (strength, dose and frequency were unknown; lot number K012473 and expiration date 26-AUG-2016). 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 pharmacy technician refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L035510, expiry date: 13-MAY-2017). Pharmacy technician stated that the vaccine underwent temperature excursion at 30.1 F for a duration of 13 hours 50 minutes. No data logger was involved and there was no previous temperature excursion. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unspecified dates, the patients might have been vaccinated with doses of GARDASIL 9 (lot # L026602, expiration date: 19-OCT-2017; lot # L043213, expiration date: 28-AUG-2017; strength, dose, frequency, route were unknown). This is one of the two reports that received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 07-JUL-2016, the patient was inadvertently administered with an improperly stored dose of PROQUAD (dose, route of administration, lot# and expiration date were not provided). No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of the several reports received from the same reporter. Follow-up information was received from the reporting nurse on 15-SEP-2016. The patient was 4-years-old. The immunization status of the patient egg, neomycin, latex and gelatin allergies was reported as "no". The patient was vaccinated with the second dose of PROQUAD in a public health clinic/ hospital and the vaccine was purchased with a public funds. The vaccine status was reported as completed. Additional information is not expected, as scheduled correspondence has been received. The patient demographics, product information and narrative were updated.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: This spontaneous report was received from a 79 year old male patient via other company (Mfr. control # 2016USA032459) and refers to himself. The patient's concurrent conditions included prostate cancer. No information on the patient's concurrent conditions and medical history was reported. On 03-AUG-2016 (also reported as 04-AUG-2016), the patient started the therapy with XTANDI 40 mg capsule, orally, 160 mg once daily, for prostate cancer. On 18-AUG-2016, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), (dose, route of administration, lot number and expiration date were not reported). Concomitant therapies included gabapentin, levothyroxine sodium (manufacturer unknown), lisinopril (manufacturer unknown), LYRICA, magnesium oxide, oxybutynin and simvastatin (manufacturer unknown). On 18-AUG-2016, the patient's arm, from elbow to shoulder became red, sore and swollen. On an unknown date in August 2016 (reported as "a few days ago"), the patient had a pneumonia shot (unspecified) and his arm broke out. No lab test information was provided. The therapy with XTANDI continued. The outcome of elbow to shoulder swollen, red and sore was reported as not recovered/not resolved. The outcome of arm broke out was reported as recovered/resolved on an unknown date in August 2016. The relatedness between the events and the suspected therapies was not reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Information has been received from a pharmacist referring to a 65 year old male patient. The patient developed herpes in his eyes over a year ago. On 15-SEP-2016 the patient was vaccinated with one dose of ZOSTAVAX (lot # M024700, expiration date 18-JUL-2016, dose was unknown, subcutaneous). Other suspect therapies included acyclovir (dose and frequency were unknown) for herpes in his eyes. No PQC was involved. The outcome of the event was unknown. The causality between the event and suspect therapies was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 19 year old non-pregnant female patient. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown date, the patient was vaccinated with the first, second and third dose of GARDASIL injection (lot # expiration date, site and doses were not reported), intramuscularly. On an unknown date, the patient had a positive Papanicolaou (PAP) smear test and she was tested positive for HPV. It was reported that the patient sought medical attention, she saw her physician. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to 4 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M004885, expiry date 23-OCT-2017) (dose and route not reported). The vaccine was exposed to temperature of 61 Fahrenheit for 3 hours. No previous temperature excursion was reported. No adverse effects and no product quality complaints (PQC) were reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 31-AUG-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II with lot # M001200 Expiration date: 28-AUG-2016 (dose and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of two reports received from the same source. 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 pharmacy intern referring to unspecified number of patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates since 07-JUL-2016, the patients were vaccinated with improperly stored doses of ZOSTAVAX which had lot # L029484 with expiry date: 06-NOV-2016 and lot# M010472 with expiry date: 01-JUN-2017 (dosing details not provided). The vaccine was exposed to a temperature of 36 degree Fahrenheit for 22 hours. The vaccine had no previous temperature excursion. The call was due to data logger. No adverse effects and no product quality complaint (PQC) reported. No further information provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 07-SEP-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II with Lot # M001200 Expiration date: 28-AUG-2016 (dose and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of two reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 17 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-SEP-2016, the patient was inadvertently vaccinated with an adult dose of RECOMBIVAX HB (lot # L048209, expiry date 31-MAY-2018), instead of the intended pediatric dose. Nurse practitioner reported that, on an unknown date in September 2016, the patient did experience "localized swelling at the injection site". The outcome of the events was unknown. Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 66 year old female patient. The patient's pertinent medical history included arthritis. No information regarding the patient's drug reactions or allergies and concomitant therapies was provided. On 09-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # L012215, expiration date: 13-JAN-2017, dose and route of administration were not provided). The injection was given in the triceps area, rather than in the deltoid area, as recommended per the pharmacy protocol. On 09-SEP-2016, the patient noticed, that her arm was extremely sore, warm and had a red area around the injection site. The following day, the patient reported to the pharmacist that, she could hardly bend her elbow, the elbow was swollen to the point that the normal wrinkles around the elbow could not be seen, the upper arm was swollen, hot to touch, and had a red area about six to six and one half inches in diameter, as well as soreness. The swelling traveled down into the patient's elbow and a little below the elbow on day 2 but that the injection site pain was less noticeable. The patient sought medical attention. The outcome of peripheral swelling, injection site redness and injection site warmth was unknown. The outcome of injection site pain was considered as recovering/resolving, as the pain was less noticeable. The relatedness between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Joint swelling, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 66 year old female patient. The patient's pertinent medical history included arthritis. No information regarding the patient's drug reactions or allergies and concomitant therapies was provided. On 09-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # L012215, expiration date: 13-JAN-2017, dose and route of administration were not provided). The injection was given in the triceps area, rather than in the deltoid area, as recommended per the pharmacy protocol. On 09-SEP-2016, the patient noticed, that her arm was extremely sore, warm and had a red area around the injection site. The following day, the patient reported to the pharmacist that, she could hardly bend her elbow, the elbow was swollen to the point that the normal wrinkles around the elbow could not be seen, the upper arm was swollen, hot to touch, and had a red area about six to six and one half inches in diameter, as well as soreness. The swelling traveled down into the patient's elbow and a little below the elbow on day 2 but that the injection site pain was less noticeable. The patient sought medical attention. The outcome of peripheral swelling, injection site redness and injection site warmth was unknown. The outcome of injection site pain was considered as recovering/resolving, as the pain was less noticeable. The relatedness between the events and PNEUMOVAX 23 was not provided. 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 registered nurse refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL (dose, route, lot# and expiration date were not reported; therapy type: digital data logger). Temperature excursion information was reported as: below 36 Fahrenheit, more than 25 times (unknown by the reporter). No adverse effects were reported. This is one of several reports received from the same reported. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 5 day old female patient. The patient's pertinent medical history and concurrent conditions were not provided. On 19-SEP-2016, the patient was inadvertently vaccinated with VAQTA lot # M009377, expiration date 17-JUN-2017, via intramuscular injection in the right thigh (Drug administered to patient of inappropriate age). No adverse event was reported. At the time of the report, the patient's status was unknown. No product quality complaint was involved. 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 nurse practitioner refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored oral ROTATEQ (lot # L039638, expiry date: 23-AUG-2017 or lot # M007124, expiry date: 05-OCT-2017. No adverse effect were reported. Follow up information was received from the nurse practitioner referring to a patient of unknown age and gender. On 31-AUG-2016, the patient was vaccinated with improperly stored  ROTATEQ, orally, lot # M007124, expiry date: 05-OCT-2017 (strength and dose number were not reported). This is one of the several reports received from the same reporter. Additional information has been requested. Patient, product and narrative were updated.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 09-SEP-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M007764, expiry date: 30-JAN-2018 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. This is one of the 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 medical assistant concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 29-JUL-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX with lot No. L034724 Expiration date: 09-DEC-2016 (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. The temperature was -14 C for 4 days. No data logger and no previous excursions involved. No adverse effects were reported. No Product Quality Complaint (PQC) was involved). This is one of three reports received from the same source. 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 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 history provided. On an unknown date, the patients were vaccinated with a doses of GARDASIL 9 following a temperature excursion (lot # L037554, expiration date: 27-Feb-2017). No apparent adverse effects were reported. The outcome of event was not reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received form a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 10-SEP-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # M007764, expiry date: 30-JAN-2018 (strength, dose, route and anatomical location were not provide). Concomitant therapies were not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified multiple patients with unknown demographics. Information on pertinent medical history, drug reaction/allergies and concomitant medications were not reported. On an unknown date, unspecified multiple patients were administered improperly stored RECOMBIVAX HB (lot# L027733 and expiry date: 13-SEP-2017) on multiple unspecified dates. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 02-SEP-2016, the patient was vaccinated with improperly stored dose of VAQTA lot number reported as: LN749, expiry date: 26-AUG-2018 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. This is one of the 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 was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 15-SEP-2016, the patient was vaccinated with a dose of PROQUAD (dosing details not known) (lot # M011664, expiry date: 08-SEP-2017) that underwent temperature excursions prior to administration. The administered doses experienced a maximum temperature excursion of 24.1 degrees Fahrenheit for 17.75 hours. The excursions happened sometime during the time frame started on an unknown date in May 2016 and ended on 14-SEP-2016. No known adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 08-SEP-2016, the patient was vaccinated with improperly stored dose of VAQTA lot number reported as: LN749, expiry date: 26-AUG-2018 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. This is one of the 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 referring to 2 patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On 15-SEP-2016, the patients were vaccinated with doses of VARIVAX (dosing details not known) (lot # L048465, expiry date: 02-DEC-2017; lot # M009765, expiry date: 23-FEB-2018) that underwent temperature excursions prior to administration. The administered doses experienced a maximum temperature excursion of 24.1 degrees Fahrenheit for 17.75 hours. The dates for the excursions happened sometime during the time frame started on an unknown date in May 2016 and ended on 14-SEP-2016. No known adverse effects were reported. This is one of two 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 was received from a medical assistant regarding unspecified multiple patients with unknown demographics. Information on pertinent medical history, drug reaction/allergies and concomitant medications were not reported. On an unknown date, unspecified multiple patients were administered improperly stored ROTATEQ (lot# M004508 with expiry date: 29-JUN-2017 and lot# M019708 with expiry date: 25-OCT-2017) on multiple unspecified dates. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the 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 registered nurse refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (dose, route, lot# and expiration date were not reported; therapy type: digital data logger). Temperature excursion information was reported as: below 36 Fahrenheit, more than 25 times (unknown by the reporter). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 06-SEP-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M007764, expiry date: 30-JAN-2018 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. This is one of the 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 registered nurse refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, route, lot# and expiration date were not reported; therapy type: digital data logger). Temperature excursion information was reported as: below 36 Fahrenheit, more than 25 times (unknown by the reporter). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions ad medical history were not reported. On an unknown date in October 2013, the patient was vaccinated with the first dose of GARDASIL 9 (lot number, expiration date, routed were not provided). Then, on an unknown date in September, the patient received the second dose of GARDASIL 9. No adverse effect were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 10-SEP-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M007764, expiry date: 30-JAN-2018 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. This is one of the 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 as received from a pharmacist refers to a patient of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On 20-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX (lot # reported as M027117, expiration date 26-JUL-2017, dose and route not reported). No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 3 months old patient. No information regarding the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was provided. On 05-AUG-2016 12:06, the patient was vaccinated with an improperly stored first dose of ROTATEQ lot # L023870 (expiration date and dose were not reported), via oral. It was reported that the vaccine was exposed to a temperature excursion described as a minimum (MIN) of 33 Fahrenheit (F) degrees for 10 minutes and a maximum (MAX) of 48 F degrees for 10 minutes. The medical assistant also stated that the MIN and MAX were not cleared previously. No previous temperature excursion was noted. Patient's concomitant medication was not provided. No adverse effects were reported. A product quality complaint was not involved. This is one of the several reports received from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose and route were unknown, lot # L043214 with expiration date 30-AUG-2017. The vaccines were exposed to temperature of 11 degree centigrade for 1 hour and 22 minutes. The vaccine also had a previous excursion (22.2 degree centigrade for 30 minutes) on unknown date. Data logger was involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On 17-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX (lot # reported as M027117, expiration date 26-JUL-2017, dose and route not reported). No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 08-SEP-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M007764, expiry date: 30-JAN-2018 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. This is one of the 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 refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (dose, route, lot# and expiration date were not reported; therapy type: digital data logger). Temperature excursion information was reported as: below 36 Fahrenheit, more than 25 times (unknown by the reporter). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site pain, Myalgia
Clinical narrative: This spontaneous report received from a physician via company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 intramuscular injection (dose, frequency, lot number and expiry date were not reported). The physician reported that the patient had been experiencing raw muscle aches at the injection site and other sites on the body since an unknown date. At the time of this report, outcome of the events was unknown and their causality assessment was not reported by the physician. There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Antinuclear antibody negative, Blood creatine phosphokinase normal, Culture throat negative, Haematocrit normal, Haemoglobin normal
Clinical narrative: This spontaneous report received from a physician via company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 intramuscular injection (dose, frequency, lot number and expiry date were not reported). The physician reported that the patient had been experiencing raw muscle aches at the injection site and other sites on the body since an unknown date. At the time of this report, outcome of the events was unknown and their causality assessment was not reported by the physician. There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pain, Pain in extremity, Platelet count normal, Red blood cell sedimentation rate increased, Streptococcus test negative
Clinical narrative: This spontaneous report received from a physician via company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 intramuscular injection (dose, frequency, lot number and expiry date were not reported). The physician reported that the patient had been experiencing raw muscle aches at the injection site and other sites on the body since an unknown date. At the time of this report, outcome of the events was unknown and their causality assessment was not reported by the physician. There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: White blood cell count decreased, X-ray normal
Clinical narrative: This spontaneous report received from a physician via company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 intramuscular injection (dose, frequency, lot number and expiry date were not reported). The physician reported that the patient had been experiencing raw muscle aches at the injection site and other sites on the body since an unknown date. At the time of this report, outcome of the events was unknown and their causality assessment was not reported by the physician. There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site pain, Myalgia
Clinical narrative: Well check up 9/8/2016 - GARDASIL #1 given. Routine vaccine. No fever. No illness. Had some subacute impetigo on groin. Began to have pain in arm and less on 9/12. No fever. No visible problems. Pain with movement. Seen on 9/15, 9/17, 9/19. Sx resolved. Sed rate 18, nl CPK, WBC 3000, x-rays nl.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Antinuclear antibody negative, Blood creatine phosphokinase normal, Culture throat negative, Haematocrit normal, Haemoglobin normal
Clinical narrative: Well check up 9/8/2016 - GARDASIL #1 given. Routine vaccine. No fever. No illness. Had some subacute impetigo on groin. Began to have pain in arm and less on 9/12. No fever. No visible problems. Pain with movement. Seen on 9/15, 9/17, 9/19. Sx resolved. Sed rate 18, nl CPK, WBC 3000, x-rays nl.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pain, Pain in extremity, Platelet count normal, Red blood cell sedimentation rate increased, Streptococcus test negative
Clinical narrative: Well check up 9/8/2016 - GARDASIL #1 given. Routine vaccine. No fever. No illness. Had some subacute impetigo on groin. Began to have pain in arm and less on 9/12. No fever. No visible problems. Pain with movement. Seen on 9/15, 9/17, 9/19. Sx resolved. Sed rate 18, nl CPK, WBC 3000, x-rays nl.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: White blood cell count decreased, X-ray normal
Clinical narrative: Well check up 9/8/2016 - GARDASIL #1 given. Routine vaccine. No fever. No illness. Had some subacute impetigo on groin. Began to have pain in arm and less on 9/12. No fever. No visible problems. Pain with movement. Seen on 9/15, 9/17, 9/19. Sx resolved. Sed rate 18, nl CPK, WBC 3000, x-rays nl.