chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JAN-2017, the patient was vaccinated with the improperly stored dose of PROQUAD subcutaneously (dose was not reported) (lot # M031568, expiration date 24-DEC-2017) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion greater than 5 degrees Fahrenheit and less than 14 degrees Fahrenheit (6.1 degrees Fahrenheit) for 41 hours and 20 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA004122: US-009507513-1702USA004127: US-009507513-1702USA004124: US-009507513-1702USA004125: US-009507513-1702USA004126: US-009507513-1702USA001032: US-009507513-1702USA004123: US-009507513-1702USA004176:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JAN-2017, the patient was vaccinated with the improperly stored dose of VARIVAX, subcutaneously (dose was not reported) (lot # M036292, expiration date 17-AUG-2017) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion greater than 5 degrees Fahrenheit and less than 14 degrees Fahrenheit (6.1 degrees Fahrenheit) for 41 hours and 20 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA001032: US-009507513-1702USA004127: US-009507513-1702USA004124: US-009507513-1702USA004125: US-009507513-1702USA004126: US-009507513-1702USA004121: US-009507513-1702USA004123: US-009507513-1702USA004176.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JAN-2017, the patient was vaccinated with the improperly stored dose of VARIVAX, subcutaneously (dose was not reported) (lot # M036292, expiration date 17-AUG-2017) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion greater than 5 degrees Fahrenheit and less than 14 degrees Fahrenheit (6.1 degrees Fahrenheit) for 41 hours and 20 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004122: US-009507513-1702USA004127: US-009507513-1702USA001032: US-009507513-1702USA004125: US-009507513-1702USA004126: US-009507513-1702USA004121: US-009507513-1702USA004123: US-009507513-1702USA004176.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JAN-2017, the patient was vaccinated with the improperly stored dose of VARIVAX, subcutaneously (dose was not reported) (lot # M031568, expiration date 24-DEC-2017) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion greater than 5 degrees Fahrenheit and less than 14 degrees Fahrenheit (6.1 degrees Fahrenheit) for 41 hours and 20 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004122: US-009507513-1702USA004127: US-009507513-1702USA004124: US-009507513-1702USA001032: US-009507513-1702USA004126: US-009507513-1702USA004121: US-009507513-1702USA004123: US-009507513-1702USA004176.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JAN-2017, the patient was vaccinated with the improperly stored dose of VARIVAX, subcutaneously (dose was not reported) (lot # M036292, expiration date 17-AUG-2017) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion greater than 5 degrees Fahrenheit and less than 14 degrees Fahrenheit (6.1 degrees Fahrenheit) for 41 hours and 20 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004122: US-009507513-1702USA004127: US-009507513-1702USA004124: US-009507513-1702USA004125: US-009507513-1702USA001032: US-009507513-1702USA004121: US-009507513-1702USA004123: US-009507513-1702USA004176.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JAN-2017, the patient was vaccinated with the improperly stored dose of VARIVAX, subcutaneously (dose was not reported) (lot # M036292, expiration date 17-AUG-2017) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion greater than 5 degrees Fahrenheit and less than 14 degrees Fahrenheit (6.1 degrees Fahrenheit) for 41 hours and 20 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004176: US-009507513-1702USA004122: US-009507513-1702USA001032: US-009507513-1702USA004124: US-009507513-1702USA004125: US-009507513-1702USA004126: US-009507513-1702USA004121: US-009507513-1702USA004123.
Sex: U
Vaccine: HEP
Symptoms: Immunisation, Therapy non-responder, Vaccination failure
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unknown number of patients (genders and ages not provided).  Information regarding medical history, concurrent conditions or concomitant therapies was not provided. On an unknown date the patients were vaccinated with RECOMBIVAX HB intramuscular injection for prophylaxis (dose, dates, route, application site and lot # were not reported). The reported stated that when the RECOMBIVAX HB vaccine first came out there were so many non-resposonders they realized the vaccine was not effective enough  (vaccination failure ) so anyone who received that original vaccine series needed to be re-vaccinated with the whole series again a year later. The patients' outcome was unknown. The relatedness between the events and RECOMBIVAX HB was unknown. Additional information is not expected as the reporter did not provide consent for follow up.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 22-OCT-2016 to 31-JAN-2017, the patients were vaccinated with improperly stored doses of VAQTA M033611 with expiration date: 02-MAR-2018 (route and dosage schedule were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. The administered vaccines experienced temperature of (48 grades Fahrenheit), more than 46 grades Fahrenheit but less than 77 grades Fahrenheit for 24 hours and on 02-DEC-2016 (33 grades Fahrenheit), between 32 grades Fahrenheit and 36 grades Fahrenheit for 60 hours. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA003016: US-009507513-1702USA004996: US-009507513-1702USA004997.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 22-OCT-2016 to 31-JAN-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot #: L048848 with expiration date: 09-AUG-2018 (route and dosage schedule were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. The administered vaccines experienced temperature of (48 grades Fahrenheit), more than 46 grades Fahrenheit but less than 77 grades Fahrenheit for 24 hours and on 02-DEC-2016 (33 grades Fahrenheit), between 32 grades Fahrenheit and 36 grades Fahrenheit for 60 hours. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA003016: US-009507513-1702USA004995: US-009507513-1702USA004997.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 22-OCT-2016 to 31-JAN-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot #: M018957 with expiration date: 22-NOV-2017 dosage schedule were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. The administered vaccines experienced temperature of (48 grades Fahrenheit), more than 46 grades Fahrenheit but less than 77 grades Fahrenheit for 24 hours and on 02-DEC-2016 (33 grades Fahrenheit), between 32 grades Fahrenheit and 36 grades Fahrenheit for 60 hours. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA003016: US-009507513-1702USA004995: US-009507513-1702USA004996:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and  refers to an unknown number of patients (gender and age unknown). On an unknown date the patient or patients were vaccinated with improperly stored  GARDASIL 9  (dose, route, application site, frequency,  and lot # were not reported) for prophylaxis. There were no adverse effects. The nurse reproted that the GARDASIL 9 was exposed to 0 to 2 °C for 67 hours. The call was due to a data logger. The patient or patients' outcome was unknown. This is one three reports from the same reporting nurse. MARRS 1611USA000874 and 1702USA005000. Additional information has been requested.; Sender's Comments: US-009507513-1611USA000874: US-009507513-1702USA005000:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and  refers to an unknown number of patients (gender and age unknown). On an unknown date the patient or patients were vaccinated with improperly stored  PNEUMOVAX 23 (dose, route, application site, frequency,  and lot # were not reported) for prophylaxis. There were no adverse effects. The nurse reported that the PNEUMOVAX 23 was exposed to 0 to 2 °C for 67 hours. The call was due to a data logger. The patient or patients'  outcome was unknown. This is one three reports from the same reporting nurse. MARRS 1611USA000874 and 1702USA004999 Additional information has been requested.; Sender's Comments: US-009507513-1611USA000874: US-009507513-1702USA004999:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (strength, dose number, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse events reported. No product quality complaint was involved. The vaccines were improperly stored with a temperature of excursion of: 32-36°F (Fahrenheit degrees) for 8 hours and 12 hours respectively. There were no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA005002: US-009507513-1702USA005003: US-009507513-1702USA002890.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (strength, dose number, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse events reported. No product quality complaint was involved. The vaccines were improperly stored with a temperature of excursion of: 32-36°F (Fahrenheit degrees) for 8 hours and 12 hours respectively. There were no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA002890: US-009507513-1702USA005003: US-009507513-1702USA005001:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally (strength, dose number, lot number and expiration date were not provided) for prophylaxis. No adverse events reported. No product quality complaint was involved. The vaccines were improperly stored with a temperature of excursion of: 32-36°F (Fahrenheit degrees) for 8 hours and 12 hours respectively. There were no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA005002: US-009507513-1702USA002890: US-009507513-1702USA005001:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a multiple patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with RECOMBIVAX HB lot # M020926 with an expiration date 11-AUG-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered doses of RECOMBIVAX HB experienced the temperature excursion between 0 and 2 degrees Celsius for 37 hours. A digital data logger was involved. There was no previous temperature excursion. Product quality complaint (PQC) was not reported. This is one two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012078:
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Lymphadenopathy, Peripheral swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A male patient (a retired physician) of unspecified age and race received PREVNAR 13 at single dose via an unspecified route for immunization on unknown date. Medical history and concomitant medication were not reported. On unknown date the patient experienced fever, very red and swollen upper arm and swollen lymph nodes. The outcome of the events was unknown.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Herpes zoster, Injection site reaction, Pain, Pyrexia, Rash vesicular
Clinical narrative: Blistering rash on arm where vaccine was administered, fevers and severe pain.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema and edema on left arm from shoulder to elbow starting approximately 24 hours after receiving Anthrax (5) vaccination. Denies any other symptoms.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Muscle spasms, Peripheral swelling
Clinical narrative: Muscle spasms (at site of inj,+ foot, thigh, facial) painful muscle at injection site(still at day 6)lg area redness below inj site still, arm swollen resolved day 6, at 24 hrs from inj fever 101 w/Tylenol on board, then 99 to 100 degree after day 3 resolved day 6.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Muscle spasms (at site of inj,+ foot, thigh, facial) painful muscle at injection site(still at day 6)lg area redness below inj site still, arm swollen resolved day 6, at 24 hrs from inj fever 101 w/Tylenol on board, then 99 to 100 degree after day 3 resolved day 6.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and 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 GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). The vaccine underwent two separate temperature excursions. In the first excursion the vaccine was exposed to temperature between 46 to 77 degrees Fahrenheit for 4 hours. The second temperature excursion details were unknown. There was no adverse effect reported. Data logger was not involved. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013513: US-009507513-1701USA013514:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and 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 PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported). The vaccine underwent two separate temperature excursions. In the first excursion the vaccine was exposed to temperature between 46 to 77 degrees Fahrenheit for 4 hours. The second temperature excursion details were unknown. There was no adverse effect reported. Data logger was not involved. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact the reporter. Sender's Comments: US-009507513-1701USA013510: US-009507513-1701USA013514.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and 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 orally (dose, lot # and expiration date were not reported). The vaccine underwent two separate temperature excursions. In the first excursion the vaccine was exposed to temperature between 46 to 77 degrees Fahrenheit for 4 hours. The second temperature excursion details were unknown. There was no adverse effect reported. Data logger was not involved. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact the reporter.; Sender's Comments: US-009507513-1701USA013510: US-009507513-1701USA013513:
Sex: U
Vaccine: MMR
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist via other company refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route of administration, lot # and expiration date were not reported).        On an unknown date, 15-20 days after onset of therapy, the patient experienced itching rash. The outcome of the event and the relatedness between the event and M-M-R II were not reported.       Additional information is not expected as there were no healthcare professional contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 27-JAN-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # reported as M023260 with expiration date on 18-AUG-2017) (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced temperature greater than 14 degrees Fahrenheit and less than 46 degrees Fahrenheit for 12 hours. A prior excursion was also reported with the same tmperature aforementioned but for 6 hours. Data logger was involved. No product quality complaint was involved. Lot number M023260 is an invalid lot number for zoster vaccine live. 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 certified medical assistant (CMA) and refers to two patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (lot # M032495, expiry date: 06-JUL-2018). Temperature excursion was over 14 degree of Fahrenheit and under 46 degree of Fahrenheit during 8 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported.  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 nurse practitioner and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JAN-2017, the patient was vaccinated with the improperly stored dose of VARIVAX, subcutaneously (dose was not reported) (lot # M036292, expiration date 17-AUG-2017) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion greater than 5 degrees Fahrenheit and less than 14 degrees Fahrenheit (6.1 degrees Fahrenheit) for 41 hours and 20 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004122: US-009507513-1702USA001032: US-009507513-1702USA004124: US-009507513-1702USA004125: US-009507513-1702USA004126: US-009507513-1702USA004121: US-009507513-1702USA004123: US-009507513-1702USA004127.
Age: 58.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: I had the Flu shot at clinic on Dec. 9, 2016. Vaccine was given at 11:15 and at 4:30 same day my arm was in extreme pain and not able to move it, up or to the side. It has been in pain for 2 months now. I feel like the shot was given too high on my Left arm, up near my shoulder blade.
Sex: U
Vaccine: HEP, MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information had been received on 18-JAN-2017 from a nurse who reported that a patient (age and gender not reported) received M-M-R II (lot# M032157, expiration 01-JUL-2018) on 18-JAN-2017 which was reconstituted with RECOMBIVAX HB 2.5/0.5 (lot# M036153, expiration 31-MAY-2018) as the diluent. No side effects reported. No further information available. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 year old female patient. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On 17-JAN-2017, the patient was vaccinated with a properly stored dose of GARDASIL 9 (lot # M028323, expiration date 26-SEP-2018; dose, route of administration were not reported). No adverse effects were reported. Additional information is not expected because there was no consent to contact physician.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an adult patient of unknown age and gender. There was no information about the patient's pertinent medical history and drug reactions or allergies. On an unknown date, the patient was inadvertently vaccinated with a pediatric dose of RECOMBIVAX HB (lot # L048848, expiration date 09-AUG-2018; exact dose, site and route of administration were not provided). No adverse effect was reported. Additional information is not expected, because there is no consent to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-DEC-2016, the patient was vaccinated with improperly stored dose of VAQTA lot # L002717 with an expiration date 02-JUN-2017, intramuscularly for prophylaxis (dose and anatomical location were not reported). There was no adverse effect reported. The administered dose of VAQTA experienced the temperature excursion from 32 to 36 degrees Fahrenheit for 4 hours. There was no previous temperature excursion. A digital data logger was not involved. Product quality complaint (PQC) was not reported. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an adult patient of unknown gender (exact age was not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JAN-2017, the patient was inadvertently administered with 1 ml of an expired dose of VAQTA 50/1 U/ ml (lot # L048222, expiration date: 19-DEC-2016) (route of administration and injection site were not reported). No adverse effects were reported. Product quality complaint  (PQC) was not involved. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 31-JAN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX with expiration date of 30-DEC-2016 (dose, frequency, route, anatomical location and lot number were not reported) for prophylaxis (expired product administered). No adverse effects were reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient. No concurrent conditions, medical history and concomitant medications were reported. The excursion occurred on 26-SEP-2016 and the vaccine was exposed to a maximum temperature of 11.6 F for 7 hours and 30 minutes and a maximum temperature of 6.2 F for 20 minutes. On 27-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX lot # M020902,expiry date:18-JUL-2017 subcutaneously for prophylaxis. No adverse event was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1609USA012216:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient. No concurrent conditions, medical history and concomitant medications were reported. The excursion occurred on 26-SEP-2016 and the vaccine was exposed to a maximum temperature of 11.6 F for 7 hours and 30 minutes and a maximum temperature of 6.2 F for 20 minutes.  On 27-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX lot # M020902,expiry date:18-JUL-2017 subcutaneously for prophylaxis. No adverse event was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1609USA012216:
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old female patient. No concurrent conditions, medical history and concomitant medications were reported. The excursion occurred on 26-SEP-2016 and the vaccine was exposed to a maximum temperature of 11.6 F for 7 hours and 30 minutes and a maximum temperature of 6.2 F for 20 minutes. On 27-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX lot # M020902,expiry date:18-JUL-2017 subcutaneously for prophylaxis. No adverse event was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1609USA012216:
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 78 year old female patient. No concurrent conditions, medical history and concomitant medications were reported.  The temperature excursion occurred on 26-SEP-2016; the vaccine was exposed to a maximum temperature of 11.6 F for 7 hours and 30 minutes, and a maximum temperature of 6.2 F for 20 minutes. On 28-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX lot # M020902,expiry date:18-JUL-2017 (dosing details was not reported) subcutaneously for prophylaxis. No adverse event was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1609USA012216:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient. No concurrent conditions, medical history and concomitant medications were reported. The temperature excursion occurred on 26-SEP-2016; the vaccine was exposed to a maximum temperature of 11.6 F for 7 hours and 30 minutes, and a maximum temperature of 6.2 F for 20 minutes. On 28-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX lot # M020902,expiry date:18-JUL-2017 (dosing details was not reported) subcutaneously for prophylaxis. No adverse event was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA012216.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year old male patient. No concurrent conditions, medical history and concomitant medications were reported. The temperature excursion occurred on 26-SEP-2016; the vaccine was exposed to a maximum temperature of 11.6 F for 7 hours and 30 minutes, and a maximum temperature of 6.2 F for 20 minutes. On 28-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX lot # M020902,expiry date:18-JUL-2017 (dosing details was not reported)  subcutaneously for prophylaxis. No adverse event was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1609USA012216:
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Swelling to left upper arm noted with associated erythema spanning 13cm x 10cm. Patient complains to pruritis; Benadryl PRN itchiness prescribed.
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Feeling hot, Loss of consciousness, Thirst
Clinical narrative: PATIENT TOLD HER MOTHER SHE WAS DIZZY AND WAS GOING TO PASS OUT. SHE PASSED OUT SECONDS LATER. SHE WAS OUT APPROXIMATELY 3 MINUTES AND "CAME TO". SHE WAS VERY THIRSTY AND STATED "IT IS VERY HOT IN HERE". TEMPERATURE ON THERMOSTAT WAS 72 DEGREES FAHRENHEIT. 911 WAS CALLED WHILE PATIENT WAS UNCONSCIOUS. EMT'S ARRIVED ABOUT 5 MINUTES AFTER THE CALL AND VITALS WERE TAKEN. BLOOD PRESSURE WAS FOUND TO BE 109/80. O2 WAS GOOD. MOTHER REFUSED ANY FURTHER MEDICAL ATTENTION. PATIENT WALKED OUT WITH MINIMAL ASSISTANCE.
Age: 18.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Rash, Vaccination site scab
Clinical narrative: Onset of non vesicular rash 10 days after vaccination on January 30.  Rash on chest, back, bilateral flank area, and thighs. Vaccination site without satellite lesions, scabbed over. Treated with BENADRYL and ZANTAC 150 mg. Follow up today, 13 February 2017, rash resolving, almost completely gone. Back station site still scabbed over with no satellite lesions observed.
Age: 53.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Redness, pain and inflammation at injection site. Patient will go to MD and was given BENADRYL. Vaccine given 2/8; SX noticed 2/11; has gotten worse since then.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia
Clinical narrative: Shot was given in Left shoulder (not arm) slight pain persisted for weeks, could not do any heavy lifting. Pain grew worse at night keeping me form sleep. Tried Icing everyday, BENGAY at night. Hot showers. Pain persisted, now in Therapy.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Vertigo
Clinical narrative: On 2/4/17, began experiencing vertigo (feeling that the room is spinning when she lies down). Cold symptoms, 1 week prior. Meds: JUNEL. Normal exam. Prescribed medicine for vertigo.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Arthralgia, Complement factor C3, Complement factor C4, Full blood count, Pain in extremity
Clinical narrative: Swelling of the hands and feet and rash in the trunk. The patient complained of pain in fingers, wrist, toes and ankles.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Peripheral swelling, Platelet count, Rash, Red blood cell sedimentation rate, Urine analysis
Clinical narrative: Swelling of the hands and feet and rash in the trunk. The patient complained of pain in fingers, wrist, toes and ankles.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Quarter size dark red, itchy spot at site of injection. Slowly itching decreased in intensity. Spot still quarter sized but now light pink as of 2/13/17 and no longer itching.
Age: 1.67
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Urticaria
Clinical narrative: Redness and hives on both arms and legs.
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with her second dose of GARDASIL 9, by intramuscular route, (strength, dose, anatomical location, lot number and expiration date were not reported), for prevent HPV. No other suspect or concomitant therapies were reported. On an unknown date, the patient experienced "hives on her chest" (urticaria). The patient sought medical attention and contacted her physician, however, it was unclear if the patient received any treatment  for her event. No product quality complain was involved. At the time of reporting, the outcome of urticaria was unknown, and, the reporter did not assess the causal relationship between the urticaria and the therapy with GARDASIL 9.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Medical Assistant concerning an unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of M-M-R II (lot number L036851, expiration date 23-SEP-2017, lot number M008588 expiration date 16-FEB-2018, dose and route were not reported) for prophylaxis. The temperature excursion was between 46° F and 77° F for 2 hours and 54 minutes, and between 32° F and 36° F for 17 hours and 42 minutes. It was reported that there was additional excursions but the reporter did not have details. There was no previous excursions involved and a data logger was related. A product qulaity complaint was not involved. Additional information has been requested. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1702USA002297:Original Case : 1702USA002297.
Sex: U
Vaccine: HEP
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender, however, it was reported that the patient was not pregnant. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient had anaphylactic reaction. It was reported that the patient was given epinephrine and sent to emergency room at an unspecified hospital. At the reporting time, the outcome of anaphylactic reaction was unknown. The reporter considered the event of anaphylactic reaction to be related to RECOMBIVAX HB. Upon internal review, the event of anaphylactic reaction was considered to be medically significant. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Blood test, Psychotic disorder
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 14 year old female patient. The patient did not have any relevant medical history or drug reactions/allergy. There were no concomitant medications. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 and at the end of August 2016, the patient received the second dose of the vaccine (dose, frequency route, lot # and expiration date were not reported) for prevention of human papillomavirus (prophylaxis). Approximately in September 2016 (reported as three weeks after administration of the second dose of the vaccine), the patient had a psychotic episode and on an unknown date, some unspecified blood tests revealed possible Lupus. Therefore, the patient had been hospitalized (reported as she was in and out of the hospital) and was scheduled for another hospital visit on approximately 15-FEB-2017 (reported as next week) to confirm her diagnosis. The patient had been in contact with her pediatrician as well as with other several specialists. At the reporting time, the patient had not recovered from the events psychotic disorder and systemic lupus erythematosus. The causality between the aforementioned events and GARDASIL 9 was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 61 year old female patient. Information regarding her pertinent medical history, drug reactions/ allergies and concomitant medications was unknown. On an unknown date in 2016 (reported as "about a year ago"), the patient was vaccinated with ZOSTAVAX for the prevention of shingles (the dose, dosage number, anatomical location, route of administration, lot # and expiration date were unknown). Subsequently, on 01-FEB-2017, the patient experienced an itchy rash around her right eye. She sought medical attention by contacting her physician. The physician was unsure if the itchy rash was shingles or not. An unspecified treatment was nevertheless prescribed for the event. It was unknown if any laboratory diagnostic studies had been performed. The outcome of the event, at the time of reporting, and the causal relationship between the event and the vaccine were unknown. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose normal, Electrocardiogram T wave normal, Electrocardiogram normal, Excessive eye blinking, Loss of consciousness
Clinical narrative: Appox. 2 mins after pt. received a flu vaccine, she became unconscious and unresponsive. Pt was sitting in a chair with her head slumped to the left with her eyes flickering. Pt was still breathing but would not respond. I call for help immediately. Staff came in the room to assist. Pt placed on oxygen via face mask at 10LPM IV 20g started in (R) hand with NS running wide open. EKG and blood glucose started 911 was called for Pt. Pt was alert and oriented when leaving.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Posture abnormal, Unresponsive to stimuli
Clinical narrative: Appox. 2 mins after pt. received a flu vaccine, she became unconscious and unresponsive. Pt was sitting in a chair with her head slumped to the left with her eyes flickering. Pt was still breathing but would not respond. I call for help immediately. Staff came in the room to assist. Pt placed on oxygen via face mask at 10LPM IV 20g started in (R) hand with NS running wide open. EKG and blood glucose started 911 was called for Pt. Pt was alert and oriented when leaving.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Blister, Erythema, Papule, Pyrexia, Rash
Clinical narrative: Rash started 2/10/17: numerous scattered red papules and a few vesicles with erythema; scattered throughout his body. Calamine lotion as needed, TYLENOL for fever.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pain in extremity
Clinical narrative: Pt. started with red, itchy, pain on Saturday 2/11/17 at localized site of reaction. Today Monday the pain is radiating down the arm. Still red.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling on the inside of arm at the elbow.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site urticaria, Injection site warmth
Clinical narrative: Pt presented to Phcy on 02/11/2017 @ 1:25 PM w/ a purple bruise on right deltiod about 1.5 to 2 inches in diameter. About 1.5 to 2 inches bellow the bruise (injection site) were 2 red whelts about 2 inches by 1 inch in size, slighty towards the rear of the arm. The bruise did not touch the welts. The welts were raised and warm to the touch. Pt said her arm "Hurt no more than usual after a shot". Pt took OTC Ibuprofen 400 yesterday and did increase her fluid intake as advised. Pt was NEG for any symptoms involving the mouth, lips, tongue, neck, throat, chest, lungs. Pt was already aware should that occure to call 911. Pt was advised to call us if gets worse.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Patient received a TDAP vaccination on 2-10-17 and noted axillary lymph node swelling on 2-13-17.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, No adverse event, Rubella antibody negative, Seroconversion test negative
Clinical narrative: This spontaneous report was received from a Certified Nurse Practitioner and refers to a 20 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with M-M-R II, dose, frequency, route, anatomical location, lot number and expiration date were not reported), for prophylaxis. On 14-JAN-2017, a blood titer's test was performed to the patient and the patient "failed to seroconvert" (measles antibody negative, rubella antibody negative and mumps antibody test negative).  No adverse events were reported. Product quality complain was not involved. At the time of reporting, the outcome of measles antibody negative, rubella antibody negative and mumps antibody test negative was unknown, and, the reporter did not assess the causal relationship between those events and the therapy with M-M-R II. This is one of several cases from the same patient.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA005671: US-009507513-1702USA005672: