chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pallor, Peripheral coldness
Clinical narrative: Employee/donor donated 689 ml of plasma and received 500 ml of saline via venipuncture per policy without incident. Donor had TDAP shot administered shortly afterwards and returned to work approx. 15 min. later. Donor soon loss consciousness for approximately 20 sec and regained consciousness by the time medical staff associate arrived to assist. Donor's additional symptoms included: cold extremities, pallor, sweating, anxiety, dizziness/lightheadedness, nausea, and weakness. Initial BP 84/55 and pulse 81 bpm. Donor was given oral fluids (20 oz of powerade) after nausea had subsided, ice packs applied, and fanned donor to alleviate the warmth. Donor recovered quickly after receiving fluids. Vitals at time oral fluids were given was BP 101/69 and pulse 82. At time of release BP 108/81 and pulse 85. Donor left center in satisfactory condition and had no further issues or complaints at this time.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Headache, Muscle spasms, Pain, Pyrexia
Clinical narrative: Patient reported that about 3 hours after receiving vaccine got very achy, muscle cramping, lower back pain, headache, fever or 103*, lasted all night. 11/9 am when she called me her fever was 100.7 without any antipyretic. Reported she was going to see her dr in the afternoon
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Skin induration, Tenderness
Clinical narrative: Significant tenderness, redness and hardened skin beginning within 24 hours of the shot and lasting for 5-6 days.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Tenderness and redness followed up by a significant lump covering the majority of my left upper arm.
Age: 6.0
Sex: F
Vaccine: FLUX, HEPA, MMRV
Symptoms: Abdominal pain upper, Eye disorder, Injection site pain, Lethargy, Restlessness
Clinical narrative: Smile is lax on 1 side of mouth. Soreness by injection site. Lethargic, belly pain, restless. Eyes dull.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness...hot to touch.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Headache, Injection site pain, Pain
Clinical narrative: 13 Hours after injection C/O headache, pain at injection site. Body aches, joint pain. Presented again on 11/9/17 complaining of continuing symptoms. She did not keep an appointment with a physician later in the day on 11/9/17. Student did not answer phone call follow up.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Prolonged left deltoid soreness. Vaccinated on 10/26/17, then seen in office on 11/08/17 reporting left deltoid still sore with most movements with no other known triggers to discomfort other than vaccination.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Autopsy, Hepatomegaly, Splenomegaly, Sudden death
Clinical narrative: She died at 4 days old. Enlarged liver. Enlarged spleen. Labeled it sudden unexplained death.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 20-year-old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On an unknown date, the patient was vaccinated with PROQUAD (strength, dose, route of administration, lot #, expiration date were not reported) for prophylaxis instead of MMR II and VARIVAX. Concomitant therapies included STERILE DILUENT. The nurse confirmed that this event was a result of human error, not product confusion. No adverse event reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unspecified patient (age and gender was not reported). The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date, the patient was vaccinated with a dose of VARIVAX (dose, strength, frequency and anatomical location were not reported) (lot N010107 with expiration date 28-MAR-2019) reconstituted with sterile diluent (unknown lot# and expiration date) and with M-M-R II rHA (dose, strength, frequency and anatomical location were not reported) (lot M039914 with expiration date 26-SEP-2018) reconstituted with sterile diluent (unknown lot # and expiration date) both intramuscularly, for prophylaxis. No adverse effects reported. No further information provided.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse, referring to unspecified number of patients of unknown ages and genders. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown) lot number N008378 with expiration date on 08-JUN-2018. On an unspecified date in 2017, the patients were vaccinated with improperly stored doses of VARIVAX lot number N017397 with expiration date on 07-JUN-2019; lot number M047662 with expiration date on 02-DEC-2018 or lot number M043582 with expiration date on 28-OCT-2018 (anatomical location and administration route were not reported) for prophylaxis. On an unspecified date in 2017, the patients were vaccinated with improperly stored doses of PROQUAD lot number N016993 with expiration date on 29-NOV-2018 or lot number N004631 with expiration date 07-AUG-2018 (anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The VARIVAX and PROQUAD vaccines had a maximum temperature excursion of -9°C to 8°C (7.2°C) during 5 hours 30 minutes, with a cumulative of 7 hours (-14°C to -10°C) and 16 hours 30 min (-9°C to 8°C). It was reported that a digital data logger was involved.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 11-OCT-2017, the patient was vaccinated with the first dose of ZOSTAVAX lot # N021172, reconstituted with sterile diluent, for prophylaxis. Thereafter on 19-OCT-2017, the patient also received a dose of ZOSTAVAX reconstituted with sterile diluent, for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Lip swelling
Clinical narrative: This spontaneous report was received from a consumer and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2016 (reported as about a year ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis (dose, route and site of administration, lot # and expiration date were not reported). On an unknown date, the patient lips swelled. The outcome of the event and the relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) were not reported. This is one of two reports received from the same reporter, who is also a patient.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug allergies/reactions were not provided. On an unspecified date, the patient was vaccinated with an improperly stored doses of PEDVAXHIB lot# reported as: M047666, expiration date: 24-OCT-2019 for prophylaxis (dose, frequency, route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion 32 degree Fahrenheit to 35 degree Fahrenheit for 6 hours. There were no adverse effects reported. There was no previous temperature excursion. Data logger was involved. The outcome were unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 30-MAY-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # M046140 with expiration date on 27-SEP-2019 (dose and route of administration were not reported). Since 25-APR-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 30-MAY-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # M046140 with expiration date on 27-SEP-2019 (dose and route of administration were not reported). Since 25-APR-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Age: 1.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up was received from the physician on 30-OCT-2017, regarding a 16-month-old patient, who on 15-JUL-2017, received a dose of improperly stored PEDVAXHIB injection, lot # N000235 with expiration date on 26-OCT-2019. The vaccine underwent temperature excursion of 34-49 degrees Fahrenheit for 302 hours. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA012766: US-009507513-1709USA007325.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32° degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up was received from the physician on 30-OCT-2017, regarding a 6-month-old patient, who on 15-JUL-2017, received a dose of improperly stored PEDVAXHIB injection, lot # N000235 with expiration date on 26-OCT-2019. The vaccine underwent temperature excursion of 34-49 degrees Fahrenheit for 302 hours. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA012766: US-009507513-1709USA012766.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow up information was received from the physician on 16-OCT-2017. The patient was 6 months old. On 17-MAY-2017, the patient received a dose of improperly stored PEDVAXHIB (lot # M046140). The patient's identifiers and the patient's guardian's identifiers were provided. Sender's Comments: US-009507513-1709USA007325.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 19-MAY-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # M046140 with expiration date on 27-SEP-2019 (dose and route of administration were not reported). Since 25-APR-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Age: 1.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 16 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 24-MAY-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # M046140 with expiration date on 27-SEP-2019 (dose and route of administration were not reported). Since 25-APR-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Age: 1.42
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 17 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 26-MAY-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # M046140 with expiration date on 27-SEP-2019 (dose and route of administration were not reported). Since 25-APR-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Age: 1.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 16 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 27-MAY-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # M046140 with expiration date on 27-SEP-2019 (dose and route of administration were not reported). Since 25-APR-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up was received from the physician on 30-OCT-2017, regarding a 6-month-old patient, who on 25-JUL-2017, received a dose of improperly stored PEDVAXHIB injection, lot # N000235 with expiration date on 26-OCT-2019. The vaccine underwent a temperature excursion of 32-49 degrees Fahrenheit for 428 hours. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA007325: US-009507513-1709USA012766.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided). Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. This is one case from several cases from the same reporter. Follow up information was received from the physician on 16-OCT-2017. The patient was 4 months old. On 08-MAY-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (lot # M046140). The patient's identifiers and the patient's guardian's identifiers were provided. Sender's Comments: US-009507513-1709USA007325.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, (dosage information and route were not informed). It was reported that the lowest temperature was 32 degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from the physician on 16-OCT-2017. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided). It was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. This is one case from several cases from the same reporter. Follow up information was received from the physician on 16-OCT-2017. The patient was 15 months old. On 13-MAY-2017, the patient was vaccinated with a dose of improperly stored dose of PEDVAXHIB (lot # M046140). The patient's identifiers and the patient's guardian's identifiers were provided. Sender's Comments: US-009507513-1709USA007325.
Age: 1.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). It was reported, that the lowest temperature was 32 degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from the physician on 16-OCT-2017. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided). It was reported, that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. This is one case from several cases from the same reporter. Follow up information was received from the physician on 16-OCT-2017. The patient was 16 months old. On 16-MAY-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (lot # M046140). The patient's identifiers and the patient's guardian's identifiers were provided. Sender's Comments: US-009507513-1709USA007325.
Age: 0.75
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 9 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 23-MAY-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # M046140 with expiration date on 27-SEP-2019 (dose and route of administration were not reported). Since 25-APR-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a currently 67 years old female patient refers to herself. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot # and expiry date were not provided). The patient received a letter from her physician's office informing, that the PNEUMOVAX 23 she received, had been improperly stored and it might not be effective for her. No adverse experiences were reported. The outcome of vaccination failure and causality assessment were not provided.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a female licensed practical nurse of unknown age reporting on herself. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 07-NOV-2017, the patient received an expired dose of M-M-R II subcutaneous, lot # L043702, expiration date 03-NOV-2017, for prophylaxis (strength and anatomical location were not reported). No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ with lot # N009962 and expiration date on 15-NOV-2018 (strength, and dose were not provided); administered orally for prophylaxis. The storage temperature of the vaccines was reported as below 32 degrees Fahrenheit (°F) (24°F to 31.6°F) for an unspecified time frame. There was a previous temperature excursion of 31°F or colder (23.7°F) for 45 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Decreased immune responsiveness, Herpes zoster, Insomnia, Pain
Clinical narrative: Information has been received on 06-NOV-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown), subcutaneous on or about 19-MAY-2009 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-OCT-2015, the patient was treated at an urgency care facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as severe herpes zoster or shingles. On or about 13-OCT-2015, the patient sought subsequent treatment by a physician for continued and ongoing symptoms of shingles causing exceptional pain and insomnia. On or about 22-OCT-2015, the patient was treated again by the same physician for new and worsening symptoms of shingles outbreaks in the L1 dermatome with persistent burning sensation radiating throughout the leg, thigh and buttock. On or about 16-NOV-2015, the patient received subsequent treatment from a physician for ongoing painful symptoms, at which time she was diagnosed with post-herpetic neuralgia, a chronic condition of nerve pain and damage caused secondary to zoster infections. The patient has been prescribed VALTREX, Prednisone, Tramadol, Gabapentin, and Nortriptyline for management of her persistent and painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received on 06-NOV-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown), subcutaneous on or about 19-MAY-2009 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-OCT-2015, the patient was treated at an urgency care facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as severe herpes zoster or shingles. On or about 13-OCT-2015, the patient sought subsequent treatment by a physician for continued and ongoing symptoms of shingles causing exceptional pain and insomnia. On or about 22-OCT-2015, the patient was treated again by the same physician for new and worsening symptoms of shingles outbreaks in the L1 dermatome with persistent burning sensation radiating throughout the leg, thigh and buttock. On or about 16-NOV-2015, the patient received subsequent treatment from a physician for ongoing painful symptoms, at which time she was diagnosed with post-herpetic neuralgia, a chronic condition of nerve pain and damage caused secondary to zoster infections. The patient has been prescribed VALTREX, Prednisone, Tramadol, Gabapentin, and Nortriptyline for management of her persistent and painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 06-NOV-2017 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 14-JAN-2014, the patient was inoculated (by an unspecified person) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-NOV-2016, she was treated (by an unspecified healthcare professional) at a medical center (facility) for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient sought subsequent treatment for ongoing and worsening symptoms, where she received a second diagnosis of new shingles outbreaks (Date not reported). The female patient has been prescribed VALTREX for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 06-NOV-2017 from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  Medical history, concurrent conditions, and concomitant medications were not provided. On or about 07-JUL-2015, the patient was inoculated (by an unspecified person) at a pharmacy with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 24-JUL-2015, he was treated by a physician (at an unspecified facility) for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 26-SEP-2015, the patient sought subsequent treatment from a female registered nurse at a Medical Center for ongoing and worsening outbreaks of shingles. The male patient has been prescribed Acyclovir, triamcinolone cream and Neomycin-Bacitracin Polymyxin for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Age: 21.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 21 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # M036059 and expiration date 03-JUN-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # M036059. On 11-MAY-2017 at 12:24, the time in the range 32° Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009229 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009229 is being deleted from our files and the case is consolidated into case # 1711USA004082 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 21.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 21 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # M036059 and expiration date 03-JUN-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # M036059. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009230 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009230 is being deleted from our files and the case is consolidated into case # 1711USA004084 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 47.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 47 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB with lot # reported as M046376 and expiration date 04-NOV-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Lot number M046376 is an invalid lot number for hepatitis b vaccine (recombinant). Follow up information was received on 18-SEP-2017 from the medical assistant, concerning RECOMBIVAX HB with lot # reported as M046376. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009238 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009238 is being deleted from our files and the case is consolidated into case # 1711USA004087 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 29.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 29 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB with lot # reported as M046376 and expiration date 04-NOV-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Lot number M046376 is an invalid lot number for hepatitis b vaccine (recombinant). Follow up information was received on 18-SEP-2017 from the medical assistant, concerning RECOMBIVAX HB with lot # reported as M046376. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009239 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009239 is being deleted from our files and the case is consolidated into case # 1711USA004090 with the correct Aware Date 18-SEP-2017.; Sender's Comments:  US-009507513-1708USA011654: