chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARZOS
Symptoms: Pyrexia, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician and refers to his 5 year old daughter. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 18-MAR-2016, the patient was vaccinated with a dose of ZOSTAVAX, intramuscularly, at an unspecified location in the thigh (dose, dosage number, lot # and expiration date were not reported), instead of being vaccinated with VARIVAX (Merck). It was also reported that she received a couple of other unspecified vaccines on the same day. The reporter stated that, on 18-MAR-2016, the patient developed a local reaction which was quite significant and aggressive for 4 or 5 days. The reporter stated that the area of injection had become the "size of a softball with a red wheal area that was warm to touch and tender" (injection site swelling) (injection site erythema) (injection site warmth) (injection site pain). The area itched quite a bit, but the patient did not break out with any type of rash (injection site pruritus). Subsequently, it was reported that, on 19-MAR-2016, she developed a fever of 101.5 F (pyrexia) and was administered ibuprofen for treatment. By 20-MAR-2016, her temperature had decreased back to normal. Following this, the reporter had contacted the patient's physician and sent a picture of the affected injection site area. The physician instructed the reporter to give the patient BENADRYL in order to alleviate the redness and swelling. It was reported that the patient received two doses of BENADRYL on 21-MAR-2016 and within 24 hours, the injection site reaction had drastically improved. Furthermore, the reporter stated that the patient had also experienced a headache (headache) for 5 days and at the time of reporting, she was still complaining of "aching in her feet and ankles" (arthralgia) (pain in extremity) and itching at the injection site. It was also reported that no laboratory diagnostic studies were performed. The patient recovered from pyrexia on 20-MAR-2016 and, at the time of reporting, was recovering from the events of injection site erythema, injection site swelling, injection site warmth and injection site pain. Additionally, she recovered from the headache on an unspecified date in March 2016. However, at the time of reporting, the patient had still not recovered from the pain in extremity, arthralgia and injection site pruritus. The reporter, also, provided no causal relationship between the events and vaccination with ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. Staring on 14-JAN-216 and on unspecified dates after, the patients were vaccinated with improperly stored doses of ROTATEQ (administration routes, lot numbers and expiration dates were not provided). The details of the temperature excursion were as follows: Temperature/time frame: 32.9F for 15 hours and 74.6F for 5 hours. There were no previous temperature excursions. No adverse effects were reported. This is one of two reports from the same reporter. additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. Information about the patients' medical histories and concurrent conditions was not provided. Starting on 14-JAN-2016 and on unspecified dates after, the patients were vaccinated with improperly stored doses of LIQUID PEDVAX HIB (administration routes, lot numbers and expiration dates were not provided). The details of the temperature excursion were as follows: Temperature/time frame: 32.9F for 15 hours and 74.6F for 15 hours. There were no previous temperature excursions. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided. On unknown dates, these patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # L046888, expiry date: 23-NOV-2017; lot # L024253, expiry date: 01-JUL-2017; lot # L039093, expiry date: 06-OCT-2017; lot # L027432, expiry date: 22-JUL-2017). The vaccine underwent a temperature excursion of 21.4 degrees Fahrenheit within the time frame of 24 hours. M-M-R II appeared on the product list, however no doses of the vaccine were administered to the patients. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, RV5
Symptoms: No adverse event, Vaccination error
Clinical narrative: Error found in reports review. Mom reports no adverse effects with phone follow-up. Aware that patient still needs 2 MMRs.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 30-MAR-2016, the patient was vaccinated with improperly stored (Merck) VARIVAX (which had a lot # of L035129 and an expiration date of 14-SEP-2017; however dose, dosage number and route of administration were not reported). The temperature excursion involved was 13F and the time frame of the excursion was 4 hours. However, no adverse effects were reported. Additionally, it was stated that there were no previous temperature excursions. Also, no product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored MMR II (lot number reported as L029266 and expiration date 04-AUG-2017, lot number L003856 and expiration date 05-FEB-2017, dose and route of administration were not reported). Concomitant therapy was not reported. The vaccine was exposed to a temperature of 0.6 Celsius degrees for 12 hours and 28 minutes total cumulative time. There was no previous temperature excursion. It was stated that it was a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored VAQTA (lot number L043209 and expiration date17-SEP-2017, dose and route of administration were not reported). Concomitant therapy was not reported. The vaccine was exposed to a temperature of 0.6 Celsius degrees for 12 hours and 28 minutes total cumulative time. There was no previous temperature excursion. It was stated that it was a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored RECOMBIVAX HB (lot number reported as M001578 and expiration date 21-NOV-2018, lot number L045117 and expiration date 06-OCT-2018, dose and route of administration were not reported). Concomitant therapy was not reported. The vaccine was exposed to a temperature of 0.6 Celsius degrees for 12 hours and 28 minutes total cumulative time. There was no previous temperature excursion. It was stated that it was a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-MAR-2016, the patient was inadvertently vaccinated with expired ROTATEQ (orally, lot # K007246, expiration date 17-MAR-2016, dose was not provided). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding to multiple unspecified number of patients of unknown age and gender. Patient demographics were not reported. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On an unknown dates the patients were vaccinated with improperly stored dose of LIQUID PEDVAX HIB Lot/batch# L038502, expiry date 16-AUG-2018, lot L035878, expiry date 11-AUG-2018 (dose number, route, anatomical location and dose units were not specified), (incorrect product storage). Concomitant medications were not reported. No adverse effects were reported. There was no Product Quality Concerns (PQC) involved. Temperature at which the product was stored was 48 degree Fahrenheit, for 5 minutes. There were no previous temperature excursion reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding multiple unspecified number of patients of unknown age and gender. Patient demographics were not reported. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On an unknown dates the patients were vaccinated with improperly stored dose of MMR II lot L020189, expiry date 03-JUN-2017, Lot L024266, expiry date 01-JUL-2017 (dose number, route, anatomical location and dose units were not specified), (incorrect product storage). Concomitant medications were not reported. No adverse effects were reported. There was no Product Quality Concerns (PQC) involved. Temperature at which the product was stored was 48 degree Fahrenheit, for 5 minutes. There were no previous temperature excursion reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding multiple unspecified number of patients of unknown age and gender. Patient demographics were not reported. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On an unknown dates the patients were vaccinated with improperly stored dose if PNEUMOVAX23 lot K020215, expiry date 15-MAY-2016 (dose number, route, anatomical location and dose units were not specified), (incorrect product storage). Concomitant medications were not reported. No adverse effects were reported. There was no Product Quality Concerns (PQC) involved. Temperature at which the product was stored was 48 degree Fahrenheit, for 5 minutes. There were no previous temperature excursion reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unspecified dates, an unspecified number of patients of were vaccinated with 25 doses of improperly stored GARDASIL lot number: K010215 (expiry date: 05-MAY-2017) and 10 doses of improperly stored GARDASIL lot number: K008931 (expiry date: 04-MAR-2017) (dosage not reported). The vaccine was stored at temperature 53.2F for 6 hours and no previous excursion was reported. No adverse symptoms reported. No Product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unspecified dates, an unspecified number of patients were vaccinated with 57 doses of improperly stored GARDASIL 9 injection lot # L045711 (expiry date: 08-MAY-2017) (dosage not reported). The vaccine was stored at temperature 53.2F for 6 hours and no previous excursion was reported. No adverse symptoms reported. No Product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding multiple unspecified number of patients of unknown age and gender. Patient demographics were not reported. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On unknown dates the patients were vaccinated with improperly stored dose of GARDASIL 9 lot # L044475, expiry date 12-MAY-2017 (dose number, dose units, route and anatomical location were not specified), (incorrect product storage). Concomitant medications were not reported. No adverse effects were reported. There was no Product Quality Concerns (PQC) involved. Temperature at which the product was stored was 48 degree Fahrenheit, for 5 minutes. There were no previous temperature excursion reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On the following below listed dates multiple unspecified patients were vaccinated with improperly stored GARDASIL lot # K014562 expiry date of 08-APR-2017. On 09-FEB-2016 and 13-FEB-2016 the GARDASIL, was exposed to a lowest temperature of + 1.0 degree centigrade for 29 minutes and 30 minutes respectively. On 10-FEB-2016, 11-FEB-2016, 14-FEB-2016 and 16-FEB-2016, GARDASIL, was exposed to a lowest temperature of +1.2 degree centigrade for 25 minutes, 22 minutes, 24 minutes and 34 minutes respectively. On 12-FEB-2016, GARDASIL, was exposed temperature of +1.3 degree centigrade for 21 minutes. On 15-FEB-2016, GARDASIL was exposed to a lowest temperature of +1.1 degree centigrade for 25 minutes. On 17-FEB-2016, GARDASIL, was exposed temperature of +0.0 degree centigrade duration not reported. On 18-FEB-2016 GARDASIL, was exposed to a lowest temperature of -1.0 degree centigrade for 12 hours  29 minutes. On 19-FEB-2016 GARDASIL was exposed to a lowest temperature of -1.1 degree centigrade for 12 hours 1 minute. Also reported that the vaccine was administered on an unspecified date from 20-FEB-2016 to 29-FEB-2016. Dosing details were not provided. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding to multiple unspecified number of patients of unknown age and gender. Patient demographics were not reported. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On an unknown dates the patients were vaccinated with improperly stored dose of ROTATEQ lot # L029618, expiry date 20-MAY-2017 (dose number, route, anatomical location and dose units were not specified), (incorrect product storage). Other suspect therapies included PEDVAX HIB Lot/batch# L038502, expiry date 16-AUG-2018, lot L035878, expiry date 11-AUG-2018 started on unknown dates. Concomitant medications were not reported. No adverse effects were reported. There was no Product Quality Concerns (PQC) involved. Temperature at which the product was stored was 48 degree Fahrenheit, for 5 minutes. There were no previous temperature excursion reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant refers to an unspecified patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 14-MAR-2016, patient was inadvertently administered with ROTATEQ suspension 2, that had been improperly stored, lot # L037921 (expiry date: 31-MAY-2017), orally (dosage not reported). The vaccine was stored at a temperature 30.2F and time frame: cumulative time of 132 hours. No previous temperature excursion was reported. No adverse effects reported. No product quality complaint (PQC) involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant refers to an unspecified patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 11-MAR-2016, patient was inadvertently administered with ROTATEQ suspension 2, that had been improperly stored, lot # L037921 (expiry date: 31-MAY-2017), orally (dosage not reported). The vaccine was stored at a temperature 30.2F and time frame included cumulative time of 132 hours. No previous temperature excursion was reported. No adverse effects reported. No product quality complaint (PQC) involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant refers to 3 unspecified patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 10-MAR-2016, 3 patients were inadvertently administered with ROTATEQ suspension 2, that had been improperly stored, lot # L037921 (expiry date: 31-MAY-2017), orally (dosage not reported). The vaccine was stored at a temperature 30.2F and time frame included cumulative time of 132 hours. No previous temperature excursion was reported. No adverse effects reported. No product quality complaint (PQC) involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant refers to an unspecified patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 14-MAR-2016, patient was inadvertently administered with GARDASIL, that had been improperly stored, lot # K010215 (expiry date: 05-MAY-2017), orally (dosage not reported). The vaccine was stored at a temperature of 30.2F and time frame: cumulative time of 132 hours. No previous temperature excursion was reported. No adverse effects reported. No product quality complaint (PQC) involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and concomitant medications was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # reported as L021655, expiry date 16-JUL-2017 (dose, albumin status, route of administration and anatomical location were not specified). The administered doses of M-M-R II underwent temperature excursion at 49 Fahrenheit degrees for 15 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On the following below listed dates multiple unspecified patients were vaccinated with improperly stored M-M-R II lot # L015280 expiry date of 30-APR-2017 and L012481 expiry date 10-APR-2017. On 09-FEB-2016 and 13-FEB-2016 the M-M-R II, was exposed to a lowest temperature of +1.0 degree centigrade for 29 minutes and 30 minutes respectively. On 10-FEB-2016, 11-FEB-2016, 14-FEB-2016 and 16-FEB-2016, M-M-R II, was exposed to a lowest temperature of +1.2 degree centigrade for 25 minutes, 22 minutes, 24 minutes and 34 minutes respectively. On 12-FEB-2016, M-M-R II, was exposed temperature of +1.3 degree centigrade for 21 minutes. On 15-FEB-2016, M-M-R II, was exposed to a lowest temperature of +1.1 degree centigrade for 25 minutes. On 17-FEB-2016, M-M-R II, was exposed temperature of +0.0 degree centigrade duration not reported. On 18-FEB-2016 M-M-R II, was exposed to a lowest temperature of -1.0 degree centigrade for 12 hours 29 minutes. On 19-FEB-2016 M-M-R II, was exposed to a lowest temperature of -1.1 degree centigrade for 12 hours 1 minute. Also reported that the vaccine was administered on an unspecified date from 20-FEB-2016 to 29-FEB-2016. On an unknown date the patients were vaccinated with improperly stored M-M-R II, lot # L015460 with an expiry date of 20-JUL-2017. Dosing details were not provided. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On the following below listed dates multiple unspecified patients were vaccinated with improperly stored ROTATEQ lot # L027719 expiry date of 28-APR-2017 and L035276 expiry date 09-JUN-2017. On 09-FEB-2016 and 13-FEB-2016 the ROTATEQ, was exposed to a lowest temperature of + 1.0 degree Centigrade for 29 minutes and 30 minutes respectively. On 10-FEB-2016, 11-FEB-2016, 14-FEB-2016 and 16-FEB-2016, ROTATEQ, was exposed to a lowest temperature of + 1.2 degree Centigrade for 25 minutes, 22 minutes, 24 minutes and 34 minutes respectively. On 12-FEB-2016, ROTATEQ, was exposed temperature of + 1.3 degree Centigrade for 21 minutes. On 15-FEB-2016, ROTATEQ, was exposed to a lowest temperature of + 1.1 degree Centigrade for 25 minutes. On 17-FEB-2016, ROTATEQ, was exposed temperature of + 0.0 degree Centigrade duration not reported. On 18-FEB-2016 ROTATEQ, was exposed to a lowest temperature of - 1.0 degree Centigrade for 12 hours 29 minutes. On 19-FEB-2016, ROTATEQ, was exposed to a lowest temperature of - 1.1 degree Centigrade for 12 hours 1 minute. Also reported that the vaccine was administered on an unspecified date from 20-FEB-2016 to 29-FEB-2016. On an unknown date the patients were vaccinated with improperly stored ROTATEQ, lot # L027719 with an expiry date of 09-JUN-2017, (incorrect product storage). Dosing details were not provided. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (dosing details were not reported) lot # L035126 expiry date 14-SEP-2017, which was stored at a temperature of -12.5 degree centigrade for 13 hours 28 minutes. The reporter stated that "VARIVAX (Merck) is considered too warm and unstable". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patients' pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On the following below listed dates multiple unspecified patient were vaccinated with improperly stored VAQTA lot # L039659 expiry date of 15-MAR-2017 and L015460 expiry date 20-JUL-2017,. On 09-FEB-2016 and 13-FEB-2016 the VAQTA, was exposed to a lowest temperature of +1.0 degree centigrade for 29 minutes and 30 minutes respectively. On 10-FEB-2016, 11-FEB-2016, 14-FEB-2016 and 16-FEB-2016, VAQTA, was exposed to a lowest temperature of +1.2 degree centigrade for 25 minutes, 22 minutes, 24 minutes and 34 minutes respectively. On 12-FEB-2016, VAQTA, was exposed temperature of +1.3 degree centigrade for 21 minutes. On 15-FEB-2016, VAQTA, was exposed to a lowest temperature of +1.1 degree centigrade for 25 minutes. On 17-FEB-2016, VAQTA, was exposed temperature of + 0.0 degree centigrade duration not reported. On 18-FEB-2016 VAQTA, was exposed to a lowest temperature of -1.0 degree centigrade for 12 hours 29 minutes. On 19-FEB-2016 VAQTA, was exposed to a lowest temperature of -1-1 degree centigrade for 12 hours 1 minute. Also reported that the vaccine was administered on an unspecified date from 20-FEB-2016 to 29-FEB-2016. On an unknown date the patients were vaccinated with improperly stored VAQTA, lot # L015460 with an expiry date of 20-JUL-2017. Dosing details were not provided. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On the following below listed dates multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB lot # L027733 expiry date of 13-SEP-2017. On 09-FEB-2016 and 13-FEB-2016 the RECOMBIVAX HB, was exposed to a lowest temperature of + 1.0 degree centigrade for 29 minutes and 30 minutes respectively. On 10-FEB-2016, 11-FEB-2016, 14-FEB-2016 and 16-FEB-2016, RECOMBIVAX HB, was exposed to a lowest temperature of + 1.2 degree centigrade for 25 minutes, 22 minutes, 24 minutes and 34 minutes respectively. On 12-FEB-2016, RECOMBIVAX HB, was exposed temperature of +1.3 degree centigrade for 21 minutes. On 15-FEB-2016, RECOMBIVAX HB, was exposed to a lowest temperature of +1.1 degree centigrade for 25 minutes. On 17-FEB-2016, RECOMBIVAX HB, was exposed temperature of +0.0 degree centigrade duration not reported. On 18-FEB-2016, RECOMBIVAX HB, was exposed to a lowest temperature of -1.0 degree centigrade for 12 hour 29 minutes. On 19-FEB-2016, RECOMBIVAX HB, was exposed to a lowest temperature of -1.1 degree centigrade 12 hours 1 minute. Also reported that the vaccine was administered on an unspecified date from 20-FEB-2016 to 29-FEB-2016. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB, lot # L033343 with an expiry date of 13-SEP-2017. Dosing details were not provided. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Myalgia, Neuralgia, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a consumer regarding herself a 58 year old female patient. Hypothyroidism was reported as pertinent medical history. Drug allergies and reactions was reported as none. On an unknown date in November 2014, the patient was vaccinated with ZOSTAVAX dose 1 (1 shot), subcutaneous. Concomitant therapies included SYNTHROID and hormones. On 15-MAR-2016, two weeks ago the patient developed shingles, rash, muscle aches, fever and strong nerve pain. She was given VALTREX for treatment as well as a topical steroid cream for the rash and sought medical attention. Therapy with ZOSTAVAX was not reintroduced. She recovered from the strong nerve pain. The outcome of shingles, rash, muscle aches, fever was reported as resolving. Adverse events improved when patient was on therapy with ZOSTAVAX. Causality between shingles, rash, muscle aches, fever and strong nerve pain and ZOSTAVAX was unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 13 x 8 cm erythematous slightly edematous area at site of DTaP.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haematoma, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old female patient. The medical history, concurrent history and concomitant medications were not reported.The drug reactions and allergies were none. On 01-MAR-2016 the patient was vaccinated with ZOSTAVAX lot # L033311, expiry date 01-DEC-2016 subcutaneous. On 02-MAR-2016, the patient developed redness, soreness, and what patient described to pharmacist as a knot at the injection site (which could not be further clarified). Patient then developed warmth at the injection site on 03-MAR-2016. On an unspecified date "over the weekend (05-MAR-2016-06-MAR-2016) she developed a rash all over her face. The rash does not hurt or itch. She also reported that the patient still had a hematoma at the injection site that developed on 03-MAR-2016 that was "the size of a silver dollar. No treatment was given for the events. No lab tests were performed. The outcome of the events were reported as not recovered/not resolved. The patient sought medical attention. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old female patient. The medical history, concurrent history and concomitant medications were not reported.The drug reactions and allergies were none. On 01-MAR-2016 the patient was vaccinated with ZOSTAVAX lot # L033311, expiry date 01-DEC-2016 subcutaneous. On 02-MAR-2016, the patient developed redness, soreness, and what patient described to pharmacist as a knot at the injection site (which could not be further clarified). Patient then developed warmth at the injection site on 03-MAR-2016. On an unspecified date "over the weekend (05-MAR-2016-06-MAR-2016) she developed a rash all over her face. The rash does not hurt or itch. She also reported that the patient still had a hematoma at the injection site that developed on 03-MAR-2016 that was "the size of a silver dollar. No treatment was given for the events. No lab tests were performed. The outcome of the events were reported as not recovered/not resolved. The patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored ROTATEQ (lot number reported as L038534 and expiration date 19-AUG-2017, lot number L026740 and expiration date 16-APR-2017, orally, dose was not reported). Concomitant therapy was not reported. The vaccine was exposed to a temperature of 0.6 Celsius degrees for 12 hours and 28 minutes total cumulative time. There was no previous temperature excursion. It was stated that it was a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Hepatitis B surface antigen negative
Clinical narrative: Information has been received from the authors of the article. The authors reported that the aim of the study was to assess the rate of adequate immune response to primary hep B vaccination series (manufacturer unknown) in patients with inflammatory bowel disease (IBD). The authors also reported that they performed a retrospective chart review of patients with IBD who had serologic samples tested for hepatitis B surface antigen (HbsAg) and hepatitis B surface antibody (HbsAb) from February 2012 to July 2015. The study was conducted at hospital. Patients up to 22 years of age were included. Adequate immune response to hep B was considered to be present when the HbsAb level was above 8 mIU/mL by our laboratory standard. Age, gender, body mass index (BMI) (presence of obesity), type of IBD, and medications were noted to assess association to these factors with inadequate response to hep B vaccination. HbsAg and HbsAb levels were tested in 98 children with IBD. Mean age of the patients was 16 (+3) years; 37 females and 61 males. Thirty-seven patients had ulcerative colitis and 61 patients had Crohn's disease. None of the patients had a positive HbsAg. This case concerns to 63 (64%) patients of unknown age and gender. The patients' medical history and concomitant therapies were not reported. On an unknown date the patients were vaccinated with hepatitis B vaccine (manufacturer unknown) (dose, dose number, route and anatomical location were unspecified). On an unknown date the 63 patients were found to be non-immune to hep B, with HbsAb level less than 8 mIU/mL (hepatitis B surface antibody negative). The outcome of the hepatitis B surface antibody negative was unknown. The authors considered the hepatitis B surface antibody negative to be related to hepatitis B vaccine (manufacturer unknown). The authors also considered that the immunity to hepatitis B after primary vaccination series is lower in patients with IBD as compared to the known immune response in the general population (64% versus 90% respectively). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # L040414 with exp. 13-APR-2017 (route and dose were not provided). No adverse effects reported. The temperature range was between 36F and 46F and the time frame was reported as worse case scenario 68 hours. It was also stated that the vaccines were not previously exposed to any temperature excursion. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates in December in December 2015, LIQUID PEDVAXHIB lot # L030865 with expiration on 07-JUN-2018 were improperly stored. Then on unspecified dates "about a week after the excursion", the patients were vaccinated with the improperly stored doses of LIQUID PEDVAXHIB (route was not provided). NO adverse effects reported.  Excursion details included: temperature: 10 degree C, time frame: 12 hours. The vaccines did not experience previous temperature excursions before. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: This spontaneous report has been received from a pharmacist via Pfizer (Company number 2016144687) on 14-MAR-2016 concerning a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. On unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (lot #, expiration date, dose, frequency, strength and route of administration were not provided). Concomitant or co-suspect therapies were not provided. On an unspecified date, the patient experienced rash and itching all over after get PNEUMOVAX 23. At the time of this report the action taken with PNEUMOVAX 23 and the outcome of rash and itching all over were not reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Local swelling, Nodule, Pruritus, Skin warm
Clinical narrative: This spontaneous report was received from a 58-year-old female consumer with asthma, blood pressure abnormal and drug reactions or allergy to penicillin. The patient's medical history included thyroidectomy. On 18-MAR-2016, the patient was vaccinated with a dose of ZOSTAVAX in the right arm (dose, route of administration and lot number not reported). Concomitant therapies included SINGULAIR, PROTONIX, LEVOTHROID, vitamins and blood pressure medicines. The reporter stated that on 19-MAR-2016, she developed a red, itchy, swollen and hot spot on the right arm near the injection site. On 20-MAR-2016, the spot on the arm quadruped in size and was bigger than a 50 cent piece. The redness on the arm, which was light red and dark red in color, was spreading all around. The patient had a big knot on the right arm. The area was really hot to the touch and itching. The patient was taking BENADRYL but it was not working. The patient went to the pharmacy. The outcome of the event was reported as not recovered/not resolved. The relationship between vaccination with ZOSTAVAX and the events was not provided. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Local reaction
Clinical narrative: This spontaneous report was received from a 58-year-old female consumer with asthma, blood pressure abnormal and drug reactions or allergy to penicillin. The patient's medical history included thyroidectomy. On 18-MAR-2016, the patient was vaccinated with a dose of ZOSTAVAX in the right arm (dose, route of administration and lot number not reported). Concomitant therapies included SINGULAIR, PROTONIX, LEVOTHROID, vitamins and blood pressure medicines. The reporter stated that on 19-MAR-2016, she developed a red, itchy, swollen and hot spot on the right arm near the injection site. On 20-MAR-2016, the spot on the arm quadruped in size and was bigger than a 50 cent piece. The redness on the arm, which was light red and dark red in color, was spreading all around. The patient had a big knot on the right arm. The area was really hot to the touch and itching. The patient was taking BENADRYL but it was not working. The patient went to the pharmacy. The outcome of the event was reported as not recovered/not resolved. The relationship between vaccination with ZOSTAVAX and the events was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 30-MAR-2016, the patient was vaccinated with improperly stored PROQUAD (which had a lot # reported to be L044057 and an expiration date of 02-MAY-2017; however dose, dosage number and route of administration were not reported). The temperature excursion involved was 13F and the time frame of the excursion was 4 hours. However, no adverse effects were reported. Additionally, it was stated that there were no previous temperature excursions. Also, no product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: 04/05/2016: Follow up information received om 05-APR-2016. Lot number L006805 is an invalid lot number for ROTOTEQ. Additional information has been requested. Narrative was updated.  This spontaneous report as received from a healthcare worker regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 25-MAR-2016, the patient was vaccinated with expired dose of ROTATEQ dose 1, 2 ml, oral, lot number L006805, expiration date- 24-MAR-2016, (expired product administered). No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain at injection site also a small lump - lasted for 4 wks - seen today - resolved.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Swelling and pain at injection site also a small lump - lasted for 4 wks - seen today - resolved.
Age: 0.58
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Injection site erythema, Nodule
Clinical narrative: Redness around site, resolved knot small; no sx vomiting; During < days.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Full blood count normal, Injection site erythema, Injection site warmth
Clinical narrative: Injection of PREVNAR given (L) deltoid on 3/25/16, developed erythema, warmth, evaluated 4/1/16 at Dr's office. Normal CBC. Started cephalexin since no resolving after 1 wk.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: Right deltoid red, warm. Patient w/nausea, weakness, chills. Was seen 72 hrs later. Given Rx for ZOFRAN and Ibuprofen.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Head injury, Syncope
Clinical narrative: Patient receiving MENACTRA and BEXSERO vaccines. MENACTRA administered in the right arm and BEXSERO was administered in the left arm patient fainted hitting the floor. Hitting his head. Was ok and Dr. did exam after.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient received: PNEUMO - VAX 06/09/2009 arm swelling and patient complained that it swelled up like Hercules, not documented in system, believe this was historical and data needed to compete form is not available. PNEUMOVAX 06/19/2015 Patient received this vaccination and had a similar but less severe reaction. He did not seek care, and no permanent damage was done. Documenting this one because there is information regarding the vaccine and the initial injection in 2009 can be seen nationally were the patient ever to transfer to another site.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Blindness, Feeling abnormal, Lethargy, Migraine
Clinical narrative: Migraine after 10 min, couldn't see. Abdominal cramps, then felt crappy, lethargic.
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting projectile
Clinical narrative: This spontaneous report as received from a nurse refers to a 6-week-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 18-MAR-2016, the patient was in the office and was administered the 1st dose in the series of ROTATEQ orally (dose, lot # and expiration date were not reported). On 18-MAR-2016, the patient projectile vomited after being administered only half of the dose of ROTATEQ. At the time of the report, the patient was still in the office. The outcome of the event was not reported. The relatedness between the event and ROTATEQ was not reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Blood test normal, Erythema, Inflammation, Rash generalised, Rash papular
Clinical narrative: Prickly Papular rash first noted on left flank area and knees. The "rash" stayed to those areas for several days then slowly spread all over. There was no redness to her skin for about the first two weeks. Her face, feet, and hands were the last affected areas. Once the papules reached her face, hands, and feet, it became more inflamed and angry red when her skin was irritated/warm/bathed. Her outer thighs were the most dense areas. As of today, her skin is still covered in papules, but do appear to be slowly decreasing in size.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Streptococcus test negative
Clinical narrative: Prickly Papular rash first noted on left flank area and knees. The "rash" stayed to those areas for several days then slowly spread all over. There was no redness to her skin for about the first two weeks. Her face, feet, and hands were the last affected areas. Once the papules reached her face, hands, and feet, it became more inflamed and angry red when her skin was irritated/warm/bathed. Her outer thighs were the most dense areas. As of today, her skin is still covered in papules, but do appear to be slowly decreasing in size.