chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, Hepatitis B core antibody negative, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to an adult patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The registered nurse stated that on two separate dates, the patient was inadvertently with the pediatric doses of RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported) and with one adult dose of RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported) on a third unspecified date. No adverse effects were reported. Follow up information has been received from the nurse on 18-FEB-2016, concerning to a 56 year old female patient, other patient's demographics and vaccination information were updated. The patient's concurrent conditions included allergy to adhesives, type 2 diabetes mellitus (DM II), osteoarthritis, peripheral vascular disorder (PVD), hyperlipidaemia, obesity, hypertension (HTN), thrombocytopenia, hepatic cirrhosis, splenomegaly, varices esophageal and peptic ulcer. On 18-JUN-2015 at 3:57 pm, the patient received the first pediatric dose of RECOMBIVAX HB and on 11-AUG-2015 at 11:16 am she received the second pediatric dose of RECOMBIVAX HB (Lot # J005078, expiration date was not reported). Laboratory tests included Hepatitis B surface antibody (also reported as Hb sab) which results was reported as non reactive and Hepatitis B core antibody (also reported as HBC) which results was reported as non reactive, the patient experienced Anti-HBs Antibody Negative. There was no life threatening illness, the patient did not require emergency room or doctor visit, did not require hospitalization, did not result in persistent or significant disability/incapacity and did not require medical or surgical intervention. At the time of the report the outcome of Ant-HBs Antibody Negative was unknown. Additional information is not expected because all correspondence was received. Patient, product, Events and narrative were updated.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 15-OCT-2015, the patient was vaccinated with a dose of improperly stored (incorrect product storage) RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLUX, HEPA, HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an 11 year old male patient. No information regarding the patient's medical history or concurrent conditions was provided. On 18-FEB-2016, the patient was vaccinated with the third dose of GARDASIL 9 injection (lot# and expiry date were not reported), 0.5 ml intramuscularly, as well as with a dose of VAQTA injection (dose, route of administration, lot# and expiry date were not reported) and with an unspecified flu vaccine. There were no concomitant therapies reported. On 18-FEB-2016, reported as today, after getting his third dose of GARDASIL 9, the patient experienced syncope. The patient did not seek medical attention. The outcome of the event was reported as recovered on 18-FEB-2016, reported as today. The relatedness between suspect therapies and the event was not provided. Additional information is not expected as the reporting physician declined any further contact.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative, Body temperature increased, Injection site pain, Screaming, Weight bearing difficulty
Clinical narrative: On 2-15-15 within 3-4 hours of vaccine pain to leg at night temp 99-100. On 2-16-15 temp 102 in AM. Leg pain worse, refused to bear wt screamed when thigh touched at injection site. After last visit pt received PNEUMOVAX in (L) thigh.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: On 2-15-15 within 3-4 hours of vaccine pain to leg at night temp 99-100. On 2-16-15 temp 102 in AM. Leg pain worse, refused to bear wt screamed when thigh touched at injection site. After last visit pt received PNEUMOVAX in (L) thigh.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 15-OCT-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. 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 pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 20-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMIBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports from the same source (original report 1602USA004808). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 28-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot # K010437, expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 04-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot# I011083, expiration date, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date were not provided). During the administration of the vaccine, the ZOSTAVAX leaked out of the "needle or syringe" and the patient received "less than a full dose" of the vaccine (underdose). The outcome of the underdose was unknown. Follow up information has been received on 19-FEB-2016 from unspecified reporter, who stated that the female patient declined to share her personal information. On 18-DEC-2015 at 11:40, during the vaccination with ZOSTAVAX (first dose administered subcutaneously in triceps), the reporter saw that the syringe was defective and majority of the vaccine leaked out. The patient refused revaccination. No adverse reaction reported. Additional information is not expected, all information has already been obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 04-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot# K010437 , expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Simplex virus test positive
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 33 year old female patient. The patient's pertinent medical history and concomitant medications were not reported. On unknown dates, the patient was vaccinated with three doses of GARDASIL (lot #, expiry date, dose, frequency, route of administration and anatomical location were not reported. On an unknown date, the patient had a test for an unspecified reason which showed that the patient was positive for herpes simplex virus 2. The outcome of the adverse event was unknown. The relatedness between the adverse event and GARDASIL was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 29-OCT-2015, the patient was vaccinated with an improperly stored dose (Oka/Merck) VARIVAX injection (lot# K010437, expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 01-FEB-2016 the patient was vaccinated with first dose of improperly stored GARDASIL (lot # K004205, expiry date 12-JAN-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that the GARDASIL experienced a temperature of 32.1 Fahrenheit (F) for a 10 hours time frame. it was also reported that there was no previous temperature excursion, it was also reported that the nurse called to report because of a data logger. No adverse effects were reported. No product quality complaint was reported. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Allergic oedema, Erythema, Swelling
Clinical narrative: This case was reported by a other health professional via other manufacturer and described the occurrence of allergic edema in a 53-year-old female patient who received DTPA vaccine. Co-suspect products included AUGMENTIN unknown for an unknown indication, PHENERGAN for an unknown indication and VIOXX for an unknown indication. Previously administered products included Aspirin (81 mg EC tablet orally daily), CYMBALTA (60 mg capsules orally two times daily), NORCO(10-325 mg per tablet orally every 6 hours as needed for pain), LAMICTAL (200 mg tablet orally twice ad ay) and PRILOSEC (40 mg capsule orally). Concurrent medical conditions included anxiety. Concomitant products included XANAX. On an unknown date, the patient received DTAP vaccine at an unknown dose, AUGMENTIN at an unknown dose and frequency, PHENERGAN at an unknown dose and frequency and VIOXX at an unknown dose and frequency. On an unknown date, an unknown time after receiving DTAP vaccine, AUGMENTIN and PHENERGAN, the patient experienced allergic edema and redness. The action taken with AUGMENTIN was unknown. The action taken with PHENERGAN was unknown. The action taken with VIOXX was unknown. On an unknown date, the outcome of the allergic edema and redness were unknown. It was unknown if the reporter considered the allergic edema and redness to be related to DTAP vaccine and AUGMENTIN. Additional details provided were as follows: On 3rd November 2011, it was reported that, the patient had experienced allergic reactions as swelling and redness after she received AUGMENTI, PHENERGAN and VIOXX (exact start dates of drug administration and event onset were not provided). On 7th November 2011, similar reactions were noted after receiving DTAP vaccine (exact start dates of vaccination and event onset were not provided). On 19th May 2015, the patient started MIRAPEX (0.25 mg tablet) one tablet by mouth in night as needed. On 19th May 2015, the patient also started ZOCOR (20 mg tablet) one tablet by mouth in night. This medication was prescribed to be stopped on 18th May 2016. On 5th October 2015, the patient started NICOTROL inhaler (10 mg per ml) one spray in each nostril 1 to 5 times per hour for 8 weeks maximum was 80 sprays.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications, drug reactions or allergies reported. On an unknown dates in 2016, the patients were vaccinated with an improperly stored doses of PEDVAXHIB (lot# L012835, expiration date 11-MAR-2018; lot# L030867, expiration date 09-JUN-2018; lot# L035878, expiration date 11-AUG-2018, dose, anatomical location and route of administration were not reported). No adverse events were reported. The reporting nurse suspected, that some doses were administered as excursion, which occurred on 29-JAN-2016. Time frame 2 hours and 4 minutes, temperatures 10.3 Celsius degree. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on concurrent conditions, medical history and drug allergies of the patient were not reported. On 10-FEB-2016 the patient started therapy with properly stored expired dose of sterile diluent, lot-1004012, expiry date -08-FEB-2016 with ZOSTAVAX (lot, expiry date, dose, units, route and anatomical location were not reported (expired product administered) (wrong technique in product usage process). Concomitant medication were not reported. On an unknown date the patient experienced no adverse event. 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 pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 16-OCT-2015, the patient was vaccinated with a dose of improperly store RECOMBIVAX HB, lot number L016427, expiration date: 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 12 months old female patient. Information about the patient's medical history and concurrent conditions was not reported. On 02-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 17-OCT-2015, the patient was vaccinated with a dose of improperly store (incorrect product storage) RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route, anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 12 months old male patient. Information about the patient's medical history and concurrent conditions was not reported. On 21-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 12 months old female patient. Information about the patient's medical history and concurrent conditions was not reported. On 13-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all schedule follow up information was received.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 15-FEB-2016, the patient was inadvertently vaccinated with an expired dose of PROQUAD (Merck) injection (lot# K010211, expiry date 17-JAN-2016; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effect was reported. There was no product quality complaint involved. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 12 months old male patient. Information about the patient's medical history and concurrent conditions was not reported. On 30-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 26-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot# K010437, expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. 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 was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 16-OCT-2015, the patient was vaccinated with a dose of improperly store (incorrect product storage) RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not provided). No adverse effects reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 12 months old female patient. Information about the patient's medical history and concurrent conditions was not reported. On 09-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all schedule follow up information was received.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from certified medical assistant (also reported as healthcare worker) refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 17-FEB-2016 the patient was inadvertently vaccinated with expired dose of M-M-R II (dosing details were not reported) lot # K00738 with an expiry date of 16-JAN-2016. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. 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 medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-FEB-2016, the patient was vaccinated with an improperly stored dose in VAQTA (exact dose, route and anatomical location were not reported, lot # L023232, expiration date 25-FEB-2016) immunization series. The administered dose experienced a temperature excursion of 70 degrees Fahrenheit for 37 hours. No adverse effects were reported. 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 pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 21-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours and 5 minutes. This is one of several reports received from the same source (original report 1602USA004808). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Incorrect route of drug administration
Clinical narrative: Information has been received from a registered pharmacist referring to an elderly patient in long-term care. On an unknown date the patient was vaccinated with ZOSTAVAX (1 DF, intramuscularly in an unspecified thigh, lot# and expired date not reported) (inappropriate schedule of vaccine administered, subcutaneous injection formulation administered by other route). The pharmacist had not been informed that the patient experienced an adverse effect. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 16-FEB-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # K002036, expiry date 10-FEB-2016, albumin status rHA, dose and route of administration not reported). No adverse effects were reported. 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 pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 18-OCT-2015, the patient was vaccinated with a dose of improperly stored (incorrect product storage) RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Face injury, Loss of consciousness, Mouth injury, Syncope
Clinical narrative: Information has been received from a female consumer referring to her 12 year old niece. Information about medical history, concurrent condition and concomitant medical was unspecified. On 16-FEB-2016 the patient was vaccinated with her first dose of (a suggested 3 dose regimen) a "HPV vaccine". it was unknown if the patient received GARDASIL or GARDASIL 9 (strength, dosage, frequency and route unspecified). On the same day, the patient felt lightheaded and failed in the doctor's office. The patient sought medical attention as she was in physician's office. The patient also hurt her face and mouth and was unconscious for a few seconds. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: UNK
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of COMVAX lot # J013884 with expiration date of ??-AUG-2016; strength, dosage, frequency and route unspecified). The vaccines were exposure in 30F for 20 hours and 53F for 19 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: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 22-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours and 5 minutes. This is one of several reports received from the same source (original report 1602USA004808). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of patient of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot# L016429 with expiration date of August 2017; strength, dosage, frequency and route unspecified). The vaccines were exposure in 30F for 20 hours and 53F for 19 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: VARCEL
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 unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L034367, exp. 18-SEP-2017, dose and route of administration was unknown). No concomitant therapy was unknown. The vaccine was exposed to an unspecified number of defrost cycles which went up to maximum of 14.7 F. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the two reports from the same reporter link. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to 3 patients of unknown age and gender. No concurrent condition or medical history was reported. On 17-FEB-2016, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L013197, exp. 26-JAN-2017, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 21-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports received from the same source (original report 1602USA004808). 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 nurse refers to 5 patients of unknown age and gender. No concurrent condition or medical history was reported. On 17-FEB-2016, the patients were vaccinated with improperly stored doses of VAQTA (lot # L039569, exp. 15-MAR-2017, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L042817, exp. 26-APR-2017, dose and route of administration was unknown). No concomitant therapy was unknown. The vaccines was exposed to an unspecified number of defrost cycles which went up to maximum of 14.7 F. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the two reports from the same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 17-FEB-2016, the patient was inadvertently vaccinated with expired dose of ZOSTAVAX lot # K020185, expiration date- 27-JAN-2016, (expired product administered). No concomitant medication was reported. 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: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect route of drug administration
Clinical narrative: Information has been received from a nurse practitioner (also reported as physician) via a company representative, referring to a 64 year old male patient. In February 2012 (reported as "4 years ago"), the patient experienced a case of shingles. On 03-FEB-2016 (reported as 2 weeks ago) (therapy start date also reported as "4 years ago"), the patient was vaccinated with his first dose of ZOSTAVAX vial (1 shot; lot# and expiration date not reported) via subdermal route (incorrect route of drug administration). On 03-FEB-2016 (reported as 2 weeks ago), the patient developed a second case of shingles. The patient sought medical attention by paying an office visit and received unspecified antiviral and pain medications as treatment. The outcome of herpes zoster was not reported. Causality between the event herpes zoster and ZOSTAVAX was not reported. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 17-OCT-2015, the patient was vaccinated with a dose of improperly store (incorrect product storage) RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. 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 pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 18-OCT-2015, the patient was vaccinated with a dose of improperly store (incorrect product storage) RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-FEB-2016, the patient was vaccinated with an expired dose of GARDASIL (lot # J013324, expiration date 12-FEB-2016, exact dose and route of administration were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. 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 pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 15-OCT-2015, the patient was vaccinated with a dose of improperly store (incorrect product storage) RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports received from the same source. 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 pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 23-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours and 5 minutes. This is one of several reports received from the same source (original report 1602USA004808). Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 04-APR-2015, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # were not reported). On 14-DEC-2015, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot # were not reported) and on 15-FEB-2016 with the third dose of GARDASIL (dose, route and lot # were not reported), what was off-schedule. There were no symptoms reported. 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 pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 14-OCT-2015, the patient was vaccinated with a dose of improperly store (incorrect product storage) RECOMBIVAX HB, lot number L016427, expiration date: 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site mass, Paraesthesia
Clinical narrative: Small lump at site of injection since administration. Today felt tingling down right arm for a few seconds which resolved an dhas not returned.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 23-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports from the same source (original report 1602USA004808). 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 pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 25-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports received from the same source (original report 1602USA004808). 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 pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 30-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports received from the same source (original report 1602USA004808). 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 pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 31-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports received from the same source (original report 1602USA004808). 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 pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 15-OCT-2015, the patient was vaccinated with a dose of improperly store RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. 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 pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 25-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time from were: .4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports received from the same source (original report 1602USA004808). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On unspecified dates, the patient received the first two doses of GARDASIL (lot numbers and expiration dates were not provided), doses, routes, anatomical locations were not reported, on 18-FEB-2016 the patient was presenting to pharmacist's office to receive the 3rd dose in series with GARDASIL 9. No adverse effect reported. No further information was provided. No product quality complaint was involved. 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 pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 23-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports received from the same source (original report 1602USA004808). 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 pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 13-OCT-2015, the patient was vaccinated with a dose of improperly store RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.8
Sex: M
Vaccine: HIBV
Symptoms: Urticaria
Clinical narrative: Hives on legs, chest, back and arms.