chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 088-JAN-2016, the patients were vaccinated with improperly stored doses of ROTATEQ orally (dose, lot # and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -1 degrees Celsius for 220 hours. Time frame/date of excursion, from 08-JAN-2016 to 24-MAY-2016. 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 as received from an office administer (also reported as an office manager) refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 11-JUL-2016, the patient was vaccinated with an improperly stored (the call was because of a data logger, lowest reached temperature: 32 Fahrenheit degrees, time frame: 57 hours) dose of GARDASIL 9 lot # M003659 expiration 20-SEP-2017, intramuscular (dose and anatomical location were not reported). 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.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, Incorrect product storage, 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 medical history and concurrent conditions were not reported. On 06-JUL-2016, the patient was inadvertently administered with two doses of PROQUAD, subcutaneously (dose, frequency and lot information were unspecified) that was improperly stored (incorrect product storage), (overdose), (medication error). On 07-JUL-2016, patient again received another dose of PROQUAD. No adverse effect reported. The outcome of the events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 13-JUL-2016 the patient was inadvertently administered an expired dose of ZOSTAVAX (19400 PFU, lot # L006392, expiration date 25-MAY-2016, route not reported. The concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a 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 14-JUL-2016, the patient was administered subcutaneously with a 0.5 ml dose of VARIVAX (lot # reported as L050561, expiration date: 14-DEC-2017) during the temperature excursion. No adverse effects were reported. Product quality complaint was not involved. This is one of the two 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 healthcare professional refers to an unspecified number of patients of unknown demographics. No patients' concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with improperly stored doses of VAQTA 50/1.0 U/ml injection (lot #, expiry date, dose, route and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 34.5 degrees Fahrenheit for 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office administer (also reported as an office manager) refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 11-JUL-2016, the patient was vaccinated with an improperly stored (the call was because of a data logger, lowest reached temperature: 32 Fahrenheit degrees, time frame: 57 hours) dose of ROTATEQ (lot # L039638, expiration date 23-AUG-2017, orally, dose was not reported). 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: HPV4, HPV4, MENB
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. On 20-JUN-2016, the patient was vaccinated with GARDASIL dose 2, 0.5 ml, intramuscular. On 29-JUN-2016, the patient was vaccinated inadvertently with GARDASIL dose 3, 0.5 ml, intramuscular. No adverse effects were reported. 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 physician refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of improperly stored VAQTA (lot # M011116 with expiration date: 17-JUN-2017, dose and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. 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 certified medical assistant refers to an unspecified number of patients of unknown age and gender. NO information regarding the patients' medical history, concurrent conditions or concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (lot # L015279 with expiration date 30-APR-2017, Lot # L024267 with expiration date 01-JUL-2017, and Lot # L027591 with expiration date 23-JUL-2017)(therapy type, dose, route of administration, and anatomical location were not provided). No adverse effect were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 67 year old female patient with diabetes. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, strength and dose not reported), subcutaneous. On approximately 16-JUN-2016 (reported as about 3 weeks ago) the patient developed chickenpox outbreak on an unknown area of the body. Then, the patient called the physician for seeking medical attention and was treated with acyclovir. No lab diagnostics studies were performed. On approximately 30-JUN-2016 (reported as about 1 week ago), the patient was recovered. The pharmacist did not provide the causality between chickenpox outbreak and ZOSTAVAX. Additional information is not expected since the reporter did not wish to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history was not reported. On 21-JUL-2016, the patient was inadvertently administered an expired dose of M-M-R II (lot #, dose, therapy type, route and site of administration were not reported) expiration date 16-JUN-2016. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient received a first dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) (dose, route and site of administration, lot# and expiration date were unknown). On 20-JUN-2016, the patient received the second dose of GARDASIL intramuscularly , lot # M014929, expiration date: 27-MAY-2017 and inadvertently on 29-JUN-2016, the patient received the third dose of GARDASIL intramuscularly, lot # M014929, expiration date: 27-MAY-2017, which was outside of the prescribing information recommendation. There was no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 17-year-old patient of unknown gender. No concurrent conditions or medical history were provided. On 09-JUL-2016, the patient was vaccinated with an adult (1 mL) dose of VAQTA 50/1.0 U/ml injection (lot# reported as M01365, expiry date: 26-MAY-2017; route and site of administration were unspecified). No concomitant medications were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager referring to an unknown number of unspecified patients (age and gender unknown). The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates starting on or after 28-APR-2016, the patients were vaccinated with improperly stored doses of VAQTA (lot # was reported as M017982, expiry date 13-SEP-2017, strength, dose, route and dose number were not provided). The vaccine was exposed to a temperature of 28.6 F for a time frame of 885 hours. There was no previous temperature excursion. "Data logger" was involved. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager referring to an unknown number of unspecified patients (age and gender unknown). The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates starting on or after 28-APR-2016, the patients were vaccinated with improperly stored doses of ROTATEQ (lot# L027719, expiry date 28-APR-2017; lot# L037574, expiry date 01-JUL-2017; lot# M002254, expiry date 15-NOV-2017, strength, dose and dose number were not provided) orally. The vaccine was exposed to a temperature of 28.6 F for a time frame of 885 hours. There was no previous temperature excursion. "Data logger" was involved. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager referring to an unknown number of unspecified patients (age and gender unknown). The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates started on or after 28-APR-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M003659, expiry date 20-SEP-2017, strength, dose, route and dose number were not provided). The vaccine was exposed to a temperature of 28.6 F for a time frame of 885 hours. There was no previous temperature excursion. "Data logger" was involved. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office administer (also reported as an office manager) refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 11-JUL-2016, the patient was vaccinated with an improperly stored dose (the call was because of a data logger, lowest reached temperature: 32 Fahrenheit degrees, time frame: 57 hours) of ROTATEQ lot # L039638 expiration date 23-AUG-2017, orally (dose was not reported). There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information ha been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager referring to an unknown number of unspecified patients (age and gender unknown). The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates starting on or after 28-APR-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L040458, expiry date 04-FEB-2018, strength, dose, route and dose number were not provided). The vaccine was exposed to a temperature of 28.6 F for a time frame of 885 hours. There was no previous temperature excursion. "Data logger" was involved. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant mediations were not reported. On 15-JUL-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot# L001311 with expiration date 06-JUL-2016, once, subcutaneous or intramuscular), which had potency data for 6 months after expiration. No adverse effects were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, 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 medical history and concurrent conditions were not reported. On 01-JUL-2016, the patient was inadvertently administered with PROQUAD, subcutaneously (dose, frequency and lot information were unspecified) that was improperly stored. No adverse effect reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to about 30 unspecified patients of unknown demographics. The patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates unspecified these patients were vaccinated with improperly stored ZOSTAVAX (lot # L017138 and expiration date 13-AUG-2016) (dosing details and anatomical location were unknown). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant regarding unspecified patients of unknown age and gender. The medical history of patients, concurrent conditions and their concomitant medications were not reported. On unspecified dates, unspecified number of patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L042836, expiry date 24-AUG-2018) dosing details unknown. It was reported that the vaccines administered were subjected to temperature excursion of 31.4 Fahrenheit (F) for a time frame of 84 hours. The vaccines were not subjected to any previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Age: 0.55
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 6 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-FEB-2016, the patient was vaccinated with dose of ROTATEQ (orally, lot # L013202; dose and expiration date were not reported) that had experienced a temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.45
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 5 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUN-2016, the patient was vaccinated with the dose of ROTATEQ (orally, lot # L013202; dose and expiration date were not reported) that had experienced a temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Addition information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Onychomycosis
Clinical narrative: This spontaneous report as received from the patient's mother refers to a female patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with the first and the second dose of GARDASIL 9 (dose, route, lot # and expiry date were not reported). Concomitant medications were not reported. On an unknown date (unspecified if after the first or the second dose of vaccine), the patient experienced nail fungal infection on an unspecified toe. The outcome of the event was unknown. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager for a physician vaccine practice via company representative refers to an unknown number of male patients. No concurrent conditions or medical history were reported. On unspecified dates between September 2015 and March 2016, an unspecified number of male patients all under the age of 18 years were inadvertently administered with subcutaneous doses of improperly stored VARIVAX lot# K011182; exp. date: 08-AUG-2016 or K011184; exp date: 16-AUG-2016 (dose not provided). Concomitant therapy was not reported. Office manager could not specify how many patients received vaccine from each lot. No adverse effects or PQC were reported. This is one of two cases from the same reporter (MARRS# 1607USA009540). Additional information is not expected because there is no consent to contact the physician.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from an office manager for a physician vaccine practice via company representative refers to an unknown number of female patients. No concurrent conditions or medical history were reported. On unspecified dates between September 2015 and March 2016, an unspecified number of female patients all under age of 18 years were inadvertently administered with subcutaneous doses of improperly stored VARIVAX lot# K011182; exp. date: 08-AUG-2016 or K011184; exp date: 16-AUG-2016 (dose not provided). Concomitant therapy was not reported. Office Manager could not specify how many patients received vaccine from each lot. No adverse effects or PQC were reported. This is one of two cases from the same reporter (#1607USA009540). Additional information is not expected because there is no consent to contact the physician.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 08-JUL-2016 the patient was vaccinated with improperly stored doses of VAQTA lot # M011116 expiration date 17-JUN-2017. Dose, route and anatomical location were not provided. No other suspect or concomitant medications were reported. Excursion details: cumulative time frame for two excursion between 07-JUL-2016 and 08-JUL-2016, 30.3 Fahrenheit degrees for 7 hours. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. (1607USA009450) Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a currently 71 year old female patient with hypertension and none drug reactions or allergies. On 20-FEB-2014, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, (dose, anatomical location, lot number and expiration date were not reported). The patient's concomitant therapies included FLEXERIL and tramadol hydrochloride. On an unknown dates, the patient had experienced three outbreaks of shingles since receiving ZOSTAVAX. The patient sought medical attention by visiting the physician and was currently being treated with valacyclovir for her current shingles outbreak. At the time of reporting, the patient did not recover from shingles outbreak. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 24 year old female patient. The patient did not have pertinent medical history, drug reactions or allergies. The patient became pregnant with Last Menstrual Period of 06-JUN-2016. On 14-JUN-2016, the patient was vaccinated with her second dose of GARDASIL, intramuscularly, (dose was not provided), lot # was reported as "m02659" with expiration date on 20-SEP-2017. Concomitant therapies included SPRINTEC and cefdinir. On 06-JUL-2016, the patient had a positive urine pregnancy test when she went to visit a health care professional office. The patient did not receive any treatment for the event. The outcome of the positive pregnancy test was reported as not recovered. The Estimated Date of Delivery would be 13-MAR-2017. The relatedness between the positive pregnancy test and therapy with GARDASIL was not stated. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant (also reported as a nurse) refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored dose of GARDASIL 9 (lot # L016428, expiry date 30-JUL-2017, dose and route of administration not reported). No adverse effects were reported. The doses of GARDASIL 9 underwent temperature excursion (48.9 degrees Fahrenheit for 17 days). There was no previous excursions. 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 a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 12-JUL-2016, the patients were orally vaccinated with improperly stored doses of the ROTATEQ (dose, frequency and indication were not reported, lot # L033543 with expiration date 30-MAY-2017; L048854 with expiration date 31-AUG-2017). Concomitant therapy was not reported. No adverse effects was reported. Administered vaccines experienced the temperature excursion of 1.9C for 30 minutes, for a cumulative time out of range of 2 hours, 30 minutes on 12-JUL-2016. Data logger was involved. 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown multiple dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot #K022285, expiry date: 12-NOV-2016, dose and route were not reported). The doses were stored under temperature of 60 F for 3 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.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 3 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-SEP-2015, the patient was vaccinated with the first dose of ROTATEQ (orally, lot # K002991; dose and expiration date were not reported) that had experienced a temperature excursion. On 14-DEC-2015, the patient was vaccinated with the second dose of ROTATEQ (orally, lot # L013202; dose and expiration date were not reported) that had experienced a temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, X-ray
Clinical narrative: This spontaneous report as received from a consumer refers to a 59 year old female patient with hypertension who was reporting on herself. The subject's pertinent medical history included high blood pressure. Concomitant therapies included unspecified high blood pressure medications. The patient had no drug reactions or allergies. On 27-JUN-2016, the patient was vaccinated with the first dose of ZOSTAVAX (dose, lot # and expiration date were not provided) administered via unknown route. On 29-JUN-2016, the patient experienced joint pain, X-ray was performed, no result was reported. The patient sought medical attention through office visit. No treatment was given for this adverse event. The action taken was not applicable. The outcome of joint pain was reported as not recovered/not resolved. The relatedness between the suspect vaccine and the event of joint pain was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were administered improperly stored ROTATEQ (lot # L038536, expiry date 19-AUG-2017, dose not reported), orally. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 12-JUL-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, frequency, route of administration and indication were not reported, lot # L017407 with expiration date 15-AUG-2017; K026246 with expiration date 28-JAN-2017). Concomitant therapy was not reported. No adverse effects was reported. Administered vaccines experienced the temperature excursion of 1.9C for 30 minutes, for a cumulative time out of range of 2 hours, 30 minutes on 12-JUL-2016. Data logger was involved. 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 as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M005714, expiry date 03-OCT-2017, dose and route of administration not reported). No adverse effects were reported. 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 medical assistant and refers to an unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L040415, expiration date: 13-APR-2017) (dose, route of administration and injection site were not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of the two 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown multiple dates, the patients were vaccinated with improperly stored doses of RECOMIVAX HB (lot # L029631, expiry date: 14-AUG-2017; lot # L000717, expiry date: 15-APR-2017, dose and route were not reported). The doses were stored under temperature of 60 F for 3 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.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a health professional via Pfizer refers to a 16 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with HPV vaccine (manufacturer unknown) (strength, dose, route and site of administration, lot # and expiry date were not reported). Other suspect therapies included TRUMENBA, 0.5 ml (strength, route and site of administration, lot # and expiry date were not reported) and MENACTRA (strength, dose, route and site of administration, lot # and expiry date were not reported). On an unknown date, after the use of the vaccines, the patient passed out for a few seconds. The outcome of the event was unknown. The relatedness between the event and the suspect therapies was not provided. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site nodule, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 54 year old female patient. The patient pertinent medical history included asthma and peptic ulcer. The patient was allergic to AVELOX, erythromycin, LEVAQUIN and codeine. On 13-JUL-2016 the patient was inadvertently vaccinated with ZOSTAVAX (Lot M018593, expiry date: 28-JUN-2016) via intramuscular route rather than the recommended subcutaneous route. On 13-JUL-2016, following administration of ZOSTAVAX, the patient experienced a knot, the size of a golf ball appeared at the injection site on an unknown arm and the same unknown arm was described as a sore arm with pain radiating from injection site to top of the shoulder. The outcome of the events was reported as not recovered. The reporter did not provide the causality between the events and the suspect therapy. Additional information had been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of improperly stored PROQUAD lot# reported as M004891 with expiration date: 25-JUL-2017 (dose and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. The patient's  medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of improperly stored GARDASIL 9 lot # M003659, with expiration date 20-SEP-2017, (dose and route of administration not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 21-JUL-2016, the patient was inadvertently administered an expired dose of M-M-R II lot # J014872, expiry date 21-NOV-215 (dose and route of administration were not reported). No adverse effect reported. Additional information is not expected as the reporter refused further contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of improperly stored RECOMBIVAX HB lot # L038018 with expiration date: 13-SEP-2017 (dose and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 12 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2015, the patient was vaccinated with the first dose of ROTATEQ (orally, lot # reported as L000433; dose and expiration date were not reported) that had experienced a temperature excursion. On 14-SEP-2015, the patient was vaccinated with the second dose of ROTATEQ (orally, lot # reported as L000433; dose and expiration date were not reported) that had experienced a temperature excursion. On 14-DEC-2015, the patient was vaccinated with the third dose of ROTATEQ (orally, lot # reported as L000433; dose and expiration date were not reported) that had experienced a temperature excursion. This is one of several reports received from the same reporter. Additional information had been requested.
Age: 0.92
Sex: M
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 11 month old patient of unknown gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 22-APR-2004, 5 days before the patient's first birthday, they were vaccinated with their first dose of M-M-R II (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient, age reported as '18" (units unspecified). The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient had titer for varicella before administration of vaccine. On an unknown date the patient was vaccinated with VARIVAX, 0.5 ml, subcutaneous (lot# and expiry date not reported). Then on and unknown date, the patient developed shingles. The outcome of event was unknown. Causality assessment was not reported. No product quality complain (PQC) involved. 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 certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant medications was reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot# L035276 with expiration date 09-JUN-2017 and lot# L037924 with expiration date 22-JUN-2017 (dose and anatomical location were not provided). No adverse effect were reported. This is one two reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Antibody test abnormal, Decreased immune responsiveness, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On an unknown date the patient was vaccinated with M-M-R II (strength, dosing details, anatomical location, lot# and expiration date were unknown). On an unknown date, following the vaccination, an unknown type of serologic testing was performed to assess the patient's immunity. The test results showed that the patient has low immunity to an unknown component of the vaccine. No adverse effects were reported. The outcome of decreased immune responsiveness was unknown. Causality assessment was not provided. No product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a pharmacist referring to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date the patients was vaccinated with RECOMBIVAX HB. The pharmacist stated that the patients received the second dose in the series of three doses of RECOMBIVAX HB later than the recommended dosing schedule interval on unknown dates, resulting in negative titers on unknown dates. It was unspecified if the patients sought medical attention. The outcome of hepatitis B surface antibody negative was unknown. 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 licensed practitioner nurse refers to a patient of unknown age. On 14-JUL-2016, the patient was vaccinated with a dose of PROQUAD lot # M002053. No adverse effects were reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Rash, Swelling
Clinical narrative: Red skin, rash, swelling and pain. Treatment: patient started BENADRYL and was advised to continue BENADRYL for few more doses and also advised to take ADVIL/Ibuprofen. Feeling a lot better.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 4 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JAN-2016, the patient was vaccinated with the first dose of ROTATEQ (orally, lot # reported as L000433; dose and expiration date were not reported) that had experienced a temperature excursion. On 14-MAR-2016, the patient was vaccinated with the second dose of ROTATEQ (orally, lot # reported as L000433; dose and expiration date were not reported) that had experienced a temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Fever (102) and headache. Tylenol.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Fatigue, Immediate post-injection reaction, Induration, Pain
Clinical narrative: Day one immediate soreness. By day two redness, swollen, by day three swelling spread to entire upper arm, still red, by fourth day swelling decreasing, but still swollen and very hard bump 2-3" in diameter, some fatigue. Took once dose ADVIL Day 2 and Day 3. Not recovered yet. It is day 4 today. Reported to doctor but it's the weekend, so don't know if doctor visit or follow up needed yet.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Peripheral swelling
Clinical narrative: Day one immediate soreness. By day two redness, swollen, by day three swelling spread to entire upper arm, still red, by fourth day swelling decreasing, but still swollen and very hard bump 2-3" in diameter, some fatigue. Took once dose ADVIL Day 2 and Day 3. Not recovered yet. It is day 4 today. Reported to doctor but it's the weekend, so don't know if doctor visit or follow up needed yet.
Age: 11.0
Sex: F
Vaccine: MNQHIB, TDAP
Symptoms: Acupuncture, Anxiety, Depression, Diarrhoea, Inflammation
Clinical narrative: Patient started with diarrhea and nausea on Friday which soon turned into depression, anxiety and panic attacks that she has never experienced before.  It is still ongoing and we are trying to treat her with alternative treatments such as supplements through a nutritionist and accupuncture.
Age: 11.0
Sex: F
Vaccine: MNQHIB, TDAP
Symptoms: Nausea, Panic attack
Clinical narrative: Patient started with diarrhea and nausea on Friday which soon turned into depression, anxiety and panic attacks that she has never experienced before.  It is still ongoing and we are trying to treat her with alternative treatments such as supplements through a nutritionist and accupuncture.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Red, swelling, hardening of the vaccination site starting around 10 days after the vaccine. Thought it was an abscess or infection at first.
Age: 64.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: REDNESS, SWELLING ON LEFT ARM.
Age: 63.0
Sex: M
Vaccine: PNC13, TTOX, VARZOS
Symptoms: Injection site reaction, Skin exfoliation
Clinical narrative: The patient came to the Pharmacy on 07/24/20416 and showed the RPH his left arm where he got vaccinated by the Rph with 2 vaccines at that arm. The vaccines provided were Prevnar and Zostavax. The Rph examined the site and the skin in the front of the muscle and it looked as if the skin had peeled off of the site. The Rph on duty gave patient triple antibiotic to cure it twice a day and gave latex free bandages to cover it. The patient left feeling better.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Pain in extremity
Clinical narrative: The pt received vaccine on 07/21. Today, she said she was experiencing a lot of pain on her arm and there was evidence of redness in the middle of her arm. She has been taking ibuprofen to relieve the pain. She said that she felt the pain a couple of hours after the vaccine but the pain is still going on until now.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Severe dermatological RX of Hives and severe itching on both sides of my face about 12 hours after Hep B vaccine. From employee health office at hospital where I work.  Still current on 07/24/216.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA
Symptoms: Blister, Rash, Skin exfoliation
Clinical narrative: Severe rash around anus, blisters, skin peeling.
Age: 12.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injected limb mobility decreased
Clinical narrative: High Fever, Chills, Fatigue, Headache, Joint Pain, Muscle Pain at injection sight (could not move arm), Muscle pain and joint pain all over body as well. Extremely bad rash around injection sight on upper arm/shoulder area looked like a severe burn. Vomiting the next day along with all the same symptoms listed above.  Symptoms lasted through Saturday 7/2/2016 except fever and vomiting. Fever & vomiting stopped on Thursday 6/30/2016.
Age: 12.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Injection site joint pain, Injection site pain, Injection site rash, Pyrexia, Vomiting
Clinical narrative: High Fever, Chills, Fatigue, Headache, Joint Pain, Muscle Pain at injection sight (could not move arm), Muscle pain and joint pain all over body as well. Extremely bad rash around injection sight on upper arm/shoulder area looked like a severe burn. Vomiting the next day along with all the same symptoms listed above.  Symptoms lasted through Saturday 7/2/2016 except fever and vomiting. Fever & vomiting stopped on Thursday 6/30/2016.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to the patients of unknown ages and genders. The patients' medical histories and concurrent conditions were not reported. On 07-MAY-2016 the patients were administered doses of improperly stored ZOSTAVAX (0.65 ml, lot# M0001745, expiration date 07-APR-2017) subcutaneously. No adverse effects were reported. On 01-JUL-2016, the reporter reported another temperature excursion of ZOSTAVAX (lot# M001745, expiration date 07-APR-2017) after the previous one. The vaccines were improperly stored on 30.6 degree Fahrenheit for 14 hours. No doses were administered after this excursion. Additional information has been requested.