chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a physician refers to a male patient of unknown age. There was no pertinent medical history and there were no drug reactions or allergies reported. On unknown dates the patient was vaccinated with dose 1 and 2 of RECOMBIVACX HB 1 ml, intramuscular (lot number reported as J008227 and expiration date unspecified for dose numbers 1 and 2 in the series. Th patient received the third dose on an unknown date (lot # J008505, expiration date 07-FEB-2016) 1 ml, intramuscular. Thimerosal status of the vaccine was not reported. There were no concomitant medications reported. On an unknown date the patient experienced negative hepatitis B titers. The physician reported that the patient had the titers measured 31 or 32 days after the third dose, and they measured less than 5 which was determined to be negative. No additional symptoms were reported. It was reported that there was no treatment given for the patient. There was no product quality complaint (PQC) involved. The outcome of the event was reported as not recovered. The causality of the event was not provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.53
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13, RV5
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme.
Age: 0.19
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 9 weeks old patient of unknown gender. On 13-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unspecified age and gender. The healthcare worker reported that, on an unknown date, GARDASIL (dose, frequency, route, anatomical location, lot number and exp. date were not reported) that underwent a temperature excursion has been administered to an unspecified amount of patients. No adverse effect was reported. Follow-up information has been received from the medical assistant who provided the patients details. It was reported that the neonate patient of unknown gender, on 13-JUN-2014 (the day of birth) was vaccinated with a dose of GARDASIL lot number H020901, expiration date verified as 05-JUL-2015 (dose, frequency, route, anatomical location not reported) that from 09-JUN-2014 was exposed to temperatures between 29 degrees F and 30 degrees F. This is one of several reports from the same source. Additional information is not expected.
Age: 0.27
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 3 months old patient of unknown gender. On 06-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health department nurse refers to unspecified number of patients. On an unknown date the patients ws vaccinated with improperly stored LIQUID PEDVAXHIB (lot no. and dose no. not reported). No concomitant medication was reported. No adverse effect were reported. Product quality complaint was not reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.84
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 10 months old patient of unknown gender. On 06-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to patients of unspecified age and gender. The medical assistant reported that, on unknown date, VAQTA (dose, frequency, route, lot number and exp. date were not reported) that underwent a temperature excursion has been administered to an unspecified amount of patients. No adverse effect was reported.   Follow-up information has been received from the medical assistant who provided the patients details. It was reported that an approximately 1 year-old patient of unknown gender, on an unspecified date in 2014 was vaccinated with a dose of VAQTA lot number J005010, expiration date 23-OCT-2015 (dose, frequency, route, anatomical location not reported) that from 09-JUN-2014 was exposed to temperatures between 29 degrees F and 30 degrees F. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 22-JUL-2014 the patient was vaccinated with ZOSTAVAX (also reported as ZOSTAVAX Vial 19400 PFU) (lot # K000328, Exp. date: 06-MAR-2015, strength, dose, frequency and route unspecified. In July 2014 the patient experienced injection site reaction. The patient sought medical attention via contacting pharmacist. The outcome of injection site reaction was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 24-JUL-2014 the patient was vaccinated with ZOSTAVAX (also reported as ZOSTAVAX vial 19400 PFU) (lot # K000328, Exp date: 06-MAR-2015, strength, dose, frequency and route unspecified). In July 2014 the patient experienced injection site reaction. The patient sought medical attention via contacting pharmacist. The outcome of injection site reaction was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.16
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 8 weeks old patient of unknown gender. On 09-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unknown number of patients of unknown age and gender. On 16-JUL-2014, improperly stored (Oka/Merck) PROQUAD lot # K004712 (injection, strength, dose, dose number, route and duration were unspecified) were administered to the unknown number of patients. No adverse symptoms reported. No further information provided. The outcome was unknown. This is one of the four reports that received from the same source. Additional information is not expected.
Age: 0.51
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 6 months old patient of unknown gender. On 10-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Activated partial thromboplastin time normal, Petechiae, Platelet count decreased, Prothrombin time normal, Pyrexia
Clinical narrative: Developed petechiae mostly trunk, few on face, thighs and upper extremities - referred to ER. Seen 6/30/14 in office for fever and tonsillitis (exudative) - strep C and S (-).
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Streptococcus test negative, Tonsillitis
Clinical narrative: Developed petechiae mostly trunk, few on face, thighs and upper extremities - referred to ER. Seen 6/30/14 in office for fever and tonsillitis (exudative) - strep C and S (-).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Local reaction
Clinical narrative: Patient developed redness wit area an erythema at 9 am and without an swelling at 5 am w diameter and pain - Erythema decreased in 24 hr but was apparent 2 days later.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Chest X-ray, Dizziness, Wheezing
Clinical narrative: 4 VACCINES GIVEN AT 12:10:  HPV, MCV IN L. DELTOID.  HEP A, TDAP R. DELTOID.  PHONE CALL FROM MOM @ 1500 STATES WENT TO PMD ENROUTE TO ER.  PT. C/O LIGHTHEADED AND WHEEZING.
Age: 0.57
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Developed hive like rash without resp distress. Tx: oral BENADRYL PRN.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient was administered live varicella vaccine on 7/25/14 to her left upper arm. On 8/1/14 patient came in with complaint of a rash on her left side. With presence of dermatome diagnosis is shingles as adverse reaction from varicella vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Anaphylactic reaction, Angiogram, Asthenia, Cough, Diarrhoea
Clinical narrative: Patient left office, had some sneezing and coughing. Was in parking lot became pale - returned to office was pale, started vomiting, alert, lungs CTA, heart reg. Pt then fainted, O2 applied, pulse Ox 98 HR 128 BP 66/38. Pt arousable, answers questions, follows commands. Then slept and transported to ER via ambulance.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Dizziness, Dysphonia, Erythema, Hypotonia, Pallor
Clinical narrative: Patient left office, had some sneezing and coughing. Was in parking lot became pale - returned to office was pale, started vomiting, alert, lungs CTA, heart reg. Pt then fainted, O2 applied, pulse Ox 98 HR 128 BP 66/38. Pt arousable, answers questions, follows commands. Then slept and transported to ER via ambulance.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Rash macular, Retching, Sneezing, Somnolence
Clinical narrative: Patient left office, had some sneezing and coughing. Was in parking lot became pale - returned to office was pale, started vomiting, alert, lungs CTA, heart reg. Pt then fainted, O2 applied, pulse Ox 98 HR 128 BP 66/38. Pt arousable, answers questions, follows commands. Then slept and transported to ER via ambulance.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Syncope, Vomiting
Clinical narrative: Patient left office, had some sneezing and coughing. Was in parking lot became pale - returned to office was pale, started vomiting, alert, lungs CTA, heart reg. Pt then fainted, O2 applied, pulse Ox 98 HR 128 BP 66/38. Pt arousable, answers questions, follows commands. Then slept and transported to ER via ambulance.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Local swelling, Pain in extremity, Pruritus
Clinical narrative: Fatigue. Pain in the arm. Itching. Localized swelling. Localized redness and rash.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Fatigue. Pain in the arm. Itching. Localized swelling. Localized redness and rash.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine give Friday. Pt taken to urgent care Saturday for red, swelling and warmth at injection site. Mother stated roughly 6-7" diameter. Advised to take BENADRYL.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abdominal pain upper, Chills, Erythema, Headache, Local swelling
Clinical narrative: Within 15 to 30 minutes pt was throwing up, Thursday night had to call ambulance to take pt to emergency room. She was nauseous, had stomach pain, headache, muscle cramps, chills, and arm tingling. Pt came in to pharmacy on Sunday 7-27-14 about 5:30pm and arm is still visibly red and swollen.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Muscle spasms, Nausea, Paraesthesia, Vomiting
Clinical narrative: Within 15 to 30 minutes pt was throwing up, Thursday night had to call ambulance to take pt to emergency room. She was nauseous, had stomach pain, headache, muscle cramps, chills, and arm tingling. Pt came in to pharmacy on Sunday 7-27-14 about 5:30pm and arm is still visibly red and swollen.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site rash, Rash
Clinical narrative: Pt received MENACTRA and not long after pt developed a rash at injection site that spread to chest arm and leg, pt was taken to ER required steroids and spread.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Human chorionic gonadotropin
Clinical narrative: Pt received vaccine 6/25/14, PMP LMP 6/10/2014 and Hcg 7/28/14; pt had stopped OCs "after last period"; received GARDASIL at potentially fertile time; pt unaware of potential for effect.
Age: 0.39
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 4 months old patient of unknown gender. On 03-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Bradycardia, Eye movement disorder, Hypovitaminosis, Immediate post-injection reaction, Pallor
Clinical narrative: She had a near syncopal episode immediately following administration with her eyes rolling, her neck falling forward, pale appearance, bradycardia, tonic clonic movements that lasted about 20 seconds total. Postictal state short lived in minutes. No incontinence. Close monitoring for 30 minutes. Water, glucose tablet and monitoring provided.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Postictal state, Posture abnormal, Presyncope, Tonic clonic movements
Clinical narrative: She had a near syncopal episode immediately following administration with her eyes rolling, her neck falling forward, pale appearance, bradycardia, tonic clonic movements that lasted about 20 seconds total. Postictal state short lived in minutes. No incontinence. Close monitoring for 30 minutes. Water, glucose tablet and monitoring provided.
Age: 0.51
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow-up information from the registered nurse who provided patients details. This report refers to a 6 month old infant patient. On 17-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB lot# J016188, expiration date 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient had an unspecified reaction to a "TB test or PPD" at an unspecified time in the past. On 19-JUL-2014 the patient was vaccinated with PNEUMOVAX23 in the left arm (dose, and route were not reported; lot number K004281, expiration date 22-FEB-2015). Concomitant therapies included hydrochlorothiazide (manufacturer unknown); simvastatin (manufacturer unknown), lisinopril (manufacturer unknown) XANAX, ibuprofen, mirtazepine (manufacturer unknown), metoprolol, ATROVENT and amlodipine. On an unspecified date in July 2014 the patient developed redness and swelling of her left arm at the injection site after receiving PNEUMOVAX23 and the events was not reported. The patient had an office visit with an unspecified physician. Additional information has been requested.
Age: 0.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 2 month old infant patient of unknown gender. On 10-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 0.2
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow-up information from the registered nurse who provided patients details. This report refers to a 10 week old infant patient. On 16-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB lot# J016188, expiration date 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 1.22
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 14 month old infant patient. On 09-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unknown number of patients of unknown age and gender. On 16-JUL-2014, improperly stored (Oka-Merck) PROQUAD (injection, strength, lot# dose, dose number, route and duration were unspecified) were administered to the unknown number of patient. No adverse symptoms reported. No further information provided. The outcome was unknown. This is one of the four reports that received from the same source. Additional information is not expected.
Age: 0.77
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow-up information from the registered nurse who provided patients details. This report refers to a 9 months old infant patient. On 12-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB lot number J016188, expiration date 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to patient of unknown age (gender not reported). In December 2013, the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, frequency and indication not reported). On 17-JUL-2014 (today), the patient visited the office and would receive the dose two of RECOMBIVAX HB. No adverse event reported. Additional information has been requested.
Age: 1.59
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 19 month old infant patient. On 09-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 0.81
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 9 months old infant patient. On 09-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Mother reports "dark, red place 9 days later where shot was given." Also describes site as "hard."
Age: 0.56
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 6 months old infant patient. On 25-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. No information about medical history, drug reactions and allergies was specified. Nurse reported that an expired dose of (Oka/Merck) PROQUAD was administered to a patient on 30-JUL-2014 (lot # H020851, expiry date 26-MAY-2014, dose 0.5 milliliter (ml) subcutaneous). No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 2 months old infant patient of unknown gender. On 09-JUN-2014, the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2014) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 1.49
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 17 months old patient of unknown gender. On 06-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to 2 patients of unknown age. No information about medical history, concurrent conditions was reported. Healthcare worker reported that on 25-JUL-2014, two doses of improperly stored (Oka/Merck) PROQUAD, have been administered to two patients (lot# not reported, 0.5 milliliter (ml), subcutaneous). No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This consentaneous report as received from a pharmacist refers to a 60 year old female patient with psoriasis and no drug reactions or allergies. On 21-JUL-2014 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, in the arm, lot # J014810, expiration date: 21-FEB-2015). None concomitant medications were reported. On 21-JUL-2014 the patient developed redness, swelling, pain and itching on her arm at the injection site after receiving ZOSTAVAX. The area of swelling and redness was reported to be 8 cm in diameter. The patient had an appointment with an unspecified dermatologist related to her history of psoriasis (scheduled prior to receiving ZOSTAVAX) who looked at her ZOSTAVAX injection site during that appointment. The patient also came back to the pharmacy to show the pharmacist her arm. There was no treatment given for the adverse event. There was none lab diagnostics studies performed. The outcome of reported adverse events was reported as not recovered. The relatedness between reported adverse events and ZOSTAVAX was not reported.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a Registered Nurse via a company representative refers to a 15 year old female patient. The patients current conditions or medical history were not reported. On an unspecified date the patient was vaccinated with the first and second dose of GARDASIL (dose, route, lot number and expiration date not reported) no adverse effects reported with the first and second dose. On an unknown date in 2014, the patient was vaccinated with the third dose of GARDASIL intramuscular injection, 1 single shot (lot number and expiration date not reported). On 29-JUL-2014, the nurse reported that after receiving the 3rd dose GARDASIL, the patient developed a severe case of  hives. The patient sought medical attention and was treated with BENADRYL (dosages, frequencies, manufacturers unknown). The patient was recovering from severe case of hives at the time of the report. No lab diagnostics were performed. Additional information is not expected as the reporter did not wanted to be contacted.
Age: 19.0
Sex: F
Vaccine: HIBV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a other health professional refers to approximately 19 year old female patient. Patient's medical history and concurrent condition was not reported. On 08-MAY-2014 the patient was vaccinated with LIQUID PEDVAXHIB (dose and frequency unknown) in the left deltoid. On an unknown date approximately in 2014 there were out of range temp logs and the vaccines that have been administered to patients. The outcome of the event was unknown. This is one of the several patients reports received from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Chest discomfort, Dizziness, Lymphadenopathy, Nausea, Neck pain
Clinical narrative: In for third dose of rabies pre-exposure (occupation risk) reports that after second dose she developed (R) side neck pain and swollen glands about 15 min. after #2 vaccination. About an hour (may have been a little sooner) developed nausea, dizziness and chest tightness that lasted 3-4 hours (reports she didn't feel it was a panic attack). Call to local allergist who recommended she be given (first allergy tested) the vaccine under the supervision of an allergist. Client will be setting up appt to do so.
Age: 0.56
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 6 months old patient of unknown gender. On 16-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Age: 0.56
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 6 months old patient of unknown gender. On 12-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health department nurse refers to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot no., dose unknown). No concomitant medication was reported. No adverse effects were reported. Product quality complaint was not reported. The outcome events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 17-JUL-2014 the patient was vaccinated subcutaneously with an expired dose of ZOSTAVAX (dose 0.65ml, lot#J004266, expiration date 12-JUL-2014). No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 28-JUL-2014, the patient was vaccinated with M-M-R II, lot # H012572, expiration date: 29-JUN-2014 (dose, strength and route were not reported).  Secondary and concomitant therapies were not reported. Nurse reported that patient received expired M-M-R II. No adverse symptoms reported.  Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to patients of unspecified age and gender. The medical assistant reported that, on unknown date, VAQTA (dose, frequency, route, lot number and exp. date were not reported) that underwent a temperature excursion has been administered to an unspecified amount of patients. No adverse effect was reported.   Follow-up information has been received from the medical assistant who provided the patients details. It was reported that a patient of unknown gender and age (date of birth reported as 05-JUN-2015), on an unspecified date in 2014 was vaccinated with a dose of VAQTA lot number J005010, expiration date 23-OCT-2014 (dose, frequency route, anatomical location not reported) that from 09-JUN-2014 was exposed to temperatures between 29 degrees F and 30 degrees F. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.11
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 4 weeks old patient of unknown gender. On 10-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.