chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Local reaction, Pain, Pyrexia, Vaccination site reaction
Clinical narrative: Initial information received from another manufacturer (service request number 1-7327089847) on 03 June 2013. The information was originally provided to the other manufacturer from a healthcare professional (pharmacist). A 58-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of Tdap vaccine (unknown manufacturer) (batch number, dose number, route and anatomical site of administration were not reported) on an unspecified date. It was reported that, the patient had experienced a bad reaction to vaccine within the last 6 months. The pharmacist reported the patient had a fever over 103 degrees Fahrenheit, body aches lasted for 3 days and a local reaction of size of an orange at vaccination site. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of events was not reported. Follow-up information received from a healthcare professional on 12 July 2013: The patient had recovered from the events on an unspecified date. Documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Bronchial hyperreactivity, Cough, Decreased appetite, Pharyngitis streptococcal, Pneumonia
Clinical narrative: Initial report received from a healthcare professional on 22 May 2013. A 12-year-old male patient had received an intramuscular first dose of MENACTRA (batch number U4284AA) in right deltoid, and an intramuscular first dose of ADACEL (batch number C4149AA) in left deltoid, both on 13 May 2013. The patient had no known allergies and no illness at the time of vaccination. The patient's concomitant medications were not reported. On 16 May 2013, 3 days after vaccination, the patient presented low-grade fever, decreased appetite, coughing and wheezing with abnormal sleeping related to coughing. Laboratory tests and corrective medications were not reported. The patient was seen by the physician on 22 May 2013. At the time of this report, the patient had not recovered from the event. Follow-up information was received on 01 July 2013 from a health care professional. The patient was diagnosed on 22 May 2013 with pneumonia, pharyngitis strep and reactive airway. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information received from a healthcare professional on 26 July 2013: The outcome of the events was unknown at the time of this report. Documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia, Sleep disorder, Wheezing
Clinical narrative: Initial report received from a healthcare professional on 22 May 2013. A 12-year-old male patient had received an intramuscular first dose of MENACTRA (batch number U4284AA) in right deltoid, and an intramuscular first dose of ADACEL (batch number C4149AA) in left deltoid, both on 13 May 2013. The patient had no known allergies and no illness at the time of vaccination. The patient's concomitant medications were not reported. On 16 May 2013, 3 days after vaccination, the patient presented low-grade fever, decreased appetite, coughing and wheezing with abnormal sleeping related to coughing. Laboratory tests and corrective medications were not reported. The patient was seen by the physician on 22 May 2013. At the time of this report, the patient had not recovered from the event. Follow-up information was received on 01 July 2013 from a health care professional. The patient was diagnosed on 22 May 2013 with pneumonia, pharyngitis strep and reactive airway. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information received from a healthcare professional on 26 July 2013: The outcome of the events was unknown at the time of this report. Documents held by sender: none.
Age: 21.0
Sex: U
Vaccine: DTAPIPVHIB, TDAP
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 12 February 2014. A 21-year-old patient had received PENTACEL instead of ADACEL on unspecified date. On same day ADACEL was also administered. Wrong vaccine was administered to the patient and it was overdose. No adverse event was reported. List of documents held by sender: None.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 16-JUL-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # H0188796 and expiry date: 24-OCT-2014) which was improperly stored. Primary reporter was reporting excursion o 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports 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 licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 01-APR-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J011828 and expiry date: 26-DEC-2014, reported as 16-DEC-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported ZOSTAVAX. This is one of the several reports 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 licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 25-SEP-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J00456 and expiry date: 15-DEC-2014) which was improperly  stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several repots 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 licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 22-NOV-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J006831 and expiry date: 14-SEP-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 03-APR-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J004159 and expiry date: 08-APR-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 31-JAN-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J002618 and expiry date: 01-MAR-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 19-DEC-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J002618 and expiry date: 01-MAR-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 27-JUN-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J00141 and expiry date: 04-JUL-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports 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 licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 24-SEP-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J001700 and expiry date: 08-MAY-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Information has been received from agency regarding an incident that occurred at a store regarding a female patient who sustained a reaction to her left arm after receiving ZOSTAVAX vaccine on 30-DEC-2014. No further information was provided. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist via field employee refers approximately 60 year old male (reported as in his sixties) immunocompromised patient. Patient medical history and other current condition was not reported. Approximately in NOVEMBER-2014 (reported as in the month of November) the patient was vaccinated with ZOSTAVAX Vial for prevention of shingles. Other co-suspects and concomitant medication was not reported. On an unknown date the patient experienced rash. It was reported that the patient sought treatment (no details were provided) reported as seen in the office. Cancer and overdose was not reported. Product quality complaint was not reported. The outcome of rash was reported as recovering/resolving. Causality assessment was not provided by the 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 licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 21-DEC-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # K011004 and expiry date: 07-NOV-2015) which was improving stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of-58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a unknown number of patients of unknown demographics. On 27-JAN-2015 the patients were inadvertently administered VARIVAX (Merck) (dose, route and lot # not reported) that had been improperly stored. No adverse effects were reported. Additional information has been requested.
Age: 1.51
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Ear infection, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 18 month old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 09-JAN-2015 the patient was vaccinated with M-M-R II (lot number: K008814 with expiry date of 19-JUN-2016), (0.5 ml, once) and VARIVAX (Merck) (lot number: K010438 with expiry date of 22-JUL-2016) (0.5 ml, once), both subcutaneously. Concomitant medications were not reported. On 11-JAN-2015, 3 days after onset of therapy the patient experienced pink maculopapular rash from the groin to the abdomen and an ear infection. No treatment was given for the adverse events. The patient sought medical attention by visiting to the office. The outcome of rash maculopapular and ear infection was reported as not recovered/not resolved. The causality of the events with VARIVAX (Merck) and M-M-R II was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender. Medical histories and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB (administration routes, lot number and expiration dates were not provided). No concomitant medications were reported, neither was any adverse effect. This is one of two reports from teh 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 licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 04-FEB-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J008433 and expiry date: 11-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall support ranged of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Vulvovaginal rash
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a non pregnant female patient of unknown age. On 05-AUG-2014 the patient was vaccinated with first dose of GARDASIL (0.5 ml, intramuscularly). On 22-SEP-2014, the patient experienced unspecified vaginal rash located on her labia. The patient was seen in an unspecified emergency room on 22-SEP-2014 and had unspecified labs drawn which resulted negative (exact date was not provided). The patient was not admitted to the hospital and was told to follow-up with her unspecified gynecologist. It was also reported that the patient was seen on 23-OCT-2014 by nurse practitioner. The outcome of unspecified vaginal rash was unknown. The relatedness between unspecified vaginal rash and vaccination with GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender. Medical histories and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (route, lot numbers and expiration dates were not provided). No concomitant medications were reported, neither was any adverse effect. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown dates (reported as since 01-DEC-2014), unspecified patients were vaccinated with GARDASIL (lot number, dose, frequency and route unspecified) that was exposed to a supported temperature excursion (incorrect product storage) on 01-DEC-2014. No adverse effect (no adverse event) have been reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. This is one of the several reports from the same reporter. Additional information has been reuqested.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Eye infection, Injection site discolouration, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: 1) Injection site red, hot, itchy, hard (size 2 inch x 1 inch big) with brown color. Lasted x2 weeks post vaccination. 2) Left eye infection (granulomatous uveitis, per doctor). Pt first noticed 12/19/14, diagnosed on 12/22/14. Treated with Valtrex 1gm, homatropine eyedrops, timolol eye drops, DUREZOL eyedrops.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Uveitis
Clinical narrative: 1) Injection site red, hot, itchy, hard (size 2 inch x 1 inch big) with brown color. Lasted x2 weeks post vaccination. 2) Left eye infection (granulomatous uveitis, per doctor). Pt first noticed 12/19/14, diagnosed on 12/22/14. Treated with Valtrex 1gm, homatropine eyedrops, timolol eye drops, DUREZOL eyedrops.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 06-AUG-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # H015630 and expiry date: 21-FEB-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old male patient. Medical history and concurrent conditions were not reported. On 13-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX to prevent shingles (route, lot number and expiration date were not provided). Concomitant therapies included acetaminophen, NORCO and finasteride. On an unknown date approximately in January 2015, the patient was prescribed methotrexate and PLAQUENIL for arthritis. The patient contacted the pharmacist concerning the event. The outcome of arthritis was unknown. 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 nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with single doses of ZOSTAVAX injection (strength, dose, route of administration, lot# and expiry date unspecified), post both supported and not supported temperature excursions. No concomitant medications were reported. No patient had reported experiencing an adverse effect due to receipt of vaccination post temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a medical assistant via agency referring to a 7 year old female patient. The patient had no relevant medical history, past drug history or concomitant medications. On 14-JAN-2015, the patient was vaccinated with a dose of with PROQUAD (Merck), lot # K007798, expiration date 29-NOV-2015, 0.5 ml, subcutaneous for her history and physical appointment, that had undergone a temperature excursion. The excursion that occurred was at 23 degrees Fahrenheit for up to 2.5 weeks. The patient's relevant laboratory data was unknown. As of 16-JAN-2015, it was unknown if the patient continued on the PROQUAD (Merck) vaccine and the outcome of receiving the PROQUAD (Merck) vaccine that had undergone excursion was unknown. This is one of several report 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 worker refers to unspecified patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown dates (reported as since 01-DEC-2014), unspecified patients were vaccinated with VAQTA (lot number, dose, frequency and route unspecified) that was exposed to a supported temperature excursion on 01-DEC-2014. No adverse effect have been reported. The outcome of the events was unknown. The causality of the events with VAQTA was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown dates (reported as since 01-DEC-2014), unspecified patients were vaccinated with ROTATEQ (lot number, dose, frequency and route unspecified) that was exposed to a supported temperature excursion on 01-DEC-2014. No adverse effect have been reported. The outcome of the events was unknown. The causality of the events with ROTATEQ was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with doses of GARDASIL (dose, route, lot numbers and expiration dates were not provided), that were improperly stored. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown dates (reported as since 01-DEC-2014), unspecified patients were vaccinated with RECOMBIVAX HB (lot number, dose, frequency and route unspecified) that was exposed to a supported temperature excursion on 01-DEC-2014. No adverse effect have been reported. The outcome of the events was unknown. The causality of the events with RECOMBIVAX HB was not reporter. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large erythematous warm patch at the site of injection.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, 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. On an unknown dates the patients were vaccinated with VAQTA (dose, route, lot numbers and expiration dates were not provided), that were improperly stored. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with doses of RECOMBIVAX HB (dose, route, lot numbers and expiration dates were not provided), that were improperly stored. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with single doses of RECOMBIVAX HB injection (strength, dose, route of administration, lot# and expiry date unspecified), post both supported and not supported temperature excursions. No concomitant medications were reported. No patient had reported experiencing an adverse effect due to receipt of vaccination post temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to 15 unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, route, lot # were not reported) which were exposed to 25.7F for 6 hours and 25 minutes. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with single doses of MMR II injection (strength, dose, route of administration, lot# and expiry date unspecified), post both supported and not supported temperature excursions. No concomitant medications were not reported. No patient had reporting experiencing an adverse effect due to receipt of vaccination post temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vacicnated with single doses of GARDASIL injection (strength, dose, route of administration, lot# and expiry date unspecified), post both supported and not supported temperature excursions. No concoitant medications were reported. No patient had reported experiencing an adverse effect due to receipt of vacination post temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
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 demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with single doses of PNEUMOVAX 23 injection (strength, dose, route of administration, lot# and expiry date unspecified), post both supported and not supported temperature excursions. No concomitant medications were reported. No patient had reported experiencing an adverse effect due to receipt of vaccination post temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with single doses of VARIVAX (Merck) 0.5 ml injected subcutaneously (strength, dose, lot# and expiry date unspecified), post both supported and not supported temperature excursions. No concomitant medications were reported. No adverse effects were reported. No patient had reported experiencing an adverse effect due to receipt of vaccination post temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 26-JAN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL, 0.5 ml, intramuscular. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age who on 27-JAN-2015, was vaccinated with a dose of PNEUNOVAX 23 (Lot No. J005068, exp. 18-JAN-2015), 0.5 ml, intramuscular. The pharmacist reported that the patient received an expired dose of PNEUMOVAX 23. No adverse effect reported. 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 medical assistant refers to a patient of unknown age and gender. No relevant medical history of the patient was reported. On 27-JAN-2015 the patient was vaccinated with an expired dose of MMR II (albumin status was unknown) (lot # H014988, expiry date 10-AUG-2014) 0.5 ml, subcutaneous. There were no concomitant medications reported. The patient experienced no adverse effects. There was no product quality complaint involved. The outcome was unknown. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Decreased appetite
Clinical narrative: Chills began night after vaccination-continued intermittently the next day dry cough. No fever, decreased appetite. No headache. No sore throat. Dry cough persisted to see PCP 1/28/15.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 12-SEP-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J014131 and expiry date:07-NOV-2015, reported as 01-JUL-2015) which was improperly stored. Primary reporter was reporting excursion of 6 since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, IPV, TD
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Immediately after administration of HPV vaccine pt fainted for few seconds about 6-8 sec (fainting).
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 25-NOV-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # K01104 and expiry date: 07-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 10-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Pruritus, Pyrexia, Swelling, Tenderness
Clinical narrative: Fevers, chills, swelling, itches, tenderness. Received at pharmacy.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Feeling cold, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 1-20-15 Left arm site red warm swollen; felt tired and cold, irritable. Today 1-21-15 left is red swelling has gone down, symptoms are now milder than 1/20/15. Afebrile 97.5.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Irritability
Clinical narrative: 1-20-15 Left arm site red warm swollen; felt tired and cold, irritable. Today 1-21-15 left is red swelling has gone down, symptoms are now milder than 1/20/15. Afebrile 97.5.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 28-MAR-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J011828 and expiry date: 26-DEC-2014, reported as 16-DEC-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Full blood count, Hypersensitivity, Induration
Clinical narrative: (L) arm pain at first- 12/23/14. Then red streaks down arm towards hand. Hard to touch/warm to touch. Very painful. 12/24/14 ER-IV antibiotics/steroid allergic reaction vs cellulitis.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Red blood cell sedimentation rate, Skin warm
Clinical narrative: (L) arm pain at first- 12/23/14. Then red streaks down arm towards hand. Hard to touch/warm to touch. Very painful. 12/24/14 ER-IV antibiotics/steroid allergic reaction vs cellulitis.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Injection site pain
Clinical narrative: This spontaneous report was received from a 63 year old female patient referring to herself with diabetes mellitus, auto immune deficiency, hypertension, blood cholesterol increased and allergy to unspecified medications. On 17-DEC-2014 (reported as two weeks ago), the patient, who had auto immune deficiency, was vaccinated with one dose of ZOSTAVAX intramuscular injection, (strength, dose, frequency and lot number were not reported), during a schedule office visit. The patient was not taking concomitant therapies. The patient started that the nurse did not administered the ZOSTAVAX according to the prescribing information, because it was administered on the top of her shoulder blade, also the patient experienced injection site pain on 17-DEC-2014. The patient did not seek medical attention, no treatment was given and lab diagnostic studies were not performed. The outcome of injection site pain was reported as recovered/resolved on an unspecified date in December 2014. The relatedness between the injection site pain and therapy with ZOSTAVAX was not reported. Additional information is not expected. There is no patient or physician's contact information.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 57 year old female patient with seasonal asthma, penicillin allergy and cephalosporin allergy, who on 02-JAN-2015, was vaccinated with a dose of ZOSTAVAX (lot # K010967, expiration date 06-NOV-2015), 0.65 ml, subcutaneously in the right arm, Concomitant therapies included VENTOLIN, omeprazole (manufacturer unknown) and acetaminophen, NORCO. The pharmacist stated the patient came into the pharmacy and told him that within 24 hours post vaccination (in January 2015), she developed a rash, 5 to 6 inches long, 3 to 4 inches wide, at the injection site which was the back of her right arm. Pharmacist stated that the patient used cortisone cream as treatment. The rash was gone within one week time. The patient recovered on an unknown date at the time of this report. Additional information is not expected because no further details provided.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Fatigue, Headache, Nausea, Vomiting
Clinical narrative: Tiredness, weakness, headache, nausea, vomit x7 noted 2 hours after vaccination. Increase fluids. TYLENOL 2 tabs every 4 hrs.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On 26-JAN-2015, the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # J005071 and expiration date 19-JAN-2015) dose 0.5 ml, intramuscular. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 1.09
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was given varicella and PROQUAD at the same time. Pt was only to give the PROQUAD, No adverse reactions.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, dose 1, 0.65 ml, lot no. unknown). On 26-JAN-2015, the patient received a second dose of ZOSTAVAX (subcutaneous, dose 2, 0.65 ml, lot no. unknown. No adverse events were reported. Additional information is not expected, because there is no authorization to contact physician.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Insomnia, Malaise, Mobility decreased, Movement disorder
Clinical narrative: This spontaneous report as received from a 67 year old female physician who is also the patient. Pertinent medical history, drug reactions or allergies were not reported. On an unspecified date in 2006, 9 years ago, the patient was vaccinated with PNEUMOVAX 23 dose 1 (dose, route, anatomical location, lot number and expiration date were unspecified). On 08-JAN-2015 the patient was vaccinated with PNEUMOVAX 23 dose 2, intramuscular (dose, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. On 08-JAN-2015, 30 minutes after receiving PNEUMOVAX 23 vaccine, the patient experienced neuralgia and movement disorder which were reported as severe pain, clarified as neurological-like pain, and inability to move the arm (also reported as she could not move her arm). The reporter also stated that she had trouble sleeping due to pain at injection site. Treatment given for the adverse events included BENADRYL, lidocaine patch and ALEVE. The outcome of neuralgia and pain at injection site was reported as not recovered. The outcome of movement disorder was reported as recovered on an unknown date in January 2015. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of several reports received from the same reporter. The patient also experienced malaise while on therapy with AVELOX (case # 1501USA011288). Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Neuralgia
Clinical narrative: This spontaneous report as received from a 67 year old female physician who is also the patient. Pertinent medical history, drug reactions or allergies were not reported. On an unspecified date in 2006, 9 years ago, the patient was vaccinated with PNEUMOVAX 23 dose 1 (dose, route, anatomical location, lot number and expiration date were unspecified). On 08-JAN-2015 the patient was vaccinated with PNEUMOVAX 23 dose 2, intramuscular (dose, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. On 08-JAN-2015, 30 minutes after receiving PNEUMOVAX 23 vaccine, the patient experienced neuralgia and movement disorder which were reported as severe pain, clarified as neurological-like pain, and inability to move the arm (also reported as she could not move her arm). The reporter also stated that she had trouble sleeping due to pain at injection site. Treatment given for the adverse events included BENADRYL, lidocaine patch and ALEVE. The outcome of neuralgia and pain at injection site was reported as not recovered. The outcome of movement disorder was reported as recovered on an unknown date in January 2015. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of several reports received from the same reporter. The patient also experienced malaise while on therapy with AVELOX (case # 1501USA011288). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received KINRIX. On 14th November 2014, the patient received KINRIX (unknown). On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional information received on 14 November 2014: The patient received KINRIX instead of BOOSTRIX. The reporter did not have the lot number and the expire date of vaccine. No adverse event was reported.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received KINRIX (batch number PY3DZ, expiry date 31st May 1926). On an unknown date, the patient received the 1st dose of KINRIX (unknown). On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received on 13 November 2014: A one year old patient was inadvertently given a dose of KINRIX as the 4th dose of DTaP. No adverse event was reported.
Age: 57.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of wrong vaccine administered in a 58-year-old female patient who received INFANRIX (batch number AC14B182BA, expiry date 28th August 2015). On 14th November 2014, the patient received INFANRIX (unknown). On an unknown date, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received on 14 November 2014: INFANRIX was administered to a 58 years old patient instead of tdap. No adverse event was reported.