chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 15-OCT-2014. The patient experienced multiple patients received FLUMIST Quadrivalent and tested positive for Flu A (lot no CH2060) which started on 05-DEC-2014. The outcome of the event of multiple patients received FLUMIST Quadrivalent and tested positive for Flu A is unknown. The report was considered to be non-serious.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Pharmacy concerning a 12 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 15-OCT-2014. The patient experienced multiple patients received FLUMIST Quadrivalent and tested positive for Flu A which started on 06-DEC-2014. The outcome of the event of multiple patients received FLUMIST Quadrivalent and tested positive for Flu A is unknown. The report was considered to be non-serious.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on an unknown date. It was reported that the patient had been administered with expired FLUMIST quadrivalent on 10-Dec-2014. The outcome of the event of expired FLUMIST quadrivalent administered is unknown. The report was considered to be non-serious.
Age: 1.48
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started during Nov-2014. It was reported that the patient had administered FLUMIST under the age of 2 years. The outcome of the event of PATIENT UNDER THE AGE OF 2 YEARS RECEIVED FLUMIST was unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning, subject of unknown gender, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 09-Dec-2014. The patient was administered expired FLUMIST on 09-Dec-2014. The outcome of the event of EXPIRED FLUMIST ADMINISTERED is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning an 11 year old, Male subject, who had been received Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 04-Dec-2014. The patient was administered by expired FLUMISTT which started on 04-Dec-2014. The outcome of the event of EXPIRED FLUMIST ADMINISTERED TO A PATIENT is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 16-Dec-2014. The patient experienced expired FLUMIST quadrivalent administered which started on 16-Dec-2014. The following products were considered to be interacting: FLUMIST quadrivalent. The outcome of the event of expired FLUMIST quadrivalent administered was unknown. The reprot was considered to be non-serious.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Physician concerning a 9 year old, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. The patient was inadvertently given FLUMIST expired vaccine which started on 15-Dec-2014. The outcome of the event of EXPIRED FLUMIST ADMINISTRATION is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 16-Dec-2014. The nurse reported that received a patient was administered expired FLUMISTT on 16-Dec-2014. She started that the patient did not report any symptoms. The outcome of the event of EXPIRED FLUMIST ADMINISTRATION is unknown. The report was considered to be non-serious.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 13 year old, Male subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 15-Dec-2014. The patient had expired FLUMIST which started on 15-Dec-2014. FLUMIST (INTRANASAL) was discontinued on 15-Dec-2014. The outcome of the event of EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Age: 19.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 19 year old, Female subject, who had been receiving FLUMSIT quadrivalent (intranasal). FLUMIST quadrivalent started on 15-Dec-2014. Patient received expired FLUMIST quadrivalent on 15-Dec-2014, FLUMIST quadrivalent was discontinued on 15-Dec-2014. The outcome of the event of expired FLUMIST quadrivalent administered is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving nasal FLUMIST Quadrivalent, started on an unknown date. The patient who received FLUMIST Quadrivalent tested positive for influenza during December 2014. The outcome of the event of POSITIVE FOR INFLUENZA is unknown. The report was considered to be non-serious. Follow-up of insignificant information received on 29-JAN-2014: Event start date was added.
Age: 1.94
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A consumer report has been received. The report concerns a 1 year old, Female consumer, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on an unknown date. It was reported that patient under age of two had received FLUMIST quadrivalent which started on 12-Dec-2014. The outcome of the event of administered FLUMIST quadrivalent to under 2 yo was unknown. The report was considered to be non-serious.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on 11-Nov-2014. Child received FLUMIST quadrivalent on 14-Nov-14 and tested positive for flu A on 06-Dec-14. The outcome of the event of two children vaccinated with FLUMIST quadrivalent tested positive for influenza A is unknown. The report was considered to be non-serious.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a Midwife nurse refers to an approximately 17 years old female patient. Pertinent Medical History and drug reactions/allergies were reported as none. Concomitant therapies included Prenatal Vitamins. The patient became pregnant with Last Menstrual Period (LMP) of 05-APR-2015 and Estimated date of delivery (EDD) of 10-JAN-2016. On an unknown date in 2015, the pregnant patient was vaccinated with GARDASIL or GARDASIL 9, (strength, lot #, dose and route of administration not provided). Nurse Midwife did not know which dose this was in the GARDASIL series. The pregnancy outcome was pending. No adverse effect was reported. No treatment was given for the adverse events. Lab diagnostics studies performed were reported as none. The patient sought medical attention by office visit. No product quality complaint (PQC) was involved. No further information was available. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant, referring to an 18 year old patient of unknown gender. Patient's pertinent medical history and concurrent conditions were not reported. The reporter stated that on 01-MAR-2013, the patient was vaccinated with the first dose of a GARDASIL (strength, dose, route, lot # and expiration date were not reported), and on 01-MAY-2015, received the second dose of the GARDASIL. The reporter stated that the third dose was not administered yet. No concomitant therapies were reported. No adverse effects were reported. No product quality complaints were reported. Additional information is not expected because the reporter did not allow to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Physician Assistant refers to a patient of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with three doses of MMR II (dose, route and lot# were not reported). No adverse experience was reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Accidental exposure to product, No adverse event, Product quality issue, Syringe issue
Clinical narrative: This spontaneous report was received from a female physician, who was also the patient. On an unknown date, while preparing the GARDASIL 9 lot # L014198, expiry date 05-AUG-2017, the stopper of the prefilled syringe had moved. When the stopper moved, the syringe spilled and had touched the patient's hand. No adverse effects were reported. A product quality complaint was filed. The outcome of the accidental exposure was unknown. 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 healthcare worker refers to a patient of unknown demographics. On an unknown date the patient was administered an improperly stored dose of (Oka/Merck) VARIVAX (lot # K003405, expiry date: 06-MAR-2016) (vaccination date, strength, dosing details were unknown). No adverse events were reported. The outcome was unknown. No product quality complaint was involved. Additional information is not expected as the reporter did not wish further contact.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Information has been received from a registered nurse (R.N.) referring to a 6 month old patient of unknown gender. The patient had no pertinent medical history or drug allergies. On an unknown date the patient was vaccinated with the third dose of ROTATEQ (oral: dose, lot# and expiration date not reported) in the series. There was no concomitant medication. The patient immediately vomited after receiving the ROTATEQ on an unknown date. The patient did not seek medical attention and no treatment was given for the event. The outcome of the event was fully recovered on an unknown date. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 20-AUG-2015 the patient was vaccinated with expired dose of PROQUAD (Merck) (lot # K002483, exp. 18-AUG-2015, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several report from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Blood pressure decreased, Dizziness, Underdose
Clinical narrative: Information has been received from a nurse referring to a 14 year old male patient. The patient had no pertinent medical history. The patient was allergic to AUGMENTIN. On 07-AUG-2015 the patient was vaccinated with GARDASIL (lot # L018286 with expiration date of 13-APR-2017, dose and strength unknown) on his right arm intramuscularly. It was reported that only 75% of GARDASIL was given because when the needle was inserted into the patient's arm, it met resistance. After the needle was withdrawn from the patient's arm, he experienced "lightheadedness". The patient's pressure was measured and it was lower than it had been earlier. The patient was positioned supine. In about 15 minutes, the patient was able to sit upright and he was given juice to drink. On the same day the patient recovered fully and was sent home. The causality was not reported. No product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a nurse referring to a 14 year old male patient. The patient had no pertinent medical history. The patient was allergic to AUGMENTIN. On 07-AUG-2015 the patient was vaccinated with GARDASIL (lot # L018286 with expiration date of 13-APR-2017, dose and strength unknown) on his right arm intramuscularly. It was reported that only 75% of GARDASIL was given because when the needle was inserted into the patient's arm, it met resistance. After the needle was withdrawn from the patient's arm, he experienced "lightheadedness". The patient's pressure was measured and it was lower than it had been earlier. The patient was positioned supine. In about 15 minutes, the patient was able to sit upright and he was given juice to drink. On the same day the patient recovered fully and was sent home. The causality was not reported. No product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On 20-AUG-2015 the patient was vaccinated with 1 dose of GARDASIL Lot K010574, expiration date 08-APR-2017 (dose, strength, route unspecified) which was exposed to temperatures outside of the recommended range. The patient had not reported an adverse experience. No product quality complaint was involved. This case is linked to the cases 1508USA010363, 1508USA010628 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. Approximately on an unknown date in August 2015 the patients were vaccinated with GARDASIL Lot K010574, expiration date 08-APR-2017 which were exposed to temperatures outside of the recommended range since 06-AUG-2015. No product quality complaint was involved. This case is linked to the cases 1508USA010627, 1508USA010628 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. Approximately on an unknown date in August 2015 the patients were vaccinated with Oral ROTATEQ Lot K014826, expiration date 28-MAY-2016 which were exposed to temperatures outside of the recommended range since 06-AUG-2015. This case is linked to the cases 1508USA010627, 1508USA010363 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from Pfizer (#2015272178) on 18-AUG-2015. This spontaneous report as received from a pharmacist refers to an adult patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the practice accidentally gave the patient a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported). The patient was supposed to received a dose of PREVNAR 13. The outcome of the adverse event was unknown. The relatedness between the adverse event and the PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 20-AUG-2015, the patient was vaccinated with expired dose of PROQUAD (Merck) (lot # K002483, exp. 18-AUG-2015, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several report from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to four unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # K018964 and expiration date 15-OCT-2016) (dos, route and lot# were not reported). No adverse effects were reported. No product quality complaint was involved. 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 healthcare worker refers to 2 patients of unknown age and gender. On 12-AUG-2015 the first patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K009876, exp. date 19-MAR-2016) (dose and route were not reported) and on 17-AUG-2015 the second patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K009876, exp. date 19-MAR-2016) (dose and route were not reported). Both of doses were improperly stored. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.28
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Round, red, raised bump on left thigh.
Age: 77.0
Sex: U
Vaccine: PPV
Symptoms: Pain, Skin reaction, Skin warm
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-AUG-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L002310, expiration date: 08-JUL-2016), dose and route were not reported. On 12-AUG-2015, the patient came back to the office with a 'skin and local reaction, warmth and minimal pain'. The outcome of the events was not reported. The causality assessment was not provided. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Exposure during breast feeding
Clinical narrative: A consumer report has been received. The report concerns a 36 year old, Female consumer, who had been receiving FLUMIST (intranasal). Concomitant medications included prenatal vitamins. FLUMIST started on 16-Dec-2003. The patient received FLUMIST on 16-DEC-2003. She was nursing her 6.5 week old infant prior to receiving FLUMIST. It was not known if she had nursed the child prior to reading the warnings in the prescribing information. FLUMIST was discontinued on 16-Dec-2003. The outcome of the event of vaccine administered to nursing mother is unknown. The report was considered to be non-serious by the reporter. Corrected report 26-Feb-2015: form completed date and other reporter type added, ethnic origin entered, associated case ID added, formulation of FLUMIST added, case was suppressed with the reason of medication error, diseases continues entered, narrative was updated.
Age: 17.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 17 year old, female patient, who had been receiving FLUMIST (intranasal). FLUMIST started on an unknown date. The patient was administered FLUMIST on 18-Nov-2014. At the time patient was not aware of being pregnant but after the administration she found out she was pregnant. Patient did not experience any adverse even4ts during or post administration. The outcome of the event of vaccine exposure during pregnancy and wrongful administration to pregnant female was unknown. The report was considered to be non-serious by reporter. The reporter considered there was no causal relationship between the wrongful administration to pregnant female and FLUMIST.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Cough, Decreased appetite, Lethargy, Pain in extremity
Clinical narrative: A report has been received from regulatory authority via pharmacist concerning a 10 year old, Female subject, Height: 48.0 Inches; Weight: 55.0 Pounds, who had been receiving FLUMIST (intranasal), 0.1 mL, 2 every 1 Day(s). FLUMIST started on an unknown date. The patient experienced cough, decreased appetite, pain in extremity, pyrexia, lethargy, asthenia and rhinorrhea. The outcome of the event of cough, decreased appetite, pain in extremity, pyrexia, lethargy, asthenia and rhinorrhea is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: A report has been received from regulatory authority via pharmacist concerning a 10 year old, Female subject, Height: 48.0 Inches; Weight: 55.0 Pounds, who had been receiving FLUMIST (intranasal), 0.1 mL, 2 every 1 Day(s). FLUMIST started on an unknown date. The patient experienced cough, decreased appetite, pain in extremity, pyrexia, lethargy, asthenia and rhinorrhea. The outcome of the event of cough, decreased appetite, pain in extremity, pyrexia, lethargy, asthenia and rhinorrhea is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a license vocational nurse refers to a patient of unknown age and gender. Patient's medical history, concurrent conditions and concomitant therapy were not reported. On 20-AUG-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot number reported as K008821, Expiry date: 19-JUN-2016) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.48
Sex: M
Vaccine: FLUN3
Symptoms: Exposure during breast feeding, No adverse event
Clinical narrative: A report has been received from consumer, concerning a male patient on 20-Jun-2013, height: 28.0 inches; weight: 16.0 pounds (child case). The patient's medical history and concomitant medications were not reported. On 13-Dec-2003, the patient's mother started receiving treatment with nasal FLUMIST (intranasal). The patient, a consumer, reported that she received FLUMIST while breast-feeding her son. The patient stated that both she, and her husband, received FLUMIST on 12/13/02 as recommended by their physician and her son's pediatrician. The patient stated that while breast-feeding, she normally received Prenatal vitamins and MICRONOR for birth control. No adverse events were associated with FLUMIST at the time of this report. The patient stated that her son was scheduled to receive his routine childhood vaccines for 6 months olds, on the week following this report. The outcome of the event of was it ok to receive FLUMIST even though I am nursing was unknown. The report was considered to be non-serious by company physician.
Age: 0.1
Sex: U
Vaccine: FLUN3
Symptoms: Exposure during breast feeding
Clinical narrative: A consumer report has been received. The report concerns a 1 month old patient. The patient's relevant history and concomitant medications were not reported. The patient had been receiving FLUMIST (intranasal) since 16-Dec-2003. The patient's mother received FLUMIST on 16-Dec-2003. She was nursing her 6.5 week old infant prior to receiving FLUMIST. It was not known if she had nursed the child prior to reading the warnings in the prescribing information. The action taken with FLUMIST was unknown. The outcome of the event of product exposure via breast milk was unknown. The company physician assessed the event of product exposure via breast milk to be non-serious.
Age: 53.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A consumer report has been received, concerning a female patient, who had been receiving Nasal FLUMIST (INTRANASAL), 0.2 milliliters. FLUMIST (INTRANASAL) started on an unknown date. It was reported that a 53 year old patient received FLUMIST for the last four years. The outcome of the event of 53 YEAR OLD RECEIVED FLUMIST FOR THE LAST FOUR YEARS was unknown. The report was considered to be non-serious by reporter. Corrected Report 09-Feb-2015: upon query answer, reporter page updated, case is medically not confirmed. Narrative updated.
Sex: U
Vaccine: FLUN3
Symptoms: Decreased appetite, Lethargy, Pain, Pyrexia, Vomiting
Clinical narrative: A consumer report has been received. The report concerns a Male consumer, who had been receiving nasal FLUMIST (intranasal) started on an unknown date. The patient experienced decreased appetite, moderate low fever, Vomiting, Moderate achey; lethargic. The outcome of the event decrease appetite is unknown and the patient recovered from the event of low fever, vomited, achey and lethargic on 06-NOV-2014. The report was considered to be non-serious. The reporter considered that there was no casual relationship between low fever and FLUMIST, vomited and FLUMIST, achey and FLUMIST and lethargic and FLUMIST.
Sex: M
Vaccine: FLUN4
Symptoms: Extra dose administered
Clinical narrative: A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving nasal FLUMIST started on an unknown date. The patient reported that Two doses of FLUMIST incorrectly administered to one patient. The outcome of the event of TWO DOSES OF FLUMIST INCORRECTLY ADMINISTERED TO ONE PATIENT is unknown. The report was considered to be non-serious. The reporter and company physician considered that there was no casual relationship between TWO DOSES OF FLUMIST INCORRECTLY ADMINISTERED TO ONE PATIENT and FLUMIST.
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A Spontaneous report has been received from a health professional concerning a male patient. Patient relevant history, concurrent diseased and concomitant drugs were not provided. Patient had been receiving nasal FLUMIST (intranasal), started on 20-Nov-2014. The patient was administered of half of the contents into the first nostril and therefore did not administer the second half of the dose into the other no which started on 20-Nov-2014 and nurse administered expired FLUMIST (from 2013) to a child. The outcome of the event of after administration of half of the contents into the first nostril and therefore did not administer the second half of the dose into the other no and nurse administered expired FLUMIST (from 2013) to a child was unknown. The report was considered to be non-serious. Reporter considered the events after administration of half of the contents into the first nostril and therefore did not administer the second half of the dose into the other no and FLUMIST and nurse administered expired FLUMIST (from 2013) to a child to be not related to the FLUMIST.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administration error
Clinical narrative: A report has been received from a health professional concerning a 10 year old female patient. No relevant history and concomitant medications of the patient were reported. The patient who had been receiving Nasal FLUMIST (intranasal) was started on an unknown date, indication was not provided. It was reported that the pharmacist administered FLUMIST with a tiny amount of the vaccine into one nostril and then majority of the vaccine into the second nostril, a few drops of vaccine dripped out which was considered as administration error on 13-Nov-2014. Action taken with FLUMIST was unknown. The outcome of the event improper administration were unknown. The report was considered to be non-serious by reporter.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Chorea, Rheumatic fever
Clinical narrative: A report has been received from a Physician concerning a 15 year old, Male patient. The patient's medical history and concomitant medications were not reported. The physician reported that the patient developed rheumatic fever after receiving nasal FLUMIST in 2012. The patient was worked up for rheumatic fever and he developed chorea. She reported that the symptoms began 2 weeks after the patient received the vaccine. The patient was doing well. The outcome of the event of rheumatic fever was unknown. The report was considered to be non-serious by reporter.
Age: 51.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, Off label use
Clinical narrative: A report had been received from a pharmacist concerning a 51 year old female patient. No concomitant medication and no medical history were provided. An off-label prescription of trivalent attentuated flu vaccine, traduced as FLUENZA by the pharmacist, was reported from a pharmacist concerning a 51-year-old female patient, treated with immuno-depressant (preparation before graft). The outcome of the event of off-label prescription of attenuated trivalent flu vaccine, traduced as FLUENZ, for an adult treated with immuno-depressant and prescription of flu vaccine concerning a 51-year-old female was unknown. The company physician considered the events to be non-serious.
Sex: U
Vaccine: FLUN3
Symptoms: Drug administration error
Clinical narrative: A spontaneous report has been received from a Health Professional concerning a patient of unknown gender. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. The patient was prescribed Nasal FLUENZ (intranasal) started on unknown date. The reporter stated that the patient experienced incorrect administration of FLUMIST- entire dose of administered into single nostril. The outcome of the event of incorrect administration of FLUMIST-entire dose administration into single nostril was unknown. The reporter considered the event of incorrect administration of FLUMIST- entire dose administered into single nostril as non-serious. The reporter and company considered the event of incorrect administration of FLUMIST-entire dose administered into single nostril with FLUENZ to be related.
Age: 21.0
Sex: F
Vaccine: FLUN3
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Study Investigator concerning a 21 year old, female subject, Height: 162.0 Centimeters; Weight: 44.4 Kilograms, enrolled in study therapy started on 03-Jun-2013 for Influenza vaccine. The patient experienced pregnancy which started on 05-Sep-2013. Study product therapy was discontinued on 03-Jun-2013. The patient recovered from the event of pregnancy on 29-Oct-2013. The event(s) occurred during the Follow-up period of this study. The outcome of the pregnancy was reported to be an Elective abortion on 29-Oct-2013. The report was considered to be non-serious. The Study was unblinded on 07-Mar-2014.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 05-AUG-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L000454 with exp. 06-JAN-2017, (route and dos were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a one unspecified patient of unknown age and gender. On 14-AUG-2015, the patient was vaccinated with a dose of improperly stored M-M-R II (reported lot number: 1010596, exp.date: 06-APR-2017) (strength, dose and route were not reported) which was exposed to a temperature outside of the recommended range. No adverse effects were reported. 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 license vocational nurse refers to a patient of unknown age and gender. Patient's medical history, concurrent conditions and concomitant therapy were not reported. On 17-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot number reported as K008821, Expiry date: 19-JUN-2016) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 17-JUL-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L000454 with exp. 06-JAN-2017, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On unspecified dates, the patient were vaccinated with improperly stored doses of VAQTA (lot number and expiration date, dose and route of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Mild maculopapular rash on trunk, limbs, and face.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Muscular weakness, Nodule, Pain in extremity
Clinical narrative: Patient calling with report of weakness, pain and knot in arm which he received TDAP developed within 24 hours.
Age: 0.54
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site swelling
Clinical narrative: Swollen leg a PCV vaccine in right leg. BENADRYL given and fine after 15 minutes.
Age: 53.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Urticaria
Clinical narrative: Hives noted on both arms, below injection site. Pt denied any shortness of breath. V/S stable. BENADRYL 50 mg IM.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram head normal, Electrocardiogram normal, Loss of consciousness, Musculoskeletal stiffness, Seizure like phenomena
Clinical narrative: After receiving the injection, immediately stood up and walked to reception area. Approximately 2 minutes after receiving injection patient fainted and while unconscious became stiff with seizure-like motions. Became conscious after 45 seconds.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: After receiving the injection, immediately stood up and walked to reception area. Approximately 2 minutes after receiving injection patient fainted and while unconscious became stiff with seizure-like motions. Became conscious after 45 seconds.
Age: 0.59
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Diarrhoea, Screaming, Vomiting
Clinical narrative: "Screaming" x 2 hrs, vomited and diarrhea x 4.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Hives, redness around injection site left arm.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Altered state of consciousness, Cold sweat, Dysstasia, Pallor
Clinical narrative: Complained feeling "like I'm going to pass out." Pale, clammy, rested for several minutes and drank water. Feeling better; attempted to walk to restroom and was unable to stand straight and said "I'm gonna pass out." Lowered to chair. Assisted to cot where she rested approx 30 min. Drank H2o and had a snack. Felt better. Left with mother. Called that eve and pt was feeling fine.
Age: 1.52
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Body temperature increased, Hand-foot-and-mouth disease, Pruritus, Rash erythematous
Clinical narrative: Low grade temp 99.8 7-16-15; Rash - reddened raised over buttocks, itching legs, hands, mouth and feet, including bottom of feet early AM 7-17-15. BENADRYL Elixir, mom states age appropriate dose administered by mouth X 2 doses. Mom emailed picture of child's rash to primary care physician and diagnosed as Hand, Foot and Mouth disease. No treatment recommended. Rash resolved in a week's time.
Age: 11.0
Sex: M
Vaccine: HPVX, MEN, TDAP
Symptoms: Rash, Skin warm
Clinical narrative: Well circumscribed rash on lateral, anterior, and inner arm on proximal and medial portions. Rash continues to spread and is hot to the touch.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Local reaction, Rash macular, Rash vesicular
Clinical narrative: This spontaneous report was received from a physician and medical assistant refers to a 18 year old male patient with history of chicken pox, seasonal allergies and allergy to amoxicillin. On 18-JUL-2015, the patient was vaccinated with the first dose of VARIVAX, lot number K009757, expiration date 09-JUL-2016, (dose, route and anatomical location were not reported). The patient's concomitant therapies included iron (unspecified), vitamins (unspecified) and FLONASE used "as needed". On 31-JUL-2015, the patient sought medical attention by visiting the physician's office due to "a local reaction at the injection site" described as "a mild erythematous macular rash", the patient also had "a couple of papules on his back and one on his abdomen" which was initially thought to be "bug bites". The next day on 01-AUG-2015, the patient was seeing again in the office and what they initially thought were papules on the patient's back got bigger and were determined to be a vesicular rash. The patient was advised to use BACTROBAN ointment for treatment. None laboratories were performed. At the time of the report, the outcome of the events above described was unknown. The relatedness between the events and therapy with VARIVAX was not reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Client called with c/o feeling of (R) arm swelling, arm pain, neck pain, hand aching and throbbing. Denies fever, denies redness. She is using warm/cold compresses and TYLENOL, and notified OB and PCP.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Cellulitis, Erythema, Pyrexia, Swelling
Clinical narrative: Redness, swelling, fever, cellulitis.
Age: 1.12
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash pustular, Varicella post vaccine
Clinical narrative: Pustule rash on face, chest and lower extremities - chickenpox rash in various stages of healing. Rx Diphenhydramine 1 tsp Q 6 hours PRN, calamine PRN to lesions.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 12-AUG-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L000454 with exp. 06-JAN-2017, (route were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Urticaria
Clinical narrative: Patient developed hives on her hips and back, rash under both arms and wrists. Patient was advised to take BENADRYL.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) injection (strength, dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse symptoms were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a license vocational nurse refers to a patient of unknown age and gender. Patient's medical history, concurrent conditions and concomitant therapy were not reported. On 18-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot number reported as K008821, Expiry date: 19-JUN-2016) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 12-AUG-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L000454 with exp. 06-JAN-2017, (route and dose were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product reconstitution issue, Underdose
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 24-JUL-2015, the patient was vaccinated with ZOSTAVAX 0.4 ml (lot#, expiration date, frequency, site of vaccination were not reported) for prevention of shingles. The ZOSTAVAX unit produced excessive foaming after reconstitution, which caused that only 0.4 ml was withdrawn into the syringe. Even though this amount was less than indicated, the injection was given to the patient. No adverse event was reported. The patient did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles
Clinical narrative: This spontaneous report was received from a Healthcare worker regarding a fellow employee who is a female patient of unknown age. Medical history of the patient was not reported. On an unspecified date of August 2015, about a week ago, the patient was vaccinated with one dose of MMR II, subcutaneous. It was reported that on an unspecified date of August 2015, the patient developed measles after receiving the vaccine. The patient sought medical attention and was seen by unspecified physician on unspecified date. The treatment details were unspecified. The outcome of the event was unknown. Causality assessment was not provided by the reporter. No further information was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to an unspecified number of patients of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (Lot No. K020758 exp. 31-OCT-2016 and Lot No. L004649 exp. 11-FEB-2016) (dose, frequency and route were not described). No concomitant therapies were provided. No adverse event information was provided. No product quality complaint was involved. This is one of two reports received from the same source (# 1508USA006747). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Vaccines given 8/20/15. On 8/22/15 Rt arm swollen and warm. Went to ER and started on antibiotic and steroids.
Sex: F
Vaccine: HEP
Symptoms: Laceration, Product quality issue, Suture insertion, Syringe issue
Clinical narrative: This spontaneous report was received from a medical assistant who refers to a female victim of unknown demography, who is also a medical assistant. On an unknown date the medical assistant was administering a vaccine to a patient with RECOMBIVAX HB (therapy type, dosage and lot # were not reported). The reporter stated that the finger flange broke off the syringe and sliced the victim's thumb and she needed stitches in her thumb. The reporter also stated that no other adverse experience did occur with the victim. Product quality complaint (PQC) was filed for the RECOMBIVAX HB syringe issue. The reporter did not provide the relatedness towards the event and the vaccine. 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 registered nurse refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (strength, dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse symptoms were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 11-AUG-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L000454 with exp. 06-JAN-2017, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Injection site discharge, Pain in extremity, Peripheral swelling
Clinical narrative: On arrival for 3 dose of Hepatitis B vaccine indicated problem after dose 2 (5 months ago) Swelling rt arm, Temp 99.9, Bubbling at area of injection. Severe pain rt arm. Dose 3 not given. Referred to PCP.