chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple, different unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medication were not reported. On an unknown dates, the patients were vaccinated with improperly stored (-14 degrees Celsius (C), for 2 hours and 48 minutes) (Merck) VARIVAX injection, lot # L029466, expiry date 06-AUG-2017, (dose and frequency not reported.) Vaccine had previous temperature excursion (-14 C) for 32.5 hours, with call because of "data logger". No adverse effects were reported. No product quality complaint (PQC) was involved. Follow up information has been received from the nurse on 11-MAR-2016. She provided the patients identifiers. On 15-FEB-2016, a patient of unknown age and gender received one dose of improperly stored (Merck) VARIVAX (stored in -14 degrees C, for 56 hours). This same vaccine was previously exposed to a high temperature of -14 C for a cumulative total of 91 hours, 18 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 5 year old female patient. On 21-MAR-2016 the patient was vaccinated with a dose of PROQUAD (Merck) (dose, route and lot # unspecified). Other suspect therapy included: on 21-MAR-2016 patient was vaccinated with VARIVAX (Merck) (dose, route and lot # unspecified). It was reported that PROQUAD (Merck) and VARIVAX (Merck) were both given today (on 21-MAR-2016) (overdose). Staff error only (drug administration error). No adverse events reported at time of call. There was no product quality complaint reported. No further details provided. Additional information is not expected. No consent to follow up with the reporter.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Blood test, Memory impairment, Myalgia, Pain
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 25 year old female patient. Patient's pertinent medical history and concomitant medication was reported as none. The patient is currently not pregnant at this time of report. Patient's drug reactions/allergies included penicillin and ZITHROMAX. On an unknown date in June 2015, the patient received PREVNAR 13 (manufacturer unknown), (dose, route, indication, lot number and expiration date unknown). On an unknown date in June 2015, after receiving PREVNAR 13 (manufacturer unknown) the patient developed "soreness in her arm" and she "couldn't lift her arm without pain." On 23-AUG-2015, the patient was vaccinated with PNEUMOVAX23 (dose, route, lot number and expiration date unknown). On 23-AUG-2015, after receiving PNEUMOVAX23, within "2 hours" the patient complained of "aches, pains, tingling in the hands, hives and intense pain on the left arm" to the physician. The patient had sought medical attention and was prescribed with prednisone as treatment for the events. The nurse reported that the patient had visited the office twice, on unspecified dates, for follow-up appointments since she received the PNEUMOVAX23 and that while "some of the effects have subsided" she continues to experience "myalgia, decreased memory and lower back pain" at this time of report. Lab test: unspecified "blood work" (unknown date): result and units not provided. The outcome of the adverse events was reported as not recovered (also reported as some of the effects have subsided). Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Paraesthesia, Urticaria
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 25 year old female patient. Patient's pertinent medical history and concomitant medication was reported as none. The patient is currently not pregnant at this time of report. Patient's drug reactions/allergies included penicillin and ZITHROMAX. On an unknown date in June 2015, the patient received PREVNAR 13 (manufacturer unknown), (dose, route, indication, lot number and expiration date unknown). On an unknown date in June 2015, after receiving PREVNAR 13 (manufacturer unknown) the patient developed "soreness in her arm" and she "couldn't lift her arm without pain." On 23-AUG-2015, the patient was vaccinated with PNEUMOVAX23 (dose, route, lot number and expiration date unknown). On 23-AUG-2015, after receiving PNEUMOVAX23, within "2 hours" the patient complained of "aches, pains, tingling in the hands, hives and intense pain on the left arm" to the physician. The patient had sought medical attention and was prescribed with prednisone as treatment for the events. The nurse reported that the patient had visited the office twice, on unspecified dates, for follow-up appointments since she received the PNEUMOVAX23 and that while "some of the effects have subsided" she continues to experience "myalgia, decreased memory and lower back pain" at this time of report. Lab test: unspecified "blood work" (unknown date): result and units not provided. The outcome of the adverse events was reported as not recovered (also reported as some of the effects have subsided). Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: CSF test normal, Computerised tomogram abnormal, Computerised tomogram head abnormal, Crying, Dyskinesia
Clinical narrative: Pt is a 12mo F Kw/no significant PMH who presents with 1 day h/o fever and shaking episodes. Pt received 12mo vaccines 1 day PTA and began having episodes of shaking and fevers, with a Tmax 102 measured at home. Pt was given TYLENOL for fevers. That night parents noticed brief jerking movement during sleep that woke her. Pt would wake briefly, cry, and then went back to sleep. This happened intermittently throughout the night. On DOA pt had several episodes where she would start crying and stiffen arms and legs for approx 10 seconds. Pt would then go limp, stare straight ahead, and be unresponsive. This would last an addition 10 seconds, episodes lasted total 20-30 seconds maximum. No cyanosis, no LOC. Pt did have possible fall off bed while with grandma last week. NO NVD, rashes. Pt has also had URI symptoms and cough intermittently for the last 3-4 weeks, was seen by PMD and diagnosed with viral URI. Pt had total of 5 episodes at home and was then brought to ED. In ED pt was febrile and noted to have several more episodes. A head CT was performed which was abnormal, showing (R) otomastoiditis. Pt was admitted to the floors for management. Pt was transferred to floors and continued to experience fevers and seizure activity. Pt was given a loading dose of phenobarbital. Pt continued to have seizure episodes, which decreased after loading with additional phenobarbital and KEPPRA. Maintenance doses were started for both. Metabolic panel to R/o inborn errors of metabolism was sent in light of normal MRI. Because of persistent fever, CSF studies were drawn but were not c/Kw infectious process. Pt had PCR equivocal for influenza and was started on TAMIFLU. Pt continued to improve on antiseizure meds. Serial EEGs were obtained daily on 3/5, 3/7, 3/8 and 3/9. Neurology had started a daily dose of phenobarbital at 2.5mg/kg bid and then continued to titrate up the KEPPRA dose until both.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Electroencephalogram, Hypotonia, Influenza virus test positive, Mastoiditis, Metabolic function test normal
Clinical narrative: Pt is a 12mo F Kw/no significant PMH who presents with 1 day h/o fever and shaking episodes. Pt received 12mo vaccines 1 day PTA and began having episodes of shaking and fevers, with a Tmax 102 measured at home. Pt was given TYLENOL for fevers. That night parents noticed brief jerking movement during sleep that woke her. Pt would wake briefly, cry, and then went back to sleep. This happened intermittently throughout the night. On DOA pt had several episodes where she would start crying and stiffen arms and legs for approx 10 seconds. Pt would then go limp, stare straight ahead, and be unresponsive. This would last an addition 10 seconds, episodes lasted total 20-30 seconds maximum. No cyanosis, no LOC. Pt did have possible fall off bed while with grandma last week. NO NVD, rashes. Pt has also had URI symptoms and cough intermittently for the last 3-4 weeks, was seen by PMD and diagnosed with viral URI. Pt had total of 5 episodes at home and was then brought to ED. In ED pt was febrile and noted to have several more episodes. A head CT was performed which was abnormal, showing (R) otomastoiditis. Pt was admitted to the floors for management. Pt was transferred to floors and continued to experience fevers and seizure activity. Pt was given a loading dose of phenobarbital. Pt continued to have seizure episodes, which decreased after loading with additional phenobarbital and KEPPRA. Maintenance doses were started for both. Metabolic panel to R/o inborn errors of metabolism was sent in light of normal MRI. Because of persistent fever, CSF studies were drawn but were not c/Kw infectious process. Pt had PCR equivocal for influenza and was started on TAMIFLU. Pt continued to improve on antiseizure meds. Serial EEGs were obtained daily on 3/5, 3/7, 3/8 and 3/9. Neurology had started a daily dose of phenobarbital at 2.5mg/kg bid and then continued to titrate up the KEPPRA dose until both.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Musculoskeletal stiffness, Nuclear magnetic resonance imaging normal, Polymerase chain reaction positive, Pyrexia, Seizure
Clinical narrative: Pt is a 12mo F Kw/no significant PMH who presents with 1 day h/o fever and shaking episodes. Pt received 12mo vaccines 1 day PTA and began having episodes of shaking and fevers, with a Tmax 102 measured at home. Pt was given TYLENOL for fevers. That night parents noticed brief jerking movement during sleep that woke her. Pt would wake briefly, cry, and then went back to sleep. This happened intermittently throughout the night. On DOA pt had several episodes where she would start crying and stiffen arms and legs for approx 10 seconds. Pt would then go limp, stare straight ahead, and be unresponsive. This would last an addition 10 seconds, episodes lasted total 20-30 seconds maximum. No cyanosis, no LOC. Pt did have possible fall off bed while with grandma last week. NO NVD, rashes. Pt has also had URI symptoms and cough intermittently for the last 3-4 weeks, was seen by PMD and diagnosed with viral URI. Pt had total of 5 episodes at home and was then brought to ED. In ED pt was febrile and noted to have several more episodes. A head CT was performed which was abnormal, showing (R) otomastoiditis. Pt was admitted to the floors for management. Pt was transferred to floors and continued to experience fevers and seizure activity. Pt was given a loading dose of phenobarbital. Pt continued to have seizure episodes, which decreased after loading with additional phenobarbital and KEPPRA. Maintenance doses were started for both. Metabolic panel to R/o inborn errors of metabolism was sent in light of normal MRI. Because of persistent fever, CSF studies were drawn but were not c/Kw infectious process. Pt had PCR equivocal for influenza and was started on TAMIFLU. Pt continued to improve on antiseizure meds. Serial EEGs were obtained daily on 3/5, 3/7, 3/8 and 3/9. Neurology had started a daily dose of phenobarbital at 2.5mg/kg bid and then continued to titrate up the KEPPRA dose until both.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Sleep disorder, Staring, Tremor, Unresponsive to stimuli
Clinical narrative: Pt is a 12mo F Kw/no significant PMH who presents with 1 day h/o fever and shaking episodes. Pt received 12mo vaccines 1 day PTA and began having episodes of shaking and fevers, with a Tmax 102 measured at home. Pt was given TYLENOL for fevers. That night parents noticed brief jerking movement during sleep that woke her. Pt would wake briefly, cry, and then went back to sleep. This happened intermittently throughout the night. On DOA pt had several episodes where she would start crying and stiffen arms and legs for approx 10 seconds. Pt would then go limp, stare straight ahead, and be unresponsive. This would last an addition 10 seconds, episodes lasted total 20-30 seconds maximum. No cyanosis, no LOC. Pt did have possible fall off bed while with grandma last week. NO NVD, rashes. Pt has also had URI symptoms and cough intermittently for the last 3-4 weeks, was seen by PMD and diagnosed with viral URI. Pt had total of 5 episodes at home and was then brought to ED. In ED pt was febrile and noted to have several more episodes. A head CT was performed which was abnormal, showing (R) otomastoiditis. Pt was admitted to the floors for management. Pt was transferred to floors and continued to experience fevers and seizure activity. Pt was given a loading dose of phenobarbital. Pt continued to have seizure episodes, which decreased after loading with additional phenobarbital and KEPPRA. Maintenance doses were started for both. Metabolic panel to R/o inborn errors of metabolism was sent in light of normal MRI. Because of persistent fever, CSF studies were drawn but were not c/Kw infectious process. Pt had PCR equivocal for influenza and was started on TAMIFLU. Pt continued to improve on antiseizure meds. Serial EEGs were obtained daily on 3/5, 3/7, 3/8 and 3/9. Neurology had started a daily dose of phenobarbital at 2.5mg/kg bid and then continued to titrate up the KEPPRA dose until both.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 22-OCT-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscular (strength, dose, lot # and expiration date were not provided). On 30-DEC-2015, the patient was vaccinated with the second dose of GARDASIL 9 intramuscular (strength, dose, lot # and expiration date were not provided). On 14-MAR-2016, the patient was vaccinated with the third dose of GARDASIL 9 intramuscular (strength, dose, lot # and expiration date were not provided). No known adverse effects were reported. The dates of vaccinations were reconfirmed with the reporter. 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 and gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On 21-MAR-2016, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 injection (lot#, expiration date 02-FEB-2016, dose, anatomical location and route of administration were not reported). The reporter stated that, this was supported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unspecified date in March 2016 (reported as about a week ago), the patient was inadvertently vaccinated with an expired dose of VARIVAX (lot # K002928, expiry date: 26-FEB-2016) (expired product administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Influenza A virus test positive, Influenza B virus test positive, Influenza like illness, Vaccination failure
Clinical narrative: Initial unsolicited report received from a physician on 10 March 2016. This case involves 6 patients (age and gender not reported) who were vaccinated with a dose of FLUZONE (batch number, expiry date, route and site of administration were not reported) on an unspecified date in September 2015. Medical history and concomitant medications were not reported. On 10 March 2016, following the vaccination patient experienced "flu like" symptoms and tested positive for A and B strains of "flu virus". It was also vaccination failure case. Laboratory investigation and corrective treatment was not reported. The outcome of event was unknown. Upon internal review, the company decided to consider the event serious because of important medical event tested positive for A and B strains of "flu virus", flu like symptoms and suspected vaccination failure. List of documents held by sender: none. Sender's Comments: As with any vaccine, vaccination with influenza vaccine may not protect 100 percent of susceptible individuals. However, additional information on the patient's immune status at the time of vaccination (medical history, concomitant medication), previous vaccinations, infectious work-up results to rule out alternative etiology and details of tests used to identify the influenza strain (e.g. PCR, nasal swab, etc.) are needed to further assess this case.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Blood chloride normal, Blood creatinine decreased, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: Seizure Like activity at approx 9pm that lasted approx 5 min, Parents Called EMS and were taken to Emergency Room. Seen back at the doctor on 3/23/2016 and admitted to hospital for IV fluids and observation.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Blood urea normal, Calcium ionised decreased, Carbon dioxide decreased, Seizure like phenomena, White blood cell count normal
Clinical narrative: Seizure Like activity at approx 9pm that lasted approx 5 min, Parents Called EMS and were taken to Emergency Room. Seen back at the doctor on 3/23/2016 and admitted to hospital for IV fluids and observation.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Influenza, Pain, Pyrexia, Vomiting
Clinical narrative: Feverish, vomiting, aching, flu symptoms.
Age: 25.0
Sex: M
Vaccine: HPV9
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Headache, Neurological examination normal
Clinical narrative: This spontaneous report as received from a physician refers to a 25 year old male patient. No concomitant medication or pertinent medical history reported. On 09-MAR-2016, the patient was vaccinated with his first dose of GARDASIL 9 lot # L017407 exp. 15-AUG-2017 (dose, site and route of administration were not reported). On 11-MAR-2016, the patient began to experience "waves of dizziness" and pain in his temples bilaterally. On 19-MAR-2016, the patient sought medical attention at an unspecified urgent care clinic, who referred him to the emergency department. The patient received REGLAN, BENADRYL, unspecified intravenous fluids and ketorolac, with unspecified results. On 19-MAR-2016 lab diagnostic studies included: Blood test with results: "unremarkable" or within normal limits. Computerised tomogram (CT scan) with results: "negative" or within normal limits. Emergency department assessment with results: no abnormalities were identified. On 21-MAR-2016, the patient was still experiencing dizziness and headaches. On 21-MAR-2016, the physician, who was examining the patient, stated that the patient reported that his sinuses felt "stuffy," but he was not experiencing vertigo or nystagmus. The physician reported that the patient was afebrile, normotensive, and his neurological assessment was within normal limits during exam on 21-MAR-2016. The patient was in the physician's care at the time of this report. The outcome of the events was reported as not recovered/not resolved at the time of the report. The relatedness between the adverse events and the suspect therapy was not reported. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: HPV9
Symptoms: Sinus congestion
Clinical narrative: This spontaneous report as received from a physician refers to a 25 year old male patient. No concomitant medication or pertinent medical history reported. On 09-MAR-2016, the patient was vaccinated with his first dose of GARDASIL 9 lot # L017407 exp. 15-AUG-2017 (dose, site and route of administration were not reported). On 11-MAR-2016, the patient began to experience "waves of dizziness" and pain in his temples bilaterally. On 19-MAR-2016, the patient sought medical attention at an unspecified urgent care clinic, who referred him to the emergency department. The patient received REGLAN, BENADRYL, unspecified intravenous fluids and ketorolac, with unspecified results. On 19-MAR-2016 lab diagnostic studies included: Blood test with results: "unremarkable" or within normal limits. Computerised tomogram (CT scan) with results: "negative" or within normal limits. Emergency department assessment with results: no abnormalities were identified. On 21-MAR-2016, the patient was still experiencing dizziness and headaches. On 21-MAR-2016, the physician, who was examining the patient, stated that the patient reported that his sinuses felt "stuffy," but he was not experiencing vertigo or nystagmus. The physician reported that the patient was afebrile, normotensive, and his neurological assessment was within normal limits during exam on 21-MAR-2016. The patient was in the physician's care at the time of this report. The outcome of the events was reported as not recovered/not resolved at the time of the report. The relatedness between the adverse events and the suspect therapy was not reported. 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 registered nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 15-MAR-2016, the patient was vaccinated with one dose of improperly stored M-M-R II lot # L024267 exp. 01-JUL-2017 (site and route of administration were not reported). There was no adverse effects reported. The temperature of the storage was 9.5 Celsius degree for 25 minutes. There was no previous temperature excursion. The reporter was call because of a "data logger". No product quality issue was involved. Additional information has been requested.
Age: 3.46
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 15 week old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 21-MAR-2016, the patient received first dose of ROTATEQ 2 ml, orally (lot # and expiration date were not reported). There were no concomitant medications provided. There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning an unspecified patient of unknown age or gender. No concurrent condition, medical history and concomitant therapies were reported. On an unspecified date, a dose of improperly stored ZOSTAVAX (lot # L027321 with expire date 21-OCT-2015) (dosing and route not reported) was administered to the patient. The storage of the vaccine was 35F for 3 hours. There was no previous temperature excursion. No adverse effects were reported.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The reporter was reporting 2 doses of MMR II (lot # L026551, expiration date 16-JUL-2017) (dosage, strength and route unknown), that had been improperly stored (temperature and time frame: 34 degree F for 3 hours 24 minutes and 47 degree F for 6 minutes), were inadvertently administered to the unspecified patients on unspecified dates. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 21-MAR-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (0.5 ml, lot # K008409, expiry date: 04-MAR-2016, intramuscular) (expired vaccine used). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 29-JAN-2016, the patient was vaccinated with dose of ZOSTAVAX vial 19400 PFU, lot # L016284 (expiry date: 07-AUG-2016), which was stored in a freezer that was not monitored "since the dose was placed in the freezer on 11-AUG-2015". The temperature of the freezer was 14F during an inspection by the state board of pharmacy on an unspecified date. No adverse experience had been reported. No additional information was provided. This is one of several reported received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 02-FEB-2016, the patient was vaccinated with dose of ZOSTAVAX vial 19400 PFU, lot # L016284 (expiry date: 07-AUG-2016), which was stored in a freezer that was not monitored "since the dose was placed in the freezer on 11-AUG-2015". The temperature of the freezer was 14F during an inspection by the state board of pharmacy on an unspecified date. No adverse experience had been reported. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 01-DEC-2015, the patient was vaccinated with dose of ZOSTAVAX vial 194500 PFU, lot # L016284 (expiry date: 07-AUG-2016), which was stored in a freezer that was not monitored "since the dose was placed in the freezer on 11-AUG-2015". The temperature of the freezer was 14F during an inspection by the state board of pharmacy on an unspecified date. No adverse experience had been reported. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Malaise, Mumps, Rubulavirus test positive
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified patients of unknown demographics. On an unknown date the patients were vaccinated with 2 doses of MMR II (dose, route and lot # unspecified). No concomitant medications were reported. The nurse reported that she received an e-mail from one of her colleagues from student health center describing that the students had received during childhood one or two doses of immunization with MMR II vaccine. Two doses were thought to provide adequate immunity; however, in several recent mumps outbreaks, many of those who became ill had already been immunized with 2 doses of MMR II. The outcome of both the events was unknown. Causality assessment was not reported. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates, 4 doses of improperly stored (Merck) VARIVAX (lot # K006134, expired date 29-APR-2016, dose and route were unknown) were vaccinated to the patients. No concomitant therapy was reported. The vaccines were stored under -1.8 degrees Celsius for 4 hours and 3 minutes. The reporter stated that there was a previous temperature excursion (-0.8 degrees Celsius for 4 hours and 45 minutes) on an unknown date. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about patient's concomitant medications, concurrent conditions and medical history as not reported. On 01-FEB-2016 the patient was vaccinated with a dose of (Merck) VARIVAX (dose and route not reported, lot number L032394 with expiration date 26-AUG-2017) that had been improperly stored (temperature ranges: 5.5F to 11.8F and time frame: 11 hours and 30 minutes). It was reported that there was a previous temperature excursion: 11.5 F for 14 hours. No adverse effects were reported. This is one of three reports received from the same reporter (other linked case # 1603USA010044 and 1603USA010236). Additional information is not expected because there was no consent to contact the physician for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On  04-NOV-2015, the patient was vaccinated with dose of ZOSTAVAX vial 194500 PFU, lot # L016284 (expiry date: 07-AUG-2016), which was stored in a freezer that was not monitored "since the dose was placed in the freezer on 11-AUG-2015". The temperature of the freezer was 14F during an inspection by the state board of pharmacy on an unspecified date. No adverse experience had been reported. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps, Rubulavirus test positive
Clinical narrative: This spontaneous report was received from a nurse refers to a college aged patient of unknown demographics. On an unknown date the patient was vaccinated with 2 doses of MMR II (dose, route and lot # unspecified). No concomitant medications were reported. The nurse reported that she received an e-mail from one of her colleagues from student health center describing that a college-aged patient who received two doses of MMR II in the past, developed a confirmed case of mumps approximately in 2016. The SHC had been investigating a probable case of mumps in an undergraduate non-residential student that had now been confirmed by laboratory testing. It was assumed that this individual was contagious from 15-FEB-2016 through 20-FEB-2016 and was on-campus during a portion of this time. The outcome of mumps was unknown. Causality assessment was not reported. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 27-MAY-2015 the patient was vaccinated with the first dose of GARDASIL (lot# K001631 with expiration 06-NOV-2016 (expiration was also reported as 06-JAN-2016), 0.5 ml) intramuscularly. On 26-JUN-2015, the patient was vaccinated with the second dose of GARDASIL (lot# K023432 with expiration 18-JUN-2016, 0.5 ml) (Inappropriate schedule of vaccine administered). On 30-OCT-2015, the patient was vaccinated with the third dose of GARDASIL (lot# was reported as L016429 is an valid lot# for GARDASIL). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about patient's concomitant medications, concurrent conditions and medical history as not reported. On 29-JAN-2016 the patient was vaccinated with a dose of (Merck) VARIVAX (dose and route not reported, lot number L032394 with expiration date 26-AUG-2017) that had been improperly stored (temperature ranges: 5.5F to 11.8F and time frame: 11 hours and 30 minutes). It was reported that there was a previous temperature excursion: 11.5 F for 14 hours. No adverse effects were reported. This is one of three reports received from the same reporter (other linked case # 1603USA010044 and 1603USA010237). Additional information is not expected because there was no consent to contact the physician for follow up.
Age: 85.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Contusion, Death, Joint dislocation
Clinical narrative: Increase joint pain. Bruise noted (R) subluxed shoulder. Death - 4 days later.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 21-MAR-2016 the patient was inadvertently received an improperly stored dose of (Merck) VARIVAX (dose and route were not reported, lot# L038132 with expiration 01-OCT-2017) (incorrect product storage). The vaccines were exposed to excursion: -13.4 centigrade for 6 hours and 47 minutes. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about patient's concomitant medications, concurrent conditions and medical history as not reported. On 21-JAN-2016 the patient was vaccinated with a dose of (Merck) VARIVAX (dose and route not reported, lot number L032394 with expiration date 26-AUG-2017) that had been improperly stored (temperature ranges: 5.5F to 11.8F and time frame: 11 hours and 30 minutes). It was reported that there was a previous temperature excursion: 11.5 F for 14 hours. No adverse effects were reported. This is one of three reports received from the same reporter (other linked case # 1603USA010236 and 1603USA010237). Additional information is not expected because there was no consent to contact the physician for follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with the improperly stored dose of (Merck) VARIVAX (lot number reported as L020000 and expiration date 02-JUN-2017, lot number reported as L020001 and expiration date 02-JUN-2017, lot number reported as L019125 and expiration date 27-MAY-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with the improperly stored dose of PROQUAD (Merck) (lot number reported as L021599 and expiration date 10-DEC-2016, lot number reported as L009210 and expiration date 17-SEP-2016, lot number reported as L002419 and expiration date 23-JUL-2016, lot number reported as L027634 and expiration date 21-JAN-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Tic, Yawning
Clinical narrative: Open mouth yawn "tic" lasting anywhere from 10-20 seconds about 30 times an hour. Over the course of 2 week, duration has lessened to 1-5 seconds and frequency lessened to 1-4 times an hour. After a month it is only noticed a couple times a month for short frequencies.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: Mom reports Friday evening 03/18/2016 that a fever started and continued through Saturday evening reporting it was never higher than 101. She reported that she was able to manage it with Tylenol. Bumpy red rash also occurred and is more prominent on the right side from the hip to just above the knee.  Speaking to mom this morning 03/23/2016 she reports that the rash has neither increased nor decreased and that you can feel it more than you can see it.
Sex: U
Vaccine: HPVX, TDAP
Symptoms: Autopsy, Death
Clinical narrative: This case was reported in a literature article and described the occurrence of unknown cause of death in a subject who received dTpa vaccine. Co-suspect products included human papillomavirus quadrivalent vaccine. On an unknown date, 11 days after receiving dTpa vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to dTpa vaccine. Additional information was provided: This case was reported in a literature article and it described the occurrence of death in a patient of unspecified gender between the ages of 9 and 26 years who had received an unspecified tetanus-diphtheria-acellular pertussis booster and an unspecified quadrivalent HPV vaccine (manufacturers unknown). The authors identified this case while performing a retrospective review of medical records looking for deaths within 30 days of vaccination. No further information on the patient's concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, the patient received an unspecified tetanus-diphtheria-acellular pertussis booster and an unspecified quadrivalent HPV vaccine. Dosages unknown; administration routes and sites unspecified; batch numbers were not provided. On an unspecified date between 1 January 2005 and 31 December 2011, 11 days after the vaccination, the patient died of unknown causes. This was a fatal case and a post-mortem was performed, but no cause of death was identified by the coroner. Treatment was unknown. According to the authors, the Vaccine Safety Datalink working group determined the relationship between the vaccines and this death to be indeterminate due to the lack of information that made impossible to confirm or discard a causal association. The authors concluded that "to our knowledge, this study currently represents the largest population-based epidemiologic investigation of the association between vaccination and death among individuals 9 to 26 years of age. Although there has been significant research conducted on deaths after vaccination in both infants and older adults, this study fills a void by investigating deaths among older children and young adults. We assessed deaths after vaccination on a population level as well as an individual level to provide a complete evaluation of vaccine safety with regard to death. This research should reassure the public with regard to the safety of quadrivalent vaccine, as well as other vaccines routinely administered to individuals 9 to 26 years of age".
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 17-year-old female patient who received BEXSERO (batch number 149001, expiry date unknown). On 7th March 2016, the patient received BEXSERO .5 ml. On 7th March 2016, less than a day after receiving BEXSERO, the patient experienced injection site pain. The patient was treated with MOTRIN. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were received as follows: This case was previously reported to a doctor. This case was reported by a certified medical assistant. The patient experienced pain at the injection site, for over 8 days. The patient had been taking over the counter MOTRIN to treat the pain. The reporter did not know the expiration date of the product. The reporter provided the 15th August 2015 as the revision date for the product.
Sex: U
Vaccine: RAB
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of allergic reaction in a unk patient who received Rabies NVS (Rabies Vaccine). On an unknown date, the patient received Rabies vaccine. On an unknown date, an unknown time after receiving Rabies vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Rabies vaccine. Additional information was provided. The pharmacist stated that an unspecified patient had an unspecified allergic reaction to an unspecified lot/exp of Rabies vaccine on an unspecified date, ordered by an unspecified physician.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Rash, Urticaria
Clinical narrative: This spontaneous report as received from a healthcare worker and refers to a 61 year old male patient. The patient had no know drug allergies or reactions, there was no pertinent medical history. On 25-FEB-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose was not provided) lot # L037797, expiration date December 2016, subcutaneously in left upper arm. There was no concomitant medication. On 25-FEB-2016 about 21:00, the patient began to develop pain in the palms of his hands and on the bottoms of his feet, his feet were swelled and he developed either a rash or hives on his torso, between his fingers, and in his groin area. On 02-MAR-2016, the patient was examined by the physician who noted that the patient still had some evidence of a rash between his fingers and did not have a rash on the groin area. The swab was performed with result reported as "there was nothing to swab". It was also reported that there was no lab diagnostics studies performed. The outcome of adverse events was reported as recovering. The relatedness between adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Foot fracture, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: This spontaneous report was received from a 53 year old female patient and refers to herself. The patient's pertinent medical history included Sjogren's syndrome (an autoimmune disorder) since approximately 2003 (reported as 12  years prior to being administered ZOSTAVAX). The patient had a history of allergic reactions to codeine (unspecified dosage, lot #, expiration date, manufacturer) with onset of hives and "throwing up and passing out briefly" on unknown dates. On an unspecified date in the middle of January 2015, the patient was vaccinated with a dose ("1 shot") of ZOSTAVAX in the unspecified arm (strength, dose, route of administration, lot # and expiration date were not provided). The vaccination was recommended to the patient by a pharmacist. No information regarding the patient's concomitant therapies was reported. On an unspecified date in the middle of January 2015 (reported as since she received ZOSTAVAX, the patient experienced "not feeling well afterwards". On an unspecified date, the patient experienced "redness and arm swelling" at the injection site of ZOSTAVAX with lasted few weeks. The patient did not seek medical attention at this time but took TYLENOL (unspecified dosage, lot #, expiration date and manufacturer) as treatment for the arm swelling. On an unknown date, the patient experienced "chills in her legs and pain in the lower part of her legs". This pain was described as "seeing and feeling the veins popping out of her legs". The patient sought medical attention with three unspecified vascular doctors and one cardiologist on unspecified dates. The patient took NEURONTIN (unspecified dosage, lot #, expiration date and manufacturer) for her leg pain, but it "aggravated the symptoms" and she stopped this medication on an unspecified date. On  unknown dates, two studies were performed: a venous Doppler of her legs and an arterial study. Both studies "only showed normal aging results". On an unknown date, the patient broken her toe (case of this injury was  unknown). The outcome of not feeling well, injection site redness and arm swelling was not reported. The outcome of chills in her legs, pain in the lower part of her legs and broken toe was considered as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.