chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates on approximately 2015 (since the initial temperature excursion was reported on 14-MAY-2015), the patients were vaccinated with 12 doses of (Oka-Merck) PROQUAD subcutaneous injection, lot # K025760, expiration date 08-JUN-2016 (strength, dose and route of administration were not reported) which were improperly stored and exposed to a temperature excursion. No information on patients concomitant medication was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of the two reports from the same reporter.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from the patient's mother, concerning her female daughter of unknown age via Center (Other Company No. US15-027834). No concurrent conditions or medical history were reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL injection once (dose, route, Lot No. were not reported) (also reported as unknown indication). No concomitant therapy was provided. The mother reported, that on an unknown date, the second and third dose of GARDASIL were administered late to her daughter (she could not remember). As on 14-JUN-2015, the patient had completed her series of GARDASIL. This is one of several reports received from the same source. Additional information is not expected due to no consent to contact was given and the reporter refused to provide any safety report information.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient with tetracycline hypersensitivity and no pertinent medical history. On 08-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # L011533, expiration date reported as July 2016, 0.65 ml, subcutaneously. Concomitant therapies included hydrochlorothiazide (manufacturer unknown). In July 2015 (reported as after receiving ZOSTAVAX), the patient experienced redness and soreness at the injection site. The patient called pharmacist. No treatment was given for the adverse event. No lab diagnostics studies were performed. The outcome of injection site erythema and injection site pain was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 14-MAY-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is sone of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from nurse refers to a patient of unknown age. The patient's pertinent medical history was not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) as a child. Concomitant medications were not reported. On an unknown date (reported as now), the patient had negative anti-varicella antibody titers that were drawn on an unspecified date. No adverse effects were reported. No product quality complaint was reported for VARIVAX (Merck). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates in approximately 2015 (since the initial temperature excursion was reported on 14-MAY-2015), the patients were vaccinated with 30 doses of VARIVAX (Merck) subcutaneous injection, 0.5 ml, lot # K020757, expiration date 31-OCT-2016 (strength was not reported) which were improperly stored and exposed to a temperature excursion. No information on patients concomitant medication was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of the two reprots from the same reporter. 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 and a nurse refers to unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that, improperly stored doses of PNEUMOVAX 23 (single dose vials, route of administrations, doses, lot numbers and expiry dates were not reported) were given to unspecified patients on unspecified dates. No adverse experience was reported. No product quality complaint (PQC) was involved. Follow up has been received from a healthcare worker on 06-JUL-2015: It was reported that on 26-MAR-2014, the patient of unknown age and gender was vaccinated with improperly stored PNEUMOVAX 23 (Lot number: J014404, Expiry date: 22-JAN-2015). This is one of several reports from the same reporter. 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 and a nurse refers to unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that, improperly stored doses of PNEUMOVAX23 (single dose vials, route of administrations, doses, lot numbers and expiry dates were not reported) were given to unspecified patients on unspecified dates (Incorrect product storage). No adverse experience was reported. No product quality complaint (PQC) was involved. Follow up has been received from a healthcare worker on 06-JUL-2015: It was reported that on 20-JAN-2014, the patient of unknown age and gender was vaccinated with improperly stored PNEUMOVAX23 (Lot number: J010654, Expiry date: 17-OCT-2014). This is one of several reports from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain lower, Activities of daily living impaired, Asthenia, Chest discomfort, Disturbance in attention
Clinical narrative: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # E2015-08033) on 10-JUL-2015. Case received from Health Care Professional via health authorities on 08-JUL-2015 under the reference number DK-DKMA-ADR 23052207 and DK-DKMA-EF012592. The case is medically confirmed. The primary reporter was a physician. A 12-year old female patient had received the first and second dose of GARDASIL (batch number: D1: G004958 D2: G004958) via intramuscular route of administration in unspecified site on 27-OCT-2011 (D1) and 12-JAN -2012 (D2). On unspecified dates in 2012, she developed lower abdominal pain, nausea, concentration impairment, memory impairment and headache. On not reported dates, she developed chronic tiredness, dizziness, stinging skin (touch of the skin gives pain), itchy skin, blackout, energy loss, body pain that moves around, sensitive skin (a touch gives pain), chest pressure, the heart cramps and feels as if she has fever. The patient has  had absence from school due to the adverse reactions.  This case is serious due to the seriousness criteria disability and other medically important condition. No other vaccines or medications. The patient has been evaluated by the pediatric department and gynecologic department, where there were no remarks (not further specified). No information on medical history provided.  At the time of reporting, the patient had not recovered from lower abdominal pain, chronic fatigue, nausea, concentration impairment, memory impairment and headache. The outcome of the remaining reactions was unknown.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Headache, Hyperaesthesia, Loss of consciousness
Clinical narrative: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # E2015-08033) on 10-JUL-2015. Case received from Health Care Professional via health authorities on 08-JUL-2015 under the reference number DK-DKMA-ADR 23052207 and DK-DKMA-EF012592. The case is medically confirmed. The primary reporter was a physician. A 12-year old female patient had received the first and second dose of GARDASIL (batch number: D1: G004958 D2: G004958) via intramuscular route of administration in unspecified site on 27-OCT-2011 (D1) and 12-JAN -2012 (D2). On unspecified dates in 2012, she developed lower abdominal pain, nausea, concentration impairment, memory impairment and headache. On not reported dates, she developed chronic tiredness, dizziness, stinging skin (touch of the skin gives pain), itchy skin, blackout, energy loss, body pain that moves around, sensitive skin (a touch gives pain), chest pressure, the heart cramps and feels as if she has fever. The patient has  had absence from school due to the adverse reactions.  This case is serious due to the seriousness criteria disability and other medically important condition. No other vaccines or medications. The patient has been evaluated by the pediatric department and gynecologic department, where there were no remarks (not further specified). No information on medical history provided.  At the time of reporting, the patient had not recovered from lower abdominal pain, chronic fatigue, nausea, concentration impairment, memory impairment and headache. The outcome of the remaining reactions was unknown.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Memory impairment, Muscle spasms, Nausea, Pain, Pain of skin
Clinical narrative: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # E2015-08033) on 10-JUL-2015. Case received from Health Care Professional via health authorities on 08-JUL-2015 under the reference number DK-DKMA-ADR 23052207 and DK-DKMA-EF012592. The case is medically confirmed. The primary reporter was a physician. A 12-year old female patient had received the first and second dose of GARDASIL (batch number: D1: G004958 D2: G004958) via intramuscular route of administration in unspecified site on 27-OCT-2011 (D1) and 12-JAN -2012 (D2). On unspecified dates in 2012, she developed lower abdominal pain, nausea, concentration impairment, memory impairment and headache. On not reported dates, she developed chronic tiredness, dizziness, stinging skin (touch of the skin gives pain), itchy skin, blackout, energy loss, body pain that moves around, sensitive skin (a touch gives pain), chest pressure, the heart cramps and feels as if she has fever. The patient has  had absence from school due to the adverse reactions.  This case is serious due to the seriousness criteria disability and other medically important condition. No other vaccines or medications. The patient has been evaluated by the pediatric department and gynecologic department, where there were no remarks (not further specified). No information on medical history provided.  At the time of reporting, the patient had not recovered from lower abdominal pain, chronic fatigue, nausea, concentration impairment, memory impairment and headache. The outcome of the remaining reactions was unknown.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Pyrexia
Clinical narrative: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # E2015-08033) on 10-JUL-2015. Case received from Health Care Professional via health authorities on 08-JUL-2015 under the reference number DK-DKMA-ADR 23052207 and DK-DKMA-EF012592. The case is medically confirmed. The primary reporter was a physician. A 12-year old female patient had received the first and second dose of GARDASIL (batch number: D1: G004958 D2: G004958) via intramuscular route of administration in unspecified site on 27-OCT-2011 (D1) and 12-JAN -2012 (D2). On unspecified dates in 2012, she developed lower abdominal pain, nausea, concentration impairment, memory impairment and headache. On not reported dates, she developed chronic tiredness, dizziness, stinging skin (touch of the skin gives pain), itchy skin, blackout, energy loss, body pain that moves around, sensitive skin (a touch gives pain), chest pressure, the heart cramps and feels as if she has fever. The patient has  had absence from school due to the adverse reactions.  This case is serious due to the seriousness criteria disability and other medically important condition. No other vaccines or medications. The patient has been evaluated by the pediatric department and gynecologic department, where there were no remarks (not further specified). No information on medical history provided.  At the time of reporting, the patient had not recovered from lower abdominal pain, chronic fatigue, nausea, concentration impairment, memory impairment and headache. The outcome of the remaining reactions was unknown.
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Nausea
Clinical narrative: Pt was given MENVEO with no reaction, GARDASIL was given 2 minutes later. About one minute later the pt became nauseous and dizzy. Pt was layed down. BP was monitored with normal readings for the pt. An ice pack was placed on the back of the neck. Recovered in 25 min.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Abnormal behaviour, Atonic seizures, Crying, Dyskinesia, Food aversion
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of atonic seizures in a 7-month-old female patient who received PEDIARIX (batch number 4233K, expiry date 5th September 2016). Concurrent medical conditions included oral candidiasis (child presented at office visit with oral candidiasis - was prescribed Nystatin). Concomitant products included Hib, PREVNAR, nystatin and TYLENOL. On 18th March 2015, the patient received the 2nd dose of PEDIARIX (intramuscular) .5 ml. On 21st March 2015, 3 days after receiving PEDIARIX, the patient experienced atonic seizures (serious criteria disability, life threatening and other), staring, screaming, crying and movements abnormal. On an unknown date, the patient experienced oral intake reduced (serious criteria disability, life threatening and other) and behavior abnormal (serious criteria disability, life threatening and other). The patient was treated with diazepam and phenobarbital. PEDIARIX was discontinued. On an unknown date, the outcome of the atonic seizures, oral intake reduced, behavior abnormal, staring, screaming, crying and movements abnormal were recovering/resolving. It was unknown if the reporter considered the atonic seizures, oral intake reduced, behavior abnormal, staring, screaming, crying and movements abnormal to be related to PEDIARIX. Additional information was provided: The subject's mother had G6P4 and delivered this child at 40 weeks via C-section. Nurse reported that the patient received 2nd dose of PEDIARIX on 18 March 2015 along with PREVNAR and HIB, three days later the child experienced an atonic seizure described as staring in space, screaming and crying and spontaneous head movement. The child continued to have these issues noted per mother at an office visit on 01 May 2015 and even noted post Emergency room visit with this 6 weeks abnormal behaviour. An EEG was ordered, but unclear if that has been completed at time of this call. On 8 July 2015 the child was seen again in physician office and noted to be thriving and doing well. PREVNAR and PENTACEL were given at this visit. The patient was followed by neuro-physician, who recommended holding Pertussis component of vaccines. The child is being managed on diazepam and phenobarbital per nurse. From the visit on 01 May 2015 it also appears the child may have received TOPAMAX, but the nurse was not able to determine a date. The nurse also noted during this call that the child had also experienced chronic food aversion and decreased bottles for over a month.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Hypophagia, Screaming, Staring
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of atonic seizures in a 7-month-old female patient who received PEDIARIX (batch number 4233K, expiry date 5th September 2016). Concurrent medical conditions included oral candidiasis (child presented at office visit with oral candidiasis - was prescribed Nystatin). Concomitant products included Hib, PREVNAR, nystatin and TYLENOL. On 18th March 2015, the patient received the 2nd dose of PEDIARIX (intramuscular) .5 ml. On 21st March 2015, 3 days after receiving PEDIARIX, the patient experienced atonic seizures (serious criteria disability, life threatening and other), staring, screaming, crying and movements abnormal. On an unknown date, the patient experienced oral intake reduced (serious criteria disability, life threatening and other) and behavior abnormal (serious criteria disability, life threatening and other). The patient was treated with diazepam and phenobarbital. PEDIARIX was discontinued. On an unknown date, the outcome of the atonic seizures, oral intake reduced, behavior abnormal, staring, screaming, crying and movements abnormal were recovering/resolving. It was unknown if the reporter considered the atonic seizures, oral intake reduced, behavior abnormal, staring, screaming, crying and movements abnormal to be related to PEDIARIX. Additional information was provided: The subject's mother had G6P4 and delivered this child at 40 weeks via C-section. Nurse reported that the patient received 2nd dose of PEDIARIX on 18 March 2015 along with PREVNAR and HIB, three days later the child experienced an atonic seizure described as staring in space, screaming and crying and spontaneous head movement. The child continued to have these issues noted per mother at an office visit on 01 May 2015 and even noted post Emergency room visit with this 6 weeks abnormal behaviour. An EEG was ordered, but unclear if that has been completed at time of this call. On 8 July 2015 the child was seen again in physician office and noted to be thriving and doing well. PREVNAR and PENTACEL were given at this visit. The patient was followed by neuro-physician, who recommended holding Pertussis component of vaccines. The child is being managed on diazepam and phenobarbital per nurse. From the visit on 01 May 2015 it also appears the child may have received TOPAMAX, but the nurse was not able to determine a date. The nurse also noted during this call that the child had also experienced chronic food aversion and decreased bottles for over a month.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information as received from   a certified medical assistant (CMA) refers to a 12-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-JUN-2015, the patient was vaccinated with a dose of GARDASIL (lot number K014191 and expiration date 10-MAY-2017) (dose and route not reported) which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site reaction, Pain
Clinical narrative: Body aches, chills, 3-4" diameter circle around injection site.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Crying
Clinical narrative: Pt had imm. at HD at approx. 9:30. Within 1 hr she was crying inconsolably and continued to do so at her appt w/me at 3 pm same day. Mom had given TYLENOL which did not alter symptoms. Pt had high pitched scream.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot#, expiration date, dose and route were not provided). No adverse effects reported. This is one of several reports received 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 licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unspecified dates since June 2015, the patients were vaccinated with doses of VARIVAX (Merck) (lot#K007781, expiration date: 28-MAY-2016 and lot# reported as K006134, expiration date: 29-APR-2016; dose and route were not provided), that have been exposed to temperatures outside of the recommended range. No adverse effects have been reported. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information as received from a certified medical assistant (C.M.A.) refers to a 15-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2015, the patient was vaccinated with a dose of GARDASIL (lot number K014191 and expiration date 10-MAY-2017) (dose and route not reported) which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker and a nurse refers to unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that, improperly stored doses of PNEUMOVAX 23 (single dose vials, route of administrations, doses, lot numbers and expiry dates were not reported) were given to unspecified patients on unspecified dates. No adverse experience was reported. No product quality complaint (PQC) was involved. Follow up has been received from a healthcare worker on 06-JUL-2015: It was reported that on 04-MAR-2014, the patient of unknown age and gender was vaccinated with improperly stored PNEUMOVAX 23 (Lot number: J010654, Expiry date: 17-OCT-2014). This is one of several reports from the same reporter. 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 and a nurse refers to unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that, improperly stored doses of PNEUMOVAX 23 (single dose vials, route of administrations, doses, lot numbers and expiry dates were not reported) were given to unspecified patients on unspecified dates. No adverse experience was reported. No product quality complaint (PQC) was involved. Follow up has been received from a healthcare worker on 06-JUL-2015: It was reported that on 26-FEB-2014, the patient of unknown age and gender was vaccinated with improperly stored PNEUMOVAX 23 (Lot number: J010654, Expiry date: 17-OCT-2014). This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown dates, the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (lot #, expiration date, dose and route were not reported). No adverse reported. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Itching/redness and swelling (R) arm 7" x 5" round (L) arm redness.
Age: 31.0
Sex: F
Vaccine: DTOX, RAB
Symptoms: Blood test, Lumbar puncture, Muscle spasms, Nuclear magnetic resonance imaging spinal, Pain in extremity
Clinical narrative: First symptom was on 6/10/2015 a stabbing pain in same hand vaccine (rabies immunoglobulin) were given and then developed into muscle spasms in legs then arms throat. It is now July 14 and I have been hospitalized 3 times and have suffered tremendously and still am. I now to date have worsening cramps & stabbing pains in extremities to the point I can barely function.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Eye swelling, Urticaria
Clinical narrative: Hives all over body, swelling around eyes.
Age: 18.0
Sex: M
Vaccine: DTAP, HPV4
Symptoms: Fall, Laceration, Loss of consciousness, Mouth injury, Syncope
Clinical narrative: Patient blacked out from syncope or seizure falling off exam table and breaking front teeth, lacerations to tongue, and inside mouth. Cuts and bumps to forehead, under nose and neck.
Age: 18.0
Sex: M
Vaccine: DTAP, HPV4
Symptoms: Tongue injury, Tooth fracture
Clinical narrative: Patient blacked out from syncope or seizure falling off exam table and breaking front teeth, lacerations to tongue, and inside mouth. Cuts and bumps to forehead, under nose and neck.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Diarrhoea, Injection site erythema, Injection site pain
Clinical narrative: Patient experienced fever, chills, body aches, loss of appetite, and vomiting. Patient also experienced diarrhea later in the next day. Patient also had soreness/redness at the injection site. The site was also warm to the touch.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Pain, Pyrexia, Vomiting
Clinical narrative: Patient experienced fever, chills, body aches, loss of appetite, and vomiting. Patient also experienced diarrhea later in the next day. Patient also had soreness/redness at the injection site. The site was also warm to the touch.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Moderate redness and swelling at (R) upper arm at site of Tdap vaccine. Mildly tender to palpation. Seen on 7/14/15.
Age: 0.21
Sex: M
Vaccine: PNC13, RV5
Symptoms: Abdominal discomfort, Diarrhoea, Ultrasound abdomen
Clinical narrative: Onset of diarrhea within <24hr after vaccine administration. Diarrhea has not improved with up to 30 episodes within 24hr period. Significant GI distress. Abdominal ultrasound has been ordered with STAT referral placed to GI.
Sex: U
Vaccine: VARZOS
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. The patient's medical history and concurrent conditions were not reported. On 24-JUN-2015, the patient was vaccinated with an expired dose of ZOSTAVAX lot # J011341, expiration date: 13-DEC-2014, subcutaneous. No concomitant therapies were reported. No known adverse effects. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On the morning of 30-JUN-2015, PNEUMOVAX 23 (SDV, MDV OR ADDITIVE) (EA) 25 was improperly exposed to 9.6C for 7 minutes. Then later that same morning on 30-JUN-2015, the patient was vaccinated with improperly exposed PNEUMOVAX 23 (SD, MDV OR ADDITIVE) (EA) 25 (lot # K006681 and expiration date 21-OCT-2015), intramuscular. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (lot#, expiration date, dose and route were not provided). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea
Clinical narrative: 8-10 clear, yellow stools/per day starting 48 hrs. after patient received ROTARIX vaccine, continuing to today's date (7-14-15) for a total of 13 days with diarrhea. Seen for issue by APRN.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient states that his arm at site of injeciton became enlarged, hard and red.  He states the reaction spread to all away around his arm and that it returned to normal within 24 hours.
Age: 1.92
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: Asthenia, Bartonella test negative, Blood bicarbonate normal, Blood calcium normal, Blood glucose increased
Clinical narrative: Acute onset weakness, fussiness, inability to stand and fever. Neuro exam revealed normal DTRs with decreased tone. CSF analysis revealed 10 WBC, normal glucose and protein and no growth. Brain MRI normal times 3. Patient empirically received doxycycline for 10 days. IVIG and prednisolone given on day of illness 4. Clinical improvement noted on day of illness 12 with increasing purposeful extremity movements and interactive gaze and smile. Patient still hospitalized and waiting placement in inpatient rehabilitation facility.
Age: 1.92
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: Blood sodium normal, C-reactive protein normal, CSF culture negative, CSF glucose normal, CSF protein normal
Clinical narrative: Acute onset weakness, fussiness, inability to stand and fever. Neuro exam revealed normal DTRs with decreased tone. CSF analysis revealed 10 WBC, normal glucose and protein and no growth. Brain MRI normal times 3. Patient empirically received doxycycline for 10 days. IVIG and prednisolone given on day of illness 4. Clinical improvement noted on day of illness 12 with increasing purposeful extremity movements and interactive gaze and smile. Patient still hospitalized and waiting placement in inpatient rehabilitation facility.
Age: 1.92
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: CSF red blood cell count positive, CSF test, CSF white blood cell count negative, Cytomegalovirus test negative, Dysstasia
Clinical narrative: Acute onset weakness, fussiness, inability to stand and fever. Neuro exam revealed normal DTRs with decreased tone. CSF analysis revealed 10 WBC, normal glucose and protein and no growth. Brain MRI normal times 3. Patient empirically received doxycycline for 10 days. IVIG and prednisolone given on day of illness 4. Clinical improvement noted on day of illness 12 with increasing purposeful extremity movements and interactive gaze and smile. Patient still hospitalized and waiting placement in inpatient rehabilitation facility.
Age: 1.92
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: Ehrlichia test, Epstein-Barr virus test negative, Haemoglobin normal, Helicobacter test negative, Herpes simplex serology negative
Clinical narrative: Acute onset weakness, fussiness, inability to stand and fever. Neuro exam revealed normal DTRs with decreased tone. CSF analysis revealed 10 WBC, normal glucose and protein and no growth. Brain MRI normal times 3. Patient empirically received doxycycline for 10 days. IVIG and prednisolone given on day of illness 4. Clinical improvement noted on day of illness 12 with increasing purposeful extremity movements and interactive gaze and smile. Patient still hospitalized and waiting placement in inpatient rehabilitation facility.
Age: 1.92
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: Immunoglobulin therapy, Irritability, Laboratory test normal, Neurological examination abnormal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Acute onset weakness, fussiness, inability to stand and fever. Neuro exam revealed normal DTRs with decreased tone. CSF analysis revealed 10 WBC, normal glucose and protein and no growth. Brain MRI normal times 3. Patient empirically received doxycycline for 10 days. IVIG and prednisolone given on day of illness 4. Clinical improvement noted on day of illness 12 with increasing purposeful extremity movements and interactive gaze and smile. Patient still hospitalized and waiting placement in inpatient rehabilitation facility.
Age: 1.92
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: Parvovirus B19 test negative, Platelet count normal, Polymerase chain reaction, Pyrexia, Varicella virus test negative
Clinical narrative: Acute onset weakness, fussiness, inability to stand and fever. Neuro exam revealed normal DTRs with decreased tone. CSF analysis revealed 10 WBC, normal glucose and protein and no growth. Brain MRI normal times 3. Patient empirically received doxycycline for 10 days. IVIG and prednisolone given on day of illness 4. Clinical improvement noted on day of illness 12 with increasing purposeful extremity movements and interactive gaze and smile. Patient still hospitalized and waiting placement in inpatient rehabilitation facility.
Age: 1.92
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: West Nile virus test negative, White blood cell count normal, Yersinia test negative
Clinical narrative: Acute onset weakness, fussiness, inability to stand and fever. Neuro exam revealed normal DTRs with decreased tone. CSF analysis revealed 10 WBC, normal glucose and protein and no growth. Brain MRI normal times 3. Patient empirically received doxycycline for 10 days. IVIG and prednisolone given on day of illness 4. Clinical improvement noted on day of illness 12 with increasing purposeful extremity movements and interactive gaze and smile. Patient still hospitalized and waiting placement in inpatient rehabilitation facility.
Age: 15.0
Sex: M
Vaccine: HEPAB
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Twinrix vaccine (recommended for ages 18 and up) was administered to a patient age 15 years and 11 months.  No adverse effect occurred. Contacted manufacturer of vaccine GSK.  Was provided study data from a 180 patient sample of 15-18 year olds. Study reported 100% seroconvergence at 7 months to the Hepatitis A component of the vaccine and 98% and 100% seroconvergence to hepatitis B vaccine component among 2 sample groups in the study 7 months after receiving Twinrix.  Also contacted CDC and was told that Twinrix can count as a dose for the 15-18 year old population however with subsequent vaccinations, the child should receive the pediatric Hep A vaccine in 6 months and the pediatric Hepatitis B vaccine in 1 and 6 months.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Patient had a 1 minute grand mal seizure while at the lake with a relative. Was evaluated in a local ER and later released. No history of any previous seizures.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: patients left deltoid was swollen and red about 3 times normal size with pain pt was treated with a in office injection of dexamethasone sodium phosphate 1mg and told to take benadryl at home
Age: 37.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Pain, Palpitations, Pyrexia
Clinical narrative: SEVERE HEADACHE, PAIN, HEART PALPITATIONS, FEVER.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Nausea, Pain, Pyrexia
Clinical narrative: Body aches, nausea, feverish, right ankle burning pain, red, warm to touch.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Body aches, nausea, feverish, right ankle burning pain, red, warm to touch.
Age: 3.0
Sex: M
Vaccine: MMR, MNQ, TYP, YF
Symptoms: Dyspnoea, Eye swelling
Clinical narrative: Pt came to our clinic, has swelling of both eyes and mom states pt has difficulty breathing, brought to treatment room, epinephrine and Benadryl given, monitored and sent home when stable, F/U appt booked for 7/15/15.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: The patient has a quarter-sized red or pinkish skin discoloration at the site of injection that has not gone away after 6 weeks.  There is no pain, itching, or hardness to it.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site haematoma
Clinical narrative: The patient has a quarter-sized red or pinkish skin discoloration at the site of injection that has not gone away after 6 weeks.  There is no pain, itching, or hardness to it.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Aggression, Agitation, Decreased appetite, Diarrhoea
Clinical narrative: Mild fever, diarrhea, and loss of appetite began on 07/01/15 Measles rash began on 07/08/15 and persisted for four days.  Inconsolable screaming for hours at a time and violent behaviors such as biting and hitting has persisted since the day after the vaccination.  Behaviorally he is different, more agitated, violent, and fussy throughout the entire day.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Emotional distress, Irritability, Pyrexia, Rash morbilliform, Screaming
Clinical narrative: Mild fever, diarrhea, and loss of appetite began on 07/01/15 Measles rash began on 07/08/15 and persisted for four days.  Inconsolable screaming for hours at a time and violent behaviors such as biting and hitting has persisted since the day after the vaccination.  Behaviorally he is different, more agitated, violent, and fussy throughout the entire day.
Sex: U
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: This spontaneous report as received from a nurse via field representative refers to 2 patients of unknown demography. The patients pertinent medical history and drug allergies were unspecified. Approximately on an unknown date in 2007 (reported as approximately 8 or 9 years ago), the 2 patients were vaccinated with GARDASIL (dose, frequency and lot# were not reported) intramuscularly. Concomitant medications were unspecified. Approximately on an unknown date in 2007 (reported as approximately 8 or 9 years ago) subsequently after vaccination, the 2 patients experienced seizures. The outcome of seizures was unknown. The relatedness of the seizures with GARDASIL was not reported. No product quality complaint was reported for GARDASIL. Upon internal review, the seizures was determined to be medically significant event. Additional information is not expected as the reporter did not wish to contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 04-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL (lot #K006960 exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: HPV4
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 who on 23-JUN-2015 was vaccinated with a dose of GARDASIL lot # K006960 (route, dose, lot # and expiration date were not provided) which were exposed to temperatures outside of the recommended range during 63 hours excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified patients of unknown age and gender. On 23-JUN-2015 the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, lot and route not provided). No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX (lot number, expiration date, route of administration and strength were not reported). Then on an unspecified date, the patient was vaccinated with a second dose of ZOSTAVAX (lot number, expiration date, route of administration and strength were not reported) (extra dose administered). There were not adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 23-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL (lot # K006960 exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Age: 1.07
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Blood culture, C-reactive protein, Chest X-ray, Full blood count
Clinical narrative: This spontaneous report as received from a physician refers to a 13 month old female patient, whose medical history included pneumonia and urinary tract infection. Drug reactions/allergies were reported as none. On 01-JUN-2015 the patient was vaccinated with VARIVAX (Merck) (Lot # K010337 exp. date not reported) (0.5 ml, frequency and route were not reported). Concomitant therapies included iron (unspecified) and ceftriaxone. A 7-days course of prednisolone (manufacturer unknown) was started on 26-JUN-2015 (25 days after vaccine). On 01-JUL-2015, the patient experienced chickenpox, 5 days after she received prednisolone (manufacturer unknown) and 30 days after she received VARIVAX (Merck). The rash was described as clean vesicles, erupting to maculopapules from head-to-toe (including, but not limited to, vaccine administration site) and "spawing" palms/soles. Number of lesions was reported as 100s. On an unspecified date the patient's body temperature was 102.5 (units not provided). The patient did not have recent varicella zoster virus (VZV) exposure neither to chickenpox nor to shingles. On 08-JUL-2015 the patient was admitted to hospital. On 09-JUL-2015 a sample from vesicles, papules and scabs was collected for the varicella zoster virus identification program (VZVIP). Varicella-Zoster Virus (VZV) packet was faxed as requested by physician. No product quality complaint (PQC) was involved. The patient sought medical attention but did not receive treatment. Lab diagnostic studies were performed (complete metabolic panel, CRP, CBC, serum immunoglobulin, HIV, chest x-ray, blood culture) with unknown results. At the time of the report, patient was still hospitalized. The outcome of chickenpox was reported as recovering. The physician did not assess the causal relationship between the VARIVAX (Merck) and the chickenpox. Additional information is not expected because all follow-up has been received.
Age: 1.07
Sex: F
Vaccine: VARCEL
Symptoms: HIV test, Immunoglobulins, Metabolic function test, Rash generalised, Rash maculo-papular
Clinical narrative: This spontaneous report as received from a physician refers to a 13 month old female patient, whose medical history included pneumonia and urinary tract infection. Drug reactions/allergies were reported as none. On 01-JUN-2015 the patient was vaccinated with VARIVAX (Merck) (Lot # K010337 exp. date not reported) (0.5 ml, frequency and route were not reported). Concomitant therapies included iron (unspecified) and ceftriaxone. A 7-days course of prednisolone (manufacturer unknown) was started on 26-JUN-2015 (25 days after vaccine). On 01-JUL-2015, the patient experienced chickenpox, 5 days after she received prednisolone (manufacturer unknown) and 30 days after she received VARIVAX (Merck). The rash was described as clean vesicles, erupting to maculopapules from head-to-toe (including, but not limited to, vaccine administration site) and "spawing" palms/soles. Number of lesions was reported as 100s. On an unspecified date the patient's body temperature was 102.5 (units not provided). The patient did not have recent varicella zoster virus (VZV) exposure neither to chickenpox nor to shingles. On 08-JUL-2015 the patient was admitted to hospital. On 09-JUL-2015 a sample from vesicles, papules and scabs was collected for the varicella zoster virus identification program (VZVIP). Varicella-Zoster Virus (VZV) packet was faxed as requested by physician. No product quality complaint (PQC) was involved. The patient sought medical attention but did not receive treatment. Lab diagnostic studies were performed (complete metabolic panel, CRP, CBC, serum immunoglobulin, HIV, chest x-ray, blood culture) with unknown results. At the time of the report, patient was still hospitalized. The outcome of chickenpox was reported as recovering. The physician did not assess the causal relationship between the VARIVAX (Merck) and the chickenpox. Additional information is not expected because all follow-up has been received.
Age: 1.07
Sex: F
Vaccine: VARCEL
Symptoms: Scab, Skin lesion, Varicella post vaccine, Varicella virus test
Clinical narrative: This spontaneous report as received from a physician refers to a 13 month old female patient, whose medical history included pneumonia and urinary tract infection. Drug reactions/allergies were reported as none. On 01-JUN-2015 the patient was vaccinated with VARIVAX (Merck) (Lot # K010337 exp. date not reported) (0.5 ml, frequency and route were not reported). Concomitant therapies included iron (unspecified) and ceftriaxone. A 7-days course of prednisolone (manufacturer unknown) was started on 26-JUN-2015 (25 days after vaccine). On 01-JUL-2015, the patient experienced chickenpox, 5 days after she received prednisolone (manufacturer unknown) and 30 days after she received VARIVAX (Merck). The rash was described as clean vesicles, erupting to maculopapules from head-to-toe (including, but not limited to, vaccine administration site) and "spawing" palms/soles. Number of lesions was reported as 100s. On an unspecified date the patient's body temperature was 102.5 (units not provided). The patient did not have recent varicella zoster virus (VZV) exposure neither to chickenpox nor to shingles. On 08-JUL-2015 the patient was admitted to hospital. On 09-JUL-2015 a sample from vesicles, papules and scabs was collected for the varicella zoster virus identification program (VZVIP). Varicella-Zoster Virus (VZV) packet was faxed as requested by physician. No product quality complaint (PQC) was involved. The patient sought medical attention but did not receive treatment. Lab diagnostic studies were performed (complete metabolic panel, CRP, CBC, serum immunoglobulin, HIV, chest x-ray, blood culture) with unknown results. At the time of the report, patient was still hospitalized. The outcome of chickenpox was reported as recovering. The physician did not assess the causal relationship between the VARIVAX (Merck) and the chickenpox. Additional information is not expected because all follow-up has been received.