chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with improperly stored PNEUMOVAX 23 (incorrect product storage) (lot # K007826, expiry date 03-FEB-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with PNEUMOVAX 23 was unknown. There was no product quality complaint reported. It was reported that the vaccines were exposed to a temperature of 32.4 degrees Fahrenheit for a cumulative total of 13 hours. This is one of the 3 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (incorrect product storage) (lot # L023230, expiry date 26-JUL-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with GARDASIL 9 was unknown. There was no product quality complaint reported. It was reported that the vaccines were exposed to a temperature of 32.4 degrees Fahrenheit for a cumulative total of 13 hours. This is one of the 3 reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Autonomic nervous system imbalance, Fatigue, Hypersomnia, Malaise
Clinical narrative: This spontaneous report derives from an internet website where a currently approximately 20-year-old patient of unknown gender reported on themself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route and lot number were unknown). Soon after the vaccination, the patient faced with the extreme fatigue and was slacking in school. The patient was in the swim team but was unable to participate or go to practices. They would come home from school, fall asleep at 15 o'clock and would sleep through the next day. The patient would feel sick and unable to get up. The patient was taken to the diagnostic center where a diagnosis of dysautonomia was made, and then was sent to the neurologist for help with their frequent migraines. There was no preventative medication for the migraines and the only thing they could do was take TYLENOL with codeine and go asleep. Sleep helped take away the migraine. The patient did not recover from the adverse events ("still tired a lot and get migraines"), but they learned to deal with them. The reporter did not assess the relationship between the suspect drug and the events (the patient's doctors rejected the idea that the vaccine was associated with the events, they blamed it on dysautonomia and said that tiredness could be due to the fact that the patient was playing all of the sports and then suddenly stopped). This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: This spontaneous report derives from an internet website where a currently approximately 20-year-old patient of unknown gender reported on themself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route and lot number were unknown). Soon after the vaccination, the patient faced with the extreme fatigue and was slacking in school. The patient was in the swim team but was unable to participate or go to practices. They would come home from school, fall asleep at 15 o'clock and would sleep through the next day. The patient would feel sick and unable to get up. The patient was taken to the diagnostic center where a diagnosis of dysautonomia was made, and then was sent to the neurologist for help with their frequent migraines. There was no preventative medication for the migraines and the only thing they could do was take TYLENOL with codeine and go asleep. Sleep helped take away the migraine. The patient did not recover from the adverse events ("still tired a lot and get migraines"), but they learned to deal with them. The reporter did not assess the relationship between the suspect drug and the events (the patient's doctors rejected the idea that the vaccine was associated with the events, they blamed it on dysautonomia and said that tiredness could be due to the fact that the patient was playing all of the sports and then suddenly stopped). This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Eyelid oedema, Fatigue
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# F108235301 and 10823530) under the Freedom of Information Act on 20-JAN-2016 referring to a 11 year old male patient. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, anatomical location, lot number and expiration date were not provided). There were no concomitant medications reported. On 23-JAN-2015, the patient experienced abdominal pain upper, rash, vomiting, tonic clonic movements, staring, pyrexia, paraesthesia, oropharyngeal pain, nausea, malaise, loss of consciousness, hypoaesthesia, fatigue, eyelid oedema, diarrhoea and chills. No treatment was given for the adverse events. The outcome of eyelid oedema, vomiting, pyrexia, nausea, malaise, fatigue, chills, diarrhoea, abdominal pain upper, tonic clonic movements, oropharyngeal pain, rash, staring, paraesthesia, loss of consciousness and hypoaesthesia was reported as not recovered. The reporter did not assess the relatedness of the events with GARDASIL. The agency considered eyelid oedema, vomiting, pyrexia, nausea, malaise, fatigue, chills, diarrhoea, abdominal pain upper, tonic clonic movements, oropharyngeal pain, rash, staring, paraesthesia, loss of consciousness and hypoaesthesia as a medically significant events. The originally reporter was not provided. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Hypoaesthesia, Loss of consciousness, Malaise, Nausea, Oropharyngeal pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# F108235301 and 10823530) under the Freedom of Information Act on 20-JAN-2016 referring to a 11 year old male patient. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, anatomical location, lot number and expiration date were not provided). There were no concomitant medications reported. On 23-JAN-2015, the patient experienced abdominal pain upper, rash, vomiting, tonic clonic movements, staring, pyrexia, paraesthesia, oropharyngeal pain, nausea, malaise, loss of consciousness, hypoaesthesia, fatigue, eyelid oedema, diarrhoea and chills. No treatment was given for the adverse events. The outcome of eyelid oedema, vomiting, pyrexia, nausea, malaise, fatigue, chills, diarrhoea, abdominal pain upper, tonic clonic movements, oropharyngeal pain, rash, staring, paraesthesia, loss of consciousness and hypoaesthesia was reported as not recovered. The reporter did not assess the relatedness of the events with GARDASIL. The agency considered eyelid oedema, vomiting, pyrexia, nausea, malaise, fatigue, chills, diarrhoea, abdominal pain upper, tonic clonic movements, oropharyngeal pain, rash, staring, paraesthesia, loss of consciousness and hypoaesthesia as a medically significant events. The originally reporter was not provided. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Paraesthesia, Pyrexia, Rash, Staring, Tonic clonic movements
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# F108235301 and 10823530) under the Freedom of Information Act on 20-JAN-2016 referring to a 11 year old male patient. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, anatomical location, lot number and expiration date were not provided). There were no concomitant medications reported. On 23-JAN-2015, the patient experienced abdominal pain upper, rash, vomiting, tonic clonic movements, staring, pyrexia, paraesthesia, oropharyngeal pain, nausea, malaise, loss of consciousness, hypoaesthesia, fatigue, eyelid oedema, diarrhoea and chills. No treatment was given for the adverse events. The outcome of eyelid oedema, vomiting, pyrexia, nausea, malaise, fatigue, chills, diarrhoea, abdominal pain upper, tonic clonic movements, oropharyngeal pain, rash, staring, paraesthesia, loss of consciousness and hypoaesthesia was reported as not recovered. The reporter did not assess the relatedness of the events with GARDASIL. The agency considered eyelid oedema, vomiting, pyrexia, nausea, malaise, fatigue, chills, diarrhoea, abdominal pain upper, tonic clonic movements, oropharyngeal pain, rash, staring, paraesthesia, loss of consciousness and hypoaesthesia as a medically significant events. The originally reporter was not provided. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# F108235301 and 10823530) under the Freedom of Information Act on 20-JAN-2016 referring to a 11 year old male patient. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, anatomical location, lot number and expiration date were not provided). There were no concomitant medications reported. On 23-JAN-2015, the patient experienced abdominal pain upper, rash, vomiting, tonic clonic movements, staring, pyrexia, paraesthesia, oropharyngeal pain, nausea, malaise, loss of consciousness, hypoaesthesia, fatigue, eyelid oedema, diarrhoea and chills. No treatment was given for the adverse events. The outcome of eyelid oedema, vomiting, pyrexia, nausea, malaise, fatigue, chills, diarrhoea, abdominal pain upper, tonic clonic movements, oropharyngeal pain, rash, staring, paraesthesia, loss of consciousness and hypoaesthesia was reported as not recovered. The reporter did not assess the relatedness of the events with GARDASIL. The agency considered eyelid oedema, vomiting, pyrexia, nausea, malaise, fatigue, chills, diarrhoea, abdominal pain upper, tonic clonic movements, oropharyngeal pain, rash, staring, paraesthesia, loss of consciousness and hypoaesthesia as a medically significant events. The originally reporter was not provided. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Sever pain at injection site. Numbness and tingling in right arm. Shooting pain in arm when arm lifted over head.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Disorientation, Dissociation, Dizziness, Fatigue, Malaise
Clinical narrative: Disassociation, malaise, disorientation, lightheaded, fatigue.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ, lot # L008574, expiration date 22-NOV-2016 or lot # L027719, expiration date 28-APR-2017 (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of minimum 34 degrees Fahrenheit for 12 hours and a maximum 50 degrees Fahrenheit for 12 hours. It was reported that the patients sought unspecified medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Tremor
Clinical narrative: Uncontrollable shaking/shivering after going to bed. happened several times until falling asleep. No further reactions, no soreness.
Age: 31.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Patient did not know she was pregnant at the time of vaccine administration on 1/11/2016.  Pregnancy test was done the following week. Manufacturer of Flumist is Medimmune.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Needle issue, Syringe issue
Clinical narrative: Needle and base because unattached from syringe when pushing plunger in. Had to pull needle and base from patient's arm.
Age: 30.0
Sex: M
Vaccine: FLUN4
Symptoms: Angiogram cerebral, Bacterial test, Bacterial test positive, CSF cell count increased, Cognitive disorder
Clinical narrative: The patient developed aseptic meningoencephalitis with symptoms starting 10 days after the Flu Mist vaccination.  Had headache and cognition deficits.  Lumbar Puncture consistent with aseptic meningitis with a lymphocytic pleocytosis, MRI with meningeal inflammation, non specific EEG.  Was treated with empiric antibiotics and has made a gradual full recovery.
Age: 30.0
Sex: M
Vaccine: FLUN4
Symptoms: Cytomegalovirus test negative, Electroencephalogram, Encephalitis, Enterovirus test negative, Headache
Clinical narrative: The patient developed aseptic meningoencephalitis with symptoms starting 10 days after the Flu Mist vaccination.  Had headache and cognition deficits.  Lumbar Puncture consistent with aseptic meningitis with a lymphocytic pleocytosis, MRI with meningeal inflammation, non specific EEG.  Was treated with empiric antibiotics and has made a gradual full recovery.
Age: 30.0
Sex: M
Vaccine: FLUN4
Symptoms: Human metapneumovirus test, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Lumbar puncture abnormal
Clinical narrative: The patient developed aseptic meningoencephalitis with symptoms starting 10 days after the Flu Mist vaccination.  Had headache and cognition deficits.  Lumbar Puncture consistent with aseptic meningitis with a lymphocytic pleocytosis, MRI with meningeal inflammation, non specific EEG.  Was treated with empiric antibiotics and has made a gradual full recovery.
Age: 30.0
Sex: M
Vaccine: FLUN4
Symptoms: Meningitis aseptic, Mumps antibody test negative, Nuclear magnetic resonance imaging brain abnormal, Pleocytosis, Respiratory syncytial virus test negative
Clinical narrative: The patient developed aseptic meningoencephalitis with symptoms starting 10 days after the Flu Mist vaccination.  Had headache and cognition deficits.  Lumbar Puncture consistent with aseptic meningitis with a lymphocytic pleocytosis, MRI with meningeal inflammation, non specific EEG.  Was treated with empiric antibiotics and has made a gradual full recovery.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Cellulitis, Decreased appetite, Pain, Pyrexia, Somnolence
Clinical narrative: Cellulitis, fever, pain, lack of appetite, sleepy.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient is reporting soreness in arm when the patient extends arms overhead to work out or exercise.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates since 29-OCT-2015, the patients were vaccinated with improperly stored doses of VAQTA (lot # L022259 and expiration date 06-APR-2017, lot # J011385 and expiration date 10-MAR-2016; exact doses and route of administration were not reported). It was reported that since 29-OCT-2015, the vaccines were exposed to temperature of 32.3F during cumulative of 7 hours. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 unspecified single dose vial (SDV)/prefilled syringe, lot # L012215 (dose, route of administration and expiry date were not specified). On an unknown date, the patient experienced unspecified adverse reaction. It was not specified if the patient sought any medical attention and if any treatment was given for the adverse event. The outcome of the event was not reported. The reporter did not provide the relatedness between the adverse reaction and PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates since 29-OCT-2015, the patients were vaccinated with improperly stored doss of ROTATEQ (lot # L004456, expiration date 07-AUG-2016, exact doses were not reported), orally. It was reported that since 29-OCT-2015, the vaccines were exposed to temperature of 32.3F during cumulative of 7 hours. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Patient's pertinent medical history and concurrent conditions were not reported. On 16-JAN-2016, the patient was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck), (route, strength, dose, frequency, lot number and expiration date were not reported). No concomitant medications were reported. No adverse event was reported and no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates since 29-OCT-2015, the patient were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # K012875, expiration date 27-AUG-2016, exact doses and route of administration were not reported). It was reported that since 29-OCT-2015, the vaccines were exposed to temperature of 32.3F during cumulative of 7 hours. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received form the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates since 29-OCT-2015, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # K008679 and expiration date 05-MAR-2017, lot # K026533 and expiration date 07-AUG-2017; exact doses and route of administration were not reported). It was reported that since 29-OCT-2015, the vaccines were exposed to temperature of 32.3F during cumulative of 7 hours. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (who was an office manager) refers to a 16 year old male patient. No information regarding the patient's medical history or concurrent conditions was provided. On 31-JUL-2014, the patient was vaccinated with the first dose of GARDASIL injection (lot# J006850, expiry date 31-MAR-2016; dose and route of administration were not reported). He received his second dose of GARDASIL injection (lot# K011492, expiry date 22-JUN-2016) on 16-OCT-2014, and the patient's third dose was GARDASIL 9 injection (lot# L007495, expiry date 24-FEB-2017; dose and route of administration were not reported), received on 06-AUG-2015. There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On approximately 1996 (reported as 20 years ago) the patient was administered a series of RECOMBIVAX HB injection (lot#, dose and route of administration not provided) at the following scheduled: 0, 2 and 16 months later. This was outside the current recommendations. No adverse effects reported. No PQC involved. No concomitant therapy reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates since 29-OCT-2015, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K007828, expiration date 02-MAR-2017, exact doses and route of administration were not reported). It was reported that since 29-OCT-2015, the vaccines were exposed to temperature of 32.3F during cumulative of 7 hours. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L018351, expiration date 11-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of minimum 34 degrees Fahrenheit for 12 hours and a maximum 50 degrees Fahrenheit for 12 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abdominal discomfort, Eye pain, Headache, Injection site pain, Pain
Clinical narrative: Her right arm hurts from her shoulder to her mid-upper arm. Hurts to put her bra on, lift her arm above her head, reaching back, and lying on that side.  Has also had a headache, says her eyes hurt since 2 days ago when it was received. Started yesterday (1/12/16) and was off and on. Worse today (1/13/16) compared to yesterday. Has also had an upset stomach, worse today. She is right handed and had her flu shot given in her left arm the same day.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Local swelling, Pain in extremity, Pyrexia
Clinical narrative: Pain on right arm, chills, fever, area is red and swollen.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Adverse reaction
Clinical narrative: Just stated had a reaction wanted to know what else to do besides ice. Told to use ADVIL/TYLENOL. Called 1/20/16 at 11 am. Called mom 1/21 said it was Rt arm.
Age: 10.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Warm to touch, pushes on it sensitive, redness, swelling below the area. Told to try ice and ibuprofen. Called on 1/20/16 at 5:20pm.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On unknown dates since 29-OCT-2015, the patients were vaccinated with improperly stored doses of GARDASIL  9 (lot # reported as L0245711, expiration date 08-MAY-2017, exact doses and route of administration were not reported). It was reported that since 29-OCT-2015, the vaccines were exposed to temperature of 32.3F during cumulative of 7 hours. No adverse effects were reported. No PQC (product quality complaint) was involved. 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 was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates since 29-OCT-2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # K021881 and expiration date 30-JUN-2016, lot # L008664 and expiration date 03-NOV-2016; exact doses and route of administration were not reported). It was reported that since 29-OCT-2015, the vaccines were exposed to temperature of 32.3F during cumulative of 7 hours. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Blood test, Computerised tomogram head, Crying
Clinical narrative: Her symptoms began with dizziness in the morning. The following week she developed an ongoing headache with extreme fatigue.  I took her back and forth to the doctor told she needed more sleep and water. Her next symptom was shortness of breath and fast heart rate with increased headache. We were sent to a cardiologist who then sent us to a neurologist. After ER visits, rheumatology, endocrinology, and two more neurologist we still had no help for my daughter who cannot think anymore her muscle and joint pain is crippling and her head hurts so bad she cannot open her eyes.  The symptoms just keep coming we are not faced with gastric issues adding to her pain. We received a POTS diagnosis from two neurologists. My daughter cannot play, read, think, stand up, take a shower.  She just lays and cries all day every day.  My straight A student is now a shell of who she used to be.  In pain and not able to care for her basic needs.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Dyspnoea, Dysstasia, Echocardiogram, Electrocardiogram
Clinical narrative: Her symptoms began with dizziness in the morning. The following week she developed an ongoing headache with extreme fatigue.  I took her back and forth to the doctor told she needed more sleep and water. Her next symptom was shortness of breath and fast heart rate with increased headache. We were sent to a cardiologist who then sent us to a neurologist. After ER visits, rheumatology, endocrinology, and two more neurologist we still had no help for my daughter who cannot think anymore her muscle and joint pain is crippling and her head hurts so bad she cannot open her eyes.  The symptoms just keep coming we are not faced with gastric issues adding to her pain. We received a POTS diagnosis from two neurologists. My daughter cannot play, read, think, stand up, take a shower.  She just lays and cries all day every day.  My straight A student is now a shell of who she used to be.  In pain and not able to care for her basic needs.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Electroencephalogram, Fatigue, Gastric disorder, Headache, Heart rate increased
Clinical narrative: Her symptoms began with dizziness in the morning. The following week she developed an ongoing headache with extreme fatigue.  I took her back and forth to the doctor told she needed more sleep and water. Her next symptom was shortness of breath and fast heart rate with increased headache. We were sent to a cardiologist who then sent us to a neurologist. After ER visits, rheumatology, endocrinology, and two more neurologist we still had no help for my daughter who cannot think anymore her muscle and joint pain is crippling and her head hurts so bad she cannot open her eyes.  The symptoms just keep coming we are not faced with gastric issues adding to her pain. We received a POTS diagnosis from two neurologists. My daughter cannot play, read, think, stand up, take a shower.  She just lays and cries all day every day.  My straight A student is now a shell of who she used to be.  In pain and not able to care for her basic needs.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Mental impairment, Myalgia, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Postural orthostatic tachycardia syndrome
Clinical narrative: Her symptoms began with dizziness in the morning. The following week she developed an ongoing headache with extreme fatigue.  I took her back and forth to the doctor told she needed more sleep and water. Her next symptom was shortness of breath and fast heart rate with increased headache. We were sent to a cardiologist who then sent us to a neurologist. After ER visits, rheumatology, endocrinology, and two more neurologist we still had no help for my daughter who cannot think anymore her muscle and joint pain is crippling and her head hurts so bad she cannot open her eyes.  The symptoms just keep coming we are not faced with gastric issues adding to her pain. We received a POTS diagnosis from two neurologists. My daughter cannot play, read, think, stand up, take a shower.  She just lays and cries all day every day.  My straight A student is now a shell of who she used to be.  In pain and not able to care for her basic needs.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Sweat test, Tilt table test positive
Clinical narrative: Her symptoms began with dizziness in the morning. The following week she developed an ongoing headache with extreme fatigue.  I took her back and forth to the doctor told she needed more sleep and water. Her next symptom was shortness of breath and fast heart rate with increased headache. We were sent to a cardiologist who then sent us to a neurologist. After ER visits, rheumatology, endocrinology, and two more neurologist we still had no help for my daughter who cannot think anymore her muscle and joint pain is crippling and her head hurts so bad she cannot open her eyes.  The symptoms just keep coming we are not faced with gastric issues adding to her pain. We received a POTS diagnosis from two neurologists. My daughter cannot play, read, think, stand up, take a shower.  She just lays and cries all day every day.  My straight A student is now a shell of who she used to be.  In pain and not able to care for her basic needs.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Pruritus, Rash, Somnolence
Clinical narrative: The patient developed itching, rash, difficulty breathing within 15 to 30 minutes. She was given a dose of Benadryl which helped relieve symptoms. She then became drowsy.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient was given immunization at 7:30 am 1/12/16, by the afternoon arm was sore, by the evening movement was painful, by the next morning pain started moving down her arm. Swollen and redness.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Register Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 23-DEC-2015 the patient was vaccinated with improperly stored dose of VARIVAX (Merck) lot # L029472, expiration date in: 06-AUG-2017 (dose and route were not provided). Concomitant therapies were not provided. The register nurse reported a temperature excursion with the following vaccine: VARIVAX (Merck), (Lot #: L029472 Expiration date on: 06-AUG-2017), Temperature: 7 degrees C, Time frame: 1 month, Outcome of excursion VARIVAX (Merck) must be used within 1 month. No adverse events were reported. No product quality complaint was involved. This is one of two cases from the same reporter (MARRS # 1601USA003459). Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: PREVNAR vaccine administered on this date. Later it was discovered patient had already received the vaccine from physician (despite patient attestation to the contrary).
Age: 36.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Abasia, Coordination abnormal
Clinical narrative: Poor coordination LE's. Cannot walk. Was sent to the hospital.
Age: 36.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Dizziness, Pain
Clinical narrative: Poor coordination LE's. Cannot walk. Was sent to the hospital.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Severe pain at the left shoulder radiating to left deltoid, associated with tingling and sharp pains to the left forearm and hand. There is less strength.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Asthenia, Pain, Poor quality sleep
Clinical narrative: Severe pain that has not gone away since the injection.  The pain wakes me up at night.  I also feel a weakness that makes dressing difficult and using the arm for lifting items.
Age: 0.85
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives treated with Benadryl.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 3 hours after vaccine administration he noted onset of pain, burning and redness to upper left arm. 3 days later he went to the emergency room with worsening of left arm erythema.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Antibody test, Blood culture, Body temperature increased, Influenza virus test, Laboratory test normal
Clinical narrative: 18 y/o M who on 19 Jan 2016 noticed rash starting on the chest. No other symptoms, no fever, no known eczema or immunocompromising conditions. On 22 Jan 2016, patient evaluated by local provider who contacted CDC with concerns that rash could be generalized vaccinia, and vaccine lives in dormitory setting (Patient has roommate and shares facilities with others whose health hx is not known). Patient was admitted to local hospital where specimens from lesions were sent for vaccinia PCR --> negative (See lab data that follows). Patient's hospital course (3 days - discharged on 25 Jan 2016) was uneventful, but he did spike a temperature of 102.2. No other systemic symptoms.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Measles antibody, Polymerase chain reaction, Rash, Rubella antibody positive, Streptococcus test
Clinical narrative: 18 y/o M who on 19 Jan 2016 noticed rash starting on the chest. No other symptoms, no fever, no known eczema or immunocompromising conditions. On 22 Jan 2016, patient evaluated by local provider who contacted CDC with concerns that rash could be generalized vaccinia, and vaccine lives in dormitory setting (Patient has roommate and shares facilities with others whose health hx is not known). Patient was admitted to local hospital where specimens from lesions were sent for vaccinia PCR --> negative (See lab data that follows). Patient's hospital course (3 days - discharged on 25 Jan 2016) was uneventful, but he did spike a temperature of 102.2. No other systemic symptoms.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Varicella virus test negative, White blood cell count increased
Clinical narrative: 18 y/o M who on 19 Jan 2016 noticed rash starting on the chest. No other symptoms, no fever, no known eczema or immunocompromising conditions. On 22 Jan 2016, patient evaluated by local provider who contacted CDC with concerns that rash could be generalized vaccinia, and vaccine lives in dormitory setting (Patient has roommate and shares facilities with others whose health hx is not known). Patient was admitted to local hospital where specimens from lesions were sent for vaccinia PCR --> negative (See lab data that follows). Patient's hospital course (3 days - discharged on 25 Jan 2016) was uneventful, but he did spike a temperature of 102.2. No other systemic symptoms.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with an improperly stored dose of GARDASIL, lot # K011562, expiration date 08-APR-2017, (strength, dose number, route and anatomical location were not reported). No adverse effects reported. The reporter stated that the vaccine was exposed to a temperature of 34F during 12 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from company representative via nurse practitioner refers to a patient of unknown demography. On an unknown date the patient was vaccinated with GARDASIL (dose and frequency were not reported) intramuscularly. The company representative reported off label use of GARDASIL (it cannot be determined if the product was GARDASIL or GARDASIL 9). The nurse reported that the patient received the third dose of GARDASIL only one month after the second dose was administered. No adverse effect reported. The outcome of off label use was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information is not expected as the reporter did not wish to be contacted.
Age: 71.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Sleep disorder, X-ray
Clinical narrative: Tenderness around the injection. Just kept getting worse to where I couldn't lift my arm and still to this date I have a joint shoulder/arm pain that prevents me from sleeping at night.
Age: 71.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Sleep disorder, X-ray normal
Clinical narrative: Tenderness around the injection. Just kept getting worse to where I couldn't lift my arm and still to this date I have a joint shoulder/arm pain that prevents me from sleeping at night.
Age: 12.0
Sex: F
Vaccine: FLUN4, HEPA, HPV9, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient had momentary loss of consciousness following HPV-9 which was final immunization. Recovered spontaneously.
Age: 0.78
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Pt developed a papular rash on the site of injection (left thigh) which progressed over the thigh, left arm and left temple over the next three days.
Age: 6.0
Sex: M
Vaccine: HIBV, MNQ, PPV, VARCEL
Symptoms: Full blood count, Injection site haemorrhage, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Client had an order from hospital to give PPSV 23, HIB, and Menveo. Client went to ER around midnight with complaints of right arm swelling and pain. Received a phone call from local pediatrician's office today stating that this child was admitted because he bleed out from the injection site of the varicella. States it was the subclavian area but unsure what side. Was asked that we do not give her special need children any shots without her approval. This RN called the hospital and found out the following information. The child went to the ER on 01/21/2016 with complaints of right shoulder pain and swelling. Child had labs of a CBC drawn. Was admitted on 01/22/2016 and discharged home on 01/23/2016. Child was given antibiotics, steroids, and Privigen while at the hospital.
Age: 6.0
Sex: M
Vaccine: HIBV, MNQ, PPV, VARCEL
Symptoms: Peripheral swelling, Platelet count decreased
Clinical narrative: Client had an order from hospital to give PPSV 23, HIB, and Menveo. Client went to ER around midnight with complaints of right arm swelling and pain. Received a phone call from local pediatrician's office today stating that this child was admitted because he bleed out from the injection site of the varicella. States it was the subclavian area but unsure what side. Was asked that we do not give her special need children any shots without her approval. This RN called the hospital and found out the following information. The child went to the ER on 01/21/2016 with complaints of right shoulder pain and swelling. Child had labs of a CBC drawn. Was admitted on 01/22/2016 and discharged home on 01/23/2016. Child was given antibiotics, steroids, and Privigen while at the hospital.
Age: 1.56
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Abasia, Body temperature increased, Cough, Crying, Diarrhoea
Clinical narrative: Left leg swollen with hives, 103 temperature.  Mom says child cried for 1 hour, could not walk on leg. Child started vomiting at the Hospital.  Child was given Benadryl, Motrin and phenergan.  Mom reports child developed a cough and diarrhea at ER.  Mom says child still has a little diarrhea today.
Age: 1.56
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site swelling, Injection site urticaria, Vomiting
Clinical narrative: Left leg swollen with hives, 103 temperature.  Mom says child cried for 1 hour, could not walk on leg. Child started vomiting at the Hospital.  Child was given Benadryl, Motrin and phenergan.  Mom reports child developed a cough and diarrhea at ER.  Mom says child still has a little diarrhea today.
Age: 0.61
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Apnoea, Body temperature increased, Chest X-ray normal, Cyanosis, Electrocardiogram normal
Clinical narrative: Pt. became limp, apneic with oral and peri-oral cyanosis x2 min several hours after receving vaccines. Mom gave rescue breaths and called EMS. When they came, Pulse Ox- 100% while on oxygen. Taken to local ER where CXR obtained (and as per Mom; no records available) it looked good. 2 hours later, in ER, Temp was 103.9.
Age: 0.61
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Hypotonia
Clinical narrative: Pt. became limp, apneic with oral and peri-oral cyanosis x2 min several hours after receving vaccines. Mom gave rescue breaths and called EMS. When they came, Pulse Ox- 100% while on oxygen. Taken to local ER where CXR obtained (and as per Mom; no records available) it looked good. 2 hours later, in ER, Temp was 103.9.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Local injection site rxns (swelling, redness, sore arm).
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with an improperly stored oral, ROTATEQ, lot # L008996, expiration date 01-DEC-2016, (strength and dose number were not reported). No adverse effects reported. The reporter stated that the vaccine was exposed to a temperature of 34F during 12 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Chronic throat clearing, Cough, Ocular hyperaemia, Rash
Clinical narrative: Acute mild anaphylactic like reaction may have been due to nuts consumed and unrelated to vaccine. This child received varicella vaccine in this office this afternoon. The father left after a few minutes, and almost as soon as he got into his automobile, the child began to cough, more than would be expected with just clearing his throat. The father gave him a food bar-containing figs. Almost immediately after receiving this he developed very prominent congestion. The father noted that he began to develop a rash on the face and had significant redness of the eyes and profuse rhinorrhea. Father immediately returned to the office for evaluation. This child does have a history of having had a positive very weak RAST test to eggs, but tolerates eating eggs without difficulty. He has not had difficulties with influenza vaccine. He had very similar reaction in the past to contact with a latex balloon, developing the nasal symptoms, cough and rash.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Respiratory tract infection, Rhinorrhoea
Clinical narrative: Acute mild anaphylactic like reaction may have been due to nuts consumed and unrelated to vaccine. This child received varicella vaccine in this office this afternoon. The father left after a few minutes, and almost as soon as he got into his automobile, the child began to cough, more than would be expected with just clearing his throat. The father gave him a food bar-containing figs. Almost immediately after receiving this he developed very prominent congestion. The father noted that he began to develop a rash on the face and had significant redness of the eyes and profuse rhinorrhea. Father immediately returned to the office for evaluation. This child does have a history of having had a positive very weak RAST test to eggs, but tolerates eating eggs without difficulty. He has not had difficulties with influenza vaccine. He had very similar reaction in the past to contact with a latex balloon, developing the nasal symptoms, cough and rash.