chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Abnormal behaviour, Arthralgia, Asthenia, Attention deficit/hyperactivity disorder, Blood test
Clinical narrative: About 1-2 weeks following flu shot, child experienced off/on severe headache, low grade fever, nausea and fatigue. On night of 12/25/2016, child experienced 103 degree fever, chills, fatigue, body aches, red cheeks, loss of appetite. Fever broke roughly by 12/27/2016. Child had loss of appetite for next few weeks. Child awoke on 1/11/17 with sudden, severe, debilitating OCD like symptoms and would not touch objects due to severe fear of germs. OCD gradually increased to the point of seeking emergency treatment on 2/4/17. Child would not step on floor in the morning to get out of bed, stating she can't do it because it is "dirty". She also had severe separation anxiety, inconsolable crying, tantrums, refused food although hungry, daytime urinary incontinence and would not let anyone touch her (never experienced any of these symptoms in past). ER staff bewildered. Recommended inpatient or partial hospitalization psych services. Parents declined as it was explained neither inpatient or partial psych hospitalization does not treat OCD. Child enrolled in outpatient therapy and OCD improved within 3 weeks to about 95%. Pt again awoke on 3/31/17 with severe debilitating OCD like symptoms, more severe than the last episode. This time, she also experienced motor facial tics with mouth, chorea like movements in arms and shoulders, severe headaches, dilated pupils in broad daylight, extremely fidgety, ADHD type symptoms, impulsivity, constantly putting hands in mouth in odd manner, vocal throat clearing tics, repeating same word three times, occasional knee pain, loss of math skills, decline in handwriting abilities at school, extreme defiance, irritability, inability to sleep due to involuntary movements of legs at night, severe separation anxiety, inconsolable crying, mild regression for 1-2 week period  thumb sucking, baby talk, playing with baby toys. The focus of the OCD obsessions switched from "germ fears" to "doing everything perfectly and repeating each little task", such as walking up and down the same step for hours, walking in and out of doorways for hours trying to get it "just right". Pt saw therapist who mentioned possible PANDAS/PANS diagnosis. Child's symptoms have somewhat subsided, but are still present to date and fluctuate day to day. Child still experiences motor tics of face and arms and repeats odd behaviors stating she can't make herself stop. Child did 3.5 hours of cartwheels nonstop yesterday as she cried hysterically that she could not make herself stop. Child lost the ability to handwrite clearly and lost math skills, dropping three grade points in school since this began. On 5/22/17 child was diagnosed with PANDAS/PANS as result of vaccine injury that triggered an autoimmune response which is attacking the brain.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Chorea, Crying, Decreased appetite, Defiant behaviour
Clinical narrative: About 1-2 weeks following flu shot, child experienced off/on severe headache, low grade fever, nausea and fatigue. On night of 12/25/2016, child experienced 103 degree fever, chills, fatigue, body aches, red cheeks, loss of appetite. Fever broke roughly by 12/27/2016. Child had loss of appetite for next few weeks. Child awoke on 1/11/17 with sudden, severe, debilitating OCD like symptoms and would not touch objects due to severe fear of germs. OCD gradually increased to the point of seeking emergency treatment on 2/4/17. Child would not step on floor in the morning to get out of bed, stating she can't do it because it is "dirty". She also had severe separation anxiety, inconsolable crying, tantrums, refused food although hungry, daytime urinary incontinence and would not let anyone touch her (never experienced any of these symptoms in past). ER staff bewildered. Recommended inpatient or partial hospitalization psych services. Parents declined as it was explained neither inpatient or partial psych hospitalization does not treat OCD. Child enrolled in outpatient therapy and OCD improved within 3 weeks to about 95%. Pt again awoke on 3/31/17 with severe debilitating OCD like symptoms, more severe than the last episode. This time, she also experienced motor facial tics with mouth, chorea like movements in arms and shoulders, severe headaches, dilated pupils in broad daylight, extremely fidgety, ADHD type symptoms, impulsivity, constantly putting hands in mouth in odd manner, vocal throat clearing tics, repeating same word three times, occasional knee pain, loss of math skills, decline in handwriting abilities at school, extreme defiance, irritability, inability to sleep due to involuntary movements of legs at night, severe separation anxiety, inconsolable crying, mild regression for 1-2 week period  thumb sucking, baby talk, playing with baby toys. The focus of the OCD obsessions switched from "germ fears" to "doing everything perfectly and repeating each little task", such as walking up and down the same step for hours, walking in and out of doorways for hours trying to get it "just right". Pt saw therapist who mentioned possible PANDAS/PANS diagnosis. Child's symptoms have somewhat subsided, but are still present to date and fluctuate day to day. Child still experiences motor tics of face and arms and repeats odd behaviors stating she can't make herself stop. Child did 3.5 hours of cartwheels nonstop yesterday as she cried hysterically that she could not make herself stop. Child lost the ability to handwrite clearly and lost math skills, dropping three grade points in school since this began. On 5/22/17 child was diagnosed with PANDAS/PANS as result of vaccine injury that triggered an autoimmune response which is attacking the brain.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Developmental regression, Diet refusal, Dyscalculia, Dysgraphia, Dyskinesia
Clinical narrative: About 1-2 weeks following flu shot, child experienced off/on severe headache, low grade fever, nausea and fatigue. On night of 12/25/2016, child experienced 103 degree fever, chills, fatigue, body aches, red cheeks, loss of appetite. Fever broke roughly by 12/27/2016. Child had loss of appetite for next few weeks. Child awoke on 1/11/17 with sudden, severe, debilitating OCD like symptoms and would not touch objects due to severe fear of germs. OCD gradually increased to the point of seeking emergency treatment on 2/4/17. Child would not step on floor in the morning to get out of bed, stating she can't do it because it is "dirty". She also had severe separation anxiety, inconsolable crying, tantrums, refused food although hungry, daytime urinary incontinence and would not let anyone touch her (never experienced any of these symptoms in past). ER staff bewildered. Recommended inpatient or partial hospitalization psych services. Parents declined as it was explained neither inpatient or partial psych hospitalization does not treat OCD. Child enrolled in outpatient therapy and OCD improved within 3 weeks to about 95%. Pt again awoke on 3/31/17 with severe debilitating OCD like symptoms, more severe than the last episode. This time, she also experienced motor facial tics with mouth, chorea like movements in arms and shoulders, severe headaches, dilated pupils in broad daylight, extremely fidgety, ADHD type symptoms, impulsivity, constantly putting hands in mouth in odd manner, vocal throat clearing tics, repeating same word three times, occasional knee pain, loss of math skills, decline in handwriting abilities at school, extreme defiance, irritability, inability to sleep due to involuntary movements of legs at night, severe separation anxiety, inconsolable crying, mild regression for 1-2 week period  thumb sucking, baby talk, playing with baby toys. The focus of the OCD obsessions switched from "germ fears" to "doing everything perfectly and repeating each little task", such as walking up and down the same step for hours, walking in and out of doorways for hours trying to get it "just right". Pt saw therapist who mentioned possible PANDAS/PANS diagnosis. Child's symptoms have somewhat subsided, but are still present to date and fluctuate day to day. Child still experiences motor tics of face and arms and repeats odd behaviors stating she can't make herself stop. Child did 3.5 hours of cartwheels nonstop yesterday as she cried hysterically that she could not make herself stop. Child lost the ability to handwrite clearly and lost math skills, dropping three grade points in school since this began. On 5/22/17 child was diagnosed with PANDAS/PANS as result of vaccine injury that triggered an autoimmune response which is attacking the brain.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Fear, Headache, Impulsive behaviour, Irritability
Clinical narrative: About 1-2 weeks following flu shot, child experienced off/on severe headache, low grade fever, nausea and fatigue. On night of 12/25/2016, child experienced 103 degree fever, chills, fatigue, body aches, red cheeks, loss of appetite. Fever broke roughly by 12/27/2016. Child had loss of appetite for next few weeks. Child awoke on 1/11/17 with sudden, severe, debilitating OCD like symptoms and would not touch objects due to severe fear of germs. OCD gradually increased to the point of seeking emergency treatment on 2/4/17. Child would not step on floor in the morning to get out of bed, stating she can't do it because it is "dirty". She also had severe separation anxiety, inconsolable crying, tantrums, refused food although hungry, daytime urinary incontinence and would not let anyone touch her (never experienced any of these symptoms in past). ER staff bewildered. Recommended inpatient or partial hospitalization psych services. Parents declined as it was explained neither inpatient or partial psych hospitalization does not treat OCD. Child enrolled in outpatient therapy and OCD improved within 3 weeks to about 95%. Pt again awoke on 3/31/17 with severe debilitating OCD like symptoms, more severe than the last episode. This time, she also experienced motor facial tics with mouth, chorea like movements in arms and shoulders, severe headaches, dilated pupils in broad daylight, extremely fidgety, ADHD type symptoms, impulsivity, constantly putting hands in mouth in odd manner, vocal throat clearing tics, repeating same word three times, occasional knee pain, loss of math skills, decline in handwriting abilities at school, extreme defiance, irritability, inability to sleep due to involuntary movements of legs at night, severe separation anxiety, inconsolable crying, mild regression for 1-2 week period  thumb sucking, baby talk, playing with baby toys. The focus of the OCD obsessions switched from "germ fears" to "doing everything perfectly and repeating each little task", such as walking up and down the same step for hours, walking in and out of doorways for hours trying to get it "just right". Pt saw therapist who mentioned possible PANDAS/PANS diagnosis. Child's symptoms have somewhat subsided, but are still present to date and fluctuate day to day. Child still experiences motor tics of face and arms and repeats odd behaviors stating she can't make herself stop. Child did 3.5 hours of cartwheels nonstop yesterday as she cried hysterically that she could not make herself stop. Child lost the ability to handwrite clearly and lost math skills, dropping three grade points in school since this began. On 5/22/17 child was diagnosed with PANDAS/PANS as result of vaccine injury that triggered an autoimmune response which is attacking the brain.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Mydriasis, Nausea, Obsessive-compulsive disorder, Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection, Pain
Clinical narrative: About 1-2 weeks following flu shot, child experienced off/on severe headache, low grade fever, nausea and fatigue. On night of 12/25/2016, child experienced 103 degree fever, chills, fatigue, body aches, red cheeks, loss of appetite. Fever broke roughly by 12/27/2016. Child had loss of appetite for next few weeks. Child awoke on 1/11/17 with sudden, severe, debilitating OCD like symptoms and would not touch objects due to severe fear of germs. OCD gradually increased to the point of seeking emergency treatment on 2/4/17. Child would not step on floor in the morning to get out of bed, stating she can't do it because it is "dirty". She also had severe separation anxiety, inconsolable crying, tantrums, refused food although hungry, daytime urinary incontinence and would not let anyone touch her (never experienced any of these symptoms in past). ER staff bewildered. Recommended inpatient or partial hospitalization psych services. Parents declined as it was explained neither inpatient or partial psych hospitalization does not treat OCD. Child enrolled in outpatient therapy and OCD improved within 3 weeks to about 95%. Pt again awoke on 3/31/17 with severe debilitating OCD like symptoms, more severe than the last episode. This time, she also experienced motor facial tics with mouth, chorea like movements in arms and shoulders, severe headaches, dilated pupils in broad daylight, extremely fidgety, ADHD type symptoms, impulsivity, constantly putting hands in mouth in odd manner, vocal throat clearing tics, repeating same word three times, occasional knee pain, loss of math skills, decline in handwriting abilities at school, extreme defiance, irritability, inability to sleep due to involuntary movements of legs at night, severe separation anxiety, inconsolable crying, mild regression for 1-2 week period  thumb sucking, baby talk, playing with baby toys. The focus of the OCD obsessions switched from "germ fears" to "doing everything perfectly and repeating each little task", such as walking up and down the same step for hours, walking in and out of doorways for hours trying to get it "just right". Pt saw therapist who mentioned possible PANDAS/PANS diagnosis. Child's symptoms have somewhat subsided, but are still present to date and fluctuate day to day. Child still experiences motor tics of face and arms and repeats odd behaviors stating she can't make herself stop. Child did 3.5 hours of cartwheels nonstop yesterday as she cried hysterically that she could not make herself stop. Child lost the ability to handwrite clearly and lost math skills, dropping three grade points in school since this began. On 5/22/17 child was diagnosed with PANDAS/PANS as result of vaccine injury that triggered an autoimmune response which is attacking the brain.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Rash erythematous, Repetitive speech, Restlessness, Separation anxiety disorder
Clinical narrative: About 1-2 weeks following flu shot, child experienced off/on severe headache, low grade fever, nausea and fatigue. On night of 12/25/2016, child experienced 103 degree fever, chills, fatigue, body aches, red cheeks, loss of appetite. Fever broke roughly by 12/27/2016. Child had loss of appetite for next few weeks. Child awoke on 1/11/17 with sudden, severe, debilitating OCD like symptoms and would not touch objects due to severe fear of germs. OCD gradually increased to the point of seeking emergency treatment on 2/4/17. Child would not step on floor in the morning to get out of bed, stating she can't do it because it is "dirty". She also had severe separation anxiety, inconsolable crying, tantrums, refused food although hungry, daytime urinary incontinence and would not let anyone touch her (never experienced any of these symptoms in past). ER staff bewildered. Recommended inpatient or partial hospitalization psych services. Parents declined as it was explained neither inpatient or partial psych hospitalization does not treat OCD. Child enrolled in outpatient therapy and OCD improved within 3 weeks to about 95%. Pt again awoke on 3/31/17 with severe debilitating OCD like symptoms, more severe than the last episode. This time, she also experienced motor facial tics with mouth, chorea like movements in arms and shoulders, severe headaches, dilated pupils in broad daylight, extremely fidgety, ADHD type symptoms, impulsivity, constantly putting hands in mouth in odd manner, vocal throat clearing tics, repeating same word three times, occasional knee pain, loss of math skills, decline in handwriting abilities at school, extreme defiance, irritability, inability to sleep due to involuntary movements of legs at night, severe separation anxiety, inconsolable crying, mild regression for 1-2 week period  thumb sucking, baby talk, playing with baby toys. The focus of the OCD obsessions switched from "germ fears" to "doing everything perfectly and repeating each little task", such as walking up and down the same step for hours, walking in and out of doorways for hours trying to get it "just right". Pt saw therapist who mentioned possible PANDAS/PANS diagnosis. Child's symptoms have somewhat subsided, but are still present to date and fluctuate day to day. Child still experiences motor tics of face and arms and repeats odd behaviors stating she can't make herself stop. Child did 3.5 hours of cartwheels nonstop yesterday as she cried hysterically that she could not make herself stop. Child lost the ability to handwrite clearly and lost math skills, dropping three grade points in school since this began. On 5/22/17 child was diagnosed with PANDAS/PANS as result of vaccine injury that triggered an autoimmune response which is attacking the brain.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder, Streptococcus test, Throat irritation, Thumb sucking, Tic
Clinical narrative: About 1-2 weeks following flu shot, child experienced off/on severe headache, low grade fever, nausea and fatigue. On night of 12/25/2016, child experienced 103 degree fever, chills, fatigue, body aches, red cheeks, loss of appetite. Fever broke roughly by 12/27/2016. Child had loss of appetite for next few weeks. Child awoke on 1/11/17 with sudden, severe, debilitating OCD like symptoms and would not touch objects due to severe fear of germs. OCD gradually increased to the point of seeking emergency treatment on 2/4/17. Child would not step on floor in the morning to get out of bed, stating she can't do it because it is "dirty". She also had severe separation anxiety, inconsolable crying, tantrums, refused food although hungry, daytime urinary incontinence and would not let anyone touch her (never experienced any of these symptoms in past). ER staff bewildered. Recommended inpatient or partial hospitalization psych services. Parents declined as it was explained neither inpatient or partial psych hospitalization does not treat OCD. Child enrolled in outpatient therapy and OCD improved within 3 weeks to about 95%. Pt again awoke on 3/31/17 with severe debilitating OCD like symptoms, more severe than the last episode. This time, she also experienced motor facial tics with mouth, chorea like movements in arms and shoulders, severe headaches, dilated pupils in broad daylight, extremely fidgety, ADHD type symptoms, impulsivity, constantly putting hands in mouth in odd manner, vocal throat clearing tics, repeating same word three times, occasional knee pain, loss of math skills, decline in handwriting abilities at school, extreme defiance, irritability, inability to sleep due to involuntary movements of legs at night, severe separation anxiety, inconsolable crying, mild regression for 1-2 week period  thumb sucking, baby talk, playing with baby toys. The focus of the OCD obsessions switched from "germ fears" to "doing everything perfectly and repeating each little task", such as walking up and down the same step for hours, walking in and out of doorways for hours trying to get it "just right". Pt saw therapist who mentioned possible PANDAS/PANS diagnosis. Child's symptoms have somewhat subsided, but are still present to date and fluctuate day to day. Child still experiences motor tics of face and arms and repeats odd behaviors stating she can't make herself stop. Child did 3.5 hours of cartwheels nonstop yesterday as she cried hysterically that she could not make herself stop. Child lost the ability to handwrite clearly and lost math skills, dropping three grade points in school since this began. On 5/22/17 child was diagnosed with PANDAS/PANS as result of vaccine injury that triggered an autoimmune response which is attacking the brain.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Urinary incontinence
Clinical narrative: About 1-2 weeks following flu shot, child experienced off/on severe headache, low grade fever, nausea and fatigue. On night of 12/25/2016, child experienced 103 degree fever, chills, fatigue, body aches, red cheeks, loss of appetite. Fever broke roughly by 12/27/2016. Child had loss of appetite for next few weeks. Child awoke on 1/11/17 with sudden, severe, debilitating OCD like symptoms and would not touch objects due to severe fear of germs. OCD gradually increased to the point of seeking emergency treatment on 2/4/17. Child would not step on floor in the morning to get out of bed, stating she can't do it because it is "dirty". She also had severe separation anxiety, inconsolable crying, tantrums, refused food although hungry, daytime urinary incontinence and would not let anyone touch her (never experienced any of these symptoms in past). ER staff bewildered. Recommended inpatient or partial hospitalization psych services. Parents declined as it was explained neither inpatient or partial psych hospitalization does not treat OCD. Child enrolled in outpatient therapy and OCD improved within 3 weeks to about 95%. Pt again awoke on 3/31/17 with severe debilitating OCD like symptoms, more severe than the last episode. This time, she also experienced motor facial tics with mouth, chorea like movements in arms and shoulders, severe headaches, dilated pupils in broad daylight, extremely fidgety, ADHD type symptoms, impulsivity, constantly putting hands in mouth in odd manner, vocal throat clearing tics, repeating same word three times, occasional knee pain, loss of math skills, decline in handwriting abilities at school, extreme defiance, irritability, inability to sleep due to involuntary movements of legs at night, severe separation anxiety, inconsolable crying, mild regression for 1-2 week period  thumb sucking, baby talk, playing with baby toys. The focus of the OCD obsessions switched from "germ fears" to "doing everything perfectly and repeating each little task", such as walking up and down the same step for hours, walking in and out of doorways for hours trying to get it "just right". Pt saw therapist who mentioned possible PANDAS/PANS diagnosis. Child's symptoms have somewhat subsided, but are still present to date and fluctuate day to day. Child still experiences motor tics of face and arms and repeats odd behaviors stating she can't make herself stop. Child did 3.5 hours of cartwheels nonstop yesterday as she cried hysterically that she could not make herself stop. Child lost the ability to handwrite clearly and lost math skills, dropping three grade points in school since this began. On 5/22/17 child was diagnosed with PANDAS/PANS as result of vaccine injury that triggered an autoimmune response which is attacking the brain.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Pain in extremity, Vaccination site pain
Clinical narrative: Pain at the site of vaccine, unable to bend arm and move certain ways. Numbness going down my arm and an occasional ache going down my arm. This occurred consistently for the past 7 1/2 months. I made the on-site doctor aware, as well as, had follow ups for the next couple weeks after the vaccine. My condition didn't improve despite taking ibuprofen and resting my arm. The doctor said it may take a few months to feel better so I let it go and just waited. I have not felt better and don't believe my range of motion has increased.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 08-MAY-2017, the patient was inadvertently vaccinated with an improperly stored single dose of M-M-R II with lot # M017348 and expiration date on 06-APR-2018 (strength and anatomical location was not reported) reconstituted with a sterile diluent (manufacturer unknown); administered subcutaneously for prophylaxis. The storage temperature was reported as 66 degrees Fahrenheit (°F) (66°F) for a time frame of 36 hours. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected as there was no consent to contact the reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 06-APR-2017 and 01-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M016193, expiration date 24-APR-2018, intramuscularly (dose was not reported) in immunization series. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 1 hour and 53 minute and of 34.7 degrees Fahrenheit for 1 hour and 25 minutes. There were no previous temperature excursions reported. A Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007706: US-009507513-1705USA007707: US-009507513-1705USA007708: US-009507513-1705USA007709: US-009507513-1705USA007710: US-009507513-1705USA007711: US-009507513-1705USA007712: US-009507513-1705USA000781.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 06-APR-2017 and 01-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M016193, expiration date 24-APR-2018, intramuscularly (dose was not reported) in immunization series. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 1 hour and 53 minute and of 34.7 degrees Fahrenheit for 1 hour and 25 minutes. There were no previous temperature excursions reported. A Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007705: US-009507513-1705USA007707: US-009507513-1705USA007708: US-009507513-1705USA007709: US-009507513-1705USA007710: US-009507513-1705USA007711: US-009507513-1705USA007712: US-009507513-1705USA000781.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies drug reactions, allergies  or medical history provided. On unknown dates, the patient received the three-dose vaccination series of RECOMBIVAX HB (route and site of administration, lot # and expiration date were not reported) for prevention of Hepatitis B. The patient was vaccinated at the appropriate age and interval, as stated in the prescribing information. On an unknown date, the patient had Hepatitis B serologic testing done and it was showing reduced antibody response. On an unknown date, the patient sought medical attention by going to pharmacy and did not receive any treatment for the event. The outcome of the event was reported as not recovered. The relatedness between the event and RECOMBIVAX HB was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Muscle disorder
Clinical narrative: This spontaneous report as received from a pharmacist, who was also thepatient, via a company representative refers to a male patient of unknown age. The patein's medical history, concurrent conditions and concomitant therapies were not reported. On 20-MAY-2016, the patient was vaccinated with ZOSTAVAX  (lot # L031274) (route of administrtaion and expiry date were not reported).  Other suspect therapies included sterile diluent (manufacturer unknown) (dose and route of administrtaion not repored). However, it was reported that, the company representative did not have information if sterile diluent (manufacturer unknown) was used fr reconstitution. Since 20-MAY-2016, reported as "sinec avccine administration", the patient was having right shoulder muscle pain and muscle problems. The outcome of right shoulder muscle pain and muscle problems was reported as not recovered. Rlatedness between right shoulder muscle pain and muscle problems ans the vaccination with ZOSTAVAX and sterile diluent (manufacturer unknown) as not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an immunization official referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition, drug and allergy history were not reported. The reporter stated that from 25-APR-2017 to 09-MAY-2017, improperly stored doses of PROQUAD lot #N002915, expiration date 24-JUL-2018 (dose and route was not reported) for prophylaxis, were administered to unspecified patients. The patients' concomitant therapies were not reported. The reporter stated that the sterile diluent used to reconstitute the vaccine was not improperly stored. No adverse effects were reported. On an unspecified date, the digital data logger registered a temperature ranges between -9° Celsius (°C) to 8°C during a time frame of 666 hours with no previous temperature excursion. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA009808.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition, drug and allergy history were not reported. On 12-MAY-2017 the patient was vaccinated with an improperly storage dose injection of LIQUID PEDVAXHIB lot # M034187, expiration date  17-MAY-2019, (route and dose were not provided) for prophylaxis. The patient's concomitant therapies were not reported.  No adverse effects were reported. The reporter stated that on an unspecified date, the LIQUID PEDVAXHIB was storaged during a time frime of five hours at a temperature ranges of 32° Celsius (°C) and 35°C with previous temperature excursion. The call was not placed because of a digital data logger. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an immunization official referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition, drug and allergy history were not reported. The reporter stated that from 25-APR-2017 to 09-MAY-2017, improperly stored doses of VARIVAX lot # M039318, expiration date 20-SEP-2018 (dose, route, frequency was not reported) for prophylaxis, were administered to unspecified patients .The patients' concomitant therapies were not reported. No adverse effects were reported. On an unspecified date, the digital data logger registered a temperature ranges between -9° Celsius (°C) to 8°C during a time frame of 666 hours with no previous temperature excursion.This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA008457:
Sex: U
Vaccine: HEPA
Symptoms: Hepatitis A antibody negative
Clinical narrative: This spontaneous report was received from an osteopathic physician referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates (reported as at an unspecified time in the past), the patients were vaccinated with unspecified doses of VAQTA (strength, dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis. It was reported that the vaccinations were administered according to series schedule. On an unknown date, the patients were tested for titers to VAQTA and the patients had negative titers. It was unknown if the patients received treatment. No adverse effects and no product quality complaint were reported. At the time of reporting, the outcome of hepatitis A antibody negative was unknown. The causal relationship between the hepatitis A antibody negative and VAQTA was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 08-DEC-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported.    This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 21-NOV-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported.    This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 28-NOV-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported.    This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-FEB-2017, the patient was vaccinated with M-M-R II recombinant human albumin (RHA) lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered doses of, M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-FEB-2017, the patient was vaccinated with improprerly stored dose of M-M-R II recombinant human albumin (RHA) lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported.        Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved.   This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case : 1705USA009742
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-MAR-2017, the patient was vaccinated with improprerly stored dose of M-M-R II recombinant human albumin (RHA) lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported.        Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved.   This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-JAN-2017, the patient was vaccinated with improperly stored dose of M-M-R II recombinant human albumin (RHA) lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case : 1705USA009742.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-MAR-2017, the patient was vaccinated with improperly stored dose of M-M-R II recombinant human albumin (RHA) lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case : 1705USA009742.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-FEB-2017, the patient was vaccinated with improperly stored dose of M-M-R II recombinant human albumin (RHA) lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of, M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case: 1705USA009742.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-MAR-2017, the patient was vaccinated with improprerly stored dose of M-M-R II lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:Original Case : 1705USA009742.
Age: 4.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Abasia, Abnormal behaviour, Aggression, Anal incontinence, Arthralgia
Clinical narrative: Child experienced urinary and bowel incontinence with loose stools one day following MMR, varicella and flu vaccines. Sent home from school. Child also experiences sore throat, aches, fatigue, fluctuating low grade fever, cough, red cheeks for 3-4 weeks. Child was simply not well from 11/9/16 through 4/23/17, with numerous flu-like symptoms and an inability to overcome them. Child woke on 4/23/17 with urinary incontinence. Complained of extreme fatigue after waking. Went right back to bed, slept for two hours and awoke screaming in excruciating pain. Stated his knees hurt, legs were weak, back of his neck hurt and had a hard time sitting up independently from a lying position. Child could not bear weight on legs. Would not let anyone touch them. Fever 101.8 after 6 mL ibuprofen. Visibly huge swollen lymph nodes in sides of neck, red cheeks, legs and knees extremely hot to touch. Child taken to ER, diagnosed with virus (unspecified) and given ibuprofen. Child able to wobble few steps with help of dr and mom. Child returned home. Child did not urinate for 14 hours, despite drinking fluids. Returned to ER on 4/24/17. Child had fever despite ibuprofen, swollen lymph nodes in neck, severe knee pain, unable to bear weight or walk, neck pain subsided by second day. Child also had dark urine, sensory hallucinations on tongue  felt like there was a hair on tongue, although we checked numerous times and it did not exist, performed constant odd repetitive hand-to-mouth movements stating he could not stop sticking fist in mouth, lethargic, dark eyes, spaced-out. Child placed on IV fluids and anti-inflammatory meds overnight. Child fever broke 4/15/17 and was able to walk. Child was discharged home but has not been the same since episode. Steady runny nose, extreme impulsivity, extreme defiance (never experienced before), irritability, occasional daytime loss of bladder and bowel, aggression and lingering cough to date. Just not back to normal self. On 5/22/17, along with older sister who was vaccinated at same time/day/place and is experiencing bizarre symptoms (separate report), child diagnosed with PANDAS/PANS due to vaccine injury triggering autoimmune response that is attacking the brain.
Age: 4.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Blood test, Borrelia test, Chromaturia, Computerised tomogram, Cough
Clinical narrative: Child experienced urinary and bowel incontinence with loose stools one day following MMR, varicella and flu vaccines. Sent home from school. Child also experiences sore throat, aches, fatigue, fluctuating low grade fever, cough, red cheeks for 3-4 weeks. Child was simply not well from 11/9/16 through 4/23/17, with numerous flu-like symptoms and an inability to overcome them. Child woke on 4/23/17 with urinary incontinence. Complained of extreme fatigue after waking. Went right back to bed, slept for two hours and awoke screaming in excruciating pain. Stated his knees hurt, legs were weak, back of his neck hurt and had a hard time sitting up independently from a lying position. Child could not bear weight on legs. Would not let anyone touch them. Fever 101.8 after 6 mL ibuprofen. Visibly huge swollen lymph nodes in sides of neck, red cheeks, legs and knees extremely hot to touch. Child taken to ER, diagnosed with virus (unspecified) and given ibuprofen. Child able to wobble few steps with help of dr and mom. Child returned home. Child did not urinate for 14 hours, despite drinking fluids. Returned to ER on 4/24/17. Child had fever despite ibuprofen, swollen lymph nodes in neck, severe knee pain, unable to bear weight or walk, neck pain subsided by second day. Child also had dark urine, sensory hallucinations on tongue  felt like there was a hair on tongue, although we checked numerous times and it did not exist, performed constant odd repetitive hand-to-mouth movements stating he could not stop sticking fist in mouth, lethargic, dark eyes, spaced-out. Child placed on IV fluids and anti-inflammatory meds overnight. Child fever broke 4/15/17 and was able to walk. Child was discharged home but has not been the same since episode. Steady runny nose, extreme impulsivity, extreme defiance (never experienced before), irritability, occasional daytime loss of bladder and bowel, aggression and lingering cough to date. Just not back to normal self. On 5/22/17, along with older sister who was vaccinated at same time/day/place and is experiencing bizarre symptoms (separate report), child diagnosed with PANDAS/PANS due to vaccine injury triggering autoimmune response that is attacking the brain.