chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: 6VAX-F, ANTH, FLUX, HBPV, IPV, MMRV
Symptoms: Pyrexia, Upper respiratory tract infection
Clinical narrative: High Fever, Confusion, Fatigue, Stiffened muscles, forgetfulness, numbness at injection sites x4, inability to follow simple commands.  From 10/15/2003 to present has been diagnosed with depression, bi-polar disorder, and ADHD/ADD.  Ear Infections, Chronic Upper Respiratory infections, continued loss of sensation at vaccine sites x2.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives - severe on hands, neck and back
Age: 57.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: VZV given on 9/20/11 - next day red, swelling (L) posterior arm with increased redness, induration 9/22/11. Hot to touch, itching approx size 2x2.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Erythema, Oedema peripheral, Urticaria
Clinical narrative: Night of shot some discomfort ,next AM redness, swelling, welts to (R) arm. Lasted 2-3 days then resolved.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site reaction
Clinical narrative: Localized erythema to left deltoid less than 48 hours after administration. Area 2 inches in length and 1.5 inches in diameter.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Injection site pain, Pyrexia
Clinical narrative: Patient developed severe (R) upper arm pain, occasionally radiating to the back, and also fever approximately 1-2 hours after receiving TIV + PPSV23. Symptoms improving with ibuprofen.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Pruritus, Urticaria
Clinical narrative: 3 hrs after dose of FLUMIST c/o hives & itching on lower extremities. Gave ZYRTEC-resolved 1 hour after dose.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dehydration, Diarrhoea, Erythema, Rash, Vomiting
Clinical narrative: upper body redness and rash vomiting diarhea dehydration (self administered liquid Benadryl and liquids after vomiting ended)
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: Patient called pharmacy 3-4 hrs. following vaccination and reported swelling & tenderness in left arm. Follow-up following morning patient reported improvement in symptoms.
Age: 0.5
Sex: U
Vaccine: PER
Symptoms: Clonic convulsion, Cognitive disorder, Convulsion, Developmental delay, Electroencephalogram abnormal
Clinical narrative: Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as Dravet syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with Dravet syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09348, -09597, -09598, and -09600. A 6-month-old patient received a pertussis vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and less than 24 hours after vaccination, developed an afebrile unilateral clonic seizure. After 1 year of age, the patient developed other seizure types including generalized tonic-clonic, myoclonic and hemiconvulsions, which were intractable to multiple medication trials. Cognitive development was described as slowing. Initial brain MRI results were normal. At 4 years of age, patient was diagnosed with Dravet syndrome based on positive SCN1A (neuronal sodium channel alpha-1 subunit) testing results which showed nonsense mutation (C5734T, Arg1912Stop) and were proved de novo through parental testing. Electroencephalogram findings at diagnosis showed generalized discharged and slowing. Outcome was not recovered. Documents held by sender: None.
Age: 0.5
Sex: U
Vaccine: PER
Symptoms: Encephalopathy, Epilepsy, Gene mutation identification test positive, Grand mal convulsion, Myoclonic epilepsy
Clinical narrative: Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as Dravet syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with Dravet syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09348, -09597, -09598, and -09600. A 6-month-old patient received a pertussis vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and less than 24 hours after vaccination, developed an afebrile unilateral clonic seizure. After 1 year of age, the patient developed other seizure types including generalized tonic-clonic, myoclonic and hemiconvulsions, which were intractable to multiple medication trials. Cognitive development was described as slowing. Initial brain MRI results were normal. At 4 years of age, patient was diagnosed with Dravet syndrome based on positive SCN1A (neuronal sodium channel alpha-1 subunit) testing results which showed nonsense mutation (C5734T, Arg1912Stop) and were proved de novo through parental testing. Electroencephalogram findings at diagnosis showed generalized discharged and slowing. Outcome was not recovered. Documents held by sender: None.
Age: 0.5
Sex: U
Vaccine: PER
Symptoms: Nuclear magnetic resonance imaging brain normal
Clinical narrative: Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as Dravet syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with Dravet syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09348, -09597, -09598, and -09600. A 6-month-old patient received a pertussis vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and less than 24 hours after vaccination, developed an afebrile unilateral clonic seizure. After 1 year of age, the patient developed other seizure types including generalized tonic-clonic, myoclonic and hemiconvulsions, which were intractable to multiple medication trials. Cognitive development was described as slowing. Initial brain MRI results were normal. At 4 years of age, patient was diagnosed with Dravet syndrome based on positive SCN1A (neuronal sodium channel alpha-1 subunit) testing results which showed nonsense mutation (C5734T, Arg1912Stop) and were proved de novo through parental testing. Electroencephalogram findings at diagnosis showed generalized discharged and slowing. Outcome was not recovered. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site infection, Injection site inflammation, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Patient has red, inflamed, and tender rash about 3 to 4 inch diameter around the injection site. Md diagnosed as an infection.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cold sweat, Nausea, Vomiting
Clinical narrative: Clammy, nausea, vomiting, weakness
Age: 1.29
Sex: F
Vaccine: DTAP, FLU3, HIBV, MMR, VARCEL
Symptoms: Body temperature increased, Lethargy, Posture abnormal, Unresponsive to stimuli, Vomiting
Clinical narrative: Patient was found in her bed, she had vomited. Was lethargic and unresponsive.  Temp was 105.7.  No difficulty breathing. Not able to sit or raise her head.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Dizziness, Flushing, Injection site erythema, Injection site warmth
Clinical narrative: Returned to clinic w/c/o feeling dizzy, burning sensation to left outer ear and skin flushed. Approximate 3-4 inch circular red warm area to injection site (left deltoid). Cool packs placed to injection and left outer ear. Benadryl 50mg mg given po. Pt monitored for 30 minutes. Symptoms resolving.
Age: 0.3
Sex: U
Vaccine: PER
Symptoms: Abnormal behaviour, Autism, Clonic convulsion, Convulsion, Cytogenetic analysis abnormal
Clinical narrative: Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as DRAVET syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with DRAVET syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related temporally to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09348, -09597, -09598, and -09599. A 4-month-old patient received a PERTUSSIS VACCINE (manufacturer unknown, lot number, route, site and date of administration not reported) and less than 24 hours after vaccination, developed an afebrile unilateral clonic seizure. After 1 year of age, the patient developed other seizure types including generalized tonic-clonic, myoclonic, absence and hemiconvulsions, which were intractable to multiple medication trials. Developmental and behavioral issues were described as "regression age 1 year" and autistic-like features. Initial brain MRI results were normal. At 3 years of age, patient was diagnosed with DRAVET syndrome based on positive SCN1A (neuronal sodium channel alpha-1 subunit) testing results which showed missense mutation (T4837C, Phe1463Leu) and were proved de novo through parental testing. Electroencephalogram findings at diagnosis showed generalized and focal discharges. Outcome was not recovered. Documents held by sender: None.
Age: 0.3
Sex: U
Vaccine: PER
Symptoms: Developmental delay, Electroencephalogram abnormal, Encephalopathy, Gene mutation, Gene mutation identification test positive
Clinical narrative: Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as DRAVET syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with DRAVET syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related temporally to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09348, -09597, -09598, and -09599. A 4-month-old patient received a PERTUSSIS VACCINE (manufacturer unknown, lot number, route, site and date of administration not reported) and less than 24 hours after vaccination, developed an afebrile unilateral clonic seizure. After 1 year of age, the patient developed other seizure types including generalized tonic-clonic, myoclonic, absence and hemiconvulsions, which were intractable to multiple medication trials. Developmental and behavioral issues were described as "regression age 1 year" and autistic-like features. Initial brain MRI results were normal. At 3 years of age, patient was diagnosed with DRAVET syndrome based on positive SCN1A (neuronal sodium channel alpha-1 subunit) testing results which showed missense mutation (T4837C, Phe1463Leu) and were proved de novo through parental testing. Electroencephalogram findings at diagnosis showed generalized and focal discharges. Outcome was not recovered. Documents held by sender: None.
Age: 0.3
Sex: U
Vaccine: PER
Symptoms: Grand mal convulsion, Myoclonic epilepsy, Nuclear magnetic resonance imaging brain normal, Petit mal epilepsy
Clinical narrative: Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as DRAVET syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with DRAVET syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related temporally to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09348, -09597, -09598, and -09599. A 4-month-old patient received a PERTUSSIS VACCINE (manufacturer unknown, lot number, route, site and date of administration not reported) and less than 24 hours after vaccination, developed an afebrile unilateral clonic seizure. After 1 year of age, the patient developed other seizure types including generalized tonic-clonic, myoclonic, absence and hemiconvulsions, which were intractable to multiple medication trials. Developmental and behavioral issues were described as "regression age 1 year" and autistic-like features. Initial brain MRI results were normal. At 3 years of age, patient was diagnosed with DRAVET syndrome based on positive SCN1A (neuronal sodium channel alpha-1 subunit) testing results which showed missense mutation (T4837C, Phe1463Leu) and were proved de novo through parental testing. Electroencephalogram findings at diagnosis showed generalized and focal discharges. Outcome was not recovered. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Pain, Pyrexia, Skin reaction
Clinical narrative: Evening after injection spiked fever (subjective) & body aches. Local skin redness at (L) deltoid injection site approx 8cm, warm to touch. Mom states today that he did this a few years ago after Flu shot. Tx: TYLENOL, ice to site.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccine positive rechallenge
Clinical narrative: Evening after injection spiked fever (subjective) & body aches. Local skin redness at (L) deltoid injection site approx 8cm, warm to touch. Mom states today that he did this a few years ago after Flu shot. Tx: TYLENOL, ice to site.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Localised oedema, Lymphadenopathy, Neck pain, Oedema peripheral, Pain
Clinical narrative: After Tdap on 9/27/11 pt. returned to office c/o soreness and edema, Lt. neck pain with adenopathy Lt. shoulder (edema & arm) 2 1/2x2" also c/o Lt jaw pain.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in jaw
Clinical narrative: After Tdap on 9/27/11 pt. returned to office c/o soreness and edema, Lt. neck pain with adenopathy Lt. shoulder (edema & arm) 2 1/2x2" also c/o Lt jaw pain.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema
Clinical narrative: Pt stated, "It started about 3 this morning (10/11/11) my arm is red and it has traveled down here". Pt was pointing to his armpit - upon assessment. Cleaned outer area of arm (area) with BETADINE swab, wiped skin with gauze, redressed scabbed site with 2x2 gauze, secured/covered with paper tape.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MNQ, RV5
Symptoms: Wrong drug administered
Clinical narrative: Patient given immunization of Meningococcal and not PREVNAR Pneumococcal.
Age: 1.75
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Condition aggravated, Convulsion
Clinical narrative: Vaccine FLUZONE 0.25mg, lot UT4159CA exp 6/30/12 administered 10/11/11 130pm. 3AM 10/12/11 mother heard child whimpering-seizure lasting 5 min. Temp 102. EMS called transported to med center for observation. No treatment, released to home.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Pt ran a fever of 102 degrees F and had the chills. Symptoms started about 8 hours after administration and lasted about 4 hours.
Age: 0.6
Sex: M
Vaccine: DTAP
Symptoms: Autism, Convulsion, Cytogenetic analysis abnormal, Developmental delay, Electroencephalogram abnormal
Clinical narrative: Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as Dravet syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with Dravet syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related temporally to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09597, -09598, -09599, and -09600. A 7-month-old male patient received Dtap (manufacturer unknown, lot number, route site and date of administration not reported) and within hours after vaccination, he became febrile and had a generalized seizure. Over the next several months, he continued to have frequent myoclonic, partial and prolonged convulsions with almost any febrile illness, including three episodes of febrile status epilepticus. Afebrile seizures and subsequent developmental stagnation with autistic like features was noted by two years of age. Previous brain MRI results were normal. An electroencephalogram at diagnosis revealed both focal and generalized epileptiform discharges. Neuronal sodium channel (alpha) 1 subunit (SCN1A) genetic test results were positive for G529A, Bly177Arg mutation, and were proved de novo through parental testing which supported a diagnosis of Dravet syndrome. The patient was 14 years of age at the time of diagnosis. Outcome was not recovered. Documents held by sender: None.
Age: 0.6
Sex: M
Vaccine: DTAP
Symptoms: Encephalopathy, Gene mutation, Gene mutation identification test positive, Myoclonic epilepsy, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as Dravet syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with Dravet syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related temporally to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09597, -09598, -09599, and -09600. A 7-month-old male patient received Dtap (manufacturer unknown, lot number, route site and date of administration not reported) and within hours after vaccination, he became febrile and had a generalized seizure. Over the next several months, he continued to have frequent myoclonic, partial and prolonged convulsions with almost any febrile illness, including three episodes of febrile status epilepticus. Afebrile seizures and subsequent developmental stagnation with autistic like features was noted by two years of age. Previous brain MRI results were normal. An electroencephalogram at diagnosis revealed both focal and generalized epileptiform discharges. Neuronal sodium channel (alpha) 1 subunit (SCN1A) genetic test results were positive for G529A, Bly177Arg mutation, and were proved de novo through parental testing which supported a diagnosis of Dravet syndrome. The patient was 14 years of age at the time of diagnosis. Outcome was not recovered. Documents held by sender: None.
Age: 0.6
Sex: M
Vaccine: DTAP
Symptoms: Partial seizures, Pyrexia, Status epilepticus
Clinical narrative: Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as Dravet syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with Dravet syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related temporally to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09597, -09598, -09599, and -09600. A 7-month-old male patient received Dtap (manufacturer unknown, lot number, route site and date of administration not reported) and within hours after vaccination, he became febrile and had a generalized seizure. Over the next several months, he continued to have frequent myoclonic, partial and prolonged convulsions with almost any febrile illness, including three episodes of febrile status epilepticus. Afebrile seizures and subsequent developmental stagnation with autistic like features was noted by two years of age. Previous brain MRI results were normal. An electroencephalogram at diagnosis revealed both focal and generalized epileptiform discharges. Neuronal sodium channel (alpha) 1 subunit (SCN1A) genetic test results were positive for G529A, Bly177Arg mutation, and were proved de novo through parental testing which supported a diagnosis of Dravet syndrome. The patient was 14 years of age at the time of diagnosis. Outcome was not recovered. Documents held by sender: None.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Malaise, Oedema peripheral, Rash
Clinical narrative: Patient had rash and swelling up and down her arm, as well as shortness of breath and malaise. It started about 4-6 hours after injection and lasted several hours.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Biopsy skin abnormal, Injection site reaction, Skin neoplasm excision
Clinical narrative: Patient received a pneumonia vaccine in left arm in 2005 in a camp (temporary) required after hurricane. Pt reported a reaction to vaccination. Pt alleges development of Basal Cell Cancer at site of  Pt had removal of basal cancer. Enclosed pathology.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: After child received shots, he stood up to leave, stated that he felt faint & slid down the wall to the floor. He did not hit his head or neck or injure himself in any way. He never lost consciousness. He was speaking throughout the event. Additionally, he reported that he had not eaten all day. Vital signs taken and were normal. Heart & lung exam were normal. After juice and crackers, he felt completely fine.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Malaise, Vision blurred
Clinical narrative: Client had received her second Hepatitis B on 9/30/11. Had reaction 15 min. after shot - headache that immediately made her sick - blurred vision. Felt "ill" for 2-3 days.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Injection site pain
Clinical narrative: Initial report was received on 28 September 2011 from a health care professional, which involved a cluster of two male patients who experienced adverse events after receiving FLUZONE HIGH-DOSE, lot number UH444AB. This case captures one of the male patients. The other patient has been captured in case number 2011-09381. A male patient (age 65-80, exact date of birth not reported) who had no illness at the time of vaccination had received on an unspecified day in September 2011 an intramuscular injection of FLUZONE HIGH-DOSE, lot number UH444AB (site was reported as left, right deltoid) and an unspecified amount of time later, experienced site pain and soreness. The patient was evaluated by a physician. He was diagnosed with cellulitis and was treated with antibiotics. The needle size used for vaccine administration was 5/8", 25 gauge. No additional information was provided at the time of the report. Outcome was reported as unknown. The reporter for this case is the same as for cases 2011-09381, 2011-09382 and 2011-09383. Documents held by sender: none.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Injection site pain
Clinical narrative: Initial report was received on 28 September 2011 from a health care professional, which involved a cluster of two male patients who experienced adverse events after receiving FLUZONE HIGH-DOSE, lot number UH444AB. This case captures one of the male patients. The other patient has been captured in case number 2011-09380. A male patient (age 65-80, exact date of birth not reported) who had no illness at the time of vaccination had received on an unspecified day in September 2011 an intramuscular injection of FLUZONE HIGH-DOSE, lot number UH444AB (site was reported as left, right deltoid) and an unspecified amount of time later, experienced site pain and soreness. The patient was evaluated by a physician. He was diagnosed with cellulitis and was treated with antibiotics. The needle size used for vaccine administration was 5/8", 25 gauge. No additional information was provided at the time of the report. Outcome was reported as unknown. The reporter for this case is the same as for cases 2011-09380, 2011-09382 and 2011-09383. Documents held by sender: none.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Varicella
Clinical narrative: Child presented with chicken pox on 10/12/11 per parent.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Injection site erythema, Injection site rash
Clinical narrative: Area shot and red, rash, flat - Lt. arm. Upset stomach last night. Tx: BENADRYL, Hydrocortisone cream 0.2%.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Influenza, Maternal exposure during pregnancy
Clinical narrative: Initial report was retrieved via the scientific literature on 26 September 2011. Objective: "To report on a multifaceted approach to increase update of the H1N1 vaccine in our ethically diverse obstetrical population". Methods: This was a retrospective study of H1N1 vaccine coverage in 157 pregnant women. The author collected data regarding age, ethnic background, spoken language, acceptance or refusal for the vaccine, whether patient required clinic or hospital evaluations for influenza symptoms and confirmed cases of H1N1. Interventions included educational sessions for team members, a prevention video to educate the patients and an electronic vaccine registry that was updated daily to identify the patients who had not yet received their vaccine. Results: Of the 157 obstetrical patients enrolled 120 (76%) were immunized. Of the remaining patients, 17 declined, 5 delivered before released of the vaccine, 2 contracted H1N1, 9 were lost to care and unreachable and 9 planned to receive the vaccine at their next appointment. The reporter had three confirmed cases of H1N1 in their practice. One of the three received the H1N1 vaccine at seven weeks gestation and seven days later contracted H1N1 (no further information was provided on this patient). The other two patients did not receive the vaccine. Conclusion: Cognizant of the historically low coverage rate for H1N1. The reporter began planning weeks in anticipation of the vaccine. They proactively instituted educational sessions for workers that stressed three strong reasons to immunization which were "pregnant women are more likely to acquired influenza after an exposure, they become more sick when they contract influenza and immunizing the mother during pregnancy decreases hospitalization and respiratory illnesses in their infants". Limitations: The 76% success rate is reported from a single clinic which acknowledges they instituted multiple interventions simultaneously. They additional allocated resources provided by their hospital including increased staffing. Finally, they had no comparator clinic where these interventions were not instituted. Per the reporter, this study may be useful as a model for other clinics and may improve vaccine coverage in this "typically under vaccinated population". Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: Initial report was received 27 September 2011 from a health care professional. A child patient (age, sex and date of birth not reported) had received an injection of FLUZONE (unspecified) a "few years ago" (lot number, route, site and date of administration not reported) and an unspecified amount of time later, the child experienced an allergic reaction. The reporter inquired about the source of the gelatin in the vaccine and stated the physician was testing a child who had an allergic reaction to FLUZONE years ago. Per the reporter, they would encourage the doctor to complete a VAERS form if it had not already been completed; but declined to provide any additional information at the time of the report. Outcome was not reported. Documents held by sender: None.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Right arm started hurting the day after the vaccination given (in right arm deltoid). There was never any redness or swelling or warmth per patient & none was evident on 10/6/11 when she came to pharmacy to report the arm pain. She gets influenza vaccine annually & has never experienced problem before. Referred to PCP.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Lip swelling, Pruritus, Throat tightness
Clinical narrative: Initial report received on 28 September 2011 from a consumer. A female patient (date of birth reported) whose medical history was unknown had received a dose of H1N1 2009 Monovalent Vaccine - Preservative (lot number unknown) on an unknown date and within minutes of receiving the vaccination felt itchy. Her lips then started to swell and she felt like her throat was closing. She was administered epinephrine and monitored. She was subsequently treated with another unknown medication and recovered. The consumer did not have any other information to offer about the reaction since it happened so long ago; and she did not want to be contacted any further; however contact information where the vaccination was administered was provided and follow-up has been requested. Documents held by sender: None.
Age: 0.3
Sex: U
Vaccine: PER
Symptoms: Convulsion, Cytogenetic analysis abnormal, Developmental delay, Electroencephalogram normal, Encephalopathy
Clinical narrative: Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as DRAVET syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with DRAVET syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related temporally to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09348, -09597, -09599, and -09600. A four-month-old patient received PERTUSSIS VACCINE (manufacturer unknown, lot number, route site and date of administration not reported) and less than 12 hours after vaccination, developed a febrile generalized convulsion. After 1 year of age, the patient developed other seizure types including generalized tonic clonic and partial seizures, which were intractable to multiple medication trials. The patient had mild expressive speech delay. Initial brain brain MRI results revealed an unspecified abnormality which later resolved. At2 year of age, patient was diagnosed with DRAVET syndrome based on positive SCN1A (neuronal sodium channel alpha-1 subunit) testing results which showed missense mutation (A1171C, Thr391Pro) and were proved de novo through parental testing. Electroencephalogram findings at diagnosis were normal. Outcome was not recovered. Documents held by sender: None.
Age: 0.3
Sex: U
Vaccine: PER
Symptoms: Epilepsy, Febrile convulsion, Gene mutation, Gene mutation identification test positive, Grand mal convulsion
Clinical narrative: Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as DRAVET syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with DRAVET syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related temporally to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09348, -09597, -09599, and -09600. A four-month-old patient received PERTUSSIS VACCINE (manufacturer unknown, lot number, route site and date of administration not reported) and less than 12 hours after vaccination, developed a febrile generalized convulsion. After 1 year of age, the patient developed other seizure types including generalized tonic clonic and partial seizures, which were intractable to multiple medication trials. The patient had mild expressive speech delay. Initial brain brain MRI results revealed an unspecified abnormality which later resolved. At2 year of age, patient was diagnosed with DRAVET syndrome based on positive SCN1A (neuronal sodium channel alpha-1 subunit) testing results which showed missense mutation (A1171C, Thr391Pro) and were proved de novo through parental testing. Electroencephalogram findings at diagnosis were normal. Outcome was not recovered. Documents held by sender: None.
Age: 0.3
Sex: U
Vaccine: PER
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Partial seizures, Speech disorder
Clinical narrative: Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as DRAVET syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with DRAVET syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related temporally to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09348, -09597, -09599, and -09600. A four-month-old patient received PERTUSSIS VACCINE (manufacturer unknown, lot number, route site and date of administration not reported) and less than 12 hours after vaccination, developed a febrile generalized convulsion. After 1 year of age, the patient developed other seizure types including generalized tonic clonic and partial seizures, which were intractable to multiple medication trials. The patient had mild expressive speech delay. Initial brain brain MRI results revealed an unspecified abnormality which later resolved. At2 year of age, patient was diagnosed with DRAVET syndrome based on positive SCN1A (neuronal sodium channel alpha-1 subunit) testing results which showed missense mutation (A1171C, Thr391Pro) and were proved de novo through parental testing. Electroencephalogram findings at diagnosis were normal. Outcome was not recovered. Documents held by sender: None.
Age: 0.33
Sex: F
Vaccine: IPV, IPV
Symptoms: Dyskinesia, Fatigue, Injection site pain, Irritability, Swelling face
Clinical narrative: Initial report was received on 29 September 2011 from a health care professional. A three month-old female patient had received on 27 August 2011 a first dose of IPOL (lot number, route and site of administration not reported) and an unspecified amount of time later on vaccination date, experienced vomiting once, a puffy face, tenderness at the injection site, irritability, tiredness and one time "jerk movement". No further information was available at the time of the report. Patient's outcome was reported as recovered. Documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: IPV, IPV
Symptoms: Vomiting
Clinical narrative: Initial report was received on 29 September 2011 from a health care professional. A three month-old female patient had received on 27 August 2011 a first dose of IPOL (lot number, route and site of administration not reported) and an unspecified amount of time later on vaccination date, experienced vomiting once, a puffy face, tenderness at the injection site, irritability, tiredness and one time "jerk movement". No further information was available at the time of the report. Patient's outcome was reported as recovered. Documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: IPV, IPV
Symptoms: Convulsion, Decreased appetite, Irritability, Lethargy, Pyrexia
Clinical narrative: Initial report was received on 29 September 2011 from a health care professional. A three month-old female patient had received on 27 August 2011 a first dose of IPOL (lot number, route and site of administration not reported) and an unspecified amount of time later on vaccination date, experienced vomiting once, a puffy face, tenderness at the injection site, irritability, tiredness and one time "jerk movement". No further information was available at the time of the report. Patient's outcome was reported as recovered. Documents held by sender: none.
Age: 0.2
Sex: M
Vaccine: PER
Symptoms: Abnormal behaviour, Autism, Chromosomal deletion, Cognitive disorder, Convulsion
Clinical narrative: Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as Dravet syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with Dravet syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related temporally to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09348, -09598, -09599, and -09600. A two-month-old male patient had received a pertussis vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and less than 12 hours after vaccination, he developed a febrile generalized convulsion. After 1 year of age, the patient developed other seizure types including generalized tonic clonic, partial and hemiconvulsions, which were intractable to multiple medication trials. Cognitive development was noted as delayed. The patient also developed behavioral issues with autistic-like features. Brain MRI results were normal. At 20 years of age, patient was diagnosed with Dravet syndrome based on his clinical phenotype and his SCN1A (neuronal sodium channel alpha-1 subunit) testing which showed the deletion of one copy of all 26 exons. Parental SCN1A testing was not possible for this patient because he had been adopted. EEG findings at the time of diagnosis revealed focal discharges and slowing. Outcome was not recovered. Documents held by sender: None.
Age: 0.2
Sex: M
Vaccine: PER
Symptoms: Cytogenetic analysis abnormal, Developmental delay, Electroencephalogram abnormal, Encephalopathy, Febrile convulsion
Clinical narrative: Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as Dravet syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with Dravet syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related temporally to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09348, -09598, -09599, and -09600. A two-month-old male patient had received a pertussis vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and less than 12 hours after vaccination, he developed a febrile generalized convulsion. After 1 year of age, the patient developed other seizure types including generalized tonic clonic, partial and hemiconvulsions, which were intractable to multiple medication trials. Cognitive development was noted as delayed. The patient also developed behavioral issues with autistic-like features. Brain MRI results were normal. At 20 years of age, patient was diagnosed with Dravet syndrome based on his clinical phenotype and his SCN1A (neuronal sodium channel alpha-1 subunit) testing which showed the deletion of one copy of all 26 exons. Parental SCN1A testing was not possible for this patient because he had been adopted. EEG findings at the time of diagnosis revealed focal discharges and slowing. Outcome was not recovered. Documents held by sender: None.