chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site swelling, Irritability, Lethargy
Clinical narrative: Pt had onset of fever of 103F, on same day at 19:00. Pt was crying, sleepy. The next day, was lethargic, wouldn't move, wouldn't let parents hold her. Injection site on leg was red and edematous.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Pt had onset of fever of 103F, on same day at 19:00. Pt was crying, sleepy. The next day, was lethargic, wouldn't move, wouldn't let parents hold her. Injection site on leg was red and edematous.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: The pt developed redness and tenderness at injection site treated at urgent care with Keflex.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Dehydration, Leukopenia, Pharyngitis
Clinical narrative: The pt developed significant and cutaneous and oral lesions (100-200). Complicated with streptpogenes pharyngitis. Required IM antibiotics. ER visit for dehydration and decreased oral intake.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: The pt developed significant and cutaneous and oral lesions (100-200). Complicated with streptpogenes pharyngitis. Required IM antibiotics. ER visit for dehydration and decreased oral intake.
Age: 2.25
Sex: M
Vaccine: DTAP, IPV
Symptoms: Rash macular
Clinical narrative: The pt experienced macular rash on cheeks, forehead, chin and ears. Few patches on and behind left ear.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Chest pain, Injection site mass, Injection site pain, Muscular weakness, Pain
Clinical narrative: The morning following the vax, the pt had pain in left arm muscle "shooting" to her heart and shoulder blade. 2 hours later complained of weakness and tachycardia. Went to the ER. 1st EKG was ok, but experienced some problems later and there was an irregularity. Discharged home with no further problems, aside from soreness and knot at injection site.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Tachycardia
Clinical narrative: The morning following the vax, the pt had pain in left arm muscle "shooting" to her heart and shoulder blade. 2 hours later complained of weakness and tachycardia. Went to the ER. 1st EKG was ok, but experienced some problems later and there was an irregularity. Discharged home with no further problems, aside from soreness and knot at injection site.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: The pt has varicella.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: The pt experienced a chicken pox like rash at the site of the varicella vaccination. Reassurance given at the office visit.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Pt has varicella.
Age: 11.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Bradycardia, Drooling, Eye movement disorder, Hypotension, Muscle twitching
Clinical narrative: Immediately following vaccines, the pt stood up and then fainted a minute later. Before fainting, the  nurse observed the pt's eyes rolling up, arms twitched and a little foaming at the mouth. The child's color was good and the child was alert a few seconds afterwards and was sent to ER. BP 90/50, P22, R20.
Age: 11.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Respiratory rate increased, Syncope
Clinical narrative: Immediately following vaccines, the pt stood up and then fainted a minute later. Before fainting, the  nurse observed the pt's eyes rolling up, arms twitched and a little foaming at the mouth. The child's color was good and the child was alert a few seconds afterwards and was sent to ER. BP 90/50, P22, R20.
Age: 9.0
Sex: M
Vaccine: HEP, HEPA, MMR
Symptoms: Rash
Clinical narrative: The Mom states that the night the pt received his vaccines he developed a rash over his trunk, cheeks and thighs which lasted 24 hours. No other complaints or problems.
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, TD
Symptoms: Coma, Convulsion, Muscle rigidity
Clinical narrative: After the last of the vaccines were administered, the pt slumped over in the chair, his body became rigid and he appeared to have a seizure. After the seizure, he was unresponsive to ammonia inhalant, verbal and tactile stimulation for about 5 minutes. Paramedics called and he was taken to the ER.
Age: 58.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: The pt states that on 4/14/01 he developed itching, red whelps that began on torso and spread to the head, arms legs. Referred to his PMD. He was seen and given medication. The diagnosis was hives. Probably not due to vaccine.
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR
Symptoms: Convulsion, Eye movement disorder, Postictal state
Clinical narrative: About 2 minutes after administration of the vaccine the pt noted to have upward rolling of eyeballs with the generalized tonic, clonic seizures lasting for less than 15 seconds with post-ictal drowsiness without urinary or fecal incontinence.
Age: 1.6
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Pyrexia, Wheezing
Clinical narrative: On 4/10/2001 the child was given the vaccines. On 4/12/2001 received a call from the mother stating the child began wheezing on the same day of vaccines, states had a fever but did not take to MD. States the fever was 106. States continues wheezing and has a fever, advised to seek medical attention stat. To inform health department after treatment has been received.
Sex: U
Vaccine: HEP
Symptoms: Sudden infant death syndrome
Clinical narrative: Information has been received from a physician who reported that she had received a call from an OB/GYN concerning a newborn female (WAES 01042680) who was vaccinated with Hep-B vaccine recombinant (yeast). The female died of sudden infant death syndrome. The reporting physician noted that the infant's father, also a physician, had a listing of as many as 40 additional cases of sudden infant death syndrome with Hep-B vaccine recombinant (yeast). No further details were provided. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician who reported that she had received a call from an OB/GYN concerning a newborn female who was vaccinated with Hep-B vaccine recombinant (yeast). The female died of sudden infant death syndrome. The reporting physician noted that the infant's father, also a physician, had a listing of as many as 40 additional cases of sudden infant death syndrome with Hep-B vaccine recombinant (yeast) (WAES01050372). No further details were provided. Additional information has been requested. Additional info from the physician indicated that this was a case of a newborn who was vaccinated with hep b vaccinee shortly after birth. A few days after birth, the newborn went home from the hospital and started to have "blue episodes." The infant was admitted to the hospital to rule out "SIDS, jaundice and sepsis." In the hospital, the infant's bilirubin was 20 and the jaundice was associated with the infant being breast-fed. The infant was subsequently discharged to home from the hospital. The physician reported that the infant did not die of SIDS, and the diagnoses had nothing to do with the hep b vaccine. At a later unspecified date the infant's mother was in the physician's office for a sick visit with an older sibling of the infant patient. The physician asked the mother how the infant was doing. The mothe rtold the physician that the infant was still having "blue episodes during feeding." The physician examined the infant and could see that the infant had "vocal cord damage due to gastric reflux." The physician referred the infant to an ENT, who made the diagnosis of gastroesophageal reflux disease. The physician reported that the infant has since recovered 100% and that the blue episodes, and the diagnosis of gastroesophageal reflux had nothing to do with the hep b vaccine. No further details were provided.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Laboratory test abnormal
Clinical narrative: Information has been received from a health NP concerning a 57 year old female, who on 4/18/01, accidentally received pneumococcal vaccine 23 polyvalent IV with renal failure and receiving dialysis 3 times a week for several years. The reporting NP stated that the pt was receiving dialysis and was scheduled to received several medications including epotin alfa (Epogen) and peucalcitol (Zemplar) during her dialysis. The pt was also scheduled to be vaccinated with pneumococcal vaccine 23 polyvalent since her last vaccination was in 9/94. It was reported that the nurse picked up the pneumococcal vaccine 23 polyvalent and administered the medication IV. The NP stated that the epotin alfa syringe and the pneumococcal vaccine were in the same size syringe. Subsequently, on the same day, 4/18/01, the pt experienced chest pain and was admitted to the hospital. A stress test was positive and results from an angiogram is still pending. Subsequently, the pt recovered from chest pain and on 4/24/01 was discharged from the hospital. On 4/25/01, the pt was in for a dialysis treatment. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Abasia, Movement disorder, Myalgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning an 11 year old female pt who on 4/24/01 was vaccinated with Hep-A virus vaccine inactivated. There was no concomitant medication. On 4/26/01, the pt presented to the office with severe muscle pain throughout her body, she could not move or walk. When the child tried to move it hurt so bad she cried. The child had a temperature of 100F and her blood pressure and pulse were normal. Additional information has been requested. Upon internal review, gait abnormality and movement disorder were determined to be "Other Medical Events".
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Angioneurotic oedema, Irritability, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a healthy 9 week old pt with no known allergies who on 2/7/00 was vaccinated with haemophilus b conjugate vaccine + hepatitis b vaccine recombinant (yeast). Concomitant vaccinations on 2/7/00 included poliovirus vaccine inactivated and diphtheria toxoid/pertussis vaccine/tetanus. On 2/10/00, the pt experienced angioedema, affecting all 4 extremities, fever, irritability and soreness. The pt recovered after 2 weeks of steroids. The pt had a similar experience following exposure to MMRII (WAES01050238). Upon internal review, the pt's experiences were considered to be "Other Medical Events". Additional information ha been requested.
Sex: M
Vaccine: MMR
Symptoms: Convulsion, Mental impairment
Clinical narrative: Information has been received from the mother of a male child with no known allergies and no medical history who was vaccinated with MMRII a few years ago. There was no concomitant medication. Subsequently, the pt experienced "seizures from the medication" that lasted through the entire evening. The mother noted the child had not been the same since and was a little slow in learning things. It was reported that the child sought unspecified medical attention. Additional information has been requested. Upon internal review, seizure and learning impairment were determined to be "Other Medical Events".
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Angioneurotic oedema, Serum sickness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 12 month old pt who on 1/3/01 was vaccinated with MMRII. On 1/6/01, the pt experienced severe angioedema with a serum sickness-like component. The pt was treated with prednisolone sodium phosphate (Pediapred) 10mg po bid for 2 weeks and recovered. The pt had a similar experience following exposure to MMRII (MSD) (WAES 01042108). Upon internal review the pt's experiences were considered to be "Other Medical Events". Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DT, HEP
Symptoms: Cyanosis, Nausea, Rash, Vomiting
Clinical narrative: On 4/5/01 at 05:00, mother reports nausea and vomiting X 3 episodes, by 11:00 AM, face with fine prickly rash, blue color to face. Admitted to hospital from approx. 12:00 to 14:00. Mother reports that doctor stated it was "effects of immunization".  Annual follow up on 11/03/2003: "Follow up was attempted in 07/2002.  We were unable to locate the patient.  Please see attached info which was transmitted to VAERS on 08/09/2002.  Patient unknown to health department for any visits other than 1 visit of 04/14/2001.  Phone # disconnected.  Physiican retired."
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Dehydration, Diarrhoea, Gastroenteritis, Oral intake reduced, Pyrexia
Clinical narrative: Dad reports on the evening he received shots, he stopped eating and had diarrhea and fever. He was taken to ER and was admitted to the hospital. Call to pediatrician, states not related to shots.  Diagnosed with acute gastroenteritis and dehyration.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Blood glucose decreased, Blood potassium increased, Diarrhoea, Hepatomegaly, Vomiting
Clinical narrative: This infant had diarrhea,and vomiting after receiving DTaP, Polio, Prevnar, HIB, and HBV on 03/08/01. He was admitted to the hospital 03/09/01. Elevated potassium, low blood sugar, and swollen liver.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Convulsion, Injection site induration, Injection site warmth, Irritability, Pain
Clinical narrative: This child was "fussy all day", "felt hot", legs were sore, (no temp taken until 8 PM). At 8 PM, temp of 100, gave Tylenol, injection sites were "hard and hot" at 8 PM. At 10 PM, his temp was 103, he was taken to the hospital. At Midnight, his temp was 104.6 at the hospital, they gave him Motrin, 10 minutes later he had a seizure. He was hospitalized. 60 day follow up on 11/04/2003: "Vaccine recipient did recover from adverse event."
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Pyrexia
Clinical narrative: This child was "fussy all day", "felt hot", legs were sore, (no temp taken until 8 PM). At 8 PM, temp of 100, gave Tylenol, injection sites were "hard and hot" at 8 PM. At 10 PM, his temp was 103, he was taken to the hospital. At Midnight, his temp was 104.6 at the hospital, they gave him Motrin, 10 minutes later he had a seizure. He was hospitalized. 60 day follow up on 11/04/2003: "Vaccine recipient did recover from adverse event."
Age: 32.0
Sex: M
Vaccine: HEPA
Symptoms: Blood creatine phosphokinase increased, Blood creatinine increased, Dermatitis, Injection site rash, Myalgia
Clinical narrative: 7/1/00 with Hep-A vaccine #1, developed rash at injection site; 3 weeks later, resolved. Progressive myalgias and heliotropic rash 9/00 to 10/00. Dx'd with dermatomyositis and ATN (acute tubular necrosis).
Age: 32.0
Sex: M
Vaccine: HEPA
Symptoms: Myositis
Clinical narrative: 7/1/00 with Hep-A vaccine #1, developed rash at injection site; 3 weeks later, resolved. Progressive myalgias and heliotropic rash 9/00 to 10/00. Dx'd with dermatomyositis and ATN (acute tubular necrosis).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Coma, Convulsion, Dehydration, Fall, Fatigue
Clinical narrative: About 1 1/2 weeks after receiving immunizations, the patient had a seizure while riding in a car. He was taken to the ER and had another seizure. He stayed in the hospital about 4 or 5 days. Tests were done and he was put on medicine, which seemed to help lessen the seizures for a while, but would then become more frequent. Meds were changed and again seizures would lessen for a while, but then come back again. Meds were changed several times, with the same results. Around the 1st of January 2001, he was put on the ketogenic diet with almost instant cessation of seizures, except for small 'tics" which he continues to have. He is now on only one med (Zonegram). The mother gives history of the patient falling on the kitchen floor and hitting his head about two months prior to onset of seizures. She states she gave him Tylenol for the headache, but did not go to a physician at the time. She also states doctors are unsure if immunizations are connected to his seizures. doc 214099, annual follow up states the following:"05/13/2002, mother states that patient continues with diet and medications plus has had seizures since 04/2001. She states that physician did not want patient to  be on the diet for more than 2 years, which will be up in 11/2002. She states that the physician plan to try taking him off the diet at that time. She thinks the patient is a little too small for his age + gets a little more tired than before but lives a "pretty well normal" life + even plays T ball. Per follow up Pt has not recovered. 12/16/2002 father states pt had recent EKG whiched showed "slowness in brain". Is no longer having tics and is continuing on Zonegram 100mg. Still on ketoganic dish, but is to be weaned off innext 2-3 months and within 6 months hopes to be eating normally. Says he has gained some weight and is now in a gymnastic class. Seizure disorder now better controlled with Ketogenic diet taking Titralac, Bug Bunny Vitamins, Zonegran. Repeated ear infection, tubes placed @ 18 months of age. Dx made at ER: facial muscle twitching, decreased responsiveness. Early 11/2000 child slipped and fell hitting back of head(?) Had HA for 4-5 hours. No further HA reported. Hospitalized 2 days @ 8 months of age for high fever and dehydration. 3rd hospital admission 01/08/2001 - 01/11/2001 for ketogenic diet instition records were obtained
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Headache, Injury, Muscle twitching, Nervous system disorder, Pyrexia
Clinical narrative: About 1 1/2 weeks after receiving immunizations, the patient had a seizure while riding in a car. He was taken to the ER and had another seizure. He stayed in the hospital about 4 or 5 days. Tests were done and he was put on medicine, which seemed to help lessen the seizures for a while, but would then become more frequent. Meds were changed and again seizures would lessen for a while, but then come back again. Meds were changed several times, with the same results. Around the 1st of January 2001, he was put on the ketogenic diet with almost instant cessation of seizures, except for small 'tics" which he continues to have. He is now on only one med (Zonegram). The mother gives history of the patient falling on the kitchen floor and hitting his head about two months prior to onset of seizures. She states she gave him Tylenol for the headache, but did not go to a physician at the time. She also states doctors are unsure if immunizations are connected to his seizures. doc 214099, annual follow up states the following:"05/13/2002, mother states that patient continues with diet and medications plus has had seizures since 04/2001. She states that physician did not want patient to  be on the diet for more than 2 years, which will be up in 11/2002. She states that the physician plan to try taking him off the diet at that time. She thinks the patient is a little too small for his age + gets a little more tired than before but lives a "pretty well normal" life + even plays T ball. Per follow up Pt has not recovered. 12/16/2002 father states pt had recent EKG whiched showed "slowness in brain". Is no longer having tics and is continuing on Zonegram 100mg. Still on ketoganic dish, but is to be weaned off innext 2-3 months and within 6 months hopes to be eating normally. Says he has gained some weight and is now in a gymnastic class. Seizure disorder now better controlled with Ketogenic diet taking Titralac, Bug Bunny Vitamins, Zonegran. Repeated ear infection, tubes placed @ 18 months of age. Dx made at ER: facial muscle twitching, decreased responsiveness. Early 11/2000 child slipped and fell hitting back of head(?) Had HA for 4-5 hours. No further HA reported. Hospitalized 2 days @ 8 months of age for high fever and dehydration. 3rd hospital admission 01/08/2001 - 01/11/2001 for ketogenic diet instition records were obtained
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Small for dates baby, Tic
Clinical narrative: About 1 1/2 weeks after receiving immunizations, the patient had a seizure while riding in a car. He was taken to the ER and had another seizure. He stayed in the hospital about 4 or 5 days. Tests were done and he was put on medicine, which seemed to help lessen the seizures for a while, but would then become more frequent. Meds were changed and again seizures would lessen for a while, but then come back again. Meds were changed several times, with the same results. Around the 1st of January 2001, he was put on the ketogenic diet with almost instant cessation of seizures, except for small 'tics" which he continues to have. He is now on only one med (Zonegram). The mother gives history of the patient falling on the kitchen floor and hitting his head about two months prior to onset of seizures. She states she gave him Tylenol for the headache, but did not go to a physician at the time. She also states doctors are unsure if immunizations are connected to his seizures. doc 214099, annual follow up states the following:"05/13/2002, mother states that patient continues with diet and medications plus has had seizures since 04/2001. She states that physician did not want patient to  be on the diet for more than 2 years, which will be up in 11/2002. She states that the physician plan to try taking him off the diet at that time. She thinks the patient is a little too small for his age + gets a little more tired than before but lives a "pretty well normal" life + even plays T ball. Per follow up Pt has not recovered. 12/16/2002 father states pt had recent EKG whiched showed "slowness in brain". Is no longer having tics and is continuing on Zonegram 100mg. Still on ketoganic dish, but is to be weaned off innext 2-3 months and within 6 months hopes to be eating normally. Says he has gained some weight and is now in a gymnastic class. Seizure disorder now better controlled with Ketogenic diet taking Titralac, Bug Bunny Vitamins, Zonegran. Repeated ear infection, tubes placed @ 18 months of age. Dx made at ER: facial muscle twitching, decreased responsiveness. Early 11/2000 child slipped and fell hitting back of head(?) Had HA for 4-5 hours. No further HA reported. Hospitalized 2 days @ 8 months of age for high fever and dehydration. 3rd hospital admission 01/08/2001 - 01/11/2001 for ketogenic diet instition records were obtained
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Convulsion, Tic
Clinical narrative: About 1 1/2 weeks after receiving immunizations, the patient had a seizure while riding in a car. He was taken to the ER and had another seizure. He stayed in the hospital about 4 or 5 days. Tests were done and he was put on medicine, which seemed to help lessen the seizures for a while, but would then become more frequent. Meds were changed and again seizures would lessen for a while, but then come back again. Meds were changed several times, with the same results. Around the 1st of January 2001, he was put on the ketogenic diet with almost instant cessation of seizures, except for small 'tics" which he continues to have. He is now on only one med (Zonegram). The mother gives history of the patient falling on the kitchen floor and hitting his head about two months prior to onset of seizures. She states she gave him Tylenol for the headache, but did not go to a physician at the time. She also states doctors are unsure if immunizations are connected to his seizures. doc 214099, annual follow up states the following:"05/13/2002, mother states that patient continues with diet and medications plus has had seizures since 04/2001. She states that physician did not want patient to  be on the diet for more than 2 years, which will be up in 11/2002. She states that the physician plan to try taking him off the diet at that time. She thinks the patient is a little too small for his age + gets a little more tired than before but lives a "pretty well normal" life + even plays T ball. Per follow up Pt has not recovered. 12/16/2002 father states pt had recent EKG whiched showed "slowness in brain". Is no longer having tics and is continuing on Zonegram 100mg. Still on ketoganic dish, but is to be weaned off innext 2-3 months and within 6 months hopes to be eating normally. Says he has gained some weight and is now in a gymnastic class. Seizure disorder now better controlled with Ketogenic diet taking Titralac, Bug Bunny Vitamins, Zonegran. Repeated ear infection, tubes placed @ 18 months of age. Dx made at ER: facial muscle twitching, decreased responsiveness. Early 11/2000 child slipped and fell hitting back of head(?) Had HA for 4-5 hours. No further HA reported. Hospitalized 2 days @ 8 months of age for high fever and dehydration. 3rd hospital admission 01/08/2001 - 01/11/2001 for ketogenic diet instition records were obtained
Age: 20.0
Sex: M
Vaccine: HEPA, IPV, TYP
Symptoms: Aphasia, Diarrhoea, Headache, Pyrexia
Clinical narrative: Fever of 105F; decreased slightly with Tylenol (given X1). By 08:00 AM, father concerned that son had a seizure. MD visit and admitted to the hospital for observation. Pt had slight diarrhea. Parent states client had a headache the morning of 4/4/01 but was well at the time of shots. No seizure noted in the hospital. Parent states client was aphasic for a short time. Discharged without dx of symptoms and clear tests.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia, Viral infection
Clinical narrative: Five days, post vax, child became febrile. Seen at hospital. On 4/24/01, after septic work-up; LP and blood cultures, child was discharged on 4/26/01. Dx'd with ? viral illness. Child discharge shows viral illness/fever.
Age: 1.8
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site hypersensitivity, Skin discolouration
Clinical narrative: The pt experienced a severe local reaction where the left thigh and the right thigh had discoloration.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site vesicles, Injection site warmth
Clinical narrative: One day post vax the pt complained of right arm redness and warmth. On 5/4 the pt was seen by a medical care associate. The right upper extremities / shoulder was erythematous and indurated with warmth and tenderness to the touch. The pt had blister formation and was referred to hospital.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: The pt experienced a 3x4 cm area of swelling and erythema inferior to injection site vaccine reaction with cellulitis. treated with Augmentin and Benadryl.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Injection site reaction, Skin discolouration, Urticaria
Clinical narrative: The pt's right leg where the vaccine was given turned deep red/purple with scattered hive like areas noted.
Age: 0.6
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Pyrexia, Staring, Tremor
Clinical narrative: The pt developed a fever of 104, shaking movements and staring spells. Tylenol and Motrin were given.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Screaming
Clinical narrative: The pt experienced a "scream" type cry for greater than 3 hours.
Age: 0.5
Sex: F
Vaccine: DTAP, PNC
Symptoms: Erythema, Lethargy, Rash macular
Clinical narrative: The pt experienced red blotches over the extremities and body. The baby was lethargic and afebrile.
Age: 1.25
Sex: U
Vaccine: DTAP, HIBV, IPV, MMR, PNC
Symptoms: Rash
Clinical narrative: The pt received the vaccines on 4/13/01 and on 4/22/01 woke from nap with rash on cheeks, stomach and bottom. Mother consulted physician and felt like it was probably due to MMR vaccine.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Mother called to say that the child had a fever approximately 24 hours post vax to 101. Given Tylenol every 6 hours and had decreased.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Choking, Injection site erythema, Irritability
Clinical narrative: Presented in ER with right leg redness (small amount). Mother states baby crying and choking. Temperature is 99.8F. Dx'd with slight local reaction to right leg.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Febrile convulsion, Viral infection
Clinical narrative: Child received vaccines on 4/18/01 and on 4/24/01 AM, developed fever and then a seizure. Was taken to hospital by EMS and dx'd as probable febrile seizure. Thought to have viral illness. Still fever today.
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Vomiting
Age: 1.7
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 9cm X 5cm firm, fluctuant swelling on right thigh with surface erythema. No marked tenderness.
Age: 1.5
Sex: M
Vaccine: DTAP, HEP, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Mom described red and swollen left thigh, 1 week after receiving 4 vaccines in left thigh with generalized rash. No fever and swelling resolved. MD observed thigh, 3 weeks after injections and swelling was resolved.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Difficulty in walking, Dyskinesia, Pyrexia
Clinical narrative: Pt's mother called our phone center seeking advice because pt had a fever, was having some jerking of extremities and wouldn't walk. Referred to ER by triage nurse. Found to have a temperature of 106F and rigors. Treated with antipyretic with symptom resolution.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV, PNC
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Pt received Prevnar vaccine in right thigh on 4/9/01. Pt returned to clinic on 4/11/01 with a hard knot, redness and swelling. Pt was limping. Dx'd with cellulitis.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Hypotonia, Irritability, Oral intake reduced, Sleep disorder, Somnolence
Clinical narrative: Slept and nursed well during the night, post vax, but the whole next day, was irritable, barely slept, barely nursed and had 1 period when she lay awake but was abnormally still. Seen in ER in the evening; irritable, drowsy but nursed some and interacted well. Did not behave normally again until 09:00 on 3/25/01.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Staring
Clinical narrative: Slept and nursed well during the night, post vax, but the whole next day, was irritable, barely slept, barely nursed and had 1 period when she lay awake but was abnormally still. Seen in ER in the evening; irritable, drowsy but nursed some and interacted well. Did not behave normally again until 09:00 on 3/25/01.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia, Screaming
Clinical narrative: Approx. 1 hour, post vax, child cried inconsolably. Mom called us after 3 1/2 hours (at 16:30 PM). She was told to give Tylenol and call back within the hour. Pt continuing to cry until 20:00 when family sent to ER. Temperature was 100.4F. Child did not stop crying until 03:00.
Age: 0.08
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Screaming
Clinical narrative: Pt tolerated 6 week shots well. Went home with mom. On 4/25/01 at 15:42, per mom, pt had non-stop crying since 4/23/01. No fever, but inconsolable. Can hear baby in the background, screaming and crying. MD suspects "pertussis" of DTAP. Resolved on 4/26/01, per mom.
Age: 1.25
Sex: M
Vaccine: MMR, PNC
Symptoms: Rash maculo-papular
Clinical narrative: Maculo papular rash on trunk, proximal extremities.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Abscess, Injection site oedema
Clinical narrative: This infant had localized swelling, mild, sterile abscess of the left thigh.
Age: 69.0
Sex: M
Vaccine: LYME
Symptoms: Dizziness, Musculoskeletal stiffness
Clinical narrative: On 4/29/01, two days post vax, the pt experienced dizziness and stiffness in his legs. No treatment was given. The pt was unsure if the adverse events were related to Lymerix. As of 4/30/01, the outcome of the events was ongoing. F/U there was no illness at the time of the vaccination. The pt did not have gout, psoriasis or crohn's disease. There was no family history of rheumatoid arthritis or lupus. The pt did not have a history of lyme disease. As of 6/13/01, the responsible physician stated that the pt had not been seen for the above-listed adverse events. He did not call or inform our office about any adverse reaction to the injection. The joint complaints were not evaluated by a physician. Swollen joints had nto been documented on physicial exam. Lab work was not performed. Joint fluid was not obtained. As of 6/14/01, the outcome of the adverse events was unknown. Dizziness does not meet ICM serious criteria, but are being submitted as an expedited report by special FDA request per the 6/26/00 ltr.
Age: 49.0
Sex: M
Vaccine: LYME
Symptoms: Hypoaesthesia, Polyarthritis
Clinical narrative: Arthritis pain in various joints, severe, much of the time, over the past year. More severe for the past 5 months. Also, numbness and tingling, especially in hands and arms. Presently taking Celebrex.
Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: Just like having Lyme disease only it went after the large joints; knees, ankles, back and neck.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Hypoaesthesia, Paralysis
Clinical narrative: The morning following vaccination, pt lost all feeling and movement in left arm for approx. 30 minutes. Experienced slow recovery over following hour. Pt has submitted this due to resistance from Navy doctor's to document and submit this adverse report.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Telephone call received from agent to field supervisor stating she received flu shot on 12/26/00 and had a seizure on 12/30/00. History of meningioma surgery removed but off since then. Seizure meds. Called PP who stated no correlation to flu shot but restarted her on seizure meds. (Tegretol). No further seizures since that date.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Telephone call received on 3/21/01 from client to clinic PHN stating she has continued to experience muscle soreness and some weakness of left arm off and on since receiving flu shot on 1/2/01. Saw her doctor who stated there was no infection and did not order any meds. Returned call from supervisor on 4/1/01. Client's arm is "gradually getting better" but still bothersome. Suggested comfort measures and to return to doctor if condition worsens.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Myalgia
Clinical narrative: Have had pain in left arm (muscle soreness) since receiving flu shot on 11/28/00. Pain is present on upward movement of arm and worse with lifting or pushing.
Age: 25.0
Sex: F
Vaccine: MMR, TD
Symptoms: Unevaluable event
Clinical narrative: Pt found out she was pregnant after receiving the MMR and TD vaccine on 3/29/01. She was counseled at time of visit to avoid pregnancy for 3 months.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Raised red area, approx. 4" X 1" on left deltoid.
Age: 39.0
Sex: M
Vaccine: MMR, TD, MMR, TD
Symptoms: Hypokinesia, Injection site pain, Injection site rash, Injection site warmth, Pain
Clinical narrative: The pt complained of elevated temp, chills, pain at the deltoid radiating to the elbow of left arm and inability to move arm. Erythema from deltoid to mid upper extremity, hot, tight skin, finger edematous and painful to touch. Two small bumps on each side of injection site. No oozing or drainage. 80mm of erythema and swelling in length.
Age: 39.0
Sex: M
Vaccine: MMR, TD, MMR, TD
Symptoms: Pyrexia, Skin disorder
Clinical narrative: The pt complained of elevated temp, chills, pain at the deltoid radiating to the elbow of left arm and inability to move arm. Erythema from deltoid to mid upper extremity, hot, tight skin, finger edematous and painful to touch. Two small bumps on each side of injection site. No oozing or drainage. 80mm of erythema and swelling in length.
Age: 39.0
Sex: M
Vaccine: MMR, TD, MMR, TD
Symptoms: Hypokinesia, Injection site erythema, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: The pt complained of elevated temp, chills, pain at the deltoid radiating to the elbow of left arm and inability to move arm. Erythema from deltoid to mid upper extremity, hot, tight skin, finger edematous and painful to touch. Two small bumps on each side of injection site. No oozing or drainage. 80mm of erythema and swelling in length.
Age: 39.0
Sex: M
Vaccine: MMR, TD, MMR, TD
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: The pt complained of elevated temp, chills, pain at the deltoid radiating to the elbow of left arm and inability to move arm. Erythema from deltoid to mid upper extremity, hot, tight skin, finger edematous and painful to touch. Two small bumps on each side of injection site. No oozing or drainage. 80mm of erythema and swelling in length.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Rash
Clinical narrative: Mother brought pt in for rash on left arm. No temperature. Rash since yesterday.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left leg red and swollen, 3 days, after immunization.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia
Clinical narrative: Transient hemi-anesthesia A follow up report received 01/22/2003 adds: It was reported that a female pt was given a post exposure series of Imovax Rabies for bat exposure. Pt experienced "flu-like" symptoms after 2nd and 3rd doses. On 02/18/2001 the pt developed numbness in left side of face, ear, arm and calf, no sensory perception in left side, now in right side. Was seen in ER on 02/18/2001, CAT scan done. Referred to neurologist and ENT doctor, MRI done, all reports sent to primary care physician. Unresolved, getting worse. Per Aventis Pasteur Inc. Medical Safety Officer's conversation with primary care physician on 02/28/2001, it was stated that the neurologist evaluated the pt and made a diagnosis of hemianesthesia. From additional correspondence received on 05/07/2001, additional laboratory data was provided. From follow-up #1 mailed correspondence received on 06/12/2001 stated, "Reviewed, nothing to add at this time. This case is closed.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: TC from pt, stating child had a rash on back area, 1 hour, post vax. Told to call MD. When RN called back, client to follow-up on condition. Parent denied rash ever present or TC made to RN; did no visit MD.
Age: 29.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Pallor, Pruritus
Clinical narrative: Immediately, post vax, pt's color was pale, palms sweaty, arms felt swollen, complained of dizziness and weakness. Symptoms continued on 4/18/01 and 4/19/01. Took 24 hour Allegra which seemed to help. Lips, hands and throat were itchy. Still feels dizzy today on 4/19/01 but improved.
Age: 29.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Swelling
Clinical narrative: Immediately, post vax, pt's color was pale, palms sweaty, arms felt swollen, complained of dizziness and weakness. Symptoms continued on 4/18/01 and 4/19/01. Took 24 hour Allegra which seemed to help. Lips, hands and throat were itchy. Still feels dizzy today on 4/19/01 but improved.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA, TD, VARCEL
Symptoms: Infection, Pyrexia
Clinical narrative: On 1/19/01, pt noticed 1st pox but by 1/20/01, covered in pox with fever of 103F. Temperature was 100F-101F on 1/21/01. Denies contact with infected individuals. Chickenpox covered body. (Vesicular lesions scabbing over in 3-4 days).
Age: 39.0
Sex: F
Vaccine: MMR, TD
Symptoms: Hypoglycaemia, Loss of consciousness
Clinical narrative: On 2/23/01, 48 hours, post vax, client was found passed out in bathtub by father. Paramedics called. Glucose given. Two days, after this incident, client could not move entire left side for about 5 minutes. Diabetic-AM blood sugar 118. States "paramedic blood sugar was 28, after above episode."
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: 11/00, client experienced nausea and vomiting. Put on Phenergan, then suppositories. 12/00, put on Tigan. 2nd Hep-B vaccine on 1/2/01, ENG5159A2/IM/LA, still nausea and vomiting. Did upper GI, gallbladder U/S and blood work-all normal. Remained sick. On 4/01, started on Prilosec and Pepto-Bismol, 1 tsp. bid with Prilosec. Mom states child would have weeks where he was better but would relapse. 3rd Hep-B ENG5184A9/IM/LA, given on 4/12/01 and is experiencing same nausea and vomiting starting on 4/23/01. Mom thinks it is a side effect from Hep-B vaccine series.
Age: 0.6
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Rash, Urticaria
Clinical narrative: Mother brought child to clinic on 4/9/01 "for shots". Mother stated that the pt developed "hives and a rash" about 5-6 hours, post vax. Mother stated pt did not have a fever. She took pt to the Medical Center for evaluation. The ER doctor told her that the DTAP vaccine caused the "hives and rash". Mother does not recall any specific treatment. She reported reaction to Peds.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Pruritus, Pyrexia
Clinical narrative: Left arm where IPV and DTAP were given, very red and swollen from upper arm to elbow. Swollen area is hard and arm is warm to touch. Mom states has been running a fever. Child is complaining of itching. Called on 4/11/01 and mom stated no complaint of itching, swelling or redness but some fever. Saw Pediatrician on 4/10/01 and dx'd severe local reaction. No treatment given and to return if worsens.
Age: 15.0
Sex: M
Vaccine: TD, VARCEL
Symptoms: Anxiety, Eye discharge, Eye swelling, Throat tightness, Tongue oedema
Clinical narrative: Received shots approx. 11:00. Parent called and reported swelling of eyes with matting. Advised to go to EMT substation immediately, EMT's alerted and reported back that child over-reacted and anxious. On 3/21/01 spoke with parent and reports problems with throat through the night. Eye and tongue swollen.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Muscle spasms, Paraesthesia, Pruritus
Clinical narrative: Pt received TD booster as routine shot on 4/13/01. On 5/24/01, she noticed an electrical "zinging or zapping" sensation going down her arms. This comes and goes. Starting 5/26/01, she noticed more itching and cramping in her (B) arms and hands. I spoke with doctor on 5/25/01 and he recommended conservative therapy and monitoring of symptoms. Pt to call me if symptoms do not resolve in 2 weeks.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA, VARCEL
Symptoms: Blood pressure decreased, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: At 10:05, post vax, pt looked pale and he's dizzy. I had his head down. At 10:10, had him lie down. BP 90/60; HR-66/min. reg. No SOB or chest pain. Pt diaphoretic. At 10:20, BP 90/70; HR-90/min. reg. Skin and lip color pink, pt states not dizzy anymore. Feeling fine and left stable.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site oedema, Injection site rash, Injection site urticaria, Pruritus
Clinical narrative: The pt experienced a rash, and hives on arm with swelling the diameter of a small orange. Now swelling is gone and it appears to be a dry occasionally itchy rash. (As stated by mom.)
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Febrile convulsion
Clinical narrative: Received a call from the mother that the child was taken to the ER by ambulance on 4/27/01 and diagnosed with febrile seizures. Mother recalls being instructed to give Tylenol every 4 hours for 24 hours but stated that she did not do so. The child was discharged on Motrin and Ceftroxil. Mother denies any allergies or medical complication.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Erythema, Oedema, Pyrexia, Urticaria
Clinical narrative: One day post vax, the pt had edema, hives and fever. The fever went to 100 and started at 9:00pm on 4/16/01 and the hives and edema by next day. Hives were from the waist down. Right hip is swollen and red.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site oedema, Injection site vesicles
Clinical narrative: The pt complained of extreme swelling with the arm 3 times the normal size. No increased temp. Seen in the ER on 4/6/01 PM. Places on antibiotics. Told had infection from shot. Called her mother on 4/9/01 she states arm remains swollen. States he told her shot should have been in leg and not deltoid. On 4/10/01 mother states the pt is on antibiotics. On 4/13/01 it is reported that the arm is blistered down to the elbow. On 4/24/01 is completely healed.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: The pt experienced swelling 6cm x 4cm to the left arm with erythema and mildly warm to the touch.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: The pt experienced rashes and itching.
Age: 1.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: The pt experienced complete upper arm left deltoid redness, a hard lump and warmth to the touch. No change in activity level.
Age: 30.0
Sex: M
Vaccine: TD
Symptoms: Malaise, Muscular weakness, Pyrexia
Clinical narrative: The client called to report adverse events 24 hours post administration of vaccine on 4/24/01. The pt complained of malaise, weakness in hands and fever. The pt had not taken temp so was unsure what it was.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Lethargy, Pyrexia, Urticaria
Clinical narrative: The pt experienced hives from the upper arm to wrist of the left arm. He made the statement "I need to get air". The pt was less alert and experienced a low grade fever.
Age: 4.0
Sex: F
Vaccine: HEPA, IPV, MMR, TD
Symptoms: Erythema, Rash
Clinical narrative: The pt experienced a red rash on her arms, legs, back, and chest. Benadryl was given.
Age: 10.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema
Clinical narrative: The pt experienced a erythema at the injection site approximately 2.5 cm in diameter.
Age: 12.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Convulsion, Fall, Hypotension, Injury, Loss of consciousness
Clinical narrative: Following vaccination, the pt fell off the exam table hitting head on floor and arms, legs and stomach were shaking (seizure) with LOC, lasting approximately 5 seconds. BP 100/70, HR 80. Ice applied, had normal neurological exam after incident, normal cardiac exam. Ice applied to face.
Age: 12.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Tremor
Clinical narrative: Following vaccination, the pt fell off the exam table hitting head on floor and arms, legs and stomach were shaking (seizure) with LOC, lasting approximately 5 seconds. BP 100/70, HR 80. Ice applied, had normal neurological exam after incident, normal cardiac exam. Ice applied to face.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: The pt developed a headache, low grade temp and red spots all over body. No treatment was given.
Age: 1.8
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: The pt complained of redness, swelling (about 3 inches surrounding injection site) pain to left upper thigh.
Age: 7.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Erythema, Eyelid oedema, Hypoxia, Injection site erythema, Respiratory distress
Clinical narrative: The pt experienced respiratory distress, nasal flaring, O2 sat at 94%, erythema at the injection site and abdomen, erythema and swelling of bilateral eyelids and neck. Respiratory rate is 60 with inspiratory and expiratory wheezing.
Age: 7.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Wheezing
Clinical narrative: The pt experienced respiratory distress, nasal flaring, O2 sat at 94%, erythema at the injection site and abdomen, erythema and swelling of bilateral eyelids and neck. Respiratory rate is 60 with inspiratory and expiratory wheezing.