chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, DTAPIPV, MMR, DTAPIPV, MMR
Symptoms: Injection site swelling, No reaction on previous exposure to drug, Skin swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of diffuse swelling in a 4-year-old male subject who was vaccinated with KINRIX. On 10 March 2009 at 13:30 the subject received 1st dose of KINRIX (.5 ml, unknown, left arm). On 10 March 2009 the subject received 2nd dose of MMR vaccine. On 11 March 2009, 24 hours after vaccination with KINRIX, at an unspecified time after vaccination with MMR vaccine, the subject experienced diffuse swelling. The subject experienced swelling of upper left arm and swelling of the chest area as well. The subject was seen for follow-up on 12 March 2009 and was started on an oral antibiotic, amoxicillin trihydrate + AUGMENTIN and BENADRYL. At the time of reporting the events were unspecified.
Age: 7.0
Sex: M
Vaccine: FLUX, HEPA, VARCEL, FLUX, HEPA, VARCEL
Symptoms: Body temperature decreased, Eosinophil percentage increased, Eosinophilic cellulitis, Erythema, Pain
Clinical narrative: This case was retrieved via a search of the scientific literature 17 March 2009. A seven-year-old male patient received Influenza virus vaccine, Hepatitis A vaccine, and Varicella vaccine (manufacturers, lot numbers, date, site, and routes of administration not reported). Seven to nine days post-vaccination, he began experiencing a rash which initially presented as a single raised, pruritic lesion on the sole of the left foot. It subsequently got larger and began to resemble cellulitis. He was treated with oral antibiotics with no effect, and the rash progressed to his face and extremities. It was described as painful and pruritic, with lesions ranging from flat and target-lesion-like to bright, red, raised, and urticarial. He developed an intermittent low grade fever, and laboratory testing revealed a WBC of 23.7 x 10 (9) L with 59% eosinophils. A lesion biopsy revealed eosinophilic cellulitis/WELL's syndrome. All symptoms resolved without treatment within eight weeks of diagnosis, and was asymptomatic at his last follow-up visit. Documents held by sender: None.
Age: 7.0
Sex: M
Vaccine: FLUX, HEPA, VARCEL, FLUX, HEPA, VARCEL
Symptoms: Pyrexia, Rash, Rash pruritic, Urticaria, White blood cell count increased
Clinical narrative: This case was retrieved via a search of the scientific literature 17 March 2009. A seven-year-old male patient received Influenza virus vaccine, Hepatitis A vaccine, and Varicella vaccine (manufacturers, lot numbers, date, site, and routes of administration not reported). Seven to nine days post-vaccination, he began experiencing a rash which initially presented as a single raised, pruritic lesion on the sole of the left foot. It subsequently got larger and began to resemble cellulitis. He was treated with oral antibiotics with no effect, and the rash progressed to his face and extremities. It was described as painful and pruritic, with lesions ranging from flat and target-lesion-like to bright, red, raised, and urticarial. He developed an intermittent low grade fever, and laboratory testing revealed a WBC of 23.7 x 10 (9) L with 59% eosinophils. A lesion biopsy revealed eosinophilic cellulitis/WELL's syndrome. All symptoms resolved without treatment within eight weeks of diagnosis, and was asymptomatic at his last follow-up visit. Documents held by sender: None.
Age: 7.0
Sex: M
Vaccine: FLUX, HEPA, VARCEL, FLUX, HEPA, VARCEL
Symptoms: Biopsy skin, Eosinophil count increased, Eosinophilic cellulitis, Erythema, Pain
Clinical narrative: This case was retrieved via a search of the scientific literature 17 March 2009. A seven-year-old male patient received Influenza virus vaccine, Hepatitis A vaccine, and Varicella vaccine (manufacturers, lot numbers, date, site, and routes of administration not reported). Seven to nine days post-vaccination, he began experiencing a rash which initially presented as a single raised, pruritic lesion on the sole of the left foot. It subsequently got larger and began to resemble cellulitis. He was treated with oral antibiotics with no effect, and the rash progressed to his face and extremities. It was described as painful and pruritic, with lesions ranging from flat and target-lesion-like to bright, red, raised, and urticarial. He developed an intermittent low grade fever, and laboratory testing revealed a WBC of 23.7 x 10 (9) L with 59% eosinophils. A lesion biopsy revealed eosinophilic cellulitis/WELL's syndrome. All symptoms resolved without treatment within eight weeks of diagnosis, and was asymptomatic at his last follow-up visit. Documents held by sender: None.
Age: 36.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Large reddened are. Swollen.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein, Arrested labour, Caesarean section, Cephalo-pelvic disproportion, Drug exposure during pregnancy
Clinical narrative: Information has been received from a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 24 year old female with a history of lactose intolerance and 1 miscarriage who on 30-NOV-2007 was vaccinated with a 1st dose of GARDASIL (lot# 659055/1522U). Concomitant therapy included prenatal vitamins. Subsequently, 2 to 3 weeks after getting her vaccination the patient became pregnant (LMP 12-dec-2007). It was reported that on 31-JAN-2008 the patient has an ultrasound, routine obstetrical diagnostic tests, and cystic fibrosis screening (results negative). It was reported that on 28-FEB-2008 the patient had serum alpha-fetoprotein test (results within range). No adverse event was reported. Follow up information was received from a charge nurse who stated that the patient delivered a healthy and normal male, at term, on 16-SEP-2008. It was reported that the patient's labor progressed to second stage, when she had an arrest of descent and was diagnosed with CPD for this birth. It was reported that the patient had a cesarean section. The reporter stated that the patient had an uncomplicated prenatal course, with the usual pregnancy related complains, nothing more. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Ultrasound scan
Clinical narrative: Information has been received from a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 24 year old female with a history of lactose intolerance and 1 miscarriage who on 30-NOV-2007 was vaccinated with a 1st dose of GARDASIL (lot# 659055/1522U). Concomitant therapy included prenatal vitamins. Subsequently, 2 to 3 weeks after getting her vaccination the patient became pregnant (LMP 12-dec-2007). It was reported that on 31-JAN-2008 the patient has an ultrasound, routine obstetrical diagnostic tests, and cystic fibrosis screening (results negative). It was reported that on 28-FEB-2008 the patient had serum alpha-fetoprotein test (results within range). No adverse event was reported. Follow up information was received from a charge nurse who stated that the patient delivered a healthy and normal male, at term, on 16-SEP-2008. It was reported that the patient's labor progressed to second stage, when she had an arrest of descent and was diagnosed with CPD for this birth. It was reported that the patient had a cesarean section. The reporter stated that the patient had an uncomplicated prenatal course, with the usual pregnancy related complains, nothing more. No further information is available.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abscess, Injection site erythema, Injection site swelling, Pyrexia, Surgery
Clinical narrative: Information has been received from a physician concerning a 70 year old male patient who on 11-MAR-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot# 663893/0128Y) 065ml. Concomitant therapy include "multiple medications". After received the vaccine the patient experienced swelling and redness at the injection site. Patient then experienced fever of 103.8. On 18-MAR-2009 the patient was admitted to the hospital and. On 19-MAR-2009 the patient was operated and had abscess. At the time of the report on 20-MAR-2009 the patient was not recovered and was still in the hospital. Swelling, redness, fever and abscess were considered to be disabling and an other important medical event for surgery. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Paralysis
Clinical narrative: Information has been received from a consumer concerning his granddaughter (a female patient of unknown age) who experienced paralysis after getting the first 0.5 ml dose of GARDASIL. Lot# was not provided. The patient was hospitalized and at the time of reporting she was still in hospital. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Cerebrovascular accident, Computerised tomogram normal, Dysarthria, Electroencephalogram normal
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with atypical seizure disorder (started following an episode of head trauma) characterized by lip smacking and dysarthria (not tonic clonic movements). She was on treatment for this. On 10-MAR-2009, the patient was vaccinated with the first dose of GARDASIL (Lot # 661841/0653X) in the right buttock and had only minor localized tenderness. Subsequently, in March 2009 the patient developed paralysis, dysarthria, pain in legs and "stroke-like symptoms". In follow-up, the physician reported that on 13-MAR-2009, 3 days after the dose, the patient developed a rash in the distribution of her quadriceps on both legs which lasted 3 days before resolving. ON 17-MAR-2009, 1 week after the dose, the patient developed dysarthria without other seizure symptoms. There were no new medications or change in medications. The patient was admitted to the hospital for evaluation: EEG, CT, CBC, blood chemistries all came back normal. She was discharged without any specific treatment. On 24-MAR-2009, the patient saw her neurologist for the dysarthria. An MRI with gadolinium was negative. That evening at home she stood up and lost consciousness. The patient complained of numbness in her right arm and leg. On 25-MAR-2009, the patient had been complaining of burning pain in the right leg (front and back) without focality. There were no objective physical findings. At the time of reporting, the patient's dysarthria persisted. Upon internal review, paralysis and stroke-like symptoms were considered to be other important medical events. Additional information has been requested.  4/17/09 Office notes received from PCP from 3/10/09 to 3/30/09. New pt visit 3/10/09.  Depoprovera and HPV#1 given.  OV 3/25/09- Pt developed injection site swelling and rash.  On 3/18/09 had a seizure with dysarthria seen in ER and admitted. Now with R arm pain and numbness.  PE (+) for slurred speech. Last night pt was dizzy, passed out, had dry heaves, leg numbness and R arm tingling. Tx with IM and po steroids. Seen 3/27/09 Still having severe,  shooting leg pain, speech improving. TX Toradol and Lyrica. Office note 3/30/09 reporting pt admitted with DX of GBS.    5/7/09 Hospital notes received from 3/18/09 to 3/19/09.   FINAL DIAGNOSIS: Seizure Disorder Unwitnessed seizure, mother states prolonged postictal phase, confused, slurred and repetitive speech.  Additional seizure in ED, shaking, eyes rolling, tongue moving, arms flexed. Returned to previous postictal state.  PE WNL other than dialated pupils. Consider possible conversion disorder.  6/4/09 DC and hospital records received DOS 3/28/09/ to 3/29/09. FINAL DIAGNOSIS: Persistant Right Leg Pain Post vaccination presents with severe right-sided leg pain. Vaccine was injected into right buttock. Depo-Provera into left leg. Seizure. Passed out, tingling and numbness on right side of body. Follow with psychiatry.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Hypoaesthesia, Laboratory test normal, Local reaction, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with atypical seizure disorder (started following an episode of head trauma) characterized by lip smacking and dysarthria (not tonic clonic movements). She was on treatment for this. On 10-MAR-2009, the patient was vaccinated with the first dose of GARDASIL (Lot # 661841/0653X) in the right buttock and had only minor localized tenderness. Subsequently, in March 2009 the patient developed paralysis, dysarthria, pain in legs and "stroke-like symptoms". In follow-up, the physician reported that on 13-MAR-2009, 3 days after the dose, the patient developed a rash in the distribution of her quadriceps on both legs which lasted 3 days before resolving. ON 17-MAR-2009, 1 week after the dose, the patient developed dysarthria without other seizure symptoms. There were no new medications or change in medications. The patient was admitted to the hospital for evaluation: EEG, CT, CBC, blood chemistries all came back normal. She was discharged without any specific treatment. On 24-MAR-2009, the patient saw her neurologist for the dysarthria. An MRI with gadolinium was negative. That evening at home she stood up and lost consciousness. The patient complained of numbness in her right arm and leg. On 25-MAR-2009, the patient had been complaining of burning pain in the right leg (front and back) without focality. There were no objective physical findings. At the time of reporting, the patient's dysarthria persisted. Upon internal review, paralysis and stroke-like symptoms were considered to be other important medical events. Additional information has been requested.  4/17/09 Office notes received from PCP from 3/10/09 to 3/30/09. New pt visit 3/10/09.  Depoprovera and HPV#1 given.  OV 3/25/09- Pt developed injection site swelling and rash.  On 3/18/09 had a seizure with dysarthria seen in ER and admitted. Now with R arm pain and numbness.  PE (+) for slurred speech. Last night pt was dizzy, passed out, had dry heaves, leg numbness and R arm tingling. Tx with IM and po steroids. Seen 3/27/09 Still having severe,  shooting leg pain, speech improving. TX Toradol and Lyrica. Office note 3/30/09 reporting pt admitted with DX of GBS.    5/7/09 Hospital notes received from 3/18/09 to 3/19/09.   FINAL DIAGNOSIS: Seizure Disorder Unwitnessed seizure, mother states prolonged postictal phase, confused, slurred and repetitive speech.  Additional seizure in ED, shaking, eyes rolling, tongue moving, arms flexed. Returned to previous postictal state.  PE WNL other than dialated pupils. Consider possible conversion disorder.  6/4/09 DC and hospital records received DOS 3/28/09/ to 3/29/09. FINAL DIAGNOSIS: Persistant Right Leg Pain Post vaccination presents with severe right-sided leg pain. Vaccine was injected into right buttock. Depo-Provera into left leg. Seizure. Passed out, tingling and numbness on right side of body. Follow with psychiatry.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Pain in extremity, Paralysis, Rash, Tenderness
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with atypical seizure disorder (started following an episode of head trauma) characterized by lip smacking and dysarthria (not tonic clonic movements). She was on treatment for this. On 10-MAR-2009, the patient was vaccinated with the first dose of GARDASIL (Lot # 661841/0653X) in the right buttock and had only minor localized tenderness. Subsequently, in March 2009 the patient developed paralysis, dysarthria, pain in legs and "stroke-like symptoms". In follow-up, the physician reported that on 13-MAR-2009, 3 days after the dose, the patient developed a rash in the distribution of her quadriceps on both legs which lasted 3 days before resolving. ON 17-MAR-2009, 1 week after the dose, the patient developed dysarthria without other seizure symptoms. There were no new medications or change in medications. The patient was admitted to the hospital for evaluation: EEG, CT, CBC, blood chemistries all came back normal. She was discharged without any specific treatment. On 24-MAR-2009, the patient saw her neurologist for the dysarthria. An MRI with gadolinium was negative. That evening at home she stood up and lost consciousness. The patient complained of numbness in her right arm and leg. On 25-MAR-2009, the patient had been complaining of burning pain in the right leg (front and back) without focality. There were no objective physical findings. At the time of reporting, the patient's dysarthria persisted. Upon internal review, paralysis and stroke-like symptoms were considered to be other important medical events. Additional information has been requested.  4/17/09 Office notes received from PCP from 3/10/09 to 3/30/09. New pt visit 3/10/09.  Depoprovera and HPV#1 given.  OV 3/25/09- Pt developed injection site swelling and rash.  On 3/18/09 had a seizure with dysarthria seen in ER and admitted. Now with R arm pain and numbness.  PE (+) for slurred speech. Last night pt was dizzy, passed out, had dry heaves, leg numbness and R arm tingling. Tx with IM and po steroids. Seen 3/27/09 Still having severe,  shooting leg pain, speech improving. TX Toradol and Lyrica. Office note 3/30/09 reporting pt admitted with DX of GBS.    5/7/09 Hospital notes received from 3/18/09 to 3/19/09.   FINAL DIAGNOSIS: Seizure Disorder Unwitnessed seizure, mother states prolonged postictal phase, confused, slurred and repetitive speech.  Additional seizure in ED, shaking, eyes rolling, tongue moving, arms flexed. Returned to previous postictal state.  PE WNL other than dialated pupils. Consider possible conversion disorder.  6/4/09 DC and hospital records received DOS 3/28/09/ to 3/29/09. FINAL DIAGNOSIS: Persistant Right Leg Pain Post vaccination presents with severe right-sided leg pain. Vaccine was injected into right buttock. Depo-Provera into left leg. Seizure. Passed out, tingling and numbness on right side of body. Follow with psychiatry.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female with no allergies who on 22-MAY-2007 was vaccinated IM with the first dose of GARDASIL (lot# 657621/0387U).  In April 2008, eleven months later, the patient experienced seizure.  A magnetic resonance imaging (MRI) was performed (result unknown).  Subsequently, the patient recovered from seizure.  On 22-OCT-2008 the patient received the second dose of GARDASIL (lot# 661530/0575X) IM 0.5mL.  The patient sought medical attention at the practice.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested.  7/27/09 Medical records received DOS 10/22/08 to 12/17/08. Includes EEG report from 5/13/08 and MR Brain from 5/15/08. Assessment: HPV. Patient presents with fatigue, sores in mouth, vaginitis. Cervical dysplasia. Acid Reflux. Alcohol use. Seizure in Fall 08  - patient considers event related to shellfish. Desires STD testing. Would like to restart Gardasil series (had initial dose in 5/07 but did not return for 2nd or 3rd doses). Dose of Gardasil given on 10/22/08 visit.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning an approximately 3 year old female, who on 29-JAN-2007 was vaccinated with the first dose of ROTATEQ (Lot # 656103/1166F), 2ml, orally; on 01-APR-2007, was vaccinated with the second dose of ROTATEQ (Lot # 656189/1239F), 2ml, orally and on 04-JUN-2007, was vaccinated with the third dose of ROTATEQ (Lot # 656392/0239U), 2ml, orally. The physician reported that the patient tested positive for rotavirus. She was hospitalized on 12-MAR-2009 and released on 12-MAR-2009. The patient had to be rehydrated at the hospital. The patient recovered on an unspecified date. Additional information has been requested.
Age: 1.6
Sex: M
Vaccine: DTAP, MMR, OPV
Symptoms: Autism, Haematology test, Rotavirus infection, Speech disorder developmental
Clinical narrative: Information has been received from a consumer concerning her approximately 20 month old son with no pertinent medical history and no known drug reactions/allergies, who on 11-MAY-2006 was vaccinated with a dose of MMR II (Lot not reported). Concomitant therapy included DTAP and POLIO. Right around the time of vaccination, the patient experienced speech delays and was finally diagnosed with autism at 4 years of age. A lot of blood work and test had been done to the patient (results not reported). At the time of reporting, 18-MAR-2009, the patient had not recovered. The patient also, experienced rotavirus and was hospitalized. Upon internal review, autism was considered to be an other Important Medical Event. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning "three of her friend's sons" who were vaccinated with MMR II (lot number, route and site not reported). Subsequently the patients developed autism. It was unspecified if the patients sought medical attention. The outcome were unknown. This is one of several reports received from the same source. Upon internal review, autism was determined to be an other important medical event. No further information is available.
Sex: F
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning a stranger's granddaughter who was vaccinated with MMR II (lot number, route and site not reported). After receiving the vaccination, the patient was diagnosed with autism. The outcome was unknown. This is one of several reports received from the same source. Upon internal review, autism was determined to be an other important medical event. No further information is available.
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a parent concerning her son via e-mail a male who was vaccinated with MMR II and subsequently the child experienced autism. The patient was given the complete recommended "CDC shots". Upon internal review, autism was determined to be an other important medical event. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Autism, Pyrexia
Clinical narrative: Information has been received from a consumer reported "she knows several children (exact number is unknown) who experienced a high fever and were diagnosed with autism a couple months after receiving a dose of MMR II. Upon internal review, autism was determined to be an other important medical event. This is one of several reports from the same source. No further information was available.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Asperger's disorder
Clinical narrative: Information has been received from the mother of her 12 year old son with a previous Pyloric Stenosis surgery, who was vaccinated with a dose of MMR II a few months after recovering from the Pyloric Stenosis surgery. The reporter stated that she was convinced that the MMR II preceded his autistic traits. The mother noted she could even trace the differences in him through pictures of before and after his MMR II shot. Upon internal review Aspergers syndrome was determined to be an other important medical event. Additional information is not expected.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Autism, Autism spectrum disorder, Chapped lips, Erythema, Erythema multiforme
Clinical narrative: Information has been received from a consumer via the internet concerning her 16 month old son who in January 2005, was vaccinated with a dose of MMR II. Concomitant therapy included PEDVAXHIB (manufacturer unknown). Other concomitant therapy included DTaP. In approximately January 2005, "approximately 10 days after the vaccines were administered", the patient "started out with a fever then a slight red rash, then it went into an event higher fever, severe red whelp rash and severe swelling, especially of his face, hands, and feet". When he woke up the morning of that 11th-12th day (approximately) after the shots, the consumer was advised to rush the patient to the ER immediately. It was reported that they "were pulled over and the police officer took one look at him (with his cracked lips, eyes almost swollen shut, with nothing on his feet but a pair of his father's socks because nothing else would fit they were so swollen), and called for an ambulance". The consumer reported that test after test was run but could not tell them what really had happened to the patient. They were given "a couple of long technical words, E-something multiforme". The basic impression was "rash all over". The patient was told to be allergic to penicillin that was given when he first presented with a fever days after the vaccines. The patient had been tested later and he was "not at all allergic to any penicillin or eggs at all", the allergist suspected the vaccines. It was reported that the patient "continued to be ill for the next couple of months after the ER visit, with blood in his stool, etc. His Measles titers were still to this day, 4 years later, extremely high. After those few months of being ill, the patient started to show signs of autism, and was later diagnosed Pervasive Developmental Disorder (PDD/NOS)". The mother reported that "he had changed, he had lost eye contact with us and stopped talking like he had before, he only said the very minimum now to get his needs met, he no longer asked questions or interacted in our world, he slipped away into his own world right before our eyes and there was nothing we could do to bring him back". Upon internal review, autism was considered to be other important medical events. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Eye swelling, Haematochezia, Measles antibody, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a consumer via the internet concerning her 16 month old son who in January 2005, was vaccinated with a dose of MMR II. Concomitant therapy included PEDVAXHIB (manufacturer unknown). Other concomitant therapy included DTaP. In approximately January 2005, "approximately 10 days after the vaccines were administered", the patient "started out with a fever then a slight red rash, then it went into an event higher fever, severe red whelp rash and severe swelling, especially of his face, hands, and feet". When he woke up the morning of that 11th-12th day (approximately) after the shots, the consumer was advised to rush the patient to the ER immediately. It was reported that they "were pulled over and the police officer took one look at him (with his cracked lips, eyes almost swollen shut, with nothing on his feet but a pair of his father's socks because nothing else would fit they were so swollen), and called for an ambulance". The consumer reported that test after test was run but could not tell them what really had happened to the patient. They were given "a couple of long technical words, E-something multiforme". The basic impression was "rash all over". The patient was told to be allergic to penicillin that was given when he first presented with a fever days after the vaccines. The patient had been tested later and he was "not at all allergic to any penicillin or eggs at all", the allergist suspected the vaccines. It was reported that the patient "continued to be ill for the next couple of months after the ER visit, with blood in his stool, etc. His Measles titers were still to this day, 4 years later, extremely high. After those few months of being ill, the patient started to show signs of autism, and was later diagnosed Pervasive Developmental Disorder (PDD/NOS)". The mother reported that "he had changed, he had lost eye contact with us and stopped talking like he had before, he only said the very minimum now to get his needs met, he no longer asked questions or interacted in our world, he slipped away into his own world right before our eyes and there was nothing we could do to bring him back". Upon internal review, autism was considered to be other important medical events. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Rash erythematous, Rash generalised, Speech disorder developmental, Swelling face, Urticaria
Clinical narrative: Information has been received from a consumer via the internet concerning her 16 month old son who in January 2005, was vaccinated with a dose of MMR II. Concomitant therapy included PEDVAXHIB (manufacturer unknown). Other concomitant therapy included DTaP. In approximately January 2005, "approximately 10 days after the vaccines were administered", the patient "started out with a fever then a slight red rash, then it went into an event higher fever, severe red whelp rash and severe swelling, especially of his face, hands, and feet". When he woke up the morning of that 11th-12th day (approximately) after the shots, the consumer was advised to rush the patient to the ER immediately. It was reported that they "were pulled over and the police officer took one look at him (with his cracked lips, eyes almost swollen shut, with nothing on his feet but a pair of his father's socks because nothing else would fit they were so swollen), and called for an ambulance". The consumer reported that test after test was run but could not tell them what really had happened to the patient. They were given "a couple of long technical words, E-something multiforme". The basic impression was "rash all over". The patient was told to be allergic to penicillin that was given when he first presented with a fever days after the vaccines. The patient had been tested later and he was "not at all allergic to any penicillin or eggs at all", the allergist suspected the vaccines. It was reported that the patient "continued to be ill for the next couple of months after the ER visit, with blood in his stool, etc. His Measles titers were still to this day, 4 years later, extremely high. After those few months of being ill, the patient started to show signs of autism, and was later diagnosed Pervasive Developmental Disorder (PDD/NOS)". The mother reported that "he had changed, he had lost eye contact with us and stopped talking like he had before, he only said the very minimum now to get his needs met, he no longer asked questions or interacted in our world, he slipped away into his own world right before our eyes and there was nothing we could do to bring him back". Upon internal review, autism was considered to be other important medical events. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Autism, Convulsion, Inflammatory bowel disease
Clinical narrative: Information has been received from a consumer via the internet reporting that she knew of toddlers who on an unspecified dates were vaccinated with MMR II. It was reported that the toddlers had seizures followed by regression into autism accompanied by inflammatory bowel disease after receiving the vaccination. The outcome was not provided at this time. It was not specified if the patients sought medical attention or not. Upon internal review, seizure and autism were considered to be other important medical events. This is one of several reports received from the same source. Attempts are being made to verify the existence of the identifiable patients.
Sex: F
Vaccine: RUB
Symptoms: Convulsion, Pyrexia, Rash, Screaming
Clinical narrative: Information has been received from a consumer concerning her daughter who on an unspecified date was vaccinated with a dose of MERUVAX II. Subsequently, "after getting vaccination", the patient developed rash, high fever, screaming and seizures. The outcome was not provided at this time. It was unspecified if the patient sought medical attention or not. The consumer also mentioned that her son had reaction to "the vaccine (name and manufacturer unknown)" (WAES # 0903USA04840). Upon internal review, seizure was considered to be an other important medical event. No further information is available.
Sex: M
Vaccine: TTOX
Symptoms: Anaphylactic shock
Clinical narrative: This serious case was received on 26 March 2009 from another manufacturer. The initial reporter was the consumer's spouse. A male patient received a Tetanus vaccine (manufacturer and lot number not reported) on an unspecified date. Post vaccination the patient experienced anaphylactic shock. The reporter was not able to provide any other information. List of Documents held by Sender: None.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Blood chloride normal, Blood creatinine normal, Blood culture negative, Blood glucose increased, Blood potassium decreased
Clinical narrative: Caretaker states pain, erythema, and tenderness developed at sites of vaccines given 3 days prior to ER admission at hospital. Erythema & warmth surrounding injection site on (R) thigh, and both arms. Fever for one night, Temp of 103.3 degrees F. Vaccines given 3/25. Seen by PMD and started on KEFLEX & BENADRYL on 3/27 erythema worsened since 3/27, especially on (R) thigh.  5/8/09 MR received for DOS 3/29-30/2009 with D/C DX:  Allergic Reaction to vaccine.  Cellulitis.  Obesity.  Asthma. Pt presented with redness and swelling at injection sites on the bilateral arms and R thigh with fever. Initially prescribed abx and benadryl by PCP but continued to worsen.  PE (+) for above with tenderness and warmth as well. Admitted for IV abx. D/C improved next day on oral abx.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Blood sodium normal, Blood urea normal, Eosinophil percentage, Haemoglobin normal, Injection site erythema
Clinical narrative: Caretaker states pain, erythema, and tenderness developed at sites of vaccines given 3 days prior to ER admission at hospital. Erythema & warmth surrounding injection site on (R) thigh, and both arms. Fever for one night, Temp of 103.3 degrees F. Vaccines given 3/25. Seen by PMD and started on KEFLEX & BENADRYL on 3/27 erythema worsened since 3/27, especially on (R) thigh.  5/8/09 MR received for DOS 3/29-30/2009 with D/C DX:  Allergic Reaction to vaccine.  Cellulitis.  Obesity.  Asthma. Pt presented with redness and swelling at injection sites on the bilateral arms and R thigh with fever. Initially prescribed abx and benadryl by PCP but continued to worsen.  PE (+) for above with tenderness and warmth as well. Admitted for IV abx. D/C improved next day on oral abx.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site pain, Injection site warmth, Lymphocyte percentage, Neutrophil percentage, Platelet count normal
Clinical narrative: Caretaker states pain, erythema, and tenderness developed at sites of vaccines given 3 days prior to ER admission at hospital. Erythema & warmth surrounding injection site on (R) thigh, and both arms. Fever for one night, Temp of 103.3 degrees F. Vaccines given 3/25. Seen by PMD and started on KEFLEX & BENADRYL on 3/27 erythema worsened since 3/27, especially on (R) thigh.  5/8/09 MR received for DOS 3/29-30/2009 with D/C DX:  Allergic Reaction to vaccine.  Cellulitis.  Obesity.  Asthma. Pt presented with redness and swelling at injection sites on the bilateral arms and R thigh with fever. Initially prescribed abx and benadryl by PCP but continued to worsen.  PE (+) for above with tenderness and warmth as well. Admitted for IV abx. D/C improved next day on oral abx.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Caretaker states pain, erythema, and tenderness developed at sites of vaccines given 3 days prior to ER admission at hospital. Erythema & warmth surrounding injection site on (R) thigh, and both arms. Fever for one night, Temp of 103.3 degrees F. Vaccines given 3/25. Seen by PMD and started on KEFLEX & BENADRYL on 3/27 erythema worsened since 3/27, especially on (R) thigh.  5/8/09 MR received for DOS 3/29-30/2009 with D/C DX:  Allergic Reaction to vaccine.  Cellulitis.  Obesity.  Asthma. Pt presented with redness and swelling at injection sites on the bilateral arms and R thigh with fever. Initially prescribed abx and benadryl by PCP but continued to worsen.  PE (+) for above with tenderness and warmth as well. Admitted for IV abx. D/C improved next day on oral abx.
Age: 44.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP, TYP
Symptoms: Contusion, Idiopathic thrombocytopenic purpura, Petechiae
Clinical narrative: Signs of bruising and petechiae in April/May 2008. Petechiae on lower legs and feet.  4/24/2009 MR received for DOS 2/17-19/2009 WITH D/c dx:  Immune Thrombocytopenia.  Pt presented with several month hx of diffuse petechiae.  Platelet counts were low (1,000 range) and pt dx with ITP. Treated as outpt with oral steroids with increase in platelets to 78K.  Pt currently presents with bleeding from the mouth and petechiae. Platelet count 0 on admission for severe thrombocytopenia 2' to ITP. PE (+) for purpuric oral lesions, petechiae and epistaxis. Tx with dexamethasone and Rituximab and d/c for further outpt tx.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL, SMALL, ANTH, PPV, SMALL, SMALL
Symptoms: Catheterisation cardiac, Dyspnoea, Electrocardiogram normal, Hyperhidrosis, Myocarditis
Clinical narrative: Developed chest pain, SOB and diaphoresis. Admitted to clinic and diagnosed with MI. Troponins elevated, EKG normal, Cardiac cath primarily normal. Seen by military cardiologist and correctly diagnosed post vaccinia Myocarditis.   4/15/09 Received medical records of 3/26-3/30/2009. FINAL DX: post vaccinia myocarditis Records reveal patient experienced chest pain after receiving multiple vaccinations w/robust take on smallpox.  Twelve days s/p vaccination, he awoke w/chest pain radiating down left arm, SOB, sweating.  Pain lessened & patient had usual day.  Late in same afternoon, pain exacerbated & went to aid station where he was dx w/panic attack; however, BP 160/116.  Tx w/O2 & NTG & transferred to local hospital on where EKG was WNL but troponin elevated.  Admitted to CCU 2/11-2/14/2009 & had normal heart cath.  Transferred to step down unit & also given pneumovax.  Developed fever of 103.8 within a few hours that lasted 24 hours then resolved.  When seen in Cardio Clinic 3/26 for echocardiogram which was WNL, dx changed to post vaccinia myocarditis & meds changed.  Not deployed & released to home.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL, SMALL, ANTH, PPV, SMALL, SMALL
Symptoms: Troponin increased
Clinical narrative: Developed chest pain, SOB and diaphoresis. Admitted to clinic and diagnosed with MI. Troponins elevated, EKG normal, Cardiac cath primarily normal. Seen by military cardiologist and correctly diagnosed post vaccinia Myocarditis.   4/15/09 Received medical records of 3/26-3/30/2009. FINAL DX: post vaccinia myocarditis Records reveal patient experienced chest pain after receiving multiple vaccinations w/robust take on smallpox.  Twelve days s/p vaccination, he awoke w/chest pain radiating down left arm, SOB, sweating.  Pain lessened & patient had usual day.  Late in same afternoon, pain exacerbated & went to aid station where he was dx w/panic attack; however, BP 160/116.  Tx w/O2 & NTG & transferred to local hospital on where EKG was WNL but troponin elevated.  Admitted to CCU 2/11-2/14/2009 & had normal heart cath.  Transferred to step down unit & also given pneumovax.  Developed fever of 103.8 within a few hours that lasted 24 hours then resolved.  When seen in Cardio Clinic 3/26 for echocardiogram which was WNL, dx changed to post vaccinia myocarditis & meds changed.  Not deployed & released to home.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL, SMALL, ANTH, PPV, SMALL, SMALL
Symptoms: Myocardial infarction, Troponin I increased
Clinical narrative: Developed chest pain, SOB and diaphoresis. Admitted to clinic and diagnosed with MI. Troponins elevated, EKG normal, Cardiac cath primarily normal. Seen by military cardiologist and correctly diagnosed post vaccinia Myocarditis.   4/15/09 Received medical records of 3/26-3/30/2009. FINAL DX: post vaccinia myocarditis Records reveal patient experienced chest pain after receiving multiple vaccinations w/robust take on smallpox.  Twelve days s/p vaccination, he awoke w/chest pain radiating down left arm, SOB, sweating.  Pain lessened & patient had usual day.  Late in same afternoon, pain exacerbated & went to aid station where he was dx w/panic attack; however, BP 160/116.  Tx w/O2 & NTG & transferred to local hospital on where EKG was WNL but troponin elevated.  Admitted to CCU 2/11-2/14/2009 & had normal heart cath.  Transferred to step down unit & also given pneumovax.  Developed fever of 103.8 within a few hours that lasted 24 hours then resolved.  When seen in Cardio Clinic 3/26 for echocardiogram which was WNL, dx changed to post vaccinia myocarditis & meds changed.  Not deployed & released to home.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL, SMALL, ANTH, PPV, SMALL, SMALL
Symptoms: Arterial occlusive disease, Catheterisation cardiac abnormal, Chest pain, Dyspnoea, Echocardiogram normal
Clinical narrative: Developed chest pain, SOB and diaphoresis. Admitted to clinic and diagnosed with MI. Troponins elevated, EKG normal, Cardiac cath primarily normal. Seen by military cardiologist and correctly diagnosed post vaccinia Myocarditis.   4/15/09 Received medical records of 3/26-3/30/2009. FINAL DX: post vaccinia myocarditis Records reveal patient experienced chest pain after receiving multiple vaccinations w/robust take on smallpox.  Twelve days s/p vaccination, he awoke w/chest pain radiating down left arm, SOB, sweating.  Pain lessened & patient had usual day.  Late in same afternoon, pain exacerbated & went to aid station where he was dx w/panic attack; however, BP 160/116.  Tx w/O2 & NTG & transferred to local hospital on where EKG was WNL but troponin elevated.  Admitted to CCU 2/11-2/14/2009 & had normal heart cath.  Transferred to step down unit & also given pneumovax.  Developed fever of 103.8 within a few hours that lasted 24 hours then resolved.  When seen in Cardio Clinic 3/26 for echocardiogram which was WNL, dx changed to post vaccinia myocarditis & meds changed.  Not deployed & released to home.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL, SMALL, ANTH, PPV, SMALL, SMALL
Symptoms: Electrocardiogram normal, Hyperhidrosis, Myocarditis, Pain, Pyrexia
Clinical narrative: Developed chest pain, SOB and diaphoresis. Admitted to clinic and diagnosed with MI. Troponins elevated, EKG normal, Cardiac cath primarily normal. Seen by military cardiologist and correctly diagnosed post vaccinia Myocarditis.   4/15/09 Received medical records of 3/26-3/30/2009. FINAL DX: post vaccinia myocarditis Records reveal patient experienced chest pain after receiving multiple vaccinations w/robust take on smallpox.  Twelve days s/p vaccination, he awoke w/chest pain radiating down left arm, SOB, sweating.  Pain lessened & patient had usual day.  Late in same afternoon, pain exacerbated & went to aid station where he was dx w/panic attack; however, BP 160/116.  Tx w/O2 & NTG & transferred to local hospital on where EKG was WNL but troponin elevated.  Admitted to CCU 2/11-2/14/2009 & had normal heart cath.  Transferred to step down unit & also given pneumovax.  Developed fever of 103.8 within a few hours that lasted 24 hours then resolved.  When seen in Cardio Clinic 3/26 for echocardiogram which was WNL, dx changed to post vaccinia myocarditis & meds changed.  Not deployed & released to home.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL, SMALL, ANTH, PPV, SMALL, SMALL
Symptoms: Myocardial infarction, Troponin I
Clinical narrative: Developed chest pain, SOB and diaphoresis. Admitted to clinic and diagnosed with MI. Troponins elevated, EKG normal, Cardiac cath primarily normal. Seen by military cardiologist and correctly diagnosed post vaccinia Myocarditis.   4/15/09 Received medical records of 3/26-3/30/2009. FINAL DX: post vaccinia myocarditis Records reveal patient experienced chest pain after receiving multiple vaccinations w/robust take on smallpox.  Twelve days s/p vaccination, he awoke w/chest pain radiating down left arm, SOB, sweating.  Pain lessened & patient had usual day.  Late in same afternoon, pain exacerbated & went to aid station where he was dx w/panic attack; however, BP 160/116.  Tx w/O2 & NTG & transferred to local hospital on where EKG was WNL but troponin elevated.  Admitted to CCU 2/11-2/14/2009 & had normal heart cath.  Transferred to step down unit & also given pneumovax.  Developed fever of 103.8 within a few hours that lasted 24 hours then resolved.  When seen in Cardio Clinic 3/26 for echocardiogram which was WNL, dx changed to post vaccinia myocarditis & meds changed.  Not deployed & released to home.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Left deltoid 13 1/2 x 12 cm reddened swollen and warm to touch. Rub area 2 Hrs. and apply ice pack for 15 min. for 24 Hrs - then warm compress.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Influenza serology positive, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Localized reaction, red, warm to touch, raised area 2 1/2 X 2 inches RT.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: L arm Swelling With mild erythema.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Patient had a hot, red, swollen lump under skin where vaccine was given. Are marked with skin marker. Patient advised to contact clinic if redness or swelling got larger. Patient advised to apply ice to are. Patient will call clinic if worsens.
Age: 1.1
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Red ring around injection site. Low grade fever. Cool compress and TYLENOL prn.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysstasia, Feeling hot, Hypotension, Pallor
Clinical narrative: Right after injection I got very hot and dizzy. I could not stand up. Health Dept had to lay me down. My blood pressure was very low, I was pale in color. After about 30 to 45 minutes I got in car and went home. Where another 2 hours before I was able to get out of bed.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Pain, Pruritus, Vaccinia
Clinical narrative: Bumps on hands and elbows itching pain 5/10 when bumped or touched. She was seen at the ER 3/18/09. Diagnosed General Vaccinia, treated with LIDEX cream bid prn.  5/26/09 Medical records received DOS 3/18/09 to 4/27/09. FINAL DIAGNOSIS: Erythema Multiforme, Adverse Drug Effect of Vaccines Smallpox. Post vaccination presented dermatitis with red papules, crusted, fingers/elbows, itching, pain when touched or bumped.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Erythema multiforme, Generalised vaccinia, HIV antibody negative, Laboratory test normal, Pain
Clinical narrative: Bumps on hands and elbows itching pain 5/10 when bumped or touched. She was seen at the ER 3/18/09. Diagnosed General Vaccinia, treated with LIDEX cream bid prn.  5/26/09 Medical records received DOS 3/18/09 to 4/27/09. FINAL DIAGNOSIS: Erythema Multiforme, Adverse Drug Effect of Vaccines Smallpox. Post vaccination presented dermatitis with red papules, crusted, fingers/elbows, itching, pain when touched or bumped.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Rash pruritic, Smear cervix normal, Urticaria
Clinical narrative: Bumps on hands and elbows itching pain 5/10 when bumped or touched. She was seen at the ER 3/18/09. Diagnosed General Vaccinia, treated with LIDEX cream bid prn.  5/26/09 Medical records received DOS 3/18/09 to 4/27/09. FINAL DIAGNOSIS: Erythema Multiforme, Adverse Drug Effect of Vaccines Smallpox. Post vaccination presented dermatitis with red papules, crusted, fingers/elbows, itching, pain when touched or bumped.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site rash, Rash maculo-papular
Clinical narrative: Developed rash on Both anterior thighs within 24 hours after vaccine slightly pink maculopapules on both thighs.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count, Local swelling, Oedema peripheral, Pain in extremity, X-ray limb
Clinical narrative: Right arm pain, swelling radiating up to neck and down to fingers.
Age: 6.0
Sex: F
Vaccine: VARZOS, VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: None as of this date.