chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.02
Sex: M
Vaccine: DTAP, MMR
Symptoms: Speech disorder, Strabismus
Clinical narrative: 10/5/00 Until Present Fever Swelling at site Lost Speech Spinning Hand Flapping High Pitched Screaming When Upset Real Sensitive To Noises Started Losing Balance And Easily Falling Easily Agitated And Irritable For No Reason Easily Upset When Situations Or Surroundings Are Changed Unresponsive To Name Or Simple Questions Detachment From Other People Hitting And Pinching, Especially In The Face, Neck, And Under Arm Personality Changed Stopped Sleeping Through The Night Repeats Words Or Starts Words Over And Over Does Not Stop Doing Something Wrong When Told Repeatedly To Stop Clings To Mom Most Of The Time Will Not Let Anyone Else Do Anything For Him But Mom Feet Are Always Hot and Sweaty With Shoes On Left Eye Occasionally Crosses Slightly
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, PNC
Symptoms: Insomnia, Irritability, Oral intake reduced, Pyrexia, Rash
Clinical narrative: Fever began 7 days after vaccinations, 100.4 to 102.1 rectally, lasted 3 days, tylenol and ibuprofen given for comfort. Rash (fine, pink, flat initially then slightly raised) began on trunk 9 days after vaccinations, spread to limbs and head on day 10, fading on day 11. Also he was irritable, had difficulty sleeping, and poor appetite.
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Bronchitis, Crying, Dehydration, Febrile convulsion, Hypokinesia
Clinical narrative: Developed a runny nose within 24 hours of receiving the vaccine. Was extremely cranky for several days later. Within 10 days of receiving the vaccine, nasal congestion cleared and a fever of 103 developed. She was given alternating doses of Tylenol and Motrin to control the fever but it never dipped below 103. She was taken to her Dr. on 6/23/2004 and diagnosed with borderline otitis media. No chest infection was present.I was given a prescription for Omnicef 125MG/5 ML Susp ABB and she received her first dose by 9:30 pm on 6/23/2004.  10 hours later, her fever spiked to 105 and she had a febrile seizure. She was taken to the ER and received Tylenol to help bring the fever down to 101. Her fever rose again throughout the night and early morning and was given overlapping, alternate doses of Tylenol and Mortin. She began to refuse solid food and would only accept about 1/4 of her ususal formula intake. She was extremely lethargic, refused to stand, crawl, sit or hold her head of and spent approximately 23 of the following 24 hours asleep. Waking only to take small amounts of formula and medication. On the evening of 6/24/2004 she awoke and began crying. I held her on my lap, belly to belly. During this time, she passed out, vomited and did not rouse until about 3 minutes after vomiting. Her fever remained steady between 104 to 105 degrees. The following morning, on 6/25/2004, I took her again to her pediatrician. He examined her stating her otitis media appeared to have cleared up, no chest infection but she was severely dehydrated and she had to be admitted to the local PICU. She was admitted on 6/25/2004 and began an IV drip only after several failed attemptes to locate a vein as she was so dehydrated. She received a chest x-ray, urine culture, CBC and other blood test. Her doctor informed me there may be a need to give her a spinal tap. During her stay at the hospital, her fever reduced and then became normal, x-ray and urine tests results were negative but blood tests suggested a viral infectionn that could not be positively determined. Throughout this time, all residents, nurses and her pediatrician reported no chest congestion of any kind, even when I asked specificall if any was detected. I was given several diagnoses throughout her stay at the hospital, from possible coxsackie, roseola, and it was intimated she may have meningitis. She was released from the hospital on 6/27/2004 with a normal temp, although she remained very sleepy and refused to eat or drink much for the next several days. On July 1, 2004 I met with her pediatrician for a follow-up visit and inquired as to what she could have had. He infoirmed me she was diagnosed with bronchitis, despite an absence of chest congestion or any cough. I inquired for the third time since her innoculation of Prevnar if this illness could have been a reaction to the vaccine, I was again told no, even though she originally presented with the very symptoms Prevnar was suppose to prevent.  Nurse follow up on 07/22/04 states: "Viral Syndrome, perihilar infiltrates."
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Oral intake reduced, Otitis media, Pyrexia, Rhinorrhoea, Somnolence
Clinical narrative: Developed a runny nose within 24 hours of receiving the vaccine. Was extremely cranky for several days later. Within 10 days of receiving the vaccine, nasal congestion cleared and a fever of 103 developed. She was given alternating doses of Tylenol and Motrin to control the fever but it never dipped below 103. She was taken to her Dr. on 6/23/2004 and diagnosed with borderline otitis media. No chest infection was present.I was given a prescription for Omnicef 125MG/5 ML Susp ABB and she received her first dose by 9:30 pm on 6/23/2004.  10 hours later, her fever spiked to 105 and she had a febrile seizure. She was taken to the ER and received Tylenol to help bring the fever down to 101. Her fever rose again throughout the night and early morning and was given overlapping, alternate doses of Tylenol and Mortin. She began to refuse solid food and would only accept about 1/4 of her ususal formula intake. She was extremely lethargic, refused to stand, crawl, sit or hold her head of and spent approximately 23 of the following 24 hours asleep. Waking only to take small amounts of formula and medication. On the evening of 6/24/2004 she awoke and began crying. I held her on my lap, belly to belly. During this time, she passed out, vomited and did not rouse until about 3 minutes after vomiting. Her fever remained steady between 104 to 105 degrees. The following morning, on 6/25/2004, I took her again to her pediatrician. He examined her stating her otitis media appeared to have cleared up, no chest infection but she was severely dehydrated and she had to be admitted to the local PICU. She was admitted on 6/25/2004 and began an IV drip only after several failed attemptes to locate a vein as she was so dehydrated. She received a chest x-ray, urine culture, CBC and other blood test. Her doctor informed me there may be a need to give her a spinal tap. During her stay at the hospital, her fever reduced and then became normal, x-ray and urine tests results were negative but blood tests suggested a viral infectionn that could not be positively determined. Throughout this time, all residents, nurses and her pediatrician reported no chest congestion of any kind, even when I asked specificall if any was detected. I was given several diagnoses throughout her stay at the hospital, from possible coxsackie, roseola, and it was intimated she may have meningitis. She was released from the hospital on 6/27/2004 with a normal temp, although she remained very sleepy and refused to eat or drink much for the next several days. On July 1, 2004 I met with her pediatrician for a follow-up visit and inquired as to what she could have had. He infoirmed me she was diagnosed with bronchitis, despite an absence of chest congestion or any cough. I inquired for the third time since her innoculation of Prevnar if this illness could have been a reaction to the vaccine, I was again told no, even though she originally presented with the very symptoms Prevnar was suppose to prevent.  Nurse follow up on 07/22/04 states: "Viral Syndrome, perihilar infiltrates."
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Viral infection, Vomiting
Clinical narrative: Developed a runny nose within 24 hours of receiving the vaccine. Was extremely cranky for several days later. Within 10 days of receiving the vaccine, nasal congestion cleared and a fever of 103 developed. She was given alternating doses of Tylenol and Motrin to control the fever but it never dipped below 103. She was taken to her Dr. on 6/23/2004 and diagnosed with borderline otitis media. No chest infection was present.I was given a prescription for Omnicef 125MG/5 ML Susp ABB and she received her first dose by 9:30 pm on 6/23/2004.  10 hours later, her fever spiked to 105 and she had a febrile seizure. She was taken to the ER and received Tylenol to help bring the fever down to 101. Her fever rose again throughout the night and early morning and was given overlapping, alternate doses of Tylenol and Mortin. She began to refuse solid food and would only accept about 1/4 of her ususal formula intake. She was extremely lethargic, refused to stand, crawl, sit or hold her head of and spent approximately 23 of the following 24 hours asleep. Waking only to take small amounts of formula and medication. On the evening of 6/24/2004 she awoke and began crying. I held her on my lap, belly to belly. During this time, she passed out, vomited and did not rouse until about 3 minutes after vomiting. Her fever remained steady between 104 to 105 degrees. The following morning, on 6/25/2004, I took her again to her pediatrician. He examined her stating her otitis media appeared to have cleared up, no chest infection but she was severely dehydrated and she had to be admitted to the local PICU. She was admitted on 6/25/2004 and began an IV drip only after several failed attemptes to locate a vein as she was so dehydrated. She received a chest x-ray, urine culture, CBC and other blood test. Her doctor informed me there may be a need to give her a spinal tap. During her stay at the hospital, her fever reduced and then became normal, x-ray and urine tests results were negative but blood tests suggested a viral infectionn that could not be positively determined. Throughout this time, all residents, nurses and her pediatrician reported no chest congestion of any kind, even when I asked specificall if any was detected. I was given several diagnoses throughout her stay at the hospital, from possible coxsackie, roseola, and it was intimated she may have meningitis. She was released from the hospital on 6/27/2004 with a normal temp, although she remained very sleepy and refused to eat or drink much for the next several days. On July 1, 2004 I met with her pediatrician for a follow-up visit and inquired as to what she could have had. He infoirmed me she was diagnosed with bronchitis, despite an absence of chest congestion or any cough. I inquired for the third time since her innoculation of Prevnar if this illness could have been a reaction to the vaccine, I was again told no, even though she originally presented with the very symptoms Prevnar was suppose to prevent.  Nurse follow up on 07/22/04 states: "Viral Syndrome, perihilar infiltrates."
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Anorexia, Herpes zoster, Irritability, Pyrexia, Rash
Clinical narrative: On June 7, 2004 my son developed a small cluster of tiny red bumps on his right buttock. After a few days the bumps developed tiny white pustules and spread in a line around his buttock toward his right hip. On 6/10/2004 I took him to his pediatrician and had him examined and was informed he had shingles. I was asked if he came into contact with anyone who had shingles or chickenpox and told his doctor that he did not. I was prescribed Bactroban Cream and Zovirax to be topically applied. He had a low grade fever of about 101 and was tired, irritable and demonstrated a loss of appetite. Since he did not come into contact with anyone who had shingles or chickenpox, I inquired if the varicella innoculation could have made him susceptable to shingles. I was told no. My son has never had the chickenpox so I was at a loss to explain how he could develop shingles without ever presenting with chickenpox first. He is not in any daycare or structured classrom setting and only associates with close family members with whom any shingles or chickenpox infection would have been known.
Sex: F
Vaccine: MMR
Symptoms: Cognitive disorder, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning his daughter, with no known allergies, who was vaccinated with MMR (lot # not reported). The pharmacist reported that his daughter, who at the time of this report, was 22 years old, and developmentally delayed, was vaccinated as a child and experienced an adverse event. Post vaccination, the patient developed a fever of 104 or higher. Unspecified medical attention was sought and the patient was treated with acetaminophen. Subsequently, the patient recovered from the fever (date not specified). It was unknown if the patient recovered from developmental delay. There was no product quality complaint involved. Upon internal medical review, developmental delay and fever of 104 or higher were considered to be other important medical events (OMIC). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning a child who, on an unspecified date, was vaccinated with MMR. The consumer reported that she had heard of a child that developed autism shortly after receiving the vaccination. The outcome of the event was not reported. The consumer also reported the experiences of her grandson after vaccination with MMR. Upon internal review, the autism was considered to be other important medical event (OMIC). No further information is available.
Age: 1.13
Sex: F
Vaccine: MMR
Symptoms: Autism, Social avoidant behaviour, Speech disorder
Clinical narrative: Information has been received from a consumer concerning his daughter, with no past medical history or allergies, who in approximately May 1998, was vaccinated with MMR (date of vaccination and lot number not reported). There was no concomitant medication. The reporter stated that his daughter was vaccinated with MMR when she was 14 to 18 months old and the next day she would not talk or look at him. There were no physical changes noted and there were no other vaccinations or medications administered. The patient was diagnosed with autism and received special education including speech and psychological therapies five days a week for years. She was not treated with medications. At the time of this report the patient was now 7 years old; she had shown improvement. She was able to read on a 6th grade level but not recovered 100%. Doctors are now stating that the patient does not have autism. There was no product quality complaint involved. The reporter considered autism to be disabling. Additional information has been requested.  Follow up on 08/04/04 states: "Follow up information from a physician stated that the pt "was not a pt at this office when (MMRII) was administered." It was also reported that the pt "did have significant autistic-like behaviors as a toddler" which were reported as improving. The reporter considered autism to be disabling. Additional information has been requested."
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal, Neutropenia, Pyrexia, Viral infection
Clinical narrative: Information has been received from a nurse and the father of an approximately 4 year old female who on 5/19/95 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. In 1998, the patient was diagnosed with leukemia. The patient was hospitalized a couple of times with a fever and neutropenia, otherwise the treatment was usually outside the hospital. In 1999, the patient's varicella antibody titer IgG was 1- 80, which should have been immunity, but the chemotherapy probably wiped out her immunity. The father reported that while receiving chemotherapy for leukemia, the patient developed a mild episode of varicella that was considered an equivocal case. In 2001, after 2.5 years, the patient finished chemotherapy. In approximately 2002 the patient developed full flown chicken pox. Unspecified medical attention was sought and no treatment was required. No chemotherapy was received at that time. In June 2002 the patient was seen in the office 10 months off therapy and was doing great. The patient was last seen at the physician's office in December 2002. She is no longer a patient in his practice. It was also noted that the patient was not vaccinated at their facility. No product quality complaint was involved.  Follow up information indicated that the patinet was treated for Acute Lymphoblastic Leukemia. Diagnosis was in 1998 and she completed treatment in 2001. It was reported that she received the vaccine prior to treatment at her pediatricians office and contracted chicken pox after therapy was completed. The patient then moved from their area. Additional information is not expected.
Sex: M
Vaccine: HIBV
Symptoms: Abnormal behaviour, Drug toxicity, Neuropathy
Clinical narrative: Information has been received from regarding a case in litigation concerning a male who has reached the age of majority but is unable to manage his own legal and business affairs who on 04/03/87 was vaccinated with a dose of Hib conj vaccine. It was also noted that the pt was vaccinated with 4 doses of DTP/HIB on 05/21/85, 07/19/85, 10/10/86.  The pt was exposed to high levels of mercury from thimerosal exposure to thimerosal laden products. In addition, he was exposed to mercury from continually inhaling and ingesting industry mercury emissions from fossil fuel driven power plants. The mercury included in the thimerosal laden products and power plant emissions together caused the pt to suffer serious and permanent neurological injuries. The pt's exposure to airborne mercury in the environment through inhalation, the food chain, and other sources contributed to the cumulative mercury toxicity and was a substantial factor causing his neurological damage. He had a heightened vulnerability to suffer neurological injuries from industrial mercury as a direct result of thimerosal exposure. As a direct and proximate cause of the toxic mercury exposure, the pt was caused to suffer serious and permanent neurological damages which include past a future mental, intellectual, developmental and neurological incapacity and associated learning disabilities, disorders, and impairments.  Upon internal review, cumulative mercury toxicity and serious and permanent neurological damages which include past and future mental, intellectual, developmental, and neurological incapacity and associated learning disabilities, disorders, and impairments were considered to be other important medical events (OMIC). Follow up information indicated that the physician who administered the vaccines to the pt reported that the pt did not receive a dose of Hib conj vaccine.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Eye disorder
Clinical narrative: Information has been received from a consumer who is the mother of a 12 month old male pt with no relevant medical history who on 06/10/04 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included MMRII. On 06/17/04, "within 1 week" the child started to develop blisters on the eyes. There was no diagnostic lab data performed. It was noted that treatment was required. The mother of the child has consulted with her pediatrician and an opthamologist. Unspecified medical attention was sought. There was no product complaint involved. The pt had not recovered. Upon internal review blisters in the eyes was considered an other important medical event (OMIC).  Additional information has been requested. This is an amended report. The adverse event of retinal disorder has been changed to eye disorder. The report is corrected as amended.
Sex: M
Vaccine: DTPHIB
Symptoms: Grand mal convulsion
Clinical narrative: This case was considered medically important (OMIC). Information regarding Tetramune vaccine (diphtheria and tetanus toxoids and pertussis vaccine adsorbed and haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate) injection) was received from a consumer regarding her son, who received a dose in 1997, and experienced grand mal seizures. Relevant medical history was not provided. Indication for Tetramune Vaccine was immunization. Product was administered in 1997. Dose regimen  was 1 dose. Additional vaccine administered on an unspecified date included Orimune vaccine (Poliovirus vaccine live oral trivalent solution). Concomitant medications were not reported. A consumer, the mother of a male child reported that her son received a dose of Tetramune in 1997 (date unspecified) and subsequently experienced "grand mal seizures". Additionally, the child received Orimune vaccine on an unspecified date and year. As of 06/23/04, the mother stated "the seizures were unresolved". No additional information was available at the time of this report.
Age: 64.0
Sex: M
Vaccine: HEPAB
Symptoms: Asthenia, Blood glucose increased, Cold sweat, Dizziness, Hypotension
Clinical narrative: Within less than one minute, client became lightheaded followed by pallor, cool and clammy skin. Blood pressure 90/70 lying down. Transported by ambulance to hospital because continued to be lightheaded. At hospital, continued with same symptoms so kept overnight.  Nurse follow up on 07/23/04 states: "weakness and nausea."
Age: 64.0
Sex: M
Vaccine: HEPAB
Symptoms: Nausea, Pallor
Clinical narrative: Within less than one minute, client became lightheaded followed by pallor, cool and clammy skin. Blood pressure 90/70 lying down. Transported by ambulance to hospital because continued to be lightheaded. At hospital, continued with same symptoms so kept overnight.  Nurse follow up on 07/23/04 states: "weakness and nausea."
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Anaemia, Condition aggravated, Contusion, Irritability, Oedema peripheral
Clinical narrative: Bruising bilaterally; legs swollen from hip to below knees. Fussy, very pale. Saw doctor at same clinic 7/1/04. HCT 11.8, Hgb 3.8. Admitted to hospital and then transferred.  Nurse follow up on 07/26/04 states: "exacerbation of anemia."
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pallor
Clinical narrative: Bruising bilaterally; legs swollen from hip to below knees. Fussy, very pale. Saw doctor at same clinic 7/1/04. HCT 11.8, Hgb 3.8. Admitted to hospital and then transferred.  Nurse follow up on 07/26/04 states: "exacerbation of anemia."
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Was in office 6/16/04 and received (IM) tetanus and IPV (SQ) in Left arm. Pt returned on 6/18/04 with arm swollen, warm and red. Told pt to apply cold compress and use Benadryl until gone.
Age: 0.92
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Arthritis bacterial, Cellulitis
Clinical narrative: Cellulitis in left leg (thigh). Seen in ER on 4/03/04 and 4/9/04. Admitted to hospital 4/9/04. Diagnosis MRSA. Cellulitis and septic arthritis of knee (left).
Age: 57.0
Sex: M
Vaccine: TD, TYP
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Nausea, extremely tired, Headache. Started taking typhoid on 6/15
Age: 55.0
Sex: F
Vaccine: TD, TYP
Symptoms: Abdominal distension, Anorexia, Diarrhoea, Fatigue, Headache
Clinical narrative: Took typhoid oral; major headache, abdominal swelling, loss of appetite, nausea, diarrhea, extremely tired
Age: 55.0
Sex: F
Vaccine: TD, TYP
Symptoms: Nausea
Clinical narrative: Took typhoid oral; major headache, abdominal swelling, loss of appetite, nausea, diarrhea, extremely tired
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Face oedema, Skin ulcer, Urticaria, Vomiting
Clinical narrative: Pt became red all over, mildly puffy, around the eyes, developed multiple urticarial lesions, vomited within 10-15 min. No resp. distress. Epil 2 ml SQ given. 3x urticaria decreased, then increased. Again sent to ER.
Age: 34.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, abdominal pain, dizziness, fever.
Age: 74.0
Sex: M
Vaccine: TYP
Symptoms: Chromaturia, Headache, Pyrexia
Clinical narrative: The client contacted us after he'd taken the 4th capsule and told us that he'd developed a headache and fever of 103 after taking the third capsule. I advised him to take Ibuprofen  q 4-6 hr and call us if he didn't improve. He also stated that his urine was darker than normal though not cloudy. He went to his family doctor on 4/21/04.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Developed redness, warmth and swelling of left upper arm 1 day after receiving vaccines.
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Feeling hot
Clinical narrative: Right deltoid erythema 6 cm x 6 cm area hot to touch. Tx. with Augmentin 200 mg bid and Benadryl
Age: 2.0
Sex: U
Vaccine: DTAP, UNK
Symptoms: Erythema, Feeling hot, Injection site mass, Tenderness
Clinical narrative: Affected arm red, warm, firm, tender (right deltoid)
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Hyperhidrosis, Pain, Palpitations, Pyrexia
Clinical narrative: Shoulder swelling and severe pain. Diffuse fever/sweats and joint pains, racing heartbeat.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Shoulder swelling and severe pain. Diffuse fever/sweats and joint pains, racing heartbeat.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site oedema
Clinical narrative: Right deltoid erythema, slightly warm and edematous around injection site. Benadryl 1-1 1/2 tsp of 4-6 PRN
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Erythema extending 11cm x 6cm + heat, edema.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: Pt got chickenpox from vaccine.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Injection site mass, Skin discolouration
Clinical narrative: Client has skin discoloration and one sided lump under skin on left deltoid since receiving Td vaccine. 5/24/04 client denies pain.
Sex: M
Vaccine: HEP
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: 1st Hep B given 5/18/2004, coughing began soon after injection; 2nd Hep B-difficulty breathing 2 hrs after injection, wheezing-the first time mother self-treated with inhalers. Mother wanted this to be reported.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site oedema
Clinical narrative: Red, swollen area. Approx. quarter size on Left lat. thigh at sight of injection.
Age: 0.67
Sex: F
Vaccine: IPV
Symptoms: Agitation, Balance disorder, Contusion, Diarrhoea, Muscle twitching
Clinical narrative: Day 1- Fussy, loss of balance, twitching of limbs when sleeping, Injection site bruised. Fussy all night. Day 2- Diarrhea, vomiting, twitching of limbs when sleeping (24 hrs after vaccine).
Age: 0.67
Sex: F
Vaccine: IPV
Symptoms: Vomiting
Clinical narrative: Day 1- Fussy, loss of balance, twitching of limbs when sleeping, Injection site bruised. Fussy all night. Day 2- Diarrhea, vomiting, twitching of limbs when sleeping (24 hrs after vaccine).
Age: 0.75
Sex: F
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: No serious adverse effects remembered.
Age: 0.83
Sex: F
Vaccine: HIBV
Symptoms: Diarrhoea
Clinical narrative: None day 1, Diah. Day 2
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Bacterial infection, Convulsion, Irritability, Laboratory test abnormal, Pyrexia
Clinical narrative: Day 1: Slept 3.5 hours after shot, fussy. Day 2: 10:00 AM - "seizure"- fever started later after seizure fever 102. Vomit in AM. Day 3: fever  99-103, fussy
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Urine analysis abnormal, Vomiting
Clinical narrative: Day 1: Slept 3.5 hours after shot, fussy. Day 2: 10:00 AM - "seizure"- fever started later after seizure fever 102. Vomit in AM. Day 3: fever  99-103, fussy
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: 104.9. 2:30 Pm child started to run a temp of 104.9. Was taken to hospital and released at 10:00PM. Was instructed to continue with Tylenol.
Age: 1.25
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Site of injection is red, hot, swollen 5x5cm, pt had fever x 2 days.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever of 104 degrees F.
Age: 1.7
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Oedema, Pyrexia
Clinical narrative: erythema, fever, edema.
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: REACTION UNEVAL
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Contusion, Erythema, Feeling hot, Swelling
Clinical narrative: Right leg red, swollen, warm and bruised. No treatment.
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, TD, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Mild varicella disease starting 6/23/2004. Had VAR immunization 6/10/04. No fever. Pt not feeling ill. Treat= symptomatic.
Age: 0.25
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Medication error
Clinical narrative: Pt received varicella vaccine by mistake.
Age: 0.75
Sex: F
Vaccine: UNK
Symptoms: Erythema, Injection site induration, Tenderness
Clinical narrative: Large localized reaction to DTaP erythema, induration, tender 4 cm. No treatment.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction
Clinical narrative: Very large local reaction to vaccine. No fever. Reaction around DTaP site (right deltoid). No intervention needed.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Fevers of 104 degrees F.
Age: 37.0
Sex: F
Vaccine: HEPAB, IPV, MEN, TD, TYP, YF
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Left hand tingle and numb when woke up, right hand tingle and numb by afternoon.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Dysphagia, Dyspnoea, Eye swelling, Hypersensitivity, Pruritus
Clinical narrative: Anthrax #1 21 Feb 2003 States that 4 days after her first Anthrax Vaccine she broke out in a rash that started on her abdomen and over a period of 2-3 days it had spread to both her legs and arms.  Describes the itchy rash as being flat small circular hyperpigmented areas about the size of a pencil head surrounded by a hypopigmented halo.    Denies any changes in shampoos, body sprays, deodorants, soaps, detergents, or foods.  States that she was overseas at the time and went to the ER for care.  They treated her for a local allergic reaction to a new product even though she denied the use of any new products. Anthrax #2 10 Mar 2003 States that rash was not resolved when they decided to give Anthrax #2.   Two days after receiving the vaccination the rash spread up her neck to her face.  She states that the itching was so bad that she could not function.  The rash was so bad that her eyes were swollen shut, she was unable to swallow and had difficulty breathing.  States that she went to the ER where she was placed her on steroids, antihistamines and Motrin.  She states that the rash did not start to clear until she was on the medication for 5 days.  States that she could not work for the first three days.   Anthrax #3 7 Nov 2003 States that with this vaccination she broke out with small flat bumps on her legs again but they seemed to have resolved in one day.  States that she only used lotion on these.  Denies any fever, headache, muscle or joint pain with any of the three vaccinations.  She is currently due for Anthrax #4.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Rash, Similar reaction on previous exposure to drug, Skin hyperpigmentation
Clinical narrative: Anthrax #1 21 Feb 2003 States that 4 days after her first Anthrax Vaccine she broke out in a rash that started on her abdomen and over a period of 2-3 days it had spread to both her legs and arms.  Describes the itchy rash as being flat small circular hyperpigmented areas about the size of a pencil head surrounded by a hypopigmented halo.    Denies any changes in shampoos, body sprays, deodorants, soaps, detergents, or foods.  States that she was overseas at the time and went to the ER for care.  They treated her for a local allergic reaction to a new product even though she denied the use of any new products. Anthrax #2 10 Mar 2003 States that rash was not resolved when they decided to give Anthrax #2.   Two days after receiving the vaccination the rash spread up her neck to her face.  She states that the itching was so bad that she could not function.  The rash was so bad that her eyes were swollen shut, she was unable to swallow and had difficulty breathing.  States that she went to the ER where she was placed her on steroids, antihistamines and Motrin.  She states that the rash did not start to clear until she was on the medication for 5 days.  States that she could not work for the first three days.   Anthrax #3 7 Nov 2003 States that with this vaccination she broke out with small flat bumps on her legs again but they seemed to have resolved in one day.  States that she only used lotion on these.  Denies any fever, headache, muscle or joint pain with any of the three vaccinations.  She is currently due for Anthrax #4.
Age: 22.0
Sex: F
Vaccine: MMR, TD, TYP
Symptoms: Chest discomfort, Eye irritation, Lacrimation increased, Pruritus, Pyrexia
Clinical narrative: Started with itching around head and face; followed by side effects similar to sinus allergies:runny, itchy eyes, runny nose, sneezing; a couple hours later felt intense chest pressure for about ten minutes; rah broke out, starting on arms and working down through body and legs throughout the day-itchy spots at first that developed into flat, red bumps.  Slept through the night, and in the morning rash was gone, fever symptoms remained.
Age: 22.0
Sex: F
Vaccine: MMR, TD, TYP
Symptoms: Rash, Rhinorrhoea, Sneezing
Clinical narrative: Started with itching around head and face; followed by side effects similar to sinus allergies:runny, itchy eyes, runny nose, sneezing; a couple hours later felt intense chest pressure for about ten minutes; rah broke out, starting on arms and working down through body and legs throughout the day-itchy spots at first that developed into flat, red bumps.  Slept through the night, and in the morning rash was gone, fever symptoms remained.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Contusion, Injection site erythema, Injection site warmth
Clinical narrative: RECIEVED CALL FROM MOTHER.CHILD RECEIVED DTAP AND IPV ON 7/2/04. HAD REDDENED, WARM AREA ZPPX 7"X 2" ON RT THIGH WHERE DTAP WAS ADMISTERED. CALLED TODAY BUT ALL SX DISAPPEARED. SLIGHT BRUISE NOTED.CHILD IS FINE NEVER HAD FEVER OR ANY OTHER SX. PT SEEN BY LOCAL PEDIATRICIAN(NEIGHBOR) WHO DID NOT FEEL A VISIT WAS NECESSARY. CHILD TOOK ZYRTEC FOR TWO DAYS.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Livedo reticularis
Clinical narrative: Patient had large mottled local reaction to thigh where vaccine was administered. (R) thigh warm, red, mottling, good capillary refill below.
Age: 0.2
Sex: M
Vaccine: DTPHIB, HEP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome, Unevaluable event
Clinical narrative: My son died on Sunday evening after getting shots on friday afternoon. He was in perfect health prior to his shots and death.  Nurse follow up on 07/26/04 states: "Complete."
Age: 1.2
Sex: M
Vaccine: DT, MMR, VARCEL
Symptoms: Asthenia, Pyrexia, Rash, Tremor
Clinical narrative: Patient received the Chicken Pox Immunization on June 30th 2004. On the 4th of July he started running a fever in the late evening, the next day his fever went up to 104.5 degrees and I had to take him to the doctor, we were able to get the fever under control, but not until the next morning, he did not have a seizure but was very weak and shaking.  He now has a mild rash on his legs and a few spots on his face. He is feeling better today, with no fever.
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Cardiac arrest, Coma, Convulsion, Gastrointestinal disorder, Hypertonia
Clinical narrative: From initial information received on 7/1/04 from a police officer regarding an adverse event occurring, it was reported that a baby (age and gender not reported) received a dose of ACTHIB, IPOL, and DIPHTHERIA, TETANUS, AND ACELLULAR PERTUSSIS VACCINE, as well as another unspecified vaccine on the same date. The lot numbers, routes and sites of administration were not reported. An unspecified amount of time later, the patient was hospitalized with cerebral and bilateral retinal hemorrhage. The child is currently in a coma. The case is currently being investigated as a case of shaken baby syndrome. The hospital physicians and a pediatrician reportedly agree that based upon the clinical evidence and condition of the child, the cause is shaken baby syndrome and is not related to the administration of the vaccines. The event is currently under police investigation. From additional information received on 7/2/04 through a telephone call with the initial reporter, the contact information for the pediatrician's office was provided. No other information was obtained at this time.  From additional information received on 06Jul04 from initial reporter, it was reported that the pt received a second dose of TRIPEDIA; a second dose of ACTHIB; a second dose of IPOL which could not be verified as an Aventis lot number, and a second dose of PREVNAR. The police investigator also provided the pt's initials and date of birth. The pt remains in a coma and a persistent vegetative state. He is scheduled to have a tracheotomy soon. No other information was provided at this time.
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Hypoxia, Infarction, Respiratory arrest, Retinal haemorrhage, Speech disorder
Clinical narrative: From initial information received on 7/1/04 from a police officer regarding an adverse event occurring, it was reported that a baby (age and gender not reported) received a dose of ACTHIB, IPOL, and DIPHTHERIA, TETANUS, AND ACELLULAR PERTUSSIS VACCINE, as well as another unspecified vaccine on the same date. The lot numbers, routes and sites of administration were not reported. An unspecified amount of time later, the patient was hospitalized with cerebral and bilateral retinal hemorrhage. The child is currently in a coma. The case is currently being investigated as a case of shaken baby syndrome. The hospital physicians and a pediatrician reportedly agree that based upon the clinical evidence and condition of the child, the cause is shaken baby syndrome and is not related to the administration of the vaccines. The event is currently under police investigation. From additional information received on 7/2/04 through a telephone call with the initial reporter, the contact information for the pediatrician's office was provided. No other information was obtained at this time.  From additional information received on 06Jul04 from initial reporter, it was reported that the pt received a second dose of TRIPEDIA; a second dose of ACTHIB; a second dose of IPOL which could not be verified as an Aventis lot number, and a second dose of PREVNAR. The police investigator also provided the pt's initials and date of birth. The pt remains in a coma and a persistent vegetative state. He is scheduled to have a tracheotomy soon. No other information was provided at this time.
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Subarachnoid haemorrhage, Visual acuity reduced
Clinical narrative: From initial information received on 7/1/04 from a police officer regarding an adverse event occurring, it was reported that a baby (age and gender not reported) received a dose of ACTHIB, IPOL, and DIPHTHERIA, TETANUS, AND ACELLULAR PERTUSSIS VACCINE, as well as another unspecified vaccine on the same date. The lot numbers, routes and sites of administration were not reported. An unspecified amount of time later, the patient was hospitalized with cerebral and bilateral retinal hemorrhage. The child is currently in a coma. The case is currently being investigated as a case of shaken baby syndrome. The hospital physicians and a pediatrician reportedly agree that based upon the clinical evidence and condition of the child, the cause is shaken baby syndrome and is not related to the administration of the vaccines. The event is currently under police investigation. From additional information received on 7/2/04 through a telephone call with the initial reporter, the contact information for the pediatrician's office was provided. No other information was obtained at this time.  From additional information received on 06Jul04 from initial reporter, it was reported that the pt received a second dose of TRIPEDIA; a second dose of ACTHIB; a second dose of IPOL which could not be verified as an Aventis lot number, and a second dose of PREVNAR. The police investigator also provided the pt's initials and date of birth. The pt remains in a coma and a persistent vegetative state. He is scheduled to have a tracheotomy soon. No other information was provided at this time.
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Apnoea, Child maltreatment syndrome, Fracture, Pulse absent, Retinal haemorrhage
Clinical narrative: From initial information received on 7/1/04 from a police officer regarding an adverse event occurring, it was reported that a baby (age and gender not reported) received a dose of ACTHIB, IPOL, and DIPHTHERIA, TETANUS, AND ACELLULAR PERTUSSIS VACCINE, as well as another unspecified vaccine on the same date. The lot numbers, routes and sites of administration were not reported. An unspecified amount of time later, the patient was hospitalized with cerebral and bilateral retinal hemorrhage. The child is currently in a coma. The case is currently being investigated as a case of shaken baby syndrome. The hospital physicians and a pediatrician reportedly agree that based upon the clinical evidence and condition of the child, the cause is shaken baby syndrome and is not related to the administration of the vaccines. The event is currently under police investigation. From additional information received on 7/2/04 through a telephone call with the initial reporter, the contact information for the pediatrician's office was provided. No other information was obtained at this time.  From additional information received on 06Jul04 from initial reporter, it was reported that the pt received a second dose of TRIPEDIA; a second dose of ACTHIB; a second dose of IPOL which could not be verified as an Aventis lot number, and a second dose of PREVNAR. The police investigator also provided the pt's initials and date of birth. The pt remains in a coma and a persistent vegetative state. He is scheduled to have a tracheotomy soon. No other information was provided at this time.
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Subarachnoid haemorrhage, Subdural haematoma
Clinical narrative: From initial information received on 7/1/04 from a police officer regarding an adverse event occurring, it was reported that a baby (age and gender not reported) received a dose of ACTHIB, IPOL, and DIPHTHERIA, TETANUS, AND ACELLULAR PERTUSSIS VACCINE, as well as another unspecified vaccine on the same date. The lot numbers, routes and sites of administration were not reported. An unspecified amount of time later, the patient was hospitalized with cerebral and bilateral retinal hemorrhage. The child is currently in a coma. The case is currently being investigated as a case of shaken baby syndrome. The hospital physicians and a pediatrician reportedly agree that based upon the clinical evidence and condition of the child, the cause is shaken baby syndrome and is not related to the administration of the vaccines. The event is currently under police investigation. From additional information received on 7/2/04 through a telephone call with the initial reporter, the contact information for the pediatrician's office was provided. No other information was obtained at this time.  From additional information received on 06Jul04 from initial reporter, it was reported that the pt received a second dose of TRIPEDIA; a second dose of ACTHIB; a second dose of IPOL which could not be verified as an Aventis lot number, and a second dose of PREVNAR. The police investigator also provided the pt's initials and date of birth. The pt remains in a coma and a persistent vegetative state. He is scheduled to have a tracheotomy soon. No other information was provided at this time.
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Cerebral haemorrhage, Child maltreatment syndrome, Coma, Retinal haemorrhage
Clinical narrative: From initial information received on 7/1/04 from a police officer regarding an adverse event occurring, it was reported that a baby (age and gender not reported) received a dose of ACTHIB, IPOL, and DIPHTHERIA, TETANUS, AND ACELLULAR PERTUSSIS VACCINE, as well as another unspecified vaccine on the same date. The lot numbers, routes and sites of administration were not reported. An unspecified amount of time later, the patient was hospitalized with cerebral and bilateral retinal hemorrhage. The child is currently in a coma. The case is currently being investigated as a case of shaken baby syndrome. The hospital physicians and a pediatrician reportedly agree that based upon the clinical evidence and condition of the child, the cause is shaken baby syndrome and is not related to the administration of the vaccines. The event is currently under police investigation. From additional information received on 7/2/04 through a telephone call with the initial reporter, the contact information for the pediatrician's office was provided. No other information was obtained at this time.  From additional information received on 06Jul04 from initial reporter, it was reported that the pt received a second dose of TRIPEDIA; a second dose of ACTHIB; a second dose of IPOL which could not be verified as an Aventis lot number, and a second dose of PREVNAR. The police investigator also provided the pt's initials and date of birth. The pt remains in a coma and a persistent vegetative state. He is scheduled to have a tracheotomy soon. No other information was provided at this time.
Sex: M
Vaccine: HEP, HEP
Symptoms: Drug ineffective, Hepatitis
Clinical narrative: This case was reported by a physician to a sales representative and described an adult male patient who did not respond to immunization with hepatitis B vaccine and expired to chronic hepatitis B. On unspecified dates, the patient received an unspecified number of doses of hepatitis B vaccine. Subsequently, on an unspecified date, a hepatitis B surface antibody titer was negative. The physician stated that the patient later died of chronic hepatitis B.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Arthropathy, Hypertension, Hypokinesia
Clinical narrative: A report was received from a healthcare professional in the USA on 6/25/04 concerning a 45 year old female vaccinee. No details were provided regarding the vaccinees medical history or whether she was taking any other medications. In October 2003, the vaccinee received an IM injection of Fluvirin. At an unspecified time after vaccination, the vaccinee developed a frozen shoulder syndrome, which she attributes to the Fluvirin. She is now receiving physical therapy for this problem. Further information will be sought. Follow up received on 15Nov04 from a health care professional in the US. The vaccinee has been identified as a 59 year old female who experienced frozen shoulder syndrome and injection site oedema after receiving and Fluvirin vaccination (batch 765753) in her left deltoid on 22Oct03. The vaccinee still experiences frozen shoulder syndrome, despite being provided with long term physical therapy treatment. The vaccinee has continued reduced mobility and pain 13 months after vaccination. The vaccinee's medical history includes C-section in 1982 and an allergy to anaestetic during the operation. She also has an allergy to penicillin since childhood and macrolides since the age of 55. Her concomitant medications include Hydrochlorothiazide, 25mg daily, for high blood pressure. The reporter considers the reaction serious due to disability and the vaccinee has been advised against influenza vaccination in the future.