chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: ANTH, TYP, ANTH
Symptoms: Amnesia, Confusional state, Disturbance in attention, Hypothyroidism, Laboratory test abnormal
Clinical narrative: The shot was given 7/26/04 at 1 pm. After the shot he started having fever, headaches, some dizziness, unable to concentrate completely, causing him to become unable to make conscience decisions, muscle weakness, fatigue, memory loss, depression, seizure which resulted in mental and physical hospitalization, as a result of the shots he has now hypothyroidism (loss of his thyroid) resulting in life time medication.  Nurse follow up on 09/22/04 states: "Final diagnosis was myxedema due to Hashimoto's thyroiditis with psychotic features.  Other findings include hallucinations, suicidal ideation, elevated liver function tests, dry skin, pruritis." Per annual report- Pt has hypothyroidism now and have to take synthroid for the rest of his life, as long as he is on the medication he is fine but of course if one day he does not take his medication he has unbalance, paranoid, unable to think. Per annual report-But he lost his thyroid and have to stay on synthroid for the rest of his life.  Sometimes he is still paranoid but we are not sure if it is the thyroid or still the adverse reaction or allergies.
Age: 23.0
Sex: F
Vaccine: ANTH, TYP, ANTH
Symptoms: Myalgia, Psychotic disorder, Pyrexia
Clinical narrative: The shot was given 7/26/04 at 1 pm. After the shot he started having fever, headaches, some dizziness, unable to concentrate completely, causing him to become unable to make conscience decisions, muscle weakness, fatigue, memory loss, depression, seizure which resulted in mental and physical hospitalization, as a result of the shots he has now hypothyroidism (loss of his thyroid) resulting in life time medication.  Nurse follow up on 09/22/04 states: "Final diagnosis was myxedema due to Hashimoto's thyroiditis with psychotic features.  Other findings include hallucinations, suicidal ideation, elevated liver function tests, dry skin, pruritis." Per annual report- Pt has hypothyroidism now and have to take synthroid for the rest of his life, as long as he is on the medication he is fine but of course if one day he does not take his medication he has unbalance, paranoid, unable to think. Per annual report-But he lost his thyroid and have to stay on synthroid for the rest of his life.  Sometimes he is still paranoid but we are not sure if it is the thyroid or still the adverse reaction or allergies.
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Insomnia, Pain
Clinical narrative: Arm was sore for 2 days after immunization given.  Pain resolved but then pain reappeared 2 days later.  Pain was much worse.  Patient c/o extreme pain when moving arm or putting pressure on area.  She was able to move the arm through full ROM but had pain.  Unable to sleep x 2 days.  No redness or induration at site on exam.
Age: 38.0
Sex: M
Vaccine: TYP
Symptoms: Injection site pain, Pruritus, Skin ulcer, Urticaria
Clinical narrative: 38 year old male, received typhoid injection around noon on 9 Sep 04.  He had soreness at the injection site shortly after receiving the injection.  Approximately seven hours later he was running and noticed pruritus on chest, posterior neck, bilateral shoulders and legs.  When he finished his run, he noticed that intensely pruritic "hives" were present on his upper lip, behind his ears, on posterior neck, bilateral shoulders, chest and legs.  Within 5  10 minutes the hives had spread across his body.  His palms and soles itched but did not have any lesions.  He took two Benadryl approximately one hour after noticing the hives.  The intense pruritus lasted for about 45 minutes after taking the Benadryl.  The lesions faded overnight.  Doctor saw him on 10 Sep 04.  At that time, he had some residual, faint lesions on his chest and left ear.  He never experienced any difficulty breathing or swallowing.  He has not had any recurrence of the lesions or pruritus.
Age: 1.05
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Condition aggravated, Febrile convulsion, Hypoxia
Clinical narrative: MMR and Varivax were administered on 9/7/04.  On 9/9/04 pt developed complex febrile seizures that were prolonged and resulted in intubation.  Ativan, Versed, Fosphenytoin, and phenobarbital were used to stop seizure.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Cyanosis, Dyskinesia, Fatigue, High-pitched crying
Clinical narrative: Patient had non-febrile seizure about 4 hours after vaccines.  She was screaming, then stiffened.  Mom noted peri-oral cyanosis.  SHe then had generalized tonic-clonic movements for 1/2-1 minute.  After that she was pale, tired but responsive.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Musculoskeletal stiffness, Pallor
Clinical narrative: Patient had non-febrile seizure about 4 hours after vaccines.  She was screaming, then stiffened.  Mom noted peri-oral cyanosis.  SHe then had generalized tonic-clonic movements for 1/2-1 minute.  After that she was pale, tired but responsive.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Cellulitis
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 year old male with no relevant medical history or allergies who on 8/17/04 was vaccinated SC right arm with a dose of MMR (lot 648164/1305N), IM in the left arm with a fifth dose of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (lot C1700AA), and SC in the left arm with a dose of poliovirus vaccine inactivated (lot X1038-@). The patient had no illness at the time of vaccination. Two days later on 8/19/04, the patient developed cellulitis like reaction on his left arm and was hospitalized. It was reported that the patient was in the hospital for only a short stay and had been discharged. The patient's recovery status was unknown at the time of this report. No further information is available.  Follow up on 09/23/04 states: "From additional information received from a health care professional, it was reported that the pt was hospitalized for one day and recovered.  It was reported that the pt's experience was considered an other important medical event (OMIC).  No further information is available."  Follow up on 10/29/04: "From additional information received on 9/09/04 from a health care professional, it was reported that the pt was hospitalized for one day and recovered from this event. The pt was vaccinated at a private doctor's office in the county and the vaccine was purchased with private funds. From additional infomation received on 10/20/04 it was reported that the pt was hospitalized at the hospital." From additional information received on 08Nov04 from a health care professional, hospital recores were provied. The pt was admitted to the hospital for further evaluation and treatment due to a reaction to immunization. Pt's mother noticed the reaction in the morning and treated the pt with Advil. The symptoms worsened and the mother brought the child to the ER. The pt c/o left are pain. Erythema, tenderness, edema and warmth at the site were also noted in the ER. The pt was given Ancef and admitted to the hospital. Treatment during hospitalization included IV fluids and Ancef. Physical examination revealed warm and dry skin as well as moderate warmth, swelling, tenderness and erythema of left upper extremity from shoulder to antecubital fossa. Blood culture results revealed no growth after five days. Assessment was within normal limits. Left arm pulses were intact. On 20Aug04, his erythema area was smaller and non tender. The pt improved and was discharged from the hospital. The pt has no history of trauma, tic or insect bites. No further information is anticipated. This case is considered closed. Follow up 02/27/05: Company remarks: (Medical Assessment) In general, cellulitis is unexpected after Daptacel administration. However, the inflammator response to injection caused by bacteria, cellulitis, was seen after administration of Daptacel and other vaccines in the post-marketing AE surveillance. In this case, the inflammation is still localized and thus no Bacteremia was detected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 year old male with no relevant medical history or allergies who on 8/17/04 was vaccinated SC right arm with a dose of MMR (lot 648164/1305N), IM in the left arm with a fifth dose of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (lot C1700AA), and SC in the left arm with a dose of poliovirus vaccine inactivated (lot X1038-@). The patient had no illness at the time of vaccination. Two days later on 8/19/04, the patient developed cellulitis like reaction on his left arm and was hospitalized. It was reported that the patient was in the hospital for only a short stay and had been discharged. The patient's recovery status was unknown at the time of this report. No further information is available.  Follow up on 09/23/04 states: "From additional information received from a health care professional, it was reported that the pt was hospitalized for one day and recovered.  It was reported that the pt's experience was considered an other important medical event (OMIC).  No further information is available."  Follow up on 10/29/04: "From additional information received on 9/09/04 from a health care professional, it was reported that the pt was hospitalized for one day and recovered from this event. The pt was vaccinated at a private doctor's office in the county and the vaccine was purchased with private funds. From additional infomation received on 10/20/04 it was reported that the pt was hospitalized at the hospital." From additional information received on 08Nov04 from a health care professional, hospital recores were provied. The pt was admitted to the hospital for further evaluation and treatment due to a reaction to immunization. Pt's mother noticed the reaction in the morning and treated the pt with Advil. The symptoms worsened and the mother brought the child to the ER. The pt c/o left are pain. Erythema, tenderness, edema and warmth at the site were also noted in the ER. The pt was given Ancef and admitted to the hospital. Treatment during hospitalization included IV fluids and Ancef. Physical examination revealed warm and dry skin as well as moderate warmth, swelling, tenderness and erythema of left upper extremity from shoulder to antecubital fossa. Blood culture results revealed no growth after five days. Assessment was within normal limits. Left arm pulses were intact. On 20Aug04, his erythema area was smaller and non tender. The pt improved and was discharged from the hospital. The pt has no history of trauma, tic or insect bites. No further information is anticipated. This case is considered closed. Follow up 02/27/05: Company remarks: (Medical Assessment) In general, cellulitis is unexpected after Daptacel administration. However, the inflammator response to injection caused by bacteria, cellulitis, was seen after administration of Daptacel and other vaccines in the post-marketing AE surveillance. In this case, the inflammation is still localized and thus no Bacteremia was detected.
Age: 1.3
Sex: M
Vaccine: PNC
Symptoms: Abscess, Bacterial infection, Drug ineffective, Sepsis
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 16 month old male patient who experienced pneumococcal bacteremia and empyema. At 16 months of age, the patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 0.5mL (IM). Concomitant medications were not reported. On an unspecified date in 2004, the patient experienced pneumococcal bacteremia and empyema. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a mother her 2 year old son who at the age of 3 months had all kinds of problems and was hospitalized for a respiratory infection, RSV, pneumonia and developed asthma which was treated with inhaled steroids. At 9 months of age, the patient experienced 8 seizures in 15 hours and was hospitalized. Treatment at that time included Phenobarbital for 7 months. Subsequently the patient was placed on divalproex sodium. The patient received a dose of MMR (dosage and date not specified). In approximately October 2000, the patient was diagnosed with autism. The mother reported that she does not think that MMR was related to her son's autism. It was reported that the patient had not been on any seizure medication in the last 6 months (since approximately March 2004) and the patient had not experienced any seizures. In follow up information it was reported that the patient had received a dose of the mumps virus vaccine live (unspecified) on 9/7/04 and was doing fine. No further information was provided. Upon internal review autism was considered to be an other important medical event (OMIC). Additional information has been requested. Follow up 03/03/05: Patient has not recovered from the adverse events.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Lethargy, Pyrexia, Rash, Screaming
Clinical narrative: Information has been received from a mother concerning her 8 year old son with side effects to any kind of sedative who at the age of 2 was vaccinated with MMR. The patient was reportedly screaming all day when he received the vaccination. Subsequently, the patient had a fever for a couple of days was vomiting, developed a rash, and was lethargic. The patient was diagnosed with attention deficit hyperactivity disorder soon after receiving the vaccination. It was also reported that the patient had dental work and was rushed to the hospital due to side affects.  Follow up information was received from a nurse practitioner concerning the 8 year old male patient who on 7/25/97 and on 8/24/04 was vaccinated with a first and second dose (lot # 648461/1306N) of MMR respectively. It was reported that following the second dose the patient developed a headache for three days and had recovered. It was also noted that on 9/13/96, 11/22/96, 1/17/97, 1/23/98 and 8/16/00 the patient was vaccinated with diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. On 3/3/04 and on 8/24/04 the patient was vaccinated with hepatitis B virus vaccine. On 9/13/96, 11/22/96, 1/17/97 and 1/23/98 the patient was vaccianted with HIB conjugate vaccine.  Upon internal review, rushed to the hospital due to side effects was considered to be an other important medical event (OMIC). It was also reported that the patient's sister also had an adverse experience following vaccination with MMR. Additional information has been requested.  Follow up on 11/02/04 states: "Follow up information was received from the reporting nurse who stated tha the child was vaccinated with a second dose of MMRII, in the right anterior thigh, SC. Concomitant vaccination that day included a second dose of Hepatitis B virus vaccine rHBsAg (yeast)(Engerix B)(Lot # ENG5570A2), in the left anterior thigh. There was no illness at the time of vaccination. Concomitant medications on 08/24/04 included methylphenidate hydrochloride (Concerta). According to the mother, on 08/24/04 the pt developed a headache for 3 days after immunization. The pt reportedly was never seen in the office. The pt recovered from headache. Upon internal medical review "rushed to the hospital due to side effects" was considered to be an other important medical event (OMIC).  It was also reported that the pt's sister also had an adverse experience following vaccination with MMRII (WAES #0408USA01844). Per mother, 'both children have reactions with every shot given.' No further information is expected." Follow up 03/03/05: Patient's recovery status is unknown.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Information has been received from a mother concerning her 8 year old son with side effects to any kind of sedative who at the age of 2 was vaccinated with MMR. The patient was reportedly screaming all day when he received the vaccination. Subsequently, the patient had a fever for a couple of days was vomiting, developed a rash, and was lethargic. The patient was diagnosed with attention deficit hyperactivity disorder soon after receiving the vaccination. It was also reported that the patient had dental work and was rushed to the hospital due to side affects.  Follow up information was received from a nurse practitioner concerning the 8 year old male patient who on 7/25/97 and on 8/24/04 was vaccinated with a first and second dose (lot # 648461/1306N) of MMR respectively. It was reported that following the second dose the patient developed a headache for three days and had recovered. It was also noted that on 9/13/96, 11/22/96, 1/17/97, 1/23/98 and 8/16/00 the patient was vaccinated with diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. On 3/3/04 and on 8/24/04 the patient was vaccinated with hepatitis B virus vaccine. On 9/13/96, 11/22/96, 1/17/97 and 1/23/98 the patient was vaccianted with HIB conjugate vaccine.  Upon internal review, rushed to the hospital due to side effects was considered to be an other important medical event (OMIC). It was also reported that the patient's sister also had an adverse experience following vaccination with MMR. Additional information has been requested.  Follow up on 11/02/04 states: "Follow up information was received from the reporting nurse who stated tha the child was vaccinated with a second dose of MMRII, in the right anterior thigh, SC. Concomitant vaccination that day included a second dose of Hepatitis B virus vaccine rHBsAg (yeast)(Engerix B)(Lot # ENG5570A2), in the left anterior thigh. There was no illness at the time of vaccination. Concomitant medications on 08/24/04 included methylphenidate hydrochloride (Concerta). According to the mother, on 08/24/04 the pt developed a headache for 3 days after immunization. The pt reportedly was never seen in the office. The pt recovered from headache. Upon internal medical review "rushed to the hospital due to side effects" was considered to be an other important medical event (OMIC).  It was also reported that the pt's sister also had an adverse experience following vaccination with MMRII (WAES #0408USA01844). Per mother, 'both children have reactions with every shot given.' No further information is expected." Follow up 03/03/05: Patient's recovery status is unknown.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Antisocial behaviour, Autism, Faecal incontinence, Lethargy, Pharyngitis
Clinical narrative: Information has been received from a mother concerning her 6 year old daughter born premature with no major health concerns who at the age of 2 was vaccinated with MMR. There were no concomitant medications. After receiving the vaccination, the child lost her words and was no longer trained to use the toilet. The patient reportedly lost all of her abilities. The mother reported that her daughter no longer knew who she was and was lethargic. The patient was diagnosed with autism shortly after receiving the vaccination. Follow up information received from a nurse practitioner concerning the 6 year old female patient who on 3/9/99 and on 8/24/04 was vaccinated with a first and second dose (lot # 648461/1306N) of MMR respectively. On 9/2/04 it was reported that within 24 hours the patient developed fever and cold symptoms. The reporter did not believe that the fever and cold symptoms were vaccine related. It was also noted that on 4/24/98, 6/26/98, 8/28/98, 9/7/99 the patient was vaccinated with diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. On 4/24/98, 6/26/98, 8/28/98, and 9/7/99, the patient was vaccinated with poliovirus vaccine. On 3/3/04 and on 9/24/04 the patient received hepatitis B virus vaccine. On 9/13/96, 11/22/96, 1/17/97, and 1/23/98 the patient was vaccinated with HIB conjugate vaccine. Unspecified medical attention was sought. No product quality complaint involved. Upon internal review autism was considered to be other important medical event (OMIC). It was also reported that the patient's brother also had an adverse experience following vaccination with MMR. No further information is expected. Follow up 03/03/05: Patient has not recovered from the adverse events.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rhinitis, Urinary incontinence
Clinical narrative: Information has been received from a mother concerning her 6 year old daughter born premature with no major health concerns who at the age of 2 was vaccinated with MMR. There were no concomitant medications. After receiving the vaccination, the child lost her words and was no longer trained to use the toilet. The patient reportedly lost all of her abilities. The mother reported that her daughter no longer knew who she was and was lethargic. The patient was diagnosed with autism shortly after receiving the vaccination. Follow up information received from a nurse practitioner concerning the 6 year old female patient who on 3/9/99 and on 8/24/04 was vaccinated with a first and second dose (lot # 648461/1306N) of MMR respectively. On 9/2/04 it was reported that within 24 hours the patient developed fever and cold symptoms. The reporter did not believe that the fever and cold symptoms were vaccine related. It was also noted that on 4/24/98, 6/26/98, 8/28/98, 9/7/99 the patient was vaccinated with diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. On 4/24/98, 6/26/98, 8/28/98, and 9/7/99, the patient was vaccinated with poliovirus vaccine. On 3/3/04 and on 9/24/04 the patient received hepatitis B virus vaccine. On 9/13/96, 11/22/96, 1/17/97, and 1/23/98 the patient was vaccinated with HIB conjugate vaccine. Unspecified medical attention was sought. No product quality complaint involved. Upon internal review autism was considered to be other important medical event (OMIC). It was also reported that the patient's brother also had an adverse experience following vaccination with MMR. No further information is expected. Follow up 03/03/05: Patient has not recovered from the adverse events.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Feeling cold, Hot flush, Hyperhidrosis, Injection site pain, Pain
Clinical narrative: Information has been received from a nurse concerning a 23 year old female with no known allergies and a concurrent condition of diabetes with elevated lipids who on 8/25/04 was vaccinated in her right arm with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647029/0460P). Concomitant therapy included insulin, simvastatin, and irbesartan. On 8/26/04, the patient called the office to report injection site soreness, hot and cold flashes which progressed to whole body aching and sweats. She also had a fever. The physician prescribed acetaminophen and ibuprofen. On 8/27/04, she went to the ER and was admitted to ICU. She improved after unknown treatment and was scheduled for discharge today or late last night. The outcome was reported as recovering. Injection site soreness, hot and cold flashes, whole body aching, sweats and fever were considered to be immediately life-threatening. No further information has been requested.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 23 year old female with no known allergies and a concurrent condition of diabetes with elevated lipids who on 8/25/04 was vaccinated in her right arm with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647029/0460P). Concomitant therapy included insulin, simvastatin, and irbesartan. On 8/26/04, the patient called the office to report injection site soreness, hot and cold flashes which progressed to whole body aching and sweats. She also had a fever. The physician prescribed acetaminophen and ibuprofen. On 8/27/04, she went to the ER and was admitted to ICU. She improved after unknown treatment and was scheduled for discharge today or late last night. The outcome was reported as recovering. Injection site soreness, hot and cold flashes, whole body aching, sweats and fever were considered to be immediately life-threatening. No further information has been requested.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Abortion, Medication error, Unintended pregnancy
Clinical narrative: Information has been received from a registered nurse concerning a 29 year old female patient who was vaccinated in another country with a dose of MMR. Post vaccination the patient developed a fever for 1 week. Subsequently, within 3 months post-vaccination, the patient became pregnant. It was reported that the patient decided to terminate her pregnancy based on information she was provided at that time and it was noted that the patient was advised to terminate her pregnancy. The nurse planned to titer the patient and check for immunity.  It was reported that the pt had an elevated temp after vaccination with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no reported medical intervention to treat fever. It was reported that pt was advised to terminate the pregnancy. No further information is available. Follow up 03/03/05: Patient has not recovered from the adverse events.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms, fever, chills, spiking temp. Note: Pt is a merchant seaman and is being treated aboard vessel at present time.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Chills, Fatigue, Influenza like illness, Nausea, Pyrexia
Clinical narrative: Flu like symptoms, fever, chills, spiking temp. Note: Pt is a merchant seaman and is being treated aboard vessel at present time.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Vomiting
Clinical narrative: Flu like symptoms, fever, chills, spiking temp. Note: Pt is a merchant seaman and is being treated aboard vessel at present time.
Age: 38.0
Sex: U
Vaccine: ANTH, HEPA
Symptoms: Hypoaesthesia
Clinical narrative: Left arm numb 5" below joint usually does not radiate, sometimes when I sleep on it I feel it in the joint and wake unable to feel the arm.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Acne, Erythema, Influenza like illness, Rash macular
Clinical narrative: Flu like symptoms stated by patient for 2 wks after 4th shot seen at ship yard March 15,2004. States flu like symptoms increase with each shift. Symptoms-Blemish on right hand side of face. Signs-Blotchy spots (red). Does not itch nor does it irritate. Course and treatment-clinic prescribed Cortizone cream and it started to go away but never completely.
Age: 25.0
Sex: M
Vaccine: ANTH, HEP, SMALL
Symptoms: Erythema multiforme, Rash erythematous, Rash maculo-papular
Clinical narrative: 18Aug04-received shots listed below, 9 days later had maculopapular, erythematous rash over entire body all at once. No vesicles, crusts, pustules. Smallpox site progressed well- major take- No other problems suspect Erythema Multiforme- minor, still has rash.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site inflammation, Injection site mass
Clinical narrative: Huge 4x7cm inflammation and induration from DTaP. 2nd pt in our office in 1 week, both from the same lot #!! We have not seen this before with DTaP!! Recovered in 2 days.
Age: 1.01
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Wheal at site of injection immediately after administration. Resolved completely after 1 dose of Benadryl 4 ml.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pruritus
Clinical narrative: Redness approx 50 cent size to right thigh with itching per mother.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Contusion, Erythema, Feeling hot, Injection site infection, Oedema
Clinical narrative: Large bruise at site by 07/24/04. Redness, swelling, soreness, warmth in band around arm between vaccine site and elbow; saw doctor in Urgent Care on 7/28/04: infection in arm, prescribed Cephalexin 500mg/3x day for 10 days. Still sore around band but much improved.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Pain
Clinical narrative: Large bruise at site by 07/24/04. Redness, swelling, soreness, warmth in band around arm between vaccine site and elbow; saw doctor in Urgent Care on 7/28/04: infection in arm, prescribed Cephalexin 500mg/3x day for 10 days. Still sore around band but much improved.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: 18cm x 15cm redness, heat, swelling at site of DTaP and Varicella vaccines.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Erythema/induration at the site of injections. No tenderness. S/s start within 24 hours of receiving the vaccinations. Tx: symptom care/cool compresses prn.
Age: 1.03
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Lethargy, Pyrexia, Rash, Somnolence
Clinical narrative: Talked on phone with mother on 9/10/04-she told me about these events that happened after receiving immunizations on 6/15/04...pt became lethargic and slept more than usual starting the evening of 6/15/04. Remained lethargic with low grade temp (IOD/rectal) until rash onset on Monday 6/20/04. She was seen by physician on Monday 6/20/04. No treatment-lethargy cleared up after rash appeared. No problems since.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site oedema, Injection site pain
Clinical narrative: Increased swelling, tenderness left upper arm 4-5-5cm Tx for localized cellulitis with cephalexin 250mg tid x 5 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Parotitis, Pyrexia
Clinical narrative: 13-14 days after MMR, DTaP, IPV developed signs consistent with left parotitis/low grade temp at home resolved in 48 hours. (Rx: Augmentin 2 days only).
Age: 0.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dyspnoea, Face oedema
Clinical narrative: Facial swelling and breathing difficulty Benadryl given, placed on 02 by EMS. Transported to hospital.
Age: 0.48
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Erythema, Feeling hot, Injection site mass, Oedema, Pain
Clinical narrative: Left arm was sore, swollen with hot to the touch, redness extended approx 65 x 50mm. Mother stated child had no temp. Instructed mother to apply cold compress to left arm site, Prn. Instructed to give child Tylenol for fever and pain (per bottle instr.) prn. Instructed to buy OTC Benadryl for s/s. Instructed to call back if s/s persisted and become worse for RN assistance to see MD in local family care clinic or go to local ER. Mother verbalized and understood all instructions given. TC with Mother, ask how child was doing. Mother stated child was fine and that the redness was gone and the arm was hard about 1/2" around injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site mass, Oedema
Clinical narrative: Left arm was hot to the touch, swollen, and the redness approx 100mm x 80mm. Mother stated child had no temp and arm was not sore. Instructed mother to apply cold compress to left arm site, Prn. Instructed to give child Tylenol for fever and pain (per bottle instr.) prn. Instructed to buy OTC Benadryl for s/s. Instructed to call back if s/s persisted and become worse for RN assistance to see MD in local family care clinic or go to local ER. Mother verbalized and understood all instructions given. TC with Mother, ask how child was doing. Mother stated child was fine and that the redness was gone and the arm was hard about 1/2" around injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Client developed red, swollen and hot skin, approx. 4x4" left upper arm at site of injection. Client had DTaP on 8/23/04.
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Rxn. in left arm starting Wed. 8/18/04 area below injection became red, swollen and hot to the touch very tender.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Pt has measles as small child, pt had MMR #1 in 1986, Pt required MMR #2 for college, given 11:15AM 9/2/04. Oral reaction (red, swollen, pain) at injection site immediately.
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Coma, Crying, Hypotonia, Vomiting
Clinical narrative: Mother describes 10 minutes of inconsolable crying 10 minutes after vaccination, followed by an emesis. Then 45 minutes of a limp "unresponsive" episode. Infant was normal after that.
Age: 1.4
Sex: M
Vaccine: DTP, PNC
Symptoms: Erythema, Injection site swelling, Skin ulcer
Clinical narrative: Erythema round raised lesion with central clearing/ clear left deltoid area.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site induration
Clinical narrative: Mom states child with hard bump to child's left leg: states better today. Has been giving child Tylenol prn.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Feeling hot, Tenderness
Clinical narrative: Warm, red, tender area measuring 11x11 cm. Left deltoid area whose DTaP was given on 8/31/04.
Age: 0.06
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion
Clinical narrative: Seen on 8/30/04 for CHS appointment at 8:15. DOB 7/7/04 per forms completed by mother. Given immunization at end of visit. After sots mother reported to RN at DOB was 8/7/04. TC to mother on 8/31. Reports child had a seizure late Monday and was taken to hospital. Child at home now and doing fine.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Dyskinesia, Eye movement disorder, Feeling abnormal, Hypotonia, Tremor
Clinical narrative: Pt became limp, held his hand and verbalized he felt "funny." Pt started shaking / having jerky movements, eyes rolled back-- this lasted all of 15sec. Pt was lying down: legs elevated, became conscious. Took apple juice.
Age: 3.5
Sex: M
Vaccine: IPV, PNC
Symptoms: Muscle twitching, Musculoskeletal stiffness
Clinical narrative: Head twitching; right arm twitching, upper extremities and upper body stiffness; no definite location; called ISCU. No treatment given.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: On the following day, hives developed and patient's mom called the on-call provider and was instructed to take Benadryl and a Prednisone taper with good effect
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Erythema, Irritability, Rash, Rash papular
Clinical narrative: Scattered papules with erythema bilateral thigh. Mom reports child with increased fussiness. Received shots 9/7/04. Mom noted rash 9/10/04. No fever.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Multiple vesicles
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Erythema, Herpes simplex, Oedema, Skin ulcer, Tenderness
Clinical narrative: Skin lesion on scrotum, edema, erythema, and tenderness of right inguinal area and right side of scrotum. Could be consistent with auto innoculation of vaccina vs genital herpes.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Vaccination complication
Clinical narrative: Skin lesion on scrotum, edema, erythema, and tenderness of right inguinal area and right side of scrotum. Could be consistent with auto innoculation of vaccina vs genital herpes.
Age: 30.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Injection site oedema, Lymphadenopathy
Clinical narrative: DEVELOPED ADENOPATHY AT BASE OF NECK ON THE SAME SIDE AS SMALLPOX VACCINE.
Age: 1.3
Sex: M
Vaccine: MMR, PNC
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Fever, generalized vesicular eruption. Still symptomatic. Antipruretics used.
Age: 1.15
Sex: F
Vaccine: HBHEPB, IPV, VARCEL
Symptoms: Conjunctivitis, Nasal congestion, Pyrexia, Rash maculo-papular
Clinical narrative: Conjunctivitis, congestion, maculopapular rash, temp of 102.9F, treated with Augmentin
Age: 6.0
Sex: M
Vaccine: DT, IPV
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Child's adoptive mother reports on 9/9/04 that child is having "cluster seizures" since 7/23/04. Prior to vx, child was on Topamax 50 mg, increased to 75 mg. States previous last known seizure 3 yrs ago. States child has not seen MD, but reporting status by phone.
Age: 59.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site reaction, Skin ulcer
Clinical narrative: 10mm secondary lesion accured at vacation site after the scab fell off on day 34. Pt. received anthrax vaccine 4th dose on 08/31/2004
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Right upper arm reddened, swollen, warm to touch, itching, about the size of a golf ball.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Abnormal behaviour, Jaundice, Pyrexia
Clinical narrative: Parent states on phone that pt has fever, personality changes, and is yellow, 09/02/04.  Instructed to go to ER.  Mom stated felt personality changes started in pm on 08/27/04.
Age: 3.0
Sex: F
Vaccine: DTAP, HBHEPB, PNC, VARCEL
Symptoms: Urticaria, Vomiting
Clinical narrative: Presented on the afternoon of the day of the shots with a hive reaction and vomiting.  Child received phenergan suppositories and did well.
Age: 1.26
Sex: M
Vaccine: DTAP, MMR, PNC
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: MOM CALLS OFFICE TODAY TO REPORT CHILD WITH FEVER >103 LAST 24 HRS AFTER IZ'S GIVEN YESTERDAY. REDNESS, SWELLING AT SITE OF DTAP, AND WON'T WB ON RIGHT (SITE OF MMR).
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Sudden infant death syndrome
Clinical narrative: Information has been received from a mother concerning her 9 week old daughter who on 8/28/02 was vaccianted with the second dose of hepatitis B virus vaccine (first dose of hepatitis B virus vaccine was given at the time of birth without incident). Secondary suspect vaccinations administered on that same day included the first dose of HIB conjugate vaccine, the first dose of poliovirus vaccine inactivated and the first dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. It was unknown if the patient had any specific illness at the time of vaccination. The patient's mother reported that on 8/31/02, approximately 72 hours post vaccination, her daughter died at home. The mother indicated that an autopsy revealed her daughter died due to sudden infant death syndrome. The mother also noted that a younger sibling had severe sleep apnea. No further information is available. From additional information received on 9/14/04 from another manufacturer, their reference number was provided. No new medically significant information was provided.
Age: 0.23
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Brain oedema, Cerebral ischaemia, Convulsion, Diabetes insipidus
Clinical narrative: Patient had fever and URI 7 days after vaccine. A day later, she had multiple seizures, rapid deterioration of mental status and died within 4 days of illness. Nurse follow up on 10/15/04 states: "Family reported infant "not breathing" prior to arrival at ER, and that PCP diagnosed a viral syndrome the day prior to arrival at ER." Medical Record received on 12/15/2004 states pt experienced status epilepticus, global anoxic brain injury, edema brain, brain hemorrhage, retinal hemorrhage, and diabetes insipidus.  Nurse follow up on 10/19/04 states: No new information. 1/6/05 Received autopsy report which states COD as complications of seizures of undetermined etiology & manner of death as natural.  Neuropathology report provides diagnoiss of global hypoxic/ischemic encephalopathy (respirator brain).
Age: 0.23
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Grand mal convulsion, Haemorrhage intracranial, Mental impairment, Pyrexia, Retinal haemorrhage
Clinical narrative: Patient had fever and URI 7 days after vaccine. A day later, she had multiple seizures, rapid deterioration of mental status and died within 4 days of illness. Nurse follow up on 10/15/04 states: "Family reported infant "not breathing" prior to arrival at ER, and that PCP diagnosed a viral syndrome the day prior to arrival at ER." Medical Record received on 12/15/2004 states pt experienced status epilepticus, global anoxic brain injury, edema brain, brain hemorrhage, retinal hemorrhage, and diabetes insipidus.  Nurse follow up on 10/19/04 states: No new information. 1/6/05 Received autopsy report which states COD as complications of seizures of undetermined etiology & manner of death as natural.  Neuropathology report provides diagnoiss of global hypoxic/ischemic encephalopathy (respirator brain).
Age: 0.23
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Upper respiratory tract infection, Viral infection
Clinical narrative: Patient had fever and URI 7 days after vaccine. A day later, she had multiple seizures, rapid deterioration of mental status and died within 4 days of illness. Nurse follow up on 10/15/04 states: "Family reported infant "not breathing" prior to arrival at ER, and that PCP diagnosed a viral syndrome the day prior to arrival at ER." Medical Record received on 12/15/2004 states pt experienced status epilepticus, global anoxic brain injury, edema brain, brain hemorrhage, retinal hemorrhage, and diabetes insipidus.  Nurse follow up on 10/19/04 states: No new information. 1/6/05 Received autopsy report which states COD as complications of seizures of undetermined etiology & manner of death as natural.  Neuropathology report provides diagnoiss of global hypoxic/ischemic encephalopathy (respirator brain).
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Arthralgia, Chest pain, Difficulty in walking, Haematuria
Clinical narrative: Sore chest and butt muscles. Then sore feet and ribs; hurt to turn in bed. Then swollen foot with rash at 2 weeks; could not walk. Something in my tailbone or nerves? Now it is in the hands, feet, and left knee. Per annual report- Still have swelling on my left hip (per MRI), 3 fingers and right foot.  I'm using crutches.  Soreness moves around in my right shoulder and neck, knees.  This past week I can feel it will be leaving.  I was told by my doctor this will be a slow recovery in August 2005. The pain is not as severe anymore. Medical record sttes arthralgia. msv
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Laboratory test abnormal, Myalgia, Oedema peripheral, Pain in extremity, Rash
Clinical narrative: Sore chest and butt muscles. Then sore feet and ribs; hurt to turn in bed. Then swollen foot with rash at 2 weeks; could not walk. Something in my tailbone or nerves? Now it is in the hands, feet, and left knee. Per annual report- Still have swelling on my left hip (per MRI), 3 fingers and right foot.  I'm using crutches.  Soreness moves around in my right shoulder and neck, knees.  This past week I can feel it will be leaving.  I was told by my doctor this will be a slow recovery in August 2005. The pain is not as severe anymore. Medical record sttes arthralgia. msv
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Cyanosis, Hypotonia, Respiratory disorder
Clinical narrative: Vaccine given on 9/7/04. Parents awoke to find infant not breathing, limp, and blue. Gave rescue breath and stimulation and baby.  Nurse follow up on 10/13/04 states: "apnea."
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Similar reaction on previous exposure to drug
Clinical narrative: Reproducible persistent arthralgias after the anthrax vaccine 1 and 3.
Age: 42.0
Sex: F
Vaccine: HEPAB
Symptoms: Dysgeusia, Hypoaesthesia
Clinical narrative: Pt immed. reported a metal taste in mouth and tongue became numb. Pt was layed down and vitals were taken. No local reaction at site of injection. An Allegra 180mg was given PO. Vitals taken every 10 min which remained stable. Pt observed for 1 hour and released.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Pt broke out in rash on 8/28/2004 with just a couple spots more on the 29th and a fever 100. Few more spots by Mon. On Thurs 9/9/04 spots are drying up.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site discolouration, Rash
Clinical narrative: Fine pink rash (blanching) -scalp/face truck (suspected viral exanthem, no other symptoms)
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis
Clinical narrative: Cellulitis left deltoid 4" x 3" Tx w/ Biaxin 250/5ml, 5ml PO bid x 10d
Age: 5.0
Sex: F
Vaccine: DTAP, HBHEPB, MMR, VARCEL
Symptoms: Feeling hot, Oedema
Clinical narrative: Left upper arm swollen, hot, states mom. Mom states took child to ER (Sat, Sun?) and obtained this form. 8/24/04 (Tues) read PPD. Arm con't hot and sl swollen. Mom states it is better.
Age: 5.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Immunization given with hive like reaction over area of immunization 10cm. Observation only.
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Erythema, Oedema, Somnolence, Vomiting
Clinical narrative: <1hour after Varivax, MMR, Hep B, Emesis w/10mm. Then Emesis x3. Father describes him as red and s/w, sleepy. No previous reactions-no known egg allergy, referred to ER. Given steroids and Benadryl. No Epi needed.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema, Pruritus
Clinical narrative: 9/1/04 DTaP, IPV, MMR given; 9/2/04 red swollen left deltoid; 9/3/04 worsening of symptoms and itching.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: 2-3 hours after administration of vaccination, pt developed localized swelling and erythema. Over the next 24 hours, developed large area of erythema warmth and induration over entire left upper arm. No fevers. Full range of motion.
Age: 1.54
Sex: F
Vaccine: DTAP, IPV
Symptoms: Urticaria
Clinical narrative: Awoke today with bumps on buttocks, arms, and legs. Consistent with hives, non pruritic, afebrile, no treatment.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Red, swollen right arm-warm to touch.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Indurated red area, left thigh lat 15x17cms size.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swelling and redness of thigh- originates at injection site of DPT.
Age: 1.15
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Infection transmission via personal contact
Clinical narrative: Developed varicella-like rash on 09/05/2004 after younger brother received varicella immunization on 08/25/2004.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Injection site mass, Irritability, Pain
Clinical narrative: R outerlateral thigh with 3 x 2.5cm area of erythema and induration. Area painful to touch. No noted streaking. Fussy.
Age: 15.0
Sex: M
Vaccine: MMR, OPV
Symptoms: Pyrexia
Clinical narrative: 13 days after receiving an MMR booster my son starting running a high temp, peaking at 104. He was under doctors care. It lasted a week.
Age: 1.28
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Oedema
Clinical narrative: Swelling to right thigh
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: Anthrax reaction day 1 after vaccination symptoms were redness, swelling, pain on site and occasional itching. This was on right arm and extended to the elbow. On day 2 symptoms were worse and swelling extended to the forearm. On Day 6, after treatment, no swelling, redness, mild itching.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: Right arm red, swollen, hard at injection site of DTaP.