chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: See attached office visit. Redness, swelling at injection site
Age: 1.37
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Office visit attached. Parent reported redness, swelling to right lateral thigh.
Age: 1.02
Sex: F
Vaccine: HBHEPB, PNC, VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia, Rash
Clinical narrative: Patient presents to clinic 04/03/2006 with low grade fever and rash.  Upon assessment by doctor, rash is varicella.  Patient had vaccine 03/22/2006.
Age: 5.0
Sex: M
Vaccine: DTP, IPV, MMR
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: DPT given right deltoid intramuscular.  2 minutes later developed pinpoint welt above site with mild redness and swelling.  Doctor was notified and checked patient immediately.  Advised to wait 15 minutes.  Ice pack applied.  2cm redness, 3cm swelling after 15 minutes some swelling on 04/04/2006.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Course consistent with varicella zoster 1/4/06 after Varivax 5/11/05 and no previous hx of varicella like illness.
Sex: F
Vaccine: MMR
Symptoms: Autism, Cough, Crying, Eye disorder, Headache
Clinical narrative: 02/09/2001 ear infection, fever, head pain. 2/23/01 fever and coughing and irritable, screaming. 3/2 still sick, ear infection and eye infection. 4/2 boil at site of injection, constipated, no bowel movement.
Sex: F
Vaccine: MMR
Symptoms: Irritability, Malaise, Nervous system disorder, Otitis media, Pyrexia
Clinical narrative: 02/09/2001 ear infection, fever, head pain. 2/23/01 fever and coughing and irritable, screaming. 3/2 still sick, ear infection and eye infection. 4/2 boil at site of injection, constipated, no bowel movement.
Sex: F
Vaccine: MMR
Symptoms: Screaming
Clinical narrative: 02/09/2001 ear infection, fever, head pain. 2/23/01 fever and coughing and irritable, screaming. 3/2 still sick, ear infection and eye infection. 4/2 boil at site of injection, constipated, no bowel movement.
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Autism, Cough, Eye disorder, Infection, Irritability
Clinical narrative: Fever and coughing and irritable. 3/14/02 ear and eye infection green mucous in eye. 4/8/02 ear and eye infection.
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Nervous system disorder, Otitis media, Pyrexia
Clinical narrative: Fever and coughing and irritable. 3/14/02 ear and eye infection green mucous in eye. 4/8/02 ear and eye infection.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Cough, Headache, Irritability, Otitis media, Pyrexia
Clinical narrative: 2 days later fever over 103 degrees for 2 days then 100 degrees for a week, throwing up and irritable.  Child said "head pain", coughing.  05/03 ear infection, ear perforated.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: 2 days later fever over 103 degrees for 2 days then 100 degrees for a week, throwing up and irritable.  Child said "head pain", coughing.  05/03 ear infection, ear perforated.
Age: 1.54
Sex: M
Vaccine: HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever 104 degrees, fever after shots at 6 months old, as well as when he got DAPT, HIB,HBV, and PCV7.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Swelling
Clinical narrative: Swollen left arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: 24 hrs ago had Dtap left arm, woke up last noc c/o leg pain x4 hrs ambulate well no limp. This AM 3x3" red hard swelling around Dtap site.
Age: 45.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Chills, Dysphagia, Dyspnoea, Erythema
Clinical narrative: A 44 year old female subject experienced a possible allergy reaction on the same day in which she had received an injection of Menactra.  Recovery status was not provided.  According to the investigator, the event was related to the study vaccine.  Follow up information received on 03/29/2006.  The subject has a past medical history of a positive PPD skin test and H. Pylori.  She has no known drug allergies.  She presented to the emergency room one hour post vaccination at 17:39 with complaints of throat tightness and soreness, hard time swallowing, mild shortness of breath, burning and pressure in her eyes bilaterally, facial redness, body weakness and aches, palpitations and chills.  She appeared lethargic.  Vital signs were T-98.2, P-82, R-16 B/P 126/85.  Cardiac assessment and EKG were normal.  Neurological exam was normal and she was speaking full sentences and had no tongue swelling or drooling.  Physical exam showed slight erythema of the tympanic membranes.  She was given Benadryl 25 mg IV.  Her discharge diagnosis was reaction to immunization.  She was instructed to call someone to give her a ride home from the facility at 19:50 and when the nurse went to do her assessment at 21:10 the subject was gone.  The recovery status was not reported at the time of this report.
Age: 45.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Eye irritation, Lethargy, Pain, Palpitations, Pharyngolaryngeal pain
Clinical narrative: A 44 year old female subject experienced a possible allergy reaction on the same day in which she had received an injection of Menactra.  Recovery status was not provided.  According to the investigator, the event was related to the study vaccine.  Follow up information received on 03/29/2006.  The subject has a past medical history of a positive PPD skin test and H. Pylori.  She has no known drug allergies.  She presented to the emergency room one hour post vaccination at 17:39 with complaints of throat tightness and soreness, hard time swallowing, mild shortness of breath, burning and pressure in her eyes bilaterally, facial redness, body weakness and aches, palpitations and chills.  She appeared lethargic.  Vital signs were T-98.2, P-82, R-16 B/P 126/85.  Cardiac assessment and EKG were normal.  Neurological exam was normal and she was speaking full sentences and had no tongue swelling or drooling.  Physical exam showed slight erythema of the tympanic membranes.  She was given Benadryl 25 mg IV.  Her discharge diagnosis was reaction to immunization.  She was instructed to call someone to give her a ride home from the facility at 19:50 and when the nurse went to do her assessment at 21:10 the subject was gone.  The recovery status was not reported at the time of this report.
Age: 45.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Throat tightness
Clinical narrative: A 44 year old female subject experienced a possible allergy reaction on the same day in which she had received an injection of Menactra.  Recovery status was not provided.  According to the investigator, the event was related to the study vaccine.  Follow up information received on 03/29/2006.  The subject has a past medical history of a positive PPD skin test and H. Pylori.  She has no known drug allergies.  She presented to the emergency room one hour post vaccination at 17:39 with complaints of throat tightness and soreness, hard time swallowing, mild shortness of breath, burning and pressure in her eyes bilaterally, facial redness, body weakness and aches, palpitations and chills.  She appeared lethargic.  Vital signs were T-98.2, P-82, R-16 B/P 126/85.  Cardiac assessment and EKG were normal.  Neurological exam was normal and she was speaking full sentences and had no tongue swelling or drooling.  Physical exam showed slight erythema of the tympanic membranes.  She was given Benadryl 25 mg IV.  Her discharge diagnosis was reaction to immunization.  She was instructed to call someone to give her a ride home from the facility at 19:50 and when the nurse went to do her assessment at 21:10 the subject was gone.  The recovery status was not reported at the time of this report.
Age: 45.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Hypersensitivity, Pain, Palpitations, Sensation of pressure, Throat tightness
Clinical narrative: A 44 year old female subject experienced a possible allergy reaction on the same day in which she had received an injection of Menactra.  Recovery status was not provided.  According to the investigator, the event was related to the study vaccine.  Follow up information received on 03/29/2006.  The subject has a past medical history of a positive PPD skin test and H. Pylori.  She has no known drug allergies.  She presented to the emergency room one hour post vaccination at 17:39 with complaints of throat tightness and soreness, hard time swallowing, mild shortness of breath, burning and pressure in her eyes bilaterally, facial redness, body weakness and aches, palpitations and chills.  She appeared lethargic.  Vital signs were T-98.2, P-82, R-16 B/P 126/85.  Cardiac assessment and EKG were normal.  Neurological exam was normal and she was speaking full sentences and had no tongue swelling or drooling.  Physical exam showed slight erythema of the tympanic membranes.  She was given Benadryl 25 mg IV.  Her discharge diagnosis was reaction to immunization.  She was instructed to call someone to give her a ride home from the facility at 19:50 and when the nurse went to do her assessment at 21:10 the subject was gone.  The recovery status was not reported at the time of this report.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Rash
Clinical narrative: A 13 year old female subject experienced a rash on the same day in which she had received an injection of Menactra.  Recovery status was not provided.  According to the investigator, the event was related to the study vaccine.  Follow up information received on 03/29/2006.  The subject developed an itchy rash on her right cheek after being vaccinated earlier that day.  She took Benadryl and was examined in an emergency room.  The rash resolved following the treatment.  At the time of this report, the subject had recovered.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Asthenia, Nausea, Syncope, Vomiting
Clinical narrative: An 18 year old female subject developed nausea and vomiting on the same day she had received a first dose of Menactra.  The event was considered to be non-serious.  No treatment or recovery status information was provided.  Follow up information received on 03/29/2006.  An 18 year old female patient who was taking Prozac at the time of the vaccination, and had no known drug allergies, had received her first intramuscular injection of Menactra, in the right arm and her first intramuscular injection of another Hepatitis A vaccine, in the left arm on 07/27/2005 at approximately 12:00.  150 minutes later, she had a near syncopal episode with weakness, nausea and vomited once.  She presented to the emergency facility and her vital signs were T-98.2, P-43, R-16, and B/P 92/25.  Her standing B/P was 107/55 and her pulse was 80.  Her cardiac, physical/neurological exam was normal.  Her speech was clear and she ambulated with a steady gait.  Her lungs were clear to auscultation and she had no shortness of breath or difficulty swallowing.  She was treated with fluids by mouth and released.  Her final diagnosis was immunization reaction.  It was not reported if the patient had fully recovered from these events at the time of this report.  According to the investigator, the event was related to the study vaccine.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Asthenia, Hypersensitivity, Nausea, Syncope, Vomiting
Clinical narrative: An 18 year old female subject developed nausea and vomiting on the same day she had received a first dose of Menactra.  The event was considered to be non-serious.  No treatment or recovery status information was provided.  Follow up information received on 03/29/2006.  An 18 year old female patient who was taking Prozac at the time of the vaccination, and had no known drug allergies, had received her first intramuscular injection of Menactra, in the right arm and her first intramuscular injection of another Hepatitis A vaccine, in the left arm on 07/27/2005 at approximately 12:00.  150 minutes later, she had a near syncopal episode with weakness, nausea and vomited once.  She presented to the emergency facility and her vital signs were T-98.2, P-43, R-16, and B/P 92/25.  Her standing B/P was 107/55 and her pulse was 80.  Her cardiac, physical/neurological exam was normal.  Her speech was clear and she ambulated with a steady gait.  Her lungs were clear to auscultation and she had no shortness of breath or difficulty swallowing.  She was treated with fluids by mouth and released.  Her final diagnosis was immunization reaction.  It was not reported if the patient had fully recovered from these events at the time of this report.  According to the investigator, the event was related to the study vaccine.
Age: 0.16
Sex: F
Vaccine: PNC
Symptoms: Convulsion
Clinical narrative: My daughter has seizures, adhd,and been sickly since this happened to her.  12/28/09 MR received for the following DOS:  Sick child DOS 02/28/06. Staph infection. Pt for physical, but not done due to Pt being uncooperative. RLE pustules and rash. Tx: antibiotics.  Well child visit DOS 08/11/06. Pt calmer this year.     Sick child visit DOS 01/23/07. DX: URI. Pt c/o cough, congestion. Tx: Phenergan with codeine, Dicel.  Sick child visit DOS 05/22/07. DX: purulent rhinitis. Pt sleeping difficulty, "onion breath", cough. Tx: zithromax.  Well child visit DOS 08/15/07. DX: Abnormal overweight. System review: wnl. Pt is overweight. Physician provided recommendations on decreasing carbohydrates and increasing healthy foods.  Sick child visit DOS 11/05/07. DX: Acute sinusitis. Pt c/o cough, running nose, congestion and fever. Tx: amoxicillin.  Sick child visit DOS 12/12/07. DX: Gastroenteritis. Pt c/o diarrhea, vomiting, congestion and runny nose. Tx: Pedialite.  Sick child visit DOS 01/02/08. DX: Otitis media and acute sinusitis. Pt c/o fever, runny nose, harsh cough. tx: codeine phosphate.  Sick child visit DOS 02/26/08. DX: Allergic sinusitis. Pt c/o cough/congestion, fever, headache. Tx: Claritine.  Sick child visit DOS 09/30/08. DX: Acute otitis media. Pt c/o runny nose, L ear pain, fever. Pt had yellow nasal drainage. Tx: omnicef.  Sick child visit DOS 12/03/08. DX: Acute sinusitis, head lice. Pt c/o vomiting, runny nose, congestion and mild cough. Tx: Omnicef and Ovide.  Sick child visit DOS 01/26/09. DX: URI, diarrhea.  Pt c/o diarrhea, sore throat, congestion, runny nose, cough.  Sick child visit DOS 03/30/09. DX: URI, sprayed Rankle.  Well child visit DOS 05/01/09. DX: Convulsive disorder. Pt to see neurologist. Tx: Diazepam, Topamax.  Sick child visit DOS 05/04/09. DX: Abdominal pain. Pt c/o diarrhea, stomach pain.     Sick child visit DOS 06/09/09. DX: Pharingitis. Pt c/o runny nose, sx, fever, sore throat, cranky. Tx: Amoxicillin. Sick child visit DOS 11/12/09. DX: Acute sinusitis, acute bronchitis. Pt c/o cough, stuffy nose.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Swelling
Clinical narrative: Vaccine reaction, probably to DTAP.  Left thigh swelling, erythema.  Induration - no fever.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site mass
Clinical narrative: Vaccine reaction, probably to DTAP.  Left thigh swelling, erythema.  Induration - no fever.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Rash, Swelling face
Clinical narrative: 04/03/2006 child received MMR, DTAP, IPB in AM, child went home (also took one dose Amoxicillin by mouth), child woke up after a nap with swollen right upper lip, itchy rash on face, arms, chest.  Prescribed Decadron, epinephrine, and Benadryl.
Age: 8.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Pain, Pyrexia
Clinical narrative: Left arm at site of injection - redness 7cm x 6cm - no induration, temperature 96.4, sore to touch.
Age: 1.6
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Encephalitis, Fall, Gait disturbance, Hypokinesia, Irritability
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a dose of MMR (lot # 645621/0271N). Concomitant therapy that day included a dose of varicella virus vaccine live. Ten days later, on 3/16/06, the patient presented to the office with falling to one side. The physician had the patient walk the halls, and the child seemed OK. As the day progressed, the patient's symptoms worsened. He was sent to the hospital with loss of motor skills. Over the night, the patient was sent to a specialized hospital, and diagnosed with acute disseminated encephalomyelitis. He was in the hospital for one week (7 days). The mother reported to the nurse that the first four days were very scary because the child had lost the ability to walk. One week after admission, the child was diagnosed to home. The patient presented to the physician's office on approximately 3/28/06 and was walking fine but was cranky. At this time, the child as recovered. The plan for this child is serial MRI's. It was noted that if this does recur, it is possible that he may have multiple sclerosis. There was no product quality complaint. The physicians at the hospital indicated that the symptoms were probably related to vaccination with the MMR. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her 3 year old son with no allergies or medical history who in 1993, during his first two years, was vaccinated SC with a dose of MMR (lot # 619795/0994D). Concomitant therapy included a dose of hepatitis B virus vaccine (lot # 614567/0280D), a whole bunch of vaccines, and Arispidol. In 1996, at 3 years of age, the patient was diagnosed with autism. Unspecified medical attention was sought. At the time of the report, the patient was noted to be 20 years old and had not recovered. A product quality complaint was not involved. It was also noted that the patient's brother received a whole bunch of vaccines at unspecified times and was diagnosed with autism at 2 years of age. Upon internal review, autism was determined to be an other important medical event (OMIC). No further information is available.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Drug hypersensitivity, Erythema, Feeling abnormal, Flushing, Insomnia
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male with cold symptoms and no other medical history or allergies, who on 3/13/05 was vaccinated with an SC dose of MMR (lot # 651815/0950R). There was no concomitant medication. On 3/14/06 the patient developed a temperature of 99.5F-102.5F rectal and he also had cold symptoms. On 3/16/06 the patient was diagnosed with an ear infection and was treated with amoxicillin. It was noted that he was wakeful at night. On 3/23/06 the patient had a fever of 101 F and was pulling at his ears. On 3/24/06 the patient was febrile, but his cheeks were flushed, he was fussy and he had a red spot on his cheek. On 3/25/06 the patient developed a macular erythematous rash on his face spreading to his trunk and extremities, was irritable but afebrile. His left ear was slightly pink and his right ear was normal. The amoxicillin was stopped and he was diagnosed with an amoxicillin reaction. Unspecified medical attention was sought. There was no product quality complaint involved. The patient's adverse events were considered to be other important medical events by the reporter (OMIC). Additional information has been requested. Information has been received from a registered nurse concerning a 12 month old male with no known medical history or allergies who on 13-MAR-2006 at 9:30 am was vaccinated SC in the right tricep with a first dose of MMR II (+) VARIVAX (Merck) process (lot #651815/0950R). Illness at the time of vaccination included cold symptoms for two days, no fever. On 14-MAR-2006 within 24 hours of vaccination the patient developed a fever of 99.5 - 102.5F. The patient was seen on 16-MAR-2006 with mild cold symptoms x4d. He had left otitis media and was treated with amoxicillin. On 23-MAR-2006 the patient had a fever of 101 F and he was pulling on his ears. On 24-MAR-2006 the patient was afebrile had flushed cheeks was slightly fussy and had one red spot on his face. On 25-MAR-2006 the patient had a rash described as confluent macular, erythematous, on his cheeks, trunk, and extremities, and he was irritable. Unspecified medical attention was sought. No laboratory diagnositic tests were performed. The patient recovered on an unspecified date. The patient had no adverse events following prior vaccination. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Irritability, No reaction on previous exposure to drug, Otitis media, Pharyngitis, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male with cold symptoms and no other medical history or allergies, who on 3/13/05 was vaccinated with an SC dose of MMR (lot # 651815/0950R). There was no concomitant medication. On 3/14/06 the patient developed a temperature of 99.5F-102.5F rectal and he also had cold symptoms. On 3/16/06 the patient was diagnosed with an ear infection and was treated with amoxicillin. It was noted that he was wakeful at night. On 3/23/06 the patient had a fever of 101 F and was pulling at his ears. On 3/24/06 the patient was febrile, but his cheeks were flushed, he was fussy and he had a red spot on his cheek. On 3/25/06 the patient developed a macular erythematous rash on his face spreading to his trunk and extremities, was irritable but afebrile. His left ear was slightly pink and his right ear was normal. The amoxicillin was stopped and he was diagnosed with an amoxicillin reaction. Unspecified medical attention was sought. There was no product quality complaint involved. The patient's adverse events were considered to be other important medical events by the reporter (OMIC). Additional information has been requested. Information has been received from a registered nurse concerning a 12 month old male with no known medical history or allergies who on 13-MAR-2006 at 9:30 am was vaccinated SC in the right tricep with a first dose of MMR II (+) VARIVAX (Merck) process (lot #651815/0950R). Illness at the time of vaccination included cold symptoms for two days, no fever. On 14-MAR-2006 within 24 hours of vaccination the patient developed a fever of 99.5 - 102.5F. The patient was seen on 16-MAR-2006 with mild cold symptoms x4d. He had left otitis media and was treated with amoxicillin. On 23-MAR-2006 the patient had a fever of 101 F and he was pulling on his ears. On 24-MAR-2006 the patient was afebrile had flushed cheeks was slightly fussy and had one red spot on his face. On 25-MAR-2006 the patient had a rash described as confluent macular, erythematous, on his cheeks, trunk, and extremities, and he was irritable. Unspecified medical attention was sought. No laboratory diagnositic tests were performed. The patient recovered on an unspecified date. The patient had no adverse events following prior vaccination. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Rash erythematous, Rash macular, Rhinitis
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male with cold symptoms and no other medical history or allergies, who on 3/13/05 was vaccinated with an SC dose of MMR (lot # 651815/0950R). There was no concomitant medication. On 3/14/06 the patient developed a temperature of 99.5F-102.5F rectal and he also had cold symptoms. On 3/16/06 the patient was diagnosed with an ear infection and was treated with amoxicillin. It was noted that he was wakeful at night. On 3/23/06 the patient had a fever of 101 F and was pulling at his ears. On 3/24/06 the patient was febrile, but his cheeks were flushed, he was fussy and he had a red spot on his cheek. On 3/25/06 the patient developed a macular erythematous rash on his face spreading to his trunk and extremities, was irritable but afebrile. His left ear was slightly pink and his right ear was normal. The amoxicillin was stopped and he was diagnosed with an amoxicillin reaction. Unspecified medical attention was sought. There was no product quality complaint involved. The patient's adverse events were considered to be other important medical events by the reporter (OMIC). Additional information has been requested. Information has been received from a registered nurse concerning a 12 month old male with no known medical history or allergies who on 13-MAR-2006 at 9:30 am was vaccinated SC in the right tricep with a first dose of MMR II (+) VARIVAX (Merck) process (lot #651815/0950R). Illness at the time of vaccination included cold symptoms for two days, no fever. On 14-MAR-2006 within 24 hours of vaccination the patient developed a fever of 99.5 - 102.5F. The patient was seen on 16-MAR-2006 with mild cold symptoms x4d. He had left otitis media and was treated with amoxicillin. On 23-MAR-2006 the patient had a fever of 101 F and he was pulling on his ears. On 24-MAR-2006 the patient was afebrile had flushed cheeks was slightly fussy and had one red spot on his face. On 25-MAR-2006 the patient had a rash described as confluent macular, erythematous, on his cheeks, trunk, and extremities, and he was irritable. Unspecified medical attention was sought. No laboratory diagnositic tests were performed. The patient recovered on an unspecified date. The patient had no adverse events following prior vaccination. Additional information is not expected.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cyanosis, Hypotonia, Somnolence, Tremor
Clinical narrative: 4 hours after administration of shot, mom noted infant to be sleepy then limp and blue, mild shakiness; then responded to stimulation. Event reoccurred 2 times after within a 30 minute period. 911 was notified and infant was taken to ER.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Discomfort in joints; neck, writs, hips, knees, ankles, top of feet, fingers.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Complained of pain shortly after receiving injection.  Severe pain caused limited range of motion.  Presented with complaints nearly 4 months after injection.
Age: 45.0
Sex: F
Vaccine: ANTH, HEP, UNK
Symptoms: Injection site induration, Malaise, Pruritus, Rash pruritic
Clinical narrative: 45 year old, female, received a third dose of Engerix B recombinant Hepatitis B on 01/11/2006, a fourth dose of Anthrax vaccine on 01/03/2006, and a fourth dose of pentavalent botulinum toxoid on 01/24/2006.  ON 10/25/2005 she received the third right deltoid dose of dotulinum toxoid.  On 12/29 she presented to the nurse with a small area of papular pruritic rash on her left upper arm which cleared with topical HC cream.  Following her Anthrax vaccine on 01/03, she developed as usual some local induration and itching measuring about 6cm associated with some generalized malaise.  The rash resolved with ice and Benadryl.  On 01/05 she again noted an area of rash on her left arm which again resolved over the next two weeks.  On 03/06/2006, she received a Dryvax vaccinia small pox vaccination on her right deltoid.  She had a childhood history of vaccination and developed a minor positive take with no satellite lesions which progressed normally through the next two weeks.  On 03/08, she again presented to the nurse with a pruritic maculo-papular rash on her right arm below the elbow.  She was given topical HC cream and advised to return if the rash progressed.  The rash did progress, extending over both arms, lower legs, low back and abdomen, very pruritic, but she did not return to the clinic.  She did go to an urgent care clinic about the last week in March, was put on a 60mg decreasing dose of Prednisone and Claritin.  This seemed to be clearing the rash, but after the 5 days was completed, the rash reocurred.  About the first of April, she returned to the urgent care, was told she had bug bites and prescribed a course of Rid which she applied but only made her symptoms worse.  She presented to the office yesterday with an Eczematoid rash maximally over her forearms, evident on her legs, low back and abdomen, which was significantly excoriated but did not suggest scabies.  Her vaccination site was mature and clean and the rash did not suggest generalized vaccinia or eczema vaccinatum. Her past medical history reveals a partial hysterectomy in 1996 and an urticarial reaction to Bactrim.  She denies any other allergic history and is on no other medications.  She had her childhood immunizations and Td booster in May of 2005 without problem.  She had a negative Tubersol PPD test in July 2005.  She has a history of asymptomatic MVP with associated murmur, on no treatment.  Her family history is significant for thyroid disease in mother and sister, but she is clinically euthyroid and her TSH in May of 2005 was 0.695 uIU/ML.  At this point the relation between her immunizations is unclear but seems to relate somewhat to her botulinum doses.  Fortunately, it doesn't appear that she experienced any serious consequences to her small pox vaccine.  I would appreciate your evaluation and opinion if her conditions does not resolve appropriately.  Since her pruritic was so symptomatic, I have given her a slightly more intense Prednisone pulse, 60 gm/day for 4 days, decreasing 20 mg/day.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Dehydration, Malaise, Pyrexia
Clinical narrative: Patient presented 2 days fever, malaise, temperature was 101 degrees.  Patient was dehydrated.
Age: 1.32
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia, Rash papular
Clinical narrative: Patient developed papular and papulovesicular rash over body 13 days after chicken pox shot.  Also had fever.  Given Atarax syrup for itching.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site mass, Swelling
Clinical narrative: Red, swollen, hard round lump.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Nonspecific reaction
Clinical narrative: Patient received vaccine on 03/29/2006
Age: 43.0
Sex: M
Vaccine: HEP, TD, VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Abdominal rash within 3 weeks after 1st varicella vaccine.  Went to primary care provider who cultured the rash and determined it was varicella.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Left thigh swelling and redness, with fever 100.8 - 101 degrees for 4 days.
Sex: U
Vaccine: HEP, TTOX
Symptoms: Chest discomfort, Discomfort, Headache, Hypoaesthesia, Neck pain
Clinical narrative: Numbness, discomfort in left arm, pain in the neck and jaw area, light chest, diarrhea, and light headache.
Sex: U
Vaccine: HEP, TTOX
Symptoms: Pain in jaw
Clinical narrative: Numbness, discomfort in left arm, pain in the neck and jaw area, light chest, diarrhea, and light headache.
Age: 9.0
Sex: M
Vaccine: HEP, IPV, MMR, TD
Symptoms: Crying, Erythema, Nervousness, Pruritus, Swelling
Clinical narrative: Mother reported to nurse within 20-30 minutes after immunizations right arm swelling, hives, redness, slight itchy.  Child nervous, crying.  Ice pack applied to right arm at site of MMR injection.  Child complained of throat feeling funny.  Expectoratal white sputum.  No swelling of throat noted.  Treated with Benadryl, symptoms subsided within 30 minutes.
Age: 9.0
Sex: M
Vaccine: HEP, IPV, MMR, TD
Symptoms: Urticaria
Clinical narrative: Mother reported to nurse within 20-30 minutes after immunizations right arm swelling, hives, redness, slight itchy.  Child nervous, crying.  Ice pack applied to right arm at site of MMR injection.  Child complained of throat feeling funny.  Expectoratal white sputum.  No swelling of throat noted.  Treated with Benadryl, symptoms subsided within 30 minutes.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site induration, Tenderness
Clinical narrative: Erythematous, indurated area in arm, non tender, warm on palpation.  Recommended cool compresses.
Age: 0.76
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema, Feeling hot
Clinical narrative: Right leg thigh medial to distal injection site erythematous, slightly warm, no induration, no tender 3x5 cm.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pruritus
Clinical narrative: Injection 03/31/2006.  Erythema, warmth began 04/03/2006.  General pruritus.  No skin peeling.  No significant swelling.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Abasia, Diarrhoea, Muscle spasms
Clinical narrative: Diarrhea for one day with no fever.  Patient then developed cramps in both legs and unable to walk.
Age: 0.16
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Agitation, Dyskinesia
Clinical narrative: Inconsolability with jerking movements, SX at this time 4/6/06 11:55 am.
Age: 9.0
Sex: F
Vaccine: DTAPH, VARCEL
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Raised red area in belly for 2 days.  Itchy was seen 04/05/2006.  Patient started on acyclovir, zyrtec.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Swollen, Red, hot to touch 3x2.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Red, Swollen arm occurred within 48 hour of vac being given.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site oedema, Rash
Clinical narrative: Swelling and induration and redness at site of injection, rash started on 4/3/06, RX Motrin 1% hydrocortisone locally.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Oedema
Clinical narrative: Right arm swelling cold compresses.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Oedema
Clinical narrative: Right arm swelling down to the dorsum of hand, distal to site of Immunization Tylenol and Benadryl.
Sex: M
Vaccine: DTAP, IPV
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema
Clinical narrative: Right arm swelling and redness.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema, Tension
Clinical narrative: Right mid arm tense, red, swelling, Tylenol and Benadryl and cold compresses.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Eye oedema, Face oedema
Clinical narrative: Varicella vaccine administered IM in left deltoid. Patient went home and Parent (mom) states after 1 hr, he developed swelling in his face and left eye completely closed up. No other problems developed. He was taken to ER and treated with steroid and one injection parent unsure. Patient was watched for 4 1/2 hours then sent home. Face swelling relieved by 4/9/06. Mom states child fine today and went to school (4/10/2006).
Age: 18.0
Sex: M
Vaccine: DTAP, HEP, MNQ
Symptoms: Abnormal behaviour, Bacterial infection, Erythema, Furuncle, Herpes zoster
Clinical narrative: Pt experienced tingling on right side of body around rib cage area, red marks on trunk. According to mother behavioral changes were present for 2 days. On 3/25/06 taken to ER because of marks on trunk. Doctor was not sure whether they were shingles because pt reported no pain, nevertheless pt prescribed Acyclovir and the use of calamine lotion to help lesions dry. On 4/2/06 Boil appeared on front lower right rib, taken to the doctor on 4/6/06 which mentioned that it was a staphylococcal infection related to shingles. Pt prescribed Bioxion XL for 5 days. Today mother reports that the lesions are healing and scabbing using Neosporin to help healing but pt reports no pain.
Age: 18.0
Sex: M
Vaccine: DTAP, HEP, MNQ
Symptoms: Paraesthesia
Clinical narrative: Pt experienced tingling on right side of body around rib cage area, red marks on trunk. According to mother behavioral changes were present for 2 days. On 3/25/06 taken to ER because of marks on trunk. Doctor was not sure whether they were shingles because pt reported no pain, nevertheless pt prescribed Acyclovir and the use of calamine lotion to help lesions dry. On 4/2/06 Boil appeared on front lower right rib, taken to the doctor on 4/6/06 which mentioned that it was a staphylococcal infection related to shingles. Pt prescribed Bioxion XL for 5 days. Today mother reports that the lesions are healing and scabbing using Neosporin to help healing but pt reports no pain.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Dizziness
Clinical narrative: A 14 year old male subject experienced syncope on the same day in which he had received an injection of Menactra.  Recovery status was not provided.  According to the investigator, the event was related to the study vaccine.  Follow up information received on 03/29/2006.  The subject felt weak shortly after receiving vaccination injections and slumped briefly to the ground.  He did not lose consciousness and had no seizure activity or actual syncope.  He denied headache, visual change, dizziness or focal deficits.  The subject remained responsive and oriented.  Motor exam showed 5/5 x 4 and sensation was intact x 4.  The subject feels well now.  He was diagnosed with presyncope.  At the time of this report, the subject had recovered.
Sex: U
Vaccine: MNQ
Symptoms: Pain, Somnolence
Clinical narrative: A patient had received an injection of Menactra, on an unspecified date.  Route and site of injection were not specified.  At an unspecified amount of time after receiving the vaccination, the patient experienced extreme sleepiness and pain.  The pain was in the patient's side, down the back and into the arm.  Per the reporter, the event required medical attention.  Recovery status or additional medical information were not provided.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 12 month old patient who was vaccinated with a dose of MMR and varicella.  Subsequently, the patient developed a measles like rash 12 days post vaccination.  Unspecified medical attention was sought.  The outcome was unspecified by the reporter.  No product quality complaint was involved.  Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: Information has been received from a health professional concerning a 15 month old white male who on 12/15/2005, at 12:00pm, was vaccinated with a subcutaneous dose of MMR and varicella.  Between 1-10 days after vaccination, in approximately December 2005, the patient developed a high fever and blotchy rash all over the body.  Subsequently, the patient recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  Follow up information from a health professional indicated that on 12/22/2005, in the morning, the patient experienced a high temperature of 100-102 from 12/22/2005 to 12/24/2005.  The patient also experienced a rash on his face.  It was reported that the patient recovered on 12/25/2005.  Additional information is not expected.
Age: 1.7
Sex: F
Vaccine: MMRV, PNC
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 19 month old female who on 01/17/2006 was vaccinated with a dose of MMR and Varicella.  Concomitant vaccinations on that same day included a dose of pneumococcal vaccine.  The physician reported that on 01/17/2006, the patient broke out in hives after vaccination.  Unspecified medical attention was sought.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 12 month old patient who was vaccinated with a dose of MMR and varicella.  Subsequently, the patient developed a measles-like rash 12 days post vaccination.  Unspecified medical attention was sought.  The outcome was unspecified by the reporter.  No product quality complaint was involved.  Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 12 month old patient who was vaccinated with a dose of MMR and varicella vaccine.  Subsequently, the patient developed a measles like rash 12 days post vaccination.  Unspecified medical attention was sought.  The outcome was unspecified by the reporter.  No product quality complaint was involved.  Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning his wife who was in her late 30s who on approximately 02/03/2006 was vaccinated with a 0.5ml dose of MMR and varicella live vaccine.  The physician reported that on approximately 02/03/2006, his wife developed swelling around the injection site.  Unspecified medical attention was sought.  In February 2006, the patients injection site swelling resolved without treatment and she was noted to be fully recovered.  Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMRV
Symptoms: Hyperhidrosis, Malaise, Oral intake reduced, Pyrexia, Rash
Clinical narrative: Information has been received from a health professional concerning a 12 month old female with ear problems and a history of rhinitis and no known allergies who on 02/08/2006 was vaccinated subcutaneously in the left leg with a 0.5ml dose of MMR and varicella vaccine live.  Concomitant therapy included amoxicillin, antipyrine, benzocaine, glycerin, and carbinoxamine maleate/pseudoephedrine HC.  The patient had right ear pain at the time of vaccination.  On 02/13/2006, 5 days post vaccination, the patient experienced a bumpy rash all over her trunk.  At another office visit on 02/15/2006 the patient had eating issues, sweating, not feeling well and fever.  The rash had spread from the trunk upward to the hairline.  The nurse reported that when she pushes the rash apart it blanches and returns.  At the time of the report the child is improving.  No product quality complaint was involved.  Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 1 year old female who 3 to 4 weeks ago, in approximately January 2006, was vaccinated subcutaneously with a dose of MMR and varicella vaccine live.  There was no concomitant medication.  7 days post vaccination in approximately February 2006, the patient experienced a measles like rash.  The patient was taken to the emergency room to be seen.  She was treated with Benadryl and subsequently recovered.  There was no product quality complaint involved.  Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: YF
Symptoms: Headache
Clinical narrative: Client developed a severe headache 1 or 2 days after the yellow fever vaccine. The headache persisted for 5 weeks. She was taking 1 to 3 Vicodin per day. The headache finally went away after a course of Prednisone.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Pyrexia, Vomiting
Clinical narrative: Fever x 3 days; chills, vomiting, weakness.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Urticaria beginning on 4-2-06.  First dose Hepatitis B vaccine was given on 3-31.  Responded to diphenhydramine and prednisone with resolution by followup visit on 4-10.
Age: 30.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Back pain, Cough, Depressed level of consciousness, Labyrinthitis, Muscle twitching
Clinical narrative: I DEVELOPED A FEVER, COUGH, BACK PAIN, ACHINESS AND COUGH WITHIN 24 HOURS.  A DAY LATER I HAD RINGING IN THE EARS.  BY DAY THREE I HAD WORSENING OF RINGING IN THE EAR ACCOMPANIED BY HEARING LOSS AND SYMPTOMS EXCEPT FOR BACK PAIN.  I ALSO DEVELOPPED A TWITCH AND DECREASED SENSATION ON THE LEFT SIDE OF MY FACE.  I STARTED ANTIBIOTICS AND HAD NO RELIEF.  I RETURNED TO THE DOCTOR ON DAY SEVEN- TODAY AND WAS TOLD I HAD VARICELLA IN MY EAR AFFECTING MY FACIAL NERVE RESULTING IN MY SYMPTOMS.  THE DOCTOR PRESCRIBED ACYCLOVIR AND SENT ME HOME AND TO FOLLOW UP WITH HER IN 8 DAYS. 8/15/06 Received medical records from hospital which consisted only of MRI of brain & audiology report.  MRI revealed left oto-mastoiditis with evidence of labyrinthitis.  Mucosal thickening in bilateral maxillary & left sphenoid sinuses/ss
Age: 30.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Pain, Pyrexia, Sinusitis, Tinnitus
Clinical narrative: I DEVELOPED A FEVER, COUGH, BACK PAIN, ACHINESS AND COUGH WITHIN 24 HOURS.  A DAY LATER I HAD RINGING IN THE EARS.  BY DAY THREE I HAD WORSENING OF RINGING IN THE EAR ACCOMPANIED BY HEARING LOSS AND SYMPTOMS EXCEPT FOR BACK PAIN.  I ALSO DEVELOPPED A TWITCH AND DECREASED SENSATION ON THE LEFT SIDE OF MY FACE.  I STARTED ANTIBIOTICS AND HAD NO RELIEF.  I RETURNED TO THE DOCTOR ON DAY SEVEN- TODAY AND WAS TOLD I HAD VARICELLA IN MY EAR AFFECTING MY FACIAL NERVE RESULTING IN MY SYMPTOMS.  THE DOCTOR PRESCRIBED ACYCLOVIR AND SENT ME HOME AND TO FOLLOW UP WITH HER IN 8 DAYS. 8/15/06 Received medical records from hospital which consisted only of MRI of brain & audiology report.  MRI revealed left oto-mastoiditis with evidence of labyrinthitis.  Mucosal thickening in bilateral maxillary & left sphenoid sinuses/ss
Age: 30.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Arthralgia, Facial palsy, Hypoacusis, Myalgia, Nervous system disorder
Clinical narrative: I DEVELOPED A FEVER, COUGH, BACK PAIN, ACHINESS AND COUGH WITHIN 24 HOURS.  A DAY LATER I HAD RINGING IN THE EARS.  BY DAY THREE I HAD WORSENING OF RINGING IN THE EAR ACCOMPANIED BY HEARING LOSS AND SYMPTOMS EXCEPT FOR BACK PAIN.  I ALSO DEVELOPPED A TWITCH AND DECREASED SENSATION ON THE LEFT SIDE OF MY FACE.  I STARTED ANTIBIOTICS AND HAD NO RELIEF.  I RETURNED TO THE DOCTOR ON DAY SEVEN- TODAY AND WAS TOLD I HAD VARICELLA IN MY EAR AFFECTING MY FACIAL NERVE RESULTING IN MY SYMPTOMS.  THE DOCTOR PRESCRIBED ACYCLOVIR AND SENT ME HOME AND TO FOLLOW UP WITH HER IN 8 DAYS. 8/15/06 Received medical records from hospital which consisted only of MRI of brain & audiology report.  MRI revealed left oto-mastoiditis with evidence of labyrinthitis.  Mucosal thickening in bilateral maxillary & left sphenoid sinuses/ss
Age: 30.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Pyrexia, Tinnitus, Viral infection
Clinical narrative: I DEVELOPED A FEVER, COUGH, BACK PAIN, ACHINESS AND COUGH WITHIN 24 HOURS.  A DAY LATER I HAD RINGING IN THE EARS.  BY DAY THREE I HAD WORSENING OF RINGING IN THE EAR ACCOMPANIED BY HEARING LOSS AND SYMPTOMS EXCEPT FOR BACK PAIN.  I ALSO DEVELOPPED A TWITCH AND DECREASED SENSATION ON THE LEFT SIDE OF MY FACE.  I STARTED ANTIBIOTICS AND HAD NO RELIEF.  I RETURNED TO THE DOCTOR ON DAY SEVEN- TODAY AND WAS TOLD I HAD VARICELLA IN MY EAR AFFECTING MY FACIAL NERVE RESULTING IN MY SYMPTOMS.  THE DOCTOR PRESCRIBED ACYCLOVIR AND SENT ME HOME AND TO FOLLOW UP WITH HER IN 8 DAYS. 8/15/06 Received medical records from hospital which consisted only of MRI of brain & audiology report.  MRI revealed left oto-mastoiditis with evidence of labyrinthitis.  Mucosal thickening in bilateral maxillary & left sphenoid sinuses/ss
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Headache, Injection site erythema, Injection site hypersensitivity, Injection site reaction, Pruritus
Clinical narrative: Mother states he has local red reaction at DTaP site with itching.  Also complains about a head ache.  Mom has given Tylenol.
Age: 30.0
Sex: F
Vaccine: SMALL
Symptoms: Blister, Pruritus, Pyrexia
Clinical narrative: Distal vesicular papules with pruritis and low grade fever.
Age: 0.53
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Agitation, Apnoea, Crying, Flushing, Heart rate increased
Clinical narrative: She received the shots at 10:30 a.m and within and hour started severely crying, to the point where she would stop breathing and nothing could console her.   She continued doing so for 12 hours.  She had a rapid heart rate of 156 when sleeping and ran a fever.  At about 10:30 p.m after still hysterically crying she started tightening herself up (drawing in her legs, turning beat red and holding her breath).  When we reached the E.R. she then projectile vomited which she has never done.  She was given tylenol every 4 hours.  The E.R. had her on moniters and observed her for several hours.  She was then given tylenol every 4 hours for 24 more hours.