chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site oedema, Injection site reaction
Clinical narrative: Right arm swollen at injection site after Pneumovax vaccine given, felt hot last night.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Parent stated left thigh was red and swollen. Tx: Benadryl 12.5mg every 8 hours prn instructed to apply warm/ cold compresses.
Age: 6.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV
Symptoms: Feeling hot, Oedema, Tenderness
Clinical narrative: Received Dtap 3 on 7/13/2004. Pt complained of swelling and tenderness to Right upper arm on 07/14/04 and taken to hospital ER at 9:00PM. Pt given 250mg Keflex QID PO x 10days. Pt returned to clinic 7/15/04 09:00AM with right upper arm swollen from deltoid muscle to 4 inches below muscle, reddened, and warm to touch, pt c/o tenderness.
Age: 16.0
Sex: F
Vaccine: HEP, TD, VARCEL
Symptoms: Dermatitis bullous, Eye pain, Pruritus
Clinical narrative: T/C from Mom has chicken pox, like rash on face, chest, back, hands and legs, 50 vesicles c/o pruritus, no fever, no cough, c/o sore eyes.
Age: 1.52
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: THIS AM DAD NOTICED RED, RAISED RING, APPROXIMATELY 2"ACROSS, AROUND INJECTION SITE ON LEFT ARM.
Age: 18.0
Sex: F
Vaccine: FLUN3
Symptoms: Diarrhoea, Muscle spasms, Pain
Clinical narrative: Abrupt diarrhea and cramping occuring one week after vaccination. Lasted 1-1/2 days. Self-care, took ibuprofin for pain. Sinus trouble for one week, following two days after vaccination.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Dysphonia
Clinical narrative: HOARSENESS, DIZZINESS.
Age: 30.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Chills, Cough, Nasal congestion, Pyrexia
Clinical narrative: fever - 101 degrees for 2 days severe coughing weakness chills head congestion
Age: 18.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Malaise, Nasal congestion, Pharyngitis, Rash
Clinical narrative: Sunburn-like rash on upper arms appeared approx. 32 hours after vaccination.  Nasal congestion, runny nose, fatigue,  "sick" feeling starting approx. 45 hours after vaccination.  Benadryl 50mg taken for rash; rash disappeared within 10 hours.  Chlortrimeton 4mg taken for cold symptoms.  Cold-like symptoms lasted 3-1/2 days.
Age: 18.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinitis, Rhinorrhoea
Clinical narrative: Sunburn-like rash on upper arms appeared approx. 32 hours after vaccination.  Nasal congestion, runny nose, fatigue,  "sick" feeling starting approx. 45 hours after vaccination.  Benadryl 50mg taken for rash; rash disappeared within 10 hours.  Chlortrimeton 4mg taken for cold symptoms.  Cold-like symptoms lasted 3-1/2 days.
Age: 1.26
Sex: M
Vaccine: MMR, PNC, PNC
Symptoms: Abnormal behaviour, Autism, Diarrhoea, Laboratory test abnormal, Pyrexia
Clinical narrative: Within 7-10 days of recieving the vaccine, he broke out in a red rash and spiked a fever of approx. 101.  I kept it down to 100.5 with Ibuprofen and Tylenol as instructed per the physicians office by phone.  Within a week, the rash and fever were gone and he began having violent tantrums (beating his head on the floor).  His speech and eye contact went away over the next few weeks.  Diagnosis, Autism.  Over two years after he recieved this vaccine, his measles IgG was still elevated at 789, indicating a chronic measles infection.  Chronic diarrhea and self injurious behavior have plagued him since the vaccination. Medical Records received on 1/26/2005 states autism.
Age: 1.26
Sex: M
Vaccine: MMR, PNC, PNC
Symptoms: Rash, Speech disorder, Viral infection
Clinical narrative: Within 7-10 days of recieving the vaccine, he broke out in a red rash and spiked a fever of approx. 101.  I kept it down to 100.5 with Ibuprofen and Tylenol as instructed per the physicians office by phone.  Within a week, the rash and fever were gone and he began having violent tantrums (beating his head on the floor).  His speech and eye contact went away over the next few weeks.  Diagnosis, Autism.  Over two years after he recieved this vaccine, his measles IgG was still elevated at 789, indicating a chronic measles infection.  Chronic diarrhea and self injurious behavior have plagued him since the vaccination. Medical Records received on 1/26/2005 states autism.
Age: 1.26
Sex: M
Vaccine: MMR, PNC, PNC
Symptoms: Autism, Medication error, Overdose
Clinical narrative: Within 7-10 days of recieving the vaccine, he broke out in a red rash and spiked a fever of approx. 101.  I kept it down to 100.5 with Ibuprofen and Tylenol as instructed per the physicians office by phone.  Within a week, the rash and fever were gone and he began having violent tantrums (beating his head on the floor).  His speech and eye contact went away over the next few weeks.  Diagnosis, Autism.  Over two years after he recieved this vaccine, his measles IgG was still elevated at 789, indicating a chronic measles infection.  Chronic diarrhea and self injurious behavior have plagued him since the vaccination. Medical Records received on 1/26/2005 states autism.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Feeling hot, Hypotension, Influenza like illness
Clinical narrative: Immediately saw sparkles, became dizzy, had poor color and was pale.  Became very hot then cooled about 5 minutes later.  Left clinic. Went to school.  Developed hives.  Developed flu like symptoms.  Fever, leg cramps.  Hospitalized in intensive care with Viral Sepsis. Discharge Summary received states vomiting, chills, rash, hypotension, tachycardia, and viral exanthema.  Follow up 03/07/05:Information on manufacturer, will have to be obtain from another facility. The patient has recovered from the adverse event(s) but states "It was hell".
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Leukocytosis, Muscle spasms, Pallor, Pyrexia, Rash
Clinical narrative: Immediately saw sparkles, became dizzy, had poor color and was pale.  Became very hot then cooled about 5 minutes later.  Left clinic. Went to school.  Developed hives.  Developed flu like symptoms.  Fever, leg cramps.  Hospitalized in intensive care with Viral Sepsis. Discharge Summary received states vomiting, chills, rash, hypotension, tachycardia, and viral exanthema.  Follow up 03/07/05:Information on manufacturer, will have to be obtain from another facility. The patient has recovered from the adverse event(s) but states "It was hell".
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Sepsis, Tachycardia, Urticaria, Viral infection, Vitreous floaters
Clinical narrative: Immediately saw sparkles, became dizzy, had poor color and was pale.  Became very hot then cooled about 5 minutes later.  Left clinic. Went to school.  Developed hives.  Developed flu like symptoms.  Fever, leg cramps.  Hospitalized in intensive care with Viral Sepsis. Discharge Summary received states vomiting, chills, rash, hypotension, tachycardia, and viral exanthema.  Follow up 03/07/05:Information on manufacturer, will have to be obtain from another facility. The patient has recovered from the adverse event(s) but states "It was hell".
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Immediately saw sparkles, became dizzy, had poor color and was pale.  Became very hot then cooled about 5 minutes later.  Left clinic. Went to school.  Developed hives.  Developed flu like symptoms.  Fever, leg cramps.  Hospitalized in intensive care with Viral Sepsis. Discharge Summary received states vomiting, chills, rash, hypotension, tachycardia, and viral exanthema.  Follow up 03/07/05:Information on manufacturer, will have to be obtain from another facility. The patient has recovered from the adverse event(s) but states "It was hell".
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Electrocardiogram abnormal, Headache, Laboratory test abnormal
Clinical narrative: CHEST PAIN, HEADACHE
Age: 45.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Coagulopathy, Fungal infection, Hepatomegaly, Multi-organ failure, Nephrosclerosis
Clinical narrative: Developed proteinuria which progressed to nephrosclerosis then eventually to multi-organ system failure and death in 2004. Received medical records from WRAMC VHC which revealed COD as glomerulosclerosis leading to multi-organ failure.  CT scan revealed fungal abscess of lungs.  Developed significant coagulation problems & was unable to be intubated due to excessive amounts of blood in his throat.
Age: 45.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Proteinuria, Pulmonary embolism, Renal failure, Viral infection
Clinical narrative: Developed proteinuria which progressed to nephrosclerosis then eventually to multi-organ system failure and death in 2004. Received medical records from WRAMC VHC which revealed COD as glomerulosclerosis leading to multi-organ failure.  CT scan revealed fungal abscess of lungs.  Developed significant coagulation problems & was unable to be intubated due to excessive amounts of blood in his throat.
Age: 45.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Immune system disorder, Multi-organ failure
Clinical narrative: Developed proteinuria which progressed to nephrosclerosis then eventually to multi-organ system failure and death in 2004. Received medical records from WRAMC VHC which revealed COD as glomerulosclerosis leading to multi-organ failure.  CT scan revealed fungal abscess of lungs.  Developed significant coagulation problems & was unable to be intubated due to excessive amounts of blood in his throat.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pneumonia, Renal failure, Respiratory failure, Tremor
Clinical narrative: From initial information received on 12/21/04 from the patient's niece regarding an adverse event occurring in the USA, it was reported that an 89 year old female patient received a dose of FLUZONE at 11:00 AM on 10/11/2004. The lot number, site and route of administration were not provided. Eight hours later, on 10/11/04 at 7:00 PM, the patient complained of dizziness and her hands were shaking. She was seen in an emergency room, was diagnosed with kidney failure and was admitted to the hospital on 10/11/04. The patient was seen by renal specialists, critical care physicians, neurologists and infectious disease. The patient was hospitalized until she died on 12/13/04. No autopsy was performed. Medical Records received on 1/07/2005 states pneumonia and respiratory failure.
Age: 1.12
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Chills, Febrile convulsion, Leukocytosis, Pyrexia
Clinical narrative: Patient had febrile seizure within 12 hours of administering vaccines (MMR, Varivax, Influenza). Temp 104.7 in ER at hospital. Admitted for observation for 24 hours. Follow up 02/16/05: Possible shivers/chills, what sounds like a generalized tonic clonic seizure. The event taks place 9.5 hours immunization. Has a twin who who did not have adverse event. Information received from discharge summary states chills.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: 02/15/2004 Received flu and PPV 23 AM 101.4 temp 8:30 or 9:00PM. Ice packs applied Wed night. All day Thurs. Took Ibuprofen yesterday and this AM (I called private MD nurse at office to call pt at home today). Referred to MD if not improved.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, TTOX
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Noticed right of 12/15/04 left arm was red. More swelling noted 12/16/04. See pack applied off and on. Redness moved further down arm, will apply ice packs and take Benadryl, will go to MD on 12/18/04 if unimproved.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Coordination abnormal, Decreased appetite
Clinical narrative: Starting on 10/25/04 the following symptoms occurred upon waking in the morning: extreme pain and burning in both hands, especially at the finger tips, swollen hands and very swollen middle finger joint on right hand. Both hands were stiff, tingling, hard to make a fist/clench, and had a grainy sensation. Both hands were weaker and more uncoordinated than before the vaccine. I experienced colder hands now. My feet especially the toes were tingling, aching and very painful. My knee joints were also aching. About one week after the vaccine, I have had intestinal problems. My bowel movements have been looser and there is a bad smell to them, other than the usual. I feel achy in the intestines and more noise is in them, such as a rumbling noise. I have a lot more gas and my urine has a strange smell. These problems continue today. Since the vaccine, I have had a diminished appetite, and have lost weight. Every morning I wake with a bad taste in my mouth. As of November 1, 2004, the following is happening to me: I now have over all my body, a tingling sensation (from head to my toes), an overall body stiffening. My face has a tingling numb sensation in it. As of November 7, 2004 I woke in the morning with very painful knee joints. I continue to have very painful hands. Both hands have sensations of numbness, burning, grainy feeling, coldness, stiffness, tingling, poor coordination, and joint pain. Overall, my body feels stiffer and weaker, and more tired than normally. My knee joints are aching and my toes feel numb and tingling and painful. I feel my nerves have been attacked by the vaccine. All of my daily and/or normal activities are affected by this extreme condition in my hands and body. I have had MS for over 10 years, and I know that these are not the type of symptoms I would experienced from MS. Given the time of onset of these symptoms (2 weeks after the vaccine was administered), I believe the vaccine has damaged my body.  As of Dec2004: My Dr has determined that these events (above) are not MS related I continue to suffer in my hands and feet.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Fatigue, Gastrointestinal hypermotility, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: Starting on 10/25/04 the following symptoms occurred upon waking in the morning: extreme pain and burning in both hands, especially at the finger tips, swollen hands and very swollen middle finger joint on right hand. Both hands were stiff, tingling, hard to make a fist/clench, and had a grainy sensation. Both hands were weaker and more uncoordinated than before the vaccine. I experienced colder hands now. My feet especially the toes were tingling, aching and very painful. My knee joints were also aching. About one week after the vaccine, I have had intestinal problems. My bowel movements have been looser and there is a bad smell to them, other than the usual. I feel achy in the intestines and more noise is in them, such as a rumbling noise. I have a lot more gas and my urine has a strange smell. These problems continue today. Since the vaccine, I have had a diminished appetite, and have lost weight. Every morning I wake with a bad taste in my mouth. As of November 1, 2004, the following is happening to me: I now have over all my body, a tingling sensation (from head to my toes), an overall body stiffening. My face has a tingling numb sensation in it. As of November 7, 2004 I woke in the morning with very painful knee joints. I continue to have very painful hands. Both hands have sensations of numbness, burning, grainy feeling, coldness, stiffness, tingling, poor coordination, and joint pain. Overall, my body feels stiffer and weaker, and more tired than normally. My knee joints are aching and my toes feel numb and tingling and painful. I feel my nerves have been attacked by the vaccine. All of my daily and/or normal activities are affected by this extreme condition in my hands and body. I have had MS for over 10 years, and I know that these are not the type of symptoms I would experienced from MS. Given the time of onset of these symptoms (2 weeks after the vaccine was administered), I believe the vaccine has damaged my body.  As of Dec2004: My Dr has determined that these events (above) are not MS related I continue to suffer in my hands and feet.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nervous system disorder, Pain, Paraesthesia, Peripheral coldness
Clinical narrative: Starting on 10/25/04 the following symptoms occurred upon waking in the morning: extreme pain and burning in both hands, especially at the finger tips, swollen hands and very swollen middle finger joint on right hand. Both hands were stiff, tingling, hard to make a fist/clench, and had a grainy sensation. Both hands were weaker and more uncoordinated than before the vaccine. I experienced colder hands now. My feet especially the toes were tingling, aching and very painful. My knee joints were also aching. About one week after the vaccine, I have had intestinal problems. My bowel movements have been looser and there is a bad smell to them, other than the usual. I feel achy in the intestines and more noise is in them, such as a rumbling noise. I have a lot more gas and my urine has a strange smell. These problems continue today. Since the vaccine, I have had a diminished appetite, and have lost weight. Every morning I wake with a bad taste in my mouth. As of November 1, 2004, the following is happening to me: I now have over all my body, a tingling sensation (from head to my toes), an overall body stiffening. My face has a tingling numb sensation in it. As of November 7, 2004 I woke in the morning with very painful knee joints. I continue to have very painful hands. Both hands have sensations of numbness, burning, grainy feeling, coldness, stiffness, tingling, poor coordination, and joint pain. Overall, my body feels stiffer and weaker, and more tired than normally. My knee joints are aching and my toes feel numb and tingling and painful. I feel my nerves have been attacked by the vaccine. All of my daily and/or normal activities are affected by this extreme condition in my hands and body. I have had MS for over 10 years, and I know that these are not the type of symptoms I would experienced from MS. Given the time of onset of these symptoms (2 weeks after the vaccine was administered), I believe the vaccine has damaged my body.  As of Dec2004: My Dr has determined that these events (above) are not MS related I continue to suffer in my hands and feet.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Skin burning sensation, Urine analysis abnormal, Weight decreased
Clinical narrative: Starting on 10/25/04 the following symptoms occurred upon waking in the morning: extreme pain and burning in both hands, especially at the finger tips, swollen hands and very swollen middle finger joint on right hand. Both hands were stiff, tingling, hard to make a fist/clench, and had a grainy sensation. Both hands were weaker and more uncoordinated than before the vaccine. I experienced colder hands now. My feet especially the toes were tingling, aching and very painful. My knee joints were also aching. About one week after the vaccine, I have had intestinal problems. My bowel movements have been looser and there is a bad smell to them, other than the usual. I feel achy in the intestines and more noise is in them, such as a rumbling noise. I have a lot more gas and my urine has a strange smell. These problems continue today. Since the vaccine, I have had a diminished appetite, and have lost weight. Every morning I wake with a bad taste in my mouth. As of November 1, 2004, the following is happening to me: I now have over all my body, a tingling sensation (from head to my toes), an overall body stiffening. My face has a tingling numb sensation in it. As of November 7, 2004 I woke in the morning with very painful knee joints. I continue to have very painful hands. Both hands have sensations of numbness, burning, grainy feeling, coldness, stiffness, tingling, poor coordination, and joint pain. Overall, my body feels stiffer and weaker, and more tired than normally. My knee joints are aching and my toes feel numb and tingling and painful. I feel my nerves have been attacked by the vaccine. All of my daily and/or normal activities are affected by this extreme condition in my hands and body. I have had MS for over 10 years, and I know that these are not the type of symptoms I would experienced from MS. Given the time of onset of these symptoms (2 weeks after the vaccine was administered), I believe the vaccine has damaged my body.  As of Dec2004: My Dr has determined that these events (above) are not MS related I continue to suffer in my hands and feet.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Received Pneumovax vaccine 12/14/04 at 09:30AM Left deltoid, chills x one hour. Noticed reaction while trying on clothes today. Red area with swelling noted left deltoid region to forearm.
Age: 32.0
Sex: M
Vaccine: FLUX, HEP, TYP
Symptoms: Alopecia
Clinical narrative: Developed alopecia in mid-Feb04 starting on both sides of head above the ears and spreading to approx 20 bald spots on top and back of scalp. Kenalog cream prescribed on 03Mar04. Received injections of 0.4cc of Kenalog in 2 spots on 31Mar04.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Musculoskeletal stiffness, Pharyngitis, Pyrexia, Rhinitis
Clinical narrative: 101 fever, stiff neck, cold symptoms x 48 hrs 8 days after FluMist.
Age: 20.0
Sex: M
Vaccine: FLUX, SMALL
Symptoms: Rash
Clinical narrative: Rash on chest and arms, Atarax and Aveeno
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness, swelling of arm at injection site
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Hypoaesthesia, Paraesthesia
Clinical narrative: Right shoulder,bicep, wrist weakness and tingling/numbness of right hand; diagnosed with Parsonage-Tumer syndrome, AKA Neuralgia Amyotrophy
Age: 20.0
Sex: U
Vaccine: ANTH
Symptoms: Migraine
Clinical narrative: New onset migraine after AVA 1. Headaches have continued until present.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Paraesthesia, Skin exfoliation
Clinical narrative: Developed peeling palms bilaterally which progressed to complete desquamation of the palms. He also developed tingling paresthesias in the fingertips of the rt hand (side of injection).
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Pruritus, Rash, Skin burning sensation
Clinical narrative: Fine red rash on Abdomen, arms, itchy, with a burning sensation. T 96.7, P72, Resp 20, B/P 118/72 Wt 145.
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis
Clinical narrative: Probable cellulitis secondary to smallpox vaccination
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Contusion, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Received PPV23 approx at 0800. Around 1500 Pt c/o swelling, redness, and pain. Pt was dx at ER visit with bruise and cellulitis. Pt also c/o swollen arm and painful swollen down pass her elbow with her elbow looking like a baseball.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Blister, Pruritus, Rash maculo-papular
Clinical narrative: Rash, pink maculopapular rash 3 ruptured vesicles, mild itch, rash began 11/24/04.
Age: 1.08
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Fatigue, Herpes zoster, Pain, Pyrexia, Rash pruritic
Clinical narrative: Pt developed a severe itching, burning rash on the lower right side of her stomach. Pain was excruitiating, so bad that her father took her to the doctor. She was diagnosed with shingles and given Acyclovir/Zovirax. She never had chicken pox but doctor said her shingles could be due to the weakened virus that was in the vaccine she received. She had a low grade fever and was fatigued. It took about 7 weeks to clear up.
Age: 1.08
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Skin burning sensation
Clinical narrative: Pt developed a severe itching, burning rash on the lower right side of her stomach. Pain was excruitiating, so bad that her father took her to the doctor. She was diagnosed with shingles and given Acyclovir/Zovirax. She never had chicken pox but doctor said her shingles could be due to the weakened virus that was in the vaccine she received. She had a low grade fever and was fatigued. It took about 7 weeks to clear up.
Age: 15.0
Sex: F
Vaccine: HEP, TD, VARCEL
Symptoms: Erythema, Rash pruritic, Skin ulcer
Clinical narrative: Small red bumps lesions over all extremities and torso, severe itching.
Age: 1.01
Sex: F
Vaccine: UNK
Symptoms: Viral infection
Clinical narrative: Chicken pox
Age: 1.02
Sex: F
Vaccine: UNK
Symptoms: Viral infection
Clinical narrative: Chicken pox
Age: 1.53
Sex: M
Vaccine: PNC
Symptoms: Erythema multiforme, Pyrexia, Skin ulcer, Varicose vein
Clinical narrative: 12/08/2004 Prevnar given. That night he ran fever that ended on 12/9. On 12/9 He also developed iridespread varicorial rash along with target lesions. Consistent with erythema multiforme.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: Erythromatic Rash 6 x 4 cm on Left arm warm non-tender.
Age: 1.26
Sex: M
Vaccine: DTAPH
Symptoms: Medication error
Clinical narrative: Expired immunization given, no adverse reaction reported.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site abscess, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: PN 12/15/2004 late PM patient complained of pain, swelling, and redness at injection site (right deltoid).  Mother reported area hot to touch.  Gave tylenol.  Mother stated she is a nurse and felt like it is a localized reaction.  On 12/16/2004 Mother received a phone call from school nurse regarding right deltoid.  Nurse told her it was as big as a baseball.  Mother took her to see the doctor.  Dr. stated to mother it was a sterile abscess vs localized reaction - Keflex for 5 days.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Abscess, Feeling hot, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: PN 12/15/2004 late PM patient complained of pain, swelling, and redness at injection site (right deltoid).  Mother reported area hot to touch.  Gave tylenol.  Mother stated she is a nurse and felt like it is a localized reaction.  On 12/16/2004 Mother received a phone call from school nurse regarding right deltoid.  Nurse told her it was as big as a baseball.  Mother took her to see the doctor.  Dr. stated to mother it was a sterile abscess vs localized reaction - Keflex for 5 days.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site reaction
Clinical narrative: PN 12/15/2004 late PM patient complained of pain, swelling, and redness at injection site (right deltoid).  Mother reported area hot to touch.  Gave tylenol.  Mother stated she is a nurse and felt like it is a localized reaction.  On 12/16/2004 Mother received a phone call from school nurse regarding right deltoid.  Nurse told her it was as big as a baseball.  Mother took her to see the doctor.  Dr. stated to mother it was a sterile abscess vs localized reaction - Keflex for 5 days.
Age: 1.37
Sex: F
Vaccine: DTAPH
Symptoms: Medication error
Clinical narrative: Expired immunization given, no adverse reaction reported.
Age: 1.27
Sex: M
Vaccine: DTAPH
Symptoms: Medication error
Clinical narrative: Expired immunization given, no adverse reaction reported.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Injection site on left lower / upper arm became swollen, hot and red about 2 inches in size.  No itching, no pain.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Pimple like lesions on the trunk, back, arm modify varicella.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash
Clinical narrative: Had Pedvax / Hib, Prevnar on 12/17, developed rash on both thighs on 12/18.
Age: 1.91
Sex: F
Vaccine: DTAPH, PNC
Symptoms: Erythema, Injection site mass, Swelling
Clinical narrative: Left leg - large knot, red and swollen.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Pt has chicken pox on 12/21/04 received Varivax on 10/1/98
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Pt was given varicella vaccine on 02/11/1997. Was diagnosed with Varicella zoster 12/24/04.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Vomiting
Clinical narrative: Began vomiting in evening 12/6/04. Continued to Wed 12/8/04 taken to ER No IV, No hospitalization. Not dehydrated per ER, taking Pedialyte and fluids. Improved Thurs okay by Fri.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Eye swelling, Pruritus, Urticaria, Vomiting
Clinical narrative: At approx 11:30 mom called and they were in the car and mom states that she is very itchy with hives everywhere. Coughing started right after shots and she vomited and her eyes are puffy. She was told to come right back to clinic. She got here no breathing problems also no wheezing, but itching a lot and hives everywhere from head to toe-big patches. Her face and eyes were very swollen and puffy, no cough here and no vomiting here. Diphenhydramine 20mg IM given. Symptoms drastically improved within 5 min of injection. Observed for 20 min and sent home.
Age: 18.0
Sex: M
Vaccine: FLUX
Symptoms: Condition aggravated, Dyspnoea, Injection site abscess, Injection site swelling
Clinical narrative: Patient was playing basketball within a couple of hours of the shot. He was hit in the arm, in the exact spot that the shot was administered, during the game and the arm swelled up drasticly. In addition, he had to use his inhaler for a coincident breathing difficulty.  His swelling was quite a bit less, later in the evening.  He was fully recovered the next morning.  He wanted it said that he had a bit more bleeding than normal from the shot location, right after the needle was withdrawn. It stopped after a few minutes.
Age: 1.34
Sex: F
Vaccine: HBHEPB, MMR, PNC
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Pt eval on 3 JAN 2005. Pt has macular/papular rash over entire body and a fever that developed on 1 JAN 2005 after receiving vaccines on 22 DEC 2004. Pt evaluated by provider and treated with comfort measures only.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Coma, Listless, Pharyngitis, Somnolence
Clinical narrative: Non-responsive, listless, sleeping continually for 9 hours then waking for 1 ounce feeding then sleeping additional 6 then 5 hour spans, admitted to hospital 12/31/04; 3 days after shots. Suspected meningitis but LP was clear, CT scan indicated fluid on the brain, fontanelles extremely recessed. Medical Records received on 2/16/2005 states pharyngitis.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypotension, Injection site oedema
Clinical narrative: At injection site right deltoid local swelling size of baseball. Vital signs taken: 70/50  Pulse 52, no SOB, light headed with dizziness. Ice pack applied to site when swelling noted. Juice given. Client placed on exam table after resting for 15 minutes B/P 100/70. Client stated she felt better and left clinic by self.
Age: 1.02
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Rash pustular
Clinical narrative: Pustules 4 on body 2 right underarm 1 arm 1 back (tiny red) occurred 14 days after administrated 1 vaccine.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: After 5pm 11/13/03 broke out in hives, legs, trunk of body. Called PP was prescribed Medrol dose pack. (Received flu shot around 10am 11/13/03).
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia, Blood iron decreased
Clinical narrative: Stressed over losing job back in May. Started new job in June, 2003. Hair loss was found by hairstylist on 08/06/03. Hair loss continued to become bigger and more noticeable. Went to Dr 09/26/03, ran lab and my iron count was down low, 11.1. He prescribed iron supplements and inj of B6/B12 every 2 weeks/multivitamin.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Injection site erythema, Injection site haemorrhage, Injection site mass
Clinical narrative: Pt developed large indurated erythematous area of entire right thigh with central ecchymosis inferior to injection site with mild bruise just under injection site.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Nasal congestion, Pruritus, Rhinorrhoea, Rhinorrhoea
Clinical narrative: Information has been received from a pharmacist concerning a healthy 70 year old female who on 12/16/04 was vaccinated in the right deltoid with pneumococcal 23v polysaccharide vaccine (lot # 649913/0577P). The patient received a prior vaccination with pneumococcal 23v polysaccharide vaccine in 1994. Concomitant therapy included influenza virus whole virion 3v inactivated. On approximately 12/18/04 the patient developed redness in both arms and 2 red nodules on the lower portion of the right arm. She also developed sniffling and a stopped nose. Unspecified medical attention was sought, and the patient was treated with diphenhydramine hydrochloride. The patient's outcome was unknown. The reporter considered redness in both arms and 2 red nodules on the lower portion of the right arm to be other important medical events (OMIC). Additional information has been requested. Follow-up information has been received from a pharmacist; the patient self-treated with diphenhydramine hydrochloride (Benadryl) tablets, after experiencing the events. At the time of the report, she was recovering. Additional follow up information has been received from a pharmacist. On 12-17-2004 erythema and pruritus developed. It was reported that the event began with redness over the affected arm, then progressed over the patient's trunk, legs, and neck up to chin. A physician was consulted. The patient recovered at home. It was reported that the reaction lasted 12-13 days, and the patient recovered from erythema and pruritus on Dec 29, 2004.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Skin nodule
Clinical narrative: Information has been received from a pharmacist concerning a healthy 70 year old female who on 12/16/04 was vaccinated in the right deltoid with pneumococcal 23v polysaccharide vaccine (lot # 649913/0577P). The patient received a prior vaccination with pneumococcal 23v polysaccharide vaccine in 1994. Concomitant therapy included influenza virus whole virion 3v inactivated. On approximately 12/18/04 the patient developed redness in both arms and 2 red nodules on the lower portion of the right arm. She also developed sniffling and a stopped nose. Unspecified medical attention was sought, and the patient was treated with diphenhydramine hydrochloride. The patient's outcome was unknown. The reporter considered redness in both arms and 2 red nodules on the lower portion of the right arm to be other important medical events (OMIC). Additional information has been requested. Follow-up information has been received from a pharmacist; the patient self-treated with diphenhydramine hydrochloride (Benadryl) tablets, after experiencing the events. At the time of the report, she was recovering. Additional follow up information has been received from a pharmacist. On 12-17-2004 erythema and pruritus developed. It was reported that the event began with redness over the affected arm, then progressed over the patient's trunk, legs, and neck up to chin. A physician was consulted. The patient recovered at home. It was reported that the reaction lasted 12-13 days, and the patient recovered from erythema and pruritus on Dec 29, 2004.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site inflammation, Rash, Skin nodule
Clinical narrative: Information has been received from a pharmacist concerning a healthy 70 year old female who on 12/16/04 was vaccinated in the right deltoid with pneumococcal 23v polysaccharide vaccine (lot # 649913/0577P). The patient received a prior vaccination with pneumococcal 23v polysaccharide vaccine in 1994. Concomitant therapy included influenza virus whole virion 3v inactivated. On approximately 12/18/04 the patient developed redness in both arms and 2 red nodules on the lower portion of the right arm. She also developed sniffling and a stopped nose. Unspecified medical attention was sought, and the patient was treated with diphenhydramine hydrochloride. The patient's outcome was unknown. The reporter considered redness in both arms and 2 red nodules on the lower portion of the right arm to be other important medical events (OMIC). Additional information has been requested. Follow-up information has been received from a pharmacist; the patient self-treated with diphenhydramine hydrochloride (Benadryl) tablets, after experiencing the events. At the time of the report, she was recovering. Additional follow up information has been received from a pharmacist. On 12-17-2004 erythema and pruritus developed. It was reported that the event began with redness over the affected arm, then progressed over the patient's trunk, legs, and neck up to chin. A physician was consulted. The patient recovered at home. It was reported that the reaction lasted 12-13 days, and the patient recovered from erythema and pruritus on Dec 29, 2004.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Nasal congestion, Skin nodule
Clinical narrative: Information has been received from a pharmacist concerning a healthy 70 year old female who on 12/16/04 was vaccinated in the right deltoid with pneumococcal 23v polysaccharide vaccine (lot # 649913/0577P). The patient received a prior vaccination with pneumococcal 23v polysaccharide vaccine in 1994. Concomitant therapy included influenza virus whole virion 3v inactivated. On approximately 12/18/04 the patient developed redness in both arms and 2 red nodules on the lower portion of the right arm. She also developed sniffling and a stopped nose. Unspecified medical attention was sought, and the patient was treated with diphenhydramine hydrochloride. The patient's outcome was unknown. The reporter considered redness in both arms and 2 red nodules on the lower portion of the right arm to be other important medical events (OMIC). Additional information has been requested. Follow-up information has been received from a pharmacist; the patient self-treated with diphenhydramine hydrochloride (Benadryl) tablets, after experiencing the events. At the time of the report, she was recovering. Additional follow up information has been received from a pharmacist. On 12-17-2004 erythema and pruritus developed. It was reported that the event began with redness over the affected arm, then progressed over the patient's trunk, legs, and neck up to chin. A physician was consulted. The patient recovered at home. It was reported that the reaction lasted 12-13 days, and the patient recovered from erythema and pruritus on Dec 29, 2004.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Nasal congestion, Pruritus, Rhinorrhoea, Rhinorrhoea
Clinical narrative: Patient, 12/21/04, reports bilateral inflammatory rash, swollen nodules on right arm; site of pneumococcal injection. Taking Benadryl. Patient recovering at home.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Skin nodule
Clinical narrative: Patient, 12/21/04, reports bilateral inflammatory rash, swollen nodules on right arm; site of pneumococcal injection. Taking Benadryl. Patient recovering at home.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site inflammation, Rash, Skin nodule
Clinical narrative: Patient, 12/21/04, reports bilateral inflammatory rash, swollen nodules on right arm; site of pneumococcal injection. Taking Benadryl. Patient recovering at home.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Nasal congestion, Skin nodule
Clinical narrative: Patient, 12/21/04, reports bilateral inflammatory rash, swollen nodules on right arm; site of pneumococcal injection. Taking Benadryl. Patient recovering at home.
Age: 0.12
Sex: M
Vaccine: HEP
Symptoms: Apnoea, Cardiovascular disorder, Cyanosis
Clinical narrative: On 12/2/04 morning, parents noticed baby not breathing. Taken to ER and pronounced DOA. Had autopsy done. Report pending. Discharge Summary received on 1/25/2005 states pt was pulseless and cyanotic.
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: Information has been received from a female consumer with unspecified allergies and hypercholesterolemia who on 12/1/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included levothyroxine Na, metoprolol succinate, clopidogrel bisulphate and fluvastatin sodium. On 12/2/04, the patient developed swelling in her arm, lymph nodes and chest. On 12/3/04, the patient was administered a steroid shot and an antibiotic. No diagnostic studies were performed. On 12/10/04 the patient recovered. No product quality complaint was involved. The reporter indicated that swelling of arm, lymph nodes, and chest were considered to be other important medical events (OMIC). Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site swelling, Pruritus, Rash erythematous
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old female social worker with a thimerosal allergy and no medical history who on the morning of 10/18/04 was vaccinated IM with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 647178/1200N), IM. There was no illness at the time of vaccination. On 10/19/04, within 24 hours of the vaccination, the patient developed a red, raised, itchy rash on the upper arm about 4 inches around the injection site. The rash formed a band around the injection site. The patient was given fexofenadine hydrochloride to treat the rash. No diagnostic tests were performed. Subsequently, the patient recovered. It was also reported that in 1999 the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine with no problems. No product quality complaint was involved. there were no relevant diagnostic tests or laboratory data. Follow up information was received from the reporting nurse. It was reported that the patient was initially prescribed diphenhydramine HCl over the phone, but had no results. The patient was seen and evaluated by a physician. The patient's reaction was considered to be an allergic reaction. The patient was not sent to the emergency room or hospitalized, but was sent to an allergy clinic for further evaluation. The patient was treated with fexofenadine HCl and subsequently recovered. The nurse did consider the patient's experience to be serious. Allergic reaction was considered to be an other important medical event (OMIC). No further information is expected.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Respiratory distress
Clinical narrative: Information has been received from a physician concerning a 50 year old hospitalized female with community acquired pneumonia and no allergies who on approximately 12/20/04 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included an unspecified influenza virus vaccine, antibiotics and steroids. On 12/21/04 twelve hours after vaccination, the patient developed acute respiratory distress. Twenty four hours after vaccination, the patient was placed on life support with a ventilator. It was reported that the patient has not recovered. No product quality complaint was involved. Acute respiratory distress was considered to be immediately life threatening. Additional information has been requested. Per Follow up report received on 06/14/2005:  Patient still has not recovered.
Age: 1.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Convulsion, Infection, Otitis media
Clinical narrative: Diagnosed with seizures, ear infection and lung infection on the evening of 9/15/03. This was reported by the ICU physician. Followed up with the ICU physician few days later and he stated the child was recovering. Have been unable to contact the mother for further details.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome. Of note, questionable parent with questionable distant history of GBS after vaccine.    02/11/05 Received Discharge summary of 11/22-11/29/2004. FINAL DX: Guillain Barre syndrome records reveal patient experienced progressive weakness begining late Oct.  Developed foot drop & had falls w/elbow fx.  When seen in Ortho clinic for elbow fx, weakness of LEs noted & pt admitted.  Neuro consult done. Reflexes decreased.  Tx w/IVIG & steroids.  Minimal improvement.  Transferred to inpatient rehab.  Follow up 01/20/05: Patient has recovered from adverse event. 60 Day Follow up: severe leg weakness, requires walker.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Laboratory test abnormal, Malaise, Myalgia, Thrombocytopenia
Clinical narrative: Patient admitted with SOB, general myalgia and malaise after flu shot; afebrile. No suggestion of CHF decompensation/ARF due to dehydration versus ACE-1. Mild flu induced by vaccine (viral syndrome)? ARF secondary to vol depletion due to viral syndrome? Thrombocytopenia due to viral syndrome?
Age: 1.19
Sex: F
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Contusion, Petechiae, Thrombocytopenia
Clinical narrative: Patient presented on 12/20/04 with bruising and petechiae. Parents thought her symptoms had occurred for a least 1 week. She had a gastrointestinal virus (vomiting/diarrhea) per parental report 1.5 weeks before. She had thrombocytopenia (platelet count down to 8,000). Received MMR 11/5/04. 60 Day Follow Up: She has had normal platelet counts twice 1/25/05 and 2/25/05. Appears to have recovered.
Age: 1.91
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Viral infection, Vomiting
Clinical narrative: Had first dose flu vaccine about 6 weeks ago. Within 2-3 days develop intermittent vomiting, mild diarrhea for 1.5-2 weeks. Otherwise well. Second dose flu shot 8 days ago. Within 2-3 days again, intermittent vomiting and diarrhea; worse in last 24 hours.
Age: 1.26
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: Patient received HIB #4, MMR #1, flu shot, and Prevnar. On 12/20/04, rash developed. 12/29, fevers off and on over last few days.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Lethargy, Nausea, Pyrexia, White blood cell count increased
Clinical narrative: Fever to 104, nausea, lethargy within 1 hour of vaccine. Previously well.
Age: 34.0
Sex: F
Vaccine: FLUN3
Symptoms: Burning sensation mucosal, Epistaxis, Rhinorrhoea
Clinical narrative: Day of vaccine, burning and runny nose which progressed to a raw spot in nose with even more burning that would not subside. Occasional bleeding from right nose.
Age: 1.0
Sex: M
Vaccine: FLU3, HBHEPB, MMR, PNC
Symptoms: Cough, Diarrhoea, Erythema, Lacrimation increased, Pyrexia
Clinical narrative: Fever 1 day after shots; temperature max 102.4 for 3 days. Blanching erythema on chest and abdomen for 3 days. Mild diarrhea, mild cough and watery eyes.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Pruritus, Rash
Clinical narrative: Rash, itching, numbness in mouth and tongue.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Rash with itching; treated with over the counter Benadryl.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Feeling hot
Clinical narrative: 11/5/03 arm got hot and feverish and continued until 12/21/03. Got black and blue. Saw doctor 2 weeks ago.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Autism
Clinical narrative: This case was reported by a consumer and described the occurrence of autism in a 30 month old male patient who received hepatitis B vaccine recombinant and diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. The reporter is the mother of the patient. A physician or other health care professional has not verified this report. On unspecified dates, the patient received administrations of Engerix B (lot ENG5216A and lot ENG5300A2) and Infanrix (lot DTPA543A2 and lot DTPA553A2). The dose numbers for these vaccinations were not provided. At an unspecified period of time following the administrations of Engerix B and Infanrix, on 11/21/04, the patient experienced autism. The event was ongoing at the time of initial reporting. Comment: Autism was assessed as medically serious (OMIC).