chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: HEP, HEPA, TD, TYP, YF, HEP, HEPA, TD, TYP, YF, HEP, HEPA, TD, TYP, YF
Symptoms: Paraesthesia
Clinical narrative: A nurse reported the occurrence of an allergic reaction in a 51 year old female who received hep A vaccine inactivated for prophylaxis. The subject's medical history included allergies to pcn, Motrin, codeine, and sulfa. The subject experienced anaphylaxis following Prempro, vitamin E, vitamin C, folic acid, calcium plus vitamin D, and vitamin B-12. On 5/23/02, the subject received injections of Havrix (720A4), Typhim Vi, tetanus and diphtheria toxoids, YF-Vax, and hep B vaccine. Two hours post-immunization, the subject developed a swollen tongue, "mild" swelling of the throat, and itching. The subject was seen in the local ER, where a physician made a diagnosis of "allergic reaction suspected to vaccines." The subject was treated with steroid NOS and antihistamine NOS. Additional info was received on 12/10/02. The events resolved on 5/28/02. The subject received her second injection of Havrix (720A4) on 11/20/02. She was pre-medicated with two unspecified medications for two days prior to receiving the second injection of Havrix. No adverse event occurred. The reporting nurse considered the allergic reaction to be possibly related to each of the vaccines administered on 5/23/02. On 12/10/02, the nurse stated that the tongue swelling was life-threatening; therefore, this report has been reclassified as serious.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Laboratory test abnormal, Myocarditis
Clinical narrative: Acute myopericarditis, chest pain, abnormal EKG, cardiac enzymes. Normal cardiac catheterization. Symptoms.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Pericarditis
Clinical narrative: Acute myopericarditis, chest pain, abnormal EKG, cardiac enzymes. Normal cardiac catheterization. Symptoms.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation, Crying, Irritability, Lethargy, Pyrexia
Clinical narrative: Inconsolable crying, extremely lethargic, fever. Pt received his vaccinations Fr. 1/10/03. In the afternoon. He slept all day Sat. We could not hardly wake him up to feed him. He slept all day Sunday also. Sun evening he was running a low grade fever about 101. During church he started crying and we prayed for him because we thought he just felt bad because of his shot. Fever is a well know side affect. When we left church his fever had subsided. Monday he seemed fussy but not bad. My daughter had a doctors appt which is is about 24 miles from where we live. So she took pt with her. She had been in the doctors office for about 30 minutes when she called me to please come get him she said he had been screaming since she left and she couldn't get him to quiet down. I drove to pick him up and when I got there one of the girls in the office was holding him and he was screaming. I took him and I couldn't console him. I had never seen anything like it. I could always get him to quit crying. I left and when we started driving he stopped crying. We went to store and bought a few things and when we started checking out he started screaming again. We left and he screamed most of the way home. He was real fussy that night. I don't remember about Tuesday but my mom who kept him during the day said that Wed. he was real fussy, and just needed to be held. He was also waking up a lot during the night. Thursday night he seemed fine, I bathed him and took him to see a friend of mine. He was laughing and talking to me. I rocked him to sleep when we got home. The next morning my daughter woke up and found him dead.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Sudden infant death syndrome
Clinical narrative: Inconsolable crying, extremely lethargic, fever. Pt received his vaccinations Fr. 1/10/03. In the afternoon. He slept all day Sat. We could not hardly wake him up to feed him. He slept all day Sunday also. Sun evening he was running a low grade fever about 101. During church he started crying and we prayed for him because we thought he just felt bad because of his shot. Fever is a well know side affect. When we left church his fever had subsided. Monday he seemed fussy but not bad. My daughter had a doctors appt which is is about 24 miles from where we live. So she took pt with her. She had been in the doctors office for about 30 minutes when she called me to please come get him she said he had been screaming since she left and she couldn't get him to quiet down. I drove to pick him up and when I got there one of the girls in the office was holding him and he was screaming. I took him and I couldn't console him. I had never seen anything like it. I could always get him to quit crying. I left and when we started driving he stopped crying. We went to store and bought a few things and when we started checking out he started screaming again. We left and he screamed most of the way home. He was real fussy that night. I don't remember about Tuesday but my mom who kept him during the day said that Wed. he was real fussy, and just needed to be held. He was also waking up a lot during the night. Thursday night he seemed fine, I bathed him and took him to see a friend of mine. He was laughing and talking to me. I rocked him to sleep when we got home. The next morning my daughter woke up and found him dead.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion, Foetal disorder, Unintended pregnancy
Clinical narrative: Information has been received concerning a 30 year old female nursing student gravidia 1 para 0, with blood group O, who about 2 weeks after her last normal menstrual period was vaccinated with a dose varicella virus vaccine live because she was varicella susceptible, and as a requirement for her nursing studies. It was noted the patient missed her next menstrual period and was subsequently determined to be pregnant. It was noted the family history for both partners was negative for medical and genetic problems. It was noted the patient was sent for genetic counseling and a targeted sonogram at approximately 15 weeks gestation. It was noted the sonogram showed the following: fetal biometric measurements compatible with gestational age, multiple echodensities in the liver and kidneys of the fetus which had the same echodensity as bone, mild subcutaneous edema of the abdomen but no ascites. It was noted the patient was offered amniocentesis for polymerase chain reaction (PRC) testing of the fluid for varicella, but she declined. It was noted that in view of the sonogram results which showed fetal tissue calcifications and the fetal hydrops, the patient elected to terminate the pregnancy. At the time of the termination, the patient declined to have an autopsy on the fetus and she declined enrollment in the varicella vaccine registry. The patient had the following lab and diagnostic testing done, with the following noted lab results: IgG and IgM for toxoplasmosis, cytomegalovirus, and parvovirus B19 were negative, herpes simplex virus (HSV) IgM was negative, venereal disease research lab test for syphlilis was negative, rubella immune, blood type was O positive and antibody screen was negative. The article noted that although there was no definitive diagnosis because the patient delcined amniocentesis for varicella PCR studies, and declined autopsy of the fetus and analysis of the fetal tissue for varicella virus it appears that the miliary fetal tissue calcifications were possibly due to the administration of varicella virus live during the cycle in which the patient became pregnant. It was noted the other potential causes for fetal tissue calcifications, which included acute infection with TORCH organism, syphilis, HSV, and genetic history were all negative in the patient. The reporter felt that miliary fetal tissue calcifications were possibly due to therapy with varicella virus vaccine live. The reporter also noted that the review of information from of the outcomes of completed pregnancies in the pregnancy registry for varicella virus vaccine from May 1995 to December 1998 indicate there is no report of fetal liver calcifications and hydrops, and to date there has been no reported cases of congenital varicella syndrome post immunization. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: HEP
Symptoms: Sudden infant death syndrome
Clinical narrative: SIDS
Sex: M
Vaccine: HBHEPB
Symptoms: Aphonia, Speech disorder
Clinical narrative: Information has been received from the mother of a male infant with no medical history and no allergies who in January 2001 at two months of age and March 2001 at four months of age was vaccinated with a first and second dose of Haemophilus B conjugate vaccine (+) hep B vaccine recombinant, respectively. There was no concomitant medication. It was reported that the child stopped talking for one to two months after receiving the vaccination. It was noted that the child was seen by the doctor about this reaction. The mother did not want to provide the doctor's info. Upon internal review, aphonia was determined to be an other important medical event (OMIC). Additional info has been requested.
Sex: M
Vaccine: MMR
Symptoms: Antisocial behaviour, Cognitive disorder, Speech disorder
Clinical narrative: This report was received from manufacturer and was assigned manufacturer control number (HQ6283021JAN2003. On 3/29/02, a male pt was vaccinated with a dose of MMR II. It was also noted that the pt was vaccinated with a dose of varicella virus vaccine live on 1/11/02. Subsequently, the pt developed symptoms of speech, language, and social delay. Symptoms of speech, language, and social delay were considered to be other important medical events (OMIC). This was originally reported by a physician. Additional info has been requested.  Reported on 03/26/2003: "Follow-up information received from a physician indicated that a 13 month old male received a dose of varicella virus vaccine live (Lot # 639130/0500L) on 01/11/2002.  The child was delivered vaginally at 36.5 weeks gestation following an uncomplicated pregnancy.  The mother of the child had a history of Choroid Plexus Cyst.  The infant weighted 6 lbx. 4 oz., apgars were 7 and 8, he was breast-fed.  The child's past medical history was not significant for many childhood illnesses.  The child had no history of allergies, however testing was currently being conducted.  The child did have an elevated Antigliadin IgG antibody test result.  On 02/08/2002, the child was evaluated which resulted in below normal levels for social development, and the results of speech development in the 16th percentile.  The child was noted to have some "shaking and jerking of the head" on 02/12/2002.  The speech delay and social delay were first noted on 02/15/2002.  Symptoms of speech, language, and social delay were considered to be other important medical events.  Additional information has been requested.  This report was previously sent to PLA V205C.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Blood creatine phosphokinase increased, Cellulitis, Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 9 year old patient with asthma who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Two days later the patient was hospitalized with a large local reaction with a fever and was diagnosed by another physician with cellulitis. It was reported that the patient had a WBC of 22,600 and an increased C-reactive protein of 8.06. It was also reported that after antibiotic therapy, the white blood cell count dropped to 7800 and the C-reactive protein to 2.33. Additional information has been requested. The follow up received on 3/12/03 states it was reported that the child was admitted for a few days and that the exact day of discharge is unknown. On 2/24/03 the child had another visit to the physician's office and it was documented in the chart that at the injection site there was mild erythema, some tenderness and the swelling was completely resolved. The physician did report that the multidose vial of the vaccine that was used was cultured and the culture was negative; the remainder of the vial was discarded. Additional info has been requested.  Reported on 04/04/2003: "Follow up information received from a registered nurse indicated that on 02/14/2003 the patient developed a temperature of 102 degrees.  The reported indicated that the patient was hospitalized for 5 days.  CT scan revealed cellulitis.  It was noted that the patient recovered.  No further information is expected.
Age: 0.6
Sex: M
Vaccine: DTAP, IPV
Symptoms: Abdominal distension, Agitation, Apnoea, Convulsion, Dehydration
Clinical narrative: Approx 8 hrs after immunization began to cry for two hours. Became more and more sharp Then vomited 10-15 times. Then had shakes and was gasping for air and howling. Went to ER-parents told them he stopped breathing at home. Tx IV fluids, CBC, CMP, UA, blood culture, CXR. Overnight observation for PO fluids and seizures. Dx: acute gastritis, MOD, dehydration, reaction to immunization.
Age: 0.6
Sex: M
Vaccine: DTAP, IPV
Symptoms: Dyspnoea, Gastritis, Gastroenteritis, Tremor, Vomiting
Clinical narrative: Approx 8 hrs after immunization began to cry for two hours. Became more and more sharp Then vomited 10-15 times. Then had shakes and was gasping for air and howling. Went to ER-parents told them he stopped breathing at home. Tx IV fluids, CBC, CMP, UA, blood culture, CXR. Overnight observation for PO fluids and seizures. Dx: acute gastritis, MOD, dehydration, reaction to immunization.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Cognitive disorder, Drug toxicity, Gastroenteritis, Mental retardation severity unspecified, Speech disorder
Clinical narrative: 1/19/01: 16 days after immunizations she was in ER and diagnosed with gastroenteritis. Also thimerosol in vaccine possibly led to accumulate toxic levels of mercury causing speech and language delays. Possible mild mental retardation. The 60 day follow up received on 5/29/03 states developmental delay at risk of mild mental retardation diagnosed by a psychologist D. We believe it was thimerosal in vaccines. Annual follow up on 04/14/04: "Pt has not recovered from adverse events.  Pt's diagnosis is severe language delay and is highly suggested that a diagnosis of mental retardation at age 5."
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Contusion, Epistaxis, Eye haemorrhage, Haemorrhage, Petechiae
Clinical narrative: Presented 1/29/03 bruises on body; petechiae as well. Negative exam otherwise. The discharge summary states epistaxis, conjuntival hemorrage, mucosal bleeding, and purpura.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Purpura, Thrombocytopenia
Clinical narrative: Presented 1/29/03 bruises on body; petechiae as well. Negative exam otherwise. The discharge summary states epistaxis, conjuntival hemorrage, mucosal bleeding, and purpura.
Age: 1.0
Sex: M
Vaccine: MMR, TTOX, VARCEL
Symptoms: Aggression, Antisocial behaviour, Autism, Neurological symptom
Clinical narrative: Autism. A 60-day follow up report states: Does not verbalize. No coherent speech sounds. Does not respond to simple commands. Not able to do self-care tasks. Far below grade level. Has been diagnosed with Autism. Severe neurological damage leading to autism. No language development or communication skills. Antisocial and aggression. He has to be watched/cared for twenty-four hours a day. He has no sense of harm or danger to himself or others.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Back pain, Chest discomfort, Dyspnoea, Rash
Clinical narrative: Back pain lower 1st four hours. Stomach pain next day. Rash with hives and tightness of chest; could not breathe. Treatment: IV steroids and Benadryl. Constant break out for 5 days.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Back pain lower 1st four hours. Stomach pain next day. Rash with hives and tightness of chest; could not breathe. Treatment: IV steroids and Benadryl. Constant break out for 5 days.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Apnoea, Cholecystitis, Goitre, Influenza like illness
Clinical narrative: Body ache, flu-like symptoms that rapidly progressed. Was diagnosed with polymyositis and desquamative interstitial pneumonitis. The discharge summary states polymyositis, pulmonary fibrosis, pneumonia, staph aureus, bacteremia, cholecystitis, respiratory failure, anxiety disorder, and leukocytosis. The 60 day follow up received states polymyositis, interstial lung disease-receiving chemotherapy and steroids. Required to use oxygen 24/7. Readmitted to hospital-3 wk stay-8 days in ICU on ventilator. Must now consider medical retirement. The follow up received on 3/31/03 states, "triggered: polymyositis, interstitial lung disease, MRSA, respiratory failure, original diagnosis congestive heart failure, 94 days in hospital."
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Leukocytosis, Lung disorder, Myositis, Otitis media, Pain
Clinical narrative: Body ache, flu-like symptoms that rapidly progressed. Was diagnosed with polymyositis and desquamative interstitial pneumonitis. The discharge summary states polymyositis, pulmonary fibrosis, pneumonia, staph aureus, bacteremia, cholecystitis, respiratory failure, anxiety disorder, and leukocytosis. The 60 day follow up received states polymyositis, interstial lung disease-receiving chemotherapy and steroids. Required to use oxygen 24/7. Readmitted to hospital-3 wk stay-8 days in ICU on ventilator. Must now consider medical retirement. The follow up received on 3/31/03 states, "triggered: polymyositis, interstitial lung disease, MRSA, respiratory failure, original diagnosis congestive heart failure, 94 days in hospital."
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngitis, Pneumonia, Pneumonitis, Polymyositis, Pulmonary fibrosis
Clinical narrative: Body ache, flu-like symptoms that rapidly progressed. Was diagnosed with polymyositis and desquamative interstitial pneumonitis. The discharge summary states polymyositis, pulmonary fibrosis, pneumonia, staph aureus, bacteremia, cholecystitis, respiratory failure, anxiety disorder, and leukocytosis. The 60 day follow up received states polymyositis, interstial lung disease-receiving chemotherapy and steroids. Required to use oxygen 24/7. Readmitted to hospital-3 wk stay-8 days in ICU on ventilator. Must now consider medical retirement. The follow up received on 3/31/03 states, "triggered: polymyositis, interstitial lung disease, MRSA, respiratory failure, original diagnosis congestive heart failure, 94 days in hospital."
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinitis, Sepsis
Clinical narrative: Body ache, flu-like symptoms that rapidly progressed. Was diagnosed with polymyositis and desquamative interstitial pneumonitis. The discharge summary states polymyositis, pulmonary fibrosis, pneumonia, staph aureus, bacteremia, cholecystitis, respiratory failure, anxiety disorder, and leukocytosis. The 60 day follow up received states polymyositis, interstial lung disease-receiving chemotherapy and steroids. Required to use oxygen 24/7. Readmitted to hospital-3 wk stay-8 days in ICU on ventilator. Must now consider medical retirement. The follow up received on 3/31/03 states, "triggered: polymyositis, interstitial lung disease, MRSA, respiratory failure, original diagnosis congestive heart failure, 94 days in hospital."
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Pt came into clinic and diagnosed with chicken pox.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Infection
Clinical narrative: Pt came into clinic and diagnosed with chicken pox.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Hallucination, Pyrexia
Clinical narrative: Pt received MMR #2 on 3/6/03 was given Motrin susp 2 tsp before immunization. Pt spiked a fever on 3/7/03 at 2pm-8pm. Each time fever spiked pt c/o "hearing lions roaring" (hallucinations).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: R leg red raised firm (+) itching at injection site. Given Orapred.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Large red raised-hot to touch swollen area at DTaP injection site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swelling and redness at injection site. Given Benadryl prn.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Headache, Malaise, Pain, Pyrexia
Clinical narrative: Fever 100.5 feeling weak, sick (+) body aches (+) headache.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Screaming
Clinical narrative: Unconsolable crying > 5 hours given Motrin for pain.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site inflammation, Pruritus, Rash
Clinical narrative: #1 dose 12/18/02 arm (entire) burned for two days. #2 dose 1/8/03 same as above. #3 dose 1/22/03 arm burned for two days. A couple of days post the shot-developed overall body rash-burning all over and itchy. Rx'd with steroid, Tagamet, and Atarax. 3/3/03 still has rash.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Dyspnoea, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Febrile illness temp to 104 degrees at home. ? severe myalgias. Headache. Mild nausea. Mild SOB. Fatigue. Began 2 d post vaccine. Improved. Tx for Myalgia and HA 5 d post vaccine. Pt currently recovering.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: Febrile illness temp to 104 degrees at home. ? severe myalgias. Headache. Mild nausea. Mild SOB. Fatigue. Began 2 d post vaccine. Improved. Tx for Myalgia and HA 5 d post vaccine. Pt currently recovering.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema and edema +1 20cm x 11cm around vaccination site on L upper arm.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain at site of injection.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Skin ulcer
Clinical narrative: Pt received vaccine in L deltoid but noticed reaction in R deltoid; after scratching area (lesion) darkened. Seen by medical center.
Age: 0.6
Sex: F
Vaccine: DTAP, FLU3, HEP, IPV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Pt was given IPV, DTaP, HBV, Prevnar and Flu vaccine on 2/27/03. That night she was taken to ER for 102 temp. She also experienced a seizure witnessed by mother. She has history of seizure disorder and is on Tegretol.
Age: 36.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Erythema, Influenza like illness, Injection site erythema, Injection site oedema, Oedema
Clinical narrative: Received anthrax ahot #6 on 2/22/03. Within hours entire upper arm red, over next two day redness extended from shoulder to wrist with swelling of entire arm and hand. Rash near elbow, flu-like symptoms (w/o fever) for two days. (+) generalized L arm nontender, swelling from uper arm to finger with erythematous patch ? of whole ext.
Age: 36.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Rash, Rash erythematous
Clinical narrative: Received anthrax ahot #6 on 2/22/03. Within hours entire upper arm red, over next two day redness extended from shoulder to wrist with swelling of entire arm and hand. Rash near elbow, flu-like symptoms (w/o fever) for two days. (+) generalized L arm nontender, swelling from uper arm to finger with erythematous patch ? of whole ext.
Age: 36.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Erythema, Influenza like illness, Rash, Swelling
Clinical narrative: Received anthrax ahot #6 on 2/22/03. Within hours entire upper arm red, over next two day redness extended from shoulder to wrist with swelling of entire arm and hand. Rash near elbow, flu-like symptoms (w/o fever) for two days. (+) generalized L arm nontender, swelling from uper arm to finger with erythematous patch ? of whole ext.
Age: 7.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Eye swelling, Sneezing
Clinical narrative: Pt rec'd vaccines on 2/26/03, began with swelling around eyes and sneezing 30 min after vaccines, also ate peanut butter and jelly, hot wings; no fever.
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Convulsion, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: It was reported that pt rec'd pneumococcal polysaccitaride vaccine, 14 hrs after injection fever of 101.2F, weak, could not lift head to drink. 24 hrs after injection fever 103.3F, 45 minutes seizure, bright red swollen upper arm injection site, very painful. 8pm fever 102F, tylenol regular pm meds threw up all fluid. Friday fever 102.0F gave Advil, 12 noon temp 99F, gave Advil and reg meds, 2:45pm temp 96F stomach hurts very weak needs help had to make her drink Gatorade . 4pm to clinic urine test, ear, nose throat check, stomach check, blood checked. Dx: reaction to vaccine 2/1 low grade fever 98-99F, weak and tired started eating lightly, drinking pedialite Gatorade. /arm injection site hot, red and swollen and hurts. 2/2/03 low grade fever, eating better, color back in face, not yellow arm injection site ,red, purple, swollen and hot. 2/3/03 Back to school, injection site pale red, purple rash still warm 99F fever.
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Pyrexia, Vomiting
Clinical narrative: It was reported that pt rec'd pneumococcal polysaccitaride vaccine, 14 hrs after injection fever of 101.2F, weak, could not lift head to drink. 24 hrs after injection fever 103.3F, 45 minutes seizure, bright red swollen upper arm injection site, very painful. 8pm fever 102F, tylenol regular pm meds threw up all fluid. Friday fever 102.0F gave Advil, 12 noon temp 99F, gave Advil and reg meds, 2:45pm temp 96F stomach hurts very weak needs help had to make her drink Gatorade . 4pm to clinic urine test, ear, nose throat check, stomach check, blood checked. Dx: reaction to vaccine 2/1 low grade fever 98-99F, weak and tired started eating lightly, drinking pedialite Gatorade. /arm injection site hot, red and swollen and hurts. 2/2/03 low grade fever, eating better, color back in face, not yellow arm injection site ,red, purple, swollen and hot. 2/3/03 Back to school, injection site pale red, purple rash still warm 99F fever.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: It was reported that the pt right leg was swollen, red and very painful, he would scream every time you moved him or he moved his leg. He was given tylenol and told me to rub myoflex on his leg for the pain. Seen same day as injection. Dx: allergic reaction.
Age: 1.7
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema, induration 5cm surrounding injection site. No treatment as of yet; watching.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Feeling hot, Musculoskeletal stiffness
Clinical narrative: Developed feverish feeling, stiff neck, and vesicular eruptions on 2/26/03. More eruptions (total 5-6) on 2/27/03. All vesicles healed 3/5/03.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Flushing
Clinical narrative: At time of discharge, face noted to be very flushed, concerned with reaction to Hep B vs. normal reaction to crying. Patient waited 15 minutes; temperature elevated slightly to 99.2, HR 76, R 18. Sight of injection note erythematous or swollen, no hives noted on trunk or arms. Per mother via phone call states she did have hives and acted weird for a while. Refused any more vaccines.
Age: 1.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Rash papular, Skin ulcer
Clinical narrative: Vesicopapular lesion at site left deltoid. Pink, scattered papules face, trunk and extremities.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Erythema 3 x 3 cm at inject site which appeared one day post vax. No treatment.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Dysphagia, Pyrexia, Salivary hypersecretion, Somnolence, Stupor
Clinical narrative: Child was "extra sleepy" and fell asleep on chair at 5 p.m. Grandmother checked on child at 5:20 and "she couldn't wake him up. His eyes were off to the side. He felt warm. His nail beds and lips were very blue." Mother called ER. States that child started to choke and was "drooling everywhere". Temp in ambulance was 104 deg. Received albuterol via nebulizer x 2 in ambulance, x 3 in ER. "He didn't really come to until he got to hospital." Discharge at 9 p.m.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Vasodilation procedure
Clinical narrative: Child was "extra sleepy" and fell asleep on chair at 5 p.m. Grandmother checked on child at 5:20 and "she couldn't wake him up. His eyes were off to the side. He felt warm. His nail beds and lips were very blue." Mother called ER. States that child started to choke and was "drooling everywhere". Temp in ambulance was 104 deg. Received albuterol via nebulizer x 2 in ambulance, x 3 in ER. "He didn't really come to until he got to hospital." Discharge at 9 p.m.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Right upper arm anterior aspect - edema, firm erythema 3-4" length. Discomfort with palpitation, no streaking, afebrile. ? early cellulitis dx. Treated with Keflex 250/5 - 6ml's TID for 10 days; warm compresses. 1 week follow up.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dyspnoea, Nausea, Nuchal rigidity, Pallor
Clinical narrative: Trouble breathing while lying down, fever, stiff neck, paleness, weakness, nausea, rapid heartbeat.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Tachycardia
Clinical narrative: Trouble breathing while lying down, fever, stiff neck, paleness, weakness, nausea, rapid heartbeat.
Age: 27.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Arthritis
Clinical narrative: Approx 1 wk post Hep A and Hep B vaccines, PT developed migrating arthritis. Responded partially to NSAIDS. C-reactive protein 2, (+) Rheum. factor at 28. Steady imprompt. Resolved 8/13/02.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Face oedema, Myalgia, Oedema peripheral
Clinical narrative: Swelling of bilat. hands/fingers. Facial swelling. Diffuse body aches.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Oedema, Oedema peripheral, Pruritus, Rash erythematous
Clinical narrative: Monday - injection given. Tuesday/Wed. - Fatigue, Thurs - Erythematous macular rash, pruritus, edema hands/feet/knees. Tx - Allegra/Benadryl
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Rash macular
Clinical narrative: Monday - injection given. Tuesday/Wed. - Fatigue, Thurs - Erythematous macular rash, pruritus, edema hands/feet/knees. Tx - Allegra/Benadryl
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Intense arm pain w/in 3-4 hrs of shot. Temp (104) w/in 12 hrs of shot. No redness or warmth at site.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site oedema, Pyrexia
Clinical narrative: Redness, swelling at inject site. Induration. Systemic - fever / chills - onset 6-12 deg after injection.
Age: 4.5
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Hives on face, chest and arms.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Injection site pain
Clinical narrative: (+) erythema 5 x 3 cm with area of induration and tenderness left deltoid (inject site). Pain and redness x 1 day. No treatment at home.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Anorexia, Asthenia, Ear pain, Fatigue
Clinical narrative: Sore arm, red knot at site. Progressively became fatigued, loss of appetite. Loss of energy level and unable to play sports at usual level. After  1 month unable to get out of bed, - strep - mono - Epstein Barr, Ear pain developed and upper respiratory problems, intermittent abdominal pain. Symptoms resolved 2 1/2 months after vaccine.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Movement disorder, Respiratory disorder
Clinical narrative: Sore arm, red knot at site. Progressively became fatigued, loss of appetite. Loss of energy level and unable to play sports at usual level. After  1 month unable to get out of bed, - strep - mono - Epstein Barr, Ear pain developed and upper respiratory problems, intermittent abdominal pain. Symptoms resolved 2 1/2 months after vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Hypokinesia, Oedema, Pain
Clinical narrative: Right deltoid swelling, tenderness and difficulty moving right arm 48 deg after immunization w/DTaP #5 treated as cellulitis - resolution.
Age: 10.0
Sex: M
Vaccine: HEPA, TD, VARCEL
Symptoms: Injection site reaction, Rash maculo-papular, Skin discolouration
Clinical narrative: Immediate red blotches at inject site, some mottling noted down to fingers.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Injection site oedema, Injection site pain
Clinical narrative: Erythema, edema with pain at sign of vaccine admin. Keflex susp 300 mg bid x 10 d. Benadryl PRN
Age: 0.6
Sex: F
Vaccine: DTAP, IPV
Symptoms: Convulsion, Pyrexia, Somnolence
Clinical narrative: Mom brought PT back to clinic. 3-5 mins post vax given, with generalized seizure, resolved after 2 mins. Temp 99.8, glucose 121; 028 at 100 % with blow by after seizure. PT fuzzy out easily counseled by mom, ab??? no preceded by cyanosis or breath-holding spell per mom.
Age: 13.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Pain, Pyrexia, Rash, Vasodilation procedure
Clinical narrative: School nurse called office stating child had temp of 101.9 deg, arm discomfort, redness and warmth at inject site, raised areas on arms and chest, no SOB, no facial swelling. School activated EMS and PT was transported to a hospital. This event occurred on 3/6/03. Back to school on 3/7/03.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pain, Vasodilation procedure
Clinical narrative: Redness and swelling below inject site, no fever noted, c/o pain, area warm to touch.
Age: 1.11
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: Mom states child had seizure at daycare on 3/5/03 at 10 a.m. Child was transferred to a medical center via ambulance. Private MD stated that she gave wrong dosage of Motrin. Stated she gave 3/4 tsp when she should have given 1 tsp. This caused increased temperature (unknown deg).
Age: 2.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Cellulitis
Clinical narrative: Cellulitis on right thigh 3 inches in diameter
Age: 3.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Ecchymosis, Erythema, Injection site reaction, Oedema, Pain
Clinical narrative: Phone call from mom this a.m. Left deltoid swollen tender. Red yesterday. upon inspection small bruise resolving 2" below inject site. Area from near shot site softer at edges.
Age: 1.08
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Otitis media, Pyrexia, Rash maculo-papular
Clinical narrative: Rash: Measles-like. Beefy red macules trunk, neck, extremities, started 6 days post vax. Febrile day 7-9. Otitis media noted on day 12.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Oedema peripheral, Vasodilation procedure
Clinical narrative: Right arm swelling, erythema, warmth. (large area) Treated with Sx care and Augmentin PO for poss cellulitis.
Age: 2.0
Sex: M
Vaccine: DTP, MMR, OPV
Symptoms: Injection site oedema, Urticaria
Clinical narrative: Pt broke out wheals over right arms (arms also swollen). No difficulty breathing.
Age: 0.6
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Decreased appetite, Pruritus, Pyrexia, Rash
Clinical narrative: Mom says rash and fever began approximately 24-48 h after getting immunizations. Rash initially only around neck, now all over body. Pt is itching with a fever of 102 deg F. Mom gave Tylenol which relieved fever temporarily. Pt is irritable with decreased appetite. Also given Benadryl prn rash.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Urticaria
Clinical narrative: Pt developed hives over entire face requiring visit to ER. Tx with Benadryl x 2d.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Oedema, Pain, Pruritus, Pyrexia, Rash
Clinical narrative: High fever. Severe rash from bottom of elbow to neck. Severe swelling. Temperature of skin about 103 degrees. Broke out in welts. Wheezing problems. Pain. Itching.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Urticaria, Wheezing
Clinical narrative: High fever. Severe rash from bottom of elbow to neck. Severe swelling. Temperature of skin about 103 degrees. Broke out in welts. Wheezing problems. Pain. Itching.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Convulsion, Pyrexia
Clinical narrative: Pt developed fever to 103 and had a seizure lasting 2-3 minutes. Was seen at hospital. Normal blood tests seizure occurred approximately 7pm 3/3/03.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Mom states R arm red and very swollen.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Infection
Clinical narrative: Chicken pox.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: L thigh hard at center with one inch in diameter red, hot spot.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Skin striae
Clinical narrative: Day after receiving Td vaccine, site became very red, swollen and tender-pt described some streaking. 2 day following, she called clinic to report. Streaking had disappeared. Still other local sx. swelling was firm, about size of "egg." Advised pt to see physician but she was unable today, tomorrow.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Pharyngolaryngeal pain, Pruritus, Pyrexia
Clinical narrative: Chicken pox lesions with itching temp sore throat.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, PPV
Symptoms: Injection site erythema, Pyrexia, Vomiting
Clinical narrative: Red area 9 x 9 cm right outer thigh. Fever (100.7) and vomiting (x3)
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swelling and redness at inject site. 5 x 5 cm Benadryl 12.5 mg after 6 hrs.
Age: 61.0
Sex: F
Vaccine: HEPA
Symptoms: Dermatitis bullous, Erythema, Injection site cellulitis, Injection site reaction
Clinical narrative: This report describes inject site cellulitis following the inadvertent admin. of Hep A vaccine inactivated into the hip of a 61 y.o. female. Medical history, concurrent conditions, and concurrent medications were not specified. On an unknown date, the PT received an injection of Havrix in the hip rather than the deltoid. On 12/5/00, the vaccinee experienced a "superficial and small" area of cellulitis on the left hip. The vaccinee was examined on 12/28/00 by the MD, who noted a 1-cm broken blister w/a 0.5-cm area of erythema surrounding the blister. She was treated twice daily w/silver sulfadiazine cream from 12/28/00 to 1/5/01. The most recent info, received on 2/15/02, indicated that the cellulitis had resolved. The reporter considered the event to be mild in severity and related to Havrix admin. On 12/29/00, the vaccinee was administered another injection of Havrix in the left deltoid. No adverse events were reported.
Age: 65.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Asthenia, Fatigue, Haemorrhage, Immunoglobulins increased, Injection site reaction
Clinical narrative: Concurrent medical condition and medications were not specified. The vaccinee had no known allergies and no illnesses at the time of the vax. On an unspecified date, the vaccinee received his first injection of Havrix. In July 01, the vaccinee received injections of inactivated poliomyelitis virus vax (Ipol) and Typhoid vax. In June 01, and  July 01, the vaccinee received his first and 2nd injections of Hep B vax Recombinant respectively. It was reported that in Oct. 01, he underwent a "routine physical" at a tertiary care center. An unspecified "clotting study" was performed. The vaccinee reported that "the clotting study showed prolonged clotting in one arm, but that the other arm was normal." To the nurse practitioner's understanding, the test was repeated and the results then were normal. An electrophoresis was performed that showed an immunoglobulin G spike. On 1/18/02, the vaccinee received his 2nd injection of Havrix. On that date, he also received his 3rd dose of Engerix-B. He received 2 injections of the 10 mcg pediatric formulation, to provide the adult dose of 20 mcg. On 1/21/02, the vaccinee developed a "moderate-size" hematoma at the Havrix inject site. It was treated w/moist, warm compresses three times daily. The reporter stated that the hematoma was moderate in intensity and possibly related to Havrix but may have also been associated w/the PT's prolonged clotting time in Oct. 01. The vaccinee also complained of sore arms, tiredness, and "vague" myalgia; the exact onset of these Sx's were unknown. As of 1/28/02, the hematoma was "resolving well". As of 2/27/02, the outcomes of the sore arms, tiredness, myalgia, and immunoglobulin G spike were unknown.
Age: 65.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Myalgia, Pain
Clinical narrative: Concurrent medical condition and medications were not specified. The vaccinee had no known allergies and no illnesses at the time of the vax. On an unspecified date, the vaccinee received his first injection of Havrix. In July 01, the vaccinee received injections of inactivated poliomyelitis virus vax (Ipol) and Typhoid vax. In June 01, and  July 01, the vaccinee received his first and 2nd injections of Hep B vax Recombinant respectively. It was reported that in Oct. 01, he underwent a "routine physical" at a tertiary care center. An unspecified "clotting study" was performed. The vaccinee reported that "the clotting study showed prolonged clotting in one arm, but that the other arm was normal." To the nurse practitioner's understanding, the test was repeated and the results then were normal. An electrophoresis was performed that showed an immunoglobulin G spike. On 1/18/02, the vaccinee received his 2nd injection of Havrix. On that date, he also received his 3rd dose of Engerix-B. He received 2 injections of the 10 mcg pediatric formulation, to provide the adult dose of 20 mcg. On 1/21/02, the vaccinee developed a "moderate-size" hematoma at the Havrix inject site. It was treated w/moist, warm compresses three times daily. The reporter stated that the hematoma was moderate in intensity and possibly related to Havrix but may have also been associated w/the PT's prolonged clotting time in Oct. 01. The vaccinee also complained of sore arms, tiredness, and "vague" myalgia; the exact onset of these Sx's were unknown. As of 1/28/02, the hematoma was "resolving well". As of 2/27/02, the outcomes of the sore arms, tiredness, myalgia, and immunoglobulin G spike were unknown.
Age: 64.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Viral infection
Clinical narrative: This report describes virus in a 64 y.o. female who received Hep A Virus inactivated virus (Havrix). The vaccinee "recently" experienced a rash after receiving amoxicillin. Concurrent conditions were unspecified. She received an unspecified concurrent medication. On 1/23/02, the vaccinee received her first dose of Havrix. Approx 3 days later, she experienced a fever of 102-103 deg. She was seen in the MD's office, where unspecified Lab tests were performed. It was thought that the fever was associated w/a virus, "because unspecified kidney and liver abnormalities were noticed." The Sx's lasted for approx 3-4 days, and then the vaccinee was "fine". As of 2/15/02, the event had resolved.
Age: 38.0
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Injection site pain, Injection site reaction, Myasthenic syndrome
Clinical narrative: This report describes muscle weakness in the left arm of a 38 y.o. male who received Hep A vax inactivated (Havrix). There was no relevant medical history, allergies, concurrent conditions / medications. He had no adverse experiences following receipt of prior immunizations. On 2/6/02, the vaccinee received his first injection of Havrix. On 2/7/02, he experienced muscle weakness and decreased strength of the left arm, and soreness at the inject site (left deltoid). The pain radiated down the arm. The vaccinee described having difficulty exercising w/his left arm. The reporter stated that the events were related to Havrix. As of 4/29/02, the events were ongoing.
Sex: F
Vaccine: HEPA
Symptoms: Rash erythematous
Clinical narrative: This report describes a red rash in a 30 to 35 y.o. female who received an injection of Havrix. Medical history and concurrent conditions were not specified. There were no concurrent medications. The vaccinee had no adverse experiences following receipt of prior immunizations. On 2/18/02, the vaccinee received her 2nd injection of Havrix. On 2/20/02, 2 days post-vax, she experienced a red rash on her neck and both arms. The vaccinee was treated w/50 mg diphenhydramine hydrochloride (Benadryl) and the event resolved on 2/23/02. The Havrix immunization series was discontinued.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Eye oedema, Oedema, Oedema peripheral
Clinical narrative: This Report describes swelling in a 19 y.o. male who received Havrix vax. The PT had no allergies and did not know if he had had any other reactions to previous vax's. Concurrent medications were not specified. On 3/8/02, the vaccinee received his first injection of Havrix. That evening at about 21:00, both hands and eyelids began to swell. The swelling went away by the next morning, but returned to a lesser extent the next evening. No medical attention was required. The reporting nurse states that "they really don't think it is necessarily related to the Havrix; could be anything." As of 3/20/02, the swelling resolved.
Age: 5.0
Sex: U
Vaccine: HEPA
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: This report describes urticaria in a 5 y.o. vaccinee of unspecified gender who received Havrix vax. Medical history, concurrent conditions, and concurrent medications were not specified. The vaccinee had not experienced adverse events following previous vax's. On an unspecified date, the vaccinee received the first injection of Havrix. That evening, the vaccinee experienced a fever of 102 deg F. Rash and urticaria developed later. The reporter stated that the events were possibly related to Havrix. As of 3/21/02, the adverse events had resolved.
Sex: M
Vaccine: HEPA
Symptoms: Abdominal pain, Fatigue, Purpura, Rash
Clinical narrative: This report describes purpura on the legs of an adult male vaccinee of unspecified age who received Havrix vax. Medical history, concurrent conditions, and concurrent medications were not specified. On 3/2/02, the vaccinee received an injection of Havrix; the # of previous injections of Havrix were not provided. On 3/15/02, he experienced purpura on his legs. An unspecified time post-vax, he also experienced rash, fatigue, and abdominal pain. He was seen by an MD. Treatment and outcome of the events were not specified.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site reaction, Medication error
Clinical narrative: Report A0365865A describes a local injection site reaction in a 34 year old female who inadvertently received hep A vaccine. There was no relevant medical history, concurrent conditions, or concurrent medications. On 3/7/02, the vaccinee inadvertently received Havrix IM, rather than purified protein derivative fo tuberculin. She experienced a local injection site reaction which resolved (date not specified).
Age: 37.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site reaction, Medication error
Clinical narrative: Report A0365871A describes a local injection site reaction in a 37 year old female who inadvertently received hep A vaccine. There was no relevant medical history, concurrent conditions, or concurrent medications. On 3/7/02, the vaccinee inadvertently received Havrix intradermally, rather than purified protein derivative of tuberculin. She experienced a local injection site reaction which resolved (date not specified).