chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.57
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Hiccups
Clinical narrative: On June 15, 2006 patient was admitted at the hospital for an event that was described as paroxysmal event after electroencephalogram was normal and seizures were ruled out.  On 08/01/2006 mother reported that child was awake in bed and she began to have "big hiccups" that lasted for 5 minutes, no cyanosis, no loss of consciousness.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Feeling jittery, Myalgia, Throat tightness
Clinical narrative: After patient received TD immunization (at 1:50 pm) she complained of shortness of breath, right side of throat felt tight and "jittery inside" blood pressure 120/98 administered BENADRYL 25mg intramuscular at 2pm and Epinephrine at 2:08 pm, oxygen at 2 liter/minute.  Post Epinephrine she began to feel better.  She left the clinic around 2:45.  Nurse practitioner called her around 3:30 and she said she felt fine. 08-03-2006 4;15 pm I called, she said she was fine, arm is sore.
Age: 1.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Rash an body noted by mother the evening of 08/07/2006.  Rash was itchy.  BENADRYL with effect
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin ulcer
Clinical narrative: Varicella vaccine breakthrough.  Rash on face legs, abdomen started 08/01/2006.  No fever, had 10-12 lesions when diagnosed with varicella in our office on 08-03-2006.
Age: 5.0
Sex: M
Vaccine: HEPA, MMR, PPV
Symptoms: Joint swelling
Clinical narrative: Received Hepatitis A, MMR, Pneumovax on 08-01-2006.  08-02-2006 mom called to report left thigh and swollen hip to knee and no weight bearing left leg.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema, Rash maculo-papular
Clinical narrative: Patient received DtaP and Hib on right thigh, IPV and Prevnar on left thigh.  In less than 10 minutes right foot/leg had red/purple splotches, redness spread to both legs.  Medical doctor notified, BENADRYL given, observed for greater than 30 minutes, improved.
Age: 75.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: From July 24,2006 to Aug 5 2006 had bas pain and swelling all around arm and down the arm to elbow. Deep redness all week and warm. Had to stop using arm all this time, had nurse at cardiac rehab fitness program check arm 3x a week. Treatment of ice and Tylenol every day. No use of arm at rehab. Nurse called Doctor to check arm on 8/28/06.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site induration, Myalgia, Pyrexia
Clinical narrative: Fever to 101, chills, myalgias, plus 2-3cm induration at injection site.
Age: 1.06
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Drug ineffective, Skin ulcer, Viral infection
Clinical narrative: Varicella Vaccine breakthrough, diagnosed with varicella 8/4/06 in our office. Had 12 lesions on arm chest. No fever.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Tenderness
Clinical narrative: Pt received MMR and DTaP in left arm on Wednesday and developed redness, swelling, tenderness evening of Wednesday, Aug 2. Mom brought boy to office Friday afternoon. H had erythema, swelling of left arm with tenderness to palpation. Mom treated pain with Motrin. Child afebrile, no other systemic symptoms. We treated him symptomatically with Benadryl, Motrin and cool compresses. Gave mom instructions to return if symptoms worsened or systemic sys like fever developed.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Feeling hot, Headache, Influenza like illness, Nausea
Clinical narrative: Per mother, pts symptoms started approx 9p Mon 8/10/06, HA, nausea, felt hot (did not check tem) flu like symptoms. During the night chills. 9am still with HA, nausea, felt warm 100F. Denied rash and breathing problems.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Per mother, pts symptoms started approx 9p Mon 8/10/06, HA, nausea, felt hot (did not check tem) flu like symptoms. During the night chills. 9am still with HA, nausea, felt warm 100F. Denied rash and breathing problems.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site discolouration, Injection site erythema, Injection site vesicles
Clinical narrative: 20 CM diameter area of blanching erythema on left thigh with 0.5cm blisters at injection site.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia, Swelling
Clinical narrative: Fever 102 within 12 hours of vaccine, swelling within 12 hours of vaccine, Tylenol, Motrin, ice.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Crying, Screaming
Clinical narrative: Up to 6 hours of high pitched cry with 1st and 2nd DTap. No other neurologic sequelae.
Age: 0.44
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Acoustic stimulation tests, Blindness, Blood test, Brain injury, Cerebrovascular accident
Clinical narrative: 5/08/2006 The day of the shots she started screaming for hours. The next day she screamed all day then about 3:00 pm got very quiet for about 2-3 hours.  She then started twitching and it became a full grand maul seizure. Taken by ambulance to er room. Flown accross state by helicoptor to hosp. In the hosp they determined she also had 2 strokes. She developed diarrhea and a rash on the top of her labia. She stayed for 7 days in icu and then 1 day in peds. Put on phenobarbital. Her body still jerks daily in severe spasms for hours. She has seizures almost daily. She went from a normal healthy 5 mo. old back to about a 1 month old the day of the seizure on May 9th.  She cannot hold her head up or control any of her limbs. She has problems sucking her bottle and is undergoing tests to see if she needs a feeding tube. Her hearing was tested at 8 months because she acts deaf.  They say her inner ear is picking up the signal but they dont think her brain is understanding it is hearing any sounds.  She is brain damaged. She is taking trileptal and phenobarbital now after more visits to er room and neurologist but still continues to have seizures almost daily. She is now 81/2 months old but still is like a 1 month old. We go back to neurologist Aug.16th. She is enrolled in a daycare treatment facility daily for therapy. It is called ppeck. They only take disabled cheildren. I am afraid she is getting worse not better. Discharge summaries state wheeze, status epilepticus. msv Medical record states vomiting. msv 1/4/10 She is completely brain damaged. Cannot sit, stand, reach, etc. Also blind and deaf. 60 day Follow-up Information 24-OCT-2006: She is totally brain damaged. She cant see and she cant hear. She still has seizures. she can only do what a brand new born does. No play, no eating (GI tube). She cant even lift her head. Her last MRI showed her brain is shrinking.
Age: 0.44
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Deafness, Diarrhoea, Dyskinesia, Dysstasia
Clinical narrative: 5/08/2006 The day of the shots she started screaming for hours. The next day she screamed all day then about 3:00 pm got very quiet for about 2-3 hours.  She then started twitching and it became a full grand maul seizure. Taken by ambulance to er room. Flown accross state by helicoptor to hosp. In the hosp they determined she also had 2 strokes. She developed diarrhea and a rash on the top of her labia. She stayed for 7 days in icu and then 1 day in peds. Put on phenobarbital. Her body still jerks daily in severe spasms for hours. She has seizures almost daily. She went from a normal healthy 5 mo. old back to about a 1 month old the day of the seizure on May 9th.  She cannot hold her head up or control any of her limbs. She has problems sucking her bottle and is undergoing tests to see if she needs a feeding tube. Her hearing was tested at 8 months because she acts deaf.  They say her inner ear is picking up the signal but they dont think her brain is understanding it is hearing any sounds.  She is brain damaged. She is taking trileptal and phenobarbital now after more visits to er room and neurologist but still continues to have seizures almost daily. She is now 81/2 months old but still is like a 1 month old. We go back to neurologist Aug.16th. She is enrolled in a daycare treatment facility daily for therapy. It is called ppeck. They only take disabled cheildren. I am afraid she is getting worse not better. Discharge summaries state wheeze, status epilepticus. msv Medical record states vomiting. msv 1/4/10 She is completely brain damaged. Cannot sit, stand, reach, etc. Also blind and deaf. 60 day Follow-up Information 24-OCT-2006: She is totally brain damaged. She cant see and she cant hear. She still has seizures. she can only do what a brand new born does. No play, no eating (GI tube). She cant even lift her head. Her last MRI showed her brain is shrinking.
Age: 0.44
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Electrocardiogram, Electroencephalogram abnormal, Electromyogram, Gene mutation identification test, Grand mal convulsion
Clinical narrative: 5/08/2006 The day of the shots she started screaming for hours. The next day she screamed all day then about 3:00 pm got very quiet for about 2-3 hours.  She then started twitching and it became a full grand maul seizure. Taken by ambulance to er room. Flown accross state by helicoptor to hosp. In the hosp they determined she also had 2 strokes. She developed diarrhea and a rash on the top of her labia. She stayed for 7 days in icu and then 1 day in peds. Put on phenobarbital. Her body still jerks daily in severe spasms for hours. She has seizures almost daily. She went from a normal healthy 5 mo. old back to about a 1 month old the day of the seizure on May 9th.  She cannot hold her head up or control any of her limbs. She has problems sucking her bottle and is undergoing tests to see if she needs a feeding tube. Her hearing was tested at 8 months because she acts deaf.  They say her inner ear is picking up the signal but they dont think her brain is understanding it is hearing any sounds.  She is brain damaged. She is taking trileptal and phenobarbital now after more visits to er room and neurologist but still continues to have seizures almost daily. She is now 81/2 months old but still is like a 1 month old. We go back to neurologist Aug.16th. She is enrolled in a daycare treatment facility daily for therapy. It is called ppeck. They only take disabled cheildren. I am afraid she is getting worse not better. Discharge summaries state wheeze, status epilepticus. msv Medical record states vomiting. msv 1/4/10 She is completely brain damaged. Cannot sit, stand, reach, etc. Also blind and deaf. 60 day Follow-up Information 24-OCT-2006: She is totally brain damaged. She cant see and she cant hear. She still has seizures. she can only do what a brand new born does. No play, no eating (GI tube). She cant even lift her head. Her last MRI showed her brain is shrinking.
Age: 0.44
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Hearing impaired, Hypercalcaemia, Hyperglycaemia, Hypokalaemia, Intensive care
Clinical narrative: 5/08/2006 The day of the shots she started screaming for hours. The next day she screamed all day then about 3:00 pm got very quiet for about 2-3 hours.  She then started twitching and it became a full grand maul seizure. Taken by ambulance to er room. Flown accross state by helicoptor to hosp. In the hosp they determined she also had 2 strokes. She developed diarrhea and a rash on the top of her labia. She stayed for 7 days in icu and then 1 day in peds. Put on phenobarbital. Her body still jerks daily in severe spasms for hours. She has seizures almost daily. She went from a normal healthy 5 mo. old back to about a 1 month old the day of the seizure on May 9th.  She cannot hold her head up or control any of her limbs. She has problems sucking her bottle and is undergoing tests to see if she needs a feeding tube. Her hearing was tested at 8 months because she acts deaf.  They say her inner ear is picking up the signal but they dont think her brain is understanding it is hearing any sounds.  She is brain damaged. She is taking trileptal and phenobarbital now after more visits to er room and neurologist but still continues to have seizures almost daily. She is now 81/2 months old but still is like a 1 month old. We go back to neurologist Aug.16th. She is enrolled in a daycare treatment facility daily for therapy. It is called ppeck. They only take disabled cheildren. I am afraid she is getting worse not better. Discharge summaries state wheeze, status epilepticus. msv Medical record states vomiting. msv 1/4/10 She is completely brain damaged. Cannot sit, stand, reach, etc. Also blind and deaf. 60 day Follow-up Information 24-OCT-2006: She is totally brain damaged. She cant see and she cant hear. She still has seizures. she can only do what a brand new born does. No play, no eating (GI tube). She cant even lift her head. Her last MRI showed her brain is shrinking.
Age: 0.44
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Laboratory test abnormal, Mobility decreased, Muscle spasms, Muscle twitching, Poor sucking reflex
Clinical narrative: 5/08/2006 The day of the shots she started screaming for hours. The next day she screamed all day then about 3:00 pm got very quiet for about 2-3 hours.  She then started twitching and it became a full grand maul seizure. Taken by ambulance to er room. Flown accross state by helicoptor to hosp. In the hosp they determined she also had 2 strokes. She developed diarrhea and a rash on the top of her labia. She stayed for 7 days in icu and then 1 day in peds. Put on phenobarbital. Her body still jerks daily in severe spasms for hours. She has seizures almost daily. She went from a normal healthy 5 mo. old back to about a 1 month old the day of the seizure on May 9th.  She cannot hold her head up or control any of her limbs. She has problems sucking her bottle and is undergoing tests to see if she needs a feeding tube. Her hearing was tested at 8 months because she acts deaf.  They say her inner ear is picking up the signal but they dont think her brain is understanding it is hearing any sounds.  She is brain damaged. She is taking trileptal and phenobarbital now after more visits to er room and neurologist but still continues to have seizures almost daily. She is now 81/2 months old but still is like a 1 month old. We go back to neurologist Aug.16th. She is enrolled in a daycare treatment facility daily for therapy. It is called ppeck. They only take disabled cheildren. I am afraid she is getting worse not better. Discharge summaries state wheeze, status epilepticus. msv Medical record states vomiting. msv 1/4/10 She is completely brain damaged. Cannot sit, stand, reach, etc. Also blind and deaf. 60 day Follow-up Information 24-OCT-2006: She is totally brain damaged. She cant see and she cant hear. She still has seizures. she can only do what a brand new born does. No play, no eating (GI tube). She cant even lift her head. Her last MRI showed her brain is shrinking.
Age: 0.44
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Posture abnormal, Rash, Screaming, Status epilepticus, Vomiting
Clinical narrative: 5/08/2006 The day of the shots she started screaming for hours. The next day she screamed all day then about 3:00 pm got very quiet for about 2-3 hours.  She then started twitching and it became a full grand maul seizure. Taken by ambulance to er room. Flown accross state by helicoptor to hosp. In the hosp they determined she also had 2 strokes. She developed diarrhea and a rash on the top of her labia. She stayed for 7 days in icu and then 1 day in peds. Put on phenobarbital. Her body still jerks daily in severe spasms for hours. She has seizures almost daily. She went from a normal healthy 5 mo. old back to about a 1 month old the day of the seizure on May 9th.  She cannot hold her head up or control any of her limbs. She has problems sucking her bottle and is undergoing tests to see if she needs a feeding tube. Her hearing was tested at 8 months because she acts deaf.  They say her inner ear is picking up the signal but they dont think her brain is understanding it is hearing any sounds.  She is brain damaged. She is taking trileptal and phenobarbital now after more visits to er room and neurologist but still continues to have seizures almost daily. She is now 81/2 months old but still is like a 1 month old. We go back to neurologist Aug.16th. She is enrolled in a daycare treatment facility daily for therapy. It is called ppeck. They only take disabled cheildren. I am afraid she is getting worse not better. Discharge summaries state wheeze, status epilepticus. msv Medical record states vomiting. msv 1/4/10 She is completely brain damaged. Cannot sit, stand, reach, etc. Also blind and deaf. 60 day Follow-up Information 24-OCT-2006: She is totally brain damaged. She cant see and she cant hear. She still has seizures. she can only do what a brand new born does. No play, no eating (GI tube). She cant even lift her head. Her last MRI showed her brain is shrinking.
Age: 0.44
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Wheezing
Clinical narrative: 5/08/2006 The day of the shots she started screaming for hours. The next day she screamed all day then about 3:00 pm got very quiet for about 2-3 hours.  She then started twitching and it became a full grand maul seizure. Taken by ambulance to er room. Flown accross state by helicoptor to hosp. In the hosp they determined she also had 2 strokes. She developed diarrhea and a rash on the top of her labia. She stayed for 7 days in icu and then 1 day in peds. Put on phenobarbital. Her body still jerks daily in severe spasms for hours. She has seizures almost daily. She went from a normal healthy 5 mo. old back to about a 1 month old the day of the seizure on May 9th.  She cannot hold her head up or control any of her limbs. She has problems sucking her bottle and is undergoing tests to see if she needs a feeding tube. Her hearing was tested at 8 months because she acts deaf.  They say her inner ear is picking up the signal but they dont think her brain is understanding it is hearing any sounds.  She is brain damaged. She is taking trileptal and phenobarbital now after more visits to er room and neurologist but still continues to have seizures almost daily. She is now 81/2 months old but still is like a 1 month old. We go back to neurologist Aug.16th. She is enrolled in a daycare treatment facility daily for therapy. It is called ppeck. They only take disabled cheildren. I am afraid she is getting worse not better. Discharge summaries state wheeze, status epilepticus. msv Medical record states vomiting. msv 1/4/10 She is completely brain damaged. Cannot sit, stand, reach, etc. Also blind and deaf. 60 day Follow-up Information 24-OCT-2006: She is totally brain damaged. She cant see and she cant hear. She still has seizures. she can only do what a brand new born does. No play, no eating (GI tube). She cant even lift her head. Her last MRI showed her brain is shrinking.
Age: 1.03
Sex: F
Vaccine: HIBV, MMR
Symptoms: Cyanosis, Loss of consciousness, Similar reaction on previous exposure to drug
Clinical narrative: received mmr and hib 8/9/06 at 12n at 7p pt had cyanosis and loss of consciousness. seen at er mom  also reports similar episode after 6mo vaccines:pediarix, hib, pcv7.  was also seen at er fo rthat episode pt is to have eeg for evaluation.
Age: 1.55
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Convulsion, Pyrexia, Urticaria
Clinical narrative: HIGH FEVER/ SIEZURE 2ND TO FEVER/ HIVES.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Pyrexia, Thirst
Clinical narrative: CLT WOKE UP AT 5:30 AM AND SAID HE WAS THIRSTY. GRANDMA SAID HE FELT VERY WARM. CHECKED HIS TEMP AND IT WAS 102.3. GAVE MOTRIN, AND PLACED ICE PACKS TO ARM AND BACK TO HELP COOL HIM DOWN. RT ARM WAS RED, AND SLIGHTLY SWOLLEN TO THE BACK OF THE RT ARM. RECHECKED TEMP AT 7AM IT WAS 100. CHECKED AGAIN AT 10 AM AND TEMP WAS NORMAL, AND HE SAID HE WAS FINE.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Dry skin, Haematochezia, Headache, Rash
Clinical narrative: Blood on stool, skin drying or rash, joints ache headache, vomits.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Vomiting
Clinical narrative: Blood on stool, skin drying or rash, joints ache headache, vomits.
Age: 1.02
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure seven days after vaccination.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Chest pain, Injection site pain, Shoulder pain
Clinical narrative: PAIN AT INJECTION SITE WITH RIGHT SHOULDER AND CHEST PAIN 2 DAYS AFTER INJECTION.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Haemolysis
Clinical narrative: 4 year old otherwise healthy girl, who was in her usual state of health until 5 days following MMR vaccine, developped acute hemolysis with autoimmune findings of direct coombs test, positive C3, negative IgG.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Right arm local reaction, slight swelling, redness, and warm to touch. Patient's parent was advised to return to clinic if any problems and to ice the area as needed, and also to take Ibuprofen.
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Cardiac arrest, Coma, Vomiting
Clinical narrative: As per Emergency Room Report dated 03/09/06: Baby was found unresponsive in her crib by her mother @ 3:15pm. Vomitous around her mouth, last seen alive @ 2:30pm when dad turned patient on back. ALS was done at scene, patient was in asystole and transported to emergency room.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Skin nodule
Clinical narrative: Adverse reactions: right arm deltoid muscle is red, swollen, warm to touch with knots to muscle. Instructed guardian to apply warm compresses and take ibuprofen q 6 hrs. Call pediatrician if further treatment needed.
Age: 1.28
Sex: M
Vaccine: DTAP, PNC, VARCEL
Symptoms: Rash papular, Rash vesicular, Skin ulcer
Clinical narrative: Numerous papular lesions scattered over body (scalp, buttocks, Abd.,legs) several are vesicular. Mom noticed it last noc (ov 8/1/2006).
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Pt had immunizations 8/4/06. On 8/5/06 went to the ER with 2 inch hot, red area w/ blister on deltoid(per mother's report). By 8/11 area had completely healed. Immunizations were given in both arms, but unsure of which ones in which arm.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Blindness, Condition aggravated, Fatigue, Headache
Clinical narrative: This 22 year old female subject was enrolled in a blinded study for the prophylaxis of genital herpes in healthy young females. The subject received IM investigational product singles dose on 3/29/2006 Site of injection was the left deltoid. On 3/29/2006, the subject received the 1st IM injection of blinded study vaccine in the left deltoid. The subject had been randomized to received the active control in this trial, an investigational formulation of Havrix vaccine containing 720 Elisa units of hepatitis A antigen and 500 ug AL OH 3. Lot number DHAVA002A. Medical history the subject reported fatigue and malaise on 29 and 30 March 2006. On April 2/2006, she developed fever 38.89C, more fatigue, malaise, headache and joint pain. These symptoms resolved by 4/10/06. The subject took Yasmin from November 1st to April 2006, ibuprofen from 4/1/06 to 4/3/06 and Tylenol from 4/3/06 to 4/4/06. The subject does not have a history of diabetes, high blood pressure, hyperlipidemia or any other chronic illness. On 4/23/06, 25 days after the 1st dose of Blinded vaccine, this 22 year old subject developed central retinal vein occlusion. Since this day the subject was experiencing episodes of vision loss in her right eye about once a day lasting for up to one hour. On 4/28/06, she consulted an ophthalmologist. Visual acuity at the time of examination was normal. The physician diagnosed central retinal vein occlusion and recommended that she got her blood pressure checked and a fasting blood sugar obtained at the student health center. These test, a chemistry panel and lipid profile were normal on 5/2/06. Testing for lyme disease, mononucleosis and influenza was negative. Blood pressure was 107/73. The subject was taken off her oral contraception and prescribed 1 baby aspirin every day. The last episode of visual symptoms resolved on 4/30/2006. The subjects vision remained normal. This event has been considered to be medically important (OMIC). The vaccination course was stopped ant the subject was withdrawn from the study. The investigator considered that there was a reasonable possibility that the central retinal vein occlusion may have been caused by investigational product due to the temporal association between the last vaccine dose administration and the onset of the event and he also considered Yasmin (Contraception) as an other possible cause for the SAE.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Malaise, Pyrexia, Retinal vein occlusion
Clinical narrative: This 22 year old female subject was enrolled in a blinded study for the prophylaxis of genital herpes in healthy young females. The subject received IM investigational product singles dose on 3/29/2006 Site of injection was the left deltoid. On 3/29/2006, the subject received the 1st IM injection of blinded study vaccine in the left deltoid. The subject had been randomized to received the active control in this trial, an investigational formulation of Havrix vaccine containing 720 Elisa units of hepatitis A antigen and 500 ug AL OH 3. Lot number DHAVA002A. Medical history the subject reported fatigue and malaise on 29 and 30 March 2006. On April 2/2006, she developed fever 38.89C, more fatigue, malaise, headache and joint pain. These symptoms resolved by 4/10/06. The subject took Yasmin from November 1st to April 2006, ibuprofen from 4/1/06 to 4/3/06 and Tylenol from 4/3/06 to 4/4/06. The subject does not have a history of diabetes, high blood pressure, hyperlipidemia or any other chronic illness. On 4/23/06, 25 days after the 1st dose of Blinded vaccine, this 22 year old subject developed central retinal vein occlusion. Since this day the subject was experiencing episodes of vision loss in her right eye about once a day lasting for up to one hour. On 4/28/06, she consulted an ophthalmologist. Visual acuity at the time of examination was normal. The physician diagnosed central retinal vein occlusion and recommended that she got her blood pressure checked and a fasting blood sugar obtained at the student health center. These test, a chemistry panel and lipid profile were normal on 5/2/06. Testing for lyme disease, mononucleosis and influenza was negative. Blood pressure was 107/73. The subject was taken off her oral contraception and prescribed 1 baby aspirin every day. The last episode of visual symptoms resolved on 4/30/2006. The subjects vision remained normal. This event has been considered to be medically important (OMIC). The vaccination course was stopped ant the subject was withdrawn from the study. The investigator considered that there was a reasonable possibility that the central retinal vein occlusion may have been caused by investigational product due to the temporal association between the last vaccine dose administration and the onset of the event and he also considered Yasmin (Contraception) as an other possible cause for the SAE.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Child maltreatment syndrome
Clinical narrative: This case was reported by a lawyer and described the occurrence of suspected shaken baby syndrome in an infant subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified dose of Pediarix (unknown, lot number not provided). Six days after vaccination with Pediarix, the subject experienced suspected shaken baby syndrome and an unspecified adverse event. The reporter stated that the defendant, who is being prosecuted for shaken baby, "claims that the infant crashed because of an adverse reaction to Pediarix, rather than due to being shaken." The infant was treated in the emergency room. Treatment was not specified. The reporter stated that "the emergency room doctors were said not to have attributed to the event(s) to the Pediarix." At the time of reporting the outcome of the events was unspecified. No further information was provided. This was considered medically serious (OMIC) by manufacturer.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Was NPO, had sports physical and given Tdap, Menactra, PPD and Hemocult. On the way out, felt dizzy and nearly fainted.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Rash erythematous, Rash papular, Rash vesicular
Clinical narrative: Two days after Menactra was given. Pt developed itchy red raised papules, vesicular rash with possible exposure to Iris plant. Doubt this is from Menactra. Claritin 10 daily.
Age: 1.0
Sex: F
Vaccine: MMRV, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: Developed fine rash on trunk, front and back and a little on face 7/31/06, on 7/29/06 ran high fever up to 103.4.
Age: 1.02
Sex: M
Vaccine: MMRV, PNC
Symptoms: Injection site hypersensitivity, Injection site rash, Irritability, Pyrexia, Rash
Clinical narrative: Brook out in rash 8 days after shot, and redness and rash nickel size 1 1/2 - 2 cm at site day 9. Intermittent fever of to 101.5 since day 8 and fussy at night x couple of nights.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pt reports right hand was numb and tingling this morning when she woke up.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site induration, Pain
Clinical narrative: Left thigh induration hot to touch and painful to touch.
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Blister, Dermatitis, Skin exfoliation, Skin reaction
Clinical narrative: Received MMR shot 08/05/2006, noted skin reaction 08/06/2006, blistering, peeling skin left 5 digits, right 3 digits, diagnosis: dermatitis.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Cellulitis, Injection site pain
Clinical narrative: 08/08/2006  Immunizations administered at 08:30 am.  08/10/2006 About 12 noon called complaining of pain, site at right deltoid "hot" to touch, 2:00, parent took child to child hospital emergency room. Doctor diagnosed as "cellulitis and prescribed SEPTRA 200mg, Transil (under treatment).
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Hypersensitivity, Pruritus, Swelling
Clinical narrative: Allergic reaction to shots, red , swollen skin and itching. BENADRYL. Temperature 97.7 on 08/09/2006, temperature 96.2 on 08/12/2006.
Age: 41.0
Sex: F
Vaccine: ANTH, DT, HEP, MNQ
Symptoms: Agitation, Anxiety, Arthralgia, Blood cholesterol increased, Disturbance in attention
Clinical narrative: Aches: joints and muscles, Aches: whole body, Agitation, Nocturnal myoclonus, Mood: anxiety, High cholesterol, Concentration trouble, respiratory rpoblems, etc.  12/8/06 Received medical records from MC which reveal patient with marital disagreements & seeking divorce since increased irritability upon returning from deployment.  Patient gained 40 lbs since return in 2004 from 1 year deployment. Additional medical problems listed as peptic ulcer dx, sleep apnea, obesity, disc disease, hypercholestreolemia, non allergic rhinitis & sinusitis, elevated LFTs dermatophytosis of nail & costochondritis.  Left hand & elbow surgery in 2001.  Patient being treated by private psychiatrist for depression, violence & PTSD.
Age: 41.0
Sex: F
Vaccine: ANTH, DT, HEP, MNQ
Symptoms: Myalgia, Myoclonus, Pain, Respiratory disorder
Clinical narrative: Aches: joints and muscles, Aches: whole body, Agitation, Nocturnal myoclonus, Mood: anxiety, High cholesterol, Concentration trouble, respiratory rpoblems, etc.  12/8/06 Received medical records from MC which reveal patient with marital disagreements & seeking divorce since increased irritability upon returning from deployment.  Patient gained 40 lbs since return in 2004 from 1 year deployment. Additional medical problems listed as peptic ulcer dx, sleep apnea, obesity, disc disease, hypercholestreolemia, non allergic rhinitis & sinusitis, elevated LFTs dermatophytosis of nail & costochondritis.  Left hand & elbow surgery in 2001.  Patient being treated by private psychiatrist for depression, violence & PTSD.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Rash
Clinical narrative: I noticed approximately 20 ant bite appearing red bumps on his legs and arms 4-5 days after he received the Chicken Pox/MMR vaccine.  Four to five days after noticing the red bumps a hard scab-like area was noticed in the center of each red bump.
Age: 71.0
Sex: M
Vaccine: HEPA, IPV, TD, YF
Symptoms: Chest pain, Dehydration, Dizziness, Fall, Pyrexia
Clinical narrative: An initial report was received regarding a 71 year-old-male who received Hepatitis A, IPV, Td and yellow fever vaccines on 02/Jun/2005.  The next day he was dizzy and fell several times and was hospitalized from 03/Jun/2005 through 06/Jun/2005.  His discharge diagnosis included febrile illness and dehydration.  This patient has a history of coronary artery disease, diabetes, prostate cancer, with a 1997 prostate resection, peripheral vascular disease, chronic atrial fibrillation, myocardial infarction in 1978, a pacemaker insertion, hypertension, dyslipidemia and a shellfish allergy.  No blood was available from the hospitalization, however he was readmitted to the emergency room on 17/Jun/2005 for chest pain and there were blood samples that were sent from that hospitalization.  The results are pending.  The medial records have been requested, but not yet received. Dizziness and fall in a 71-year-old patient may be related to past medical history of cardiac disorders (coronary and peripheral vascular disease, atrial fibrillation as well as to febrile illness and dehydration.  The role of the vaccines cannot be ruled out in the occurrence of fever although work up is not available in order to rule out an infectious disease.  Chest pain can not be assessed due to total lack of information concerning this event.
Age: 22.0
Sex: M
Vaccine: HEP, JEV
Symptoms: Abnormal behaviour, Hyperhidrosis, Hypotension, Nausea, Syncope
Clinical narrative: Initial report received from a health care professional on 15Jul05. A 22 yr old male pt with no significant past medical history, had received a SC injection of JE Vax, lot EJN212C, in the left arm and an IM inj of Hep B vaccine lot AHBV125AA, in the right deltoid on 11Jul05 at  3:00PM. Five mins later, the pt experienced a near syncope episode. He began acting funny and stated that he was seeing white spots. He developed nausea and vomited once. He was sweating and his blood pressure dropped to 90/70mmHg. His pulse was 60. The pt did not lose consciousness. The pt recovered from these events.
Age: 22.0
Sex: M
Vaccine: HEP, JEV
Symptoms: Visual disturbance, Vomiting
Clinical narrative: Initial report received from a health care professional on 15Jul05. A 22 yr old male pt with no significant past medical history, had received a SC injection of JE Vax, lot EJN212C, in the left arm and an IM inj of Hep B vaccine lot AHBV125AA, in the right deltoid on 11Jul05 at  3:00PM. Five mins later, the pt experienced a near syncope episode. He began acting funny and stated that he was seeing white spots. He developed nausea and vomited once. He was sweating and his blood pressure dropped to 90/70mmHg. His pulse was 60. The pt did not lose consciousness. The pt recovered from these events.
Age: 44.0
Sex: F
Vaccine: IPV, TDAP, IPV, TDAP
Symptoms: Erythema, Hypoaesthesia, Pruritus, Rash macular
Clinical narrative: Initial report received on 1/30/06 from a health care professional. A 44 year old female pt with a history of allergy to Penicillin had received an IM injection of Adacel, lot number C2340AA, in the left deltoid and a SC injection of Ipol, lot number Y0324-2, in the left arm on 1/26/06 at 10:00, 22 hours later she experienced a mildly itchy macular red rash on her neck and torso, she experienced no other symptoms. No relevant diagnostic test lab date were collected. At the time of this report the rash was improving. Follow up information received on 3/10/06 from a physician. Per the reporter, when the pt developed the mildly itchy macular red rash, other causes were ruled out at that time, but the rash turned out to be poison oak that was acquired ten days prior. No other information is expected. The adverse events were updated to reflect this new information.
Age: 44.0
Sex: F
Vaccine: IPV, TDAP, IPV, TDAP
Symptoms: Erythema, Rash macular, Rash pruritic
Clinical narrative: Initial report received on 1/30/06 from a health care professional. A 44 year old female pt with a history of allergy to Penicillin had received an IM injection of Adacel, lot number C2340AA, in the left deltoid and a SC injection of Ipol, lot number Y0324-2, in the left arm on 1/26/06 at 10:00, 22 hours later she experienced a mildly itchy macular red rash on her neck and torso, she experienced no other symptoms. No relevant diagnostic test lab date were collected. At the time of this report the rash was improving. Follow up information received on 3/10/06 from a physician. Per the reporter, when the pt developed the mildly itchy macular red rash, other causes were ruled out at that time, but the rash turned out to be poison oak that was acquired ten days prior. No other information is expected. The adverse events were updated to reflect this new information.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Cellulitis
Clinical narrative: Initial report received on 3/10/06 from a health care provider. A five year old female pt with no significant medical history, had received her fifth intra muscular injection of Decavac, lot number C2345AA, this lot number is inconsistent with manufacturer, lot number for this product, in the left arm and her fourth IM injection of IPOL, lot number Y0638-2, in the right arm on 3/3/06 at 17:15. Two days later, at 11:00 she developed a 6cm x 5cm area of cellulitis on the right leg. She was treated with Keflex 250 mg 5ml, 2 tsp three times a day for ten days. A CBC was completed results not reported. Per the reporter, it is unknown if the pt recovered from these events at the time of this report. Follow up information received on 4/10/06. Per the responsible physician, the pt received the IM injection of Daptacel dose 5, lot number C2375AA in the left thigh. Previously, product was reported with lot number C2345 which corresponds to Decavac. The pt received Ipol in the right thigh. Cellulitis occurred on the left leg. CBC done on 3/6/06 showed elevated RDW 14.8 (normal 11.5-14.5), other wise normal. Differential Seg 41, Lymph 52, Eosin 6, Baso 1. Per responsible physician, the pt recovered. Follow up information received on 5/1/06 from a health care provider. Cellulitis was a clinical diagnosis. There was no regional lymphadenopathy. The pts oral temp was 102 degs F for three days. Per the reporter, the event resolved. Additional documents received and available in source file, lab report.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Cellulitis, Injection site reaction, Red blood cell abnormality
Clinical narrative: Initial report received on 3/10/06 from a health care provider. A five year old female pt with no significant medical history, had received her fifth intra muscular injection of Decavac, lot number C2345AA, this lot number is inconsistent with manufacturer, lot number for this product, in the left arm and her fourth IM injection of IPOL, lot number Y0638-2, in the right arm on 3/3/06 at 17:15. Two days later, at 11:00 she developed a 6cm x 5cm area of cellulitis on the right leg. She was treated with Keflex 250 mg 5ml, 2 tsp three times a day for ten days. A CBC was completed results not reported. Per the reporter, it is unknown if the pt recovered from these events at the time of this report. Follow up information received on 4/10/06. Per the responsible physician, the pt received the IM injection of Daptacel dose 5, lot number C2375AA in the left thigh. Previously, product was reported with lot number C2345 which corresponds to Decavac. The pt received Ipol in the right thigh. Cellulitis occurred on the left leg. CBC done on 3/6/06 showed elevated RDW 14.8 (normal 11.5-14.5), other wise normal. Differential Seg 41, Lymph 52, Eosin 6, Baso 1. Per responsible physician, the pt recovered. Follow up information received on 5/1/06 from a health care provider. Cellulitis was a clinical diagnosis. There was no regional lymphadenopathy. The pts oral temp was 102 degs F for three days. Per the reporter, the event resolved. Additional documents received and available in source file, lab report.
Age: 43.0
Sex: F
Vaccine: HEPA, IPV, RUB, TYP, HEPA, IPV, RUB, TYP
Symptoms: Back pain, Feeling hot, Headache, Hypokinesia, Injection site erythema
Clinical narrative: Initial report received from another manf. The report was reported by a nurse to a sales rep. A 43 yr old, female pt received several vaccines on 21Jun05: IPOL (lot not reported) in the left deltoid; Havrix (lot and dose not reported) in left arm; Meruvax II (lot not reported) in right deltoid; Typhoid (manf unk, lot numb not reported) in the right deltoid. At an unspecified time following the receipt of the immunizations on 21Jun05, the pt experienced headache, back and neck pain and injection site redness, pain and swelling. The site of the injection reaction was not specified to IPOL or Havrix. On 22Jun05 the pt experienced swelling, redness, and pain in the upper left arm. On 23Jun05, the subject experienced a decreased range of motion on the left arm and injection site warm. The events were ongoing at the time of initial reporting, 23Jun05. The pt had no reported medical history. The pt's concurrent conditions and concurrent medications were not reported.
Age: 43.0
Sex: F
Vaccine: HEPA, IPV, RUB, TYP, HEPA, IPV, RUB, TYP
Symptoms: Injection site oedema, Injection site pain, Neck pain
Clinical narrative: Initial report received from another manf. The report was reported by a nurse to a sales rep. A 43 yr old, female pt received several vaccines on 21Jun05: IPOL (lot not reported) in the left deltoid; Havrix (lot and dose not reported) in left arm; Meruvax II (lot not reported) in right deltoid; Typhoid (manf unk, lot numb not reported) in the right deltoid. At an unspecified time following the receipt of the immunizations on 21Jun05, the pt experienced headache, back and neck pain and injection site redness, pain and swelling. The site of the injection reaction was not specified to IPOL or Havrix. On 22Jun05 the pt experienced swelling, redness, and pain in the upper left arm. On 23Jun05, the subject experienced a decreased range of motion on the left arm and injection site warm. The events were ongoing at the time of initial reporting, 23Jun05. The pt had no reported medical history. The pt's concurrent conditions and concurrent medications were not reported.
Age: 43.0
Sex: F
Vaccine: HEPA, IPV, RUB, TYP, HEPA, IPV, RUB, TYP
Symptoms: Back pain, Feeling hot, Headache, Injection site erythema, Injection site pain
Clinical narrative: Initial report received from another manf. The report was reported by a nurse to a sales rep. A 43 yr old, female pt received several vaccines on 21Jun05: IPOL (lot not reported) in the left deltoid; Havrix (lot and dose not reported) in left arm; Meruvax II (lot not reported) in right deltoid; Typhoid (manf unk, lot numb not reported) in the right deltoid. At an unspecified time following the receipt of the immunizations on 21Jun05, the pt experienced headache, back and neck pain and injection site redness, pain and swelling. The site of the injection reaction was not specified to IPOL or Havrix. On 22Jun05 the pt experienced swelling, redness, and pain in the upper left arm. On 23Jun05, the subject experienced a decreased range of motion on the left arm and injection site warm. The events were ongoing at the time of initial reporting, 23Jun05. The pt had no reported medical history. The pt's concurrent conditions and concurrent medications were not reported.
Age: 43.0
Sex: F
Vaccine: HEPA, IPV, RUB, TYP, HEPA, IPV, RUB, TYP
Symptoms: Injection site swelling, Movement disorder, Neck pain
Clinical narrative: Initial report received from another manf. The report was reported by a nurse to a sales rep. A 43 yr old, female pt received several vaccines on 21Jun05: IPOL (lot not reported) in the left deltoid; Havrix (lot and dose not reported) in left arm; Meruvax II (lot not reported) in right deltoid; Typhoid (manf unk, lot numb not reported) in the right deltoid. At an unspecified time following the receipt of the immunizations on 21Jun05, the pt experienced headache, back and neck pain and injection site redness, pain and swelling. The site of the injection reaction was not specified to IPOL or Havrix. On 22Jun05 the pt experienced swelling, redness, and pain in the upper left arm. On 23Jun05, the subject experienced a decreased range of motion on the left arm and injection site warm. The events were ongoing at the time of initial reporting, 23Jun05. The pt had no reported medical history. The pt's concurrent conditions and concurrent medications were not reported.
Age: 12.0
Sex: F
Vaccine: TD, TTOX
Symptoms: Arthralgia, Injection site mass, Injection site oedema, Rash
Clinical narrative: Joint pain and weakness to the extent she was/is unable walk, eat or sit at times.  The onset of joint issues is accomplished by high to moderate fever.  The first month and half she had daily attacks of sudden pain, swelling, weakness and fever.  Now, it seems to flare up mainly prior to the drain.  Her joints still swell and it becomes difficult or impossible to walk and she cries of pain after is has intense.  We have taken her to the emergency room and doctor who told us to give her pain her pain/fever medications and pray it improved on time it should take, but might develop.
Age: 12.0
Sex: F
Vaccine: TD, TTOX
Symptoms: Arthralgia, Asthenia, Crying, Pain, Pyrexia
Clinical narrative: Joint pain and weakness to the extent she was/is unable walk, eat or sit at times.  The onset of joint issues is accomplished by high to moderate fever.  The first month and half she had daily attacks of sudden pain, swelling, weakness and fever.  Now, it seems to flare up mainly prior to the drain.  Her joints still swell and it becomes difficult or impossible to walk and she cries of pain after is has intense.  We have taken her to the emergency room and doctor who told us to give her pain her pain/fever medications and pray it improved on time it should take, but might develop.
Age: 12.0
Sex: F
Vaccine: TD, TTOX
Symptoms: Swelling
Clinical narrative: Joint pain and weakness to the extent she was/is unable walk, eat or sit at times.  The onset of joint issues is accomplished by high to moderate fever.  The first month and half she had daily attacks of sudden pain, swelling, weakness and fever.  Now, it seems to flare up mainly prior to the drain.  Her joints still swell and it becomes difficult or impossible to walk and she cries of pain after is has intense.  We have taken her to the emergency room and doctor who told us to give her pain her pain/fever medications and pray it improved on time it should take, but might develop.