chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.77
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: This is one case out of a cumulative total of 17 cases received during the surveillance period from 01 January 2010 to 25 March 2011. Initial report received on 25 March 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance. The subject's vaccine history included one dose of PENTACEL (lot number not reported) received on 19 February 2010, and three prior doses of DAPTACEL; lot number C2958BA received on 05 December 2008, lot number C2957AA received on 19 September 2008 and lot number C2951BA received on 25 July 2008, (routes and sites of administration not reported). The subject developed cold-like symptoms and on 20 January 2011, approximately 11 months after the last dose, developed a cough. On 14 February 2011, the subject developed a paroxysmal cough with a whoop and posttussive vomiting. The subject also experienced sleep disturbance. It was unknown if she experienced apnea. Laboratory testing included negative PCR on 05 March 2011, but the case was epidemiologically linked to a laboratory confirmed case. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of AUGMENTIN/CE starting on 16 February 2011 (duration of treatment not reported). The subject was not hospitalized. At the time of final contact on 10 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 50 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.77
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 17 cases received during the surveillance period from 01 January 2010 to 25 March 2011. Initial report received on 25 March 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance. The subject's vaccine history included one dose of PENTACEL (lot number not reported) received on 19 February 2010, and three prior doses of DAPTACEL; lot number C2958BA received on 05 December 2008, lot number C2957AA received on 19 September 2008 and lot number C2951BA received on 25 July 2008, (routes and sites of administration not reported). The subject developed cold-like symptoms and on 20 January 2011, approximately 11 months after the last dose, developed a cough. On 14 February 2011, the subject developed a paroxysmal cough with a whoop and posttussive vomiting. The subject also experienced sleep disturbance. It was unknown if she experienced apnea. Laboratory testing included negative PCR on 05 March 2011, but the case was epidemiologically linked to a laboratory confirmed case. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of AUGMENTIN/CE starting on 16 February 2011 (duration of treatment not reported). The subject was not hospitalized. At the time of final contact on 10 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 50 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.77
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test normal, Nasopharyngitis, Polymerase chain reaction
Clinical narrative: This is one case out of a cumulative total of 17 cases received during the surveillance period from 01 January 2010 to 25 March 2011. Initial report received on 25 March 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance. The subject's vaccine history included one dose of PENTACEL (lot number not reported) received on 19 February 2010, and three prior doses of DAPTACEL; lot number C2958BA received on 05 December 2008, lot number C2957AA received on 19 September 2008 and lot number C2951BA received on 25 July 2008, (routes and sites of administration not reported). The subject developed cold-like symptoms and on 20 January 2011, approximately 11 months after the last dose, developed a cough. On 14 February 2011, the subject developed a paroxysmal cough with a whoop and posttussive vomiting. The subject also experienced sleep disturbance. It was unknown if she experienced apnea. Laboratory testing included negative PCR on 05 March 2011, but the case was epidemiologically linked to a laboratory confirmed case. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of AUGMENTIN/CE starting on 16 February 2011 (duration of treatment not reported). The subject was not hospitalized. At the time of final contact on 10 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 50 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.25
Sex: F
Vaccine: HEPA, MMR
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Fever up to 102.4 for 4 days.  Given Motrin for comfort.  Small red dots on torso and back and neck that appeared on 4/4/2011.
Age: 1.52
Sex: M
Vaccine: MMR
Symptoms: Febrile convulsion
Clinical narrative: Febrile Seizure
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: fever, vomiting, body aches, headache
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Erythema, Injection site erythema, Pain, Pain in extremity, Pruritus
Clinical narrative: 3/25 Nickel size red spot at vacc site, arm very sore, over next 7 days area of redness more diffuse, warm to touch and very sore. And 3/29, red spots on back, top of head with itching. On 4/1 rash over all of scalp, forehead, back & trunk, severe itching. ER visit 4/1 - Dx Chicken Pox.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Rash, Skin warm, Varicella
Clinical narrative: 3/25 Nickel size red spot at vacc site, arm very sore, over next 7 days area of redness more diffuse, warm to touch and very sore. And 3/29, red spots on back, top of head with itching. On 4/1 rash over all of scalp, forehead, back & trunk, severe itching. ER visit 4/1 - Dx Chicken Pox.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Varicella
Clinical narrative: 3/25 Nickel size red spot at vacc site, arm very sore, over next 7 days area of redness more diffuse, warm to touch and very sore. And 3/29, red spots on back, top of head with itching. On 4/1 rash over all of scalp, forehead, back & trunk, severe itching. ER visit 4/1 - Dx Chicken Pox.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Erythema, Injection site erythema, Pain, Pain in extremity, Pruritus
Clinical narrative: Pt started having symptoms of chicken pox 3/21/11, diagnosed with chicken pox on 3/28/11, treated with ZOVIRAX 800mg course.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Rash, Skin warm, Varicella
Clinical narrative: Pt started having symptoms of chicken pox 3/21/11, diagnosed with chicken pox on 3/28/11, treated with ZOVIRAX 800mg course.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Varicella
Clinical narrative: Pt started having symptoms of chicken pox 3/21/11, diagnosed with chicken pox on 3/28/11, treated with ZOVIRAX 800mg course.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Gait disturbance, Injection site pain, Injection site swelling, Pain, Sleep disorder
Clinical narrative: Limping on leg around 6:30pm. Noticed swelling around 11:00pm when pt was still awake from the pain, father took him to E.R. where not much of anything was done told to use MOTRIN and ice. No redness, just swelling and tenderness. Brought to Dr. office left leg severe swelling from knee to groin, very tender.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Swelling
Clinical narrative: Limping on leg around 6:30pm. Noticed swelling around 11:00pm when pt was still awake from the pain, father took him to E.R. where not much of anything was done told to use MOTRIN and ice. No redness, just swelling and tenderness. Brought to Dr. office left leg severe swelling from knee to groin, very tender.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture negative, Blood electrolytes normal, CSF culture negative, Culture urine negative, Full blood count normal
Clinical narrative: Received 4 mo vaccines 1/21/11. That evening, while being held, vomited x 1, suddenly went limp; eyes rolled back, shallow breathing, looked grey - x 15 min. EMS called - to ER - ok, admitted for observation, D/C next day 1/22/11. Readmitted 1/23 with lethargy; sepsis w/u (-) including BC, CSF, Lytes, CBC.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Gaze palsy, Hypopnoea, Hypotonia, Lethargy, Liver function test normal
Clinical narrative: Received 4 mo vaccines 1/21/11. That evening, while being held, vomited x 1, suddenly went limp; eyes rolled back, shallow breathing, looked grey - x 15 min. EMS called - to ER - ok, admitted for observation, D/C next day 1/22/11. Readmitted 1/23 with lethargy; sepsis w/u (-) including BC, CSF, Lytes, CBC.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Sepsis, Skin discolouration, Vomiting
Clinical narrative: Received 4 mo vaccines 1/21/11. That evening, while being held, vomited x 1, suddenly went limp; eyes rolled back, shallow breathing, looked grey - x 15 min. EMS called - to ER - ok, admitted for observation, D/C next day 1/22/11. Readmitted 1/23 with lethargy; sepsis w/u (-) including BC, CSF, Lytes, CBC.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Diarrhoea, Dizziness, Pain, Pallor, Vomiting
Clinical narrative: Dizzy, pale, body ache, vomited x 1, diarrhea x 2.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pyrexia
Clinical narrative: (R) arm with 11x10cm erythema x 5 cm indurated center, no fluctuance. Fever 102 today. TYLENOL PRN fever.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Erythema, Feeling hot, Induration, Local reaction, Swelling
Clinical narrative: Patient had local reaction to DTaP #5: Heat redness & firm - sm. amount of swelling, redness = 10x9cm.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass, Axillary pain, Breast pain, Injection site pain, Oedema peripheral
Clinical narrative: After pt got vaccine that day, that night shot site started hurting, on 3/27/11 noticed swelling & golf ball size knot under armpit - pain radiated from armpit to (L) breast, pt used cold & warm compresses.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Received vaccine on 3-11-11. Arm very sore, swelling could not move without severe pain. Called clinic was told it is normal. Called again after 10 days. Went back to clinic was put on Nanaproxen & FLEXERIL. As of 3-1-11 arm still in pain.
Age: 7.0
Sex: M
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Convulsion, Electroencephalogram, Epilepsy, Nuclear magnetic resonance imaging, Rasmussen encephalitis
Clinical narrative: Had seizure 1-2 mos. after vaccination, in another country, right side getting weaker and weaker, no fever. Diagnose with Rasmussen's encephalitis, intractable complex-partial epilepsy 2007.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal discomfort, Musculoskeletal pain, X-ray limb normal
Clinical narrative: Patient c/o "shoulder" pain x 1 month after HPV vaccine. X-ray shoulder - neg. MD examined - deltoid area discomfort - mild, no limited ROM.
Age: 0.34
Sex: F
Vaccine: MMRV, PNC13, RVX
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Arrived at office 3/30/11 at 10AM. R. arm - red, sore, hot and hard over bicep muscle. Pt states sx started over weekend. Soreness, chills, site hot. Still having soreness, heat & hard but no other sx.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Arrived at office 3/30/11 at 10AM. R. arm - red, sore, hot and hard over bicep muscle. Pt states sx started over weekend. Soreness, chills, site hot. Still having soreness, heat & hard but no other sx.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Urticaria
Clinical narrative: Urticaria to trunk. No redness or swelling to mouth. Lungs clear. BENADRYL 50mg given.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Injection site rash, Rash
Clinical narrative: Rash started at injection site and went down arm to wrist. Contacted family physician & was treated for shingles for 4 months.
Age: 1.58
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Chest X-ray, Pneumonia
Clinical narrative: Diagnosed with pneumonia 5 days after getting vaccines. Treated with 10 days of AUGMENTIN 400mg/5ml 5ml BID.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Vomiting for 5 days post immunization. Keeping hydrated. No immunization site reaction.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Corneal reflex decreased, Laboratory test normal, Petit mal epilepsy, Pyrexia, Unresponsive to stimuli
Clinical narrative: Fever - 103 deg five days after shots! Day after vaccine 30 sec episode of non blinking/non responsive. 2 days after vaccine - 20 episodes of same, 1 lasting 5 min. Rest were 30-60 seconds.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Diarrhoea, Irritability, Pyrexia, Rash papular
Clinical narrative: 3/9 - started low grade fever, loose stools. 3/11 - developed full body papular rash & irritability.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Bursitis, Joint range of motion decreased, Muscle strain, Pain
Clinical narrative: 2 hrs after shot severe tendonitis & bursitis. Etodolac 2+ months til could not tolerate; then ibuprofen. 3 Dr. appts, 2 mos. PT repeated muscle strains. Considerable loss range of motion, chronic pain, weakness.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Tendonitis
Clinical narrative: 2 hrs after shot severe tendonitis & bursitis. Etodolac 2+ months til could not tolerate; then ibuprofen. 3 Dr. appts, 2 mos. PT repeated muscle strains. Considerable loss range of motion, chronic pain, weakness.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Feeling cold, Injection site pain, Oedema peripheral, Pruritus
Clinical narrative: Received Tdap injection on 3/28/11. Tuesday noted sx of feeling cold, soreness of arm where injection was received. Temp 102 degrees F. Wednesday returned to work temp 102 degrees F and fell to WNL at noc. Thursday temp 99.4 degrees F and affected arm itchy, warm and swollen.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Received Tdap injection on 3/28/11. Tuesday noted sx of feeling cold, soreness of arm where injection was received. Temp 102 degrees F. Wednesday returned to work temp 102 degrees F and fell to WNL at noc. Thursday temp 99.4 degrees F and affected arm itchy, warm and swollen.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Diarrhoea, Frequent bowel movements, Haematochezia, Occult blood positive
Clinical narrative: Three days after administration of ROTARIX, patient began having bloody stools. (+) diarrhea, frequent stooling.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient complaint of pain in (L) arm since HPV injection. Doctor found no tenderness, no swelling, difficulty with full extension of (L) arm. No s/s of infection.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash erythematous
Clinical narrative: Pt received 2nd MMR shot on 22 Mar 11, first received 5 Jan 11. Five days after 2nd MMR shot, pt woke up with red non-itchy bumps on right forearm and all over both lower extremities. Pt states denying changing any habits. Has been using cortisone cream.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and tenderness at injection site. Given ibuprofen and recommended hot packs over area.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Large area that is red & raised around injection site. Site looks like little bumps on entire thigh. (Rt thigh - where PREVNAR 13 was given) - Advised to apply cool compress, mark area of redness, CB should sx worsen.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Injection site induration, Injection site mass, Pain
Clinical narrative: Right arm (upper) "golf ball" sized hard lump. Sore for 7-10 days. Lump persisted 7-10 days.
Age: 4.0
Sex: F
Vaccine: MMRV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented 48 hr after immunization with 15x20cm area of erythema, warmth and swelling (L) leg -> site of PREVNAR injection.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Axillary pain, Body temperature increased, Cough, Dysphagia, Erythema
Clinical narrative: 4-5 pm her upper arm and axillary became tender and sore. 6-7 Neck area near "adams apple" became edematous. 8pm continued signs of swelling, back of tongue feeling thick, hard to swallow. 8:15 took 1 Benadryl 25mg and 2 ibuprofen 200mg. 8:40 took another Benadryl 25mg and called her family physician. 9:30pm c/o feeling like she had to clear her throat coughing, neck red and warm to touch.  Taken to ER.  Given solumedrol and Benadryl IV push, Temp 99.2.  Xray taken of neck region.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Localised oedema, Pain in extremity, Skin warm, Swelling, Tenderness
Clinical narrative: 4-5 pm her upper arm and axillary became tender and sore. 6-7 Neck area near "adams apple" became edematous. 8pm continued signs of swelling, back of tongue feeling thick, hard to swallow. 8:15 took 1 Benadryl 25mg and 2 ibuprofen 200mg. 8:40 took another Benadryl 25mg and called her family physician. 9:30pm c/o feeling like she had to clear her throat coughing, neck red and warm to touch.  Taken to ER.  Given solumedrol and Benadryl IV push, Temp 99.2.  Xray taken of neck region.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Throat irritation, Tongue disorder, X-ray
Clinical narrative: 4-5 pm her upper arm and axillary became tender and sore. 6-7 Neck area near "adams apple" became edematous. 8pm continued signs of swelling, back of tongue feeling thick, hard to swallow. 8:15 took 1 Benadryl 25mg and 2 ibuprofen 200mg. 8:40 took another Benadryl 25mg and called her family physician. 9:30pm c/o feeling like she had to clear her throat coughing, neck red and warm to touch.  Taken to ER.  Given solumedrol and Benadryl IV push, Temp 99.2.  Xray taken of neck region.
Sex: F
Vaccine: HEP, HEP
Symptoms: Autism, Decreased appetite, Encephalitis, Jaundice, Laboratory test
Clinical narrative: Lethargic from birth, no appetite, jaundice. From day 4 after birth endless, shrill, inconsolable screaming, day and night, 18 hours a day, for almost a week, then screamed 8 hours a day until 9 weeks old. Encephalitis caused by hepatitis B vaccine given when a few hours old. Autism diagnosed when 20 months old.
Sex: F
Vaccine: HEP, HEP
Symptoms: Lethargy, Screaming
Clinical narrative: Lethargic from birth, no appetite, jaundice. From day 4 after birth endless, shrill, inconsolable screaming, day and night, 18 hours a day, for almost a week, then screamed 8 hours a day until 9 weeks old. Encephalitis caused by hepatitis B vaccine given when a few hours old. Autism diagnosed when 20 months old.
Sex: F
Vaccine: HEP, HEP
Symptoms: Autism, Encephalitis, Screaming
Clinical narrative: Lethargic from birth, no appetite, jaundice. From day 4 after birth endless, shrill, inconsolable screaming, day and night, 18 hours a day, for almost a week, then screamed 8 hours a day until 9 weeks old. Encephalitis caused by hepatitis B vaccine given when a few hours old. Autism diagnosed when 20 months old.
Age: 19.0
Sex: F
Vaccine: DTP, SMALL, TYP
Symptoms: Activities of daily living impaired, Diplegia
Clinical narrative: both my arms became paralyzed, my college roommate had to help me get dressed and carried my tray in the cafeteria for two days
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain, Pruritus, Rash erythematous
Clinical narrative: Swelling and erythema to arm from 2" above elbow extending to upper arm, shoulder, and anterior axilla. Painful. Pt reported itching, red rash about 8 hrs. after injection. Prednisone burst x 1 wk. (20mg BID x 7 days).
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Swelling and erythema to arm from 2" above elbow extending to upper arm, shoulder, and anterior axilla. Painful. Pt reported itching, red rash about 8 hrs. after injection. Prednisone burst x 1 wk. (20mg BID x 7 days).
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Arm was swollen & red.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Bradycardia, Hyperhidrosis, Hypotension
Clinical narrative: Pt became hypotensive, bradycardic, and diaphoretic. Monitored BP, HR, pulse ox, water, lollipop and trendelenberg about 45 min to recovery.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Local reaction to ADACEL in Lt deltoid and PPD placed in left forearm. Redness, itchiness and swelling to deltoid & forearm.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Oedema peripheral, Pruritus, X-ray normal
Clinical narrative: Local reaction to ADACEL in Lt deltoid and PPD placed in left forearm. Redness, itchiness and swelling to deltoid & forearm.
Age: 33.0
Sex: F
Vaccine: YF
Symptoms: Adverse drug reaction, Blood test, Electrocardiogram, Fatigue, Full blood count
Clinical narrative: States had fatigue on night of vaccine for next 24 hours. Also began to have flu like symptoms with muscle tightening and cramping. This became worse each day leading to ER visit on 3/20. States ER physician said it was SE to YF vaccine. Pt states symptoms have gradually gone away.
Age: 33.0
Sex: F
Vaccine: YF
Symptoms: Influenza like illness, Muscle spasms, Muscle tightness
Clinical narrative: States had fatigue on night of vaccine for next 24 hours. Also began to have flu like symptoms with muscle tightening and cramping. This became worse each day leading to ER visit on 3/20. States ER physician said it was SE to YF vaccine. Pt states symptoms have gradually gone away.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cold sweat, Death, Hypophagia, Hypotonia, Respiratory arrest
Clinical narrative: 4-1-2011 mother presents to clinic requesting child, immunization record. Mother reports that her baby died 3-31-2011 at approximately 10:50 am. She reports the following: On 3-30-11 at 12:30pm she brought patient to the CHD for a routine well baby visit and immunizations. The child was done with the visit and receiving his shots by about 1pm. The rest of the day the child was sleepy and ate about 2 oz of formula vs his normal 7 oz at a time. At 11:30 pm she performed his routine diaper change and feeding. At that time he was moist to touch, but not running a fever (she never took his temperature but he felt warm to touch). 3-31-11 2AM; the baby accompanied the family to the ER for another child's scraped knee. They returned at 4AM, in which the mother reports she fed the baby 2 oz and did a diaper change. 10:40 AM the mother woke up and checked the baby, the baby was sleeping on his stomach. She reports that she does not believe in putting the baby on his back, because she thinks the baby will choke, she admits that she was trained by the provider, he should be on his back for sleeping. She then went out to the garage to have a cigarette. She returned at 10:50 am to get the baby up. The babies arm was flopped out and looked yellow, she checked the baby for breathing, and he was not breathing, then called 911. I gave the mother a copy of the child's immunization record. Offered Healthy Start bereavement services, she declined, stating she has enough family support for that.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Skin warm, Somnolence, Yellow skin
Clinical narrative: 4-1-2011 mother presents to clinic requesting child, immunization record. Mother reports that her baby died 3-31-2011 at approximately 10:50 am. She reports the following: On 3-30-11 at 12:30pm she brought patient to the CHD for a routine well baby visit and immunizations. The child was done with the visit and receiving his shots by about 1pm. The rest of the day the child was sleepy and ate about 2 oz of formula vs his normal 7 oz at a time. At 11:30 pm she performed his routine diaper change and feeding. At that time he was moist to touch, but not running a fever (she never took his temperature but he felt warm to touch). 3-31-11 2AM; the baby accompanied the family to the ER for another child's scraped knee. They returned at 4AM, in which the mother reports she fed the baby 2 oz and did a diaper change. 10:40 AM the mother woke up and checked the baby, the baby was sleeping on his stomach. She reports that she does not believe in putting the baby on his back, because she thinks the baby will choke, she admits that she was trained by the provider, he should be on his back for sleeping. She then went out to the garage to have a cigarette. She returned at 10:50 am to get the baby up. The babies arm was flopped out and looked yellow, she checked the baby for breathing, and he was not breathing, then called 911. I gave the mother a copy of the child's immunization record. Offered Healthy Start bereavement services, she declined, stating she has enough family support for that.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Administered vaccinations about 3:17pm. Hep A in the left deltoid and HPV in the right deltoid. Pt had left the room to go into waiting room and then fainted. He awakened, responded to us, was assessed then was able to be put in chair for further evaluation. Totally recovered by 3:25pm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Excoriation, Pruritus, Rash, Skin lesion
Clinical narrative: 4/5/11 came into office because of rash noticed since day before on back, belly, neck! Dr examined noted scattered red papular lesions over trunk & extremities & in scalp, mildly pruritic - all lesions excoriated.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Varicella
Clinical narrative: 4/5/11 came into office because of rash noticed since day before on back, belly, neck! Dr examined noted scattered red papular lesions over trunk & extremities & in scalp, mildly pruritic - all lesions excoriated.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Left upper with 4cm diameter blister, some mild erythema Treatment:  blister unroofed with sterile scissors and pick ups.  Some clear liquid was drained
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Crying, Ear infection, Ear pain, Ear, nose and throat examination abnormal, Influenza
Clinical narrative: Uncontrollable crying, acute ear pain, fever of 101 degrees, and pain in injected leg.  Ear pain started in on ear and moved into second ear the following day.  Leg pain and fever persisted into following day as well.  Ibuprofen controlled fever, ear pain, and leg pain.  Called doctor who recommended warm oil for ear pain, but I did not do this.  On Feb. 10, 2011, became very ill with extreme temps.  Took son into see doctor, but nothing was diagnosed.  On 2/14/11, we went back to the doctor and patient (son) showed an ear infection and tested positive for influenza A.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Influenza A virus test positive, Injection site pain, Malaise, Pyrexia, Streptococcus test
Clinical narrative: Uncontrollable crying, acute ear pain, fever of 101 degrees, and pain in injected leg.  Ear pain started in on ear and moved into second ear the following day.  Leg pain and fever persisted into following day as well.  Ibuprofen controlled fever, ear pain, and leg pain.  Called doctor who recommended warm oil for ear pain, but I did not do this.  On Feb. 10, 2011, became very ill with extreme temps.  Took son into see doctor, but nothing was diagnosed.  On 2/14/11, we went back to the doctor and patient (son) showed an ear infection and tested positive for influenza A.
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Apnoeic attack, Blood culture, Bradycardia, Full blood count
Clinical narrative: Severe apneic and bradycardic episodes. Total of 10, requiring stimulation and 2-3 bag and mask and also increasing flow and fio2 to 2LPM and fio2 to 40%. Did CBC and Blood Culture.
Age: 4.0
Sex: M
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: on right thigh, where PCV13 was given, there was erythema/swelling/heat noted morning after vaccine which spread daily, tried cold compresses/ibuprofen/Benadryl and on day 3 when reaction continued with spreading erythema started Bactrim, no purulence or fever, area was the size of a hand
Age: 38.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Raised, red area, hot to touch and itching, the size is 3 inches X 5 inches
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: Severe Dizziness during car ride home from clinic visit.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Fatigue, Full blood count, Headache, Liver function test
Clinical narrative: Fever 100.2, Chills, Malaise, Myalgias, Fatigue, HA, nausea
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Malaise, Metabolic function test, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever 100.2, Chills, Malaise, Myalgias, Fatigue, HA, nausea
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Urine analysis, Viral test negative
Clinical narrative: Fever 100.2, Chills, Malaise, Myalgias, Fatigue, HA, nausea
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS, WARMTH, SWELLING @ INJECTION SITE TO L DELTOID WHICH HAS IMPROVED WITHIN ;AST 24 HOURS WITH USE OF TYLENOL. ALSO REPORTS HEADACHE DAILY SINCE Td injection.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Deep soreness in arm, that has lasted for over 2 months. Still sore, it hasn't healed or gone away yet.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Dyskinesia, Gaze palsy, Screaming
Clinical narrative: Screaming for 3-4 hours, unconsolably. Patient then had an episode of her eyes rolling back and jerking movements of the extremities for approximately 30 seconds, possibly seizure activity.
Age: 53.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Day #56 post vaccination c/o severe pain in left arm since 02/10/2011 without improvment. When moves left arm has severe pain in shoulder 10/10 on pain scale radiating down arm r/o brachial neuritis.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray
Clinical narrative: Severe pain when shot was given. Pain has gotten worse and never stopped over the months with limited use of arm. Have had accupunture with no relief from the pain.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Convulsion, Crying, Eye disorder, Infantile spitting up
Clinical narrative: On day of vaccination, patient developed a fever of approx 104 degrees.  The fever, along with inconsolable screaming/crying persisted for approximately 1 week.  At that time, patient had what appeared to be seizure-like behavior.  His arms were thrown back, his eyes wide and back arched.  Immediately after each seizure episode he would cry and spit up.  These symptoms lasted until approximately 2/12.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Posture abnormal, Pyrexia, Screaming
Clinical narrative: On day of vaccination, patient developed a fever of approx 104 degrees.  The fever, along with inconsolable screaming/crying persisted for approximately 1 week.  At that time, patient had what appeared to be seizure-like behavior.  His arms were thrown back, his eyes wide and back arched.  Immediately after each seizure episode he would cry and spit up.  These symptoms lasted until approximately 2/12.
Age: 0.75
Sex: M
Vaccine: PNC13
Symptoms: Bronchiolitis, Cough, Dyspnoea, Hyperhidrosis, Insomnia
Clinical narrative: Wet, chest cough with fever. Labored breathing. Sleeplessness.
Age: 0.75
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Wet, chest cough with fever. Labored breathing. Sleeplessness.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Rash
Age: 0.41
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Convulsion, Food allergy, Staring, Unresponsive to stimuli
Clinical narrative: Seizure lasting 1 minute. Eyes glazed over and rhythmic rocking started, could not be distracted and was not responding to me for the duration of the event. This happened almost once daily for 6 months. This child has allergy now to Gluten, soy, dairy.
Age: 1.37
Sex: F
Vaccine: DTAPIPVHIB, FLU3, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Apparent cellulitis of right thigh - being treated with 7 day course of KEFLEX.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Received flu shot on 9/16/2010. About 2 weeks later he reported his arm began to hurt right at the injection site and he started to have pain thru out the day and at nite. He went to doctor in Feb. Still has pain but seems to be getting better.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, VARCEL
Symptoms: Blister, Erythema, Rash generalised, Skin warm, Varicella
Clinical narrative: 3/31/11 pt had a rash & mother stated felt warm. Assessed diffuse rash with streaks of papular erythema. Given BENADRYL 12.5 mg/5mL 1-2 tsp Q 6 hrs PRN. 4/4/11 pt returned to clinic rash is raised, turned yellow, filling with fluid. Dr. dx'd Varicella.
Age: 29.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administration error
Clinical narrative: None misadministration.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Right arm red/swollen/itchy/sore from elbow to shoulder. Applied ice pack/took ibuprofen. Redness gone, swelling down by 3/26/11, 1000. Declined visit to M.D.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse concerning 9 patients who received the RECOMBIVAX HB series on schedule in 2008 and had negative hepatitis B titers. The patients received vaccinations from lot #s 660951/0398X, 662114/0866X (thimerosal free) and 660951/0399X) (not corresponding doses specified). The nurse also stated that the RECOMBIVAX HB was properly stored while in her facility. At the time of the report the patients had not recovered. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a register nurse concerning about 50% dialysis patients who were vaccinated with RECOMBIVAX HB 40mcg/ml (therapy route and site unknown). The nurse reported that she had noticed that 50% of the dialysis patients who received the RECOMBIVAX HB in the past responded with low titers. Follow-up information has been received from the nurse. She stated that "the 50% of dialysis patients that responded with low titers to RECOMBIVAX HB" was not what her phone call was about. She stated that she was asking about the reformulation of RECOMBIVAX HB and she did not remember saying anything about dialysis patients or low titers. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician and a nurse or office manager concerning a few adult patients who were vaccinated with pediatric version of RECOMBIVAX HB by doubling up on the dose. Subsequently the patients experienced not reaching sufficient titer levels. At the time of reporting, the outcome was unknown. The patient's sought unspecified medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 1.1
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Induration, Pruritus, Rash papular, Skin lesion
Clinical narrative: Information has been received from a health care professional concerning a 26 month old male patient who on 16-JUN-2008 was vaccinated with the first dose of VARIVAX (Merck) (Lot # 659339/1516U) subcutaneously. Concomitant vaccine given on the same day included the fourth dose of PREVENAR (Lot # C57538) intramuscularly. There were no illnesses at time of vaccination. It was reported that on 19-JUL-2009 the patient experienced pruritic lesions, 20-30 of different sizes and different stages and firm papular lesions, there was no fever. It was reported that the patient recovered on 27-JUL-2009. No further information is available.
Age: 1.02
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Rash (urticaria) within 24 hrs of Hep A #1, PREVNAR 13, Varicella.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Blood test normal, Electrocardiogram abnormal, Fatigue, Nervousness, Presyncope
Clinical narrative: Dose #2. Approx 1 - 1 1/2 hrs after 2nd dose ENGERIX B given pt developed shaky feeling, had near syncopal episode, ED visit revealed abnormal EKG --> admitted overnight --> EKG changes resolved within 24hr. Blood tests all normal. Mild reaction 3-4 days after dose #1 2/28/11 of fatigue.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Blood glucose increased, Blood urea increased, C-reactive protein increased, Injection site erythema, Injection site swelling
Clinical narrative: Fever 102, swelling & redness of injection site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Fever 102, swelling & redness of injection site.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Ultrasound scan abnormal, Urine human chorionic gonadotropin positive, Uterine haemorrhage
Clinical narrative: Information has been received from a certified medical assistant, for the Pregnancy Registry for GARDASIL, concerning a 15 year old female with no pertinent medical history and allergy to pork who on 27-MAR-2008 was vaccinated with the first dose of GARDASIL 0.5 mL, IM. On 29-MAY-2008, the patient received the second dose of GARDASIL 0.5 mL, IM. It was reported that the patient received the third dose of GARDASIL (lot# 665266/1378Y) 0.5 mL, IM into her right arm on 26-FEB-2010 and was pregnant. Concomitant vaccination included the first dose of HAVRIX given on 26-FEB-2010. It was reported that the patient had a urine pregnancy test which came back positive on the same day of vaccination. The patient's last menstrual period was on 02-FEB-2010 and the estimated delivery date is 09-NOV-2010. Follow up information was received from a physician. It was reported that the patient had no significant past medical history or concurrent conditions and had no previous pregnancies. On 26-FEB-2010, the patient was vaccinated IM with third 0.5mL dose of GARDASIL (lot number 665266/1378Y). There was no other concomitant medication used in this pregnancy. The patient's LMP was on 02-FEB-2010 with an EDD of 09-NOV-2010. Follow up information was received via telephone call from the medical assistant who stated that the patient reported that on an unspecified date she had a possible miscarriage (no HCP confirmation) and had bled profusely. The medical assistant also reported that on an unspecified date the patient's ultrasound revealed an empty uterine sac, however her blood work confirmed pregnancy. The medical assistant reported "it may had been too early to see the baby with the ultrasound". The medical assistant reported it was noted in the chart "the patient possibly had a miscarriage and then the patient got pregnant again. It was not clear if the patient's first pregnancy ended as a miscarriage, and then the patient became pregnant again". The medical assistant went on to report that the patient was referred to OB/GYN. At 40 weeks gestation on 21-DEC-2010 the patient had a healthy male baby (WAES# 1103USA03674). Upon internal review possible miscarriage was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, No therapeutic response
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not reported). There was no concomitant medication. The physician reported that the patient came down with a light case of the shingles about three months after she had the ZOSTAVAX (Merck) shot and they now considered her a non-responder. The patient sought unspecified medical attention. The patient was treated with acyclovir (manufacturer unknown). Upon the time of the report, the patient's present status was unknown. The patient's a light case of the shingles and they considered her a non-responder were considered to be an other important medical event by the physician. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Pt received vaccines (PENTACEL, Hep B, PREVNAR, & ROTATEQ) on 4/1 - evening of 4/3 pt developed hives without respiratory compromise. No fever no seizures.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Hypoaesthesia, Pregnancy test negative
Clinical narrative: Patient complained of full-body numbness for about one week after injection. Numbness subsided without intervention.
Age: 1.15
Sex: M
Vaccine: DTAP
Symptoms: Erythema multiforme, Eye swelling, Injection site erythema, Injection site macule, Injection site rash
Clinical narrative: Initial report was received from a health care professional on 18 and 23 February 2011. A 13 month-old male patient who had no illness at the time of vaccination and pre-existing conditions were reported as none had received on 10 February 2011, a second dose intramuscular right thigh injection of DAPTACEL, lot number C3514AA. On 14 February 2011, the patient started to develop hives at the injection site and by 16 February 2011 the hives had spread to his arms, legs, body and back. The patient was evaluated by a physician. Treatments and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information was received from a health care professional on 28 March 2011 who reported that the event diagnosis was erythema multiforme. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious. On 16 February 2011 the patient was evaluated by his physician for a rash that started five days after receiving a DAPTACEL vaccine. According to the physician the patient was doing well but developed the rash around the administration site of the vaccine. The rash worsened and spread to the whole body. Physical exam revealed the patient had hives over his entire body. He had "target lesions, pink mac-pap (illegible) lesions on legs and an increased concentration at vaccination site". The patient also had swollen eyes but "not shut". Treatment included BENADRYL 3 - 4 cc by mouth every six hours as needed. The patient was given a prescription for steroids however it was reported the Mother was hesitant to give them to the patient. The patient has a history of saggital synostosis and had an unspecified surgery. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 1.15
Sex: M
Vaccine: DTAP
Symptoms: Injection site urticaria, Rash generalised, Rash maculo-papular, Skin lesion, Urticaria
Clinical narrative: Initial report was received from a health care professional on 18 and 23 February 2011. A 13 month-old male patient who had no illness at the time of vaccination and pre-existing conditions were reported as none had received on 10 February 2011, a second dose intramuscular right thigh injection of DAPTACEL, lot number C3514AA. On 14 February 2011, the patient started to develop hives at the injection site and by 16 February 2011 the hives had spread to his arms, legs, body and back. The patient was evaluated by a physician. Treatments and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information was received from a health care professional on 28 March 2011 who reported that the event diagnosis was erythema multiforme. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious. On 16 February 2011 the patient was evaluated by his physician for a rash that started five days after receiving a DAPTACEL vaccine. According to the physician the patient was doing well but developed the rash around the administration site of the vaccine. The rash worsened and spread to the whole body. Physical exam revealed the patient had hives over his entire body. He had "target lesions, pink mac-pap (illegible) lesions on legs and an increased concentration at vaccination site". The patient also had swollen eyes but "not shut". Treatment included BENADRYL 3 - 4 cc by mouth every six hours as needed. The patient was given a prescription for steroids however it was reported the Mother was hesitant to give them to the patient. The patient has a history of saggital synostosis and had an unspecified surgery. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.