chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site rash, Rash
Clinical narrative: Approx. 24-36 hrs. after vaccines listed below patient developed rash across her back and thighs bilat. Mtr. called ER at hosp on 7/10/11 (Sat) soon after & they told her to give child BENADRYL and rash quickly resolved.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Macule
Clinical narrative: Cellulitis, fever. Left arm, redness, tenderness & swelling to lateral deltoid with several red macules on skin. DEPO MEDROL 80mg IM given 7-15-11 (1311).
Age: 51.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Rash macular
Clinical narrative: Cellulitis, fever. Left arm, redness, tenderness & swelling to lateral deltoid with several red macules on skin. DEPO MEDROL 80mg IM given 7-15-11 (1311).
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site of injection - arm is red hot & swollen. Is getting better w time consulted w pharmacist, MD & manufacturer otherwise patient feels fine.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Convulsion, Fall, Head injury, Syncope
Clinical narrative: Patient receive 2 vaccines ADACEL (Tdap) & MENACTRA (MCV) and stood up. Was talking to a provider and suddenly fainted and fell to the floor and bumped her head. Per nurse practitioner, pt appeared to have a "seizure". Pt woke up within 1-2 minutes and was alert and oriented. 911 was called.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: An itchy raised and red rash on his left thigh that was noticed when the patient woke up on the morning of 7/20/11.
Age: 40.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Nausea, Neuralgia, Nuclear magnetic resonance imaging, Pain, Pyrexia
Clinical narrative: Employee had aches,nausea, vomitting, fever of 100 starting approx 24 hrs later. Over course of next 3 weeks, sxs worsened, temp up to 102.9, and then hospitalized July 12-16 for fever, pain, neuralgia, possible encephalopathy. Continues on steroids and acyclovir.
Age: 40.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Vomiting
Clinical narrative: Employee had aches,nausea, vomitting, fever of 100 starting approx 24 hrs later. Over course of next 3 weeks, sxs worsened, temp up to 102.9, and then hospitalized July 12-16 for fever, pain, neuralgia, possible encephalopathy. Continues on steroids and acyclovir.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Deafness, Dizziness, Loss of consciousness
Clinical narrative: My son felt light headed, had loss of hearing and vision and passed out. Came to and passed out again. This happened 3 times and lasted for 30 minutes.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Convulsion, Dizziness, Loss of consciousness, Nausea
Clinical narrative: Patient felt light headed, thought he was going to throw up...passed out and had a seizure!
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Nausea
Clinical narrative: Headache, slight nausia, slight diarrea.
Age: 1.52
Sex: M
Vaccine: MMR, PNC13
Symptoms: Measles, Rash
Clinical narrative: rash, measles
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Rash generalised
Clinical narrative: (12:54-given vaccine);(14:05 patient complained of itching, got rash all over body, called MD and gave patient benadryl 25mg); (14:10 patient asymptomatic).
Age: 23.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chest discomfort, Dry throat, Dyspnoea, White blood cell count increased
Clinical narrative: Tightness in chest, short of breath, dry throat.
Age: 17.0
Sex: M
Vaccine: FLUX, SMALL, TTOX, TYP
Symptoms: Arteriogram coronary abnormal, Arteriosclerosis, Cardiac disorder, Condition aggravated, Dyspnoea
Clinical narrative: Short of breath with physical exercise. At the age of 23 diagnose with major heart condition, block arteries.
Age: 17.0
Sex: M
Vaccine: FLUX, SMALL, TTOX, TYP
Symptoms: Dyspnoea exertional
Clinical narrative: Short of breath with physical exercise. At the age of 23 diagnose with major heart condition, block arteries.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Hard lump and redness at site. Hot and swollen some soreness and itching.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Hard lump and redness at site. Hot and swollen some soreness and itching.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria
Clinical narrative: Developed 2cm localized erythema surrounding MMR and VZV vaccine inj. sites with urticarial wheel.  No difficulty breathing or other reaction.  No treatment.  Called family 23 hours later - "bumps" decreasing in size - baby doing well.
Age: 28.0
Sex: F
Vaccine: HEPA, SMALL, YF
Symptoms: Culture, Injection site pruritus, Skin lesion, Vaccination site papule, Vaccination site pustule
Clinical narrative: Patient noticed 3 papular bumps around smallpox vaccination site that were intensely itchy. Bumps progressed into pustular lesions.
Age: 28.0
Sex: F
Vaccine: HEPA, SMALL, YF
Symptoms: Vaccination site rash
Clinical narrative: Patient noticed 3 papular bumps around smallpox vaccination site that were intensely itchy. Bumps progressed into pustular lesions.
Age: 1.76
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, PNC, VARCEL
Symptoms: Pruritus, Pyrexia, Rash generalised, Tongue discolouration
Clinical narrative: Parents brought in child on 7/20/11 c/o rash all over body, non toxic appearance, since morning positive fever overnight. Rash initially started on face and has spread to trunk, arms & legs, positive pruritus. Negative n/v, positive white coating on tongue. No known ill contacts. Pt has 5 siblings none of which have rash. Pt is eating & sleeping well. Pt had immunizations given on 7/9/11. Mother denied any fever/rash/vesicles or irritability following immunizations. Pt given TYLENOL, BENADRYL & Nystatin oral swish. ER precautions given & f/u in 24 hrs.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Activities of daily living impaired, Chills, Immediate post-injection reaction, Muscle disorder
Clinical narrative: Immediately arm hurt and got progressively worse. By evening was in a lot of pain, unable to lift arm to change clothes. Fever, nausea, chills, upset stomach. Took EXCEDRIN, fever went down a bit but around 100 degrees now. No swelling or redness but muscle feels tough. Called doctor this morning but specified that pt probably had something not related to vaccination.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Immediately arm hurt and got progressively worse. By evening was in a lot of pain, unable to lift arm to change clothes. Fever, nausea, chills, upset stomach. Took EXCEDRIN, fever went down a bit but around 100 degrees now. No swelling or redness but muscle feels tough. Called doctor this morning but specified that pt probably had something not related to vaccination.
Age: 0.28
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Abdominal X-ray, Abdominal mass, Crying, Induration, Intussusception
Clinical narrative: Started with a painful fit and finally pushed out a bowel movement.  After that the fierce vomiting and painful squeals about every 30-45 minutes.  Pt could not keep anything down even for seconds after having them.  At around 9am I noticed a larger lump in her sunken stomach that felt very hard.  Was headed to hospital when pediatrician called and requested to go to his office instead of emergency room.  Saw him at 2 and the vomitting had continued until bile.  Saw the Pediatrician and he sent us to Childrens health care. There we had an x-ray and then an ultrasound to conclude it was intussusception.
Age: 0.28
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Irritability, Pain, Screaming, Stomach mass, Ultrasound abdomen abnormal
Clinical narrative: Started with a painful fit and finally pushed out a bowel movement.  After that the fierce vomiting and painful squeals about every 30-45 minutes.  Pt could not keep anything down even for seconds after having them.  At around 9am I noticed a larger lump in her sunken stomach that felt very hard.  Was headed to hospital when pediatrician called and requested to go to his office instead of emergency room.  Saw him at 2 and the vomitting had continued until bile.  Saw the Pediatrician and he sent us to Childrens health care. There we had an x-ray and then an ultrasound to conclude it was intussusception.
Age: 0.28
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Vomiting, X-ray abnormal
Clinical narrative: Started with a painful fit and finally pushed out a bowel movement.  After that the fierce vomiting and painful squeals about every 30-45 minutes.  Pt could not keep anything down even for seconds after having them.  At around 9am I noticed a larger lump in her sunken stomach that felt very hard.  Was headed to hospital when pediatrician called and requested to go to his office instead of emergency room.  Saw him at 2 and the vomitting had continued until bile.  Saw the Pediatrician and he sent us to Childrens health care. There we had an x-ray and then an ultrasound to conclude it was intussusception.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: raised Rash, redness on left arm. Warm to touch.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness
Clinical narrative: Light headedness, dizziness.
Age: 35.0
Sex: M
Vaccine: MEN
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient complained the injection site was red raised,itchy and warm to the touch.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: SWELLING AND 6/10 PAIN IN LEFT DELTOID.  RELEASED W/O LIMITATIONS AND TO FOLLOW UP AS NEEDED.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: PT. COMPLAINING OF PAIN ON LEFT ARM WITH REDNESS AND SWELLING.  TOLD TO TAKE TYLENOL AND USE ICE PACK.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Full blood count abnormal, Rash, Urine analysis normal
Clinical narrative: Rash to face and trunk.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Choking, Convulsion, Cough, Drug screen positive, Endotracheal intubation
Clinical narrative: The patient developed a choking/coughing episode resulting in him becoming unresponsive. Patient's wife started CPR, paramedics were called, patient had pulse, but subsequently had seizure activity; patient was intubated and brought to ER by helicopter; eye surgery pending for "burst vessels"; patient lost to followup
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Eye haemorrhage, Unresponsive to stimuli
Clinical narrative: The patient developed a choking/coughing episode resulting in him becoming unresponsive. Patient's wife started CPR, paramedics were called, patient had pulse, but subsequently had seizure activity; patient was intubated and brought to ER by helicopter; eye surgery pending for "burst vessels"; patient lost to followup
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema to both shoulders no tenderness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site mass
Clinical narrative: Pt has a large bump on both (R) & (L) upper thighs.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Injection site cellulitis, Skin warm, Tenderness
Clinical narrative: Cellulitis at administration site - erythema, induration, warmth, & tenderness started day after administration & worsened by day 2. Treated with KEFLEX, po for 7 days.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right leg redness and swelling, warm to the touch. Size of area 14 x 11 cm on (R) thigh. Meds = KEFLEX 250mg tid x 10 days.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Induration, Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: Local swelling/redness at injection sites (Rt & Lt thighs); fever. Positive induration; non-tender. Seen in office 7/21/11. Tx -> cool pack to sites & infant TYLENOL PRN. (RT = 1 x 1.5 cm & 1.5 x 2 cm) (LT = <0.5cm).
Age: 0.76
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Erythema, Pruritus, Rash generalised
Clinical narrative: Rash all over body and red and itchy.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, HPV4, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus
Clinical narrative: Red irritation on (R) deltoid 5 1/2 cm x 5 1/2 cm. Pt. claimed it itched a lot.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Urticaria
Clinical narrative: Hives tx: ZYRTEC.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site discolouration, Injection site induration, Injection site swelling
Clinical narrative: 6 cm area of induration & swellling (R) upper arm, non-tender. 4 cm area of non-tender swelling (L) arm no erythema noted but darker pigmented skin.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Erythema, Skin warm, Syncope, Tenderness
Clinical narrative: MENVEO inj given: 7/20/2011 later redness, fainted 7/21; MENVEO IM in Right arm Lot # 10053 Novartis VIS: 1/28/08. Red, hot, tender 7 3/4 cm x 5 cm (R) arm, no pruritus.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2" diameter red elevation around site of injection.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Dollar size red elevation around site of injection.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: About 12 hrs after administration, patient developed pain in left shoulder (injection site) left elbow, left knee and in neck. Also developed stiffness and numbness in fingers. Was seen in emergency room. Evaluation in ED positive only for neck pain. Patient given MOTRIN with relief of pain.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Urine analysis normal
Clinical narrative: About 12 hrs after administration, patient developed pain in left shoulder (injection site) left elbow, left knee and in neck. Also developed stiffness and numbness in fingers. Was seen in emergency room. Evaluation in ED positive only for neck pain. Patient given MOTRIN with relief of pain.
Age: 1.33
Sex: F
Vaccine: PNC13
Symptoms: Rash generalised
Clinical narrative: Patient broke out with rash on her body.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, PNC, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Made list of shots needed from pt, opened freezer grabbed ZOSTAVAX put back turned around & looked at list again did my KINRIX & PREVNAR. Went back to freezer opened & grabbed bottle to right drew up & had employee double check. Thought it was PROQUAD not ZOSTAVAX. Employee had asked me to look at the kids immun rec. to see what they needed. I made her the list of what they needed. Employee drew them up, asked me to check them I read all of them & checked dosages. For some reason it didn't click that it was ZOSTAVAX for kids and I okay'd her. I will forever now verbally read aloud every vaccination when checking someone.
Age: 1.26
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 17 x 9 cm indurated, red area at (Lt) upper thigh (injection site). Pt on Ab for Dx impetigo - to finish course. Monitor leg & watch for increased s/s &/or refusal to walk.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Arm swollen, red, ached very bad for 3 days. Dr prescribed steroid cream and cellophane wrap. In 2 days swollen went done, but pain still remain when she sleeps on arm.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Diarrhoea, Vomiting
Clinical narrative: T- 102.4, with TYLENOL & MOTRIN (max doses) sponging with cool water, vomiting & diarrhea for over 12 hours.
Age: 36.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient received her Tdap on 7/20/11 and returned to our office on 7/21/11 with severe pain & swelling in left deltoid. She was tx with antibiotics & oral steroids. She came back on 7/22/11 with worsening symptoms. Area of swelling was measured at 7cm across & 8 cm in length. IM steroid & oral BENADRYL given - will continue to be monitored.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Received a TDAP at employee health on 7/21/11 developed with fever 5 hours after vaccine of 103-104, chills, fatigue, headache, nausea and shakiness.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Tremor
Clinical narrative: Received a TDAP at employee health on 7/21/11 developed with fever 5 hours after vaccine of 103-104, chills, fatigue, headache, nausea and shakiness.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Deafness, Syncope
Clinical narrative: Fainted, lost hearing 20-30 minutes after vaccination. Fully recovered 15-20 minutes after fainting.
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Pyrexia, Tremor, Vaccination complication
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Adenovirus test, Agitation, Alpha 1 globulin increased, Alpha 2 globulin normal, Analgesic drug level therapeutic
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Antibody test negative, Antibody test positive, Aphasia, Beta globulin increased, Blood albumin normal
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Blood alcohol normal, Blood calcium normal, Blood chloride increased, Blood culture negative, Blood folate normal
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Blood iron decreased, Blood magnesium increased, Blood sodium increased, Blood thyroid stimulating hormone increased, Blood urea increased
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Borrelia test negative, C-reactive protein increased, CSF cell count normal, CSF culture negative, CSF glucose
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: CSF immunoglobulin increased, CSF lymphocyte count increased, CSF monocyte count increased, CSF protein increased, CSF test normal
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: CSF virus no organisms observed, CSF white blood cell count increased, Central nervous system lesion, Chills, Communication disorder
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Computerised tomogram head, Computerised tomogram normal, Confusional state, Culture urine negative, Cytomegalovirus test
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Cytomegalovirus test negative, Cytomegalovirus test positive, Drug screen negative, Dyskinesia, Electrocardiogram abnormal
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Electroencephalogram, Electrophoresis protein, Electrophoresis protein abnormal, Enterovirus test negative, Epstein-Barr virus test negative
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Full blood count normal, Fungal test negative, Gram stain negative, HIV antibody negative, Haemoglobin normal
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Hepatitis B core antibody negative, Hepatitis C antibody negative, Hepatitis C virus test, Herpes simplex serology negative, Human herpes virus 6 serology negative
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Immunoglobulins normal, Incontinence, Influenza virus test, Iron binding capacity total normal, Liver function test normal
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Neurological examination normal, Nuclear magnetic resonance imaging brain abnormal, Pain, Platelet count normal, Polymerase chain reaction
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Prealbumin increased, Protein urine, Pyrexia, Red blood cell sedimentation rate normal, Sinus tachycardia
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Specific gravity urine increased, Specific gravity urine normal, Speech disorder, Thyroxine free normal, Transferrin saturation
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Transferrin saturation decreased, Treponema test, Treponema test negative, Treponema test positive, Unresponsive to stimuli
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Urine alcohol test negative, Urine ketone body present, Vaccination complication, Varicella virus test negative, Viral test negative
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Vitamin B12 normal, Vomiting, West Nile virus test negative, White blood cell count normal
Clinical narrative: Fever of 102.0 orally, and body "shakes".
Age: 15.0
Sex: M
Vaccine: DTAP
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Body pain localized to legs and arms, fatigue, headache.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Ear pain, Erythema, Facial pain, Influenza like illness
Clinical narrative: Myalgia one side of face, right hand turned red; stiff neck; flu-like symptoms; lymph nodes swollen under right armpit; neck and shoulders and liver area uncomfortable. 7/18/11: UPDATE:  lymph nodes above shoulder blades swollen; face pain & earache; no fever or rash; most other symptoms gone; feeling better.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Musculoskeletal discomfort, Musculoskeletal stiffness, Myalgia
Clinical narrative: Myalgia one side of face, right hand turned red; stiff neck; flu-like symptoms; lymph nodes swollen under right armpit; neck and shoulders and liver area uncomfortable. 7/18/11: UPDATE:  lymph nodes above shoulder blades swollen; face pain & earache; no fever or rash; most other symptoms gone; feeling better.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Dizziness, Fall, Nausea
Clinical narrative: Patient fell to the floor from a sitting position after becoming dizzy 3 minutes following injections.  Did not lose consciousness.  Stated she felt nauseous.  Was nervous for injection.  Reported not eating much for breakfast.  Mom states long history of getting anxious for a variety of issues.  BP (92/62) and pulse (81) WNL.  Patient waited at clinic for 15 minutes and stated she felt fine to leave.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles rash along right T-1 dermatone. treated w Valtrex.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: RED RAISED RASH ABOUT 1.5 IN IN DIAMETER.  ITCHY.  DOES NOT LOOK LIKE SHINGLES.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Pruritus
Clinical narrative: A painful, swollen rash showed up at injection site the day after injection. Patient applied hydrocortisone cream to control pruritus and it helped. Cleared up on Friday 7/22/11.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Chest X-ray abnormal, Pneumonia, Type IV hypersensitivity reaction
Clinical narrative: Patient received vaccine purchased by employer on 7/14/2011 administered by Board of Health. Vaccine MMR. Patient states he was "immune" by blood titer and still had to receive shot. Developed subsequent delayed hypersensitivity reaction. Ended up in hospital.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Childhood disintegrative disorder, Fatigue, Lethargy, Listless, Slow response to stimuli
Clinical narrative: Very lethargic, motor skills slow to respond, listless, unable to focus, tiredness, stopped verbal noises and cooing as previously done, lasted approx. 2 weeks, gradually improved.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Vision blurred
Clinical narrative: Very lethargic, motor skills slow to respond, listless, unable to focus, tiredness, stopped verbal noises and cooing as previously done, lasted approx. 2 weeks, gradually improved.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Patient reported numbness in left arm (vaccinated arm) patient waited additional 10-15 min. No other symptoms. Patient went home, called patient at home 2 hr later vaccinated arm was ok.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Pt had localized redness & itching, but also experienced itching on arms & legs treated with BENADRYL.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage, Pregnancy test positive
Clinical narrative: Miscarriage, heavy bleeding.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia, Rash erythematous
Clinical narrative: Injection site sore, warm and very swollen; low fever; applied cool compress, gave children's ibuprophen. Arm issue 6 days; fever 3 days. On 7/22/2011 complained of itchy red bump; applied hydrocortizone cream. More bumps appeared. Continued hydrocortizone cream at each site. Upon review of record, it appears that clinic nurse didn't examine child's immunization records and proceeded to give duplicate immunizations that were given to same child on 3/11/2010 including MMR, IPV, DTaP and Varicella. I do not know what to do about this error. I do not know what the long-or-short-term adverse affects will be.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash pruritic
Clinical narrative: Injection site sore, warm and very swollen; low fever; applied cool compress, gave children's ibuprophen. Arm issue 6 days; fever 3 days. On 7/22/2011 complained of itchy red bump; applied hydrocortizone cream. More bumps appeared. Continued hydrocortizone cream at each site. Upon review of record, it appears that clinic nurse didn't examine child's immunization records and proceeded to give duplicate immunizations that were given to same child on 3/11/2010 including MMR, IPV, DTaP and Varicella. I do not know what to do about this error. I do not know what the long-or-short-term adverse affects will be.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, pruritis, Swelling and warmth in left deltoid muscle (injection site.) Treated with diphenhydramine and acetaminophen.
Age: 46.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Gingival pain, Hypoaesthesia, Hypoaesthesia oral, Sensitivity of teeth, Toothache
Clinical narrative: Sensitivity/soreness in gums/teeth, numbness in fingers, arm, arm, and lips.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swollen by injection site, red and itchy.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Decreased appetite, Dyspnoea, Pyrexia, Rash generalised, Urticaria
Clinical narrative: four hours later he began with a very high fever, no appetite, Hives/rashes all over body, whizzing had problems breathing.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Wheezing
Clinical narrative: four hours later he began with a very high fever, no appetite, Hives/rashes all over body, whizzing had problems breathing.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: CSF culture negative, CSF glucose decreased, CSF protein normal, CSF test normal, CSF white blood cell count negative
Clinical narrative: Generalized vaccinia - presenting as diffuse macular-papular vesicular rash on face/torso/chest/left shoulder. Worsened over next 5 days and admitted to isolation bed at medical center for supportive care.  Fevers, headache, nausea and vomiting upon admission.  Negative lumbar puncture and resolving symptoms now HD#4.  Case discussed with Vaccine Healthcare Network provider, medical center.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Generalised vaccinia, Gram stain, Gram stain negative, Haemoglobin normal, Headache
Clinical narrative: Generalized vaccinia - presenting as diffuse macular-papular vesicular rash on face/torso/chest/left shoulder. Worsened over next 5 days and admitted to isolation bed at medical center for supportive care.  Fevers, headache, nausea and vomiting upon admission.  Negative lumbar puncture and resolving symptoms now HD#4.  Case discussed with Vaccine Healthcare Network provider, medical center.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Lumbar puncture normal, Metabolic function test, Nausea, Platelet count decreased, Pyrexia
Clinical narrative: Generalized vaccinia - presenting as diffuse macular-papular vesicular rash on face/torso/chest/left shoulder. Worsened over next 5 days and admitted to isolation bed at medical center for supportive care.  Fevers, headache, nausea and vomiting upon admission.  Negative lumbar puncture and resolving symptoms now HD#4.  Case discussed with Vaccine Healthcare Network provider, medical center.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Rash, Rash maculo-papular, Rash vesicular, Vomiting, White blood cell count normal
Clinical narrative: Generalized vaccinia - presenting as diffuse macular-papular vesicular rash on face/torso/chest/left shoulder. Worsened over next 5 days and admitted to isolation bed at medical center for supportive care.  Fevers, headache, nausea and vomiting upon admission.  Negative lumbar puncture and resolving symptoms now HD#4.  Case discussed with Vaccine Healthcare Network provider, medical center.
Age: 38.0
Sex: F
Vaccine: DTP
Symptoms: Bone pain, Injection site pain, Pain in extremity
Clinical narrative: 4 Months after tetanus shot my arm still hurts. It feels like an ache inside my bone and it is especially prominent in the cold. Injection site is also sore when pressure is applied.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Full blood count, Impaired work ability, Injection site swelling, Malaise
Clinical narrative: ARTHUS REACTION:  swelling of upper left arm (injection site), fevers, muscle aches and stiffness all over the entire body, mental fogginess, followed by muscle spasm.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Metabolic function test, Muscle spasms, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: ARTHUS REACTION:  swelling of upper left arm (injection site), fevers, muscle aches and stiffness all over the entire body, mental fogginess, followed by muscle spasm.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Urine analysis
Clinical narrative: ARTHUS REACTION:  swelling of upper left arm (injection site), fevers, muscle aches and stiffness all over the entire body, mental fogginess, followed by muscle spasm.
Age: 1.22
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: This is one case out of a cumulative total of 23 cases solicited from the Electronic Disease Surveillance System during the surveillance period from 01 January 2010 to 14 July 2011. These 23 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP-combination vaccines from other manufacturers are not reported as per study protocol. Initial report was received on 14 July 2011 from the Investigator participating in the above-mentioned 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 database. The subject's vaccine history included three doses of PENTACEL; dose one lot number C3243AB received on 23 April 2009, dose two and three lot number C3293AA received on 22 June 2009 and 20 August 2009 and one dose of DAPTACEL; lot number C3191AA on 11 May 2010 (routes and sites of administration not reported). Approximately one year after the last dose, on 16 May 2011, the subject developed cough. Eight days later, the subject developed a paroxysmal cough with whoop. The subject also experienced cold-like symptoms, post-tussive vomiting and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 31 May 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 02 June 2011 for five days. The subject was not hospitalized. At the time of final contact on 06 June 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.22
Sex: F
Vaccine: DTAP
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 23 cases solicited from the Electronic Disease Surveillance System during the surveillance period from 01 January 2010 to 14 July 2011. These 23 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP-combination vaccines from other manufacturers are not reported as per study protocol. Initial report was received on 14 July 2011 from the Investigator participating in the above-mentioned 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 database. The subject's vaccine history included three doses of PENTACEL; dose one lot number C3243AB received on 23 April 2009, dose two and three lot number C3293AA received on 22 June 2009 and 20 August 2009 and one dose of DAPTACEL; lot number C3191AA on 11 May 2010 (routes and sites of administration not reported). Approximately one year after the last dose, on 16 May 2011, the subject developed cough. Eight days later, the subject developed a paroxysmal cough with whoop. The subject also experienced cold-like symptoms, post-tussive vomiting and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 31 May 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 02 June 2011 for five days. The subject was not hospitalized. At the time of final contact on 06 June 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Convulsion, Electrocardiogram, Electroencephalogram
Clinical narrative: Seizure, Taken to Christiana Hospital, Newark, De Followed up w/Neurologist, Several seizures since, medicated.
Age: 59.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Lymphoedema, Pain, Pyrexia
Clinical narrative: C/O FEVER 100.9; BODY ACHES; EDEM TO RIGHT AXILLA LYMPH NODES; HA.
Age: 24.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Pt EXPERIENCED A GREAT AMOUNT OF SWELLING, AND REDNESS IN THE LEFT ARM THAT LASTED THREE DAY. hE ONLY RECIEVED RELIEF WITH FOLLOW UP TREATMENT OF STERIODS AND MOTRIN.
Age: 12.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Convulsion, Cyanosis, Loss of consciousness, Mydriasis, Pallor
Clinical narrative: Pt. became pale and lips slightly cyanotic, pupils dilated, loss of consciousness and mild seizing of body for about 10 seconds.
Age: 0.8
Sex: M
Vaccine: DTAP
Symptoms: Gaze palsy, Nervous system disorder, Tic, Tremor, Vaccine positive rechallenge
Clinical narrative: Initial report was received 14 July 2011 from a consumer, who is also the patient's parent. A male patient received at nine months of age, a second dose intramuscular injection of TRIPEDIA on 15 April 2008 (lot number, route, and site of administration not reported) and approximately five days later, he experienced tics and his eyes rolled back in head repeatedly, lasting one minute, occurring several times a day, then gradually tapering off for three to four months until resolved. He also experienced one episode of full body tremor (specific date of onset not reported). The patient was evaluated by a neurologist who diagnosed the event as tics - neuro misfire. The patient had not received any other vaccinations within four weeks prior to receiving TRIPEDIA. Concomitant medications consisted of PRILOSEC. The patient had no pre-existing medical conditions and no illness at the time of vaccination. The patient previously experienced the same symptoms after receiving a first dose of TRIPEDIA. Outcomes were recovered. Documents held by sender: None.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: This is one case out of a cumulative total of 22 cases solicited from the Electronic Disease Surveillance System during the surveillance period from 01 January 2010 to 12 July 2011. These 22 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP-combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 12 July 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject's vaccine history included one dose of DAPTACEL, lot number C3514AA received on 07 June 2011, and 3 doses of PENTACEL; lot number C3497AA received on 27 November 2009, lot number C3362AA received on 02 October 2009 and lot number C3304AA received on 31 July 2009 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 25 June 2011, approximately 18 days after the last dose. On 30 June 2011, the subject developed a paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 29 June 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of AZITHROMYCIN starting on 01 July 2011 for five days. The subject was not hospitalized. At the time of final contact on 09 July 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 22 cases solicited from the Electronic Disease Surveillance System during the surveillance period from 01 January 2010 to 12 July 2011. These 22 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP-combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 12 July 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject's vaccine history included one dose of DAPTACEL, lot number C3514AA received on 07 June 2011, and 3 doses of PENTACEL; lot number C3497AA received on 27 November 2009, lot number C3362AA received on 02 October 2009 and lot number C3304AA received on 31 July 2009 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 25 June 2011, approximately 18 days after the last dose. On 30 June 2011, the subject developed a paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 29 June 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of AZITHROMYCIN starting on 01 July 2011 for five days. The subject was not hospitalized. At the time of final contact on 09 July 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 53.0
Sex: F
Vaccine: DT
Symptoms: Asthma, Chest X-ray normal, Chills, Injection site erythema, Injection site swelling
Clinical narrative: Initial report was received 15 June 2011 from a health care professional. A 58-year-old female patient (age calculates to 53 years) who had a history of asthma and allergies to codeine and iodine, had received an intramuscular right deltoid injection of DECAVAC, lot number U3492BA on 28 April 2011, and within 24 hours, the injection site became hot, swollen and reddened. An unspecified amount of time later, she complained of fever, chills, and generalized achiness. Approximately one and a half months later (also reported as "now"), she had experienced asthma attacks. The patient was evaluated by her physician (date and results of doctor visit were not reported). Laboratory and diagnostic testing noted WBC 3.4 and a normal chest x-ray. The patient had no concurrent illness at the time of vaccination and she had been taking HCTZ (diuretic) concomitantly. She had not experienced any adverse events after receipt of previous vaccinations. She had received a prior dose of DECAVAC "years ago". According to the reporter, the patient remains having issues. Outcome was reported as not recovered. Follow-up information was received from a health care professional on 14 July 2011. The patient's age was confirmed as 53-years old. The patient had no additional medical history reported. The onset for the event was reported as 29 April 2011 and lasted for about one and a half weeks but the asthma signs and symptoms occurred again in May. One occurred after the vaccine and then again one few weeks later. The patient also experienced wheezing during the asthma attack. The patient was treated with inhalers but required no hospitalization. The etiology or trigger was not identified for the recent asthma attacks. The patient's doctor (MD) stated that he thought it was linked to the vaccine. The outcome was reported as recovered on 04 July 2011. The reporter for this case is the same as case number 2011-03459, 2011-03461 and 2011-03462.
Age: 53.0
Sex: F
Vaccine: DT
Symptoms: Injection site warmth, Pain, Pyrexia, Wheezing, White blood cell count decreased
Clinical narrative: Initial report was received 15 June 2011 from a health care professional. A 58-year-old female patient (age calculates to 53 years) who had a history of asthma and allergies to codeine and iodine, had received an intramuscular right deltoid injection of DECAVAC, lot number U3492BA on 28 April 2011, and within 24 hours, the injection site became hot, swollen and reddened. An unspecified amount of time later, she complained of fever, chills, and generalized achiness. Approximately one and a half months later (also reported as "now"), she had experienced asthma attacks. The patient was evaluated by her physician (date and results of doctor visit were not reported). Laboratory and diagnostic testing noted WBC 3.4 and a normal chest x-ray. The patient had no concurrent illness at the time of vaccination and she had been taking HCTZ (diuretic) concomitantly. She had not experienced any adverse events after receipt of previous vaccinations. She had received a prior dose of DECAVAC "years ago". According to the reporter, the patient remains having issues. Outcome was reported as not recovered. Follow-up information was received from a health care professional on 14 July 2011. The patient's age was confirmed as 53-years old. The patient had no additional medical history reported. The onset for the event was reported as 29 April 2011 and lasted for about one and a half weeks but the asthma signs and symptoms occurred again in May. One occurred after the vaccine and then again one few weeks later. The patient also experienced wheezing during the asthma attack. The patient was treated with inhalers but required no hospitalization. The etiology or trigger was not identified for the recent asthma attacks. The patient's doctor (MD) stated that he thought it was linked to the vaccine. The outcome was reported as recovered on 04 July 2011. The reporter for this case is the same as case number 2011-03459, 2011-03461 and 2011-03462.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Ear pain, Lymph node pain, Lymphadenopathy, Mononucleosis heterophile test negative, Oropharyngeal pain
Clinical narrative: Returned to Employee Health Clinic on 7/14- c/o of swollen neck glands lg. tender anterior cervical node on (R) and single occipital node on (L). Sore throat, (R) ear pain. Seen by MD. Strept screen "negative" considered viral. Seen by MD 7/15 with fine morbilliform rash on forearms, back & abdomen ? MD to viral exanthem vs Rx MMR. Mono "negative".
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Rash morbilliform, Rubella antibody negative, Streptococcus test negative, Tuberculin test negative, White blood cell count decreased
Clinical narrative: Returned to Employee Health Clinic on 7/14- c/o of swollen neck glands lg. tender anterior cervical node on (R) and single occipital node on (L). Sore throat, (R) ear pain. Seen by MD. Strept screen "negative" considered viral. Seen by MD 7/15 with fine morbilliform rash on forearms, back & abdomen ? MD to viral exanthem vs Rx MMR. Mono "negative".
Age: 56.0
Sex: M
Vaccine: TYP
Symptoms: Asthenia, Blood test, Malaise, Vomiting
Clinical narrative: Patient described taking oral Typhoid vaccine and becoming ill with weakness and vomiting. Had to be taken from work to the ER by ambulance. Did not report episode until 6/2011.