chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.32
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash macular, Skin discolouration, Urine analysis, Vomiting
Clinical narrative: Information has been received from a consumer concerning his 16 month old daughter with no medical history and no drug allergies/reactions who on 26-MAY-2011 or 27-MAY-2011 was vaccinated with a dose of MMR II (lot # not reported). The reporter stated that his daughter received MMR II and later experienced high fevers to 105F. It was unknown if the child received additional vaccines when MMR II was administered. On 02-JUN-2011 she did not respond to APAP or ibuprofen with temperature fluctuating to 100F and then back up to 104F-105F. The next day, on 03-JUN-2011 the patient was in a weird state of mind, not cheerful like she usually was but lethargic. She had purple toned skin that looked black and blue. Later that day she was taken to hospital emergency room. She then had shivering which the doctor said was a probable febrile seizure with dehydration. She had one episode of vomiting during an exam of her mouth and throat. Her temperature was 104.5. She was admitted to the hospital. She was treated with intravenous fluids and intravenous ROCEPHIN. Fever decreased. No seizure activity. On 04-JUN-2011 the patient was discharged from the hospital. On 05-JUN-2011 the patient experienced a blotchy rash in chest, neck, cheeks for 24 hours and tired, lethargic, very weak, fever again to 101F. The patient was seen by pediatrician on 05-JUN-2011 with possible roseola. Today, on 07-JUN-2011 she was starting to eat and doing a little better. Also her sister had a history of epilepsy and her cousin had Guillain-Barre at age 2. Chest x ray, blood and urine tests were performed with no results provided. At the time of reporting, the patient was recovering. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Rash macular
Clinical narrative: Rash began 5-25-11. Consists of erythematous macules, almost confluent, most notable on chest, entire neck, up hairline, low back, groin region, axillary regions but also to arms & legs. Tx: Loratadine 10mg QD, Ranitidine 150 BID, MEDROL dose pak.
Age: 18.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Asthenia, Fatigue, Injection site erythema, Local reaction, Pain
Clinical narrative: Fever later in day. Local reaction - red to arm where both shots given. Feels weak, tired, body aches.
Age: 18.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Pyrexia
Clinical narrative: Fever later in day. Local reaction - red to arm where both shots given. Feels weak, tired, body aches.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Rash erythematous, Scab, Skin lesion
Clinical narrative: Lesion on chin and multiple lesions to suprapubic area. At onset red bumps and have progessed to crusted lesions. At present self innoculator vs opportunistic infections. To be evaluated by primary care manager.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Post vaccination autoinoculation, Rash erythematous, Scab, Skin lesion
Clinical narrative: Lesion on chin and multiple lesions to suprapubic area. At onset red bumps and have progessed to crusted lesions. At present self innoculator vs opportunistic infections. To be evaluated by primary care manager.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: FEVER 103 1HR AFTER VACCINE GIVEN, BODY RASH X3 DAYS WITH FEVER. FEVER CONTROL WITH MOTRIN AND TYLENOL. FOLLOWUP VISIT ON 5/11/11 NO FEVER, BABY HAPPY AND EATING.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Ataxia, CSF glucose normal, CSF protein increased, Convulsion, Disorientation
Clinical narrative: dizziness, disorientation, nausea, vomiting, ataxia, seizures
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Electroencephalogram normal, Lumbar puncture abnormal, Nausea, Vomiting
Clinical narrative: dizziness, disorientation, nausea, vomiting, ataxia, seizures
Age: 1.66
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Autopsy, Cerebral haemorrhage, Child maltreatment syndrome, Computerised tomogram abnormal, Computerised tomogram head
Clinical narrative: Baby had cold symptoms, cough, congestion, a little vomiting. My son came home at 7:20 p.m. On 5/10 to babysitter advising baby was napping from 6 p.m. Patient was face down on bed. My son laid next to him and put his hand on his back and he noticed he wasn't breathing right. He lifted him and turned him over and his one side of face and mouth was drooping and his right arm and leg kept jolting. No left side movement at all. 911 was immeidately called. CT scan showed bleeding on brain. Three hours later transferred by ambulance to Hospital (not airlifted) was put on respirator at Medical Center. Got to another hospital had another CT scan, bleed was worse underwent neurosurgery and brains was hemorrhaging too bad. Neurosurgeons said bleed was too bad and injuries were consistent with shaken baby syndrome. Patient had no brain activity or breathing capacity at all. Passed away on 5/13 at 10:30 a.m. Initial Autopsy was inconclusive. Undergoing more tests. Patient on 5/5 had PVC (Pneumococcal Vaccine and Varicella Vaccine). It is being treated as a homicide by Prosecutor's office. A local chiropractor told us about a link with vaccines and brain injuries similar to shaken baby. We wanted to report this since he did get these two recent injections. Awaiting second autopsy. They said brain and eyes were sent to specialist around the country.
Age: 1.66
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Cough, Death, Dyskinesia, Mechanical ventilation, Nasopharyngitis
Clinical narrative: Baby had cold symptoms, cough, congestion, a little vomiting. My son came home at 7:20 p.m. On 5/10 to babysitter advising baby was napping from 6 p.m. Patient was face down on bed. My son laid next to him and put his hand on his back and he noticed he wasn't breathing right. He lifted him and turned him over and his one side of face and mouth was drooping and his right arm and leg kept jolting. No left side movement at all. 911 was immeidately called. CT scan showed bleeding on brain. Three hours later transferred by ambulance to Hospital (not airlifted) was put on respirator at Medical Center. Got to another hospital had another CT scan, bleed was worse underwent neurosurgery and brains was hemorrhaging too bad. Neurosurgeons said bleed was too bad and injuries were consistent with shaken baby syndrome. Patient had no brain activity or breathing capacity at all. Passed away on 5/13 at 10:30 a.m. Initial Autopsy was inconclusive. Undergoing more tests. Patient on 5/5 had PVC (Pneumococcal Vaccine and Varicella Vaccine). It is being treated as a homicide by Prosecutor's office. A local chiropractor told us about a link with vaccines and brain injuries similar to shaken baby. We wanted to report this since he did get these two recent injections. Awaiting second autopsy. They said brain and eyes were sent to specialist around the country.
Age: 1.66
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Neurosurgery, Respiratory tract congestion, VIIth nerve paralysis, Vomiting
Clinical narrative: Baby had cold symptoms, cough, congestion, a little vomiting. My son came home at 7:20 p.m. On 5/10 to babysitter advising baby was napping from 6 p.m. Patient was face down on bed. My son laid next to him and put his hand on his back and he noticed he wasn't breathing right. He lifted him and turned him over and his one side of face and mouth was drooping and his right arm and leg kept jolting. No left side movement at all. 911 was immeidately called. CT scan showed bleeding on brain. Three hours later transferred by ambulance to Hospital (not airlifted) was put on respirator at Medical Center. Got to another hospital had another CT scan, bleed was worse underwent neurosurgery and brains was hemorrhaging too bad. Neurosurgeons said bleed was too bad and injuries were consistent with shaken baby syndrome. Patient had no brain activity or breathing capacity at all. Passed away on 5/13 at 10:30 a.m. Initial Autopsy was inconclusive. Undergoing more tests. Patient on 5/5 had PVC (Pneumococcal Vaccine and Varicella Vaccine). It is being treated as a homicide by Prosecutor's office. A local chiropractor told us about a link with vaccines and brain injuries similar to shaken baby. We wanted to report this since he did get these two recent injections. Awaiting second autopsy. They said brain and eyes were sent to specialist around the country.
Age: 46.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea, Flatulence, Muscle spasms
Clinical narrative: Stomach cramps, which got much worse after the second dose. Muscle cramping, diarrhea, Gas, Cramping became severe.  Symptoms lasted for five days.  I could not finish the dosing.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Caesarean section, Drug exposure during pregnancy, Premature delivery
Clinical narrative: Information has been received from a mother, for GARDASIL, a Pregnancy Registry product, concerning her 20 year old daughter with penicillin allergy and no pertinent medical history, who on 09-AUG-2010 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot # not reported). There was no concomitant medication. The patient told the physician that she was not pregnant before she received a shot. The mother reported that the patient became pregnant 4 or 5 days prior to getting the shot. On an unspecified date, the patient had blood tests taken (the results not reported). The patient did not seek medical attention. Follow-up information has been received from an administrator reporting from the patient's chart that the patient (LMP: on approximately 28-JUL-2010, EDD: on approximately 05-MAY-2011) delivered a healthy female baby on 01-APR-2011 via C-section (cesarean section). The neonate weighed 7 lbs. 0 oz. at 35 weeks gestation. There were no congenital anomalies noted in the patient's OB/delivery record. Upon internal review, the C-section was determined to be an other important medical event. The baby's experience has been captured in WAES1009USA00163B1. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Normal newborn, Premature delivery
Clinical narrative: Information has been received from a mother, for GARDASIL, a Pregnancy Registry product, concerning her 20 year old daughter with penicillin allergy and no pertinent medical history, who on 09-AUG-2010 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot # not reported). There was no concomitant medication. The patient told the physician that she was not pregnant before she received a shot. The mother reported that the patient became pregnant 4 or 5 days prior to getting the shot. On an unspecified date, the patient had blood tests taken (the results not reported). The patient did not seek medical attention. Follow-up information has been received from an administrator reporting from the patient's chart that the patient (LMP: on approximately 28-JUL-2010, EDD: on approximately 05-MAY-2011) delivered a healthy female baby on 01-APR-2011 via C-section (cesarean section). The neonate weighed 7 lbs. 0 oz. at 35 weeks gestation. There were no congenital anomalies noted in the patient's OB/delivery record. Upon internal review, the C-section was determined to be an other important medical event. The baby's experience has been captured in WAES1009USA00163B1. Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Dyspnoea, Myalgia, Oedema peripheral, Urticaria
Clinical narrative: First broke out in hives in folds of arms and on neck, some wheezing and shortness of breath.  Later hands and feet swollen and muscles and joints ached for weeks.
Age: 46.0
Sex: F
Vaccine: ANTH
Symptoms: Wheezing
Clinical narrative: First broke out in hives in folds of arms and on neck, some wheezing and shortness of breath.  Later hands and feet swollen and muscles and joints ached for weeks.
Age: 25.0
Sex: M
Vaccine: TYP, UNK
Symptoms: Dizziness, Nausea, Pallor, Presyncope
Clinical narrative: VASO VAGAL, NAUSEA, LOSS OF SKIN COLOR, LIGHT HEADEDNESS
Age: 0.84
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Urticaria
Clinical narrative: Patient began to have hives all over her face and chest, no fever, no coughing or any other discomfort. Hives subsided after 2 days.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site haematoma, Local reaction, Skin warm, Swelling
Clinical narrative: Local reaction of palm size 9 cm x 8 cm reddened area. Raised & warm & tender. Is 8 cm below site 1 cm bruise at site. Treated with cold compress/ice, BENADRYL.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Local reaction of palm size 9 cm x 8 cm reddened area. Raised & warm & tender. Is 8 cm below site 1 cm bruise at site. Treated with cold compress/ice, BENADRYL.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Body temperature increased, Feeling hot, Hyperhidrosis, Pain
Clinical narrative: States she developed a temp of 101 on 6/9/11, felt achy and had lots of sweating.  States had mild rash to left lower forearm. States she felt weak, achy and sweating 6/10 & 6/11. States on Sunday 6/12 temp was 99-100 and achy and sweaty and weak and tongue was thick.  6/14 feels like she is weak and hot and not sweating today, but symptoms are improving.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Tongue disorder
Clinical narrative: States she developed a temp of 101 on 6/9/11, felt achy and had lots of sweating.  States had mild rash to left lower forearm. States she felt weak, achy and sweating 6/10 & 6/11. States on Sunday 6/12 temp was 99-100 and achy and sweaty and weak and tongue was thick.  6/14 feels like she is weak and hot and not sweating today, but symptoms are improving.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Paralysis, Sensory loss
Clinical narrative: Information has been received from a nurse, concerning her daughter, a 17 year old female (relevant medical history unspecified), who in 2010 ("last year") was vaccinated with the second dose of GARDASIL (lot #, route and injection site not reported). There were no other vaccinations or concomitant medications at the same visit. In 2010, the day after the vaccination, the patient became paralyzed from the waist down and lost feeling in her legs. She was taken to the Emergency Room (hospital unknown). She was not admitted and 3-5 days later she recovered. Vaccination with GARDASIL was discontinued after the second dose. Paralyzed from the waist down and lost feeling in legs was considered to be significant disability or incapacity by the reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Received DTAP, Polio and varicella vaccines in left arm on 6-6-11. There is swelling, redness approx. 7 cm x 7 cm.
Age: 1.14
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia, Wheezing
Clinical narrative: 6/8/11 received HIB vaccine. 6/9/11 developed fever T max 102 degrees - some wheezing noted at time of fever. ADVIL given fever decreased.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Hyperhidrosis, Joint stiffness, Pain
Clinical narrative: Per pt - first three days - fever, chills, sweating, achy resolved. Arm sore - shoulder joints tight and sore no redness or swelling - slowly getting better.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Per pt - first three days - fever, chills, sweating, achy resolved. Arm sore - shoulder joints tight and sore no redness or swelling - slowly getting better.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Paraesthesia, Rash macular, Vaccination site pain
Clinical narrative: Approx 51 hours after vaccination, patient developed 1 1/4" red blotch around vacc. area with soreness, swelling & itching. Symptoms continued for additional 30 hours before improvement. Started to improve after taking BENADRYL. Swelling was up to 4" below vac. site & tingling could be felt in neck & shoulder blade. No fever. Redness lasted 10 days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site swelling
Clinical narrative: Approx 51 hours after vaccination, patient developed 1 1/4" red blotch around vacc. area with soreness, swelling & itching. Symptoms continued for additional 30 hours before improvement. Started to improve after taking BENADRYL. Swelling was up to 4" below vac. site & tingling could be felt in neck & shoulder blade. No fever. Redness lasted 10 days.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Varicella like rash.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site nodule, Injection site pain, Neuralgia
Clinical narrative: Pt. received flu shot 11/12/2010. Came back to pharmacy to report a second time that she is still experiencing: soreness at site of injection, nerve pain extending down to elbow, knot at injection site which all limits her activities due to the pain.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 6/2/11 red, warm large area (L) upper arm at injection site. 6/3/11 area measured 6.5" x 4".
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received immunizations on 6-6-11. Mom noticed on the morning of 6-8-11 that her left thigh was red and swollen and warm to touch. The red swollen area was 12 cm by 16 cm measured by the pediatrician. BENADRYL 2 tsp every 6 hours and cool compresses were recommended. Will recheck if worsens.
Sex: U
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Mom called 6/6/11 to report baby began running fever after getting shots 6/1. Additionally, developed a rash which worsened over the next 4 days. Took baby to be checked at ED on 6/6/11.
Age: 1.54
Sex: M
Vaccine: DTAP
Symptoms: Irritability, Pain in extremity
Clinical narrative: Pt became very irritable & has leg pain.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Pt had a warm, red lump at site of injection. Pt saw doctor who advised ice packs and ibuprofen.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: Redness & warmth at/below injection site extending approx 3" around & below site. Reaction occurred 3 days after vaccine administered.
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Dysphagia, Neck pain, Paraesthesia, Swollen tongue, Vision blurred
Clinical narrative: Tingling on right side of face, tongue swelling, difficulty swallowing, left neck pain, left eye blurred vision. Progression in about 15 minutes. 50mg BENADRYL taken immediately. Symptoms subsided within 40-45 minutes.
Age: 49.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Full blood count normal, Laboratory test normal, Lymphadenopathy, Pyrexia, Rash generalised
Clinical narrative: Body rash, high fever. Axilla lymph adenopathy.
Age: 1.34
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: On 5-26-11 pt developed rash, received MMR on 5-17-11.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Muscle atrophy, Muscular weakness, Neuritis, Pain, Pain in extremity
Clinical narrative: *Patient presented with acute upper extremity pain followed by weakness of left upper arm and mild symptoms in right arm. MD/orthopedist working diagnosis: brachial plexus neuritis. Treated with VOLTAREN & conservative measures. Patient continues to recover, experiencing upper extremity weakness & muscle loss. *Acute onset of pain was preceded by mild symptoms December 2010.
Age: 22.0
Sex: F
Vaccine: JEV1, JEV1
Symptoms: Headache, Pruritus, Rash, Urticaria
Clinical narrative: Reports 24 hrs after vaccination that pt. developed hives (mostly on stomach), rash, itching and headache. Consulted PMD, took BENADRYL p.o. and sx subsided. Then 48 hrs after vaccination pt developed the same sx, took BENADRYL p.o. and sx subsided. No diff. breathing reported. Pt was never evaluated in person by a physician. No further sx.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Generalised erythema, Hypersensitivity
Clinical narrative: Systemic reaction, head to toe positive erythema.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: S/E From Tdap & MENACTRA given both at LD - red, swollen, warm to touch, area about 2" x 3". Mom call advice nurse. Applied warm compress, gave Ibuprofen. Pt was relieved. No itchiness. Seen MD. Ordered to apply cold packs within 48 not relieved, SEPTRA ABX.
Age: 0.31
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Cyanosis, Erythema, Injection site reaction, Local reaction
Clinical narrative: Leg turned blue 2 hours after injection. 911 called. Positive redness -> Pt seen positive pulses + 2 femoral/popliteal/DP. Positive redness severe local reaction -> responded to BENADRYL and prescribed Prednisone.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Pyrexia
Clinical narrative: Family came in 6/2/11 for additional vaccines. This family is very anxious about vaccination and is having us give one or two shots at a time. As we were discussing which shots to give they reported fever "very high" 101.8 forehead strip and continuous crying after the April 1, 2011 shots. They said she was very hard to console. This lasted a long time hard to tell if it was 3 hours of inconsolable crying.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Computerised tomogram thorax normal, Injection site pain, Laboratory test normal, Lymphadenopathy, Night sweats
Clinical narrative: Pt had Tdap - he then developed (R) shoulder pain, lymphadenopathy, night sweats. Eval in ER, PCP & by surgeon.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Face injury, Fall
Clinical narrative: Pt was feeling well when he left the office, he went home, did not eat lunch, went to swimming pool, felt faint and fell & hit face. Temperature outside near 100 degrees.
Age: 27.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Injection site reaction, Scab, Skin lesion
Clinical narrative: Pt autoinoculated - locations 2cm below site of vaccine (on Left deltoid), as well as below chin. Currently each site (as well as vaccine site) has lesion with 40-50% scabbing. Pt noticed lesions 5 days ago.
Age: 27.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Injection site reaction, Post vaccination autoinoculation, Scab, Skin lesion
Clinical narrative: Pt autoinoculated - locations 2cm below site of vaccine (on Left deltoid), as well as below chin. Currently each site (as well as vaccine site) has lesion with 40-50% scabbing. Pt noticed lesions 5 days ago.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash erythematous, Rash pruritic, Swelling face
Clinical narrative: Pt presented with rash around mouth area. Worsened to include itchy red rash down neck & swelling below jaw line. Pt took 25 mg BENADRYL, rash down neck disappeared & swelling below jawline went down.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site haematoma, Injection site pain, Pyrexia
Clinical narrative: TDAP: (L) arm (deltoid) became very painful & non-functional x 3 wks. with associated bruising extending to elbow. Also developed high fever (>103) x 4 days.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site dryness, Injection site erythema, Injection site pain, Injection site papule, Injection site pruritus
Clinical narrative: (R) upper arm (Tdap site) with 5 x 8 cm dry itchy papular red tender reaction. (L) upper arm (MENACTRA site) with 14 x 14 cm dry red itchy tender papular reaction. Both sites better after BENADRYL 50 mg.
Age: 1.01
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives 5 days after injection.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Injection site induration
Clinical narrative: Erythema 7.5 x 5 cm with induration at injection site.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus
Clinical narrative: Patient received inj. (SQ) on 18 May to left arm. No reaction appeared until Sunday 22 May. Area appears red (approx 5 cm) and feels a "bit itchy" color has changed from red to purple. Does not seem to be enlarging. Reported to doctor on 5-24-11 at 12:19 pm. Dr. off on Tuesday - will review & address on 5-25-11.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody positive, Back pain, Blood cortisol, Cognitive disorder, Computerised tomogram
Clinical narrative: Severe head, neck, back pain. Cognitive decline. Brain fog. Fever, blacking out (syncope). Pressure in head and neck, dizziness. Nausea. Chronic fatigue/several weeks duration/have seen Neurologist, ENT, Rheumatologist/many labs, MRI, CAT scan, LP - no definitive diagnosis to date.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Loss of consciousness
Clinical narrative: Severe head, neck, back pain. Cognitive decline. Brain fog. Fever, blacking out (syncope). Pressure in head and neck, dizziness. Nausea. Chronic fatigue/several weeks duration/have seen Neurologist, ENT, Rheumatologist/many labs, MRI, CAT scan, LP - no definitive diagnosis to date.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Lumbar puncture, Metabolic function test, Nausea, Neck pain, Nuclear magnetic resonance imaging
Clinical narrative: Severe head, neck, back pain. Cognitive decline. Brain fog. Fever, blacking out (syncope). Pressure in head and neck, dizziness. Nausea. Chronic fatigue/several weeks duration/have seen Neurologist, ENT, Rheumatologist/many labs, MRI, CAT scan, LP - no definitive diagnosis to date.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rheumatoid factor
Clinical narrative: Severe head, neck, back pain. Cognitive decline. Brain fog. Fever, blacking out (syncope). Pressure in head and neck, dizziness. Nausea. Chronic fatigue/several weeks duration/have seen Neurologist, ENT, Rheumatologist/many labs, MRI, CAT scan, LP - no definitive diagnosis to date.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Feeling hot, Influenza like illness
Clinical narrative: Received ADACEL 12 hours later c/o flu-like sx - chills - then hot.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: (R) thigh 3 cm erythema, slightly indurated. Conservative tx (cool packs, TYLENOL PRN). F/U instructs for need to return to clinic. Area marked with skin scribe.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Erythema, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: 5-25-11 Tdap given - in morning (Wed). 5-27-11 (AM) - Rt arm soreness (Fri). 5-28-11 (Sat) - AM - Rt arm feels bruised, HA in sinus area pain 4/10 - took ADVIL and GOODY Powder, Rt arm painful 3/10. 5-30-11 (Mon) AM - HA ended. Rt arm still sore, bruised feeling, now reddened. 5-31-11 (Tues) AM - Eval by EH RN - Rt arm site red 14cm x 9cm at injection site, 1+ edema, deltoid site is very warm to touch, very tender to touch, cool compress applied, BENADRYL at hs.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pain in extremity, Sinus headache
Clinical narrative: 5-25-11 Tdap given - in morning (Wed). 5-27-11 (AM) - Rt arm soreness (Fri). 5-28-11 (Sat) - AM - Rt arm feels bruised, HA in sinus area pain 4/10 - took ADVIL and GOODY Powder, Rt arm painful 3/10. 5-30-11 (Mon) AM - HA ended. Rt arm still sore, bruised feeling, now reddened. 5-31-11 (Tues) AM - Eval by EH RN - Rt arm site red 14cm x 9cm at injection site, 1+ edema, deltoid site is very warm to touch, very tender to touch, cool compress applied, BENADRYL at hs.
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: Patient developed rash after three hours up on administration.
Age: 18.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Child felt fine after his vaccinations but had syncopal episode while driving home approximately 10 minutes after vaccinations.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: About an hour after the vaccination, I experienced a rash and itching around the site of the injection. The rash & itching lasted a total of 7 days after the injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red rash the size of a half dollar at the injection site.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood culture negative, Culture urine negative, Disorientation, Dizziness, Dyskinesia
Clinical narrative: Approximately 2 minutues following injection, child fell out of chair and onto the floor. Child had involuntary muscle movements of upper extremities; eyes were rolling back; non-responsive for ~ 45 seconds. Upon regaining responsiveness child reported was disoriented and reported that her head hurt. A few hours following the event the child reported to her mother that following the injection she began to feel dizzy and had a headache.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Fall, Gaze palsy, Headache, Unresponsive to stimuli, Urine analysis abnormal
Clinical narrative: Approximately 2 minutues following injection, child fell out of chair and onto the floor. Child had involuntary muscle movements of upper extremities; eyes were rolling back; non-responsive for ~ 45 seconds. Upon regaining responsiveness child reported was disoriented and reported that her head hurt. A few hours following the event the child reported to her mother that following the injection she began to feel dizzy and had a headache.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site joint pain, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Significant swelling, redness, heat and pain at the injection site (left deltoid). Muscle pain in left arm. Left shoulder joint pain.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: Significant swelling, redness, heat and pain at the injection site (left deltoid). Muscle pain in left arm. Left shoulder joint pain.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site pain, Nuclear magnetic resonance imaging, Pain in extremity, Pyrexia
Clinical narrative: Right arm hurt more than usual after flu shots shortly after shot given.  At 11 p.m. had chills, fever.  Right arm continued to hurt for 1-2 weeks.  Noticed Left arm also started hurting during the 2nd week after shot.  Describes pain as 11 on 1-10 pain scale. Saw different MD, who did MRI, and referred to Physical Therapy.  Completed PT in 6 weeks, with continued but less severe pain.  Also noticed left leg pain.  Continues with pain in both upper arms and left leg, rated as 4 on 1-10 pain scale.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Anxiety, Dizziness, Erythema, Feeling hot, Hypersensitivity
Clinical narrative: On 6/10/11, employee received the 3rd and final dose of the Hepatitis B vaccine. Patient reported to his unit to work his shift. At an unknown time, he reported not feeling well, dizzy, nauseated, and vomited x1. He was assessed at 5:15 p.m. by our psychiatric hospital physician and was referred to a local hospital for further evaluation and treatment. Patient was seen by a physician at the local hospital and was advised that he had an "allergic reaction to the Hepatitis B vaccine. No more Hep B Vaccine". Patient was able to return to work on the same day.  Note: Patient also reported that at the time of his 2nd dose of the Hep B vaccine he had a reaction stating his arm turned red, felt "hot" and anxious.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Malaise, Nausea, Vaccination complication, Vomiting
Clinical narrative: On 6/10/11, employee received the 3rd and final dose of the Hepatitis B vaccine. Patient reported to his unit to work his shift. At an unknown time, he reported not feeling well, dizzy, nauseated, and vomited x1. He was assessed at 5:15 p.m. by our psychiatric hospital physician and was referred to a local hospital for further evaluation and treatment. Patient was seen by a physician at the local hospital and was advised that he had an "allergic reaction to the Hepatitis B vaccine. No more Hep B Vaccine". Patient was able to return to work on the same day.  Note: Patient also reported that at the time of his 2nd dose of the Hep B vaccine he had a reaction stating his arm turned red, felt "hot" and anxious.
Age: 11.0
Sex: M
Vaccine: YF, YF
Symptoms: Chest discomfort, Dizziness, Rash, Syncope, Vomiting
Clinical narrative: Patient received SQ Yellow Fever vaccination in his left upper arm @ ~ 0915 & had a syncopal episode ~ 5 minutes later lasting 5 minutes. Patient kept supine and apparently recovered completely within 15 minutes. Mother given instructions to take patient home with no physical activity for the rest of the morning.  Received a phone call @ ~ 10:10 AM from the patient's mother reporting that the patient had become lightheaded again and vomited food from breakfast. She also indicated that the patient had a fine yellow, non-pruritic rash on his abdomen and had briefly c/o a tightness in his chest, although he was presently not SOB and was speaking in full sentences without difficulty. His mother was given instructions to take the child to the nearest emergency department. She agreed to do so. Approximately 1 hour later I again called the patient's mother to check on his progress. She stated he had been taken back to a treatment room, had been given Benadryl and was now experiencing a decreasing rash with no other symptoms.
Age: 11.0
Sex: M
Vaccine: YF, YF
Symptoms: Yellow skin
Clinical narrative: Patient received SQ Yellow Fever vaccination in his left upper arm @ ~ 0915 & had a syncopal episode ~ 5 minutes later lasting 5 minutes. Patient kept supine and apparently recovered completely within 15 minutes. Mother given instructions to take patient home with no physical activity for the rest of the morning.  Received a phone call @ ~ 10:10 AM from the patient's mother reporting that the patient had become lightheaded again and vomited food from breakfast. She also indicated that the patient had a fine yellow, non-pruritic rash on his abdomen and had briefly c/o a tightness in his chest, although he was presently not SOB and was speaking in full sentences without difficulty. His mother was given instructions to take the child to the nearest emergency department. She agreed to do so. Approximately 1 hour later I again called the patient's mother to check on his progress. She stated he had been taken back to a treatment room, had been given Benadryl and was now experiencing a decreasing rash with no other symptoms.
Age: 40.0
Sex: F
Vaccine: ANTH, PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Due to the site the date is set as 06/14, however actual onset date is 06/15/2011. Nurse in ER called, and notified Patient visited ER this morning, left deltoid swollen, rash around the left deltoid area and radiated. No fever. Patient given Benadryl and some antibiotics and left.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Anaemia haemolytic autoimmune, Biopsy bone marrow, Blood test, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy
Clinical narrative: Onset of petechiae on legs and then arms and mouth over next 24 hours platelet count dropped to 1000. Developed formal ITP diagnosed by hematologist on 3/25/2011. Admitted to hospital and given steroids and IgG. On 3/29/2011 developed autoimmune hemolytic anemia as well.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test, Petechiae, Platelet count decreased
Clinical narrative: Onset of petechiae on legs and then arms and mouth over next 24 hours platelet count dropped to 1000. Developed formal ITP diagnosed by hematologist on 3/25/2011. Admitted to hospital and given steroids and IgG. On 3/29/2011 developed autoimmune hemolytic anemia as well.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, swelling, redness, and pain at injection site about 5 x 5 inches.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Sleep disorder, Ultrasound scan
Clinical narrative: Tdap 5/31/11 was given to pt. Her arm became sore, and she stated it woke her up at night due to the pain. On 6/14/11 she came into the office and stated her mother told her when she was an infant she had a reaction to the tetanus combo vaccine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mild swelling & redness to left anterior thigh.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site scab, Injection site swelling
Clinical narrative: 6/14/11 - 410pm - c/o of increased pain, redness, & swelling of Right deltoid x 5 days after getting Tdap injection on 6/9/11. Intermittent fevers - (R) deltoid - very tender to touch. Yellowish scab noted at injection site. No fluctuance noted at site. Erythematous areas noted at injection site. A - Possible adverse reaction vs cellulitis. P - Rx given for KEFLEX & BACTRIM DS x 10 days.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: 6/14/11 - 410pm - c/o of increased pain, redness, & swelling of Right deltoid x 5 days after getting Tdap injection on 6/9/11. Intermittent fevers - (R) deltoid - very tender to touch. Yellowish scab noted at injection site. No fluctuance noted at site. Erythematous areas noted at injection site. A - Possible adverse reaction vs cellulitis. P - Rx given for KEFLEX & BACTRIM DS x 10 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Erythemic rash on the right breast approx 2 - 1 x 2 cm and 1 on right at waist line - did not follow dermatome.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Pruritus, Rash erythematous
Clinical narrative: Redness & swelling at injection site & red rash on body. Pt. felt "warm". Pt. used hydrocortisone 1% on site & ice. Pt. reported to be "much better" on 6/14/11 at 9:05 AM. Itching has subsided.
Age: 1.55
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Eyelid oedema, Rash macular
Clinical narrative: Erythematous macular of cheeks, upper neck & back. Swollen eyelids, no SOB, mental status normal, child active, no fever.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Parotid gland enlargement, Pyrexia, Swelling face
Clinical narrative: (R) facial swelling & redness developed at daycare on 6/9/11 with fever 102 overnight. No other symptoms. No runny nose. No cough, acting fine on exam on 6/10/11 at 4pm noted (R) lower cheek/jaw parotid gland firm, edema, mild redness nontender to gentle palpitation. Jaw has full ROM. Exam negative otherwise/impression Parotiditis secondary to MMR vaccine with fever.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever 1 week after shots - lasted 3 days. Rash 9 days after shots.
Age: 1.49
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Peripheral coldness
Clinical narrative: Both hands red, swollen, and cold.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus
Clinical narrative: Employee reported itching arms, ears, back, hip areas approx. 2 hours after receiving vaccine. Employee declined to go to ER only accepted BENADRYL 25-50mg dose. States alleviated somewhat.
Age: 0.73
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Rash
Clinical narrative: Rash on face, neck and stomach started last pm. Giving BENADRYL 3/4 tsp po q6h.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient developed cellulitis at injection site.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Headache
Clinical narrative: A few hours after administration pt became very tired. She then got a headache and her back became sore. ER visit followed.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability, Laboratory test, Lethargy, Pallor
Clinical narrative: Vaccines -> few hrs later child seemed more fussy than NL but nursed well. Mother provided dose of TYLENOL. Shortly after, child had "pale lips" but was breathing normally. ? slightly lethargic. Child taken to ER for eval.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site nodule, Injection site rash, Injection site swelling
Clinical narrative: As soon as withdrawing the needle from arm the area around the site began swelling and turning red. Applied ice to site and patient took BENADRYL at home. Area stayed red & swollen for 5 days. Still has a knot at injection site small dry rash and less redness.
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Anaphylactic reaction, Apnoea, Cyanosis, Death, Hypopnoea
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in an infant male subject who was vaccinated with DTAP vaccine (manufacturer unspecified). The subject's medical history included seizure. On an unspecified date the subject received unspecified dose of DTAP vaccine (unknown route, unknown lot number). 20 to 30 minutes after vaccination with DTAP vaccine, the subject experienced anaphylaxis. After nap, he experienced cyanosis, apnea, shallow breathing and respiratory arrest. A pathology report showed interstitial edema. The subject died, cause of death is not specified. It was unknown whether an autopsy was performed. Initial case was retrieved from the scientific literature on 08 June 2011. The National Vaccine Injury Compensation Program (VICP) was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for several vaccines. In 2009, the VICP charged the Institute of Medicine with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute of Medicine's review, the author undertook a systematic analysis of the VICP''s anaphylaxis case experiences. The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31, 2009. Cases were categorized as anaphylaxis, possibly allergic-not anaphylaxis, and not anaphylaxis or allergic. The anaphylaxis cases all met the Brighton Collaboration (BC) case definition and were further subdivided into 3 levels of diagnostic certainty using major and minor criteria, with level 1 being the greatest level of certainty. Possible allergic cases were defined as those for which there were signs and/or symptoms compatible with an allergic reaction occurring within 4 hours of injection but that did not meet any of the BC case definitions for anaphylaxis. All of our anaphylaxis cases met the BC diagnostic certainty and, with an interval of 0 to 4 hours, are consistent with the current VIT. This case was classified at level 2 of certainty. This review represented the first systematic approach in analyzing the VICP experience with anaphylaxis and will be useful when the VIT is updated. This is one of 9 cases reported in the same article and represented 8 different vaccines containing at least 11 different vaccine antigens.
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Oedema, Respiratory arrest
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in an infant male subject who was vaccinated with DTAP vaccine (manufacturer unspecified). The subject's medical history included seizure. On an unspecified date the subject received unspecified dose of DTAP vaccine (unknown route, unknown lot number). 20 to 30 minutes after vaccination with DTAP vaccine, the subject experienced anaphylaxis. After nap, he experienced cyanosis, apnea, shallow breathing and respiratory arrest. A pathology report showed interstitial edema. The subject died, cause of death is not specified. It was unknown whether an autopsy was performed. Initial case was retrieved from the scientific literature on 08 June 2011. The National Vaccine Injury Compensation Program (VICP) was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for several vaccines. In 2009, the VICP charged the Institute of Medicine with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute of Medicine's review, the author undertook a systematic analysis of the VICP''s anaphylaxis case experiences. The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31, 2009. Cases were categorized as anaphylaxis, possibly allergic-not anaphylaxis, and not anaphylaxis or allergic. The anaphylaxis cases all met the Brighton Collaboration (BC) case definition and were further subdivided into 3 levels of diagnostic certainty using major and minor criteria, with level 1 being the greatest level of certainty. Possible allergic cases were defined as those for which there were signs and/or symptoms compatible with an allergic reaction occurring within 4 hours of injection but that did not meet any of the BC case definitions for anaphylaxis. All of our anaphylaxis cases met the BC diagnostic certainty and, with an interval of 0 to 4 hours, are consistent with the current VIT. This case was classified at level 2 of certainty. This review represented the first systematic approach in analyzing the VICP experience with anaphylaxis and will be useful when the VIT is updated. This is one of 9 cases reported in the same article and represented 8 different vaccines containing at least 11 different vaccine antigens.