chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Anaphylactic reaction, Hypersensitivity, Wheezing
Clinical narrative: Initial information has been received from an office manager and a nurse practitioner concerning a 4 year old male patient with asthma, allergic reaction to bee sting. On 18-FEB-2013, the patient was vaccinated with the second dose of M-M-R II(lot H012140 exp date 29-JUN-2014)  (dose, route were not reported). Other suspect vaccination included second dose of (Merck) VARIVAX (lot H016911 exp date 10-SEP-2014) (18-FEB-2013). Concomitant vaccination given the same day included a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified) (18-FEB-2013), tetanus toxoid(diphtheria toxoid(+) pertussis acellular vaccine (unspecified) (+) and IPOL (18-FEB-2013) (dose, route were not reported), all of them on the same date. Concomitant therapies included ibuprofen, budesonide. On 18-FEB-2013, the patient was given ibuprofen and 4 vaccines and within 5 minutes he had an allergic reaction. He began wheezing and was administered oxygen, albuterol and epinephrine. He was transferred and admitted to the hospital. The nurse practitioner stated that the reaction was anaphylactic and life threatening. At the time of report, the patient had not recovered. Anaphylactic reaction was considered to be life threatening, medically significant and disabling by the reporter. Additional information has been requested.
Age: 0.76
Sex: M
Vaccine: IPV
Symptoms: Vomiting
Clinical narrative: Child vomited food eaten for dinner.
Sex: F
Vaccine: MMR
Symptoms: Adverse reaction, Malaise, Vaccination failure
Clinical narrative: This spontaneous report as received from a registered nurse refers to a current 47 year old female patient without drug reactions or allergies. On an unknown date the patient was vaccinated with M-M-R II (lot number, dose, route and injection site were not reported) when the patient was young and again when she was 19 years old (approximately in 1985). On unknown date the patient had never developed immunity and also experienced a bad reaction and got really sick. The nurse did not know when the patient experienced this bad reaction and got really sick. The outcome of adverse event was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Sore left deltoid that has persisted x 6 months.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Headache
Clinical narrative: Chills, stomach ache, vomiting, diarrhea, headache, overall weakness.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Chills, stomach ache, vomiting, diarrhea, headache, overall weakness.
Age: 36.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Itching, redness, swelling, soreness, no treatment received. 11.5 X 7 cm.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection reddened, warm, swollen, hard, and stayed this way for one week.
Age: 0.36
Sex: F
Vaccine: RVX
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Throwing up and mild diarrhea.
Age: 1.67
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Erythema, Rash
Clinical narrative: Mom noticed a rash on patient torso, red, bumpy, no other symptoms, no itching, no swelling.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient received shingles vaccine and approximately 5 weeks later starting to develop rashes that appear to be shingles.  Patient believes that vaccine to be the trigger.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient received shingles vaccine and approximately 5 weeks later starting to develop rashes that appear to be shingles.  Patient believes that vaccine to be the trigger.
Age: 60.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Activities of daily living impaired, Central nervous system lesion, Gait disturbance, Hypoaesthesia, Laboratory test
Clinical narrative: Initial case was received from a healthcare professional, who was also the patient, on 11 February 2013, with follow-up information on 12 February 2013. A 60-year-old female patient received an injection of TYPHIM Vi, Sanofi Pasteur SA, lot number unknown, (route, site, side and dose in series not reported) and an injection of Hepatitis A vaccine, other manufacturer, (lot number, route, site, side and dose in series not reported) on 09 January 2013 at work place in preparation (prep) for travel. The patient traveled on 16 January 2013. On Saturday, 19 January 2013, ten days post vaccination; the patient noticed she could not "place right foot correctly when walking" but thought she was tired from the trip. Then on 20 January 2013, reported as in the morning "am" Sunday, she could not feel left side from naval to toes and was limping. On Monday, she sought medical treatment and saw a neurologist; the followed up with neurologist. The patient had no past medical history and no known allergies. She had received no other vaccinations within four weeks of vaccinations and had no illness at time of vaccination. On unspecified dates, a magnetic resonance imaging (MRI) showed lesion on T3-T4; and unspecified other numerous tests were performed. The neurologist diagnosed the patient with transverse myelitis post vaccination and treated her with high doses of steroids. At time of report the patient still had a limp, was using a cane, and had not returned to work. She was continuing follow-up treatment and had appointment with neurologist on 14 February 2013. The patient's outcome was reported as not recovered. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Myelitis transverse, Nuclear magnetic resonance imaging spinal cord abnormal, Walking aid user
Clinical narrative: Initial case was received from a healthcare professional, who was also the patient, on 11 February 2013, with follow-up information on 12 February 2013. A 60-year-old female patient received an injection of TYPHIM Vi, Sanofi Pasteur SA, lot number unknown, (route, site, side and dose in series not reported) and an injection of Hepatitis A vaccine, other manufacturer, (lot number, route, site, side and dose in series not reported) on 09 January 2013 at work place in preparation (prep) for travel. The patient traveled on 16 January 2013. On Saturday, 19 January 2013, ten days post vaccination; the patient noticed she could not "place right foot correctly when walking" but thought she was tired from the trip. Then on 20 January 2013, reported as in the morning "am" Sunday, she could not feel left side from naval to toes and was limping. On Monday, she sought medical treatment and saw a neurologist; the followed up with neurologist. The patient had no past medical history and no known allergies. She had received no other vaccinations within four weeks of vaccinations and had no illness at time of vaccination. On unspecified dates, a magnetic resonance imaging (MRI) showed lesion on T3-T4; and unspecified other numerous tests were performed. The neurologist diagnosed the patient with transverse myelitis post vaccination and treated her with high doses of steroids. At time of report the patient still had a limp, was using a cane, and had not returned to work. She was continuing follow-up treatment and had appointment with neurologist on 14 February 2013. The patient's outcome was reported as not recovered. Documents held by sender: None.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Abnormal faeces, Back pain, Blood test, Computerised tomogram
Clinical narrative: From 10/13/12 Pancreatitis 3 days after vaccine abdominal pain radiated to back feel worse after eating nausea, indigestion, acid reflux oily smelly stool, respiratory symptom.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspepsia, Gastrooesophageal reflux disease, Nausea, Pain, Pancreatitis
Clinical narrative: From 10/13/12 Pancreatitis 3 days after vaccine abdominal pain radiated to back feel worse after eating nausea, indigestion, acid reflux oily smelly stool, respiratory symptom.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory disorder, Steatorrhoea, Stool analysis
Clinical narrative: From 10/13/12 Pancreatitis 3 days after vaccine abdominal pain radiated to back feel worse after eating nausea, indigestion, acid reflux oily smelly stool, respiratory symptom.
Age: 9.0
Sex: M
Vaccine: TD
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting & diarrhea 6 days after vaccine.
Age: 1.68
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Body temperature increased, Injection site swelling, Irritability
Clinical narrative: Temp of 104, fussy & cranky for 24-36 degrees after injection Lg amt swelling at injection site.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Coma, Malaise
Clinical narrative: Pt received vaccines on 8/31/12 and didn't feel well 3 days later. Was hospitalized & went into a coma on 9/3/12 for 2 weeks. Patient is doing well now.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Unevaluable event
Clinical narrative: Pt received vaccines on 8/31/12 and didn't feel well 3 days later. Was hospitalized & went into a coma on 9/3/12 for 2 weeks. Patient is doing well now.
Age: 0.16
Sex: F
Vaccine: HIBV
Symptoms: Chest X-ray normal, Crying, Cyanosis, Electrocardiogram normal, Full blood count normal
Clinical narrative: Following HIB and SYNAGIS injection, patient crying and diaphoretic and then suddenly went pale approximately 1 min later. No sign of breathholding or reflux. Patient became quite pale and then dusky/blue, seemed to stop breathing for a second. Was stimulated with sternal rub and began breathing. Was not really crying but just whimpering and pale for about 2-3 minutes after the event. First HR about 1-2 minutes after the event was noted to be 50-60, so possibly some sort of vagal episode. Sent to ED for further evaluation, expect called.
Age: 0.16
Sex: F
Vaccine: HIBV
Symptoms: Heart rate decreased, Hyperhidrosis, Pallor, Respiratory arrest
Clinical narrative: Following HIB and SYNAGIS injection, patient crying and diaphoretic and then suddenly went pale approximately 1 min later. No sign of breathholding or reflux. Patient became quite pale and then dusky/blue, seemed to stop breathing for a second. Was stimulated with sternal rub and began breathing. Was not really crying but just whimpering and pale for about 2-3 minutes after the event. First HR about 1-2 minutes after the event was noted to be 50-60, so possibly some sort of vagal episode. Sent to ED for further evaluation, expect called.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Mom called 2/21/13 - RN spoke to 16 y/o male pt who c/o waking up on 2/21/13 morning w/rash all over body. C/O rash being red round raised bumps that itch on face, trunk, arms & legs. Pt denied any wheezing, SOB. now or at any time. Pt denied weakness, rapid or irregular heart beat or dizziness.
Age: 1.55
Sex: F
Vaccine: HEPA
Symptoms: Abscess, Culture wound positive, Incisional drainage, Staphylococcal infection, Staphylococcus test positive
Clinical narrative: Developed abscess -MRSA at injection site 2 days later. Performed incision & drainage & antibiotics.
Age: 38.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Erythema, Headache, Pain, Swelling
Clinical narrative: Redness, swelling, pain, headache started the night of 2/19/13. Pt. came in 2/21/13 to be seen, felt symptom's were getting worse. Tx: Antibiotics, TYLENOL, warm compress to site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Swelling, Urticaria
Clinical narrative: Developed hives and swelling 5 hours after receiving vaccines. Hives were only on the face, nowhere else.
Age: 60.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Induration, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: Reaction to PNEUMOVAX. Day 1 no reaction. Day 2 redness 1-2 inches below injection site. Day 3 +4 +5 fever and swelling of arm from elbow to shoulder - became hot and hard to the touch. Day 6/7 - showing improvement.
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Sepsis
Clinical narrative: Patient's entire arm became red and swollen approximately 12 hours after injection. Patient went to the local ER and was diagnosed with blood poisoning and was given antibiotics and steroids.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Fatigue, Injection site erythema
Clinical narrative: Extreme swelling and redness, itchiness at vaccination location. Extreme joint aches, pains, weakness, tiredness stomach problems, possible skin infection. All the above lasted 4 weeks.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Extreme swelling and redness, itchiness at vaccination location. Extreme joint aches, pains, weakness, tiredness stomach problems, possible skin infection. All the above lasted 4 weeks.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity, Rash, Skin warm
Clinical narrative: Left arm pain and swelling, rash and warm to touch.
Age: 26.0
Sex: F
Vaccine: PPV, HEPA, HPV4, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 26 year old female patient with asthma and allergy to ULTRAM. On 19-FEB-2013, the patient was vaccinated with a 0.5 ml IM dose of GARDASIL (Lot # H013831 expiration date 06-MAR-2015), intramuscularly, a dose of VAQTA (route and Lot # not reported). Concomitant therapies included ADACEL PROAIR and ZOVIA. The nurse reported that on 19-FEB-2013, within 1 minute after administration of VAQTA, ADACEL and GARDASIL the patient experienced dizziness and feeling faint. The patient then became unconscious and had a minimal seizure with involuntary movements for 30 seconds. The patient was incontinent of urine. After reviving, the patient was provided lemonade, was monitoring in the office and fully recovered in 45 minutes. The nurse stated that the patient had not eaten on the days of administration. There were no Lab diagnosis or studies performed. Upon internal review patient became unconscious and minimal seizure with involuntary movements were considered medically significant. This is one of two reports received concerning the same patient. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: PPV, HEPA, HPV4, TDAP
Symptoms: Convulsion, Dizziness, Dyskinesia, Loss of consciousness, Urinary incontinence
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 26 year old female patient with asthma and allergy to ULTRAM. On 19-FEB-2013, the patient was vaccinated with a 0.5 ml IM dose of GARDASIL (Lot # H013831 expiration date 06-MAR-2015), intramuscularly, a dose of VAQTA (route and Lot # not reported). Concomitant therapies included ADACEL PROAIR and ZOVIA. The nurse reported that on 19-FEB-2013, within 1 minute after administration of VAQTA, ADACEL and GARDASIL the patient experienced dizziness and feeling faint. The patient then became unconscious and had a minimal seizure with involuntary movements for 30 seconds. The patient was incontinent of urine. After reviving, the patient was provided lemonade, was monitoring in the office and fully recovered in 45 minutes. The nurse stated that the patient had not eaten on the days of administration. There were no Lab diagnosis or studies performed. Upon internal review patient became unconscious and minimal seizure with involuntary movements were considered medically significant. This is one of two reports received concerning the same patient. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Lethargy, Myalgia
Clinical narrative: Approximately 6 hours post injection, sudden onset of arthralgia, myalgia, headache, and lethargy that lasted approx. 10 days. My MD gave me a homeopathic remedy for 2 weeks.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash morbilliform, Rubella
Clinical narrative: Rash appeared on trunk then on extremities and face - morbilliform rash - appears to be like Rubella, no itching.  Appeared suddenly.
Age: 50.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Cellulitis, Erythema, Pain in extremity, Vaccination complication
Clinical narrative: Painful, red arm.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Diarrhoea, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Headache began at 6:30 PM, then he became nauseated and ran a slight fever.  He vomited between 1:30 AM and 5:30 AM and had mild diarrhea.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Headache, Influenza virus test negative
Clinical narrative: 62 y/o male seen in clinic for Zoster vaccine.  Discussed any known allergies, current illness.  Zosta given SC, left upper arm.  Tolerated well.  Client reports that @ 2 pm began having chills, dull headache.  EMS called by coworker.  T: 103.5 and BP 210/100.  Taken to ER.  T - 103.9.  Monitored @ ER for 2-3 hours.  Temp came down and when released @ 7 pm, BP 120/56.  ER also checked for flu - negative.  Contacted 2/14/13 - doing well, no problems.  Reports no reaction @ IZ site.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, Blood magnesium normal, Convulsion, Culture urine negative, Full blood count normal
Clinical narrative: Seizure beginning with R arm shaking, subsequently whole body shaking, unresponsive, lasted ~5-7 minutes.  EMS called, arrived 10 minutes after onset at which point shaking stopped.  Another 25 sec episode of whole body shaking in ambulance.  Not back to baseline when first arrived in ED (irritable, not tracking, minimally responsive to mom's voice) but at baseline prior to discharge.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Metabolic function test normal, Tremor, Unresponsive to stimuli
Clinical narrative: Seizure beginning with R arm shaking, subsequently whole body shaking, unresponsive, lasted ~5-7 minutes.  EMS called, arrived 10 minutes after onset at which point shaking stopped.  Another 25 sec episode of whole body shaking in ambulance.  Not back to baseline when first arrived in ED (irritable, not tracking, minimally responsive to mom's voice) but at baseline prior to discharge.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Neck pain
Clinical narrative: Neck pain, hip pain.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site atrophy, Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: Injection site reaction: skin discoloration, redness, tenderness, and indentation that has been present for 4 months and is still present.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: PATIENT DEVELOPED SHINGLES OUTBREAK.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abasia, Arthropathy, Pain in extremity
Clinical narrative: Per MD patient complained of lower limb pain diagnosis code 729.5. Patient states that she was unable to walk because her hip would give out and have radiating pain down the leg.
Age: 64.0
Sex: M
Vaccine: HEP
Symptoms: Joint swelling, Pruritus, Rash
Clinical narrative: Developed rash on arms, legs, trunk, knees swollen, c/o itchiness. Per advise of his physician, he took OTC antihistimine as treatement of symptoms.
Sex: U
Vaccine: HIBV
Symptoms: Convulsion
Clinical narrative: The author of the literature article described clinical characteristics of children alleging seizure disorder as an injury due to vaccination. Retrospective record review of vaccine-alleged seizure disorder cases in children aged <2 years filing a claim during 1995-2006. The NVICP retrieved 242 cases alleging seizure as vaccine injury. Of 96 cases retrieved thus far, 71 were filed in 1995-6, 10 in 1997-2002. Half were male. Vaccines implicated (sometimes multiple) included Hib (manufacturer unknown). 2 patients had a seizure within 72 hours of vaccination. A significant number of children with alleged vaccine induced seizure disorders had pre-existing neurological or neurodevelopmental abnormalities. Among those developing chronic epilepsy, many had clinical features suggesting genetically determined epilepsy. The patients outcome was not reported. Upon internal review, the event of vaccine-alleged seizure disorder was considered medically significant. This is one of several reports from the same source. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Chest discomfort, Chills, Nasopharyngitis, Pharyngeal oedema
Clinical narrative: Severe throat swelling & tightness, tightness Left chest, cold & shivering.  During the night, I was awoken with abdo pain & vomiting thee times.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness, Vomiting
Clinical narrative: Severe throat swelling & tightness, tightness Left chest, cold & shivering.  During the night, I was awoken with abdo pain & vomiting thee times.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Extreme pain, severe itching and redness that has lasted through today.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site rash
Clinical narrative: Rash on top of both thigh areas around the injection sites.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HIBV, IPV, RVX
Symptoms: Convulsion
Clinical narrative: Seizure, reported it to baby's nurse at clinic, she notified her pediatrician. Told to bring baby to the ER which we did. Treated in the ER, diagnosed as having a seizure.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Oedema peripheral, Pyrexia
Clinical narrative: Fever x 3 d. Swelling of the upper arm - ice, BENADRYL. Dizziness.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Burning sensation, Oedema peripheral
Clinical narrative: Pts. Mom called 2/20/13 late pm. Stating son had reaction to chicken pox shot. Had a large swollen area that burned on (L) back of arm where shot had been given. Made pt. appt. for 2/21/13 at 9:15/AM.
Age: 1.13
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Livedo reticularis, Rash
Clinical narrative: Within 15 mins of vaccine administration mother noticed rash on chest & back. Injection sites ck'd redness & warmth noted bil - mottled rash. BENADRYL 25/5ml 2.5ml PO given. Rash resolved dc'd home with inst to give BENADRYL q6 & ZYRTEC 2.5ml for next 3 days. To go to ER if reoccurs.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Middle insomnia, Nerve injury, Pain in extremity
Clinical narrative: Patient reports pain in arm and is waking up at night. After discussing with doctor, he believes a nerve may have been impacted by the vaccine.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Redness, edema, sm induration at injection site. Arthralgia throughout body.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Developed redness and swelling at MMRV site the evening after vaccination. Also developed slight fever. Redness swelling continued to increase after the next 3 days.
Age: 1.06
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR
Symptoms: Injection site mass
Clinical narrative: 02/20/2013 Mother noticed a lump on client's right thigh the middle of this week (02/20/13). Today it is the size of a pea, not red in color, and bothers the client upon palpation of the bump. Mother has given client TYLENOL. Encouraged to speak with doctor on Monday if mother is still concerned.
Sex: U
Vaccine: MMR
Symptoms: Convulsion
Clinical narrative: The author of the literature article described clinical characteristics of children alleging seizure disorder as an injury due to vaccination. Retrospective record review of vaccine-alleged seizure disorder cases in children ages <2 years filing a claim during 1995-2006. The NVICP retrieved 242 cases alleging seizure as vaccine injury. Of 96 cases retrieved thus far, 71 were filed in 1995-6, 10 in 1997-2002. Half were male. Vaccines implicated (sometimes multiple) included Measles, Mumps, Rubella  (manufacturer unknown). 17 patients had a seizure within 72 hours of vaccination. A significant number of children with alleged vaccine induced seizure disorders had pre-existing neurological or neurodevelopmental abnormalities. Among those developing chronic epilepsy, many had clinical features suggesting genetically determined epilepsy. The patients outcome was not reported. Upon internal review, the event of vaccine-alleged seizure disorder was considered medically significant. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Guillain-Barre syndrome, Mobility decreased, Oedema peripheral, Respiratory failure
Clinical narrative: Information has been received from a lawyer regarding a case in litigation. It is alleged that a female on 03OCT2012, was vaccinated with a dose of ZOSTAVAX (Merck) Lot #1160AA. After the pharmacist administered the medication, the patient began having side effects, swollen arm and redness, did not want to "seize" after patient called the pharmacist many times and instructions were given in what to do by pharmacist. On 14OCT2012, the patient was hospitalized since she could not "more" her arms and legs. In the hospital, the patient was diagnosed with Guillain-Barre Syndrome and had respiratory failure. As to date, the patient is taking physical therapy. Upon internal review, Guillain Barre was determined to be a medical significant event. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC, VARCEL
Symptoms: Cough, Rash pruritic
Clinical narrative: Rash about 4 hrs after injections. Rash is pruritic, minor cough, no fever. Rash is on his hands, arms, legs, neck and back. Topical HCS 1% bid x 1 week PRN, PO BENADRYL, Calamine lotion, oatmeal baths.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Extreme pain.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Reddened area 4 x 2 1/2 in area warm to touch, tenderness at Dtap site.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Telephone call to Emp Health from pt on 2/22/13 with initial complaint of onset of spasms in arm she rec'd injection in that began 2 wks after injection. She experienced spasms twice daily x 1 month. Now with soreness in arm to elbow. She declined to come to EH for evaluation. She will f/u with PCP.
Age: 29.0
Sex: M
Vaccine: HEPAB, TDAP, YF
Symptoms: Blood test, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Pt. stated he started having tingling sensations in both hands, both feet & (R) side of face starting 2.5-3 wks after Yellow Fever vaccination. Tingling constant initially now occurs periodically. This information was reported to clinic 02/19/13.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: This spontaneous report as received from a Medical Assistant who administers vaccines refers to a currently 18 year old female patient with not pertinent Medical history or Drug reactions/allergies. On 25-JAN-2013, the patient was vaccinated intramuscularly with the first and only dose of GARDASIL lot # 0324AE, Expire date: 20-OCT-2014 (dose not reported). No concomitant medications reported. The medical assistant noted the patient stated that on the same day (25-JAN-2013) she "experienced swelling in both hands as well as hives on an unspecified part of her body." The outcome of the events was unknown. No treatment was given to the patient. No lab tests were performed. The patient sought Medical Attention by calling the office about that. The causal assessment was not provided by the reporter. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to two patients of unknown age and gender. On 13-FEB-2013, the patient was vaccinated with a dose of ROTATEQ (lot # 670243/0921AA, expiration date 15-DEC-2012) orally. It was not known which dose in the ROTATEQ vaccination series this dose was administered. No adverse effect reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Foetal disorder, Ultrasound antenatal screen abnormal
Clinical narrative: This spontaneous report as received from a physician refers to a fetus patient with approximately date of conception on 07-JUN-2012. The patient's mother was vaccinate with GARDASIL third dose on 01-JUN-2012. On 06-OCT-2012 a ultrasound was performed to the patients mother and revealed fetal Pelviectasis. On 09-JAN-2013 follow up growth of fetal pelviectasis was performed. It was reported the estimated delivery date on 28-FEB-2013. The outcome of fetal pelviectasis is unknown. Additional information has been requested.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 01-FEB-2013 the patient was vaccinated with a dose of ROTATEQ (lot # 670243/0921AA, expiration date 15-DEC-2012) orally. It was not known which dose in the ROTATEQ series this dose was administered. No adverse effect reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. In September 2012, the patient was vaccinated with the first dose of GARDASIL (injection) (lot#, dose and route not reported). On 20-FEB-2012, the patient presented to the office to get the second dose of GARDASIL. No adverse event reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 69 year old female patient who with cortisone allergy and pain killers allergy and no pertinent medical history who on an unknown date was vaccinated with a dose of ZOSTAVAX (route not provided). Concomitant therapies included levothyroxine sodium, PREVACID and hydrochlorothiazide. No other co-suspect therapies were provided. The consumer reported that after receiving ZOSTAVAX she developed shingles in September 2012. She stated that it was a severe case of shingles. She also reported that that she was given unspecified shingle pills, which were not efficacious in treating her shingles outbreak. No laboratory tests were performed. At the time of the report, the patient's outcome was not provided. Additional information is not expected.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 42 year old female patient. On an unknown date in October 2012, the patient was vaccinated intramuscularly with a dose of 0.5 milliliter (ml) PNEUMOVAX 23 (lot # H011780, expiry 16-FEB-2014) in the left deltoid muscle. The patient was also concomitantly vaccinated with a dose of FLUZONE (manufacturer unknown) in the same anatomical location. On an unknown date in October 2012, the patient experienced redness, swelling and pain at both injection sites which did not develop for 24 hours. She stated that the patient did not seek treatment for the injection site reactions and has since recovered. The causality for redness, swelling and pain at both injection sites with PNEUMOVAX 23 was unknown. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 87 year old female patient. Her medical history included shingles in 1997. On 17-APR-2012 the patient was vaccinated with ZOSTAVAX (lot number not provided). On 27-MAY-2012 the patient experienced shingles. The outcome of shingles was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX. Concomitant medication was not provided. On an unknown date the patient experienced redness around the injection site, not long after the shot. There was no rash. The redness around the injection site improved after stopping therapy. Patient present status: about a week after it started. The relatedness for the adverse event was not reported for ZOSTAVAX. Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 7 year old(reported as 7.5 years) male patient. On 11-FEB-2013, the patient was vaccinated with the first dose of GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications were not reported. No adverse symptoms reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a Nurse refers to a currently 13 year old male patient with no pertinent Medical history or Drug reactions/allergies. On 06-AUG-2012 and on 19-OCT-2012, the patient was vaccinated, respectively, with the first and second dose of GARDASIL. On 18-FEB-2013, the patient was vaccinated intramuscularly (IM) with a 0.5 ml dose of GARDASIL lot # H016238, Expire date; 11-APR-2015. No concomitant Medications reported. On 19-FEB-2013, 24 hours after receiving the third dose of GARDASIL, the patient developed pain, warmth, pinkness at injection site. Nurse stated the patient's mother that the patient's pain was slightly more on 20-FEB-2013 so mother placed an ice pack on it. Patient's outcome was reported as not recovered. No lab tests were performed. The patient sought Medical Attention, his mother contacted office. The causal assessment was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. The patient received CERVARIX in 2011 (exact date unspecified, CERVARIX was provided at another unspecified provider). On 20-FEB-2013 the patient was vaccinated with GARDASIL (lot # unspecified). No adverse event reported. The outcome of the event was unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot# unspecified) one year ago in approximately February 2012. The patient developed redness at the injection site after receiving the dose. She also complained of increased blood pressure after receiving the dose. The onset date of the events was not reported. The outcome of increased blood pressure and redness at the injection site was reported as recovered. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood folate normal, Blood iron normal, Blood test normal, Dizziness
Clinical narrative: This spontaneous report was received from a registered nurse who refers to a 22 year old female patient (with none pertinent medical history and none drug reactions/allergies) who was not in pregnant. On 15-JAN-2013 the patient was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot # reported H013831, exp. date 06-MAR-2015). Concomitant therapies included AMOXICILLIN which was taking on the day of vaccination (reason unknown). On an unknown date in 2013 the patient experienced nausea, body aches, muscle aches, abdominal pain, headache and dizziness. On 29-JAN-2013 and 04-FEB-2013 the patient sought medical attention via office visit. The patient did not receive any treatment for adverse events. On an unknown date in 2013 the patient had abdominal ultrasound test and blood tests including: comprehensive metabolic panel (CMP), lipid pane, complete blood count (CBC), thyroid tests, folic acid, B12 and iron level. All laboratory and diagnostic study results were within normal limits. The outcome of body aches, muscle aches, abdominal pain, headache, dizziness and nausea was reported as not recovered/not resolved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Headache, Lipids normal, Metabolic function test normal, Myalgia
Clinical narrative: This spontaneous report was received from a registered nurse who refers to a 22 year old female patient (with none pertinent medical history and none drug reactions/allergies) who was not in pregnant. On 15-JAN-2013 the patient was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot # reported H013831, exp. date 06-MAR-2015). Concomitant therapies included AMOXICILLIN which was taking on the day of vaccination (reason unknown). On an unknown date in 2013 the patient experienced nausea, body aches, muscle aches, abdominal pain, headache and dizziness. On 29-JAN-2013 and 04-FEB-2013 the patient sought medical attention via office visit. The patient did not receive any treatment for adverse events. On an unknown date in 2013 the patient had abdominal ultrasound test and blood tests including: comprehensive metabolic panel (CMP), lipid pane, complete blood count (CBC), thyroid tests, folic acid, B12 and iron level. All laboratory and diagnostic study results were within normal limits. The outcome of body aches, muscle aches, abdominal pain, headache, dizziness and nausea was reported as not recovered/not resolved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Thyroid function test normal, Ultrasound abdomen normal, Vitamin B12 normal
Clinical narrative: This spontaneous report was received from a registered nurse who refers to a 22 year old female patient (with none pertinent medical history and none drug reactions/allergies) who was not in pregnant. On 15-JAN-2013 the patient was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot # reported H013831, exp. date 06-MAR-2015). Concomitant therapies included AMOXICILLIN which was taking on the day of vaccination (reason unknown). On an unknown date in 2013 the patient experienced nausea, body aches, muscle aches, abdominal pain, headache and dizziness. On 29-JAN-2013 and 04-FEB-2013 the patient sought medical attention via office visit. The patient did not receive any treatment for adverse events. On an unknown date in 2013 the patient had abdominal ultrasound test and blood tests including: comprehensive metabolic panel (CMP), lipid pane, complete blood count (CBC), thyroid tests, folic acid, B12 and iron level. All laboratory and diagnostic study results were within normal limits. The outcome of body aches, muscle aches, abdominal pain, headache, dizziness and nausea was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot#, dose and route not reported). The patient was vaccinated with ZOSTAVAX that the pharmacist predrew in a syringe and stored in a refrigerator for 2 hours before administering. No adverse symptoms reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a 60 years old female consumer with allergy to intravenous contrast media (IV dye). On 08-JAN-2013, the patient was vaccinated with ZOSTAVAX (dose and lot number were not provided) (1 time vaccine), subcutaneous in the right arm. Concomitant therapies included TRILIPIX, DIOVAN, ZETIA, CARVEDILOL, ASPIRIN, isovat, XANAX and LANSOPRAZOLE. On 08-JAN-2013, the patient had pain in his arm right and the shoulder, from bicep through shoulder on his right arm. That was the injection arm. He described the pain as feeling like the arm was going to fall off. The patient sought medical attention. The patient received therapy with steroids. Lab diagnostics studies were not performed. The outcome for pain in his arm right arm shoulder right (injection arm) was reported as not recovered/not resolved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age who on an unknown date, was vaccinated with GARDASIL (dose, route and lot # not provided). No concomitant medications were reported. The physician informed that on February 2012 (about 1 year ago), a patient after being vaccinated with GARDASIL, developed hives. The patient did not receive any treatment for adverse event. On unspecified date, the patient recovered, on therapy. No further information obtained for this AE. The outcome of hives was reported as recovered/resolved. The relatedness adverse event was unknown for GARDASIL. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 20 week old patient (gender unknown) who on 19-FEB-2013 was vaccinated with the first dose of ROTATEQ suspension (lot #, dose not reported). No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Accidental exposure to product, Eye pruritus, Ocular hyperaemia
Clinical narrative: This spontaneous report as received from a registered nurse refers to another registered nurse of unknown age. On 19-FEB-2013 the registered nurse splashed M-M-R II (lot# unspecified) into her own eye, while retracting the needle on the syringe after M-M-R II was administered to a patient. The reporter stated the nurse's eye was itchy and red. The nurse mentioned the patient did not receive less than a full dose of M-M-R II. The outcome of the events was not reported. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On12-FEB-2013 the patient was vaccinated with a dose of expired ROTATEQ (lot # 670243/0921AA, expiration date 15-DEC-2012) orally. It was not known which dose in the ROTATEQ, oral vaccination series this dose of administered. No adverse effect reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 07-FEB-2013 the patient was vaccinated with a dose of expired ROTATEQ (lot # 670243/0921AA, expiration date 15-DEC-2012) orally. It was not known which dose in the ROTATEQ vaccination series this dose was administered. No adverse effect reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a female consumer of unknown age (who is a Nurse Practitioner) reporting on herself via company representative. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, Lot # and route not reported). No concomitant Medications reported. The patient stated she had developed a case of shingles after she had received ZOSTAVAX (onset date: approximately in April or May 2012). It "cleared up in a couple days," but she still had post herpetic neuralgia (PHN) in her right hand. The patient was treated with spinal corticosteroids (unspecified) "steroids" and anti-virals. The patient sought Medical attention. The relatedness between the events and ZOSTAVAX was unknown. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 29-JAN-2013 the patient was vaccinated with a dose of expired live, oral ROTATEQ (lot # 670243/0921AA, expiration date 15-DEC-2012) orally. It was not known which dose in the live, oral ROTATEQ vaccination series this dose was administered. No adverse effect reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 06-FEB-2013 the patient was vaccinated with a dose of expired live, oral, ROTATEQ (lot # 670243/0921AA, expiration date 15-DEC-2012). It was not known which dose in the live, oral ROTATEQ vaccination series this dose was administered. No adverse effect reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 31-JAN-2013, the patient was vaccinated with a dose of expired ROTATEQ (lot # 670243/0921AA, expiration date 15-DEC-2012) orally. It was not known which dose in the ROTATEQ vaccination series this dose was administered. No adverse effect reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 0.56
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Condition aggravated, Convulsion, Electroencephalogram abnormal
Clinical narrative: Seizures after giving 6 month vaccines Dtap, IPV, Hib, PREVENAR, Rota, seizure (GTC) occurred on the night of the visit.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Condition aggravated, Cough, Juvenile arthritis, Pain
Clinical narrative: Pt gets body ache and joint pain like she is having a flare of her juvenile rheumatoid arthritis and a cough, symptoms now improving but still persistent.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Condition aggravated, Cough, Nasal congestion, Pain
Clinical narrative: Pt gets body ache and joint pain like she is having a flare of her juvenile rheumatoid arthritis and a cough, symptoms now improving but still persistent.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rheumatoid arthritis
Clinical narrative: Pt gets body ache and joint pain like she is having a flare of her juvenile rheumatoid arthritis and a cough, symptoms now improving but still persistent.
Age: 66.0
Sex: M
Vaccine: VARCEL
Symptoms: Chills, Feeling cold, Headache, Injection site pain, Injection site swelling
Clinical narrative: Arm was sore & swollen 8cm x 10cm below injection site on 2/22.  Early morning I woke up shivering, unable to get warm. Put on fleece pants and shirt, & sox and wore to bed to get warm.  I was awake on & off for about 5 hrs, shivering.  Woke up 7 AM with bad headache (I rarely get headaches.)