chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MMR, MNQ, TDAP, HEPA, HPV4, MMR, MNQ, TDAP
Symptoms: Headache, Intensive care, Nuclear magnetic resonance imaging, Pulmonary embolism
Clinical narrative: Information has been received from an agency concerning an 16 year old female patient with a history of anxiety and four years ago was diagnosed as having thrombophilia per mother, and patient medical history showed methylenetetrahydrofolate reductase (MTHFR) mutation, who on 19-NOV-2008, was vaccinated with the first dose of GARDASIL (lot # 659653/1448U) IM into left arm; first dose of MMR II (Lot # 659706/0266X) subcutaneously into the right arm; first dose of MENACTRA (Lot # U2620AA) IM into left arm; first dose of HAVRIX (Lot # AHAVB246AA) IM into right arm; and first dose of BOOSTRIX (Lot # AC52B030AA) IM into the right arm. Concomitant therapy included LOVENOX, SEROQUEL and COUMADIN. The patient had cold symptoms, coughing and nasal congestion. On 24-NOV-2008, the patient complaint of difficulty breathing, chest pains and headache. The patient went to hospital emergency room. The patient was admitted and hospitalized two days in ICU and three days on the hematology unit according to mother. Diagnosis pulmonary embolism. Another emergency visit to hospital on 13-FEB-2009, for symptoms of diarrhea and bloody stools. 25-FEB-2009, records received for date of service 24-NOV-2008 to 28-NOV-2008, diagnosed pulmonary embolism. Patient presented with increasing shortness of breath, worsening cough and chest wall pain for two weeks. Seen in ED 1 week prior with shortness of breath and Chest X-ray determined to be asthma. Chest X-ray, venous blood draw, CAT scan, Nuclear contrast test, and many other test but mother can not remember. Laboratories reported: On admission Chest X-ray revealed increased perihilar marking and CT chest angiogram showed decreased att. The VAERS ID # is 340119. A standard lot check was performed. All in-process quality checks for the lot number 659653/1448U Were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements for the Center and was released. No further information is available.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MMR, MNQ, TDAP, HEPA, HPV4, MMR, MNQ, TDAP
Symptoms: Asthma, Chest X-ray abnormal, Chest pain, Computerised tomogram abnormal, Cough
Clinical narrative: Information has been received from an agency concerning an 16 year old female patient with a history of anxiety and four years ago was diagnosed as having thrombophilia per mother, and patient medical history showed methylenetetrahydrofolate reductase (MTHFR) mutation, who on 19-NOV-2008, was vaccinated with the first dose of GARDASIL (lot # 659653/1448U) IM into left arm; first dose of MMR II (Lot # 659706/0266X) subcutaneously into the right arm; first dose of MENACTRA (Lot # U2620AA) IM into left arm; first dose of HAVRIX (Lot # AHAVB246AA) IM into right arm; and first dose of BOOSTRIX (Lot # AC52B030AA) IM into the right arm. Concomitant therapy included LOVENOX, SEROQUEL and COUMADIN. The patient had cold symptoms, coughing and nasal congestion. On 24-NOV-2008, the patient complaint of difficulty breathing, chest pains and headache. The patient went to hospital emergency room. The patient was admitted and hospitalized two days in ICU and three days on the hematology unit according to mother. Diagnosis pulmonary embolism. Another emergency visit to hospital on 13-FEB-2009, for symptoms of diarrhea and bloody stools. 25-FEB-2009, records received for date of service 24-NOV-2008 to 28-NOV-2008, diagnosed pulmonary embolism. Patient presented with increasing shortness of breath, worsening cough and chest wall pain for two weeks. Seen in ED 1 week prior with shortness of breath and Chest X-ray determined to be asthma. Chest X-ray, venous blood draw, CAT scan, Nuclear contrast test, and many other test but mother can not remember. Laboratories reported: On admission Chest X-ray revealed increased perihilar marking and CT chest angiogram showed decreased att. The VAERS ID # is 340119. A standard lot check was performed. All in-process quality checks for the lot number 659653/1448U Were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements for the Center and was released. No further information is available.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MMR, MNQ, TDAP, HEPA, HPV4, MMR, MNQ, TDAP
Symptoms: Diarrhoea, Dyspnoea, Haematochezia, Headache, Intensive care
Clinical narrative: Information has been received from an agency concerning an 16 year old female patient with a history of anxiety and four years ago was diagnosed as having thrombophilia per mother, and patient medical history showed methylenetetrahydrofolate reductase (MTHFR) mutation, who on 19-NOV-2008, was vaccinated with the first dose of GARDASIL (lot # 659653/1448U) IM into left arm; first dose of MMR II (Lot # 659706/0266X) subcutaneously into the right arm; first dose of MENACTRA (Lot # U2620AA) IM into left arm; first dose of HAVRIX (Lot # AHAVB246AA) IM into right arm; and first dose of BOOSTRIX (Lot # AC52B030AA) IM into the right arm. Concomitant therapy included LOVENOX, SEROQUEL and COUMADIN. The patient had cold symptoms, coughing and nasal congestion. On 24-NOV-2008, the patient complaint of difficulty breathing, chest pains and headache. The patient went to hospital emergency room. The patient was admitted and hospitalized two days in ICU and three days on the hematology unit according to mother. Diagnosis pulmonary embolism. Another emergency visit to hospital on 13-FEB-2009, for symptoms of diarrhea and bloody stools. 25-FEB-2009, records received for date of service 24-NOV-2008 to 28-NOV-2008, diagnosed pulmonary embolism. Patient presented with increasing shortness of breath, worsening cough and chest wall pain for two weeks. Seen in ED 1 week prior with shortness of breath and Chest X-ray determined to be asthma. Chest X-ray, venous blood draw, CAT scan, Nuclear contrast test, and many other test but mother can not remember. Laboratories reported: On admission Chest X-ray revealed increased perihilar marking and CT chest angiogram showed decreased att. The VAERS ID # is 340119. A standard lot check was performed. All in-process quality checks for the lot number 659653/1448U Were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements for the Center and was released. No further information is available.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MMR, MNQ, TDAP, HEPA, HPV4, MMR, MNQ, TDAP
Symptoms: Musculoskeletal chest pain, Nasal congestion, Nasopharyngitis, Pulmonary embolism
Clinical narrative: Information has been received from an agency concerning an 16 year old female patient with a history of anxiety and four years ago was diagnosed as having thrombophilia per mother, and patient medical history showed methylenetetrahydrofolate reductase (MTHFR) mutation, who on 19-NOV-2008, was vaccinated with the first dose of GARDASIL (lot # 659653/1448U) IM into left arm; first dose of MMR II (Lot # 659706/0266X) subcutaneously into the right arm; first dose of MENACTRA (Lot # U2620AA) IM into left arm; first dose of HAVRIX (Lot # AHAVB246AA) IM into right arm; and first dose of BOOSTRIX (Lot # AC52B030AA) IM into the right arm. Concomitant therapy included LOVENOX, SEROQUEL and COUMADIN. The patient had cold symptoms, coughing and nasal congestion. On 24-NOV-2008, the patient complaint of difficulty breathing, chest pains and headache. The patient went to hospital emergency room. The patient was admitted and hospitalized two days in ICU and three days on the hematology unit according to mother. Diagnosis pulmonary embolism. Another emergency visit to hospital on 13-FEB-2009, for symptoms of diarrhea and bloody stools. 25-FEB-2009, records received for date of service 24-NOV-2008 to 28-NOV-2008, diagnosed pulmonary embolism. Patient presented with increasing shortness of breath, worsening cough and chest wall pain for two weeks. Seen in ED 1 week prior with shortness of breath and Chest X-ray determined to be asthma. Chest X-ray, venous blood draw, CAT scan, Nuclear contrast test, and many other test but mother can not remember. Laboratories reported: On admission Chest X-ray revealed increased perihilar marking and CT chest angiogram showed decreased att. The VAERS ID # is 340119. A standard lot check was performed. All in-process quality checks for the lot number 659653/1448U Were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements for the Center and was released. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Encephalitis, Herpes simplex serology negative, Nuclear magnetic resonance imaging brain abnormal, Polymerase chain reaction
Clinical narrative: Information has been received from a consumer concerning her daughter, a 20 year old female patient with no drug reactions or allergies and a history of factor V, who on 12-FEB-2009 was vaccinated with her first dose of GARDASIL (lot number, site and route not reported). Concomitant therapy included Albuterol. During the vaccination week, the patient experienced terrible headaches. On Monday 16-FEB-2009, the patient was taken to the hospital because she had fainting spells, seizures, fever and also had swelling of the brain once at the hospital. The brain biopsy, magnetic resonance imaging and blood work was performed with no result reported. She was hospitalized for three weeks and still was not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy brain, Blood test, Brain oedema, Convulsion, Headache
Clinical narrative: Information has been received from a consumer concerning her daughter, a 20 year old female patient with no drug reactions or allergies and a history of factor V, who on 12-FEB-2009 was vaccinated with her first dose of GARDASIL (lot number, site and route not reported). Concomitant therapy included Albuterol. During the vaccination week, the patient experienced terrible headaches. On Monday 16-FEB-2009, the patient was taken to the hospital because she had fainting spells, seizures, fever and also had swelling of the brain once at the hospital. The brain biopsy, magnetic resonance imaging and blood work was performed with no result reported. She was hospitalized for three weeks and still was not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laboratory test, Nuclear magnetic resonance imaging, Pyrexia, Syncope
Clinical narrative: Information has been received from a consumer concerning her daughter, a 20 year old female patient with no drug reactions or allergies and a history of factor V, who on 12-FEB-2009 was vaccinated with her first dose of GARDASIL (lot number, site and route not reported). Concomitant therapy included Albuterol. During the vaccination week, the patient experienced terrible headaches. On Monday 16-FEB-2009, the patient was taken to the hospital because she had fainting spells, seizures, fever and also had swelling of the brain once at the hospital. The brain biopsy, magnetic resonance imaging and blood work was performed with no result reported. She was hospitalized for three weeks and still was not recovered. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hemiparesis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of brain stroke in a 62-year-old male subject who was vaccinated with FLUARIX. Concurrent medical conditions included diabetes, and the subject was recovering from a mild cold at the time of injection. The subject had no adverse events following previous vaccinations. On 12 January 2009 at 18:00 the subject received 1st dose of FLUARIX (.5 ml unknown, left arm). No other vaccines were given on 12 January 2009. In late February 2009, a unspecified time after vaccination with FLUARIX, the subject experienced left brain stroke. The subject was in the hospital for other unspecified medical issues when the stroke occurred. The healthcare professional considered the event was disabling. At the time of reporting the event was improved. The healthcare professional considered the event was unrelated to vaccination with FLUARIX.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cerebrovascular accident
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of brain stroke in a 62-year-old male subject who was vaccinated with FLUARIX. Concurrent medical conditions included diabetes, and the subject was recovering from a mild cold at the time of injection. The subject had no adverse events following previous vaccinations. On 12 January 2009 at 18:00 the subject received 1st dose of FLUARIX (.5 ml unknown, left arm). No other vaccines were given on 12 January 2009. In late February 2009, a unspecified time after vaccination with FLUARIX, the subject experienced left brain stroke. The subject was in the hospital for other unspecified medical issues when the stroke occurred. The healthcare professional considered the event was disabling. At the time of reporting the event was improved. The healthcare professional considered the event was unrelated to vaccination with FLUARIX.
Age: 3.0
Sex: U
Vaccine: HIBV
Symptoms: Death, Meningitis
Clinical narrative: It was reported in a newspaper article that a 3 year old received one dose of PEDVAXHIB (manufacturer unknown), and had onset of clinical syndrome of meningitis in February 2008, and died. No further information was available.
Sex: U
Vaccine: HIBV
Symptoms: Death, Haemophilus infection
Clinical narrative: It was reported in a newspaper article that a child in who had received the full primary series of PEDVAXHIB (manufacturer unknown) (dates not reported) died of Hib disease, in 2008 a spokeswoman for the Health Department reported. She was unable to provide more details. No further information was available.   4/20/09 FDA spoke with the NJ health authority.  The child received 3 doses of HIBV (unknown brand) and died of a brain abscess.  The official did not know whether an autopsy had been performed, nor whether the abscess was cultured..
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Arthralgia, Blood test abnormal, Death, Pyrexia, Streptococcal bacteraemia
Clinical narrative: Information has been received from a physician concerning an 11 year old female who on 30-MAR-2009 (last week) was vaccinated with the first dose of GARDASIL. Concomitant therapy included VAQTA, MENACTRA and DTAP (unspecified) on the same day. Patient complained about sore throat a week prior to vaccination. A week later some kind test was performed and it showed that a group A strep in the blood was found. On approximately 30-MAR-2009, after getting the first dose of GARDASIL the patient experienced fever and pain in the hip after getting the vaccine. The patient died on 03-APR-2009. The patient sought unspecified medical attention. Additional information has been requested. 4/24/09 ER record received for DOS 4/1/09 with dx: Fever.  Pediatric Viral syndrome.  Pt presented with L hip pain and fever. PE (+) for tenderness over L anterior thigh. Tx with analgesic and d/c. 4/24/09 ER record received for DOS 4/3/09 with dx:  Post-vaccination reaction. Pt presented again to ER with fever of 102'F, body aches, inability to walk 2' to leg pain, nausea, vomiting, rash and polymyagias.  PE (+) for extremity pain and swelling, rash, as well as not sleeping and acting differently. Transferred to higher level of care. 4/24/09 MR received for DOS 4/3-4/2009 with Final DX:  Necrotizing fasciitis (gram (+) cocci with septic shock).  Pt expired 4/4/09. Pt admitted from local facility for eval of fever with difficulty ambulating. Neuro/ortho consults on arrival with probable dx: infectious myositis.  Tx with IV abx however IV access was lost and pt became hypotensive and with eveidence of septic shock with cardiovascular instability.  Pt intubated and despite extensive resuscitation efforts pt expired. 4/24/09 Autopsy report received with COD:  Necrotizing Fasciitis (Gram (+)) with septic shock.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Streptococcal identification test positive
Clinical narrative: Information has been received from a physician concerning an 11 year old female who on 30-MAR-2009 (last week) was vaccinated with the first dose of GARDASIL. Concomitant therapy included VAQTA, MENACTRA and DTAP (unspecified) on the same day. Patient complained about sore throat a week prior to vaccination. A week later some kind test was performed and it showed that a group A strep in the blood was found. On approximately 30-MAR-2009, after getting the first dose of GARDASIL the patient experienced fever and pain in the hip after getting the vaccine. The patient died on 03-APR-2009. The patient sought unspecified medical attention. Additional information has been requested. 4/24/09 ER record received for DOS 4/1/09 with dx: Fever.  Pediatric Viral syndrome.  Pt presented with L hip pain and fever. PE (+) for tenderness over L anterior thigh. Tx with analgesic and d/c. 4/24/09 ER record received for DOS 4/3/09 with dx:  Post-vaccination reaction. Pt presented again to ER with fever of 102'F, body aches, inability to walk 2' to leg pain, nausea, vomiting, rash and polymyagias.  PE (+) for extremity pain and swelling, rash, as well as not sleeping and acting differently. Transferred to higher level of care. 4/24/09 MR received for DOS 4/3-4/2009 with Final DX:  Necrotizing fasciitis (gram (+) cocci with septic shock).  Pt expired 4/4/09. Pt admitted from local facility for eval of fever with difficulty ambulating. Neuro/ortho consults on arrival with probable dx: infectious myositis.  Tx with IV abx however IV access was lost and pt became hypotensive and with eveidence of septic shock with cardiovascular instability.  Pt intubated and despite extensive resuscitation efforts pt expired. 4/24/09 Autopsy report received with COD:  Necrotizing Fasciitis (Gram (+)) with septic shock.
Sex: F
Vaccine: HPV4
Symptoms: Meningitis
Clinical narrative: Information has been received from a medical assistant concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (dose, route and lot number not provided). On an unspecified date the patient developed spinal meningitis after vaccination. The medical assistant reported that the patient was not in her practice so no details other than she was hospitalized were known. The reporter stated that she heard of this "second hand" through a person that knew the person that developed the meningitis. She believed this was reported previously. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Loss of consciousness, Respiratory arrest
Clinical narrative: Information has been received from a consumer concerning one of her cousins who was vaccinated with MMR II. After receiving the vaccine, the patient had loss of consciousness for a while. The consumer stated that most of her family members had this immune disorder that made them react to live vaccines that were given in combination with other live vaccines. Follow up has been received from the consumer who stated that her cousin "passed out and quit breathing" after getting MMR II. This is one of several reports received from the same source. Upon internal review "quit breathing" was determined to be an other important medical event. Additional information is not available.
Sex: M
Vaccine: MMR
Symptoms: Loss of consciousness, Respiratory arrest
Clinical narrative: Information has been received from a consumer concerning her husband's uncle who was vaccinated with a dose of MMR II. The reporter stated that the patient "passed out and quit breathing" after getting MMR II. This is one of several reports received from the same source. Upon internal review "quit breathing" was determined to be an other important medical event. Additional information is not available.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction, Food allergy
Clinical narrative: Information has been received from a physician concerning a 4 year old male who was vaccinated with the second dose of MMR II "standard dose" (lot # not available). The patient experienced a "gelatin anaphylaxis" after receiving the second dose of MMR II. The patient was given "epinephrine injection" (manufacturer unknown). It was unknown if the patient experienced AE with the first dose of MMR II. On an unknown date, the patient recovered from gelatin anaphylaxis. The patient sought medical attention with the physician. Gelatin anaphylaxis was considered to be an other important medical event by the physician. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Asperger's disorder, Autism, Familial risk factor
Clinical narrative: Information has been received from a consumer concerning a male patient who is a member of his wife's family, who on an unspecified date was vaccinated with a dose of MMR II. On an unknown date, the patient developed autism (Asperger's Syndrome). Consumer did not know the details but suspects MMR II was involved because the grandfather, who is a physician, and related to both families suggested the consumer space out the vaccines when vaccinating the consumer's son to prevent this from happening again in the family. Consumer also mentioned the brother to the child that had autism also was "a little developmentally slow". Consumer did not wish to provide any additional information as he was not close with that family and had no real details. The patient did not seek medical attention. At the time of reporting, the patient had not recovered. Upon internal review, autism (Asperger's Syndrome) was considered to be an other important medical event. No further information is available.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Drug exposure during pregnancy, Vaginal haemorrhage
Clinical narrative: Information has been received from a medical assistant, for the Pregnancy Registry for GARDASIL, concerning an 18 year old female with sulfa allergy and no pertinent medical history who was vaccinated IM with the first and second 0.5 ml doses of GARDASIL by different provider and was vaccinated IM with the third 0.5ml dose of GARDASIL (lot #: 659962/1740U) on 01-DEC-2008. Concomitant therapy included loratadine. The patient who received the three doses of GARDASIL was pregnant. The patient's last menstrual period was 29-NOV-2008 and estimated delivery date was 05-SEP-2009. The patient experienced vaginal bleeding and was hospitalized at an unspecified time period. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None Stated
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Asthenia, Convulsion, Pallor, Syncope
Clinical narrative: Patient left office after getting 4 vaccines. She was standing at window to make another appt. She asked for water then had a syncopal episode with ? of seizure activity. Very pale, weakness. Pt laid in waiting room. Pulse 56, BP 116/38. Was given apple juice & crackers. She had only eaten chocolate and water for breakfast. Moved to exam room. She was monitored for about 30 minutes. Rechecked by MD then left feeling fine.
Age: 2.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: (red, swollen, warm, painful;  he had fever last night)  Cellulitis L lateral leg that developed 8 days after receiving immunizations;  it is immediately over vaccine site.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 2" oval area of redness & induration at injection site.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Blood test, Chest X-ray, Cough, Febrile convulsion, Influenza serology
Clinical narrative: Cough, fever- Sat morning (3/28/09) all at once (10am).  Seizure from fever (102.9) (at 1:45PM).  (Hep A given on 3/19/09) (MOTRIN given even today to help control fever)
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Streptococcal identification test, Urine analysis
Clinical narrative: Cough, fever- Sat morning (3/28/09) all at once (10am).  Seizure from fever (102.9) (at 1:45PM).  (Hep A given on 3/19/09) (MOTRIN given even today to help control fever)
Age: 0.9
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Urticaria
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash - BENADRYL Rash X 24 hours:  Started 7 days after antibiotic/vaccine *Rash is worse on Right side (thigh) at injection site where MMR & VARICELLA given
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Neurological examination, X-ray
Clinical narrative: Patient came in for MD visit 4/8/2009, with complaint of on and off neck pain.  Patient and pt's mother feels pain started after HPV vaccines, HPV vaccine series given 5/17/2007, 8/31/2007 and 1/17/2008.  Neck pain reported first on 12/22/2007 MD visit, stated neck pain for 4 months.  5/26/09 Medical records received DOS 2/3/07 to 5/7/09. Seen 9/21/07 for c/o sharp LLQ pain. Assess:  Abd pain.  Seen 12/22/07 for c/o several month hx of neck pain. Tight traps on PE.  MIP joint tenderness noted. DX:  Cervicalgia.  R arm numbness/tingling noted 12/31/07.  Neck pain continues through 4/2009. Post vaccination: Eczema, deltoid muscle pain, torticollis, neck pain, runny nose, rash lower extremities and right arm / hand, decreased hearing, back pain, myopia, hallux valgus,
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Employee reports fever ranging from 100 degrees F - 103 degrees F and vomiting starting 4/3/09 through 4/4/09.  Also reports body aches.  No treatment needed.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia, Sick relative
Clinical narrative: Developed fever, high 103 degrees after IZS on 4/7/09. F/U in our office on 4/8/09 temp 100.9 taken TYLENOL. Mom states household sick.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Antinuclear antibody, Blood creatine phosphokinase, Borrelia burgdorferi serology, Electromyogram abnormal, Full blood count
Clinical narrative: Pain, redness & edema left deltoid within one wk injection. As redness & edema resolved pain radiated to left shoulder neck right shoulder and down both arms. Within 3 wks pain severe, unable to lift right arm independently unable to sleep.  Medical Doctor referred to Neurology.  Prescribed LYRICA & VOLTAREN. Muscle weakness & muscle damage & wasting. Physiotherapy prescribed.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Insomnia, Mobility decreased
Clinical narrative: Pain, redness & edema left deltoid within one wk injection. As redness & edema resolved pain radiated to left shoulder neck right shoulder and down both arms. Within 3 wks pain severe, unable to lift right arm independently unable to sleep.  Medical Doctor referred to Neurology.  Prescribed LYRICA & VOLTAREN. Muscle weakness & muscle damage & wasting. Physiotherapy prescribed.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Muscle atrophy, Muscle injury, Muscular weakness, Musculoskeletal pain, Neck pain
Clinical narrative: Pain, redness & edema left deltoid within one wk injection. As redness & edema resolved pain radiated to left shoulder neck right shoulder and down both arms. Within 3 wks pain severe, unable to lift right arm independently unable to sleep.  Medical Doctor referred to Neurology.  Prescribed LYRICA & VOLTAREN. Muscle weakness & muscle damage & wasting. Physiotherapy prescribed.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity, Rheumatoid factor
Clinical narrative: Pain, redness & edema left deltoid within one wk injection. As redness & edema resolved pain radiated to left shoulder neck right shoulder and down both arms. Within 3 wks pain severe, unable to lift right arm independently unable to sleep.  Medical Doctor referred to Neurology.  Prescribed LYRICA & VOLTAREN. Muscle weakness & muscle damage & wasting. Physiotherapy prescribed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Warm to touch and little swelling LD.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Vomiting
Clinical narrative: Headache same day lasted 3 days. Throwing up two days after.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Flu Shot
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug hypersensitivity, Erythema, Pruritus, Rash generalised
Clinical narrative: On 4/3 observed rash arms, hands, face and neck woke developing a redness that I first thought was sun burn. Over the course of the next two days it appeared to be getting worse and I was experiencing itching in all those areas. 4/6/09 I went to the Clinic and saw Doctor. I was sent to ER. I was seen by Doctor and PAC in the emergency room. I was given a BENADRYL injection and a steroid injection. I was released from the ER with prescriptions for HYDROXYZINE formula and PREDNISONE with instructions to see my dermatologist. I saw the dermatologist on 4/9/09. She felt that the rash was improving, however she did prescribe a topical ointment for the arms, face and neck. I am to follow up with her on Friday April 17th.
Age: 14.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pain in extremity
Clinical narrative: Pt received shingles vaccine @ approx 9:30 am on 3/12/09. R arm. Pt called 3/17/09 @ 10:30 am to report R arm soreness and pain that wraps around the entire R arm. Plus overall feeling of "yuckiness". No treatment for soreness given at time of call. Pt wonders if shingles vaccine and oral acyclavir (taken on same day) interacted? R arm pain lasted "several" days.
Age: 21.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Rash, Skin nodule, Tenderness
Clinical narrative: Nodular rash red indurated 1 1/2 inch round red mildly tender area  1/2 inch above injections ; injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 41/2"x 51/2" duration, warm to touch, swelling.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Gaze palsy, Musculoskeletal stiffness, Staring, Unresponsive to stimuli
Clinical narrative: As per mom, he was drinking juice, dropped cup & became unresponsive with a blank stare.  Eyes rolled backward & he became very stiff.  He had been febrile all day.  Taken to ER within minutes & temp 104 degrees F.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: Severe left arm pain, fever, chills and palpitations lasting 24 hours.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & slight swelling posterior Rt upper arm
Age: 4.0
Sex: U
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Abdominal pain, Culture urine, Pyrexia, Streptococcal identification test negative, Urine analysis abnormal
Clinical narrative: She got a fever the evening of the immunizations admitted abdominal pain. As of 4/7/09, she had had the fever 6 days.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Child became very pale, lightheaded and felt like she was going to faint. Child was also slightly diaphoretic. Had child lay down and gave water.
Age: 1.0
Sex: M
Vaccine: HIBV, IPV
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiform - treatment 5 days oral steroids 1/2 tsp one daily
Age: 1.42
Sex: M
Vaccine: DTAP, MMR, PNC, VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Zoster Vaccine administered to child instead of varicella.  No adverse symptoms noted at this time.  Vaccine was administered 4/15/2009 at 10:45 am.  Medical Director and Supervisor notified of incident.  Mother notified of wrong vaccine given as well as educated to watch for localized reaction.  Phone numbers given to contact Health Department.
Age: 1.42
Sex: M
Vaccine: DTAP, MMR, PNC, VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Zoster Vaccine administered to child instead of varicella.  No adverse symptoms noted at this time.  Vaccine was administered 4/15/2009 at 10:45 am.  Medical Director and Supervisor notified of incident.  Mother notified of wrong vaccine given as well as educated to watch for localized reaction.  Phone numbers given to contact Health Department.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Drug exposure during pregnancy
Clinical narrative: Vaccinated with ACAM2000 during pregnancy.  Pregnancy resulted in full term healthy delivery.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother noted Left upper arm was swollen, red, and warm to the touch 24 hours after shots received. Child saw Dr 4-15-09. Nurse noted redness and swelling of left upper ext down to pt elbow. Area was warm to the touch, but child not complaining of much pain. No fever or chills. Treatment given was antibiotic and steriod. Mother to call if area does not improve.
Age: 41.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: At 1800, noted dime size erythemia at SQ injection site of the Varicella vaccine on Left upper arm.  On 04/09/09 at 1215, area measured 4 x 3 cm and was red, hard, warm, and itching.  The largest size noted extended to 3 cm proximal to left elbow and 3 cm proximal to the left upper arm with warmth, erythemia, and itching.  Patient took Xyzal 5 mg po x 1 day and applied topical hydrocortisone cream PRN for 4 days.  By 09/12/2009, most symptoms had resolved.  On 19/13/2009, all symptoms resolved.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Patient presented to the emergency room 6 hours after shots with febrile seizures. Repeat episode of febrile seizure 24 hours after first episode.
Age: 45.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Arthralgia, Chills, Musculoskeletal pain, Pyrexia, Swelling
Clinical narrative: Chills, fever, joint aches Right shoulder very swollen and painful
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Anaphylactic reaction, Condition aggravated, Crying, Dyspnoea, Eczema
Clinical narrative: within half-hour of Pentacel injection, patient returned to office inconsolable, copious thick secretions, trouble breathing, worsening of his eczema.  gave one dose of epinephrine IM, within 10 minutes significant improvement in sx, within 30-45 minutes had complete resolution of symptoms.  consistent with anaphylactic reaction to vaccine.  6/08/09 Received PCP office records which consisted of Allergy Consult done 5/28/2009. FINAL DX: vaccine reaction, anaphylaxis; and atopic dermatitis Records reveal patient experienced coughing, screaming, difficulty breathing, excess mucous production, rash on legs, throat swelling following Pentacel vaccination.  Tx in office w/epi, benadryl & tylenol & sent home w/tapering steroids & continued benadryl.  No sequelae & family carries epi-pen.  Continued w/rash on ankles, face & back.  Only initial page of consult sent, remainder requested.  6/10/09 Received vaccine & PCP office records for 4/3/09. Records reveal approx 15 min s/p vaccination, returned to office w/increased rash, increased secretions, inconsolable crying & screaming.  Tx w/epi IM, Tylenol & Benadryl both PO.  6/16/09 Received remainder of Allergy Consult done 5/28/09. FINAL DX: vaccine reaction, anaphylaxis; atopic dermatitis Records reveal pt referred for additional labs tests for allergies prior to next set of vaccinations.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Increased upper airway secretion
Clinical narrative: within half-hour of Pentacel injection, patient returned to office inconsolable, copious thick secretions, trouble breathing, worsening of his eczema.  gave one dose of epinephrine IM, within 10 minutes significant improvement in sx, within 30-45 minutes had complete resolution of symptoms.  consistent with anaphylactic reaction to vaccine.  6/08/09 Received PCP office records which consisted of Allergy Consult done 5/28/2009. FINAL DX: vaccine reaction, anaphylaxis; and atopic dermatitis Records reveal patient experienced coughing, screaming, difficulty breathing, excess mucous production, rash on legs, throat swelling following Pentacel vaccination.  Tx in office w/epi, benadryl & tylenol & sent home w/tapering steroids & continued benadryl.  No sequelae & family carries epi-pen.  Continued w/rash on ankles, face & back.  Only initial page of consult sent, remainder requested.  6/10/09 Received vaccine & PCP office records for 4/3/09. Records reveal approx 15 min s/p vaccination, returned to office w/increased rash, increased secretions, inconsolable crying & screaming.  Tx w/epi IM, Tylenol & Benadryl both PO.  6/16/09 Received remainder of Allergy Consult done 5/28/09. FINAL DX: vaccine reaction, anaphylaxis; atopic dermatitis Records reveal pt referred for additional labs tests for allergies prior to next set of vaccinations.
Age: 1.08
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Convulsion, Skin warm
Clinical narrative: On 4/14/09 mother reported child had seizure 1 hr after arriving home from getting vaccines on 12/16/08. Skin was "very hot." Child was taken to local ER. 3 wks later, child was reported to have had another seizure at daycare.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic
Clinical narrative: Patient called our office to inform us that she had "pumps all over her body and they itch really bad." She states that she woke up with the pump and itching this morning. Her mom gave her a Benadryl pill.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Body temperature increased
Clinical narrative: High body temperature 103.2 F
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site discharge, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: 1.5 CM AREA DIRECTLY OVER LEFT DELTOID MUSCLE WHERE VACCINE GIVEN WAS BLISTERED, OPEN AND OOZING.  LARGE SURROUNDING AREA OF REDNESS AND SWELLING APPROXIMATELY 10 CM IN DIAMETER.
Age: 15.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MMR, TDAP
Symptoms: Amenorrhoea, Pregnancy test negative
Clinical narrative: AMENORHEA SINCE DECEMBER '08. PREGNANCY TEST NEG. MOTHER REPORTS NEVER HAD A PROBLEM BEFORE GETTING THE GARDASIL VACCINE.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Disturbance in attention, Headache, Impaired work ability, Myalgia
Clinical narrative: Was given a shot of PPV Pneumococcal Polysaccharide.  Reaction: Runny nose, severe Arm Pain, fever 99.2 next day from shot, temp 102 second day from shot, muscle ache, head ache, not thinking clearly.  Unable to go into work on second day from dose.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Rhinorrhoea
Clinical narrative: Was given a shot of PPV Pneumococcal Polysaccharide.  Reaction: Runny nose, severe Arm Pain, fever 99.2 next day from shot, temp 102 second day from shot, muscle ache, head ache, not thinking clearly.  Unable to go into work on second day from dose.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site infection, Injection site inflammation
Clinical narrative: Woke up with severe pain yesterday at right upper arm injection site. Mom called nurse and discussed. Temp 100. Redness and tight area as big as Mom's palm present today. Dr at walkin clinic stated area  very  inflamed or infected and gave antiobiotic. Augmentin given. Told Mom to return in 48 -72 hours if not inproved.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site pain
Clinical narrative: Woke up with severe pain yesterday at right upper arm injection site. Mom called nurse and discussed. Temp 100. Redness and tight area as big as Mom's palm present today. Dr at walkin clinic stated area  very  inflamed or infected and gave antiobiotic. Augmentin given. Told Mom to return in 48 -72 hours if not inproved.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Dyspnoea, Headache, Myalgia, Nasal congestion
Clinical narrative: PPV vacine shot on 4/13, 99.4 fever on 4/14, fever of 102 4/15, Stuffed up nose, cough, breathing impacted.  Muscle ache, sever are pain after shot for more than24 hours.  Head ache.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: PPV vacine shot on 4/13, 99.4 fever on 4/14, fever of 102 4/15, Stuffed up nose, cough, breathing impacted.  Muscle ache, sever are pain after shot for more than24 hours.  Head ache.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dry skin, Eczema, Erythema, Pruritus, Rash
Clinical narrative: States 2-3 days after recieving 1st Gardasil dose in LD, she developed a red, dry, itchy skin rash to left arm, shoulder to knuckles. Also present on knuckles. Self-treated initially with hydrocortisone cream. Seen at health center for same symptoms on 1-27-09. Treated with rx for triamcinolone cream. Diagnosis at that time was eczema. No prior hx of same. Resolved after approx. 2 weeks; student gave this history upon returning for 2nd Gardasil dose on 3-31-09. After discussion with manufacturor and MD, second dose was not given due to the possibility of an allergic reaction and student advised that it would be recommended that she discontinue series at this time. Student given info. sent from Merck as well as CDC and websites for further information.
Age: 38.0
Sex: F
Vaccine: HEPA, JEV
Symptoms: Injection site erythema, Injection site haematoma, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: One day post-vaccination with JE-VAX, client's arm was swollen, red, and itchy from elbow to shoulder and felt hard to the touch. Topical benadryl during daytime and oral benadryl at night time did not relieve symptoms. Client spoke to pharmacist at her health insurance provider 2 days post-vaccination, who advised her not to receive additional doses of JE-VAX but that she could consider trying new IXIARO vaccine for Japanese Encaphalitis if doses become available before travel. 9 days post-vaccination, client's arm is still tender to touch but redness, itchiness, and swelling have been relieved. A small bruise at the injection site, square in shape, is still visible. Hepatitis A dose #2 vaccine was given IM in same arm on same day, with no soreness or side effects.
Age: 38.0
Sex: F
Vaccine: HEPA, JEV
Symptoms: Injection site swelling
Clinical narrative: One day post-vaccination with JE-VAX, client's arm was swollen, red, and itchy from elbow to shoulder and felt hard to the touch. Topical benadryl during daytime and oral benadryl at night time did not relieve symptoms. Client spoke to pharmacist at her health insurance provider 2 days post-vaccination, who advised her not to receive additional doses of JE-VAX but that she could consider trying new IXIARO vaccine for Japanese Encaphalitis if doses become available before travel. 9 days post-vaccination, client's arm is still tender to touch but redness, itchiness, and swelling have been relieved. A small bruise at the injection site, square in shape, is still visible. Hepatitis A dose #2 vaccine was given IM in same arm on same day, with no soreness or side effects.
Age: 1.22
Sex: M
Vaccine: MMR, VARCEL, MMR
Symptoms: Blood product transfusion, Contusion, Gingival bleeding, Petechiae, Platelet count decreased
Clinical narrative: Petechial rash + bruising + oral bleeding 4/10. 4/11 ER - transferred to hospital. IVIG + Prednisone for thrombocytopenic purpura.   4/21 Link w/344276. 4/21/09 Received hospital medical records of 4/12-4/14/2009. FINAL DX: immune thrombocytopenia purpura; recent viral infection Records reveal patient experienced rash all over that increased to blotching & bruising.  Seen in ER where plt count 3K & pt transferred to higher level of care.  Sick family member w/flu-like symptoms.  Pt had clear rhinorrhea x 1 wk & was teething.  Heme/Onc consult done.  Tx w/IVIG x 2. steroids.  Improved  & d/c to home on tapering steroids w/PCP f/u.  Follow-up - Continue's blood test so far so good. Visit with hematologist -stable.
Age: 1.22
Sex: M
Vaccine: MMR, VARCEL, MMR
Symptoms: Thrombocytopenic purpura
Clinical narrative: Petechial rash + bruising + oral bleeding 4/10. 4/11 ER - transferred to hospital. IVIG + Prednisone for thrombocytopenic purpura.   4/21 Link w/344276. 4/21/09 Received hospital medical records of 4/12-4/14/2009. FINAL DX: immune thrombocytopenia purpura; recent viral infection Records reveal patient experienced rash all over that increased to blotching & bruising.  Seen in ER where plt count 3K & pt transferred to higher level of care.  Sick family member w/flu-like symptoms.  Pt had clear rhinorrhea x 1 wk & was teething.  Heme/Onc consult done.  Tx w/IVIG x 2. steroids.  Improved  & d/c to home on tapering steroids w/PCP f/u.  Follow-up - Continue's blood test so far so good. Visit with hematologist -stable.
Age: 1.22
Sex: M
Vaccine: MMR, VARCEL, MMR
Symptoms: Blood product transfusion, Contusion, Platelet count decreased, Rash erythematous, Rash macular
Clinical narrative: Petechial rash + bruising + oral bleeding 4/10. 4/11 ER - transferred to hospital. IVIG + Prednisone for thrombocytopenic purpura.   4/21 Link w/344276. 4/21/09 Received hospital medical records of 4/12-4/14/2009. FINAL DX: immune thrombocytopenia purpura; recent viral infection Records reveal patient experienced rash all over that increased to blotching & bruising.  Seen in ER where plt count 3K & pt transferred to higher level of care.  Sick family member w/flu-like symptoms.  Pt had clear rhinorrhea x 1 wk & was teething.  Heme/Onc consult done.  Tx w/IVIG x 2. steroids.  Improved  & d/c to home on tapering steroids w/PCP f/u.  Follow-up - Continue's blood test so far so good. Visit with hematologist -stable.
Age: 9.0
Sex: F
Vaccine: FLU3, PPV, VARCEL
Symptoms: Blood culture negative, Eosinophil count normal, Haematocrit normal, Haemoglobin normal, Heart rate normal
Clinical narrative: Fever to 101-102. (R) arm erythema and severe pain out of proportion to exam - R/O invasive strep.  4/27/09 Received hospital medical records of 1/7-1/8/2009. FINAL DX: right arm with vaccine injection cellulitis Records reveal patient experienced pain in right upper arm since evening of vaccination.  Next day developed fever & RUE swelling & erythema with decreased right elbow ROM.  Erythema continued to enlarge w/warmth & increased pain & unable to fully extend elbow.  Tx w/oral antibiotics but condition did not improve.  PCP exam suggested possible invasive strep & pt hospitalized for IV antibiotics.  Remained stable, site improved & d/c to home on continued oral antibiotics.
Age: 9.0
Sex: F
Vaccine: FLU3, PPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Lymphocyte count normal, Monocyte count normal, Platelet count normal
Clinical narrative: Fever to 101-102. (R) arm erythema and severe pain out of proportion to exam - R/O invasive strep.  4/27/09 Received hospital medical records of 1/7-1/8/2009. FINAL DX: right arm with vaccine injection cellulitis Records reveal patient experienced pain in right upper arm since evening of vaccination.  Next day developed fever & RUE swelling & erythema with decreased right elbow ROM.  Erythema continued to enlarge w/warmth & increased pain & unable to fully extend elbow.  Tx w/oral antibiotics but condition did not improve.  PCP exam suggested possible invasive strep & pt hospitalized for IV antibiotics.  Remained stable, site improved & d/c to home on continued oral antibiotics.