chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Body temperature, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received 2 vaccines at 18 month WCC.  Mother reported symptoms started the day after - redness, swelling, warmth, and tenderness at vaccine site (PREVNAR) in left thigh.  Denied elevation of temperature.  Assessed at office on 9/5, confirming reported symptoms; temp 98.9 rectal.  Advised Tylenol/Motrin, cool compresses, and monitoring of symptoms/fever.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Started to developed welts later that day, covering arms, torso and legs.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pneumonia vaccine given about 2:30. Pain left arm woke her up at 12:00. Sharp pain injection site down. Throbbes from time to time. Pain on scale "1-10" is 920.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Nausea, Oedema peripheral, Pain in extremity, Visual field defect
Clinical narrative: Donor stated she had no peripheral vision in left eye, she is nauseous and dizzy. Left arm slightly swollen and sore to the touch. 09-05-08; Donor stated no treatment was necessary. 09/05/08
Age: 1.1
Sex: M
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash erythematous, Swelling face, Testicular swelling
Clinical narrative: Patient developed a fever shortly after receiving his immunisations on 8/29. Parents report some swelling of face and testicles, but resolved in a few days. Temp. increased 101deg F. He's had recurrent fevers and developed a red rash all over the body.
Age: 1.4
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Reports symptoms started 24 hours after vaccine administration. Left arm with area of erythema, swelling, and warmth at site of injection. Afebrile. Advised ice and Tylenol and return if symptoms worsen.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Incorrect dose administered
Clinical narrative: Invalid dose of Hib vaccine administered, Hib vaccine, reconstituted with sterile water instead of Hib diluent, No adverse reaction noted
Age: 29.0
Sex: F
Vaccine: HEP, HIBV, IPV, TD
Symptoms: Unevaluable event
Clinical narrative: No adverse event.  HIB administered to a 29 year old. No adverse event.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Rash
Clinical narrative: States started with swollen glands in the neck on day 10 after vaccine then on day 11 started with a fine pinpoint rash all over trunk, arms and legs.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Immune response at all 4 injection sites and treated just in case for cellulitis.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Erythema around injection site.  MMR and Varicella within less than 10 minutes.  No warmth.
Age: 6.0
Sex: M
Vaccine: DT, IPV, MMR
Symptoms: Alopecia
Clinical narrative: Unimmunized patient who was begun on "catch up" series has developed alopecia.  Family feels immunizations are the cause.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient was supposed to be given DTAP, and was given PEDIARIX by mistake, along with IPV, MMR and VARICELLA.  Child suffered no ill effects from this after administration of vaccines.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Leg swollen, itchy
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Fatigue, Lethargy, Oedema peripheral
Clinical narrative: Patient complained of leg, arm and hand edema 2 hours after vaccine given.  Also complained of feeling tired, lethargic and generalized weakness x 2 days.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: vet sates PNEUMOVAX injection caused arm to swell so huge you could see it through huge shirt", described area as red, hot to touch and has to use a sling for 2-3 months because he was unable to use it.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash on belly and chest
Age: 8.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Rash
Clinical narrative: (L) arm round rash measuring 3.5 x 3.4 cm. (R) arm oval rash measuring 11cm x 11cm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Left arm swollen from deltoid to just above elbow. Swelling moderate area warm to touch.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Rash
Clinical narrative: Left and right thigh rash appear on both thighs around injection site five minutes after injections were given.  Patient referred to doctor.  Grandmother came with patient.  Telephone call to father notified of rash and ask to have MD check rash.
Age: 0.38
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: "None"
Sex: F
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: No adverse event
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Skin warm, Urticaria
Clinical narrative: Quarter-size urticarial type lesion confluent with adjacent nickel sized lesion with some appearance. Both with pinpoint puncture wound in center. Warm to touch on left upper outer thigh on 8-28-08 --- DTaP an VARIVAX given in left thigh on 8.25.08
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Urticaria
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Haematemesis, Pyrexia
Clinical narrative: High fever 102.6 documented, 103.3 at home, in office (TM) and non-bilous/non-bloody emesis 5 x within 24 hours.
Age: 1.8
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Started with fever on 8/27/08 - fever got up to 105.6 during the night - gave Tylenol, helped some.  Brought into clinic 8/28/08 to be evaluated.  Questionable reaction to vaccine (Dtap).
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Dizziness postural, Dyspnoea, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: Evening of vaccine, developed hives. Mother treated with Benadryl OTC. Resolved by noon 8/21/08. No reaction noted at inj. site. On 8/23/08 developed fever (low-grade), HA, fatigue occas. dizziness with standing, neck stiffness and mild SOB. Seen in office 8/25/08- temo 99.8, all other exam WNL.
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia, Urticaria
Clinical narrative: Evening of vaccine, developed hives. Mother treated with Benadryl OTC. Resolved by noon 8/21/08. No reaction noted at inj. site. On 8/23/08 developed fever (low-grade), HA, fatigue occas. dizziness with standing, neck stiffness and mild SOB. Seen in office 8/25/08- temo 99.8, all other exam WNL.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Rash, Rhinorrhoea, Urticaria
Clinical narrative: Received vaccines on 8/28/07 and mom states that 2 days later, patient developed rash (hives) that's more on body.  Patient also with runny nose.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: VARIVAX vaccine was administered, I ordered immunization in error, believing it was childs 2nd shift. In fact, it was his third shot. No adverse reaction. No symptoms after shot. No consequences medically noted.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test negative, Parotid gland enlargement
Clinical narrative: R parotid gland enlargement, tenderness x 3 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Induration, Oedema peripheral, Pain
Clinical narrative: 1 cm induration and swelling left thigh without redness or fever. Slight pain with walking onset 8-27-08
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Erythema left deltoid.
Age: 12.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site - upper right arm.  Inner redness 4cm x 6cm, outer redness 15cm x 12cm.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Inflammation
Clinical narrative: Severe localized inflammatory response with rubrequent depigmentation
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: CSF glucose abnormal, CSF lymphocyte count abnormal, CSF monocyte count decreased, CSF protein increased, CSF white blood cell count increased
Clinical narrative: Initial report received on 30 April 2008 from the Food and Drug Administration (FDA), VAERS # 307133. The FDA received the original report from a health care professional. A 14-year-old male patient, who had concurrent illnesses or past medical history, had received a first intramuscular left arm injection of MENACTRA (Lot # U2562AA) on 25 February 2008. On 06 March 2008, 10 days post-vaccination, the patient developed Guillain-Barre syndrome. The patient was hospitalized for five days. The dates of hospitalization were not provided. Relevant diagnostic tests included a lumbar puncture test that revealed protein 143, white blood cells 7 (78% lymphocytes, and 10% monocytes), no red blood cells, and glucose of 60 in the spinal fluid. An MRI of the brain and spine was normal. At the time of this report, it was "unknown" if the patient had recovered. Follow-up information received on 27 June 2008 from the Centers for Disease Control and Prevention (VAERS # 307133). The patient was hospitalized from 11 March 2008 to 19 March 2008 for gait disturbance. Clinical exam and CSF were thought to be consistent with GBS. The patient was treated with five days of "IVIG" (intravenous immunoglobulins) and was discharged to a rehabilitation facility. (Date not provided). CISA review of this case has confirmed GBS level 2 of diagnostic of certainty of the case definition developed by The GBS working group.
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Initial report received on 30 April 2008 from the Food and Drug Administration (FDA), VAERS # 307133. The FDA received the original report from a health care professional. A 14-year-old male patient, who had concurrent illnesses or past medical history, had received a first intramuscular left arm injection of MENACTRA (Lot # U2562AA) on 25 February 2008. On 06 March 2008, 10 days post-vaccination, the patient developed Guillain-Barre syndrome. The patient was hospitalized for five days. The dates of hospitalization were not provided. Relevant diagnostic tests included a lumbar puncture test that revealed protein 143, white blood cells 7 (78% lymphocytes, and 10% monocytes), no red blood cells, and glucose of 60 in the spinal fluid. An MRI of the brain and spine was normal. At the time of this report, it was "unknown" if the patient had recovered. Follow-up information received on 27 June 2008 from the Centers for Disease Control and Prevention (VAERS # 307133). The patient was hospitalized from 11 March 2008 to 19 March 2008 for gait disturbance. Clinical exam and CSF were thought to be consistent with GBS. The patient was treated with five days of "IVIG" (intravenous immunoglobulins) and was discharged to a rehabilitation facility. (Date not provided). CISA review of this case has confirmed GBS level 2 of diagnostic of certainty of the case definition developed by The GBS working group.
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Blood product transfusion, CSF glucose normal, CSF lymphocyte count normal, CSF protein increased, CSF white blood cell count
Clinical narrative: Initial report received on 30 April 2008 from the Food and Drug Administration (FDA), VAERS # 307133. The FDA received the original report from a health care professional. A 14-year-old male patient, who had concurrent illnesses or past medical history, had received a first intramuscular left arm injection of MENACTRA (Lot # U2562AA) on 25 February 2008. On 06 March 2008, 10 days post-vaccination, the patient developed Guillain-Barre syndrome. The patient was hospitalized for five days. The dates of hospitalization were not provided. Relevant diagnostic tests included a lumbar puncture test that revealed protein 143, white blood cells 7 (78% lymphocytes, and 10% monocytes), no red blood cells, and glucose of 60 in the spinal fluid. An MRI of the brain and spine was normal. At the time of this report, it was "unknown" if the patient had recovered. Follow-up information received on 27 June 2008 from the Centers for Disease Control and Prevention (VAERS # 307133). The patient was hospitalized from 11 March 2008 to 19 March 2008 for gait disturbance. Clinical exam and CSF were thought to be consistent with GBS. The patient was treated with five days of "IVIG" (intravenous immunoglobulins) and was discharged to a rehabilitation facility. (Date not provided). CISA review of this case has confirmed GBS level 2 of diagnostic of certainty of the case definition developed by The GBS working group.
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Gait disturbance, Guillain-Barre syndrome, Lumbar puncture abnormal, Monocyte count decreased, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Initial report received on 30 April 2008 from the Food and Drug Administration (FDA), VAERS # 307133. The FDA received the original report from a health care professional. A 14-year-old male patient, who had concurrent illnesses or past medical history, had received a first intramuscular left arm injection of MENACTRA (Lot # U2562AA) on 25 February 2008. On 06 March 2008, 10 days post-vaccination, the patient developed Guillain-Barre syndrome. The patient was hospitalized for five days. The dates of hospitalization were not provided. Relevant diagnostic tests included a lumbar puncture test that revealed protein 143, white blood cells 7 (78% lymphocytes, and 10% monocytes), no red blood cells, and glucose of 60 in the spinal fluid. An MRI of the brain and spine was normal. At the time of this report, it was "unknown" if the patient had recovered. Follow-up information received on 27 June 2008 from the Centers for Disease Control and Prevention (VAERS # 307133). The patient was hospitalized from 11 March 2008 to 19 March 2008 for gait disturbance. Clinical exam and CSF were thought to be consistent with GBS. The patient was treated with five days of "IVIG" (intravenous immunoglobulins) and was discharged to a rehabilitation facility. (Date not provided). CISA review of this case has confirmed GBS level 2 of diagnostic of certainty of the case definition developed by The GBS working group.
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Red blood cell count normal
Clinical narrative: Initial report received on 30 April 2008 from the Food and Drug Administration (FDA), VAERS # 307133. The FDA received the original report from a health care professional. A 14-year-old male patient, who had concurrent illnesses or past medical history, had received a first intramuscular left arm injection of MENACTRA (Lot # U2562AA) on 25 February 2008. On 06 March 2008, 10 days post-vaccination, the patient developed Guillain-Barre syndrome. The patient was hospitalized for five days. The dates of hospitalization were not provided. Relevant diagnostic tests included a lumbar puncture test that revealed protein 143, white blood cells 7 (78% lymphocytes, and 10% monocytes), no red blood cells, and glucose of 60 in the spinal fluid. An MRI of the brain and spine was normal. At the time of this report, it was "unknown" if the patient had recovered. Follow-up information received on 27 June 2008 from the Centers for Disease Control and Prevention (VAERS # 307133). The patient was hospitalized from 11 March 2008 to 19 March 2008 for gait disturbance. Clinical exam and CSF were thought to be consistent with GBS. The patient was treated with five days of "IVIG" (intravenous immunoglobulins) and was discharged to a rehabilitation facility. (Date not provided). CISA review of this case has confirmed GBS level 2 of diagnostic of certainty of the case definition developed by The GBS working group.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Back pain, Dizziness, Fatigue, Headache
Clinical narrative: Initial report was received 14 August 2008 from a health care professional. A 19-year-old male patient with no pre-existing medical conditions, had received an intramuscular injection (site not reported), of MENACTRA, lot number U2422AA and 12 to 15 hours later, complained of chest tightness, a sore arm and had difficulty lifting his arm, nausea, headache, a rash under his arm, and his legs felt heavy and weak. The patient had no concurrent illness and had not received any concomitant vaccines. The reporter stated the patient was planned  to be evaluated by the physician. At the time of the report, the patient had not recovered from the event.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Initial report was received 14 August 2008 from a health care professional. A 19-year-old male patient with no pre-existing medical conditions, had received an intramuscular injection (site not reported), of MENACTRA, lot number U2422AA and 12 to 15 hours later, complained of chest tightness, a sore arm and had difficulty lifting his arm, nausea, headache, a rash under his arm, and his legs felt heavy and weak. The patient had no concurrent illness and had not received any concomitant vaccines. The reporter stated the patient was planned  to be evaluated by the physician. At the time of the report, the patient had not recovered from the event.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Injection site warmth, Musculoskeletal pain, Nausea, Pain in extremity, Sensation of heaviness
Clinical narrative: Initial report was received 14 August 2008 from a health care professional. A 19-year-old male patient with no pre-existing medical conditions, had received an intramuscular injection (site not reported), of MENACTRA, lot number U2422AA and 12 to 15 hours later, complained of chest tightness, a sore arm and had difficulty lifting his arm, nausea, headache, a rash under his arm, and his legs felt heavy and weak. The patient had no concurrent illness and had not received any concomitant vaccines. The reporter stated the patient was planned  to be evaluated by the physician. At the time of the report, the patient had not recovered from the event.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Chest discomfort, Headache, Hypokinesia, Injected limb mobility decreased, Nausea
Clinical narrative: Initial report was received 14 August 2008 from a health care professional. A 19-year-old male patient with no pre-existing medical conditions, had received an intramuscular injection (site not reported), of MENACTRA, lot number U2422AA and 12 to 15 hours later, complained of chest tightness, a sore arm and had difficulty lifting his arm, nausea, headache, a rash under his arm, and his legs felt heavy and weak. The patient had no concurrent illness and had not received any concomitant vaccines. The reporter stated the patient was planned  to be evaluated by the physician. At the time of the report, the patient had not recovered from the event.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Pain, Rash, Sensation of heaviness
Clinical narrative: Initial report was received 14 August 2008 from a health care professional. A 19-year-old male patient with no pre-existing medical conditions, had received an intramuscular injection (site not reported), of MENACTRA, lot number U2422AA and 12 to 15 hours later, complained of chest tightness, a sore arm and had difficulty lifting his arm, nausea, headache, a rash under his arm, and his legs felt heavy and weak. The patient had no concurrent illness and had not received any concomitant vaccines. The reporter stated the patient was planned  to be evaluated by the physician. At the time of the report, the patient had not recovered from the event.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Hypoaesthesia, Muscle spasms, Paraesthesia
Clinical narrative: Initial information was received on 25 August 2008 from a health care professional.  An 11 year old patient received an injection of MENACTRA (U2621AA) and BOOSTRIX (manufacturer GSK, lot number not reported) on 11 July 2008.  On 19 August 2008 the patient received an injection of GARDASIL (manufacturer Merck, lot number not reported).  On 25 August 2008 the patient reported symptoms of "legs numb and hurting".  The patient was unaware when the symptoms began.  The recovery status was unknown.  No further information was provided.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Initial information was received on 25 August 2008 from a health care professional.  An 11 year old patient received an injection of MENACTRA (U2621AA) and BOOSTRIX (manufacturer GSK, lot number not reported) on 11 July 2008.  On 19 August 2008 the patient received an injection of GARDASIL (manufacturer Merck, lot number not reported).  On 25 August 2008 the patient reported symptoms of "legs numb and hurting".  The patient was unaware when the symptoms began.  The recovery status was unknown.  No further information was provided.
Age: 32.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Burning sensation, Headache, Hypoaesthesia, Muscle spasms, Paraesthesia
Clinical narrative: Initial report received from a consumer on 27 August 2008 and 29 August 2008.  Additional information received on 02 September 2008 from the CDC (VAERS ID 323476).  A 32-year-old female patient had received an intramuscular left deltoid injection of MENACTRA (batch number U2422AA) on 07 August 2008, and ten minutes later she experienced burning sensation, acute muscle spasms, numbness of the hands, paresthesias, headache and severe localized back pain.  The patient reported that she had developed acute transverse "mylitis".  The event required an emergency room/doctor visit and a two-day hospitalization.  Corrective treatment included intravenous SOLU-MEDROL, cyclobenzaprine, DILAUDID, DECADRON and ibuprofen.  It was reported that the patient recovered from the event.  It was also reported that the patient is scheduled to see another neurologist (reason not provided).
Age: 32.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Back pain, Burning sensation, Headache, Hypoaesthesia, Muscle spasms
Clinical narrative: Initial report received from a consumer on 27 August 2008 and 29 August 2008.  Additional information received on 02 September 2008 from the CDC (VAERS ID 323476).  A 32-year-old female patient had received an intramuscular left deltoid injection of MENACTRA (batch number U2422AA) on 07 August 2008, and ten minutes later she experienced burning sensation, acute muscle spasms, numbness of the hands, paresthesias, headache and severe localized back pain.  The patient reported that she had developed acute transverse "mylitis".  The event required an emergency room/doctor visit and a two-day hospitalization.  Corrective treatment included intravenous SOLU-MEDROL, cyclobenzaprine, DILAUDID, DECADRON and ibuprofen.  It was reported that the patient recovered from the event.  It was also reported that the patient is scheduled to see another neurologist (reason not provided).
Age: 32.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Myelitis transverse, Paraesthesia
Clinical narrative: Initial report received from a consumer on 27 August 2008 and 29 August 2008.  Additional information received on 02 September 2008 from the CDC (VAERS ID 323476).  A 32-year-old female patient had received an intramuscular left deltoid injection of MENACTRA (batch number U2422AA) on 07 August 2008, and ten minutes later she experienced burning sensation, acute muscle spasms, numbness of the hands, paresthesias, headache and severe localized back pain.  The patient reported that she had developed acute transverse "mylitis".  The event required an emergency room/doctor visit and a two-day hospitalization.  Corrective treatment included intravenous SOLU-MEDROL, cyclobenzaprine, DILAUDID, DECADRON and ibuprofen.  It was reported that the patient recovered from the event.  It was also reported that the patient is scheduled to see another neurologist (reason not provided).
Sex: M
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated PO with a 2.0 ml dose of ROTATEQ (date not reported).  It was reported that the patient was taken to the hospital due to a case of intussusception after vaccination (date not reported).  The course of treatment and the outcome were not reported.  The reporter felt that the intussusception was life-threatening.  A product quality complaint was not involved.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abasia, Dizziness, Headache, Nausea, Vertigo
Clinical narrative: Information has been received from a 62 year old female with drug hypersensitivity to codeine who on 20-AUG-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included LIPITOR and ATACAND and therapy unspecified.  On 22-AUG-2007, the patient experienced headaches, vertigo, dizziness, nausea and vomiting. In addition her legs locked up on her and she was temporarily unable to walk.  When this occurred she had to be hospitalized for one week.  While in the hospital many tests were performed (results not reported).  Her legs returned to normal but the other adverse symptoms lasted through December 2007, before going away.  Subsequently, the patient recovered from headache, vertigo, dizziness, nausea and vomiting.  She did not want us to contact her physician.  No further information is available.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Information has been received from a 62 year old female with drug hypersensitivity to codeine who on 20-AUG-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included LIPITOR and ATACAND and therapy unspecified.  On 22-AUG-2007, the patient experienced headaches, vertigo, dizziness, nausea and vomiting. In addition her legs locked up on her and she was temporarily unable to walk.  When this occurred she had to be hospitalized for one week.  While in the hospital many tests were performed (results not reported).  Her legs returned to normal but the other adverse symptoms lasted through December 2007, before going away.  Subsequently, the patient recovered from headache, vertigo, dizziness, nausea and vomiting.  She did not want us to contact her physician.  No further information is available.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Musculoskeletal chest pain, Rash
Clinical narrative: Information has been received from a physician concerning an 81 year old female with an allergy to codeine who on 23-FEB-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot #656608/0032U).  Concomitant therapy included ADVAIR and VENTOLIN.  On 27-JUL-2008 the patient developed shingles.  Shingles began with pain on her left lateral chest wall.  On 30-JUL-2008 the patient was seen in the office and had a small, "quarter size" rash and severe pain on her chest wall.  No laboratory diagnostics studies were performed.  The patient was prescribed VALTREX and PERCOCET.  At the time of the report, the patient's shingles persisted.  The reporting physician felt that the patient's shingles were an other important medical event.  Additional information has been requested.
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Autism
Clinical narrative: Information has been received regarding a case in litigation from a consumer concerning her son who on an unspecified date was vaccinated with PEDVAX HIB (OMPC) (lot #646153/0342N), VARIVAX (Oka/Merck) (MSD) (lot # 648751/0447P) and MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (MSD) (lot #645522/0780P).  Subsequently the patient was diagnosed with autism.  Upon internal review, the patient's autism was considered to be an other important medical event.  Additional information is not expected.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Body temperature increased, Erythema, Headache, Immunisation reaction
Clinical narrative: Information has been received from a physician concerning a 52 year old male with penicillin allergy who on 25-AUG-2008 was vaccinated into the left upper arm (route unspecified) with PNEUMOVAX 23 (lot #659150/1384U).  The physician reported that on 26-AUG-2008 the patient developed a severe local and systemic reaction to vaccination with PNEUMOVAX 23.  The local reaction was an erythema 3 inches in diameter that was warm, red and swollen.  The  systemic reaction was described as a fever up to 102 degrees F, general malaise, headache and generalized muscle and joint pain described as arthralgia.  The patient had no known history of a previous vaccination with PNEUMOVAX 23.  At the time of the report the patient was recovering.  No further information was available to report.  A lot check has been requested.  The physician considered erythema 3 inches in diameter that was warm, red and swollen and fever up to 102 degrees F, general malaise, headache and generalized muscle and joint pain to be disabling.  Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Local reaction, Malaise, Myalgia, Pyrexia, Skin warm
Clinical narrative: Information has been received from a physician concerning a 52 year old male with penicillin allergy who on 25-AUG-2008 was vaccinated into the left upper arm (route unspecified) with PNEUMOVAX 23 (lot #659150/1384U).  The physician reported that on 26-AUG-2008 the patient developed a severe local and systemic reaction to vaccination with PNEUMOVAX 23.  The local reaction was an erythema 3 inches in diameter that was warm, red and swollen.  The  systemic reaction was described as a fever up to 102 degrees F, general malaise, headache and generalized muscle and joint pain described as arthralgia.  The patient had no known history of a previous vaccination with PNEUMOVAX 23.  At the time of the report the patient was recovering.  No further information was available to report.  A lot check has been requested.  The physician considered erythema 3 inches in diameter that was warm, red and swollen and fever up to 102 degrees F, general malaise, headache and generalized muscle and joint pain to be disabling.  Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a physician concerning a 52 year old male with penicillin allergy who on 25-AUG-2008 was vaccinated into the left upper arm (route unspecified) with PNEUMOVAX 23 (lot #659150/1384U).  The physician reported that on 26-AUG-2008 the patient developed a severe local and systemic reaction to vaccination with PNEUMOVAX 23.  The local reaction was an erythema 3 inches in diameter that was warm, red and swollen.  The  systemic reaction was described as a fever up to 102 degrees F, general malaise, headache and generalized muscle and joint pain described as arthralgia.  The patient had no known history of a previous vaccination with PNEUMOVAX 23.  At the time of the report the patient was recovering.  No further information was available to report.  A lot check has been requested.  The physician considered erythema 3 inches in diameter that was warm, red and swollen and fever up to 102 degrees F, general malaise, headache and generalized muscle and joint pain to be disabling.  Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Activities of daily living impaired, Arthralgia, Body temperature increased, Erythema, Headache
Clinical narrative: Information has been received from a physician concerning a 54 year old male with no drug allergies who on 26-AUG-2008 was vaccinated with PNEUMOVAX 23 (lot #659150/1384U).  The physician reported that on 27-AUG-2008 the patient developed a severe local and systemic reaction to vaccination with PNEUMOVAX 23.  The local reaction was erythema 3 inches in diameter that was warm, red and swollen.  The patient had had trouble raising his arm over his head, and had spent the last 3 days in bed.  The systemic reaction was described as a fever up to 102 degrees F, general malaise, headache and generalized muscle and joint pain described as arthralgia.  The patient had no known history of a previous vaccination with PNEUMOVAX 23.  At the time of the report the patient was recovering.  No further information was available to report.  A lot check has been requested.  The physician considered erythema 3 inches in diameter that was warm, red and swollen; trouble raising his arm over his head; spent the last 3 days in bed; fever up to 102 degrees F; general malaise; headache; and generalized muscle and joint pain to be disabling.  Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Hypokinesia, Immunisation reaction, Injected limb mobility decreased, Local reaction, Malaise
Clinical narrative: Information has been received from a physician concerning a 54 year old male with no drug allergies who on 26-AUG-2008 was vaccinated with PNEUMOVAX 23 (lot #659150/1384U).  The physician reported that on 27-AUG-2008 the patient developed a severe local and systemic reaction to vaccination with PNEUMOVAX 23.  The local reaction was erythema 3 inches in diameter that was warm, red and swollen.  The patient had had trouble raising his arm over his head, and had spent the last 3 days in bed.  The systemic reaction was described as a fever up to 102 degrees F, general malaise, headache and generalized muscle and joint pain described as arthralgia.  The patient had no known history of a previous vaccination with PNEUMOVAX 23.  At the time of the report the patient was recovering.  No further information was available to report.  A lot check has been requested.  The physician considered erythema 3 inches in diameter that was warm, red and swollen; trouble raising his arm over his head; spent the last 3 days in bed; fever up to 102 degrees F; general malaise; headache; and generalized muscle and joint pain to be disabling.  Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Pyrexia, Skin warm, Swelling
Clinical narrative: Information has been received from a physician concerning a 54 year old male with no drug allergies who on 26-AUG-2008 was vaccinated with PNEUMOVAX 23 (lot #659150/1384U).  The physician reported that on 27-AUG-2008 the patient developed a severe local and systemic reaction to vaccination with PNEUMOVAX 23.  The local reaction was erythema 3 inches in diameter that was warm, red and swollen.  The patient had had trouble raising his arm over his head, and had spent the last 3 days in bed.  The systemic reaction was described as a fever up to 102 degrees F, general malaise, headache and generalized muscle and joint pain described as arthralgia.  The patient had no known history of a previous vaccination with PNEUMOVAX 23.  At the time of the report the patient was recovering.  No further information was available to report.  A lot check has been requested.  The physician considered erythema 3 inches in diameter that was warm, red and swollen; trouble raising his arm over his head; spent the last 3 days in bed; fever up to 102 degrees F; general malaise; headache; and generalized muscle and joint pain to be disabling.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix abnormal, Colposcopy abnormal, Drug administered at inappropriate site, Mucosal inflammation, Papilloma viral infection
Clinical narrative: Initial and follow-up information has been received from a nurse concerning a 20 year old female who on 07-APR-2008 was vaccinated intramuscularly into the left gluteus with the first 0.5 ml dose of GARDASIL (lot no. 659655/1486U). On 29-May-2008, the patient had a colposcopy done which showed positive for human papilloma virus. The biopsy showed squamous mucosa and attached endocervical glandular mucosa with mild chronic inflammation and reactive changes. Focal changes suggestive of human papillomavirus-associated cytopathic effect. The patient stated that she had only one sexual partner (1st partner for each other). On 06-JUN-2008 the patient was vaccinated intramuscularly into the left deltoid with the second 0.5 ml dose of GARDASIL (lot no. 660387/1967U). At the time of this report, the patient was still positive for human papilloma virus. The patient sought unspecified medical attention. The reporter considered human papilloma viral infection to be other important medical event. Additional information is not expected. All medical records are available upon request.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site bruising, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Pt seen 9-4-05 for PE, given DTaP and Varivax in Left thigh, appox. 4pm.On 9-5-08 at 7pm noticed red, hot to touch, hard, grapefruit size area at site of one injection on left thigh.  Seen on office 9-6-2008 the following morning. Dx left ear infection (LOM) and Left immunization site with possible cellulitis vs local reaction.  advised benadryl Q6 hours while awake and put on Cefdinir, warm compresses to area.Left upper lat. thigh imm. site was 8 cm x 8.5 cm erythema and induration. Mom told to call if worse. Per telephone conversation, w/mom 9-8-08, site had faded lots on 9-7-08, but 9-8-08 no hardness can be felt, much lighter, almost a faded bruise look, not hot to touch.  Mom did not give any bedadryl, did give cefdinir.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site warmth, Otitis media
Clinical narrative: Pt seen 9-4-05 for PE, given DTaP and Varivax in Left thigh, appox. 4pm.On 9-5-08 at 7pm noticed red, hot to touch, hard, grapefruit size area at site of one injection on left thigh.  Seen on office 9-6-2008 the following morning. Dx left ear infection (LOM) and Left immunization site with possible cellulitis vs local reaction.  advised benadryl Q6 hours while awake and put on Cefdinir, warm compresses to area.Left upper lat. thigh imm. site was 8 cm x 8.5 cm erythema and induration. Mom told to call if worse. Per telephone conversation, w/mom 9-8-08, site had faded lots on 9-7-08, but 9-8-08 no hardness can be felt, much lighter, almost a faded bruise look, not hot to touch.  Mom did not give any bedadryl, did give cefdinir.
Age: 20.0
Sex: F
Vaccine: HPV4, IPV
Symptoms: Chills, Dizziness, Flushing, Nausea, Pain
Clinical narrative: 0658 9-9-08 SYNCOPE, BODY ACHES, CHILLS, NAUSEA, LIGHT HEADED, FLUSHED FACIAL CHEEKS, PALMS ERYTHEMIC, PRURITIS PALMS, DIPHENHYDRAMINE 25MG PO TIMES ONE, TYLENOL 975MG PO TIMES ONE GIVEN.
Age: 20.0
Sex: F
Vaccine: HPV4, IPV
Symptoms: Palmar erythema, Pruritus, Syncope
Clinical narrative: 0658 9-9-08 SYNCOPE, BODY ACHES, CHILLS, NAUSEA, LIGHT HEADED, FLUSHED FACIAL CHEEKS, PALMS ERYTHEMIC, PRURITIS PALMS, DIPHENHYDRAMINE 25MG PO TIMES ONE, TYLENOL 975MG PO TIMES ONE GIVEN.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Brain oedema, Hemiparesis
Clinical narrative: three weeks after vaccine administration client developed right sided weakness that progressively got worse he was admitted to hospital for swelling on brain.  Patient is still hospitalized
Age: 0.69
Sex: M
Vaccine: DTAPHEPBIP, HBHEPB, PNC
Symptoms: Accidental overdose, Injection site induration, Injection site irritation, Injection site rash, Injection site swelling
Clinical narrative: Pt presented with swelling and irritation around injection site and also developed a slight rash on his leg. His mother also noted a small hard spot on the injection site. Pt had a slight fever which is now under control. Pt is otherwise fine.
Age: 0.69
Sex: M
Vaccine: DTAPHEPBIP, HBHEPB, PNC
Symptoms: Pyrexia, Wrong drug administered
Clinical narrative: Pt presented with swelling and irritation around injection site and also developed a slight rash on his leg. His mother also noted a small hard spot on the injection site. Pt had a slight fever which is now under control. Pt is otherwise fine.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: EMPLOYEE CAME AFTER RECEIVING VACCINE. LEFT UPPER ARM RED HOT AND EDEMATOUS. COMPLAINT OF FOREHEAD AND NOSE ITCHING.CALLED PHARMACY AND DISPENSED BENADRYL 50 MG. ICE PACK TO LEFT UPPER ARM. HAVE EMPLOYEE CHECKING IN WITH NURSE MANAGER TO CHECK UPPER ARM AND STATUS OF EMPLOYEE. EMPLOYEE INSTRUCTED TO COME SEE ME IF SYMPTOMS BECOME WORSE AND WILL ALSO CHECK IN FIRST THING TOMORROW MORNING.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Arthralgia, Biopsy skin normal, Dizziness, Headache
Clinical narrative: "HAIR LOSS,AND IRREGULAR MENSES,JOINT PAIN, HEADACHES ETC: Our daughter, who had completed her series of 3 vaccinations of "Gardisil" has been experiencing considerable hair loss.  Her first shot was in May 24, 2007, the second on July 26, 2007 and the third and final on November 27, 2007. Here are the other specifics....our daughter was 13 turning fourteen. She has had every blood test imaginable to rule out the obvious which may cause hair loss such as thyroid disease, polycystic ovary disease, diabetes, and the list goes on and on. Everything came back negative.  We even have a future appointment scheduled with a rheumatologist this coming November 08.  We have seen the Endocrinologist and two dermatologists (a scalp biopsy proved negative to any infection, disease, etc.  Granted, she had a typical amount of stress during the school year, as any young teen would, but nothing to cause this.  Everyday our daughter says to us, "you should see how much hair fell out in the shower today". She's so afraid to brush or comb it because of the extreme shedding. She literally, to date has half the amount of hair she had one year ago.  Let me tell you she had beautiful hair.  The hair loss is becoming quite visible at the forward part of her scalp.  This has been devastating, hair is everything to a teen. (to anyone this is devastating) We must also mention that her periods have been totally out of whack.  She went 6 months at one point without one.  It finally came back, but it is so sporadic, getting every two weeks, at times extremely heavy, etc... She also complains of intermitent dizziness.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Menorrhagia
Clinical narrative: "HAIR LOSS,AND IRREGULAR MENSES,JOINT PAIN, HEADACHES ETC: Our daughter, who had completed her series of 3 vaccinations of "Gardisil" has been experiencing considerable hair loss.  Her first shot was in May 24, 2007, the second on July 26, 2007 and the third and final on November 27, 2007. Here are the other specifics....our daughter was 13 turning fourteen. She has had every blood test imaginable to rule out the obvious which may cause hair loss such as thyroid disease, polycystic ovary disease, diabetes, and the list goes on and on. Everything came back negative.  We even have a future appointment scheduled with a rheumatologist this coming November 08.  We have seen the Endocrinologist and two dermatologists (a scalp biopsy proved negative to any infection, disease, etc.  Granted, she had a typical amount of stress during the school year, as any young teen would, but nothing to cause this.  Everyday our daughter says to us, "you should see how much hair fell out in the shower today". She's so afraid to brush or comb it because of the extreme shedding. She literally, to date has half the amount of hair she had one year ago.  Let me tell you she had beautiful hair.  The hair loss is becoming quite visible at the forward part of her scalp.  This has been devastating, hair is everything to a teen. (to anyone this is devastating) We must also mention that her periods have been totally out of whack.  She went 6 months at one point without one.  It finally came back, but it is so sporadic, getting every two weeks, at times extremely heavy, etc... She also complains of intermitent dizziness.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Anorexia, Fatigue, Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: First day fussy, tired, fever 101, anorexia, irritation at site. 2nd day inflammation, grew x 4 days, Sat 9/6 peak inflammation, hot, red circular.  1 week after injection large (10.5 cm x 8 cm) circular erythematous border with central clearing with firm nodule at site.  Fever x 2 days.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site irritation, Injection site nodule, Injection site warmth, Irritability, Pyrexia
Clinical narrative: First day fussy, tired, fever 101, anorexia, irritation at site. 2nd day inflammation, grew x 4 days, Sat 9/6 peak inflammation, hot, red circular.  1 week after injection large (10.5 cm x 8 cm) circular erythematous border with central clearing with firm nodule at site.  Fever x 2 days.
Age: 1.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC
Symptoms: Injection site urticaria, Pyrexia
Clinical narrative: Several minutes after receiving immunizations (At approx 3 PM) child developed a single hive 10mm in size adjacent to MMRV administration site.  No other adverse events or other hives.  Color was good. No respiratory problems.  Child playing, walking and drinking bottle.  Hrt rate 132.  Observed child for 50 minutes and no changes in status.  Hive fading.  ER was notified and child transported by parents to local ER at about 3:52 PM.  Per phone call to mom on 9/9 child was ordered benadryl po and tylenol/motrin alternating.  Other than mild fever child not experiencing any other problems.
Age: 0.8
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Acoustic stimulation tests normal, Autism spectrum disorder, Pyrexia, Social avoidant behaviour
Clinical narrative: After receiving flu shot developed a fever that was on and off for a week. Used Tylenol and motrin with no effect. He completly changed after that. Would not respond to name no eye contact. We took him to get hearing test done, no problems. Took him to specialist... AUTISM SPECTRUM DISORDER.  9/29/2008 PCP office notes received beginning with 9 mon WCC 11/10/06. PE WNL. Frequent UR sx throughout early 2007. 15 mon WCC 5/1/07 with no expressive words or pointing to body parts. 1 word vocab at 18 months. Delayed speech noted 7/20/07 as well as food aversions. Neuro referral-3/2008. 12/4/08 MR received from neuro dated 6/23/08 with DX: Autistic Spectrum Disorder. 1/26/2010 Autism-Encephalopathy.
Age: 0.8
Sex: M
Vaccine: FLU3
Symptoms: Unresponsive to stimuli
Clinical narrative: After receiving flu shot developed a fever that was on and off for a week. Used Tylenol and motrin with no effect. He completly changed after that. Would not respond to name no eye contact. We took him to get hearing test done, no problems. Took him to specialist... AUTISM SPECTRUM DISORDER.  9/29/2008 PCP office notes received beginning with 9 mon WCC 11/10/06. PE WNL. Frequent UR sx throughout early 2007. 15 mon WCC 5/1/07 with no expressive words or pointing to body parts. 1 word vocab at 18 months. Delayed speech noted 7/20/07 as well as food aversions. Neuro referral-3/2008. 12/4/08 MR received from neuro dated 6/23/08 with DX: Autistic Spectrum Disorder. 1/26/2010 Autism-Encephalopathy.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Urticaria
Clinical narrative: Papular urticaria 6 days after administration of Varivax.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Feeling hot, Hyperhidrosis, Induration, Oedema peripheral
Clinical narrative: Redness and swelling in arm within several hours; hard lump and feverish type sweating persisting for 3 days. Family physician recommended taking Tylenol or Alleve or something similar to treat symptoms.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Rash
Clinical narrative: 8-29-08 No fever, muscle spasms per Dr. in ER and he felt normal.  Rash to trunk front and back, worse on the back.