chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Breech presentation, Caesarean section, Drug exposure during pregnancy, Laboratory test normal, Ultrasound scan normal
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female patient with no known drug allergies who on 24-APR-2008 (also reported as 28-APR-2008) was vaccinated with the first 0.5 ml IM dose of GARDASIL. On 26-JUN-2008 the patient received the second 0.5 ml IM dose of GARDASIL. On 24-OCT-2008 the patient received the third 0.5 ml IM dose of GARDASIL (lot # 659439/1267U). Concomitant therapy included insulin and SYNTHROID. At the time of the third dose the patient reported she was pregnant and LMP was 06-OCT-2008. Lab diagnostics studies included ultrasound and bloodwork. Ultrasound showed that LMP was 06-AUG-2008. Estimated delivery date was 13-MAY-2009. Bloodwork for OB profile was performed with all results in normal limits. The patient sought unspecified medical attention. Follow up information has been received from a completed questionnaire by a physician. It was reported on the questionnaire that the patient with diabetes, hypothyroidism had no complication and no infections or illnesses during pregnancy. On 24-DEC-2008, 18-FEB-2009, 01-APR-2009, 15-APR-2009 and 29-APR-2009, the patient had ultrasounds which were normal. On 30-APR-2009 at 38 weeks from LMP, the patient underwent a cesarean section due to breech and had a normal female liveborn infant. There were no congenital anomalies. She was 9 lbs 2.2 oz weight, 21 inches long, apgar score was 9/9. Upon internal review, cesarean section due to breech was considered to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Toxic shock syndrome
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who is a tampon user and who on an unknown date was vaccinated with the first dose of GARDASIL. Three days later, the patient experienced toxic shock syndrome and was admitted to the hospital. It was reported that the patient was menstruating and was using a tampon at that time. The physician stated that the patient survived but she spent one week in the hospital. The patient's final outcome was not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Encephalitis, Herpes zoster, Herpes zoster ophthalmic, Laboratory test abnormal
Clinical narrative: Information has been received from a pharmacist concerning a 69 year old female patient who on 11-MAR-2009 was vaccinated SQ with 0.65 mL of ZOSTAVAX (Oka/Merck) (lot # 663175/1553X). On 13-MAR-2009 the patient experienced shingles. The patient's shingles outbreak included eye involvement. On an unspecified date the patient recovered. The patient was seen at the practice. Follow up information received from the physician's office indicated that she was a 69 year old female patient (weight 159.4 lb) with no illness at time of vaccination who on approximately 15-MAR-2009, "4 days after vaccination" developed shingles on the fifth cranial nerve with eye involvement, and then on an unspecified date experienced encephalitis. On an unspecified date she was hospitalized for 7 days. At the time of the report, the patient had improved. Shingles on the fifth cranial nerve with eye involvement and encephalitis were considered to be disabling. Additional information has been requested.
Age: 1.91
Sex: F
Vaccine: HEPA
Symptoms: Cough, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: Patient had vaccines 6/10/09. Had High fever (TMAX 104.1) (6/11/09), given TYLENOL/MORIN; No vomiting, no seizures. Also with runny nose, mild cough, - on ZYRTEC.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling and warmth at the site of injection the size of a golf ball.  Entire thigh was swollen.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Back pain, Cough, Hypophagia, Injection site pain, Lethargy
Clinical narrative: Sore at injection site. Low grade fever; back pain started 6/4 in pm; lethargic; aches; cough; weakness in limbs, decreased PO all lasted 2 days. No long term sequelae.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Muscular weakness, Pain, Pyrexia
Clinical narrative: Sore at injection site. Low grade fever; back pain started 6/4 in pm; lethargic; aches; cough; weakness in limbs, decreased PO all lasted 2 days. No long term sequelae.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Site reaction- Red, itchy, warm 2 1/2
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Cough, Decreased appetite, Pyrexia
Clinical narrative: Stated after patient received shots child began to run a high fever of 104 - 105 degrees, and developed a cough.  Stated also had decrease in appetite.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Headache, Syncope
Clinical narrative: Pt given VAQTA and MENACTRA. After MENACTRA (approx 1 min) Pt slumped to side and fainted. Recovered immediately c/o dizziness and headache.
Age: 18.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Erythema, Joint swelling, Pruritus, Pruritus generalised, Rash
Clinical narrative: Pt received vaccines approx. at 2:30 pm on 6-11-09 mom states at 8:00 pm that night pt began with redness and itching to palms of hands. Hands had splotches on them with a welt on thumb. Awoke at 3:30 am with severe itching to hands, arms, legs, face and back. Back had small bumps. Still had some itching on 6-12-09 in AM. Mom also states pt had some welts on shoulder and back and pt felt like knees & face were swollen.
Age: 18.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Rash macular, Swelling face, Urticaria
Clinical narrative: Pt received vaccines approx. at 2:30 pm on 6-11-09 mom states at 8:00 pm that night pt began with redness and itching to palms of hands. Hands had splotches on them with a welt on thumb. Awoke at 3:30 am with severe itching to hands, arms, legs, face and back. Back had small bumps. Still had some itching on 6-12-09 in AM. Mom also states pt had some welts on shoulder and back and pt felt like knees & face were swollen.
Age: 25.0
Sex: F
Vaccine: SMALL
Symptoms: Lymphadenitis
Clinical narrative: acute postvaccinial lymphadenitis beginning post-vaccine day 5, involving left axillary, supraclavicular and cervical nodes, non-suppurative, no systemic symptoms; smallpox vaccine administered to left deltoid
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, DTAP, MNQ
Symptoms: Dysarthria, Gait disturbance, Headache, Lethargy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: on 5/23/09 developed headaches that progressed to lethargy, slurred speech and imbalanced gait. He was hospitalized 6/2/09 (and remains hospitalized) with waxing and waning symptoms. He has abnormalities on MRI that were initially presumed to be from acute demylinating encephalomyelitis however the pattern was not really ideal for this diagnosis. He was treated with standard steroids without much improvement. His EEG showed diffuse slowing and a pattern that might be suggestive of a metabolic abnormality but his metabolic studies have been negative.  7/9/09 DC summary received DOS 6/2/09 to 6/24/09 FINAL DX: Postinfectious or infectious involment of basal ganglia, Acute disseminated encephalomyelitis 'ADEM'. Patient presented with headache and altered mental status, sleepiness, ataxia. URI symptoms. Progressed to slurred speech and and discoordinated movements. Drooling, tongue tremor. Decreasing PO intake. IVIG. Parkinsonial like symptoms: tremors, rigidity, shuffling gait.  6/26/09 Received hospital medical records for6/2 -6/24/2009. FINAL DX: likely viral encephalitis; thrombocytopenia secondary to viral illness. Records reveal patient experienced HA, nasal congestion, sore throat, dry cough x approx 2 wks.  Seen by PCP where strep test neg.  Briefly improved then worsened w/severe HA, gen malaise, fatigue,  & altered mental status.  Dx w/sinusitis & tx w/antibiotics.  Continued to worsen until unable to verbally respond or recognize family members.  Taken to PCP due to decreased oral intake, difficult to walk, falling asleep while walking, speech slurred.  Seen in ER where CT scan, CXR & labs were WNL.  Tx w/steroids & d/c to home.  Continued to have difficulties.  Returned to PCP who dx w/sinusitis & changed antibiotics.  Continued to worsen & seen in different ER.  Neuro consult done.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, DTAP, MNQ
Symptoms: Balance disorder, Central nervous system lesion, Dysarthria, Electroencephalogram abnormal, Facial palsy
Clinical narrative: on 5/23/09 developed headaches that progressed to lethargy, slurred speech and imbalanced gait. He was hospitalized 6/2/09 (and remains hospitalized) with waxing and waning symptoms. He has abnormalities on MRI that were initially presumed to be from acute demylinating encephalomyelitis however the pattern was not really ideal for this diagnosis. He was treated with standard steroids without much improvement. His EEG showed diffuse slowing and a pattern that might be suggestive of a metabolic abnormality but his metabolic studies have been negative.  7/9/09 DC summary received DOS 6/2/09 to 6/24/09 FINAL DX: Postinfectious or infectious involment of basal ganglia, Acute disseminated encephalomyelitis 'ADEM'. Patient presented with headache and altered mental status, sleepiness, ataxia. URI symptoms. Progressed to slurred speech and and discoordinated movements. Drooling, tongue tremor. Decreasing PO intake. IVIG. Parkinsonial like symptoms: tremors, rigidity, shuffling gait.  6/26/09 Received hospital medical records for6/2 -6/24/2009. FINAL DX: likely viral encephalitis; thrombocytopenia secondary to viral illness. Records reveal patient experienced HA, nasal congestion, sore throat, dry cough x approx 2 wks.  Seen by PCP where strep test neg.  Briefly improved then worsened w/severe HA, gen malaise, fatigue,  & altered mental status.  Dx w/sinusitis & tx w/antibiotics.  Continued to worsen until unable to verbally respond or recognize family members.  Taken to PCP due to decreased oral intake, difficult to walk, falling asleep while walking, speech slurred.  Seen in ER where CT scan, CXR & labs were WNL.  Tx w/steroids & d/c to home.  Continued to have difficulties.  Returned to PCP who dx w/sinusitis & changed antibiotics.  Continued to worsen & seen in different ER.  Neuro consult done.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, DTAP, MNQ
Symptoms: Gait disturbance, Headache, Lethargy, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: on 5/23/09 developed headaches that progressed to lethargy, slurred speech and imbalanced gait. He was hospitalized 6/2/09 (and remains hospitalized) with waxing and waning symptoms. He has abnormalities on MRI that were initially presumed to be from acute demylinating encephalomyelitis however the pattern was not really ideal for this diagnosis. He was treated with standard steroids without much improvement. His EEG showed diffuse slowing and a pattern that might be suggestive of a metabolic abnormality but his metabolic studies have been negative.  7/9/09 DC summary received DOS 6/2/09 to 6/24/09 FINAL DX: Postinfectious or infectious involment of basal ganglia, Acute disseminated encephalomyelitis 'ADEM'. Patient presented with headache and altered mental status, sleepiness, ataxia. URI symptoms. Progressed to slurred speech and and discoordinated movements. Drooling, tongue tremor. Decreasing PO intake. IVIG. Parkinsonial like symptoms: tremors, rigidity, shuffling gait.  6/26/09 Received hospital medical records for6/2 -6/24/2009. FINAL DX: likely viral encephalitis; thrombocytopenia secondary to viral illness. Records reveal patient experienced HA, nasal congestion, sore throat, dry cough x approx 2 wks.  Seen by PCP where strep test neg.  Briefly improved then worsened w/severe HA, gen malaise, fatigue,  & altered mental status.  Dx w/sinusitis & tx w/antibiotics.  Continued to worsen until unable to verbally respond or recognize family members.  Taken to PCP due to decreased oral intake, difficult to walk, falling asleep while walking, speech slurred.  Seen in ER where CT scan, CXR & labs were WNL.  Tx w/steroids & d/c to home.  Continued to have difficulties.  Returned to PCP who dx w/sinusitis & changed antibiotics.  Continued to worsen & seen in different ER.  Neuro consult done.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 6/10/2009 Patients Mother called office and reported that Left arm at site where daughter received vaccine is red, hot and swollen.  Provider Dr. made aware orders received: apply warm moist on off every 20 mins., elevate, apply cortisone cream. 6/11/2009 2:48 p.m. Mother calls back office arm worse hard, hot, and swollen. Pt scheduled for appointment with Dr.  4:30 Pt at office for appt exam preformed found to have cellulitis of the Left arm at injection site. Prescribed Keflex 250/tsp 1 tsp four times daily
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Paraesthesia, Paraesthesia oral, Rash, Tachycardia
Clinical narrative: 14:30 vaccine administered pt became     flushed,tachycardia,thick tongue.tingleing in lips and through out body. Pt evaluated in Occ Health.  Remained in Occ Health untill 16:00.Pt. was given 25mg.po of Benadryl and a repeat dose in 20 min.Sent home with a 50mg po dost to be taken at HS.HR decreased flushing decreased.Felt fine to drive no grogginess.Fol up next day 6/11/09,mild rash on face and arms.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Tongue disorder
Clinical narrative: 14:30 vaccine administered pt became     flushed,tachycardia,thick tongue.tingleing in lips and through out body. Pt evaluated in Occ Health.  Remained in Occ Health untill 16:00.Pt. was given 25mg.po of Benadryl and a repeat dose in 20 min.Sent home with a 50mg po dost to be taken at HS.HR decreased flushing decreased.Felt fine to drive no grogginess.Fol up next day 6/11/09,mild rash on face and arms.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Client fainted for a few seconds.  I held her in chair until she came to and then we got her on the exam table and let her rest for about 15 minutes.  She was fine then and left with her parents.  Client also stated she had had nothing to eat yet, shot was given at 10:45am.
Age: 58.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Body temperature increased, Chills, Headache, Influenza like illness, Injection site erythema
Clinical narrative: Exactly 24 hours from the vaccination time patient stated that she had a raised reddened area around the injection site(left deltoid)and she started experiencing what she called "flu-like" symptoms. Approximately 32 hours after vaccination she stated that her temperature reached 101 degrees F and she was experiencing chills and extreme pain in her left arm. Today, almost 72 hours after vaccination, she is still feeling the same except her temperature is 99 degrees F. She stated that she had been taking Motrin for the inflammation in her arm and headache. I encourared her to increase her fluid intake and to take Tylenol. I also encouraged her to see her physician if symptoms continued after 72 hours.
Age: 58.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Injection site inflammation, Pain in extremity
Clinical narrative: Exactly 24 hours from the vaccination time patient stated that she had a raised reddened area around the injection site(left deltoid)and she started experiencing what she called "flu-like" symptoms. Approximately 32 hours after vaccination she stated that her temperature reached 101 degrees F and she was experiencing chills and extreme pain in her left arm. Today, almost 72 hours after vaccination, she is still feeling the same except her temperature is 99 degrees F. She stated that she had been taking Motrin for the inflammation in her arm and headache. I encourared her to increase her fluid intake and to take Tylenol. I also encouraged her to see her physician if symptoms continued after 72 hours.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Muscular weakness, Peripheral coldness, Sensory loss, Spinal X-ray
Clinical narrative: decreased sensation in left arm, left arm weakness, and cold left hand
Age: 23.0
Sex: F
Vaccine: HEPAB, HPV4
Symptoms: Hypoaesthesia, Oedema peripheral
Clinical narrative: Approximately 24 hrs after vaccination. Noted left arm swelling and c/o numbness from shoulder to wrist. After 48 hrs remains swollen but no erythema numbness improving from elbow to wrist. Normal ROM,no weakness. Will try ibuprofen for inflammation.
Age: 36.0
Sex: M
Vaccine: JEV, YF
Symptoms: Ear discomfort, Erythema, Flushing, Pruritus
Clinical narrative: Pt was experiencing itchy palms and also had pressure in his ears. Pt was red and flushed. Pt also had itching on the back of his head. Epi was administered.
Age: 1.58
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema
Clinical narrative: area surrounding vaccine site was red 2-3 inches in diameter in right arm, no induration,no heat present
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus, Sleep disorder, Urticaria
Clinical narrative: Patient is 28 year old male with complaints of hives that started showing up within the first week of getting home from deployment.  He reports it was about the first week in May of 2008.  He reports the only place he will get hives is on the left upper arm.  Never has hives anywhere else on the body.  He gets hives 1-2 times a day and they seem worse at night.  He reports that they are typically silver dollar sized and he typically has 6-8 hives at a time.  He has not taken anything for them but they go away in 1-2 hours.  He complains the hives are itchy and they can awaken from sleep due to the itching.  No dizziness or lightheaded.  No known triggers.  Nothing known to make better.  He reports that all his Anthrax shots and his Smallpox shot were in the left arm.  His last Anthrax shot was in 16 May 2008 and he feels that his reactions started after that shot.  He thought it was spider bites initially but when they kept coming back in the same area he thought that was unusual.
Age: 43.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood creatine phosphokinase, Discomfort, Muscle spasms, Neck pain, Red blood cell sedimentation rate
Clinical narrative: Day after immunizations began having neck pain with radiation down back; right arm discomfort and then later in week right knee lateral discomfort and right lateral small toe discomfort, Symptoms not worsening, but not resolved 8 day later.  Also 8 days later had slightly reduced subjective sensation left arm and left leg, not worsening.  Patient given Ibuprofen for inflammation and Flexeril for muscle spasm.  Exam revealed no neurologic deficit or swelling or erythema.  Mild muscle spasm, neck and mild tenderness neck, right arm, right lateral knee and right lateral 5th toe.
Age: 43.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Sensory disturbance, Tenderness
Clinical narrative: Day after immunizations began having neck pain with radiation down back; right arm discomfort and then later in week right knee lateral discomfort and right lateral small toe discomfort, Symptoms not worsening, but not resolved 8 day later.  Also 8 days later had slightly reduced subjective sensation left arm and left leg, not worsening.  Patient given Ibuprofen for inflammation and Flexeril for muscle spasm.  Exam revealed no neurologic deficit or swelling or erythema.  Mild muscle spasm, neck and mild tenderness neck, right arm, right lateral knee and right lateral 5th toe.
Age: 28.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Rash maculo-papular
Clinical narrative: Individual developed a maculopapular rash at the varivax injection site, on 5/25/2009.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Pain in extremity, Pruritus
Clinical narrative: Reports rash and swelling noted in left deltoid.  Received 2 vaccines on 06/11/09, noticed soreness in Left arm 14 hours later. Awakened next  morning ~ 26 hours later without problems until after showering. Pt states then noticed itching and rash on left arm with soreneess at the site of one of the injections. Observed by this writer~ 27 hours urticarial rash noted around one injection site~ 7x4 cm . Skin warm to touch and client afebrile (T- oral 98.4 F. To RTC on Monday with medical provider for followup.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Rash, Skin warm, Urticaria
Clinical narrative: Reports rash and swelling noted in left deltoid.  Received 2 vaccines on 06/11/09, noticed soreness in Left arm 14 hours later. Awakened next  morning ~ 26 hours later without problems until after showering. Pt states then noticed itching and rash on left arm with soreneess at the site of one of the injections. Observed by this writer~ 27 hours urticarial rash noted around one injection site~ 7x4 cm . Skin warm to touch and client afebrile (T- oral 98.4 F. To RTC on Monday with medical provider for followup.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left Deltoid muscle red/swollen and warm to touch 1 and 2 days after administration. Size of tennis ball.  Improving today on day 2.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Induration, Oedema peripheral, Pain in extremity
Clinical narrative: CHILD RECEIVED VACCINE ON 06/09/09 AT PRIMARY CARE AROUND 4PM WENT HOME AND HOUR LATER ARM BECAME SORE AND HARD AND SWELLED UP APPLIED ICE AND GAVE MOTRIN 100MG, WOKE UP NEXT MORNING SWELLING REALLY WORSE MADE APPT FOR PRIMARY DR TO SEE HIM. WENT TO SEE DR (ONLY ONE AVAILIABLE TO SEE HIM) SHE SAID IT WAS JUST A REACTION AND SHOULD TAKE SOME TIME WEEKS FOR SWELLING TO GO DOWN GIVE MOTRIN 200MG FOR PAIN AND SWELLING.... RETURNED HOME THAT EVENING SWELLING WORSE BUT NOW WAS HOT TO TOUCH AND RED BLOTCHY GOING ALL THE WAY DOWN ARM INTO BACK AND NECK...TO ER, WAS TOLD IT WAS CELLULITIS FROM SHOT....FOLLOW UP CLOSLY WITH PRIMARY DR. AND WAS GIVEN PRESCRIPTION FOR KEFLEX.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Rash macular, Skin warm, White blood cell count increased, X-ray
Clinical narrative: CHILD RECEIVED VACCINE ON 06/09/09 AT PRIMARY CARE AROUND 4PM WENT HOME AND HOUR LATER ARM BECAME SORE AND HARD AND SWELLED UP APPLIED ICE AND GAVE MOTRIN 100MG, WOKE UP NEXT MORNING SWELLING REALLY WORSE MADE APPT FOR PRIMARY DR TO SEE HIM. WENT TO SEE DR (ONLY ONE AVAILIABLE TO SEE HIM) SHE SAID IT WAS JUST A REACTION AND SHOULD TAKE SOME TIME WEEKS FOR SWELLING TO GO DOWN GIVE MOTRIN 200MG FOR PAIN AND SWELLING.... RETURNED HOME THAT EVENING SWELLING WORSE BUT NOW WAS HOT TO TOUCH AND RED BLOTCHY GOING ALL THE WAY DOWN ARM INTO BACK AND NECK...TO ER, WAS TOLD IT WAS CELLULITIS FROM SHOT....FOLLOW UP CLOSLY WITH PRIMARY DR. AND WAS GIVEN PRESCRIPTION FOR KEFLEX.
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Autoimmune disorder, Blindness, Cognitive disorder, Headache
Clinical narrative: This case was reported via a statement of injuries received via a lawyer and described the occurrence of flu-like symptoms in an adult male subject who was vaccinated with LYMERIX, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced flu-like symptoms, headaches, vision loss, possible memory loss and decreased activities of daily life, as well as "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX".  At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: LYME
Symptoms: Influenza like illness, Musculoskeletal pain, Neurological symptom
Clinical narrative: This case was reported via a statement of injuries received via a lawyer and described the occurrence of flu-like symptoms in an adult male subject who was vaccinated with LYMERIX, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced flu-like symptoms, headaches, vision loss, possible memory loss and decreased activities of daily life, as well as "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX".  At the time of reporting the outcome of the events was unspecified.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Rash & pain at injection site (~ 3" inch diameter), oval shape rash /redness.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Platelet count decreased, Rash pustular, Swelling
Clinical narrative: Pt came in with what looked like bug bites - Mom stated they appeared with VARCELLA shot + getting worse - Mom took child to hospital - trans. Pt to Hospital- Dr stated  that it was a reaction to Varicella shot - The rash was large - swelling area with pus tips > 0 2 1/2 CM
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness with swelling to right arm.
Age: 1.3
Sex: F
Vaccine: IPV, PNC
Symptoms: Injection site erythema
Clinical narrative: Large erythematous rxn to both legs, 6 x 6".
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Large, warm and tender indurated area at site of VARIVAX- 7x9cm.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: After MENACTRA injection. Child had brief syncopal episode. Lasted about 30 seconds, then alert, normal neurologically.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Injection site erythema
Clinical narrative: Erythema confluent smooth area L deltoid. Local Rx.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Convulsion, Dyskinesia, Feeling cold, Full blood count normal, Lethargy
Clinical narrative: On 05/26/09 after receiving immunizations the child had rhythmic movements of arms and legs followed by lethargic periods where baby was unresponsive or drowsy for about 1/2 hour. He would suck on a pacifier. Baby felt cold to mother during the night. No spells on 5/27 but was hospitalized on 5/28 @ 19:50 until 5/29 @ 13:45 after having seizure like symptoms again that afternoon. No fever or illness noted. No episodes since then. Does have a grandmother on seizure medication. Neurologist contacted. Instructed if seizure >5 min. long have parents bring child to ER and EEG will probably be needed. Takes formula.  6/22/09 Hospital records / ICD-9 codes received DOS 5/28/09 to 5/29/09. Assessment: 'Episodic spells'. Patient presents with mother describing 'episodic spells' would 'ball up' and become unresponsive. Drowsy post for 1/2 hour. Neurologist recommends EEG if symptoms recur. ICD-9 codes: 780.39
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Metabolic function test, Somnolence, Unresponsive to stimuli
Clinical narrative: On 05/26/09 after receiving immunizations the child had rhythmic movements of arms and legs followed by lethargic periods where baby was unresponsive or drowsy for about 1/2 hour. He would suck on a pacifier. Baby felt cold to mother during the night. No spells on 5/27 but was hospitalized on 5/28 @ 19:50 until 5/29 @ 13:45 after having seizure like symptoms again that afternoon. No fever or illness noted. No episodes since then. Does have a grandmother on seizure medication. Neurologist contacted. Instructed if seizure >5 min. long have parents bring child to ER and EEG will probably be needed. Takes formula.  6/22/09 Hospital records / ICD-9 codes received DOS 5/28/09 to 5/29/09. Assessment: 'Episodic spells'. Patient presents with mother describing 'episodic spells' would 'ball up' and become unresponsive. Drowsy post for 1/2 hour. Neurologist recommends EEG if symptoms recur. ICD-9 codes: 780.39
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Muscle spasms, Paraesthesia
Clinical narrative: Patient complains of headache after 1 hour of Hep A shot, muscle cramps on the left arm, tingling of the left fingers.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Hyperhidrosis, Muscle spasms, Musculoskeletal stiffness, Nausea
Clinical narrative: Donor states she has muscle cramps over both shoulders, back neck, these symptoms appeared 15 minutes after shot, nausea, sweating. 3 hours after shot patient complains of neck stiffness, 6/12/2009.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red puffy reaction at site of VARIVAX. Slightly tender. 6x6 cm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Patient presented to office with redness, hot to touch, knot at injection site, and treated with VERIPRED 20mg.
Age: 66.0
Sex: F
Vaccine: PPV, TD, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt received ZOSTAVAX vaccine on 6/10/09 - RTC on 6/12/09 C/o pain, red, warm to touch at injection site. Advised warm compresses. Given RX for Duricef X 10 days.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Instant swelling and redness at injection site. Ice pack applied. BENADRYL given one per day.
Sex: U
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site 1 week after administration.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Right deltoid pain with radiating to neck and forearm. Paraesthesia in right arm following Tdap immunization.
Age: 1.2
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Blister, Rash generalised
Clinical narrative: 6/7/09 Head to toe rash.  Blisters mostly on chest.  6/12/09 Rash almost gone.  0 blisters.
Age: 28.0
Sex: F
Vaccine: TTOX
Symptoms: Chest discomfort, Nausea, Pallor, Skin warm
Clinical narrative: Tightness, in chest, pale, warm, nauseated.  Cold packs were applied, she denied any difficulties breathing and recovered completely within a few minutes.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain, Body temperature increased, Dizziness, Loss of consciousness, Pain in extremity
Clinical narrative: Evening of 5/27. arm pain On 5/28. abdominal pain, leg pain; tingling backs of legs & feet. Light headed, passed out in shower. Temp 100.8.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Paraesthesia
Clinical narrative: Evening of 5/27. arm pain On 5/28. abdominal pain, leg pain; tingling backs of legs & feet. Light headed, passed out in shower. Temp 100.8.
Age: 1.5
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Blood culture, Body temperature increased, Cyanosis, Full blood count, Gaze palsy
Clinical narrative: Child was at daycare. He took a longer than average afternoon nap and woke up a little warm. He was standing at the window with his caregiver when his eyes rolled back and he appeared to loose consciousness. Cyanotic around lips, shaking. No tonic/clonic movements. Lasted 2 minutes. Transported to ER via ambulance. Temp on arrival 104.3 degrees.
Age: 1.5
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Loss of consciousness, Skin warm, Tremor
Clinical narrative: Child was at daycare. He took a longer than average afternoon nap and woke up a little warm. He was standing at the window with his caregiver when his eyes rolled back and he appeared to loose consciousness. Cyanotic around lips, shaking. No tonic/clonic movements. Lasted 2 minutes. Transported to ER via ambulance. Temp on arrival 104.3 degrees.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Dyskinesia, Feeling cold, Lethargy
Clinical narrative: Had immunization on 5/26/09, had episodic spells of rhythmic movements of arms and legs followed by lethargic episodes. Baby felt cold to mother during the night. No spells on 5/27/09. Again had seizure type symptoms on 5/28/09 in the afternoon - Mother reports  no fevers. Child was seen in clinic on 5/29/09 by Dr. Baby breastfeeds and takes some solids. No more seizures - since Thursday. Mother has seizure disorder and takes TOPAMAX. Dr. notified neurologist and was told if seizures last > 5 minutes parents should bring child to ER and EEG maybe needed.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, RV5
Symptoms: Failure to thrive, Seborrhoeic dermatitis
Clinical narrative: Child developed Abnormal Seborrheic dermatitis after vaccination, also Failure to Thrive.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: rash to MMR 10 days post vaccine
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Erythema, Pain in extremity, Rash, Swelling
Clinical narrative: About two days after my 2nd vaccine, my was swollen and extremely red above the injection site. Soon after, I developed a rash (starting on my back).  Eventually the rash moved to my face (including scalp), behind my ears, arms, and legs.  This morning, June 14, 2009, I woke up with blunt pain in the joints of my right thumb.  I have taken anti-inflammatory medicine (ibuprofen), and have applied cortizone cream to the rash areas.  Nothing is helping.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Pt received vaccine in the hospital. Approximately 1.5 days after administration RN noticed moderate swelling and redness of right upper extremity where pt received vaccination.  Pt complained of mild pain and only when blood pressure cuff was used.  RN called pharmacist (myself).  I asked her to outline area and alert doctor of adverse reaction in the am.  I added this vaccine to the pt's allergy list.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Urticaria, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 19 year old female with sulfonamide allergy, allergy to PEDIAZOLE and AUGMENTIN, who on 02-FEB-2007 was vaccinated with the first dose of GARDASIL 0.5 ml, I.M., on 04-APR-2007 was vaccinated with the second dose of GARDASIL (lot# 653736/0014U) 0.5 ml, I.M. Concomitant therapy included YASMIN. The patient developed hives some time after receiving both dose 1 and 2. At some point the patient had to be hospitalized and was given I.V. BENADRYL and steroids. On 13-JUN-2007, the patient was vaccinated with the third dose of GARDASIL (lot# 656050/0245U) 0.5 ml, I.M. The physician did not know if the patient had a reaction after third dose. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood product transfusion, Computerised tomogram normal, Depressed level of consciousness, Electroencephalogram, Fatigue
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 19 year old female who on 17-JUN-2008 was vaccinated with the first 0.5 ml dose of GARDASIL (lot number not provided). Concomitant therapy included MENACTRA. On 11-AUG-2008 the patient experienced fatigue and walking problem. The patient was hospitalized from 21-AUG-2008 to 24-AUG-2008 and on 24-AUG-2008 the patient was diagnosed with Guillain Barre syndrome. At the time of reporting the patient was not recovered. Follow up information was received from a Registered Nurse (R.N.) on 06-MAY-2009 via telephone provided the patient's name and date of birth. She confirmed that the patient received the first and only dose of GARDASIL on 17-JUN-2008 (lot# 660391/0063X) along with concomitant vaccine MENACTRA. The AE onset date was 11-AUG-2008 around 1:00 am. She went to the emergency room via ambulance with intolerable head and muscle pain, difficulty walking, nausea, and change of responsiveness. At the emergency room she was told that it was "viral" and was sent home. On 21-AUG-2008 she had a follow up doctor visit and she went into another hospital, while there she was referred to a neurologist. A CAT scan (negative results), EEG, Spinal Tap, MRI, and ultrasound of her bladder were performed. She was diagnosed with Guillain Barre syndrome. She was hospitalized from 21-AUG-2008 to 24-AUG-2008. She received globulin intravenously, pain medication, and physical therapy. Prior to this the patient had a baby. It was reported that as of 17-MAR-2009 the patient was still recovering and still going to physical therapy. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Gait disturbance, Guillain-Barre syndrome, Headache, Lumbar puncture, Myalgia
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 19 year old female who on 17-JUN-2008 was vaccinated with the first 0.5 ml dose of GARDASIL (lot number not provided). Concomitant therapy included MENACTRA. On 11-AUG-2008 the patient experienced fatigue and walking problem. The patient was hospitalized from 21-AUG-2008 to 24-AUG-2008 and on 24-AUG-2008 the patient was diagnosed with Guillain Barre syndrome. At the time of reporting the patient was not recovered. Follow up information was received from a Registered Nurse (R.N.) on 06-MAY-2009 via telephone provided the patient's name and date of birth. She confirmed that the patient received the first and only dose of GARDASIL on 17-JUN-2008 (lot# 660391/0063X) along with concomitant vaccine MENACTRA. The AE onset date was 11-AUG-2008 around 1:00 am. She went to the emergency room via ambulance with intolerable head and muscle pain, difficulty walking, nausea, and change of responsiveness. At the emergency room she was told that it was "viral" and was sent home. On 21-AUG-2008 she had a follow up doctor visit and she went into another hospital, while there she was referred to a neurologist. A CAT scan (negative results), EEG, Spinal Tap, MRI, and ultrasound of her bladder were performed. She was diagnosed with Guillain Barre syndrome. She was hospitalized from 21-AUG-2008 to 24-AUG-2008. She received globulin intravenously, pain medication, and physical therapy. Prior to this the patient had a baby. It was reported that as of 17-MAR-2009 the patient was still recovering and still going to physical therapy. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Nausea, Nuclear magnetic resonance imaging, Ultrasound scan
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 19 year old female who on 17-JUN-2008 was vaccinated with the first 0.5 ml dose of GARDASIL (lot number not provided). Concomitant therapy included MENACTRA. On 11-AUG-2008 the patient experienced fatigue and walking problem. The patient was hospitalized from 21-AUG-2008 to 24-AUG-2008 and on 24-AUG-2008 the patient was diagnosed with Guillain Barre syndrome. At the time of reporting the patient was not recovered. Follow up information was received from a Registered Nurse (R.N.) on 06-MAY-2009 via telephone provided the patient's name and date of birth. She confirmed that the patient received the first and only dose of GARDASIL on 17-JUN-2008 (lot# 660391/0063X) along with concomitant vaccine MENACTRA. The AE onset date was 11-AUG-2008 around 1:00 am. She went to the emergency room via ambulance with intolerable head and muscle pain, difficulty walking, nausea, and change of responsiveness. At the emergency room she was told that it was "viral" and was sent home. On 21-AUG-2008 she had a follow up doctor visit and she went into another hospital, while there she was referred to a neurologist. A CAT scan (negative results), EEG, Spinal Tap, MRI, and ultrasound of her bladder were performed. She was diagnosed with Guillain Barre syndrome. She was hospitalized from 21-AUG-2008 to 24-AUG-2008. She received globulin intravenously, pain medication, and physical therapy. Prior to this the patient had a baby. It was reported that as of 17-MAR-2009 the patient was still recovering and still going to physical therapy. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Gaze palsy, Loss of consciousness, Tremor
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female patient who on 16-APR-2009 was vaccinated with the first dose of GARDASIL.  There was no concomitant vaccines administered when the patient received GARDASIL.  The patient fainted immediately after receiving the vaccination.  The patient lost consciousness for a couple of seconds and then regained consciousness.  The patient was evaluated within the office in the Extended Care area.  The patient was fine and had recovered.  The patient was not hospitalized.  The R.N. did not feel that the incident was life-threatening or disabling.  The R.N. did not think the patient would continue the GARDASIL series.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female patient who on 16-APR-2009 was vaccinated with the first dose of GARDASIL.  There was no concomitant vaccines administered when the patient received GARDASIL.  The patient fainted immediately after receiving the vaccination.  The patient lost consciousness for a couple of seconds and then regained consciousness.  The patient was evaluated within the office in the Extended Care area.  The patient was fine and had recovered.  The patient was not hospitalized.  The R.N. did not feel that the incident was life-threatening or disabling.  The R.N. did not think the patient would continue the GARDASIL series.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Back pain, Blister, Gait disturbance, Genital lesion
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female with allergy to (BENADRYL) who on 28-APR-2009 was vaccinated with the first dose of GARDASIL (lot # 660389/1968U) (route not reported). There was no concomitant medication. " 3 hours after getting vaccine" the patient experienced fever, low back pain, hip pain difficulty walking. The patient also mentioned that she had blisters on her labia (she stated she had not had them before). The patient stated she called the pharmacy hot line and was told that this was normal reaction and told to take (TYLENOL) (manufacturer unspecified) after that patient stated she started feeling better. Follow-up information received from registered nurse revealed that the patient had no pertinent medical history. No other vaccines were administered at the same date as GARDASIL. The condition was not considered disabling or life threatening. The patient recovered on an unspecified date. It was unknown if a second dose of GARDASIL will be given. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female with allergy to (BENADRYL) who on 28-APR-2009 was vaccinated with the first dose of GARDASIL (lot # 660389/1968U) (route not reported). There was no concomitant medication. " 3 hours after getting vaccine" the patient experienced fever, low back pain, hip pain difficulty walking. The patient also mentioned that she had blisters on her labia (she stated she had not had them before). The patient stated she called the pharmacy hot line and was told that this was normal reaction and told to take (TYLENOL) (manufacturer unspecified) after that patient stated she started feeling better. Follow-up information received from registered nurse revealed that the patient had no pertinent medical history. No other vaccines were administered at the same date as GARDASIL. The condition was not considered disabling or life threatening. The patient recovered on an unspecified date. It was unknown if a second dose of GARDASIL will be given. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Back pain, Blister, Gait disturbance, Genital rash
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female with allergy to (BENADRYL) who on 28-APR-2009 was vaccinated with the first dose of GARDASIL (lot # 660389/1968U) (route not reported). There was no concomitant medication. " 3 hours after getting vaccine" the patient experienced fever, low back pain, hip pain difficulty walking. The patient also mentioned that she had blisters on her labia (she stated she had not had them before). The patient stated she called the pharmacy hot line and was told that this was normal reaction and told to take (TYLENOL) (manufacturer unspecified) after that patient stated she started feeling better. Follow-up information received from registered nurse revealed that the patient had no pertinent medical history. No other vaccines were administered at the same date as GARDASIL. The condition was not considered disabling or life threatening. The patient recovered on an unspecified date. It was unknown if a second dose of GARDASIL will be given. No further information is available.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Fall, Pallor, Syncope, Tremor
Clinical narrative: Information has been received from an office manager concerning a 13 year old female with no pertinent medical history or drug reactions or allergies who on 12-MAY-2009 was vaccinated with the first 0.5 ml dose of GARDASIL (lot # 661953/1130X) in the left arm. Concomitant suspect therapy included a dose of VARIVAX (lot # 659455/0228Y) administered in the right arm. Other concomitant therapy included (MENACTRA) and (HAVRIX). On 12-MAY-2009, "after receiving all of these vaccinations", the patient became pale and fainted. The patient was still at the physician's office when the symptoms occurred and began to recover within ten minutes. At the time of this report, the patient's final outcome was not specified. No lab tests were done. The patient was seen at the office and sought unspecified medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from an office manager concerning a 13 year old female with no pertinent medical history or drug reactions or allergies who on 12-MAY-2009 was vaccinated with the first 0.5 ml dose of GARDASIL (lot # 661953/1130X) in the left arm. Concomitant suspect therapy included a dose of VARIVAX (lot # 659455/0228Y) administered in the right arm. Other concomitant therapy included (MENACTRA) and (HAVRIX). On 12-MAY-2009, "after receiving all of these vaccinations", the patient became pale and fainted. The patient was still at the physician's office when the symptoms occurred and began to recover within ten minutes. At the time of this report, the patient's final outcome was not specified. No lab tests were done. The patient was seen at the office and sought unspecified medical attention. Additional information has been requested.