chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.01
Sex: F
Vaccine: DTAP, HEP, HIBV, MMR
Symptoms: Cognitive disorder, Drug toxicity, Hypotonia, Laboratory test abnormal, Mental retardation severity unspecified
Clinical narrative: This case was reported by a lawyer and described the occurrence of neurological injury in a male subject who was vaccinated with hepatitis B vaccine (Engerix B) and or unidentified hepatitis B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced serious and permanent neurological injuries which was attributed to toxic mercury exposure. The following information was received via medical records, the subject was vaccianted with Hep B on 8/23/94 and 1/27/95. The subject was vaccianted with Dtap on 3/24/94 and 5/25/94, the subject was also vaccianted with oral polio, Hib adn MMR for prophylaxis. A pediatric master problem list indicated the following hypotonia/poor condition 1/24/97, developmental delay 1/23/98, and pervasive developmental disorder 5/22/98. No delays were noted during the first year, and at 12 months was able to say mama. The subject did not walk until 18 years of age. AT two years old she had a few words, which were lost by age three years. At age tow she also began to scream for 5 to 10 minutes per episode for no known reason. According to progress notes dated 1/23/98, the subject experienced problems with toilet training, was not speaking, and made fleeting eye contact. Neurological examination revealed hypotonia. Impression included developmental delay with loss of speech. The subject was referred for evaluation of possible probable Rett's syndrome with deteriorating milestones, loss of language, and hypotonia floppiness. In April 1998, the subject was hospitalized for diagnosis of Rett syndrome due to excellent hand use and ability to follow simple commands. She was assessed to have pervasive developmental disorder. She exhibited severe tantrums, initially treated with Prozac and later changed to clonidine. On 5/13/98, testing revealed cognitive skills commensurate with a 12 month level as measured by the Battelle Developmental inventory. Expressive and receptive speech and language skills, and fine motor and socialization skills, were below expected for age. At that time it was noted that the subject was exhibiting stereotypical behaviors consistent with autism. On 9/2/1998, the subject was treated in the ER for an accidental overdose of Clonidine, at that time she was noted to have a mental age of approx 22 months. By approx Feb 2000, she had begun to repeat words and was using some sign language, and was described as having made continued progress in a special education program which included speech and language therapy. By Jan 2001, the subject had been diagnosed with autism, and she failed a vision test at school. On 4/30/04, the subjects mother reported an increase in combative behavior and property destruction.
Age: 1.01
Sex: F
Vaccine: DTAP, HEP, HIBV, MMR
Symptoms: Nervous system disorder, Repetitive speech, Screaming, Staring, Visual disturbance
Clinical narrative: This case was reported by a lawyer and described the occurrence of neurological injury in a male subject who was vaccinated with hepatitis B vaccine (Engerix B) and or unidentified hepatitis B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced serious and permanent neurological injuries which was attributed to toxic mercury exposure. The following information was received via medical records, the subject was vaccianted with Hep B on 8/23/94 and 1/27/95. The subject was vaccianted with Dtap on 3/24/94 and 5/25/94, the subject was also vaccianted with oral polio, Hib adn MMR for prophylaxis. A pediatric master problem list indicated the following hypotonia/poor condition 1/24/97, developmental delay 1/23/98, and pervasive developmental disorder 5/22/98. No delays were noted during the first year, and at 12 months was able to say mama. The subject did not walk until 18 years of age. AT two years old she had a few words, which were lost by age three years. At age tow she also began to scream for 5 to 10 minutes per episode for no known reason. According to progress notes dated 1/23/98, the subject experienced problems with toilet training, was not speaking, and made fleeting eye contact. Neurological examination revealed hypotonia. Impression included developmental delay with loss of speech. The subject was referred for evaluation of possible probable Rett's syndrome with deteriorating milestones, loss of language, and hypotonia floppiness. In April 1998, the subject was hospitalized for diagnosis of Rett syndrome due to excellent hand use and ability to follow simple commands. She was assessed to have pervasive developmental disorder. She exhibited severe tantrums, initially treated with Prozac and later changed to clonidine. On 5/13/98, testing revealed cognitive skills commensurate with a 12 month level as measured by the Battelle Developmental inventory. Expressive and receptive speech and language skills, and fine motor and socialization skills, were below expected for age. At that time it was noted that the subject was exhibiting stereotypical behaviors consistent with autism. On 9/2/1998, the subject was treated in the ER for an accidental overdose of Clonidine, at that time she was noted to have a mental age of approx 22 months. By approx Feb 2000, she had begun to repeat words and was using some sign language, and was described as having made continued progress in a special education program which included speech and language therapy. By Jan 2001, the subject had been diagnosed with autism, and she failed a vision test at school. On 4/30/04, the subjects mother reported an increase in combative behavior and property destruction.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Left arm swollen and red.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Headache, Hyperhidrosis, Influenza, Lymphadenopathy, Pain
Clinical narrative: Presented on 9/29/06 with c/o HA, sweats, bodyaches. Reported receiving smallpox vaccine approximately 1 week prior. Physical exam noted + Tender lymphadenopathy to the L axilla. Smallpox vaccination site within normal limits. Diagnosed as "spv flu". Orders given for quarters times 48 hours (may go to FOB, if able but continue quarters if necessary), f/u on Monday at TMC, Toradol 60mg IM given for HA, 1L normal saline given IV, Mobic 7.5mg 1-2 at supper, Tylenol #3 prn.
Age: 34.0
Sex: M
Vaccine: SMALL, TYP, SMALL
Symptoms: Chest pain, Injection site erythema, Lymphadenopathy
Clinical narrative: Presented to ER on 8/19/06 with c/o pain in the L shoulder and axilla. He had received his smallpox vaccination approximately 10 days prior. Physical Exam noted: L axilla lymphadenopathy, reddened area to the L upper arm where smallpox vaccination had been given. Patient was afebrile. Additionally he c/o of some L upper lateral chest pain. A CXR and Labs were obtained. Dx: L axillary lymphadenopathy secondary to smallpox vaccination. Orders given for Ibuprofen 600mg q 6 hours, #8 were dispensed. Vicodin 5/500 one every 4-6  hours, #12 were dispensed. Patient was to follow up.
Age: 34.0
Sex: M
Vaccine: SMALL, TYP, SMALL
Symptoms: Lymphadenopathy
Clinical narrative: Presented to ER on 8/19/06 with c/o pain in the L shoulder and axilla. He had received his smallpox vaccination approximately 10 days prior. Physical Exam noted: L axilla lymphadenopathy, reddened area to the L upper arm where smallpox vaccination had been given. Patient was afebrile. Additionally he c/o of some L upper lateral chest pain. A CXR and Labs were obtained. Dx: L axillary lymphadenopathy secondary to smallpox vaccination. Orders given for Ibuprofen 600mg q 6 hours, #8 were dispensed. Vicodin 5/500 one every 4-6  hours, #12 were dispensed. Patient was to follow up.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Erythema, Injection site warmth, Pruritus
Clinical narrative: Arm swelled, turned red & hot, itched and then later was very painful.  This was not just local.  The swelling spread to encompass whole upper arm and into the elbow.  Swelling was over 8-9 inches vertically in the upper arm and spread around the full width of the arm to include the underside ~13-14 inches.  Also had some minor swelling of hand.  During this time I ran a low grade fever became light headed and weak.  Though I was still up and around.  It is now 24 hours later and the swelling has not gone down yet though I have taken Allegra and Advil.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Arm swelled, turned red & hot, itched and then later was very painful.  This was not just local.  The swelling spread to encompass whole upper arm and into the elbow.  Swelling was over 8-9 inches vertically in the upper arm and spread around the full width of the arm to include the underside ~13-14 inches.  Also had some minor swelling of hand.  During this time I ran a low grade fever became light headed and weak.  Though I was still up and around.  It is now 24 hours later and the swelling has not gone down yet though I have taken Allegra and Advil.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Dizziness, Myalgia, Nausea, Pharyngolaryngeal pain
Clinical narrative: 10-04-06 3:45 p.m.was running and became nauseated, dizzy. 10:00pm throat became sore when swollowing. Muscles in neck were sore/stiff ("like when you sleep wrong on neck") 10:30pm Hives on back, stomack, neck, and shoulders) chills until 2:30pm 10-5-06 a.m. few hives on shoulders. no nausea. neck aches/stiff. Instructed to see physician as soon as possible. Noted will see her doctor this morning.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: 10-04-06 3:45 p.m.was running and became nauseated, dizzy. 10:00pm throat became sore when swollowing. Muscles in neck were sore/stiff ("like when you sleep wrong on neck") 10:30pm Hives on back, stomack, neck, and shoulders) chills until 2:30pm 10-5-06 a.m. few hives on shoulders. no nausea. neck aches/stiff. Instructed to see physician as soon as possible. Noted will see her doctor this morning.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Chills, Erythema, Swelling
Clinical narrative: A 76 year old female patient received Pneumovax® vaccine on 4/26/06.  After returning home, she developed chills but no fever, swollen arm from elbow to the shoulders, truncal warmth and redness and some skin blistering.  The patient had received Pneumovax® 4-5 years previously without any reaction. After she returned to the clinic on 4/27/06, she was advised to take Advil® and Benadryl®, and no fever was noted. She was instructed to return or visit the ER if symptoms worsened, or if she experienced trouble breathing.
Age: 20.0
Sex: M
Vaccine: HEP, VARCEL, HEP
Symptoms: Coordination abnormal, Dizziness, Headache
Clinical narrative: Received second Hep B on 6/22/06.  Began to have dizziness and ataxia on approximately 7/27/06.  Also received varivax on 6/22/06. 10/26/06-seen in ER discharged from ER on 7/28/06 records do not indicate a hospitalization DX: headache, dizziness and giddiness and tension headache. Presented to ER with c/o headache, dizzy in morning. Seen in ER at 15:30. Felt good prior to presenting at ER.
Age: 20.0
Sex: M
Vaccine: HEP, VARCEL, HEP
Symptoms: Balance disorder, Coordination abnormal, Dizziness, Gait disturbance
Clinical narrative: Received second Hep B on 6/22/06.  Began to have dizziness and ataxia on approximately 7/27/06.  Also received varivax on 6/22/06. 10/26/06-seen in ER discharged from ER on 7/28/06 records do not indicate a hospitalization DX: headache, dizziness and giddiness and tension headache. Presented to ER with c/o headache, dizzy in morning. Seen in ER at 15:30. Felt good prior to presenting at ER.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, IPV, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient presented to office 48 hours post immunization with redness 3cm in diameter and tenderness at the immunization site.
Age: 15.0
Sex: F
Vaccine: HEP, IPV, MMRV
Symptoms: Medication error
Clinical narrative: No adverse reaction occured. However Proquad is not licensed for over the age of 12 years.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, MMR
Symptoms: Injection site warmth, Swelling
Clinical narrative: Right arm edematous and warm to touch above the elbow, no fever or tenderness.
Age: 38.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Dizziness, Headache, Rash
Clinical narrative: SKIN RASH, JOINT PAINS, HEADACHE, DIZZINESS.
Age: 38.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Dizziness, Erythema, Headache, Rash
Clinical narrative: SKIN RASH, JOINT PAINS, HEADACHE, DIZZINESS.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Pt received flu shot at 11:00am.  At 11:05, pt reported feeling numbness in left arm and lip, tingling in head, and flushing. Admin Benadryl 50 mg PO.  At 11:15 am, pt reports relief of symptoms.  No rash, itching, or hives noted at any times.  No resp symptoms present.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Pruritus
Clinical narrative: On 10/3/06  started itching all over body around 2:30pm-3:00pm and Right eye swelling started called Dr.  Put on Prednisone 10 mg, taking 6 tablets one day and reducing down by one until gone.  Went to see Dr. on 10/05/06 had albuteral breathing treatment, advised to use Advair Diskus 100/50 1 puff twice a day until better.  Also told to get Benadryl 25mg 1 pill twice a day, and artificial tears to help with swelling of eye.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Client states a little pain and swelling on Tuesday, September 26 with increasing pain and swelling on Sunday October 1, 2006.  On Thursday, October 5, when seen by RN, Left deltoid slightly reddened with not edema present with little discomfort voiced.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Drooling, Facial palsy, Hypoaesthesia, Lacrimation increased, Nasal congestion
Clinical narrative: Teary left eye, dripping left nostril, then drooling out of left side of mouth when eating, numbness entire left side of face down to chest including throat and neck. Eye does not close. Mouth when smiling droop on left side - can't smile, can't pronounce words with P or B- can't form whistle type mouth. Had flu injection Sat. afternoon and Mon afternoon developed symptoms. First thought could then when couldnt eat dinner without drooling and numbness, went to E.R. Had CT scan, various blood tests until l0:30 that night, and they thought it was Bells Palsy but could not be sure positively if it was a stroke.  I was referred me to my internist where I went Tues morning. He would like to do an MRI to completly rule out stroke but I said to wait. Meanwhile I am taking prednisone 20 mg. 4 for three days, 3 for three days, 2 for two days and l for one day along with Valtrex 1 gram 2 x a day for 7 days along with various eye ointments to keep my left eye lubricated (as it is blood red and hurts) along with wearing a patch.  Do not know at this time how much, if any, permanent damage this shall leave me with nor how long this shall continue with my entire left eye, head, face and neck and throat being numb.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Speech disorder
Clinical narrative: Teary left eye, dripping left nostril, then drooling out of left side of mouth when eating, numbness entire left side of face down to chest including throat and neck. Eye does not close. Mouth when smiling droop on left side - can't smile, can't pronounce words with P or B- can't form whistle type mouth. Had flu injection Sat. afternoon and Mon afternoon developed symptoms. First thought could then when couldnt eat dinner without drooling and numbness, went to E.R. Had CT scan, various blood tests until l0:30 that night, and they thought it was Bells Palsy but could not be sure positively if it was a stroke.  I was referred me to my internist where I went Tues morning. He would like to do an MRI to completly rule out stroke but I said to wait. Meanwhile I am taking prednisone 20 mg. 4 for three days, 3 for three days, 2 for two days and l for one day along with Valtrex 1 gram 2 x a day for 7 days along with various eye ointments to keep my left eye lubricated (as it is blood red and hurts) along with wearing a patch.  Do not know at this time how much, if any, permanent damage this shall leave me with nor how long this shall continue with my entire left eye, head, face and neck and throat being numb.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Hot flush, Injection site erythema, Injection site pain, Injection site warmth, Sleep disorder
Clinical narrative: Had influenza shot on Tuesday Octboter 2 around 1:00pm.  No complications Tuesday night.  On Wednesday, noticed about a baseball size red welt at injection site severe redness, tenderness, and warmth at sight.  Also experienced all over body "burning sensation", like a hot flash.  No visible signs of inflammation or redness on outward skin.  Felt as like internal "cooking".  Felt sunburn like but with no redness.  Was unable to get any sleep due to soreness of arm or hot flash sensations.  Was advised by employee health to take ibuprofen.  I took ibuprofen 800mg x 2 doses and hot flashes resolved but came back after ibuprofen wore off.  Redness and swelling at arm is not resolved at this time
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Thermal burn, Urticaria
Clinical narrative: Had influenza shot on Tuesday Octboter 2 around 1:00pm.  No complications Tuesday night.  On Wednesday, noticed about a baseball size red welt at injection site severe redness, tenderness, and warmth at sight.  Also experienced all over body "burning sensation", like a hot flash.  No visible signs of inflammation or redness on outward skin.  Felt as like internal "cooking".  Felt sunburn like but with no redness.  Was unable to get any sleep due to soreness of arm or hot flash sensations.  Was advised by employee health to take ibuprofen.  I took ibuprofen 800mg x 2 doses and hot flashes resolved but came back after ibuprofen wore off.  Redness and swelling at arm is not resolved at this time
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Dyspnoea, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Right arm, swelling, reddened, site hot, redness, redness moved down right arm, trouble breathing took to ER late Friday evening, ER personnel instructed clients mother to give Benadryl according to package insert.
Age: 1.03
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site rash
Clinical narrative: Rash and red, swelling on right thigh (inner thigh).
Age: 1.03
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site warmth
Clinical narrative: Rash and red, swelling on right thigh (inner thigh).
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Condition aggravated, Headache, Otitis media, Pain
Clinical narrative: Prescribed amoxicillin for ear infection. Felt bad the next day symptoms aggravated as day progressed, complaining of aching today, fever 101, headache, chills. Taken to ER at night, given Benadryl and stopped amoxicillin. Problems continued and lasted for entire weekend. Today pt feels fine.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Prescribed amoxicillin for ear infection. Felt bad the next day symptoms aggravated as day progressed, complaining of aching today, fever 101, headache, chills. Taken to ER at night, given Benadryl and stopped amoxicillin. Problems continued and lasted for entire weekend. Today pt feels fine.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration
Clinical narrative: Left arm erythema and mild induration 9cm by 5cm. No secretion in side of injection. Varivax
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Coordination abnormal, Ear pain, Guillain-Barre syndrome, Hypoaesthesia, Malaise
Clinical narrative: A 19 year old male pt with a history of infectious mononucleosis, neck mall, lymphadenopathy 6/14/06, migraines, and ADD, had received a dose of Menactra on 6/26/06. The lot number, route and site of administration was not reported. Six days post immunization on 7/2/06 the pt developed numbness in an unspecified site. Treatment, diagnostic tests, and lab date performed were not reported. Per the reported, the symptom of numbness were Not GBS. The recovery status of the pt is unk.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Nerve injury, Paraesthesia, Viral infection
Clinical narrative: A 19 year old male pt with a history of infectious mononucleosis, neck mall, lymphadenopathy 6/14/06, migraines, and ADD, had received a dose of Menactra on 6/26/06. The lot number, route and site of administration was not reported. Six days post immunization on 7/2/06 the pt developed numbness in an unspecified site. Treatment, diagnostic tests, and lab date performed were not reported. Per the reported, the symptom of numbness were Not GBS. The recovery status of the pt is unk.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Hypoaesthesia
Clinical narrative: A 19 year old male pt with a history of infectious mononucleosis, neck mall, lymphadenopathy 6/14/06, migraines, and ADD, had received a dose of Menactra on 6/26/06. The lot number, route and site of administration was not reported. Six days post immunization on 7/2/06 the pt developed numbness in an unspecified site. Treatment, diagnostic tests, and lab date performed were not reported. Per the reported, the symptom of numbness were Not GBS. The recovery status of the pt is unk.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Facial palsy
Clinical narrative: Initial report received on 27/Sep/2006.  A 15-year-old male patient, with no pre-existing medical conditions and who was not taking any other medications, had received a dose of Menactra, and a dose of Adacel, lot number C2457AA, on an unspecified date.  The lot number for Menactra, and the routes and sites of administration for the Adacel and Menactra were not reported.  Twenty four hours post immunization, the patient developed Bell's Palsy.  Per the reporter, the patient did not have any hospitalization for this adverse event.  This case was considered as non-serious.  The recovery status of the patient is unknown.  The recovery status of the patient is unknown.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, HEPA, MNQ, TDAP, HEPA, MNQ, TDAP
Symptoms: Facial palsy
Clinical narrative: Initial report received on 27/Sep/2006.  A 15-year-old female patient had received a dose of Menactra, lot number U2004AA, a dose of Adacel, lot number reported, and a dose of another manufacturer's Hepatitis A vaccine on 07/Jul/2006.  The route and site of administration were not provided for any of the vaccines.  The trade name and manufacturer was not reporter for the Hepatitis A vaccine.  One day post-immunization, the patient developed Bell's palsy-right side.  The patient was seen by a neurologist as an outpatient on 27/Jul/2006, who indicated that the patient had been treated with Prednisone for seven days, and Valtrex for ten days.  On 27/Jul/2006, the patient had mild right facial paralysis.  Her neurologic exam was otherwise benign.  This case was considered as non-serious.  The recovery status of the patient is unknown.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cellulitis, Facial palsy
Clinical narrative: Initial report received on 27/Sep/2006 from agency.  A 16-year-old female patient had received an injection of Menactra, lot number U1852AA, on 28/Jul/2006.  Thirty-one days post vaccination, on 28/Aug/2006, the patient developed Bell's Palsy.  She was examined in an emergency room on 28/Aug/2006.  The patient had a follow-up outpatient appointment on 11/Sep/2006.  Symptoms remained.  A lyme titer was negative.  Additional information was not provided.  This case was considered as non serious.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Facial palsy
Clinical narrative: Initial report received on 27/Sep/2006 from agency.  A 16-year-old female patient had received an injection of Menactra, lot number U1852AA, on 28/Jul/2006.  Thirty-one days post vaccination, on 28/Aug/2006, the patient developed Bell's Palsy.  She was examined in an emergency room on 28/Aug/2006.  The patient had a follow-up outpatient appointment on 11/Sep/2006.  Symptoms remained.  A lyme titer was negative.  Additional information was not provided.  This case was considered as non serious.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: CSF test abnormal, Chills, Headache, Herpes simplex serology negative, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a pharmacist concerning a 28 year old healthy, non smoker female with no drug reactions, allergies and a history of migraines who on 9/20/06 was vaccianted with a dose of varicella virus vaccine live (lot 652804/0263F). There was no concomitant medication. On 9/24/06, the pt developed a small, widely distributed, vesicular rash, tiredness, headache, nausea, and a runny nose. The headache pain increased over several hours, and she went to the ER. A lumbar puncture was done ant it was positive for  WBCs, but negative for varicella. The pt was hospitalized with a diagnosis of viral meningitis possibly related to a recent vaccination with varicella virus vaccine live. She was treated with IV acyclovir. On 9/29/06, she was discharged from the hospital with a diagnosis of nonspecific viral meningitis. The outcome was recovered, and she was noted to be doing fine. No other information was available. There was no product quality complaint. The report also considered the even to be an other important medical event (OMIC). Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Pain, Polymerase chain reaction, Protein total, Pyrexia, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 28 year old healthy, non smoker female with no drug reactions, allergies and a history of migraines who on 9/20/06 was vaccianted with a dose of varicella virus vaccine live (lot 652804/0263F). There was no concomitant medication. On 9/24/06, the pt developed a small, widely distributed, vesicular rash, tiredness, headache, nausea, and a runny nose. The headache pain increased over several hours, and she went to the ER. A lumbar puncture was done ant it was positive for  WBCs, but negative for varicella. The pt was hospitalized with a diagnosis of viral meningitis possibly related to a recent vaccination with varicella virus vaccine live. She was treated with IV acyclovir. On 9/29/06, she was discharged from the hospital with a diagnosis of nonspecific viral meningitis. The outcome was recovered, and she was noted to be doing fine. No other information was available. There was no product quality complaint. The report also considered the even to be an other important medical event (OMIC). Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Rash pruritic, Skin ulcer, Varicella, White blood cell count
Clinical narrative: Information has been received from a pharmacist concerning a 28 year old healthy, non smoker female with no drug reactions, allergies and a history of migraines who on 9/20/06 was vaccianted with a dose of varicella virus vaccine live (lot 652804/0263F). There was no concomitant medication. On 9/24/06, the pt developed a small, widely distributed, vesicular rash, tiredness, headache, nausea, and a runny nose. The headache pain increased over several hours, and she went to the ER. A lumbar puncture was done ant it was positive for  WBCs, but negative for varicella. The pt was hospitalized with a diagnosis of viral meningitis possibly related to a recent vaccination with varicella virus vaccine live. She was treated with IV acyclovir. On 9/29/06, she was discharged from the hospital with a diagnosis of nonspecific viral meningitis. The outcome was recovered, and she was noted to be doing fine. No other information was available. There was no product quality complaint. The report also considered the even to be an other important medical event (OMIC). Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Fatigue, Headache, Laboratory test abnormal, Meningitis, Nausea
Clinical narrative: Information has been received from a pharmacist concerning a 28 year old healthy, non smoker female with no drug reactions, allergies and a history of migraines who on 9/20/06 was vaccianted with a dose of varicella virus vaccine live (lot 652804/0263F). There was no concomitant medication. On 9/24/06, the pt developed a small, widely distributed, vesicular rash, tiredness, headache, nausea, and a runny nose. The headache pain increased over several hours, and she went to the ER. A lumbar puncture was done ant it was positive for  WBCs, but negative for varicella. The pt was hospitalized with a diagnosis of viral meningitis possibly related to a recent vaccination with varicella virus vaccine live. She was treated with IV acyclovir. On 9/29/06, she was discharged from the hospital with a diagnosis of nonspecific viral meningitis. The outcome was recovered, and she was noted to be doing fine. No other information was available. There was no product quality complaint. The report also considered the even to be an other important medical event (OMIC). Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Rash vesicular, Rhinorrhoea
Clinical narrative: Information has been received from a pharmacist concerning a 28 year old healthy, non smoker female with no drug reactions, allergies and a history of migraines who on 9/20/06 was vaccianted with a dose of varicella virus vaccine live (lot 652804/0263F). There was no concomitant medication. On 9/24/06, the pt developed a small, widely distributed, vesicular rash, tiredness, headache, nausea, and a runny nose. The headache pain increased over several hours, and she went to the ER. A lumbar puncture was done ant it was positive for  WBCs, but negative for varicella. The pt was hospitalized with a diagnosis of viral meningitis possibly related to a recent vaccination with varicella virus vaccine live. She was treated with IV acyclovir. On 9/29/06, she was discharged from the hospital with a diagnosis of nonspecific viral meningitis. The outcome was recovered, and she was noted to be doing fine. No other information was available. There was no product quality complaint. The report also considered the even to be an other important medical event (OMIC). Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Anorexia, Asthenia, CSF test abnormal, Fatigue, Headache
Clinical narrative: Information has been received from a pharmacist concerning a 28 year old healthy, non smoker female with no drug reactions, allergies and a history of migraines who on 9/20/06 was vaccianted with a dose of varicella virus vaccine live (lot 652804/0263F). There was no concomitant medication. On 9/24/06, the pt developed a small, widely distributed, vesicular rash, tiredness, headache, nausea, and a runny nose. The headache pain increased over several hours, and she went to the ER. A lumbar puncture was done ant it was positive for  WBCs, but negative for varicella. The pt was hospitalized with a diagnosis of viral meningitis possibly related to a recent vaccination with varicella virus vaccine live. She was treated with IV acyclovir. On 9/29/06, she was discharged from the hospital with a diagnosis of nonspecific viral meningitis. The outcome was recovered, and she was noted to be doing fine. No other information was available. There was no product quality complaint. The report also considered the even to be an other important medical event (OMIC). Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Nausea, Rash pustular, Rhinorrhoea, Viral infection
Clinical narrative: Information has been received from a pharmacist concerning a 28 year old healthy, non smoker female with no drug reactions, allergies and a history of migraines who on 9/20/06 was vaccianted with a dose of varicella virus vaccine live (lot 652804/0263F). There was no concomitant medication. On 9/24/06, the pt developed a small, widely distributed, vesicular rash, tiredness, headache, nausea, and a runny nose. The headache pain increased over several hours, and she went to the ER. A lumbar puncture was done ant it was positive for  WBCs, but negative for varicella. The pt was hospitalized with a diagnosis of viral meningitis possibly related to a recent vaccination with varicella virus vaccine live. She was treated with IV acyclovir. On 9/29/06, she was discharged from the hospital with a diagnosis of nonspecific viral meningitis. The outcome was recovered, and she was noted to be doing fine. No other information was available. There was no product quality complaint. The report also considered the even to be an other important medical event (OMIC). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: 2 separate reactions Tdap 6x4 1/2" area hot to touch. Induration of biceps upper arm started day of injection given seen in office 9/28/06, Gardasil 3 1/2 x 3" hot to touch started 3 days after shot for both ice and Ibuprophen.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Shoulder pain
Clinical narrative: Shot was administered around 12:30pm. Pt complained of severe pain at 3:30pm. She went to Dr at 4:00 but they could not see her. 4:15 she went to ER. ER nurse gave IV injection of Dilaudid and nausea med. ER took X ray of shoulder. Was given another inj of Dilaudid. Sent home with RX for prednisone, pain, muscle relaxants.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site reaction
Clinical narrative: Had Dtap vaccine #5 has 7x17 cm of erythema cellulitis of left outer arm. Placed on warm compress and antibiotics.
Age: 45.0
Sex: M
Vaccine: HEP, HEPA, TD, TYP
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea, Diarrhea, lasted 2 days.
Age: 20.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Bronchospasm
Clinical narrative: Vaccinated at 10:15 am observed x 30 min, left called at 11:15 reporting bronchospasm 11:25, Xopenex neb at 11:40, Zyrtec PO, Epi 0.3 SQ at 11:45. Home on Zyrtec and Tagamet PO.
Age: 18.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Hypoaesthesia, Laboratory test abnormal, Medication error, Pain
Clinical narrative: Seriousness Criteria other medically significant (OMIC). Initial report received on 6/28/06 from a health care professional. An 18 year old male pt with no significant medical history and who had recently cut his left finger, had received his second IM injection of Decavac, lot number U1724BA, in the left deltoid on 5/18/06. Three days post immunization, the pt developed right anterior thigh numbness with associated weakness and pain. The pt was treated with anti inflammatory medication and was referred to a neurologist. The pts appointment with the neurologist is scheduled for 7/20/06. The recovery status of the pt was reported as not recovered. Follow up information received on 9/11/06. Per the reporter, the pt did not have any recent sports on non related sports injuries at the time of the adverse event on 5/21/06. He was prescribed Naprosyn in the physicians office for the adverse event. Reportedly no diagnostic test lab date were performed. The pt was subsequently evaluated by a neurologist and an EMG/NCS test was reported as being negative. The contact information was provided for the neurology consult. The pt did require subsequent plastic surgery for complications of the laceration to the left index finger. At the time of this report, the pt had not recovered from these adverse events. Follow up information received on 9/22/06. A copy of the neurology consult on 7/20/06 was received. Per the reporter, the pt had actually received the Decavac vaccination on 5/18/06, in the buttock not the deltoid as previously reported. This is not a recommended site of administration by the manufacturer for Decavac. The pt presented on 7/20/06, with numbness on the right anterior thigh. He stated he had no pain just numbness. He said that walking increased the numbness, but that he did not have any back pain, and that his left leg was fine. On examination by the neurologist, the pt had normal reflexes in his arms, but the right knee jerk was somewhat decreased compared to the left. Motor strength testing showed obvious abnormalities. Sensory exam revealed scratch sensation subjectively decreased over the entire circumference of the right thigh anterior posterior, lateral, and medial to the mid buttock and to above the inguinal ligament. Nerve conduction study revealed screening motor and sensory studies to be normal. The neurologist impression was right thigh circumferential numbness with no electrical evidence of any peripheral nerve injury to account for the numbness. The circumferential numbness is not an anatomic distribution as multiple nerve and root territories are involved. It is possible that there has been some spinal cord injury. A suggestion for imaging of the thoracic, lumbar spine, and brain were made ad multiple sclerosis can produce unusual areas of numbness. These test were not scheduled at this visit. The recovery status of the pt was reported as not recovered. Due to medical evaluation of this new information, this case is being upgraded to serious.
Age: 18.0
Sex: M
Vaccine: TD
Symptoms: Sensory disturbance
Clinical narrative: Seriousness Criteria other medically significant (OMIC). Initial report received on 6/28/06 from a health care professional. An 18 year old male pt with no significant medical history and who had recently cut his left finger, had received his second IM injection of Decavac, lot number U1724BA, in the left deltoid on 5/18/06. Three days post immunization, the pt developed right anterior thigh numbness with associated weakness and pain. The pt was treated with anti inflammatory medication and was referred to a neurologist. The pts appointment with the neurologist is scheduled for 7/20/06. The recovery status of the pt was reported as not recovered. Follow up information received on 9/11/06. Per the reporter, the pt did not have any recent sports on non related sports injuries at the time of the adverse event on 5/21/06. He was prescribed Naprosyn in the physicians office for the adverse event. Reportedly no diagnostic test lab date were performed. The pt was subsequently evaluated by a neurologist and an EMG/NCS test was reported as being negative. The contact information was provided for the neurology consult. The pt did require subsequent plastic surgery for complications of the laceration to the left index finger. At the time of this report, the pt had not recovered from these adverse events. Follow up information received on 9/22/06. A copy of the neurology consult on 7/20/06 was received. Per the reporter, the pt had actually received the Decavac vaccination on 5/18/06, in the buttock not the deltoid as previously reported. This is not a recommended site of administration by the manufacturer for Decavac. The pt presented on 7/20/06, with numbness on the right anterior thigh. He stated he had no pain just numbness. He said that walking increased the numbness, but that he did not have any back pain, and that his left leg was fine. On examination by the neurologist, the pt had normal reflexes in his arms, but the right knee jerk was somewhat decreased compared to the left. Motor strength testing showed obvious abnormalities. Sensory exam revealed scratch sensation subjectively decreased over the entire circumference of the right thigh anterior posterior, lateral, and medial to the mid buttock and to above the inguinal ligament. Nerve conduction study revealed screening motor and sensory studies to be normal. The neurologist impression was right thigh circumferential numbness with no electrical evidence of any peripheral nerve injury to account for the numbness. The circumferential numbness is not an anatomic distribution as multiple nerve and root territories are involved. It is possible that there has been some spinal cord injury. A suggestion for imaging of the thoracic, lumbar spine, and brain were made ad multiple sclerosis can produce unusual areas of numbness. These test were not scheduled at this visit. The recovery status of the pt was reported as not recovered. Due to medical evaluation of this new information, this case is being upgraded to serious.
Age: 1.02
Sex: M
Vaccine: DTAP, HBHEPB, HEPA, MMRV, PNC
Symptoms: Erythema, Rash
Clinical narrative: Pt presented to clinic on yesterday 10/02/06, at 3pm with a reddened rash to entire body.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Pain, Swelling, Unevaluable event
Clinical narrative: The patient experienced localized swelling, redness, and pain of the right deltoid. Size 4 inch by 3 inch.
Age: 51.0
Sex: F
Vaccine: DTAP
Symptoms: Blister, Cellulitis, Erythema, Injection site mass, Lymphadenopathy
Clinical narrative: Initial report received on 20/Sep/2006 from a health care professional.  A 51-year-old female patient, with no past medical history, had received a left deltoid injection of Adacel, lot number unknown, on 15/Sep/2006.  The next day, she noticed a "lump".  Two days later, her upper arm became red and swollen from the elbow to the shoulder, and she developed blistering. The patient was examined by a physician and diagnosed with cellulitis. She was treated with KEFLEX. The patient was not certain of the needle size used during administration or the date of her prior Tetanus/Diphtheria vaccination (most likely 5-10 years ago).  At the time of this report, the patient had not recovered.  Information received on 04 December 2006: The reported lot number was and upon internal review, it was confirmed to a TRIPEDIA product. The vaccine was administered intramuscularly. The onset of the "blistering" was 16 September 2006 and it was 2" wide and 1" long. The "lump" was confirmed to be a lymphadenopathy. The diagnosis of cellulitis was clinical and the reported symptoms were limited to the injection site. The patient was treated with antibiotics, OTC BENADRYL/TYLENOL and cold compresses. The cellulitis resolved on 04 October 2006 and the patient recovered.
Age: 51.0
Sex: F
Vaccine: DTAP
Symptoms: Swelling
Clinical narrative: Initial report received on 20/Sep/2006 from a health care professional.  A 51-year-old female patient, with no past medical history, had received a left deltoid injection of Adacel, lot number unknown, on 15/Sep/2006.  The next day, she noticed a "lump".  Two days later, her upper arm became red and swollen from the elbow to the shoulder, and she developed blistering. The patient was examined by a physician and diagnosed with cellulitis. She was treated with KEFLEX. The patient was not certain of the needle size used during administration or the date of her prior Tetanus/Diphtheria vaccination (most likely 5-10 years ago).  At the time of this report, the patient had not recovered.  Information received on 04 December 2006: The reported lot number was and upon internal review, it was confirmed to a TRIPEDIA product. The vaccine was administered intramuscularly. The onset of the "blistering" was 16 September 2006 and it was 2" wide and 1" long. The "lump" was confirmed to be a lymphadenopathy. The diagnosis of cellulitis was clinical and the reported symptoms were limited to the injection site. The patient was treated with antibiotics, OTC BENADRYL/TYLENOL and cold compresses. The cellulitis resolved on 04 October 2006 and the patient recovered.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site rash
Clinical narrative: Initial report received on 18/Sep/2006 from a health care professional.  A 14-year-old female patient had received an intramuscular, first dose injection of Menactra, lot number U1860AA, on 12/Sep/2006.  The next day, she developed a rash at the injection site that progressed to the opposite bicep, neck, face, back and feet.  She was examined on 18/Sep/2006 for a systemic rash.  Concomitant medication included ZOLOFT.  At the time of this report, recovery status was unknown. Follow-up information received 4-10-08. Patient recovered.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Initial report received on 08/Sep/2006 from a nurse.  An 18-year-old female with no current illnesses, no known allergies, no pre-existing medical conditions, but who was taking Orth Tri-Cyclen had received a subcutaneous dose of Menactra, lot number U2135AA, in the right deltoid, on 05/Sep/2006.  Subcutaneous injection of Menactra are not a recommended route of administration by the manufacturer.  24 hours post vaccination, the patient developed redness and swelling at the injection site, and complained of flu-like symptoms.  Per the reporter, the flu-like symptoms only lasted one to two days.  At the time of this report, the deltoid area had become more red and swollen, and the patient was seen by a physician who prescribed an ointment.  The patient has not recovered from these adverse events. Follow-up information received on 10/Sept/2004. Per the reporter, the patient had not received any other meningococcal, diphtheria toxoid vaccine in the past. The MENACTRA was inadvertently administered subcutaneously on 05/Sept/2004. The patient has experienced a 10 cm area of erythema and heat at the site of the injection with no joint involvement. Flu-like symptoms, and presented malaise with fatigue. The patient was prescribed ALAVERT for seven days, and a antihistamine ointment as previously reported as treatment for the adverse events. Reportedly, the patient completely had a resolution of the adverse events when she had returned for an office visit in 11/Sept/2004. No further information is expected.
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Medication error
Clinical narrative: Injection site inflammation, injection site erythema, injection site swelling, wrong route of administration.
Sex: U
Vaccine: MNQ
Symptoms: Injection site induration, Injection site oedema, Injection site pain, Injection site rash, Medication error
Clinical narrative: A total of 101 persons in seven states were reported to have received Menactra SC in error instead of IM route. The lot numbers and dates of administration were not reported. Of the 101 persons, 100 were contacted by their health care providers and advised of the administration error. Twelve non serious adverse events were reported among 54 persons from whom providers solicited such information. Eleven events were local reactions including injection site rash, tenderness, swelling, induration, or pain. One pt experienced a fever of one days duration. No additional information was provided regarding the individual pts or the reported adverse events. Further information is not expected.
Sex: U
Vaccine: MNQ
Symptoms: Pyrexia, Tenderness
Clinical narrative: A total of 101 persons in seven states were reported to have received Menactra SC in error instead of IM route. The lot numbers and dates of administration were not reported. Of the 101 persons, 100 were contacted by their health care providers and advised of the administration error. Twelve non serious adverse events were reported among 54 persons from whom providers solicited such information. Eleven events were local reactions including injection site rash, tenderness, swelling, induration, or pain. One pt experienced a fever of one days duration. No additional information was provided regarding the individual pts or the reported adverse events. Further information is not expected.