chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Serum sickness
Clinical narrative: A report was received from a consumer on 31May06, concerning a 46 yr old female vaccinee. The vaccinee has a medical history of Graves disease, for which she is being treated with levothyroxine daily. On 04Nov03 the vaccinee received Fluvirin vaccination. Within 24 hrs of the injection she began experiencing severe hot flashes, numbness and tingling, joint pain, night sweats and gait abnormalities. The symptoms have subsided slowly over the past three years, with significant improvement in the last four months, but have not yet completely resolved. The vaccinee was seen by a neurologist soon after the vaccination and serum sickness was diagnosed. Follow up information was received on 19 July 2006 from the subjects Neurologist. Following flu vaccination in November 2003 the vaccines felt generally "achy". She noted some whole body paresthesia, muscle aches, fatiguability and a suspicion regarding peripheral neuropathy was raised. The vaccinee denied any history of visual changes, and any family history of multiple sclerosis. The vaccinee has been monitored since March 2003., when she sustained a needlestick injury, and was subsequently found to have a false positive HIV result. Upon examination no neurological deficits were detected, distal and proximal strength and sensation were preserved. Gait and co-ordination were normal. Cranila nerve and mental status examination were unremarkable. Reflexes were symetric at 1/4 throughout including ankle jerks. The general impression was that the whol body paresthesia and pain following vaccination probably represented some immunological derangement similar to that seen in "serum sickness" and is improving. She did not appear at this time to have any clinical evidence of GUILLIAN-BARRE syndrome, peripheral neuropathy or multiple sclerosis, however an EMG of the lower extremities is to be performed to determine whether or not there is evidence of peripheral neuropathy. Awaiting follow up report from the vaccinees primary physician.
Age: 18.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Chest pain, Hypersensitivity, Injection site hypersensitivity, Injection site oedema, Pain
Clinical narrative: Swelling, redness, hives localized to immunization site, pain radiating to back reaction progressed later on 6/4/ to fever, vomiting and chest pain prompting hospital admission.
Age: 18.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: Swelling, redness, hives localized to immunization site, pain radiating to back reaction progressed later on 6/4/ to fever, vomiting and chest pain prompting hospital admission.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Difficulty in walking, Hypokinesia, Musculoskeletal stiffness, Pain
Clinical narrative: Had both shots 6/1/06 came into office next day legs felt like jello, hard to walk, low grade fever (100.4) felt stiff all over, was hospitalized had trouble moving legs. C/o pain, weakness, achy was given IV fluids, IV antibiotics within 4 hrs was much improved, was rechecked on 6/5/06 no other problems.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Had both shots 6/1/06 came into office next day legs felt like jello, hard to walk, low grade fever (100.4) felt stiff all over, was hospitalized had trouble moving legs. C/o pain, weakness, achy was given IV fluids, IV antibiotics within 4 hrs was much improved, was rechecked on 6/5/06 no other problems.
Age: 43.0
Sex: M
Vaccine: DTP, TYP
Symptoms: Alopecia, Amblyopia, Amnesia, Anxiety, Arrhythmia
Clinical narrative: Ache bones, ache joint, ache joints and muscles, acid reflux, alopecia, amblyopia, amnesia, mood anxiety, heart arrhythmia, balance problems, concentration difficulty, loss of concentration, leg cramps, depression, energy loss, hair loss, heart palpitations, impotence, memory difficulty, memory failure, memory loss, memory bad, nervousness anxiety, pain back, pain knees and hips, pain lower back, pain joint and muscle pain and stiffness, pain bone and joint, pain muscle and joint, pain ear, pain back, sleep insomnia, sleep problems, sleep feel no refreshed upon waking up, tachycardia, weight gain,
Age: 43.0
Sex: M
Vaccine: DTP, TYP
Symptoms: Arthralgia, Asthenia, Back pain, Balance disorder, Depression
Clinical narrative: Ache bones, ache joint, ache joints and muscles, acid reflux, alopecia, amblyopia, amnesia, mood anxiety, heart arrhythmia, balance problems, concentration difficulty, loss of concentration, leg cramps, depression, energy loss, hair loss, heart palpitations, impotence, memory difficulty, memory failure, memory loss, memory bad, nervousness anxiety, pain back, pain knees and hips, pain lower back, pain joint and muscle pain and stiffness, pain bone and joint, pain muscle and joint, pain ear, pain back, sleep insomnia, sleep problems, sleep feel no refreshed upon waking up, tachycardia, weight gain,
Age: 43.0
Sex: M
Vaccine: DTP, TYP
Symptoms: Disturbance in attention, Ear pain, Erectile dysfunction, Insomnia, Memory impairment
Clinical narrative: Ache bones, ache joint, ache joints and muscles, acid reflux, alopecia, amblyopia, amnesia, mood anxiety, heart arrhythmia, balance problems, concentration difficulty, loss of concentration, leg cramps, depression, energy loss, hair loss, heart palpitations, impotence, memory difficulty, memory failure, memory loss, memory bad, nervousness anxiety, pain back, pain knees and hips, pain lower back, pain joint and muscle pain and stiffness, pain bone and joint, pain muscle and joint, pain ear, pain back, sleep insomnia, sleep problems, sleep feel no refreshed upon waking up, tachycardia, weight gain,
Age: 43.0
Sex: M
Vaccine: DTP, TYP
Symptoms: Muscle spasms, Musculoskeletal stiffness, Myalgia, Nervousness, Palpitations
Clinical narrative: Ache bones, ache joint, ache joints and muscles, acid reflux, alopecia, amblyopia, amnesia, mood anxiety, heart arrhythmia, balance problems, concentration difficulty, loss of concentration, leg cramps, depression, energy loss, hair loss, heart palpitations, impotence, memory difficulty, memory failure, memory loss, memory bad, nervousness anxiety, pain back, pain knees and hips, pain lower back, pain joint and muscle pain and stiffness, pain bone and joint, pain muscle and joint, pain ear, pain back, sleep insomnia, sleep problems, sleep feel no refreshed upon waking up, tachycardia, weight gain,
Age: 43.0
Sex: M
Vaccine: DTP, TYP
Symptoms: Sleep disorder, Stomach discomfort, Tachycardia, Weight increased
Clinical narrative: Ache bones, ache joint, ache joints and muscles, acid reflux, alopecia, amblyopia, amnesia, mood anxiety, heart arrhythmia, balance problems, concentration difficulty, loss of concentration, leg cramps, depression, energy loss, hair loss, heart palpitations, impotence, memory difficulty, memory failure, memory loss, memory bad, nervousness anxiety, pain back, pain knees and hips, pain lower back, pain joint and muscle pain and stiffness, pain bone and joint, pain muscle and joint, pain ear, pain back, sleep insomnia, sleep problems, sleep feel no refreshed upon waking up, tachycardia, weight gain,
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Arthralgia, Bone pain, Chest pain, Cough
Clinical narrative: Aches joints and muscles, fever, headache continuous, cough, vomiting, pain stomach, pain chest, pain knees and hips, pain elbow and shoulder, pain bone and joint, pain in feet like electrical shocks, skin rashes, extremely painful, sinus nasal continuous,
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Headache, Myalgia, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Aches joints and muscles, fever, headache continuous, cough, vomiting, pain stomach, pain chest, pain knees and hips, pain elbow and shoulder, pain bone and joint, pain in feet like electrical shocks, skin rashes, extremely painful, sinus nasal continuous,
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Rash, Sinusitis, Vomiting
Clinical narrative: Aches joints and muscles, fever, headache continuous, cough, vomiting, pain stomach, pain chest, pain knees and hips, pain elbow and shoulder, pain bone and joint, pain in feet like electrical shocks, skin rashes, extremely painful, sinus nasal continuous,
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Low-grade fever and local reaction redness and swelling at site.
Age: 50.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Rash vesicular
Clinical narrative: Td given 5/30/06. No reaction to Hep A (#!) c/o red, blister in appearance rash on 6/1/06 (2 days later) or R elbow L armpit, L upper arm area, both sides of neck and spots on "torso". Pt questioned poss poison ivy exposure as walked doge in park known for poison ivy and has sensitivity to it. Had not called MD (traveling to China next day). Advised to call MD (after hours, Friday :M).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Urticaria
Clinical narrative: Left arm with red welt 2 1/2 by 1 inch wraps around arm, not hot to the touch. Spoke with after hours triage @1958p. Went to U.C. (Sun Health Surprise). Diagnoses with cellulitis put on Zmax.
Age: 0.51
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Erythema, Oedema peripheral, Swelling
Clinical narrative: Patient was given vaccines in office on 6/5/06. Also started on new formula today 6/6/06, Enfamil Lipil. Developed redness and swelling of trunk, ears and extremities 1/2 hour after
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Rec'd DTAP # 5 and IPOL #4 L arm on 5/31/06. Mom brought to office 6/2/06 with complaints of L arm redness and swelling. Dx'd with early cellulitis. Prescribed antibiotics.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Agitation, Crying
Clinical narrative: Inconsolable crying X 48 hrs after shots. Tried Tylenol and behavior interventions without success. Resolved spontaneously.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Blister, Cellulitis, Erythema, Swelling
Clinical narrative: Patient given shots on 6/2/06. On 6/4/06 mom called child had left arm red and swollen with few blisters not draining early cellulitis.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Contusion, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Developed erythema with induration on left deltoid measuring 10.5cm X 8.5cm, tender, bruising and hot to touch. Treated with ice, cephalexin for dx of cellulitis.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Headache, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: Awoke approximately 3 AM (approximately 12 hr post vaccine) with severe H/A, fever, stiff neck, myalgias. Missed 3 days of school.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Dyspnoea, Lacrimal disorder, Urticaria
Clinical narrative: Increased lacrimation, shortness of breath, urticarial rash. 25mg of po Benadryl given (+) 12mg of IM Decadron given. No wheezing.
Age: 1.18
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Developed fever 101-103 off/on, rash on stomach/chest 5/29/06.
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Fatigue, Injection site hypersensitivity, Injection site pain, Injection site swelling
Clinical narrative: Fatigue, fever, local swelling, pain and bruising at site of injection.
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fatigue, fever, local swelling, pain and bruising at site of injection.
Age: 1.05
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Rash, maculopapular (varicella) and scab.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Developed varicella mild case. (rash, itches) about 10 lesions. Treatment: Benadryl, calamine lotion.
Age: 1.27
Sex: F
Vaccine: HEPA, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Rash and fever
Age: 1.31
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Broke out with fever Saturday 6/3/06. Now has rash all over her body, itching on her head.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Crying
Clinical narrative: Inconsolable crying X 48 hrs after shots. Tried Tylenol and behavior interventions without success. Resolved spontaneously.
Age: 1.14
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Abnormal behaviour
Clinical narrative: Per mom, pt had significant behavioral changes "spinning in circles", "hitting", "throwing food" and was "inappropriately giggling". Resolved after approximately 72 hrs. Pt is being referred to a neurologist.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pediarix given on 4/27/06. L upper arm edematous, warm to touch, erythematous, redness 6 inches elongated redness. Tx: Clarinex and Augmentin.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pediarix given 5/23/06. On 05/25/06, left arm red and swollen, warm to touch, larger than 2 inches. TX: Rocephin IM and Augmentin.
Age: 1.53
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Contusion, Petechiae, Platelet count decreased, Rash, Thrombocytopenic purpura
Clinical narrative: idiopathic thrombocytopenic purpura 06/14/06-4 page office notes received from MD, patient's pediatrician. Office note for 5/3/06 date of vaccine documented that child missed 15 and 18 month well baby visits. HX included pregnancy complication of beta strep colonization, pregnancy induced HTN, vaginal delivery. Physical exam within normal limits. Visit of 5/31/06 with complaint of rash 5 day duration, parent called office on 5/30/06 with c/o unusual bruising and rash. No fever noted, acting normally appetite and sleep fine, one nosebleed weekend prior to this visit. Physical exam revealed petechiae over torso with various sizes and stages of bruises in unusual places, no active bleeding, respiratory normal, cardiovascular normal, abdomen normal. Liver down 1 cm.  Referred to hospital for lab and ER visit.  08/03/06-ER report received. DC DX: ITP Chief Complaint: low platelet count 3,000, bruises and petechia. HX Present Illness: Red spots and easy bruisability began day before ER visit. Urine test at MD office prior to ER visit negative. CBC showed platelet count 3,000.  Physical Exam: Temp 36.4, HR 168. Pupils equal reactive to light. TMS are clear bilaterally. One petechia on her left anterior tongue. Tonsils non swollen and no erythema or exudate. Skin shows significant amount of bruising on her extremities bilaterally upper and lower as well as on her back and some petechia noted on her truck, particularly on her anterior chest. No signs of active bleeding, no nose bleeding and no eye bleeding. Small petechia on her right eye. Treated with IV therapy and discharged home from ER.
Age: 1.05
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC
Symptoms: Injection site erythema, Injection site nodule, Injection site reaction, Injection site swelling
Clinical narrative: LOCAL REACTION AT INJECTION SITE ON LEFT THIGH. 7.5MM RAISED RED NODULE OBSERVED BY MOM WHO CALLED FOR AN APPOINTMENT.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Coma, Dyskinesia, Loss of consciousness, Screaming
Clinical narrative: Mother ran from her car stating the patient was unconscious.  Found patient, unresponsive, with strong pulse and adequate respirations.  Patient remained unresponsive for approximately 1.5 minutes.  When patient aroused,she Came out screaming and moving her body in an eratic manner.  Post episode recovery took about 5 minutes for patient to become verbal without screaming and moving about.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Coma, Crying, Loss of consciousness, Screaming, Syncope
Clinical narrative: Mother ran from her car stating the patient was unconscious.  Found patient, unresponsive, with strong pulse and adequate respirations.  Patient remained unresponsive for approximately 1.5 minutes.  When patient aroused,she Came out screaming and moving her body in an eratic manner.  Post episode recovery took about 5 minutes for patient to become verbal without screaming and moving about.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Hangover, Headache
Clinical narrative: Approximately 1 hour after vaccination patient felt lightheaded.  That evening she developed a headache and felt like she had a "hang over" the next morning.  Patient stated that this feeling lasted for 1 week, but now she is feeling better.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pain, Pyrexia
Clinical narrative: LEFT DELTOID SWOLLEN, RED, HOT TO THE TOUCH, GENERALIZED FEVER AND BODY ACHES
Age: 0.56
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Lymphadenitis, Pneumonia, Premature baby
Clinical narrative: Office was notified of death of child by Epidemiologist of State on 06-05-2006. Sudden infant death on 05/31/2006 immunizations given on 05/25/2006. 7/31/06 Received autopsy report which stated COD as pneumonia with pathological diagnoses as bilateral acute hemorrhagic pneumonia; small reducible periunbilical hernia; slyphadenitis of mesenteric lymh nodes; & history of prematurity./ss
Age: 18.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema
Clinical narrative: 3CM RED AREA AROUND INJECTION SITE.  NO PAIN, ITCHING OR OTHER COMPLICATIONS OBSERVED.  PT WILL RETURN MON. 6/12/06 FOR MONITORING.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 10 x 8 cm of erythema, calor and induration at site of IZ.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 4cm X 3cm erythema, warm. No raised or indurated.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Dry throat, Erythema, Pruritus
Clinical narrative: Immunizations adm. about 4 PM. Parents noted child red skin, itching, scratchy throat and chills and presented to the office. He was dazed, throaty, pruritus but ///. Given dexamethasone 4mg and Benadryl 25mg for acute symptoms. Completely improvement in 2 items. Had ///. Placed on Orapred for 48 hours.
Sex: F
Vaccine: DTAP
Symptoms: Balance disorder, Dizziness, Dysphagia, Muscular weakness, Nausea
Clinical narrative: Sick to stomach, unsteady on feet, difficulty swallowing, arm felt limp, pain on shoulder. Has nausea but only gagging, has not thrown up yet. Feels weak, dizzy like if did not eat in last 5 days but has been eating.
Sex: F
Vaccine: DTAP
Symptoms: Pain
Clinical narrative: Sick to stomach, unsteady on feet, difficulty swallowing, arm felt limp, pain on shoulder. Has nausea but only gagging, has not thrown up yet. Feels weak, dizzy like if did not eat in last 5 days but has been eating.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Coma, Sudden infant death syndrome
Clinical narrative: HBV was given on a routine WCC on the regular 3 day recommended follow up from the Hospital on 5-11-06.  Weight had returned to almost birth weight and the baby was not jaundiced and eating well.  Sunday am 5-14-06 while in the hospital I was asked to go to the ED regarding a resusitation attempt on this infant who was found in the bed unresponsive.  Resusitation was unsuccessful. 7/7/06 Received ER medical records which reveal patient arrived in full arrest & was unable to be resuscitated.  9/15/06 Received autopsy report which reveal COD as SIDS./ss
Age: 12.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Cough, Encephalitis, Headache, Hypoaesthesia
Clinical narrative: A 12-year-old female patient with a history of seasonal allergies, and a pre-existing mild URI symptoms had received an intra-muscular injection of Menactra, lot number U1877AA, in the left arm on 12/Jan/2006. Fifteen days later, she was seen in the physicians office with a two week history of a cough, headache times one day and a complaint of not being able to feel her legs and arms times eight hours. On that day, her exam was normal except for decreased ability to discriminate between sharp and dull sensation. On 02/Feb/2006 she was admitted to the hospital with a fever and decreased strength to her lower extremities. She was diagnosed with ADEM. Her symptoms resolved after 36 hours with no treatment.
Age: 12.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Hypokinesia, Pyrexia
Clinical narrative: A 12-year-old female patient with a history of seasonal allergies, and a pre-existing mild URI symptoms had received an intra-muscular injection of Menactra, lot number U1877AA, in the left arm on 12/Jan/2006. Fifteen days later, she was seen in the physicians office with a two week history of a cough, headache times one day and a complaint of not being able to feel her legs and arms times eight hours. On that day, her exam was normal except for decreased ability to discriminate between sharp and dull sensation. On 02/Feb/2006 she was admitted to the hospital with a fever and decreased strength to her lower extremities. She was diagnosed with ADEM. Her symptoms resolved after 36 hours with no treatment.
Age: 12.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Pyrexia, Sensory disturbance
Clinical narrative: A 12-year-old female patient with a history of seasonal allergies, and a pre-existing mild URI symptoms had received an intra-muscular injection of Menactra, lot number U1877AA, in the left arm on 12/Jan/2006. Fifteen days later, she was seen in the physicians office with a two week history of a cough, headache times one day and a complaint of not being able to feel her legs and arms times eight hours. On that day, her exam was normal except for decreased ability to discriminate between sharp and dull sensation. On 02/Feb/2006 she was admitted to the hospital with a fever and decreased strength to her lower extremities. She was diagnosed with ADEM. Her symptoms resolved after 36 hours with no treatment.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Back pain, CSF test abnormal, Guillain-Barre syndrome, Headache, Paraesthesia
Clinical narrative: From information received from an intensive Guillain-Barre syndrome case finding search conducted in the state for the time period from 01 March 2005 to 15 October 2005, it was reported that a 19-year-old female patient, with a pre-existing illness of respiratory influenza, had received a left arm injection of Menactra vaccine, lot number reported as U16388, on 15/Sep/2005. Route of administration was not reported. Eighteen days post-vaccination, on 03/Oct/2005, the patient developed middle back pain, tingling sensations on her arms and face and a headache. The patient was diagnosed with Guillain-Barre Syndrome, on 17/Oct/2005, and hospitalized. A CT scan of the head was negative. The patient's blood work-up and "CTR" were also negative. Per the report, a spinal tap was positive. Recover status was not reported. Follow-up information received  on 02/Mar/2006. It was reported that the patient's pre-existing illnesses included sinus pressure and viral symptoms. The diagnosis of Guillain-Barre Syndrome was confirmed per the hospital record. The patient's Lyme disease serology was negative, and a serum B12 and thyroid function were normal. She was admitted to the hospital on 07/Oct/2006 and was treated with IV immunoglobulin. She was discharged on 11/Oct/2005 and recovered from the events. The reporter (source) of this case is the same as cases 200600419 and 200600421.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Back pain, Guillain-Barre syndrome, Headache, Paraesthesia
Clinical narrative: From information received from an intensive Guillain-Barre syndrome case finding search conducted in the state for the time period from 01 March 2005 to 15 October 2005, it was reported that a 19-year-old female patient, with a pre-existing illness of respiratory influenza, had received a left arm injection of Menactra vaccine, lot number reported as U16388, on 15/Sep/2005. Route of administration was not reported. Eighteen days post-vaccination, on 03/Oct/2005, the patient developed middle back pain, tingling sensations on her arms and face and a headache. The patient was diagnosed with Guillain-Barre Syndrome, on 17/Oct/2005, and hospitalized. A CT scan of the head was negative. The patient's blood work-up and "CTR" were also negative. Per the report, a spinal tap was positive. Recover status was not reported. Follow-up information received  on 02/Mar/2006. It was reported that the patient's pre-existing illnesses included sinus pressure and viral symptoms. The diagnosis of Guillain-Barre Syndrome was confirmed per the hospital record. The patient's Lyme disease serology was negative, and a serum B12 and thyroid function were normal. She was admitted to the hospital on 07/Oct/2006 and was treated with IV immunoglobulin. She was discharged on 11/Oct/2005 and recovered from the events. The reporter (source) of this case is the same as cases 200600419 and 200600421.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial report received on 22/Feb/2006.  From information received from an intensive Guillain-Barre syndrome case finding search conducted in the time period from 01 March 2005 to 15 October 2005, it was reported that  an 18-year-old patient, with a  pre-existing illness reported as "10/19 resp Gl" had received an injection of Menactra vaccine on 13/Jul/2005.  Route and site of administration were unknown.  Other vaccines were reported as "HEP".  Additional information was not provided.  An onset date for this event is provided as 06/Nov/2005, 116 days post-vaccination although symptoms were not provided.  However, on the following day of 07/Nov/2005, the patient was diagnosed with Guillain-Barre Syndrome.  The event required hospitalization.  recovery status was not reported.  Follow-up information received on 02/Mar/2006.  The patient's Lyme and West Nile Virus studies were negative.  The patient had received an injection of Hepatitis B Vaccine on 27/Aug/2005, and an injection of Hepatitis A Vaccine, on 21/Sep/2005.  Per the report, the patient recovered from the event.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Astigmatism, Diplopia
Clinical narrative: Initial report received on 02/Mar/2006. An 18-year-old male patient who was taking Albuterol, had received an administration (route and site not reported) of Menactra on 30/Jan/2006. Twenty days later, he began having double vision in the left eye and was given a tentative diagnosis of optical neuritis. The patient was seen in th emergency room on 23/Feb/2006. No other information was provided regarding this visit. At the time of this report, the patient was going to be having an MRI and lab work in the next week. (OMIC)
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Diplopia, Optic neuritis
Clinical narrative: Initial report received on 02/Mar/2006. An 18-year-old male patient who was taking Albuterol, had received an administration (route and site not reported) of Menactra on 30/Jan/2006. Twenty days later, he began having double vision in the left eye and was given a tentative diagnosis of optical neuritis. The patient was seen in th emergency room on 23/Feb/2006. No other information was provided regarding this visit. At the time of this report, the patient was going to be having an MRI and lab work in the next week. (OMIC)
Age: 19.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Demyelination, Hypoaesthesia, Myelitis transverse, Paraesthesia
Clinical narrative: Initial report received on 3/2/06.A 19 year old female patient with a history of hypothyroidism, had received an IM injection of Menactra, lot number U1677AA, in the right arm on 8/8/05. 12 days later, she experienced numbness and tingling in the soles of her feet on the right leg. She also experienced numbness and tingling that briefly affected the buttock and periurethral area. There was no motor weakness. The patient was seen by a neurologist and a MRI was completed. The results of the MRI demonstrated demyelination that was consistent with transverse myelitis. The symptoms lasted a questionable three weeks. (OMIC)
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Convulsion, Encephalitis, Mental impairment
Clinical narrative: Initial report received on 02Mar06. An 11 yr old male pt, with a pre-existing history of mild exercise induced asthma and seasonal allergies, received an IM, right arm injection of Menactra, lot U1384AB, on 01Feb06. Concomitant medications included albuterol, as needed. Fourteen days post vaccination, he experienced changes in mental status and seizure activity. At that time, he was diagnosed with acute meningoencephalitis based upon MRI and clinical finding and hospitalized. He was treated with high dose Solu Medrol and anti epileptic medications. At the time of discharge from the hospital the pt was improved.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Laboratory test abnormal, Migraine
Clinical narrative: Initial report received on 06Apr06. An 18 yr old male pt had received an IM, left arm, first dose injection of Menactra, lot U1658AA, on 01Jul05. Results of a test for Epstein [[name]] virus, obtained on 18Aug05, were positive, and the pt was subsequently diagnosed with mononucleosis. On 02Feb06, the pt experienced upper respiratory infection symptoms. From 17Feb06 to 28Feb06, the pt was hospitalized for Guillain [[name]]e syndrome although specific symptoms of that event were not provided. The pt was then re examined, on 18Mar06, 260 days post vaccination, complaining of migraine headache, and continuing weakness and numbness. He was again admitted to the hospital for possible recurrent Guillain [[name]]e syndrome or other neurological entity; and, as of 21Mar06, he remained hospitalized. The onset of the events was reported as Feb06, approx seven months post vaccination. The pt also had bilateral medial patellar resections approx one week prior to the onset of the symptoms. At the time of this report, the pt had not recovered.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Mononucleosis syndrome, Viral infection
Clinical narrative: Initial report received on 06Apr06. An 18 yr old male pt had received an IM, left arm, first dose injection of Menactra, lot U1658AA, on 01Jul05. Results of a test for Epstein [[name]] virus, obtained on 18Aug05, were positive, and the pt was subsequently diagnosed with mononucleosis. On 02Feb06, the pt experienced upper respiratory infection symptoms. From 17Feb06 to 28Feb06, the pt was hospitalized for Guillain [[name]]e syndrome although specific symptoms of that event were not provided. The pt was then re examined, on 18Mar06, 260 days post vaccination, complaining of migraine headache, and continuing weakness and numbness. He was again admitted to the hospital for possible recurrent Guillain [[name]]e syndrome or other neurological entity; and, as of 21Mar06, he remained hospitalized. The onset of the events was reported as Feb06, approx seven months post vaccination. The pt also had bilateral medial patellar resections approx one week prior to the onset of the symptoms. At the time of this report, the pt had not recovered.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Migraine, Mononucleosis syndrome
Clinical narrative: Initial report received on 06Apr06. An 18 yr old male pt had received an IM, left arm, first dose injection of Menactra, lot U1658AA, on 01Jul05. Results of a test for Epstein [[name]] virus, obtained on 18Aug05, were positive, and the pt was subsequently diagnosed with mononucleosis. On 02Feb06, the pt experienced upper respiratory infection symptoms. From 17Feb06 to 28Feb06, the pt was hospitalized for Guillain [[name]]e syndrome although specific symptoms of that event were not provided. The pt was then re examined, on 18Mar06, 260 days post vaccination, complaining of migraine headache, and continuing weakness and numbness. He was again admitted to the hospital for possible recurrent Guillain [[name]]e syndrome or other neurological entity; and, as of 21Mar06, he remained hospitalized. The onset of the events was reported as Feb06, approx seven months post vaccination. The pt also had bilateral medial patellar resections approx one week prior to the onset of the symptoms. At the time of this report, the pt had not recovered.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Nervous system disorder, Upper respiratory tract infection, Viral infection
Clinical narrative: Initial report received on 06Apr06. An 18 yr old male pt had received an IM, left arm, first dose injection of Menactra, lot U1658AA, on 01Jul05. Results of a test for Epstein [[name]] virus, obtained on 18Aug05, were positive, and the pt was subsequently diagnosed with mononucleosis. On 02Feb06, the pt experienced upper respiratory infection symptoms. From 17Feb06 to 28Feb06, the pt was hospitalized for Guillain [[name]]e syndrome although specific symptoms of that event were not provided. The pt was then re examined, on 18Mar06, 260 days post vaccination, complaining of migraine headache, and continuing weakness and numbness. He was again admitted to the hospital for possible recurrent Guillain [[name]]e syndrome or other neurological entity; and, as of 21Mar06, he remained hospitalized. The onset of the events was reported as Feb06, approx seven months post vaccination. The pt also had bilateral medial patellar resections approx one week prior to the onset of the symptoms. At the time of this report, the pt had not recovered.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Lymph nodes enlarged. Fever Initial report received on 20/Mar/2006 from a health care provider. An 11 year old female patient with a history of type I diabetes mellitus had received her first administration (route not reported) of Menactra, lot number U1859AA in the left arm and her first administration (route not reported) of another manufacturer's Boostrix vaccine, manufacturer GlaxoSmithKline, lot number AC52800AB in the right arm on 14/Mar/2006 at 14:00. At an unspecified time later, she developed swollen lymph nodes and a fever of 100.6 degrees Fahrenheit. No diagnostic/laboratory data was collected. The patient was treated with Keflex 500mg for ten days. The recovery status was unknown at the time of this report.
Age: 15.0
Sex: F
Vaccine: HEP, MNQ, TDAP, HEP, MNQ, TDAP, HEP, MNQ, TDAP
Symptoms: Guillain-Barre syndrome, Muscular weakness, Urinary retention
Clinical narrative: Initial report received on 28Mar06. A 15 yr old female pt had received her first dose of Menactra, lot number U1494AB, Adacel, lot number C2151AC, and a third dose of Engerix B, lot number 256AA, on 22Mar06. Two days later, she was admitted to the pediatric intensive care unit (PICU) with left leg weakness followed by weakness bilaterally in her hip flexion. She had a loss of two point discrimination of the lower extremities below her knees. She also had urinary retention. The records of this pt reportedly stated possibly early GBS. On admission her CSF analysis had a protein level of 29. An MRI of spine dose on 26Mar06 states there is mild enhancement throughout the nerve roots in the lumbar spinal canal that involved the cauda equina and at the surface of the conus medullaris. With the pt's symptomatology, the findings are highly suspicious of post viral etiology and infection in the form of Guillain Barre. This needs to be further correlated with CSF analysis and with pt's symptoms. The pt also had an EMG, nerve conduction study and oligoclonal antibody test, but there were no results provided. She was started on IVIG and her symptoms were treated as Guillain Barre syndrome. At the time of this report the pt had not recovered from these events and she was still hospitalized.
Age: 15.0
Sex: F
Vaccine: HEP, MNQ, TDAP, HEP, MNQ, TDAP, HEP, MNQ, TDAP
Symptoms: Guillain-Barre syndrome, Muscular weakness, Paraesthesia
Clinical narrative: Initial report received on 28Mar06. A 15 yr old female pt had received her first dose of Menactra, lot number U1494AB, Adacel, lot number C2151AC, and a third dose of Engerix B, lot number 256AA, on 22Mar06. Two days later, she was admitted to the pediatric intensive care unit (PICU) with left leg weakness followed by weakness bilaterally in her hip flexion. She had a loss of two point discrimination of the lower extremities below her knees. She also had urinary retention. The records of this pt reportedly stated possibly early GBS. On admission her CSF analysis had a protein level of 29. An MRI of spine dose on 26Mar06 states there is mild enhancement throughout the nerve roots in the lumbar spinal canal that involved the cauda equina and at the surface of the conus medullaris. With the pt's symptomatology, the findings are highly suspicious of post viral etiology and infection in the form of Guillain Barre. This needs to be further correlated with CSF analysis and with pt's symptoms. The pt also had an EMG, nerve conduction study and oligoclonal antibody test, but there were no results provided. She was started on IVIG and her symptoms were treated as Guillain Barre syndrome. At the time of this report the pt had not recovered from these events and she was still hospitalized.
Age: 15.0
Sex: F
Vaccine: HEP, MNQ, TDAP, HEP, MNQ, TDAP, HEP, MNQ, TDAP
Symptoms: Asthenia, Guillain-Barre syndrome, Laboratory test abnormal, Urinary retention
Clinical narrative: Initial report received on 28Mar06. A 15 yr old female pt had received her first dose of Menactra, lot number U1494AB, Adacel, lot number C2151AC, and a third dose of Engerix B, lot number 256AA, on 22Mar06. Two days later, she was admitted to the pediatric intensive care unit (PICU) with left leg weakness followed by weakness bilaterally in her hip flexion. She had a loss of two point discrimination of the lower extremities below her knees. She also had urinary retention. The records of this pt reportedly stated possibly early GBS. On admission her CSF analysis had a protein level of 29. An MRI of spine dose on 26Mar06 states there is mild enhancement throughout the nerve roots in the lumbar spinal canal that involved the cauda equina and at the surface of the conus medullaris. With the pt's symptomatology, the findings are highly suspicious of post viral etiology and infection in the form of Guillain Barre. This needs to be further correlated with CSF analysis and with pt's symptoms. The pt also had an EMG, nerve conduction study and oligoclonal antibody test, but there were no results provided. She was started on IVIG and her symptoms were treated as Guillain Barre syndrome. At the time of this report the pt had not recovered from these events and she was still hospitalized.
Age: 1.28
Sex: F
Vaccine: DTAPH, MMRV, DTAP, HIBV, MMRV
Symptoms: Crying, Infection, Pain, Skin disorder, Skin ulcer
Clinical narrative: Seriousness Criteria Other medically significant (OMIC). Initial report received on 6/1/2006 from another manufacturer, report number WAES0603USA03955. The information in this report was originally provided to the other manufacturer from a health care professional. A 16 month old female patient with no medical history or allergies had received a dose of ActHib, a dose of Tripedia, and a dose of ProQuad (measles, mumps, rubella and varicella Zoster vaccine lot number 652232/0772R on 2/21/2006. The ActHib and Tripedia were administered together as the product Trihibit and the lot numbers, route and site of administration were not provided. The route and site of administration were not reported for the ProQuad. 27 days post immunization, the patient developed painful weeping lesions that crusted over along one dermatome. The lesions were on her right leg, upper thigh. The skin was denuded and showed evidence of a skin infection. There were less than 50 lesions. Unspecified medical attention was sought. No laboratory diagnostic tests were performed. The patient was treated with Augmentin. At the time of this report, the antibiotic therapy had been discontinued and the patient was recovering but she had not been seen for a follow up visit. There were no product quality complaints involved.
Age: 1.28
Sex: F
Vaccine: DTAPH, MMRV, DTAP, HIBV, MMRV
Symptoms: Crying, Infection, Skin disorder, Skin ulcer
Clinical narrative: Seriousness Criteria Other medically significant (OMIC). Initial report received on 6/1/2006 from another manufacturer, report number WAES0603USA03955. The information in this report was originally provided to the other manufacturer from a health care professional. A 16 month old female patient with no medical history or allergies had received a dose of ActHib, a dose of Tripedia, and a dose of ProQuad (measles, mumps, rubella and varicella Zoster vaccine lot number 652232/0772R on 2/21/2006. The ActHib and Tripedia were administered together as the product Trihibit and the lot numbers, route and site of administration were not provided. The route and site of administration were not reported for the ProQuad. 27 days post immunization, the patient developed painful weeping lesions that crusted over along one dermatome. The lesions were on her right leg, upper thigh. The skin was denuded and showed evidence of a skin infection. There were less than 50 lesions. Unspecified medical attention was sought. No laboratory diagnostic tests were performed. The patient was treated with Augmentin. At the time of this report, the antibiotic therapy had been discontinued and the patient was recovering but she had not been seen for a follow up visit. There were no product quality complaints involved.
Age: 45.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Chills, Dysphagia, Dyspnoea, Erythema
Clinical narrative: Allergic reaction Palpitations Shortness of breath Throat tightness Swallowing difficult Weakness generalized Sensation of pressure in eye Post Licensure safety surveillance study of routine use of meningococcal (Group A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (Menactra) trail code MTA30. Subject 37065751 Initial report received on 20/Mar/2006 from an investigator participating in the above mention trail in the USA under reference number MTA30. A 44 year old female subject experienced a "possible allergic reaction" on the same day in which she had received an injection of Menactra, lot number not provided. Recovery status was not provided. According to the investigator the event was related to the study vaccine. Follow-up information received on 29/Mar/2006. The subject has a past medical history of a positive PPD skin test and H. Pylori. She has no known drug allergies. She presented to the emergency room one hour post-vaccination at 17:39 with complaints of throat tightness and soreness, hard time swallowing, mild shortness of breath, burning and pressure in her eyes bilaterally, facial redness, body weakness and aches, and palpitations and chills. She appeared lethargic. Vital signs were T 98.2, P 82, R 16, B/P 126/85. Cardiac assessment and EMG were normal. Neurological exam was normal and she was speaking full sentences and had no tongue swelling or drooling. Physical exam showed slight erythema of the tympanic membranes. She was given Benadryl 25mg IV. Her discharge diagnosis was reaction to immunization. She was instructed to call someone to give her a ride home from the facility at 19:50 and when the nurse went to do her assessment at 21:10 the subject was gone. The recovery status was not reported at the time of this report.
Age: 45.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Eye irritation, Lethargy, Pain, Palpitations, Pharyngolaryngeal pain
Clinical narrative: Allergic reaction Palpitations Shortness of breath Throat tightness Swallowing difficult Weakness generalized Sensation of pressure in eye Post Licensure safety surveillance study of routine use of meningococcal (Group A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (Menactra) trail code MTA30. Subject 37065751 Initial report received on 20/Mar/2006 from an investigator participating in the above mention trail in the USA under reference number MTA30. A 44 year old female subject experienced a "possible allergic reaction" on the same day in which she had received an injection of Menactra, lot number not provided. Recovery status was not provided. According to the investigator the event was related to the study vaccine. Follow-up information received on 29/Mar/2006. The subject has a past medical history of a positive PPD skin test and H. Pylori. She has no known drug allergies. She presented to the emergency room one hour post-vaccination at 17:39 with complaints of throat tightness and soreness, hard time swallowing, mild shortness of breath, burning and pressure in her eyes bilaterally, facial redness, body weakness and aches, and palpitations and chills. She appeared lethargic. Vital signs were T 98.2, P 82, R 16, B/P 126/85. Cardiac assessment and EMG were normal. Neurological exam was normal and she was speaking full sentences and had no tongue swelling or drooling. Physical exam showed slight erythema of the tympanic membranes. She was given Benadryl 25mg IV. Her discharge diagnosis was reaction to immunization. She was instructed to call someone to give her a ride home from the facility at 19:50 and when the nurse went to do her assessment at 21:10 the subject was gone. The recovery status was not reported at the time of this report.
Age: 45.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Throat tightness
Clinical narrative: Allergic reaction Palpitations Shortness of breath Throat tightness Swallowing difficult Weakness generalized Sensation of pressure in eye Post Licensure safety surveillance study of routine use of meningococcal (Group A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (Menactra) trail code MTA30. Subject 37065751 Initial report received on 20/Mar/2006 from an investigator participating in the above mention trail in the USA under reference number MTA30. A 44 year old female subject experienced a "possible allergic reaction" on the same day in which she had received an injection of Menactra, lot number not provided. Recovery status was not provided. According to the investigator the event was related to the study vaccine. Follow-up information received on 29/Mar/2006. The subject has a past medical history of a positive PPD skin test and H. Pylori. She has no known drug allergies. She presented to the emergency room one hour post-vaccination at 17:39 with complaints of throat tightness and soreness, hard time swallowing, mild shortness of breath, burning and pressure in her eyes bilaterally, facial redness, body weakness and aches, and palpitations and chills. She appeared lethargic. Vital signs were T 98.2, P 82, R 16, B/P 126/85. Cardiac assessment and EMG were normal. Neurological exam was normal and she was speaking full sentences and had no tongue swelling or drooling. Physical exam showed slight erythema of the tympanic membranes. She was given Benadryl 25mg IV. Her discharge diagnosis was reaction to immunization. She was instructed to call someone to give her a ride home from the facility at 19:50 and when the nurse went to do her assessment at 21:10 the subject was gone. The recovery status was not reported at the time of this report.