chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: LYME
Symptoms: Loss of libido, Musculoskeletal pain, Myalgia, Nervous system disorder, Nightmare
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced pain in his joints and muscles, headaches, flu-like symptoms, fatigue, possible memory loss, cognitive dysfunction, rashes, vision disorders, cardiac problems, insomnia, and decreased activities of daily life. it was reported that she experienced, among other things, rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX, including, but not limited to, the events above. At the time of reporting the outcome of the events were was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 29 February 2007 via information obtained from an interview between the subject and lawyers. The subject received the first, second, and third doses of LYMERIX in October 1999, December 1999, and December 2000. In March 2000, the subject developed muscle and joint aches. In 2000, he began experiencing nightmares. In approximately 2001 he developed an irregular heart beat. In approximately 2002, he experienced loss of libido with swollen scrotum, and "shortly" thereafter developed depression, "lack of social activities", and short temper. In approximately 2006 he experienced memory loss. In approximately 2007 he developed anxiety. On unspecified dates, he experienced blood clots in his legs and methicillin resistant staphylococcus aureus (MRSA) infection. He indicated that he required stent placement for treatment of irregular heartbeat. He underwent carpal tunnel surgery, and surgery with removal of a "lap lesion" and bone spur from the subject's shoulder. Other treatment included an unspecified mood stabilizer, EFFEXOR, XANAX, and possibly VIAGRA. He reported two blood clots that occurred at different times, one in the left leg above the knee, and later one in the right leg above the knee. Blood clots were treated with HEPARIN and COUMADIN. He was hospitalized due to MRSA, and was treated with antibiotics. In September 2008, he experienced suicidality and was hospitalized, and subsequently received behavioural counseling. With the exception of MRSA, blood clots, and irregular heartbeat, the events were unresolved at the time of this report.
Age: 44.0
Sex: M
Vaccine: LYME
Symptoms: Rash, Scrotal swelling, Social avoidant behaviour, Staphylococcal infection, Suicidal ideation
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced pain in his joints and muscles, headaches, flu-like symptoms, fatigue, possible memory loss, cognitive dysfunction, rashes, vision disorders, cardiac problems, insomnia, and decreased activities of daily life. it was reported that she experienced, among other things, rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX, including, but not limited to, the events above. At the time of reporting the outcome of the events were was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 29 February 2007 via information obtained from an interview between the subject and lawyers. The subject received the first, second, and third doses of LYMERIX in October 1999, December 1999, and December 2000. In March 2000, the subject developed muscle and joint aches. In 2000, he began experiencing nightmares. In approximately 2001 he developed an irregular heart beat. In approximately 2002, he experienced loss of libido with swollen scrotum, and "shortly" thereafter developed depression, "lack of social activities", and short temper. In approximately 2006 he experienced memory loss. In approximately 2007 he developed anxiety. On unspecified dates, he experienced blood clots in his legs and methicillin resistant staphylococcus aureus (MRSA) infection. He indicated that he required stent placement for treatment of irregular heartbeat. He underwent carpal tunnel surgery, and surgery with removal of a "lap lesion" and bone spur from the subject's shoulder. Other treatment included an unspecified mood stabilizer, EFFEXOR, XANAX, and possibly VIAGRA. He reported two blood clots that occurred at different times, one in the left leg above the knee, and later one in the right leg above the knee. Blood clots were treated with HEPARIN and COUMADIN. He was hospitalized due to MRSA, and was treated with antibiotics. In September 2008, he experienced suicidality and was hospitalized, and subsequently received behavioural counseling. With the exception of MRSA, blood clots, and irregular heartbeat, the events were unresolved at the time of this report.
Age: 44.0
Sex: M
Vaccine: LYME
Symptoms: Surgery, Thrombosis, Visual impairment
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced pain in his joints and muscles, headaches, flu-like symptoms, fatigue, possible memory loss, cognitive dysfunction, rashes, vision disorders, cardiac problems, insomnia, and decreased activities of daily life. it was reported that she experienced, among other things, rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX, including, but not limited to, the events above. At the time of reporting the outcome of the events were was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 29 February 2007 via information obtained from an interview between the subject and lawyers. The subject received the first, second, and third doses of LYMERIX in October 1999, December 1999, and December 2000. In March 2000, the subject developed muscle and joint aches. In 2000, he began experiencing nightmares. In approximately 2001 he developed an irregular heart beat. In approximately 2002, he experienced loss of libido with swollen scrotum, and "shortly" thereafter developed depression, "lack of social activities", and short temper. In approximately 2006 he experienced memory loss. In approximately 2007 he developed anxiety. On unspecified dates, he experienced blood clots in his legs and methicillin resistant staphylococcus aureus (MRSA) infection. He indicated that he required stent placement for treatment of irregular heartbeat. He underwent carpal tunnel surgery, and surgery with removal of a "lap lesion" and bone spur from the subject's shoulder. Other treatment included an unspecified mood stabilizer, EFFEXOR, XANAX, and possibly VIAGRA. He reported two blood clots that occurred at different times, one in the left leg above the knee, and later one in the right leg above the knee. Blood clots were treated with HEPARIN and COUMADIN. He was hospitalized due to MRSA, and was treated with antibiotics. In September 2008, he experienced suicidality and was hospitalized, and subsequently received behavioural counseling. With the exception of MRSA, blood clots, and irregular heartbeat, the events were unresolved at the time of this report.
Age: 53.0
Sex: F
Vaccine: LYME
Symptoms: Activities of daily living impaired, Arthralgia, Depressed level of consciousness, Exostosis, Fatigue
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecifeid dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, joint swelling, possible nerve injury, possible autoimmune disease and activities of daily living impaired. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow-up information received on 26 February 2009 via records from an interview between the subject and lawyers. The subject received the first, second, and third doses of LYMERIX ON 04 May 1999, 04 June 1999, and 30 June 2000. Between June 2000 and the winter of 2000, the subject developed achiness, joint pain and stiffness, fatigue, diminished alertness, and diminished memory. Diminished alertness was assessed to be medically significant by GSK. The subject noted that diminished alertness and diminished memory occurred when she was fatigued. In 2008, she experienced "popping" of the right knee. The subject reported hip pain that was attributed to a bone spur. Treatment included ibuprofen and glucosamine/chondroitin. The events were unresolved at the time of this report.
Age: 53.0
Sex: F
Vaccine: LYME
Symptoms: Joint stiffness, Joint swelling, Memory impairment, Pain
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecifeid dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, joint swelling, possible nerve injury, possible autoimmune disease and activities of daily living impaired. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow-up information received on 26 February 2009 via records from an interview between the subject and lawyers. The subject received the first, second, and third doses of LYMERIX ON 04 May 1999, 04 June 1999, and 30 June 2000. Between June 2000 and the winter of 2000, the subject developed achiness, joint pain and stiffness, fatigue, diminished alertness, and diminished memory. Diminished alertness was assessed to be medically significant by GSK. The subject noted that diminished alertness and diminished memory occurred when she was fatigued. In 2008, she experienced "popping" of the right knee. The subject reported hip pain that was attributed to a bone spur. Treatment included ibuprofen and glucosamine/chondroitin. The events were unresolved at the time of this report.
Age: 42.0
Sex: M
Vaccine: FLUN3
Symptoms: Acute disseminated encephalomyelitis, Blindness transient, Central nervous system lesion, Electroencephalogram abnormal, Hypersensitivity
Clinical narrative: Flu Mist administered as part of annual physical exam caused a severe allergic reaction in right nostril and eye.  Paient started losing vision in right eye (upper visual field) and was diagnosed with Optic Neuritis and brain lesions.  Patient was treated with IV and Oral Steroids at Hospital.  Vision and visual field restored in several days, but brain lesions persist.  Patient diagnosed with "post-vaccinial ADEM" (Acute Disseminated Encephalomyelitis) and currently working with a nuerologist hospital.  Recent EEG showed "damage" caused by the Optic Neuritis. 3/19/09 Received Neuro clinic medical records 10/9/08-2/20/2009. FINAL DX: ADEM & optic neuritis s/p vaccination per neurologist.   Records reveal patient experienced optic neuritis, diagnosed at outside facility & seen starting 10/10 for IV steroids x 3 days.
Age: 42.0
Sex: M
Vaccine: FLUN3
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Optic neuritis, Vaccination complication, Visual field tests abnormal
Clinical narrative: Flu Mist administered as part of annual physical exam caused a severe allergic reaction in right nostril and eye.  Paient started losing vision in right eye (upper visual field) and was diagnosed with Optic Neuritis and brain lesions.  Patient was treated with IV and Oral Steroids at Hospital.  Vision and visual field restored in several days, but brain lesions persist.  Patient diagnosed with "post-vaccinial ADEM" (Acute Disseminated Encephalomyelitis) and currently working with a nuerologist hospital.  Recent EEG showed "damage" caused by the Optic Neuritis. 3/19/09 Received Neuro clinic medical records 10/9/08-2/20/2009. FINAL DX: ADEM & optic neuritis s/p vaccination per neurologist.   Records reveal patient experienced optic neuritis, diagnosed at outside facility & seen starting 10/10 for IV steroids x 3 days.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Dizziness, Hyperacusis, Hyperhidrosis, Nausea
Clinical narrative: sudden paleness, weakness, dizziness, distortion of hearing, sweating, nausea, wretching and vomiting (small amount, no food) within about 5 minutes of vaccine, event lasted about 1 or 2  minutes, no treatment
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Pallor, Vomiting
Clinical narrative: sudden paleness, weakness, dizziness, distortion of hearing, sweating, nausea, wretching and vomiting (small amount, no food) within about 5 minutes of vaccine, event lasted about 1 or 2  minutes, no treatment
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This Tdap was given as no history of tetanus was known for a long time.  Client had received one on 01-22-2008. This was found when I went to enter the shot, and I should have looked at that prior to administration of the shot.  Cient was informed and no known reaction or complication is known.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: PATIENT REFERS DIZZINESS, PERSPIRATION AND PALENESS.LASTED FOR 20 MINUTES. RECOVERED AFTER LAYING DOWN.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Developed 4cm red hive with central elevation.  Given 12.5 mg benadryl.  Observed for 1 hour.  No SOA.  Redness improved to 2 cm and no longer raised.  No known hx of allergy to chickens.  Has eaten eggs, given varicella without reaction.
Age: 29.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Dyspnoea, Pruritus generalised, Urticaria
Clinical narrative: Developed shortness of breath, hives, itching all over approximately 30 minutes after being given PPD, Influenza vaccine, and Tdap.  Sent to ER; received diphenhydramine, epinephrine, atarax, solumedrol and Rx for medrol dose pack, zantac.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dyskinesia, Erythema, Immediate post-injection reaction, Musculoskeletal stiffness, Pallor
Clinical narrative: Within 1 minute of receiving Menactra inj, became pale, slid to floor out of chair. RN lowered to floor. Stiffened body for approx 15-30 secs, face reddened, woke up w/arms flailing, given O2 via mask at 2L approx 3 mins, BP 120/78 lying. Oriented x3.  Remained lying on floor approx 10 mins, then up in chair 20 mins, Alert and talking appropriately.  Walked to class unassisted.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Back pain, Fatigue, Headache, Lip swelling, Myalgia
Clinical narrative: After getting the gardasil vaccine three weeks ago, my daughter has severe back pain, general muscle aches, fatigue and terrible headaches. She also had swelling of her mouth and lips. I am very concerned about her back problem because it is very unusual and the doctor really doesn't know what is wrong. These symptoms didn't occur until after her first dose of gardasil. SHE WILL NOT BE RECEIVING THE LAST TWO DOSES OF THE DRUG! 4/1/09-records received-office visit 2/2/09-C/O hives rash on body since 2/7/09, itchy and red-seen in ED started on prednisone. assessment:dermatitis secondary to PCN. 2/17/09 office visit C/O bad headaches every couple of days. Not eating for one week but drinking soda and caffeine. Fatigue. Assessment possible eating diorder possible cause of headaches suspect underlying mood disorder. Received Gardasil/Adacel Menactra. Referred to eating disorder clinic. Office visit 3/2/09-C/O inflammation in upper back with pain began day before and is a recurrent porblem however first time seen for the problem. Assessment muscle sprain likely secondary to month of coughing. 3/10/09-requests referral to specialist. Office visit 3/17/09 C/O hives and persistent back pain.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Oedema mouth
Clinical narrative: After getting the gardasil vaccine three weeks ago, my daughter has severe back pain, general muscle aches, fatigue and terrible headaches. She also had swelling of her mouth and lips. I am very concerned about her back problem because it is very unusual and the doctor really doesn't know what is wrong. These symptoms didn't occur until after her first dose of gardasil. SHE WILL NOT BE RECEIVING THE LAST TWO DOSES OF THE DRUG! 4/1/09-records received-office visit 2/2/09-C/O hives rash on body since 2/7/09, itchy and red-seen in ED started on prednisone. assessment:dermatitis secondary to PCN. 2/17/09 office visit C/O bad headaches every couple of days. Not eating for one week but drinking soda and caffeine. Fatigue. Assessment possible eating diorder possible cause of headaches suspect underlying mood disorder. Received Gardasil/Adacel Menactra. Referred to eating disorder clinic. Office visit 3/2/09-C/O inflammation in upper back with pain began day before and is a recurrent porblem however first time seen for the problem. Assessment muscle sprain likely secondary to month of coughing. 3/10/09-requests referral to specialist. Office visit 3/17/09 C/O hives and persistent back pain.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: RECEIVED 15 MONTH SHOTS 4 DAYS AGO- STARTED WITH SWELLING OF LEFT LEG. NO TEMPERATURE. CAME TO OFFICE- 1" X 1.25" BUMP WITH SWELLING AND REDNESS MEASURED. SYMPTOMATIC TREATMENT ADVISED.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HEP, PNC
Symptoms: Computerised tomogram normal, Convulsion, Dyskinesia, Electroencephalogram normal
Clinical narrative: Patient started jerking/seizure for about 1-3 seconds.  Then had about a dozen episode's of the jerking/seizures for about 3-5 seconds.  The patient was taken to the ER and then transfered and was admitted for 3 days.  No other treatment was given.3/16/09-records received for DOS 2/16-2/17/09-DC DX-Movements that are not due to seizures (non-epileptic events). Presented with episodes that occurred day after immunization, bilateral arm abduction with head drop followed by irritability decreased activity for few days. Now back to normal prior to admission. Parents saw vidoes on internet related to infantile spasms and requested admission.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: injection site reaction: redness and soreness-next day and lasting 5+ days. Itching after several days.
Age: 56.0
Sex: U
Vaccine: PPV
Symptoms: Colon cancer, Metastasis
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was diagnosed with colon adenocarcinoma, metastatic. Vaccination took place on 1/31/2008. According to the physician, the relationship is 'None'. We would be happy to forward the Study's SAE Reporting Form upon request.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Death, Drug toxicity
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, died on 10/31/2008 of multiple drug intoxication. Vaccination took place on 3/13/2008. According to the physician, the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request   3/12/09 Death certificate states COD as multiple drug intoxication.  SAE & ER medical records from study center reveal patient found asystolic w/o signs of trauma.  Patient was not on any know medications.
Age: 20.0
Sex: F
Vaccine: YF
Symptoms: Confusional state, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, Nausea and vometing, mental confusion.This is info taken from the patients mom. Stated pt recovered and is now @ her travel destination. Attempted to call the mother back X3 for more specific information without success.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Alanine aminotransferase increased, Antinuclear antibody positive, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood creatine phosphokinase MB
Clinical narrative: Onset of bilateral profound bilateral brachial weakness approx. 6-weeks after having received the split influenza vaccination (injectable).  Vaccine was administered on 8-Jan-2009.  Onset of symptoms approx. 15-Feb-09.  Patient hospitalized on 5-Mar-2009. 3/13/09 MR received for DOS 3/5-xx/2009 (not yet d/c). DX:  Bilateral Brachial Plexopathy.  Pt presented with 3 week hx of bilateral upper extremity sensory and motor loss.  Initially began as R arm muscle pain and progressed.  While running on 2/20/09 pt developed problems breathing which then progressed to R neck, shoulder and arm pain.  later developed BUE weakness and numbness. Markedly decreased exercise tolerance. Admitted to r/o GBS/demyelinating process. 15 lb wt loss in last 2 weeks d/t decreased appetite. Neuro exam (+) for decreased stength 0-2/5 in UEs. UE DTRs absent R, diminished L. Sensory loss bilaerally of UEs.  Resting O2 sat 93%.  Tx with IV steroids with little improvement. Continues with breathing difficulty when supine.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase normal, Fibrin D dimer increased, Granulocytes abnormal, Lymphocyte count increased, Monocyte count increased
Clinical narrative: Onset of bilateral profound bilateral brachial weakness approx. 6-weeks after having received the split influenza vaccination (injectable).  Vaccine was administered on 8-Jan-2009.  Onset of symptoms approx. 15-Feb-09.  Patient hospitalized on 5-Mar-2009. 3/13/09 MR received for DOS 3/5-xx/2009 (not yet d/c). DX:  Bilateral Brachial Plexopathy.  Pt presented with 3 week hx of bilateral upper extremity sensory and motor loss.  Initially began as R arm muscle pain and progressed.  While running on 2/20/09 pt developed problems breathing which then progressed to R neck, shoulder and arm pain.  later developed BUE weakness and numbness. Markedly decreased exercise tolerance. Admitted to r/o GBS/demyelinating process. 15 lb wt loss in last 2 weeks d/t decreased appetite. Neuro exam (+) for decreased stength 0-2/5 in UEs. UE DTRs absent R, diminished L. Sensory loss bilaerally of UEs.  Resting O2 sat 93%.  Tx with IV steroids with little improvement. Continues with breathing difficulty when supine.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Rheumatoid factor negative, White blood cell count increased
Clinical narrative: Onset of bilateral profound bilateral brachial weakness approx. 6-weeks after having received the split influenza vaccination (injectable).  Vaccine was administered on 8-Jan-2009.  Onset of symptoms approx. 15-Feb-09.  Patient hospitalized on 5-Mar-2009. 3/13/09 MR received for DOS 3/5-xx/2009 (not yet d/c). DX:  Bilateral Brachial Plexopathy.  Pt presented with 3 week hx of bilateral upper extremity sensory and motor loss.  Initially began as R arm muscle pain and progressed.  While running on 2/20/09 pt developed problems breathing which then progressed to R neck, shoulder and arm pain.  later developed BUE weakness and numbness. Markedly decreased exercise tolerance. Admitted to r/o GBS/demyelinating process. 15 lb wt loss in last 2 weeks d/t decreased appetite. Neuro exam (+) for decreased stength 0-2/5 in UEs. UE DTRs absent R, diminished L. Sensory loss bilaerally of UEs.  Resting O2 sat 93%.  Tx with IV steroids with little improvement. Continues with breathing difficulty when supine.
Age: 1.3
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Body temperature increased, Convulsion, Feeling hot, Loss of consciousness
Clinical narrative: At 4:45 PM child felt warm.  Mother did not take temperture.  At 8:15 or 8:20 PM child 's temperture 103.3.  Child started to have a seizure.  Ambulance called.  Child transported to Hospital.  Dr. was the attending doctor in the ER.  Child was unconscious for ten minutes.  Child had been given Pentacel and Prevnar at a child's clinic earlier in the day.  Mother said child never had a seizure  before or after any vaccines.  Mother instructed to call family doctor.  Mother called me at 3:15 PM 03-10-09.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Less than 5 mins after Varivax given, pt developed erythema at and above injection site. Per drs order gave pt dose of oral benedryl.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Rash papular
Clinical narrative: Mother presented to office with child reported that Varicella was given 2/26/09.  Papular rash appeared on child 3/8/09.  No fever was noted.  Child was given Benadryl on 3/9/09.  Greater than 50 papules were noted on trunk of body, stomach, back and upper legs.
Age: 42.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Back pain, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: On 03/10/2009 at approximately 2:45pm the above named pt. was in the clinic with her daughter who was receiving services and the pt came to me at the Immunization lab door and asked me if she could ask a question about a vaccine she had on 02/12/2009. Pt stated to me that she received 2 vaccines that day, one in each deltoid. She also stated that starting that day, after receiving a Tdap in her left deltoid and a Hepatitis B in her right, she has had pain in the upper left arm, left shoulder area, across the shoulders to the mid-back area and up into her neck. She also stated that she cannot move her left arm away from her body without extreme pain, she cannot move her elbow back behind her without extreme pain and she pin pointed very tender areas from the left deltoid area and atop of the left shoulder area. She also stated she was taking Ibuprofen for the pain. I asked if she had seen a doctor since 02/12/2009 for this problem and she stated, she has not seen a doctor because she doesn't have insurance or the money to go to the doctor. I then reported these complaints to my Supervisor who then reported it to the County Nurse Mgr. After discussing the issue at hand I informed the patient to continue the Ibuprofen every 6-8 hours as needed for pain, to use warm compresses on 15 minutes and off 15 minutes as often as she could. I then gave her the phone number to an agency and advised her to make an appointment there with a doctor to be evaluated. Patient stated she understood the instructions given to her.
Age: 42.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Tenderness
Clinical narrative: On 03/10/2009 at approximately 2:45pm the above named pt. was in the clinic with her daughter who was receiving services and the pt came to me at the Immunization lab door and asked me if she could ask a question about a vaccine she had on 02/12/2009. Pt stated to me that she received 2 vaccines that day, one in each deltoid. She also stated that starting that day, after receiving a Tdap in her left deltoid and a Hepatitis B in her right, she has had pain in the upper left arm, left shoulder area, across the shoulders to the mid-back area and up into her neck. She also stated that she cannot move her left arm away from her body without extreme pain, she cannot move her elbow back behind her without extreme pain and she pin pointed very tender areas from the left deltoid area and atop of the left shoulder area. She also stated she was taking Ibuprofen for the pain. I asked if she had seen a doctor since 02/12/2009 for this problem and she stated, she has not seen a doctor because she doesn't have insurance or the money to go to the doctor. I then reported these complaints to my Supervisor who then reported it to the County Nurse Mgr. After discussing the issue at hand I informed the patient to continue the Ibuprofen every 6-8 hours as needed for pain, to use warm compresses on 15 minutes and off 15 minutes as often as she could. I then gave her the phone number to an agency and advised her to make an appointment there with a doctor to be evaluated. Patient stated she understood the instructions given to her.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Pt c/o extremely sore arm with mild warmth in the deltoid since day injection was given.  He is on day 5 of pain in that arm, which is longer than what the manufacturer's data suggests is normal.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Child seen in health center on 03/04/09 with a rash that started on 03/03/09.  Rash scattered throughtout body:  slightly raised or macular, erythematous blotchy eruptions.  No fever.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Anorexia, Dizziness, Skin discolouration, Vertigo
Clinical narrative: Pt felt dizzy a few minutes after HPV vaccine.  Pt also felt her L arm turning different color.  Pt has not eaten whole day prior to vaccination.  Pt given food & water & instructed to lie down until vertigo resolved.  No change in color between arms noted by myself.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Erythema, Irritability, Musculoskeletal stiffness, Respiratory arrest, Salivary hypersecretion
Clinical narrative: The patient received 0.4cc of Infants Tylenol. An hour later she received DTAP, IPV, Hepatitis B, Haemophilus Inf. B, Prevnar and Rotateq. The patient was fussy after the shots were given. Two hours after vaccine administration,  she became stiff all over, stopped breathing, saliva was coming out of her mouth and her skin turned red.  All of this lasted about 20 seconds during which time the mother started patting her back. She was given 2 ounces of formula and fell asleep.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Foetal disorder, Pregnancy
Clinical narrative: I received my first and only dose of Gardasil in late September, I beleive it was the 20th.  I found out in October that I was pregnant.  My due date based on ultrasound was June 25, 2009 making the date of conception around October 2, 2008- after I received the vaccine.  In January, the baby was diagnosed with Trisomy 18.  He did not survive.
Age: 0.25
Sex: M
Vaccine: HEP, HIBV, IPV
Symptoms: Crying, Immediate post-injection reaction, Rash erythematous, Urticaria
Clinical narrative: Immediately after vaccination, a few red hive-looking rash spots appeared on my son's face/neck/arm and knee. Also, difficult to console crying a for a few hours, a few hours after vaccination. He received the Polio, Hib and Heb B vaccine today.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Anorexia, Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: Within 16 hrs, had sore arm, legs, headache, fever of 101.3, tiredness, dizzy, lack of appetite.  With Jr. Motrin and cold compresses on arm and legs with cool rag on forhead broght down temp to 99.6 within an hour and half.  Other symtoms accuring on and off into the night.  Not sure what else to follow.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Tenderness
Clinical narrative: Within 16 hrs, had sore arm, legs, headache, fever of 101.3, tiredness, dizzy, lack of appetite.  With Jr. Motrin and cold compresses on arm and legs with cool rag on forhead broght down temp to 99.6 within an hour and half.  Other symtoms accuring on and off into the night.  Not sure what else to follow.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient was given her first flu shot with Fluvirin on October 29, 2008.  To date she still has muscle tenderness at the injection site.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Lymphadenopathy
Clinical narrative: Onset 3/10/09 2 red areas 1 to inner aspect of (L) arm 1 to back of (L) arm (slightly raised) swelling noted to axillary gland (L).
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature, Erythema, Tenderness
Clinical narrative: TDAP given 2/27/2009. (left deltoid) seen in office 3/4/09 for left delt was erythematous and tender. 4X4 cm area, no lymphadenitis but slightly tender under Lt axilla. Temp 98.0 Pt started on PREDNISONE 3/5/09.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Rash on trunk and local swelling, pain, itching at vaccination site. Antihistamines Prescribed.
Age: 1.59
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Swollen x 48 hours-entire leg 2x NL size fever up to 104.2 degrees x > 2 day after vaccine.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity, Tenderness, Ultrasound scan abnormal
Clinical narrative: 12/8/08 - Rt shoulder tenderness, pain with motion, radiation of pain to wrist/hand - ACE wrap, ice or heat, IBUPROFEN, light duty at work 12/29/08 - worsening pain - ice, PREDINSONE burst 1/8/09 - Ice, IBUPROFEN, avoid painful motions 2/4/09 - Ultrasound - Slightly hypoechoic region apparently within the deltoid muscle. 3/4/09 - NSAIDS, pain medication, physical therapy
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: None stated
Age: 72.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Localized redness and tenderness to site of injection.
Age: 19.0
Sex: M
Vaccine: FLU3, HEPAB, MMR, MNQ, TDAP
Symptoms: Albumin CSF decreased, CSF culture negative, CSF immunoglobulin increased, CSF oligoclonal band absent, CSF protein increased
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 316500. A 19-year-old male patient with no pre-existing medical conditions had received a first dose intramuscular left arm injection of MENACTRA (lot number U2566AA), a first dose intramuscular right arm injection of ADACEL (lot number C2775AA), a first dose intramuscular left arm injection of FLULAVAL (lot number AFFLA050AA), a first dose subcutaneous right arm injection of MMR II (lot number 0868U), and a first dose intramuscular right arm injection of TWINRIX (lot number AHABB103AA). The event began 29 February 2008, 31 days post vaccination. The Follow-up information included medical records for dates of service 03 March - 23 May 2008 which included a discharge diagnosis of Guillain-Barre Syndrome and a secondary diagnosis of: syndrome of inappropriate antidiuretic hormone (SIADH), constipation, right hand 5th metacarpal fracture and depression. The patient presented on 03 March 2008 with a four day history of progressive ascending numbness and motor weakness which began at the ankles, to the upper extremities. Laboratory and diagnostic test results showed CSF - no oligoclonal bands. CSF albumin 49.7. CSF IGG synthesis high at 4.7. CSF protein 79.3. CSF cx (-), otherwise decreased vital capacity and was intubated on 09 March 2008 for seven days, then extubated. The patient had no further respiratory issues and received treatment with intravenous immune globulins (IVIG). The patient then developed inappropriate antidiuretic hormone secretion (SIADH) and was put on fluid restriction. The patient showed some sensation and motor function improvement; however complained of depression and pain in the feet. Neurology noted "choriform" movements and prescribed "CLONAZAPAM", and symptoms resolved. The patient was also noted to have developed bilateral ankle contractures. On 23 May 2008, the patient was discharged and continued with outpatient rehabilitation. The patient's recovery status was unknown at the time of the report. Documents held by sender: None. Follow-up information received on 25 March 2009 from the Centers for Disease Control and Prevention (CDC) (VAERS number 316500). The level of diagnostic certainty for this confirmed GBS case is level 2 using the case definition.
Age: 19.0
Sex: M
Vaccine: FLU3, HEPAB, MMR, MNQ, TDAP
Symptoms: Chest X-ray abnormal, Constipation, Depression, Endotracheal intubation, Fracture
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 316500. A 19-year-old male patient with no pre-existing medical conditions had received a first dose intramuscular left arm injection of MENACTRA (lot number U2566AA), a first dose intramuscular right arm injection of ADACEL (lot number C2775AA), a first dose intramuscular left arm injection of FLULAVAL (lot number AFFLA050AA), a first dose subcutaneous right arm injection of MMR II (lot number 0868U), and a first dose intramuscular right arm injection of TWINRIX (lot number AHABB103AA). The event began 29 February 2008, 31 days post vaccination. The Follow-up information included medical records for dates of service 03 March - 23 May 2008 which included a discharge diagnosis of Guillain-Barre Syndrome and a secondary diagnosis of: syndrome of inappropriate antidiuretic hormone (SIADH), constipation, right hand 5th metacarpal fracture and depression. The patient presented on 03 March 2008 with a four day history of progressive ascending numbness and motor weakness which began at the ankles, to the upper extremities. Laboratory and diagnostic test results showed CSF - no oligoclonal bands. CSF albumin 49.7. CSF IGG synthesis high at 4.7. CSF protein 79.3. CSF cx (-), otherwise decreased vital capacity and was intubated on 09 March 2008 for seven days, then extubated. The patient had no further respiratory issues and received treatment with intravenous immune globulins (IVIG). The patient then developed inappropriate antidiuretic hormone secretion (SIADH) and was put on fluid restriction. The patient showed some sensation and motor function improvement; however complained of depression and pain in the feet. Neurology noted "choriform" movements and prescribed "CLONAZAPAM", and symptoms resolved. The patient was also noted to have developed bilateral ankle contractures. On 23 May 2008, the patient was discharged and continued with outpatient rehabilitation. The patient's recovery status was unknown at the time of the report. Documents held by sender: None. Follow-up information received on 25 March 2009 from the Centers for Disease Control and Prevention (CDC) (VAERS number 316500). The level of diagnostic certainty for this confirmed GBS case is level 2 using the case definition.
Age: 19.0
Sex: M
Vaccine: FLU3, HEPAB, MMR, MNQ, TDAP
Symptoms: Guillain-Barre syndrome, Hand fracture, Hypoaesthesia, Inappropriate antidiuretic hormone secretion, Joint contracture
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 316500. A 19-year-old male patient with no pre-existing medical conditions had received a first dose intramuscular left arm injection of MENACTRA (lot number U2566AA), a first dose intramuscular right arm injection of ADACEL (lot number C2775AA), a first dose intramuscular left arm injection of FLULAVAL (lot number AFFLA050AA), a first dose subcutaneous right arm injection of MMR II (lot number 0868U), and a first dose intramuscular right arm injection of TWINRIX (lot number AHABB103AA). The event began 29 February 2008, 31 days post vaccination. The Follow-up information included medical records for dates of service 03 March - 23 May 2008 which included a discharge diagnosis of Guillain-Barre Syndrome and a secondary diagnosis of: syndrome of inappropriate antidiuretic hormone (SIADH), constipation, right hand 5th metacarpal fracture and depression. The patient presented on 03 March 2008 with a four day history of progressive ascending numbness and motor weakness which began at the ankles, to the upper extremities. Laboratory and diagnostic test results showed CSF - no oligoclonal bands. CSF albumin 49.7. CSF IGG synthesis high at 4.7. CSF protein 79.3. CSF cx (-), otherwise decreased vital capacity and was intubated on 09 March 2008 for seven days, then extubated. The patient had no further respiratory issues and received treatment with intravenous immune globulins (IVIG). The patient then developed inappropriate antidiuretic hormone secretion (SIADH) and was put on fluid restriction. The patient showed some sensation and motor function improvement; however complained of depression and pain in the feet. Neurology noted "choriform" movements and prescribed "CLONAZAPAM", and symptoms resolved. The patient was also noted to have developed bilateral ankle contractures. On 23 May 2008, the patient was discharged and continued with outpatient rehabilitation. The patient's recovery status was unknown at the time of the report. Documents held by sender: None. Follow-up information received on 25 March 2009 from the Centers for Disease Control and Prevention (CDC) (VAERS number 316500). The level of diagnostic certainty for this confirmed GBS case is level 2 using the case definition.
Age: 19.0
Sex: M
Vaccine: FLU3, HEPAB, MMR, MNQ, TDAP
Symptoms: Movement disorder, Muscular weakness, Pain in extremity
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 316500. A 19-year-old male patient with no pre-existing medical conditions had received a first dose intramuscular left arm injection of MENACTRA (lot number U2566AA), a first dose intramuscular right arm injection of ADACEL (lot number C2775AA), a first dose intramuscular left arm injection of FLULAVAL (lot number AFFLA050AA), a first dose subcutaneous right arm injection of MMR II (lot number 0868U), and a first dose intramuscular right arm injection of TWINRIX (lot number AHABB103AA). The event began 29 February 2008, 31 days post vaccination. The Follow-up information included medical records for dates of service 03 March - 23 May 2008 which included a discharge diagnosis of Guillain-Barre Syndrome and a secondary diagnosis of: syndrome of inappropriate antidiuretic hormone (SIADH), constipation, right hand 5th metacarpal fracture and depression. The patient presented on 03 March 2008 with a four day history of progressive ascending numbness and motor weakness which began at the ankles, to the upper extremities. Laboratory and diagnostic test results showed CSF - no oligoclonal bands. CSF albumin 49.7. CSF IGG synthesis high at 4.7. CSF protein 79.3. CSF cx (-), otherwise decreased vital capacity and was intubated on 09 March 2008 for seven days, then extubated. The patient had no further respiratory issues and received treatment with intravenous immune globulins (IVIG). The patient then developed inappropriate antidiuretic hormone secretion (SIADH) and was put on fluid restriction. The patient showed some sensation and motor function improvement; however complained of depression and pain in the feet. Neurology noted "choriform" movements and prescribed "CLONAZAPAM", and symptoms resolved. The patient was also noted to have developed bilateral ankle contractures. On 23 May 2008, the patient was discharged and continued with outpatient rehabilitation. The patient's recovery status was unknown at the time of the report. Documents held by sender: None. Follow-up information received on 25 March 2009 from the Centers for Disease Control and Prevention (CDC) (VAERS number 316500). The level of diagnostic certainty for this confirmed GBS case is level 2 using the case definition.
Age: 20.0
Sex: M
Vaccine: FLUN3, HEPAB, MMR, MNQ, TDAP
Symptoms: Activities of daily living impaired, Asthenia, Blood product transfusion, C-reactive protein increased, Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 318648. SERIOUSNESS CRITERIA: OTHER- MEDICALLY SIGNIFICANT. A 20-year-old male received an injection of MENACTRA (lot number U2409AA), ADACEL (lot number C2842AA), FLUMIST (MedImmune, lot number 500476P), MMR II (Merck, lot number 0868U), and TWINRIX (GlaxoSmithKline, lot number AHABB103AA) on 18 December 2007. He had no illness at the time of vaccination. Four days after vaccination, on 22 December 2007, the patient began experiencing weakness, paresthesias of the lower extremities, and difficulty walking. He underwent physical therapy, but did not improve, and was subsequently referred to a neurologist. His condition progressed to include weakness and paresthesias of the upper extremities and impaired activities of daily living. Diagnostic testing showed elevated CRP (7.59) and ESR, and EMG/NCV were abnormal in upper and lower extremities. Ct of the C-spine/head and foot x-ray were within normal limits. Genetic testing revealed an abnormality (gene mutation identification test positive). In June 2008 he underwent treatment with intravenous immunoglobulins, and had some improvement. He was medically separated from his occupation, and required a brace on the right foot in order to walk. Final diagnosis as of 07 July 2008 was demyelinating polyneuritis, chronic inflammatory (active). Information received from CDC stated that the patient was diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP). Outcome was not provided. Documents held by sender: None
Age: 20.0
Sex: M
Vaccine: FLUN3, HEPAB, MMR, MNQ, TDAP
Symptoms: Computerised tomogram normal, Demyelinating polyneuropathy, Electromyogram abnormal, Gait disturbance, Gene mutation identification test positive
Clinical narrative: This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 318648. SERIOUSNESS CRITERIA: OTHER- MEDICALLY SIGNIFICANT. A 20-year-old male received an injection of MENACTRA (lot number U2409AA), ADACEL (lot number C2842AA), FLUMIST (MedImmune, lot number 500476P), MMR II (Merck, lot number 0868U), and TWINRIX (GlaxoSmithKline, lot number AHABB103AA) on 18 December 2007. He had no illness at the time of vaccination. Four days after vaccination, on 22 December 2007, the patient began experiencing weakness, paresthesias of the lower extremities, and difficulty walking. He underwent physical therapy, but did not improve, and was subsequently referred to a neurologist. His condition progressed to include weakness and paresthesias of the upper extremities and impaired activities of daily living. Diagnostic testing showed elevated CRP (7.59) and ESR, and EMG/NCV were abnormal in upper and lower extremities. Ct of the C-spine/head and foot x-ray were within normal limits. Genetic testing revealed an abnormality (gene mutation identification test positive). In June 2008 he underwent treatment with intravenous immunoglobulins, and had some improvement. He was medically separated from his occupation, and required a brace on the right foot in order to walk. Final diagnosis as of 07 July 2008 was demyelinating polyneuritis, chronic inflammatory (active). Information received from CDC stated that the patient was diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP). Outcome was not provided. Documents held by sender: None