chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Hypersensitivity, Pain, Palpitations, Sensation of pressure, 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.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Asthenia, Nausea, Syncope, Vomiting
Clinical narrative: Pre-syncope Weakness Vomiting Nausea Post licensure safety surveillance study of routine use of meningococcal (Groups A, C, Y and W-135) toxoid conjugate vaccine (Menactra), trail code MTA30. Initial report received on 20/Mar/2006 from an investigator participating in the above mentioned trail in the USA under the reference number MTA30. An 18 year old female subject developed nausea nd vomiting on the same day she had received a first dose of Menactra. The lot number was not reported. The event was considered to be non-serious. No treatment or recovery status information was provided. Follow-up information received on 29/Mar/2006. An 18 year old female patient who was taking Prozac at the time of the vaccination and had no known drug allergies had received her first 0.5ml intra-muscular injection of Menactra. Manufacturer sanofi Pasteur, inc. lot number U1525AB, in the right arm and her first intra-muscular injection of another manufacture's Hepatis A vaccine lot number 0202A in the left arm on 27/Jul/2005 at approximately 12:00. 150 minutes later, she had a near syncopal episode with weakness nausea and vomited xl. She presented to the emergency facility and her vital signs were T 98.2, P 42, R 16 and B/P 92/25. Her standing B/P was 107/55 and her Pulse was 80. Her cardiac physical/neurological exam was normal. Her speech was clear and she ambulated with a steady gait. Her lungs were clear to auscultation and she had no shortness of breath or difficulty swallowing. She was treated with fluids by mouth and released. Her final diagnosis was immunization reaction. It was not reported if the patient had fully recovered from these events at the time of this report According to the investigator the event was related to the study vaccine
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Asthenia, Hypersensitivity, Nausea, Syncope, Vomiting
Clinical narrative: Pre-syncope Weakness Vomiting Nausea Post licensure safety surveillance study of routine use of meningococcal (Groups A, C, Y and W-135) toxoid conjugate vaccine (Menactra), trail code MTA30. Initial report received on 20/Mar/2006 from an investigator participating in the above mentioned trail in the USA under the reference number MTA30. An 18 year old female subject developed nausea nd vomiting on the same day she had received a first dose of Menactra. The lot number was not reported. The event was considered to be non-serious. No treatment or recovery status information was provided. Follow-up information received on 29/Mar/2006. An 18 year old female patient who was taking Prozac at the time of the vaccination and had no known drug allergies had received her first 0.5ml intra-muscular injection of Menactra. Manufacturer sanofi Pasteur, inc. lot number U1525AB, in the right arm and her first intra-muscular injection of another manufacture's Hepatis A vaccine lot number 0202A in the left arm on 27/Jul/2005 at approximately 12:00. 150 minutes later, she had a near syncopal episode with weakness nausea and vomited xl. She presented to the emergency facility and her vital signs were T 98.2, P 42, R 16 and B/P 92/25. Her standing B/P was 107/55 and her Pulse was 80. Her cardiac physical/neurological exam was normal. Her speech was clear and she ambulated with a steady gait. Her lungs were clear to auscultation and she had no shortness of breath or difficulty swallowing. She was treated with fluids by mouth and released. Her final diagnosis was immunization reaction. It was not reported if the patient had fully recovered from these events at the time of this report According to the investigator the event was related to the study vaccine
Age: 12.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Joint range of motion decreased, Lymphadenopathy, Pain, Rash
Clinical narrative: Seriousness criteria: Other Medically Significant (OMIC). Initial report received from a healthcare provider on 5/24/06. An 11 year old male pt, with no past medical history, had received a left deltoid injection of Decavac, lot number U1587CA, on 5/12/06. Four hours later, the pt developed a generalized rash (no hives) and entire left arm pain. He was examined during an office visit, two days post/vax, and was administered Benadryl and Depo-Medrol. The symptoms resolved after six days. At the time of this report, the pt had recovered.
Age: 12.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Pain, Rash
Clinical narrative: Seriousness criteria: Other Medically Significant (OMIC). Initial report received from a healthcare provider on 5/24/06. An 11 year old male pt, with no past medical history, had received a left deltoid injection of Decavac, lot number U1587CA, on 5/12/06. Four hours later, the pt developed a generalized rash (no hives) and entire left arm pain. He was examined during an office visit, two days post/vax, and was administered Benadryl and Depo-Medrol. The symptoms resolved after six days. At the time of this report, the pt had recovered.
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Pain, Paraesthesia, Throat tightness
Clinical narrative: Initial report (VAERS #256342) was received on 05/30/2006. A 16-year-old male patient, with a medical history of asthma and environmental allergies, had received an injection of Menactra, lot number U1946AA, on 03/24/2006. Thirteen days later, the patient experienced "Tingling, numbness in hands, feet". Recovery status was not reported. Additional details were not provided. Follow-up information received 15 June 2006 indicates a diagnosis of Guillain Barre Syndrome.
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Initial report (VAERS #256342) was received on 05/30/2006. A 16-year-old male patient, with a medical history of asthma and environmental allergies, had received an injection of Menactra, lot number U1946AA, on 03/24/2006. Thirteen days later, the patient experienced "Tingling, numbness in hands, feet". Recovery status was not reported. Additional details were not provided. Follow-up information received 15 June 2006 indicates a diagnosis of Guillain Barre Syndrome.
Age: 17.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Abnormal behaviour, Aggression, Agitation, Crying, Hypoaesthesia
Clinical narrative: Tingling of extremity Aggressive behavior Initial report received from the Centers for Disease Control and Prevention, VAERS report #256343, on 30/May/2006. A 17 year old male patient had received an injection of Menactra, lot number U1783AA, on 08/May/2006. One day later, he experienced aggressive behavior and tingling in his upper and lower extremities. Recover status was not reported. Additional information was not provided.
Age: 17.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Meningitis, Paraesthesia
Clinical narrative: Tingling of extremity Aggressive behavior Initial report received from the Centers for Disease Control and Prevention, VAERS report #256343, on 30/May/2006. A 17 year old male patient had received an injection of Menactra, lot number U1783AA, on 08/May/2006. One day later, he experienced aggressive behavior and tingling in his upper and lower extremities. Recover status was not reported. Additional information was not provided.
Age: 17.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Abnormal behaviour, Paraesthesia
Clinical narrative: Tingling of extremity Aggressive behavior Initial report received from the Centers for Disease Control and Prevention, VAERS report #256343, on 30/May/2006. A 17 year old male patient had received an injection of Menactra, lot number U1783AA, on 08/May/2006. One day later, he experienced aggressive behavior and tingling in his upper and lower extremities. Recover status was not reported. Additional information was not provided.
Age: 17.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Abnormal behaviour, Amnesia, Crying, Headache, Hypoaesthesia
Clinical narrative: Tingling of extremity Aggressive behavior Initial report received from the Centers for Disease Control and Prevention, VAERS report #256343, on 30/May/2006. A 17 year old male patient had received an injection of Menactra, lot number U1783AA, on 08/May/2006. One day later, he experienced aggressive behavior and tingling in his upper and lower extremities. Recover status was not reported. Additional information was not provided.
Age: 17.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Myalgia, Neck pain, Paraesthesia
Clinical narrative: Tingling of extremity Aggressive behavior Initial report received from the Centers for Disease Control and Prevention, VAERS report #256343, on 30/May/2006. A 17 year old male patient had received an injection of Menactra, lot number U1783AA, on 08/May/2006. One day later, he experienced aggressive behavior and tingling in his upper and lower extremities. Recover status was not reported. Additional information was not provided.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site warmth, Swelling
Clinical narrative: Left thigh swollen, warm to touch; on 6/2/06. Rx Benadryl 12-5/5 1/2 tsp PO TID.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site warmth, Swelling
Clinical narrative: Right deltoid swollen, warm to touch about 1" in diameter. Rx Benadryl.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Skin ulcer
Clinical narrative: Within 24 hours, 1cm red induration lesion at injection site with 2 other lesions on same arm. One 4cm; the other 1cm. All in deltoid region.
Age: 38.0
Sex: F
Vaccine: HEPAB, IPV, TYP, YF
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: On 5/4/06, awoke w/hives. Seen in ER, dx'd as reaction to pollens and given CLARITIN. Today, 5/5/06, is itching but no visible hives. Due for second dose today. Discussed situation w/epidemiology then CDC. CDC recommended continuing series because of high risk work in a foreign country. Client agrees. No reactions following 2nd and 3rd doses.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Anaphylactic reaction, Pneumonia, Rash, Urticaria
Clinical narrative: Initial report received from a healthcare provider on 5/24/2006. A 25 year old female patient, with no past medical history, had received an injection for Decavac, lot number U1587CA, on 4/10/2006. Six hours post immunization, the patient developed a generalized rash with hives. She was examined in an ER and admitted to the hospital for six days for anaphylaxis. The patient was treated with epinephrine. The hives persisted for approximately one week. During an office visit seven days post immunization, she was given Depo Medrol. Nine days post immunization, she was re examined in the office and diagnosed with pneumonia. This resolved on 5/2/2006, 13 days following that office visit. At the time of this report, the patient had recovered. The reporter in this case is the same as for case 200601265.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Injection site rash, Injection site swelling, Rash maculo-papular, Rash pruritic
Clinical narrative: Information has been received from a registered nurse concerning a 38 year old female with no allergies or medical history who on 5/19/2006 was vaccinated SC with a dose of varicella virus vaccine live. There was no concomitant medication. Six to seven days after vaccination, on approximately 5/25/2006, the patient broke out in a rash at the sit of injection under the right arm. This one rash was the size of a fifty cent piece with five raised areas. The rash got bigger to the size of a silver dollar with a tail. The rash was more of an oblong shape that looked lumpy. It was noted to be more of a vesicular rash and there were approximately seven raised areas that were itchy and looked like hives. The patient was treated wit diphenhydramine hydrochloride Benadryl. The rash was reported to be better and about the size of a quarter with a bruised color and purple color and the lesion amounts were less. At the time of the report, the patient was recovering. no diagnostic laboratory tests were performed. A product quality complaint was not involved. The patients experience was considered to be an other important medical event by the reporter (OMIC). Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin discolouration, Skin ulcer, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 38 year old female with no allergies or medical history who on 5/19/2006 was vaccinated SC with a dose of varicella virus vaccine live. There was no concomitant medication. Six to seven days after vaccination, on approximately 5/25/2006, the patient broke out in a rash at the sit of injection under the right arm. This one rash was the size of a fifty cent piece with five raised areas. The rash got bigger to the size of a silver dollar with a tail. The rash was more of an oblong shape that looked lumpy. It was noted to be more of a vesicular rash and there were approximately seven raised areas that were itchy and looked like hives. The patient was treated wit diphenhydramine hydrochloride Benadryl. The rash was reported to be better and about the size of a quarter with a bruised color and purple color and the lesion amounts were less. At the time of the report, the patient was recovering. no diagnostic laboratory tests were performed. A product quality complaint was not involved. The patients experience was considered to be an other important medical event by the reporter (OMIC). Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Acne, Agitation, Alopecia, Amblyopia, Angina pectoris
Clinical narrative: Skin neoplasm carcinoma melanoma.
Age: 55.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Anxiety, Arrhythmia, Arthralgia, Asthenia, Balance disorder
Clinical narrative: Skin neoplasm carcinoma melanoma.
Age: 55.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Chest pain, Confusional state, Coordination abnormal, Depression, Disturbance in attention
Clinical narrative: Skin neoplasm carcinoma melanoma.
Age: 55.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Dizziness, Dry mouth, Dyspepsia, Dyspnoea, Eczema
Clinical narrative: Skin neoplasm carcinoma melanoma.
Age: 55.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Erectile dysfunction, Eye disorder, Face oedema, Fatigue, Gastrointestinal perforation
Clinical narrative: Skin neoplasm carcinoma melanoma.
Age: 55.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Headache, Hypertension, Hypoaesthesia, Influenza, Insomnia
Clinical narrative: Skin neoplasm carcinoma melanoma.
Age: 55.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Malignant melanoma, Memory impairment, Mental impairment, Migraine, Muscle spasms
Clinical narrative: Skin neoplasm carcinoma melanoma.
Age: 55.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Myocarditis, Neoplasm skin, Nuchal rigidity, Nuclear magnetic resonance imaging brain abnormal, Pain
Clinical narrative: Skin neoplasm carcinoma melanoma.
Age: 55.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Palpitations, Paraesthesia, Pharyngitis, Photophobia, Pruritus
Clinical narrative: Skin neoplasm carcinoma melanoma.
Age: 55.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Renal failure, Respiratory disorder, Rhinitis, Rhinorrhoea, Sinusitis
Clinical narrative: Skin neoplasm carcinoma melanoma.
Age: 55.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Skin cancer, Skin discolouration, Skin exfoliation, Sleep disorder, Sluggishness
Clinical narrative: Skin neoplasm carcinoma melanoma.
Age: 55.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Sneezing, Speech disorder, Tinnitus, Tremor
Clinical narrative: Skin neoplasm carcinoma melanoma.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Syncope
Clinical narrative: Fainted X 3 lasting about 5 min total. Bilateral extremity weakness. Pt is being monitored by PA by phone.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mom phoned office 6/6/06 to report swollen, red, hot deltoid at injection site. Went to prompt care and was dx'd with cellulitis. Treated with warm compresses and Keflex. Comments from ER: Pt had vaccines 4 days ago to R arm. Now red, swollen and painful.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Child became faint upon rising from the chair after the injection. Helped to the floor. Her feet were elevated and she transitioned to a sitting then standing position. Walked on her own independently from the clinic.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC
Symptoms: Hypotonia, Pyrexia
Clinical narrative: Started with fever, 9 days after shot then next day about 4PM started with being very limp, would not wake up to stimulation. both sites. /// went to ER X2. Gave IV, antibiotic, blood work and a spinal tap. Got much better approx. 24 hours after start of symptoms.
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Pyrexia
Clinical narrative: Fever 104 (ax) in afternoon after AM vaccination. (Temp was 99.1 (ax) before shot at home and 97.1 in office.)
Age: 1.57
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site mass
Clinical narrative: 5cmx5cm firm mass on right anterior thigh.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Left arm red, muscle pain and swelling at injection site. Treatment: observe site.
Age: 1.03
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Feeling hot, Rash, Skin ulcer
Clinical narrative: Received MMR, Varicella, and PedvaxHIB on 4/25/06. TC from mom reports rash x1 week. Feels warm, teething also, eating, and sleeping normal - normal activities. Note 4 pox - forehead, right chin, mid back, and left upper buttock. All intact.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Impaired healing, Pyrexia
Clinical narrative: On 5/4/06, received call from audiologist. Reports significant hearing loss, sudden onset noticed last 6 months; no conductive. Questions relation to MMR vaccine. #1 admission 5/96 after reports of adverse effects. #2 admission 8/99 (8/4/99) after call on 8/17/99 from mom reporting high fever - not seen by medical provider.
Age: 54.0
Sex: F
Vaccine: MEN
Symptoms: Hot flush
Clinical narrative: Feeling flushed but no fever, headache, pressure/aching of eyes, nausea. Symptoms not relieved with aspirin or Benadryl.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site warmth, Pain, Swelling
Clinical narrative: Right arm swollen, warm to touch, painful from top of shoulder to mid-deltoid, started May 10/06 AM, day after vaccine given.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Lethargy, Vomiting
Clinical narrative: Lethargy, with frequent awakenings to initial state. Emesis 1 time; no sepsis.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction, Injection site swelling, Pyrexia, Rash
Clinical narrative: Mom reported that on Sat. 4/22 at 09:15 AM, her daughter awoke with a very swollen Lt leg. Mom said leg appeared to be twice normal size with swelling and a red rash from her hip down to the knee. Her temp. was 99-99.8. Parents called their Pediatrician and was instructed to take her to the ER. They went to ER and mom says they were told it was an allergic reaction and to use ice and Tylenol to treat. Mom said the leg is improving and swelling is down.
Age: 15.0
Sex: F
Vaccine: TTOX
Symptoms: Swelling face
Clinical narrative: C/o swelling of face. Seen in ER, given Benadryl, returned to school.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Vomiting
Clinical narrative: 2 hrs after vaccines given, mother reports R arm turned red from shoulder to elbow and swollen. Child c/o itching. Mom gave Benadryl and Tylenol. Child then threw up.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Pyrexia
Clinical narrative: Mom reports infant has been crying since Tuesday evening (06/06/06) after having received shots on Tuesday morning (6/6/06). Mom reports fever of 102 degrees at 7 PM Tuesday evening and treated fever with infant Tylenol every 5 hours for past 2 days and continues to cry now.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Hyperhidrosis
Clinical narrative: She became ill, feeling dizzy, nauseated, has shortness of breath, fatigue, fever, chills and sweating. She fainted within a couple of minutes of the onset.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Pyrexia, Syncope
Clinical narrative: She became ill, feeling dizzy, nauseated, has shortness of breath, fatigue, fever, chills and sweating. She fainted within a couple of minutes of the onset.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Fatigue, Lymphadenopathy, Myalgia, Oedema peripheral
Clinical narrative: MMR given on 5/23/06. On 6/2/06 started with sore muscles, blurry vision, sore joints, upset stomach. On 6/3/06, fatigue, fever. On 6/4/06, bumps on face, spreading to ears on side mouth, neck, chest, arms, stomach, legs. Swelling of face and feet, entire body swollen. MD evaluation on 6/5/06, erythematous, macular-papular pruritic rash, inguinal lymphadenopathy and posterior lymphadenopathy, bilaterally (neck).
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash maculo-papular, Stomach discomfort, Swelling face, Vision blurred
Clinical narrative: MMR given on 5/23/06. On 6/2/06 started with sore muscles, blurry vision, sore joints, upset stomach. On 6/3/06, fatigue, fever. On 6/4/06, bumps on face, spreading to ears on side mouth, neck, chest, arms, stomach, legs. Swelling of face and feet, entire body swollen. MD evaluation on 6/5/06, erythematous, macular-papular pruritic rash, inguinal lymphadenopathy and posterior lymphadenopathy, bilaterally (neck).
Sex: U
Vaccine: DTAP
Symptoms: Injection site mass
Clinical narrative: Patient had bump on left leg where shot was given.
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Derealisation, Hypoaesthesia, Pyrexia
Clinical narrative: Pt called 6/2/06 stating had fever (slight) and felt "weird". Denied other problems. Instructed to continue Tylenol every 4-6 hrs as fever is not uncommon. Pt called again 6/5/06 stating that on 6/3/06, she woke up and R arm and side were numb. Went to urgent care that morning. Urgent care said reaction unrelated to vaccine and follow-up with private MD if symptoms continue.
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Contusion, Feeling abnormal, Hypoaesthesia, Muscular weakness, Neck pain
Clinical narrative: Pt called 6/2/06 stating had fever (slight) and felt "weird". Denied other problems. Instructed to continue Tylenol every 4-6 hrs as fever is not uncommon. Pt called again 6/5/06 stating that on 6/3/06, she woke up and R arm and side were numb. Went to urgent care that morning. Urgent care said reaction unrelated to vaccine and follow-up with private MD if symptoms continue.
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pain, Pyrexia, Tenderness
Clinical narrative: Pt called 6/2/06 stating had fever (slight) and felt "weird". Denied other problems. Instructed to continue Tylenol every 4-6 hrs as fever is not uncommon. Pt called again 6/5/06 stating that on 6/3/06, she woke up and R arm and side were numb. Went to urgent care that morning. Urgent care said reaction unrelated to vaccine and follow-up with private MD if symptoms continue.
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Derealisation, Hypoaesthesia, Pyrexia
Clinical narrative: Patient called on 6/2/06 stating had fever ("slight") and felt "weird".  Denied other problems.  Instructed to continue Tylenol every 4-6 hours as fever is not uncommon.  Patient called again on 6/5/06 stating that on 6/3/06 she woke up and right arm and side were numb.  Stated that she went to clinic that morning (6/3/06).  Clinic determined that reaction unrelated to vaccine and to follow-up with private MD if symptoms continue.
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Contusion, Feeling abnormal, Hypoaesthesia, Muscular weakness, Neck pain
Clinical narrative: Patient called on 6/2/06 stating had fever ("slight") and felt "weird".  Denied other problems.  Instructed to continue Tylenol every 4-6 hours as fever is not uncommon.  Patient called again on 6/5/06 stating that on 6/3/06 she woke up and right arm and side were numb.  Stated that she went to clinic that morning (6/3/06).  Clinic determined that reaction unrelated to vaccine and to follow-up with private MD if symptoms continue.
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pain, Pyrexia, Tenderness
Clinical narrative: Patient called on 6/2/06 stating had fever ("slight") and felt "weird".  Denied other problems.  Instructed to continue Tylenol every 4-6 hours as fever is not uncommon.  Patient called again on 6/5/06 stating that on 6/3/06 she woke up and right arm and side were numb.  Stated that she went to clinic that morning (6/3/06).  Clinic determined that reaction unrelated to vaccine and to follow-up with private MD if symptoms continue.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Cellulitis developed with red, hot and firm areas at and adjacent to injection site. Started on antibiotic, antihistamine, anti-inflammatory and ice packs. Upper left arm 3" X 6" into axilla.
Age: 1.0
Sex: F
Vaccine: HBHEPB, HEPA, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: On 4/15/06 Present in office 4/15/06 with local vaccine reaction. Top of left leg was red and indurated. Comvax and MMRV had both been injected in left leg on 4/3/06.
Age: 24.0
Sex: F
Vaccine: JEV, TYP
Symptoms: Nasal oedema, Rash erythematous
Clinical narrative: 5/5/06-Called felt like a reaction to vaccine, noticed Friday "felt swelling of R nostril. Saturday visibly swelling R nostril slight swelling, nostril not closed. 6/7/06-Talked with client, said swelling  R nostril resolved by 6/6/06. Client talked with doctor on Saturday, 6/3/06 re: swelling nostril. Doctor instructed client to apply ice pack to R nostril and take Benadryl as directed. 6/7/06-Client stated noted rash chest. By 6/6/06 PM covering small area only, several pink, raised areas noted Jap. Enc. vaccine. Held to talk doctor on Monday 6/12/06.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site swelling
Clinical narrative: Approx. 5mm palpable, non-tender area of swelling at injection site. No treatment required, resolved spontaneously. Appeared at site of DTAP injection.
Age: 1.41
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Scattered papules in various stages: crusted with some vesicles. Vesicles on soles of feet.
Age: 1.16
Sex: M
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Irritability, Lymphadenopathy, Nasal congestion, Parotid gland enlargement
Clinical narrative: Lymphadenopathy vs swollen parotid glands, fever, congestion, fussy, breathing heavy. To MD for evaluation on 6/5/06. Possible SE of MMR.
Age: 1.16
Sex: M
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Lymphadenopathy vs swollen parotid glands, fever, congestion, fussy, breathing heavy. To MD for evaluation on 6/5/06. Possible SE of MMR.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Approximately 36 hours after receiving pneumococcal vaccine patient developed edema, redness, and pain to left upper arm in deltoid region. Arm x-rayed; no fracture found.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site discolouration, Injection site induration
Clinical narrative: Blanching rash Rt leg, area hard to touch about 1" long X 13" width. Tx: Augmentin 600mg bid; Benadryl Cream bid, Benadryl 1 tsp qid. Seen by MD.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Pain
Clinical narrative: 24 hours after vaccine, slight erythema. At 144 hours, 2" induration with erythema, pain.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and slight swelling on right deltoid. Started on 6/2/06. No pain. Rx Benadryl syrup and Ibuprofen. Watch for tenderness and return if pain appears.
Age: 1.66
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: 6/3/06 at 20:39, pt presented to ER for rash. Dx'd varicella. Temp. 37.4C. D/C to home with Benadryl and Calamine lotion.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received DTAP in left thigh and area red and warm to touch, swollen at site tender to touch 9cm X 5.5cm redness and swelling to top of left thigh.
Age: 1.61
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Multiple papules on an erythematous base at various stages.
Age: 22.0
Sex: F
Vaccine: DT, HEPA, TYP, YF
Symptoms: Thrombocytopenia
Clinical narrative: Patient had Typhim Vi, Tetanus diptheria, and yellow fever on 5/18/06, no immediate issue.  Patient admitted to Hospital ICU with severe thrombocytopenia (possible ITP) during June(in hospital 6/8/06) unsure of admit dates etc...
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Rash
Clinical narrative: Awoke on Sat June 10, 2006 with rash and itching generalized over entire body. Mother instructed child to take Benadryl (OCT). Rash and itching were gone by Sunday June 11, AM.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pruritus, Pyrexia, Rash, Viral infection
Clinical narrative: Client received varicella vaccine 5/23/06. 6/5/06 woke up with fever. 6/6/06 blisters noted on face with itching, eventually spreading all over body. Seen by Dr. 6/8/06 and Dx. with chickenpox disease.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Alopecia, Rash
Clinical narrative: Per parent history: pt developed acute onset hair loss from scalp and rash to arms after receipt of vaccinations.  On exam three days later (performed by associate of PCP): pt had significant absence of hair with underlying smooth scalp to frontal aspect of scalp; dry patches noted to bilateral arms; remainder of exam was withing normal limits. Observation recommender with follow-up exam by PCP in four days.
Age: 14.0
Sex: M
Vaccine: HEP, TDAP, VARCEL
Symptoms: Blister, Rash, Viral infection
Clinical narrative: Child reported to mother blisters on body 6/2/06. Mother took child to the emergency room where he was Dx with chickenpox disease. No fever.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dysphagia, Headache, Injection site erythema, Neck pain
Clinical narrative: The vaccine (brand name Adacel) was admistered at 8:30 on Friday June 9th. I felt arm pain throughout the day, but have experienced that in the past and felt that was normal. I could not fall asleep on Friday night. I had severe chills, a fever, heart palpitations and pain throughout my entire body including my neck and terrible headache. On Saturday morning my pain had escalated and I could barely complete normal tasks. I was exhausted after minimal exertion such as walking to my car. On a scale of 1 - 10, my pain was an 8. I took ibuprofen and spent the day in bed. My  injection site was swollen, but not red. In the afternoon I felt a  little better, but as I started doing things, the symptoms came back. Again I have a low grade fever, chills and was very pale. I was lightheaded and still had the same terribel headache. My throat was swollen and it hurt to swallow, but did not cause wheezing. This persisted through the day. On Sunday I felt less pain throighout my entire body, but the neck pain and severe headache still were present. My arm was less painful and I was able to move it to 90 degrees. Again I took ibuprofen. On Monday the same symptoms existed, again less severe, except for the headache and neck pain. Again I took ibuprofen and slept a lot.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Palpitations, Pharyngeal oedema, Pyrexia
Clinical narrative: The vaccine (brand name Adacel) was admistered at 8:30 on Friday June 9th. I felt arm pain throughout the day, but have experienced that in the past and felt that was normal. I could not fall asleep on Friday night. I had severe chills, a fever, heart palpitations and pain throughout my entire body including my neck and terrible headache. On Saturday morning my pain had escalated and I could barely complete normal tasks. I was exhausted after minimal exertion such as walking to my car. On a scale of 1 - 10, my pain was an 8. I took ibuprofen and spent the day in bed. My  injection site was swollen, but not red. In the afternoon I felt a  little better, but as I started doing things, the symptoms came back. Again I have a low grade fever, chills and was very pale. I was lightheaded and still had the same terribel headache. My throat was swollen and it hurt to swallow, but did not cause wheezing. This persisted through the day. On Sunday I felt less pain throighout my entire body, but the neck pain and severe headache still were present. My arm was less painful and I was able to move it to 90 degrees. Again I took ibuprofen. On Monday the same symptoms existed, again less severe, except for the headache and neck pain. Again I took ibuprofen and slept a lot.
Age: 18.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Apnoea, Arrhythmia, Blood pressure increased, Convulsion, Dizziness
Clinical narrative: Immediately after administering HBV and Menactra patient said he was getting dizzy. Pt. placed himself on the floor and I gave him Spirits of Ammonia to smell. He then thought he was going to vomit so placed him upright with his head forward into waste receptacle. He fainted and then had a seizure with his eyes dilated , tongue twisted, clonic contractions of his arms and then tremors of his arms. He had apnea and heart rate was slow. Color was extremely pale. This lasted about a minute. Pt. had no history of seizures prior to this although had fainted several times before. When sizure was over he quickly became aware of his surroundings and vital signs showed BP 160/80 and AP 60®ular O2 was administer Blood sugar was 70. Paramedics were called and pt. was transported to hospital. Mother was called and she said she had had the same reaction to a Mantoux test several years ago and no reason for the seizure was found except for fear of shots. Blood work at the hospital as normal and he was released home with instructions to follow-up with his family physician
Age: 18.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Dyskinesia, Mydriasis, Nausea, Pallor, Syncope
Clinical narrative: Immediately after administering HBV and Menactra patient said he was getting dizzy. Pt. placed himself on the floor and I gave him Spirits of Ammonia to smell. He then thought he was going to vomit so placed him upright with his head forward into waste receptacle. He fainted and then had a seizure with his eyes dilated , tongue twisted, clonic contractions of his arms and then tremors of his arms. He had apnea and heart rate was slow. Color was extremely pale. This lasted about a minute. Pt. had no history of seizures prior to this although had fainted several times before. When sizure was over he quickly became aware of his surroundings and vital signs showed BP 160/80 and AP 60®ular O2 was administer Blood sugar was 70. Paramedics were called and pt. was transported to hospital. Mother was called and she said she had had the same reaction to a Mantoux test several years ago and no reason for the seizure was found except for fear of shots. Blood work at the hospital as normal and he was released home with instructions to follow-up with his family physician
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Petechiae, Rash
Clinical narrative: Child developed rash on 6/9/2006 inwhich parent called Health Department. No fever, aches, swelling at injection site. Parent described rash as petechiae with no itching or problems breathing. Stated son had been sleeping on couch for the past 4 nights and that was the only change in habits from time of vaccination to time of onset of rash. Called back on 6.12 and rash had resolved with no further sequelae.
Age: 31.0
Sex: M
Vaccine: ANTH, ANTH, MEN, ANTH
Symptoms: Thyroid function test abnormal, Tremor
Clinical narrative: I was given three Anthrax shots between March 03 and July 03. I did report a headache at the time, but was told that was in relation to a neck injury. When I came home in August, I still had headaches, and my body began to hurt all over, I could not sleep and as of today, still have problems. My short term memory was affected, and at times, I would get brain fog. As the months passed, I began to get worse. I finally saw a pain doctor who told me I had chronic fatigue. He gave me medications, but they didnt seem to help. Over the next few months, I saw other doctors who told me it was in my head, or that I had fibrolyalgia. I also developed tremors where my hands and legs shake. Finally, I had enough. I felt like I had been hit by a truck and dragged 100 miles. I felt like I had the flu constantly. It was hard for me to walk because of the pain, or at times, even get out of bed. I went to see another doctor. She did blood work on me, and found that at least 10 of my bodily functions were malfunctioning. My thyroid, insulin, testosterone and 7 more. I have to get infusions now, and also testosterone shots. I take oxcontin for the pain, requip now because I have this creppy crawling feeling on my legs at night and sometimes goes up my body. I take Xyrem to help me sleep. I take other meds alos and supplements. I am no longer able to work. She diagnosed me with Fibromyalgia and told me that the Anthrax shot did this to me. There is no other explanation. She said she had worked at the VA, and this was common to the anthrax vaccine. My life is hell now. Always feeling like I have the flu and everything else going wrong with me. Im 35, this shouldnt be happening. I do have blood reports to prove this and a doctor attesting to this. 07/03/06-36 pages of records received from patient. Anthrax vaccine received 03/38/03. On 06/17/03 patient submitted a formal statement to the U.S. Army stating that on 04/02/03 "while doing P.T. sit ups he felt neck pop/crack and immediately became in pain". Trouble sleeping unable to turn head to left at time with arm soreness upon awakening.  Also indicated he had been advised he will be send back for a medical board and discharge. Notes also include H&P dated 06/03/04 indicate original injury in Fall of 2002 with "crunch" base of skull and left arm lasting 304 months. Pain in knees, elbows, buttocks, hips, hands, low back, neck. Oxycodone did not help.  Past surgeries include ortho on L knee and R elbow in 1990.  DX of cervical neck pain, insomnia, fatigue and anxiety. RX with Klonipin, Paxil and Ambien. Physical therapy treatments in 6/04. Per annual follow up no further information is available.  Follow-up: Emergent BioSolutions has no further information on this report. In the event that additional relevant medical information is received, a follow up report will be submitted. 60 day Follow-up Information 06-NOV-2006: Anxiety, mood swings, low killer cells, low testosterone, pituatary, insulin resistence, Epstein Barr virus, headaches, fatigue, fibromyalgia, chronic fatigue, seiazures, hypothroidsin
Age: 31.0
Sex: M
Vaccine: ANTH, ANTH, MEN, ANTH
Symptoms: Restless legs syndrome, Sleep disorder
Clinical narrative: I was given three Anthrax shots between March 03 and July 03. I did report a headache at the time, but was told that was in relation to a neck injury. When I came home in August, I still had headaches, and my body began to hurt all over, I could not sleep and as of today, still have problems. My short term memory was affected, and at times, I would get brain fog. As the months passed, I began to get worse. I finally saw a pain doctor who told me I had chronic fatigue. He gave me medications, but they didnt seem to help. Over the next few months, I saw other doctors who told me it was in my head, or that I had fibrolyalgia. I also developed tremors where my hands and legs shake. Finally, I had enough. I felt like I had been hit by a truck and dragged 100 miles. I felt like I had the flu constantly. It was hard for me to walk because of the pain, or at times, even get out of bed. I went to see another doctor. She did blood work on me, and found that at least 10 of my bodily functions were malfunctioning. My thyroid, insulin, testosterone and 7 more. I have to get infusions now, and also testosterone shots. I take oxcontin for the pain, requip now because I have this creppy crawling feeling on my legs at night and sometimes goes up my body. I take Xyrem to help me sleep. I take other meds alos and supplements. I am no longer able to work. She diagnosed me with Fibromyalgia and told me that the Anthrax shot did this to me. There is no other explanation. She said she had worked at the VA, and this was common to the anthrax vaccine. My life is hell now. Always feeling like I have the flu and everything else going wrong with me. Im 35, this shouldnt be happening. I do have blood reports to prove this and a doctor attesting to this. 07/03/06-36 pages of records received from patient. Anthrax vaccine received 03/38/03. On 06/17/03 patient submitted a formal statement to the U.S. Army stating that on 04/02/03 "while doing P.T. sit ups he felt neck pop/crack and immediately became in pain". Trouble sleeping unable to turn head to left at time with arm soreness upon awakening.  Also indicated he had been advised he will be send back for a medical board and discharge. Notes also include H&P dated 06/03/04 indicate original injury in Fall of 2002 with "crunch" base of skull and left arm lasting 304 months. Pain in knees, elbows, buttocks, hips, hands, low back, neck. Oxycodone did not help.  Past surgeries include ortho on L knee and R elbow in 1990.  DX of cervical neck pain, insomnia, fatigue and anxiety. RX with Klonipin, Paxil and Ambien. Physical therapy treatments in 6/04. Per annual follow up no further information is available.  Follow-up: Emergent BioSolutions has no further information on this report. In the event that additional relevant medical information is received, a follow up report will be submitted. 60 day Follow-up Information 06-NOV-2006: Anxiety, mood swings, low killer cells, low testosterone, pituatary, insulin resistence, Epstein Barr virus, headaches, fatigue, fibromyalgia, chronic fatigue, seiazures, hypothroidsin
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Chest pain, Dyspnoea
Clinical narrative: Pt presented in 24 hrs with chest pain, sob, arthralgias generalized weakness, and photophobia. 6/6 @3 - Difficulty breathing, sore, weak in arms. 6/7 @AM - Difficulty moving arms. @PM - Trouble walking. 6/8 - Could barely move, arranged for emergency treatment at hospital. @ PM - Admitted --> 6/18. 60 day Follow-up Information 24-AUG-2006: Receiving physical therapy for residual muscle weakness; dad reports 75% recovery.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Dyspnoea, Gait disturbance, Hypokinesia, Muscular weakness, Pain
Clinical narrative: Pt presented in 24 hrs with chest pain, sob, arthralgias generalized weakness, and photophobia. 6/6 @3 - Difficulty breathing, sore, weak in arms. 6/7 @AM - Difficulty moving arms. @PM - Trouble walking. 6/8 - Could barely move, arranged for emergency treatment at hospital. @ PM - Admitted --> 6/18. 60 day Follow-up Information 24-AUG-2006: Receiving physical therapy for residual muscle weakness; dad reports 75% recovery.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Photophobia
Clinical narrative: Pt presented in 24 hrs with chest pain, sob, arthralgias generalized weakness, and photophobia. 6/6 @3 - Difficulty breathing, sore, weak in arms. 6/7 @AM - Difficulty moving arms. @PM - Trouble walking. 6/8 - Could barely move, arranged for emergency treatment at hospital. @ PM - Admitted --> 6/18. 60 day Follow-up Information 24-AUG-2006: Receiving physical therapy for residual muscle weakness; dad reports 75% recovery.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Arthralgia, Back pain, Gait disturbance, Hypokinesia, Lethargy
Clinical narrative: Pt presented in 24 hrs with chest pain, sob, arthralgias generalized weakness, and photophobia. 6/6 @3 - Difficulty breathing, sore, weak in arms. 6/7 @AM - Difficulty moving arms. @PM - Trouble walking. 6/8 - Could barely move, arranged for emergency treatment at hospital. @ PM - Admitted --> 6/18. 60 day Follow-up Information 24-AUG-2006: Receiving physical therapy for residual muscle weakness; dad reports 75% recovery.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Chest pain, Dyspnoea
Clinical narrative: In less than 24 hrs pt was lethargic and had pain on joints. Taken to the doctor who prescribed Motrin. On Thursday was barely able to lift legs and admitted to Intensive Care at Hospital. Pt was released from hospital on Saturday and continued to take Motrin for pain. Readmitted to hospital on Monday. Currently is barely able to move, can't lift legs, has back pain. Pt is a football player. Doctors at hospital have not given a diagnosis yet, but confident that vax caused problems. For more details you may contact parents via cell phone.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Dyspnoea, Gait disturbance, Hypokinesia, Muscular weakness, Pain
Clinical narrative: In less than 24 hrs pt was lethargic and had pain on joints. Taken to the doctor who prescribed Motrin. On Thursday was barely able to lift legs and admitted to Intensive Care at Hospital. Pt was released from hospital on Saturday and continued to take Motrin for pain. Readmitted to hospital on Monday. Currently is barely able to move, can't lift legs, has back pain. Pt is a football player. Doctors at hospital have not given a diagnosis yet, but confident that vax caused problems. For more details you may contact parents via cell phone.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Photophobia
Clinical narrative: In less than 24 hrs pt was lethargic and had pain on joints. Taken to the doctor who prescribed Motrin. On Thursday was barely able to lift legs and admitted to Intensive Care at Hospital. Pt was released from hospital on Saturday and continued to take Motrin for pain. Readmitted to hospital on Monday. Currently is barely able to move, can't lift legs, has back pain. Pt is a football player. Doctors at hospital have not given a diagnosis yet, but confident that vax caused problems. For more details you may contact parents via cell phone.