chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: M
Vaccine: FLUN(H1N1), FLUN(H1N1), FLUN(H1N1), FLUN(H1N1), FLUN(H1N1)
Symptoms: Fatigue, Frustration, Hypothyroidism, Irritability, Learning disability
Clinical narrative: There is residual cognitive impairments that persist since the H1N1 vaccination.  Patient still gets fatigued after just one hour of physical activity whereas his norm had been to have boundless energy.  Unable to perform sustained cognitive function such as doing homework for 30 minutes without showing visible signs of fatigue (eyes looking glazed and with "bags" under eyes) and yawning.  Is more moody and easily frustrated than prior to the H1N1 vaccination.  Had had 40 hyperbaric oxygen therapy treatments (HBOTs) from April-June 2010 and this cured patient's dysesthesia and allodynia in his feet.  Gained 10 pounds unaccounted for totally by diet and exercise level (he had been ill but was kept active as much as possible and diet was controlled).  April 2010: Independent physician unaffiliated with facility ordered tests that showed hypothyroidism and glycine orally was given for urine test to detect heavy metal toxicity; test result were pending when pt was hospitalized from May 5-May 7, 2010, for EEG study and received Lyme test and nerve conduction study test.  All came back negative. Pt was sent to facility due to looking toxic on 5/4/10. Facility did not do any testing for toxicity despite me (patient's mother) begging for them to be done so we can find cause of patient's illness.  Since May, 2010, patient has been on alpha lipoic acid, magnesium, calcium, Drenamin, thyroid medication, Floradix.  July 12, 2010, patient finally got appointment to see independent physician who had ordered urine test in April:  test showed mercury toxicity; physician said he had only given glycine and not EDTA or another mercury chelator.  He said if he had given a mercury chelator like EDTA, patient's mercury level would have been much higher.  He said the glycine was not chelating for mercury.  Since July 12, 2010, patient was started on Super Thisilyn and glycine for mercury detox.  Patient has been 100% wheel chair free since May, 2010.   In May, 2010, neuropsych testing showed psychosocial stressors and somatism in patient and showed significantly decreased mental processing speed.  Neuropsychologist unable to determine if H1N1 vaccine caused patient's problems and recommended psychotherapy and recommended that school allow patient to have 50% more time for doing his schoolwork due to slow mental processing at the level of a learning disability. Parents refuse to believe that psychosocial stressor and somatism is the cause of patient's problems becasue patient was normal before H1N1 vaccination and symptoms came on so suddenly after H1N1 vaccination.
Age: 9.0
Sex: M
Vaccine: FLUN(H1N1), FLUN(H1N1), FLUN(H1N1), FLUN(H1N1), FLUN(H1N1)
Symptoms: Mental impairment, Metal poisoning, Mood altered, Nerve conduction studies normal, Neuropsychological test abnormal
Clinical narrative: There is residual cognitive impairments that persist since the H1N1 vaccination.  Patient still gets fatigued after just one hour of physical activity whereas his norm had been to have boundless energy.  Unable to perform sustained cognitive function such as doing homework for 30 minutes without showing visible signs of fatigue (eyes looking glazed and with "bags" under eyes) and yawning.  Is more moody and easily frustrated than prior to the H1N1 vaccination.  Had had 40 hyperbaric oxygen therapy treatments (HBOTs) from April-June 2010 and this cured patient's dysesthesia and allodynia in his feet.  Gained 10 pounds unaccounted for totally by diet and exercise level (he had been ill but was kept active as much as possible and diet was controlled).  April 2010: Independent physician unaffiliated with facility ordered tests that showed hypothyroidism and glycine orally was given for urine test to detect heavy metal toxicity; test result were pending when pt was hospitalized from May 5-May 7, 2010, for EEG study and received Lyme test and nerve conduction study test.  All came back negative. Pt was sent to facility due to looking toxic on 5/4/10. Facility did not do any testing for toxicity despite me (patient's mother) begging for them to be done so we can find cause of patient's illness.  Since May, 2010, patient has been on alpha lipoic acid, magnesium, calcium, Drenamin, thyroid medication, Floradix.  July 12, 2010, patient finally got appointment to see independent physician who had ordered urine test in April:  test showed mercury toxicity; physician said he had only given glycine and not EDTA or another mercury chelator.  He said if he had given a mercury chelator like EDTA, patient's mercury level would have been much higher.  He said the glycine was not chelating for mercury.  Since July 12, 2010, patient was started on Super Thisilyn and glycine for mercury detox.  Patient has been 100% wheel chair free since May, 2010.   In May, 2010, neuropsych testing showed psychosocial stressors and somatism in patient and showed significantly decreased mental processing speed.  Neuropsychologist unable to determine if H1N1 vaccine caused patient's problems and recommended psychotherapy and recommended that school allow patient to have 50% more time for doing his schoolwork due to slow mental processing at the level of a learning disability. Parents refuse to believe that psychosocial stressor and somatism is the cause of patient's problems becasue patient was normal before H1N1 vaccination and symptoms came on so suddenly after H1N1 vaccination.
Age: 9.0
Sex: M
Vaccine: FLUN(H1N1), FLUN(H1N1), FLUN(H1N1), FLUN(H1N1), FLUN(H1N1)
Symptoms: Pallor, Somatoform disorder, Staring, Urine mercury abnormal, Weight increased
Clinical narrative: There is residual cognitive impairments that persist since the H1N1 vaccination.  Patient still gets fatigued after just one hour of physical activity whereas his norm had been to have boundless energy.  Unable to perform sustained cognitive function such as doing homework for 30 minutes without showing visible signs of fatigue (eyes looking glazed and with "bags" under eyes) and yawning.  Is more moody and easily frustrated than prior to the H1N1 vaccination.  Had had 40 hyperbaric oxygen therapy treatments (HBOTs) from April-June 2010 and this cured patient's dysesthesia and allodynia in his feet.  Gained 10 pounds unaccounted for totally by diet and exercise level (he had been ill but was kept active as much as possible and diet was controlled).  April 2010: Independent physician unaffiliated with facility ordered tests that showed hypothyroidism and glycine orally was given for urine test to detect heavy metal toxicity; test result were pending when pt was hospitalized from May 5-May 7, 2010, for EEG study and received Lyme test and nerve conduction study test.  All came back negative. Pt was sent to facility due to looking toxic on 5/4/10. Facility did not do any testing for toxicity despite me (patient's mother) begging for them to be done so we can find cause of patient's illness.  Since May, 2010, patient has been on alpha lipoic acid, magnesium, calcium, Drenamin, thyroid medication, Floradix.  July 12, 2010, patient finally got appointment to see independent physician who had ordered urine test in April:  test showed mercury toxicity; physician said he had only given glycine and not EDTA or another mercury chelator.  He said if he had given a mercury chelator like EDTA, patient's mercury level would have been much higher.  He said the glycine was not chelating for mercury.  Since July 12, 2010, patient was started on Super Thisilyn and glycine for mercury detox.  Patient has been 100% wheel chair free since May, 2010.   In May, 2010, neuropsych testing showed psychosocial stressors and somatism in patient and showed significantly decreased mental processing speed.  Neuropsychologist unable to determine if H1N1 vaccine caused patient's problems and recommended psychotherapy and recommended that school allow patient to have 50% more time for doing his schoolwork due to slow mental processing at the level of a learning disability. Parents refuse to believe that psychosocial stressor and somatism is the cause of patient's problems becasue patient was normal before H1N1 vaccination and symptoms came on so suddenly after H1N1 vaccination.
Age: 9.0
Sex: M
Vaccine: FLUN(H1N1), FLUN(H1N1), FLUN(H1N1), FLUN(H1N1), FLUN(H1N1)
Symptoms: Wheelchair user, Yawning
Clinical narrative: There is residual cognitive impairments that persist since the H1N1 vaccination.  Patient still gets fatigued after just one hour of physical activity whereas his norm had been to have boundless energy.  Unable to perform sustained cognitive function such as doing homework for 30 minutes without showing visible signs of fatigue (eyes looking glazed and with "bags" under eyes) and yawning.  Is more moody and easily frustrated than prior to the H1N1 vaccination.  Had had 40 hyperbaric oxygen therapy treatments (HBOTs) from April-June 2010 and this cured patient's dysesthesia and allodynia in his feet.  Gained 10 pounds unaccounted for totally by diet and exercise level (he had been ill but was kept active as much as possible and diet was controlled).  April 2010: Independent physician unaffiliated with facility ordered tests that showed hypothyroidism and glycine orally was given for urine test to detect heavy metal toxicity; test result were pending when pt was hospitalized from May 5-May 7, 2010, for EEG study and received Lyme test and nerve conduction study test.  All came back negative. Pt was sent to facility due to looking toxic on 5/4/10. Facility did not do any testing for toxicity despite me (patient's mother) begging for them to be done so we can find cause of patient's illness.  Since May, 2010, patient has been on alpha lipoic acid, magnesium, calcium, Drenamin, thyroid medication, Floradix.  July 12, 2010, patient finally got appointment to see independent physician who had ordered urine test in April:  test showed mercury toxicity; physician said he had only given glycine and not EDTA or another mercury chelator.  He said if he had given a mercury chelator like EDTA, patient's mercury level would have been much higher.  He said the glycine was not chelating for mercury.  Since July 12, 2010, patient was started on Super Thisilyn and glycine for mercury detox.  Patient has been 100% wheel chair free since May, 2010.   In May, 2010, neuropsych testing showed psychosocial stressors and somatism in patient and showed significantly decreased mental processing speed.  Neuropsychologist unable to determine if H1N1 vaccine caused patient's problems and recommended psychotherapy and recommended that school allow patient to have 50% more time for doing his schoolwork due to slow mental processing at the level of a learning disability. Parents refuse to believe that psychosocial stressor and somatism is the cause of patient's problems becasue patient was normal before H1N1 vaccination and symptoms came on so suddenly after H1N1 vaccination.
Sex: M
Vaccine: DTAP, VARCEL, DTAP, VARCEL
Symptoms: Crying, Erythema, Vomiting
Clinical narrative: After varicella vaccine patient had one episode of emesis.  Leg became red at the injection site then the face and rest of the body became red.  The nurse gave 0.1ml epinephrine.  No change in rash after that.  EMS called and patient brought to hospital.
Sex: M
Vaccine: DTAP, VARCEL, DTAP, VARCEL
Symptoms: Erythema, Injection site erythema, Rash, Vomiting
Clinical narrative: After varicella vaccine patient had one episode of emesis.  Leg became red at the injection site then the face and rest of the body became red.  The nurse gave 0.1ml epinephrine.  No change in rash after that.  EMS called and patient brought to hospital.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood cholinesterase, Muscular weakness, Myasthenia gravis, Tensilon test abnormal
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a dose of GARDASIL. Subsequently the patient experienced an adverse experience, but did not mention what the experience was. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Follow up information has been received from a nurse who reported that the 12 year old female patient with no illness at the time of vaccination, on 23-NOV-2009 was vaccinated intramuscularly with the second dose of GARDASIL (lot # 660612/0229x). On 01-JAN-2010 the patient experienced muscle weakness which was diagnosed as myasthenia gravis. Myasthenia gravis was considered to be an other important medical event due to medical/surgical intervention. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscular weakness, Myasthenia gravis
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a dose of GARDASIL. Subsequently the patient experienced an adverse experience, but did not mention what the experience was. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Follow up information has been received from a nurse who reported that the 12 year old female patient with no illness at the time of vaccination, on 23-NOV-2009 was vaccinated intramuscularly with the second dose of GARDASIL (lot # 660612/0229x). On 01-JAN-2010 the patient experienced muscle weakness which was diagnosed as myasthenia gravis. Myasthenia gravis was considered to be an other important medical event due to medical/surgical intervention. No further information is available.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature normal, Erythema, Injection site erythema, Injection site warmth, Pain
Clinical narrative: Received Tdap 07-08-2010. Client stated pain started the day after receiving shot-continue to hurt everyday and began swelling on 07-13-2010-with redness on 07-15-2010. Came to HD today. Pain under arm. T-98.6. Reddened area 4 x 4 in at and below injection site and warm to touch. Client referred to MD for evaluation client also instructed to apply ice packs and take MOTRIN to reduce swelling.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Received Tdap 07-08-2010. Client stated pain started the day after receiving shot-continue to hurt everyday and began swelling on 07-13-2010-with redness on 07-15-2010. Came to HD today. Pain under arm. T-98.6. Reddened area 4 x 4 in at and below injection site and warm to touch. Client referred to MD for evaluation client also instructed to apply ice packs and take MOTRIN to reduce swelling.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Paraesthesia
Clinical narrative: Back pain 3 hours post injection - ongoing pain radiating onto groin and tingling both hands.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Decreased appetite, Hepatitis, Hepatomegaly
Clinical narrative: Initial information received from a consumer on 09 Jul 2010: This patient received the first dose of RABAVERT (batch number: 426011A, expiry date: not provided), intramuscular on 22 Jun 2010. The patient developed nausea, vomiting and loss of appetite on 23 Jun 2010. The patient received the second dose of RABAVERT on 29 Jun 2010. On an unknown date after second dose the symptoms was worsened. The patient was visited to clinic, and was found to have enlarged liver, hepatitis and liver enzymes aspartate aminotransferase (ASR) and alanine aminotransferase (ALT) were raised 15 times than normal limit. The outcome of the events reported was condition unchanged.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Nausea, Vomiting
Clinical narrative: Initial information received from a consumer on 09 Jul 2010: This patient received the first dose of RABAVERT (batch number: 426011A, expiry date: not provided), intramuscular on 22 Jun 2010. The patient developed nausea, vomiting and loss of appetite on 23 Jun 2010. The patient received the second dose of RABAVERT on 29 Jun 2010. On an unknown date after second dose the symptoms was worsened. The patient was visited to clinic, and was found to have enlarged liver, hepatitis and liver enzymes aspartate aminotransferase (ASR) and alanine aminotransferase (ALT) were raised 15 times than normal limit. The outcome of the events reported was condition unchanged.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Lip swelling, Oedema peripheral, Pyrexia
Clinical narrative: Patient experienced swelling and pain at injection site as well as swelling down arm. Also had low grade fever (101 degrees F) and experienced lip swelling without resp. involvement.
Age: 1.89
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: ACTHIB was inadvertently reconstituted with sterile water instead of diluent provided. No signs/symptoms of adverse reaction. There was not an adverse reation.  Error was discovered on 7/15/10.  Left blank on form since no adverse event.
Age: 1.01
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Blister
Clinical narrative: Multiple vesicles ~ 25 total. Hands, chest, scalp, back.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Local reaction, Pain, Skin warm, Swelling
Clinical narrative: Received KINRIX (DTaP/IPV) on (L) thigh 2nd day had large local rxn, red, hot, swollen, soreness, no painful.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect dose administered
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old male with a history of cancer and head and neck surgery who on 20-JUN-2008 was inadvertently vaccinated with a double dose of ZOSTAVAX (Merck) (lot # not provided). It was reported that at the time of the report, the patient was in the hospital. The diagnosis was not known. The patient's wife contacted the pharmacist and stated that the patient had also developed shingles in addition to the reason for his hospitalization. As of 09-JUL-2010 the patient had not recovered. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Swelling and hives on right thigh after administering VAR,  PCV 13. Patient was given BENADRYL and it cleared up after couple of minutes.
Age: 21.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Injection site anaesthesia, Injection site erythema, Injection site papule, Injection site swelling, Paraesthesia
Clinical narrative: Left arm numbness and tingling, redness and raised bump from Anthrax vaccination/swelling in left arm.
Age: 64.0
Sex: M
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site swelling, Pallor
Clinical narrative: Developed swelling at injection site /and surrounding blanching erythema. BENADRYL 25 mg 1 po. Ice to affected area.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Visual impairment
Clinical narrative: Child c/o "funny vision" from (R) eye, severe headache and dizziness approximately 4-5 hours after receiving GARDASIL #1 on 4/23/10 no treatment. We were informed of this 2 months afterwards when child came for #2 GARDASIL.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Neonatal disorder, Premature labour
Clinical narrative: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a male baby's 24 year old mother with anxiety and depression and no known allergies who on 15-OCT-2007 was vaccinated with the first dose of GARDASIL. On 14-JAN-2008 she was vaccinated intramuscularly with the second 0,5 ml dose of GARDASIL (lot no. 659055/1522U). Concomitant therapy included WELLBUTRIN. Her LMP was 07-JAN-2008. Due date was 13-OCT-2008. On approximately 17-AUG-2008 the mother delivered a baby boy "at around 32 weeks gestation, almost two months early". The physician did not remember exactly and did not have the patient's chart at her immediate disposal. The physician also followed the baby in her practice. The physician reported "he was now around nine months old and weighed around 15 pounds. He had some failure to thrive issues and had some developmental delays". No further information was provided at this time. Follow-up information received from the physician concerning that the mother had experienced prolonged premature rupture of membranes and was given intravenous PITOCIN and steroids for the baby since less that 34 weeks gestation. The baby had fetal distress in labor which the physician thought was not surprising given the age and loss of amniotic fluid, but she delivered vaginally on 27-AUG-2008, at 32+2 weeks gestation (her EDD was 13-OCT-2008). The baby had a patent foramen ovale, "which is now almost gone", and tachycardia for which he was followed by a pediatric cardiologist. "We are not worried about this though", The most concerning problem the baby had was his weight gain. The physician saw him in Mid-Jun and he only weighed 15LBS, and he was having some reflux problems for which he was sent to a pediatric gastroenterologist. The physician read from a form that the pediatric gastroenterologist consult dated 19-Mar-2009 which noted the baby was seen for his atrial-septal defect/patent foramen ovale, which was almost gone, and he had a normal echocardiogram, with recommended followed up in one or two years. the baby's patent foramen ovale were considered to be congenital anomaly. No additional information is available. The mother's adverse effects were captured in WAES# 0807USA04408. This information was previously reported in 0807USA04408.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site oedema, Injection site urticaria, Injection site warmth
Clinical narrative: Edema, redness, warmth and welts at side of varicella vacc immediately after vacc.
Age: 1.39
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Pt vaccinated on 7/8/10, MMR, Varicella, HIB, PREVNAR, HIB. Mother states patient had fever of 102 axillary in evening of vaccination, was given TYLENOL and Ibuprofen which reduced fever to normal for 4 hrs but returned to 102 after 4 hours. Mom states she kept patient medicated to keep fever down and he was afebrile after 48 hrs.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: C-reactive protein normal, Chest X-ray normal, Cough, Diarrhoea, Full blood count normal
Clinical narrative: Diarrhea, cough, irritability, poor sleep, vomiting, sneezing that began 24 hours following vaccines.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Irritability, Poor quality sleep, Sneezing, Urinary system X-ray, Urinary system x-ray normal
Clinical narrative: Diarrhea, cough, irritability, poor sleep, vomiting, sneezing that began 24 hours following vaccines.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Diarrhea, cough, irritability, poor sleep, vomiting, sneezing that began 24 hours following vaccines.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site pruritus, Injection site rash, Malaise
Clinical narrative: Redness, rash, itchy at site joint pain, general malaise.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became very swollen and red. It was also itchy and warm. The patient took Ibuprofen and was fine within seven days.
Age: 1.26
Sex: F
Vaccine: HIBV, PNC
Symptoms: Apnoea, Convulsion, Electroencephalogram normal, Endotracheal intubation, Erythema
Clinical narrative: 2 days after getting vaccination - had febrile seizure - beg as focal then generalized - apnea - intubated x about 24 hr. Full recovery with signif local reaction (L) arm with swelling, erythema and tenderness.
Age: 1.26
Sex: F
Vaccine: HIBV, PNC
Symptoms: Febrile convulsion, Local reaction, Oedema peripheral, Partial seizures, Tenderness
Clinical narrative: 2 days after getting vaccination - had febrile seizure - beg as focal then generalized - apnea - intubated x about 24 hr. Full recovery with signif local reaction (L) arm with swelling, erythema and tenderness.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Chills, Headache, Muscle spasms, Pain
Clinical narrative: Information has been received from a 65 year old female patient with an allergy to horse serum and with no relevant medical history who on 08-JUL-2010 was vaccinated IM with the first dose of PNEUMOVAX 23 in her left upper arm. Concomitant therapy included trazodone HCl, EVISTA and FEMHRT. The patient reported that she went to the physician for a routine physical. As a part of the physical because of her age, 65, she received the vaccination. She had been fasting for 12 hours prior to her visit. After her vaccine injection on 08-JUL-2010, while making her way out of the office, she took a sip of water and began to feel stomach cramps and a headache. She then re-entered the office and was brought to an exam room and upon entering the room began experiencing severe back spasms that were very painful. She was placed prone onto an exam table and given a back massage to alleviate the spasms. They subsided after 20 minutes. The physician was perplexed as to why she was experiencing these symptoms. The patient then left the office and while driving home she started to experience severe pelvic pain along with leg, hand and foot pain. She felt very sleepy upon arriving home and went in to lay down, but then started experiencing severe chills that lasted for approximately 2 hours. When the chills finally passed she was symptom free and was fully recovered on 09-JUL-2010. Stomach cramps, headache, severe back spasms, severe pelvic pain, leg, hand and foot pain, felt very sleepy and severe chills were considered to be disabling. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pelvic pain, Somnolence
Clinical narrative: Information has been received from a 65 year old female patient with an allergy to horse serum and with no relevant medical history who on 08-JUL-2010 was vaccinated IM with the first dose of PNEUMOVAX 23 in her left upper arm. Concomitant therapy included trazodone HCl, EVISTA and FEMHRT. The patient reported that she went to the physician for a routine physical. As a part of the physical because of her age, 65, she received the vaccination. She had been fasting for 12 hours prior to her visit. After her vaccine injection on 08-JUL-2010, while making her way out of the office, she took a sip of water and began to feel stomach cramps and a headache. She then re-entered the office and was brought to an exam room and upon entering the room began experiencing severe back spasms that were very painful. She was placed prone onto an exam table and given a back massage to alleviate the spasms. They subsided after 20 minutes. The physician was perplexed as to why she was experiencing these symptoms. The patient then left the office and while driving home she started to experience severe pelvic pain along with leg, hand and foot pain. She felt very sleepy upon arriving home and went in to lay down, but then started experiencing severe chills that lasted for approximately 2 hours. When the chills finally passed she was symptom free and was fully recovered on 09-JUL-2010. Stomach cramps, headache, severe back spasms, severe pelvic pain, leg, hand and foot pain, felt very sleepy and severe chills were considered to be disabling. Additional information has been requested.
Age: 71.0
Sex: U
Vaccine: FLU(H1N1), HEPAB, TD
Symptoms: Rash
Clinical narrative: Received TWINRIX #2 TD and H1N1 vaccine-developed a flat rash to inner elbows x 1 day denies any issues.
Age: 17.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Dizziness, Retching, Swelling face, Throat tightness, Urticaria
Clinical narrative: Gagging/wretching, hives, swollen face, dizzy, "throat closing up", loud dry heaves.
Age: 12.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Headache, Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Pt started with headache, subjective fever and slight redness at site 2-3 hrs after injection. Presented in office 48 hrs after injection with 3x3 inch redness and 2 x 2 inch hardness. Grandmother states headache and fever x 48 hrs. No fever at time of office visit. Treatment-BENADRYL and MOTRIN/TYLENOL.
Age: 0.49
Sex: M
Vaccine: PNC13
Symptoms: Crying, Feeling abnormal, Irritability, Pyrexia
Clinical narrative: 7/13/10 5 hours after PCV 13 was administered was very fussy, crying, no fever at that time, seen at ER, on 7/14/10 seen at office, baby still not himself, better, fever 101.2 degrees F (R).
Age: 54.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Cheilitis, Erythema, Herpes zoster, Pruritus
Clinical narrative: VARIVAX imm. 7/14/19. Went to ER 7/16/19 AM with 2 blisters and lg. red area lower lip, chin and cheek. Teeth hurt on that side, itching. Dx with shingles.
Age: 54.0
Sex: F
Vaccine: VARCEL
Symptoms: Toothache
Clinical narrative: VARIVAX imm. 7/14/19. Went to ER 7/16/19 AM with 2 blisters and lg. red area lower lip, chin and cheek. Teeth hurt on that side, itching. Dx with shingles.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Skin rash erythema and pain 10 cm around shot.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Hypertension, Laboratory test normal, Tinnitus, Visual impairment
Clinical narrative: After receiving Hep B #2: She developed HTN/ringing in ears started 1/10 with visual distortions symptoms. Continue to increase. Visiting clinic and many physician. No answer or resolution. TC to us with info as noted - thinks its the Hep B vaccine. On7/14/10 waited 6 months to call.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test, Rash pruritic
Clinical narrative: Itchy rash.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Soreness of arm reported by child, nurse noted slight redness and some swelling on 7/16 when preparing to give allergy shot.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hypersomnia, Pyrexia
Clinical narrative: Mother called at 2042 hrs as a child as been running fever this afternoon up to 104+ rectally.  The child did have two month immunizations given earlier today.  Physical exam at that time was normal.  Since then the child has been sleeping more than usual but is easily arousable to full awake, she is been tolerating p.o. feeds well, she is not excessively irritable, she had no vomiting or rashes.  Mother states the child is actually smiling a little bit this evening even though she is still running fever of 103 after having tepid bath.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Computerised tomogram normal, Dizziness, Formication, Headache, Lumbar puncture normal
Clinical narrative: Pt states she awoke from sleep with head pressure, and a "weird crawling like" sensation down right arm and leg, "all the way to my toes", along with dizziness.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Body temperature normal, Computerised tomogram normal, Dizziness, Ear, nose and throat examination normal, Headache
Clinical narrative: Pt states she awoke from sleep with head pressure, and a "weird crawling like" sensation down right arm and leg, "all the way to my toes", along with dizziness.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Heart rate normal, Lumbar puncture normal, Paraesthesia
Clinical narrative: Pt states she awoke from sleep with head pressure, and a "weird crawling like" sensation down right arm and leg, "all the way to my toes", along with dizziness.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Blood test normal, Chest X-ray normal, Chills, Fatigue, Feeling abnormal
Clinical narrative: On Friday, 06/25/2010 patient reports she started to feel lethargic. On Saturday afternoon she had chills and fever of 103.8. She began to alternate taking Tylenol and Motrin every 4 hrs. She wasn't able to sleep, had muscle aches and chills. By Sunday fever was 102.4 and she felt awful. She was drinking fluids but on Monday morning went to the  ER .She had a negative chest x-ray, her blood and urine tests were negative. She reports that she had a swollen node in her left armpit. She was given a liter of IV fluids, her fever was 101.7 and she was almost discharged when her fever spiked. She was given more Motrin and discharged when her fever was lower. She said she was in the ER for approx. 5 hrs. When she left she was still quite fatigued. She said she had missed work from 6/28 through 7/02. She felt much better by 7/03.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Impaired work ability, Insomnia, Lethargy, Lymphadenopathy, Myalgia
Clinical narrative: On Friday, 06/25/2010 patient reports she started to feel lethargic. On Saturday afternoon she had chills and fever of 103.8. She began to alternate taking Tylenol and Motrin every 4 hrs. She wasn't able to sleep, had muscle aches and chills. By Sunday fever was 102.4 and she felt awful. She was drinking fluids but on Monday morning went to the  ER .She had a negative chest x-ray, her blood and urine tests were negative. She reports that she had a swollen node in her left armpit. She was given a liter of IV fluids, her fever was 101.7 and she was almost discharged when her fever spiked. She was given more Motrin and discharged when her fever was lower. She said she was in the ER for approx. 5 hrs. When she left she was still quite fatigued. She said she had missed work from 6/28 through 7/02. She felt much better by 7/03.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: On Friday, 06/25/2010 patient reports she started to feel lethargic. On Saturday afternoon she had chills and fever of 103.8. She began to alternate taking Tylenol and Motrin every 4 hrs. She wasn't able to sleep, had muscle aches and chills. By Sunday fever was 102.4 and she felt awful. She was drinking fluids but on Monday morning went to the  ER .She had a negative chest x-ray, her blood and urine tests were negative. She reports that she had a swollen node in her left armpit. She was given a liter of IV fluids, her fever was 101.7 and she was almost discharged when her fever spiked. She was given more Motrin and discharged when her fever was lower. She said she was in the ER for approx. 5 hrs. When she left she was still quite fatigued. She said she had missed work from 6/28 through 7/02. She felt much better by 7/03.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Lethargy, Pallor, Rash maculo-papular, Skin lesion
Clinical narrative: Numerous satellite lesions to right deltoid region and right shoulder.  Numerous satellite lesions on back, scattered lesions on chest, and behind left ear.  Macular papular rash on chest and back.  Pale and lethargic.  Sent to ED for evaluation.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Dysphemia, Rash, Skin warm
Clinical narrative: Spreading rash hot to the touch. Now my son stutters when he speaks. He has never stuttered before. I thought this might self correct but it has continued.
Age: 13.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Pt. received 2 varicella immunizations at same time. One done correctly subq, the second completed incorrectly IM. Syringes were clearly labeled in one tray for pt. and his sibling. MA picked up the wrong syringe, labeled Varicella instead of Tdap and did not check the label. There was no immediate reaction to the injection IM. MA immediately notified Site RN who assessed pt. and informed mother and pt. of error. Possible reactions to injection described to mother and pt. Mother instructed to call office for any concerns or symptoms. Mother verbalized understanding.
Age: 19.0
Sex: M
Vaccine: ANTH, HEPA, SMALL
Symptoms: Dermatitis contact, Skin lesion
Clinical narrative: Two satellite like lesions noted though dx with contact dermatitis by provider.  Coban and Telfa applied.  Instruction on proper care provided to patient-verbal instruction and written instruction. Verbalized understanding.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Adverse event
Clinical narrative: This person NEVER received a Smallpox Vaccination.  He believes that he was inoculated by a fellow soldier on 07/03/2010.  He was given written and verbal instructions on how to care for the site and bandages.  Verbalized understanding.  Also seen by provider.
Age: 1.25
Sex: M
Vaccine: HIBV, IPV
Symptoms: Coordination abnormal, Crying, Fall, Laboratory test normal
Clinical narrative: Flapping of hands, intermittent through until 5 AM 04/23/2010. Uncontrollable crying all day of 04/22/2010. Sudden loss of coordination, twice. Falling over, uncharacteristic of this patient, once from seated, once from standing.
Age: 44.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Chills, Dehydration, Dermatitis allergic, Diarrhoea
Clinical narrative: Arm pain & tenderness, fever, chills, n/v, diarrhea. Admitted and cellulitis treated with Septra. Discharge w/ Septra & readmitted for severe Septra allergy-rash, dehydration, n/v.  Was treated and discharged on 5/18. Has been seen by neurology for continued muscle weakness, slowness of speech. Workup pending.
Age: 44.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Drug hypersensitivity, Muscular weakness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Arm pain & tenderness, fever, chills, n/v, diarrhea. Admitted and cellulitis treated with Septra. Discharge w/ Septra & readmitted for severe Septra allergy-rash, dehydration, n/v.  Was treated and discharged on 5/18. Has been seen by neurology for continued muscle weakness, slowness of speech. Workup pending.
Age: 44.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Speech disorder, Tenderness, Vomiting
Clinical narrative: Arm pain & tenderness, fever, chills, n/v, diarrhea. Admitted and cellulitis treated with Septra. Discharge w/ Septra & readmitted for severe Septra allergy-rash, dehydration, n/v.  Was treated and discharged on 5/18. Has been seen by neurology for continued muscle weakness, slowness of speech. Workup pending.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Dizziness, Headache, Injection site pain, Pyrexia
Clinical narrative: Severe injection site pain, severe headache, dizziness and extended 104 degree fever.
Age: 53.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Chills, Decreased appetite, Pyrexia
Clinical narrative: Exact time of onset unknown.  Pt stated that he began to have fever, chills, and loss of appetite.  Symptoms began to resolve today.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: On 07/16 patient presented to pharmacy with a 2.5 to 3 inch wide and 4 inch long red area where she was given Zostavax on 7/13. She has had no other symptoms ot signs of illness. I refered her to her primary care. She was going to drive over after we talked, have not followed up with patient yet.
Age: 41.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Arthralgia, Swelling
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of joint pain in a 41-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject's medical history included acid reflux, high blood pressure and right shoulder surgery. Concurrent medications included PROPRANOLOL, SEROQUEL, XANAX, HCTZ, NAPROSYN and NEXIUM. On 13 July 2010 at 13:30 the subject received 3rd dose of ENGERIX B (1 ml, unknown route, left arm). On 13 July 2010, approximately 3 hours after vaccination with ENGERIX B, the subject experienced joint pain and swelling. At 17:00 the subject experienced joint pain, and at 19:30 swelling occurred. The healthcare professional considered the events were disabling and life threatening. The subject was referred to the emergency room by her treating health clinic and was advised to take ibuprofen. At the time of reporting the events were unresolved.
Age: 41.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Arthralgia, Diarrhoea, Local swelling, Musculoskeletal stiffness, Pain
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of joint pain in a 41-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject's medical history included acid reflux, high blood pressure and right shoulder surgery. Concurrent medications included PROPRANOLOL, SEROQUEL, XANAX, HCTZ, NAPROSYN and NEXIUM. On 13 July 2010 at 13:30 the subject received 3rd dose of ENGERIX B (1 ml, unknown route, left arm). On 13 July 2010, approximately 3 hours after vaccination with ENGERIX B, the subject experienced joint pain and swelling. At 17:00 the subject experienced joint pain, and at 19:30 swelling occurred. The healthcare professional considered the events were disabling and life threatening. The subject was referred to the emergency room by her treating health clinic and was advised to take ibuprofen. At the time of reporting the events were unresolved.
Age: 35.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Hyperaesthesia, Injection site erythema, Injection site induration, Injection site swelling, Oedema peripheral
Clinical narrative: Swelling on L deltoid when got home after vaccination given at 2:16 PM. The next morning "whole arm was swollen". On 7/16/2010 at 11:15 AM approximately 2 inch area with erythema/swelling/hard to touch/patient grimace on touch on L deltoid.
Age: 1.65
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness over the left anterior thigh.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Sensation of heaviness
Clinical narrative: Very sore arm with feeling of heaviness in upper arm that has lasted over 2 weeks after imm.
Age: 15.0
Sex: F
Vaccine: HPV4, MEN, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Patient fainted for about 20 seconds in waiting room as she walked out, father was able to break fall, no injuries reported by patient or visible injuries, patient was brought back to treatment room, vitals were obtained and normal, patient was released and self ambulated to vehicle.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Hurting at injection site then arm swelling from shoulder to tips of fingers on entire right side of arm per dr 4 tsp liq Benadryl (12.5/5) given at 6:30 PM when pt returned to night clinic ice applied to area.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal X-ray, Abdominal pain upper, Blood test, Dizziness, Fatigue
Clinical narrative: Light headed, dizzy, head ache, general malaise, fatigue, stomach ache.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Malaise, Skull X-ray, Stool analysis, Urine analysis
Clinical narrative: Light headed, dizzy, head ache, general malaise, fatigue, stomach ache.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Death
Clinical narrative: None stated
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Induration, Local reaction, Skin discolouration, Skin warm, Tenderness
Clinical narrative: KINRIX given 7/14/10. 13 x 15 cm pink, warm area around injection tender, induration 2 cm on (R) thigh- reaction noted 7/16/2010.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: Pt's left arm started itching immediately after receiving vaccine. Had red, raised area - gave 2 tsp. BENADRYL, applied ice to area. Area improved after giving BENADRYL. Pt was discharged.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Eye discharge, Eye pruritus, Eye swelling, Polymerase chain reaction, Skin lesion
Clinical narrative: 25 y/o male, is exposed to recent vaccines of Smallpox vaccine by wrestling contact on 24 Jun 10 and develops right arm contact transmission with vaccinial lesions and eye itching. Left eye symptoms progress to swelling, leakage and lid lesions and eventually diagnosed as Ocular Vaccinia. Patient is currently on treatment with Ophthalmology.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccinia virus infection
Clinical narrative: 25 y/o male, is exposed to recent vaccines of Smallpox vaccine by wrestling contact on 24 Jun 10 and develops right arm contact transmission with vaccinial lesions and eye itching. Left eye symptoms progress to swelling, leakage and lid lesions and eventually diagnosed as Ocular Vaccinia. Patient is currently on treatment with Ophthalmology.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Injection site erythema, Injection site pain, Rash
Clinical narrative: Erythema and pain at vaccine site. Rash on neck, trunk, arms, legs. Rash 'burning' in the neck area. Patient given BENADRYL 50 mg IM in ER and discharged with BENADRYL 25 mg tablets. Vitals on arrival : HR-71 B/P-148/81 Temp-98.5.
Age: 70.0
Sex: F
Vaccine: TD
Symptoms: Headache, Oedema peripheral, Pain, Pyrexia, Swelling
Clinical narrative: Approx 12 hours post vaccination sx's started. Fever, body aches, (L) axillary swelling, (L) arm swelling elbow to shoulder, headache. Tx: cool compresses and TYLENOL.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pruritus, Swelling
Clinical narrative: Raised, itchy bumps and general swelling started approximately 12 hrs after immunizations given.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Back injury, Dizziness, Fall, Head injury, X-ray normal
Clinical narrative: Pt c/o dizzy episode 5-7 min post vaccination. Pt fell and hit head and back. Physical exam at office ok. However, mom took pt to ER for further evaluation. F/u x-ray WNL.
Age: 1.17
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles, Rash
Clinical narrative: Hard bump under injection site and redness around the site within 24 hours of vaccine. Then 13 days later, got a rash. Multiple vesicular lesions confluent in a small spot directly over site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site extravasation, Injection site reaction, Injection site swelling
Clinical narrative: (L) upper arm swollen red and very tense with small amt yellow exudate weeping, 1/4 of upper arm extending to area just behind shoulder, no hives, no tenderness.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Nausea, Vertigo, Vomiting
Clinical narrative: Patient states shortly after receiving vaccine she felt dizzy. Then later that day nausea and vomiting. The world is virtually spinning when her eyes are open. Treatment = Meclizine 25 mg TID x 21.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, warm to touch, swelling in (L) deltoid. No fever, no swelling of face, lips, tongue. No difficulty swallowing no respiratory distress.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Headache, Immediate post-injection reaction, Injection site pain, Oedema peripheral
Clinical narrative: Pt complained of severe pain at injection site and throughout upper arm & shoulder immediately after vaccination. Arm became very swollen later in day. She also experienced headache & started feeling weak.
Age: 64.0
Sex: M
Vaccine: HEPAB, PPV, TDAP, VARZOS
Symptoms: Chest X-ray normal, Computerised tomogram normal, Full blood count, Headache, Injection site erythema
Clinical narrative: Patient received PNEUMOVAX 23 and ZOSTAVAX on RIGHT deltoid area on 7/2/2010. Seen in E.D. on 7/05/2010 for fever 104 degrees with mild erythema to RIGHT deltoid only-no abscess. Had headaches and myalgias by 7/3/2010- No other symptoms or findings. Treated with ceftriaxone IV and Vancomycin in E.D. with TYLENOL for fever & pain and oral doxycycline.
Age: 64.0
Sex: M
Vaccine: HEPAB, PPV, TDAP, VARZOS
Symptoms: Lumbar puncture normal, Myalgia, Pain, Pyrexia, Urine analysis abnormal
Clinical narrative: Patient received PNEUMOVAX 23 and ZOSTAVAX on RIGHT deltoid area on 7/2/2010. Seen in E.D. on 7/05/2010 for fever 104 degrees with mild erythema to RIGHT deltoid only-no abscess. Had headaches and myalgias by 7/3/2010- No other symptoms or findings. Treated with ceftriaxone IV and Vancomycin in E.D. with TYLENOL for fever & pain and oral doxycycline.