chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: HEPAB, IPV
Symptoms: Sensory loss, Thyroid function test, Thyroxine normal
Clinical narrative: In early JUL 2014, patient returned to training. (Hx of GBS in APR 2014 VAERS filed. On approximately 10 JUL 2014, patient experienced URI symptoms including cough, runny nose, dull headache, and mild body aches; he did not seek care for these symptoms. On 18 JUL 2014, patient received TWINRIX (dose #2) and IPV vaccines. On 19 JUL 2014, patient awoke with numbness of his hands and feet with mild LE weakness. On 21 JUL 2014, patient sought evaluation for these symptoms, which had not progressed, and was subsequently admitted. During his hospitalization, patient again received a 5-day course of IVIG. His EMG on 22 JUL 2014, showed evidence of acquired SM demyelinating polyradiculopathy of the lower and upper limbs, and his differential diagnosis included recurrent GBS vs. Chronic Inflammatory Demyelinating Neuropathy (CIDP). At time of discharge on 26 JUL 2014, patient's symptoms had nearly resolved except for some paresthesias; his upper and lower extremity strength was reported as 5/5. On 28 JUL 2014, patient reported decreased sensation to palmar aspects of fingers and thumb on both hands, decreased sensation to toes and soles of both feet, and mild weakness of legs. He also felt his gait was slightly impaired due to weakness in his legs. On 18 AUG 2014, patient continued to report tingling in bilateral feet/toes and hands, but no numbness or weakness. By 09 SEP 2014, all of patient's symptoms had resolved. On 17 OCT 2014, a follow-up Neurology evaluation was completed by Dr. At that time, patient's physical exam was normal, but his EMG of bilateral upper and lower limbs was abnormal, showing "electrophysiologic evidence of generalized sensorimotor peripheral neuropathy with demyelinating features." This EMG, however, was significantly improved from his EMG of 22 JUL 2014. In Nov 2014, patient was reassigned and he is currently awaiting physical evaluation. He exercises daily and denies any residual symptoms.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Throbbing, hot pain at injection site, went to urgent care 10/27/14, placed on anti-inflammatories, FU private MD 11/10 on MEDROL and anti-inflammatories. To FU early 2015.
Age: 0.86
Sex: F
Vaccine: FLU3, MMR
Symptoms: Pyrexia, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: On 12/20/14 patient developed fever to 101 degrees, red macular-papular rash that started at hairline and progressed down trunk over 2 days. Fever resolved after 24 hrs. Rash fading out by 2-3 days. Patient did well, no treatment.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Peripheral swelling
Clinical narrative: Swelling of (R) arm after injection - was seen in emergency room - supportive care.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Musculoskeletal pain, Pain in extremity
Clinical narrative: Sept 9 - received flu shot, Sept 11 - asked when pain would stop. Severe pain in upper arm, shoulder, and collar bone, continued burning sensation in all of arm - contacted PCP 1 month after shot.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local rxn, arm was hot, red, inflamed, swelled to size of softball at ZOSTAVAX injection site.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Full blood count, Henoch-Schonlein purpura, Laboratory test normal, Pyrexia, Rash
Clinical narrative: Patient developed HSP on 12-18-14. No UA or kidney findings as of 12-23-14. BP NL. He did also have viral illness 2 wks prior to rash w/ fever then.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Red blood cell sedimentation rate increased, Viral infection
Clinical narrative: Patient developed HSP on 12-18-14. No UA or kidney findings as of 12-23-14. BP NL. He did also have viral illness 2 wks prior to rash w/ fever then.
Age: 31.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Diagnosed with cellullitis to left arm at site of injection.
Age: 91.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Enterococcus test positive, Injection site abscess, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Injection site was swollen, red and tender, cellulitis/abcess at injection site. Patient received injection and was discharged to nursing home facility and re-admitted next day with elevated WBC of 21,500 (urine culture positive also).
Age: 91.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, White blood cell count increased
Clinical narrative: Injection site was swollen, red and tender, cellulitis/abcess at injection site. Patient received injection and was discharged to nursing home facility and re-admitted next day with elevated WBC of 21,500 (urine culture positive also).
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Soreness, swelling around injection.
Age: 64.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Dyspnoea, Rash
Clinical narrative: Patient broke out in a rash a couple hours later, had trouble breathing, eyes were partially shut. Patient felt better after using Benadryl. Patient is very sensitive to medications and the last time she got vaccinated (about 15 years ago), she also had an allergic reaction.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Pain in extremity, Skin warm
Clinical narrative: At the shot area it became red. The red area was getting bigger going down my arm, it was hot and it hurt. Went to walk in. The Dr gave me Cephalexin, 500 mg 4 times a day per 10 days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection given on 12-17-14. On 12-19-14 patient noticed 4-5 cm red raised area around injection site. Area sore, slept on that arm. No itching. Area also looked a little lumpy.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Chickenpox diagnosed despite vaccination.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Large amount of swelling noted in the.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Itching, broke out, swelling at site. TYLENOL at home. Steroids given at ER. (Prednisone, BENADRYL, PEPCID in ER)
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Nausea, Pain, Vomiting
Clinical narrative: Sweats, chills, nausea, vomiting, achy.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Initial report was received on 08 November 2013 from a health care professional. A two month-old patient who had no illness at the time of vaccination had received on 04 November 2013 the following vaccines: an intramuscular dose 1 injection of DAPTACEL, lot number C4452AA (site of administration not reported), ACTHIB (lot number, route and site of administration not reported), IPOL (lot number, route and site of administration not reported), PREVNAR (other manufacturer, lot number, route and site of administration not reported) and Rotavirus (other manufacturer, lot number, route and site of administration not reported) and two days later on 06 November 2013, the baby had inconsolable crying for 12 hours and was taken to the ER and was then hospitalized for observation (dates not reported). No further information was available at the time of the event. The patient's outcome was not recovered/unknown. Follow up information received from a healthcare professional on 17 December 2013. The responsible physician contact number update. The patient had received dose 1 of ACTHIB vaccine (lot number: UH849AA), dose 1 of IPOL vaccine (lot number: H1605), dose 1 of PREVENAR vaccine (manufacturer: Pfizer, lot number: 652010) and an oral dose 1 of Rotavirus vaccine (manufacturer: Merck, lot number: H016259). Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Local reaction, Rash erythematous
Clinical narrative: Localized injection site reaction. Slight swelling and small red bumps around injection site. Patient applied cold compress and was advised to take an antihistamine. Also advised to follow up with her primary care physician if the rash worsened or any systemic events occurred.
Age: 20.0
Sex: F
Vaccine: FLUN4
Symptoms: Swelling face, Urticaria
Clinical narrative: Patient broke out in hives and "got puffy in her face" - 1 1/2 hrs after receiving the nasal flu vaccine.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Oedema peripheral, Skin warm, Swelling
Clinical narrative: About 8hrs after vaccine developed tenderness, swelling, erythemas warmth. Symptoms from elbow to upper arm with SOB T98 BP 120/84 P66. PE: NAD non toxic. Left upper ext: with edema, warmth, erythema over lateral portion. No ulcers. no target lesions imp: Cl oral: no lesions. Tx = NAPROSYN, prednisone taper.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: About 8hrs after vaccine developed tenderness, swelling, erythemas warmth. Symptoms from elbow to upper arm with SOB T98 BP 120/84 P66. PE: NAD non toxic. Left upper ext: with edema, warmth, erythema over lateral portion. No ulcers. no target lesions imp: Cl oral: no lesions. Tx = NAPROSYN, prednisone taper.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Rash erythematous
Clinical narrative: After receiving PNEUMOVAX injection on 12-24-14 noticed a red rash under arm and spreading up towards arm pit area. As of 12-29-14 problem has resolved.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Gingival swelling, Oral mucosal blistering, Pyrexia
Clinical narrative: After receiving influenza vaccine (IM) on 11/25/14 patient developed a few days of fever, gum swelling, and mouth blisters. Resolved within one week. No previous adverse reaction to flu shot given in 2010.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Expired product administered
Clinical narrative: I gave outdated KINRIX - Exp. date was 11-23-14 I told father and he will bring child in one month for repeat dose.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Expired product administered
Clinical narrative: I gagve outdated KINRIX. Exp. date was 11-23-14 I told father and he will bring child back in 1 month to repeat dose.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt developed intense pain in left shoulder within an hour of getting vaccine, unable to lift arm, had redness and swelling in upper arm.
Sex: U
Vaccine: TYP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 23 July 2013. A patient was administered TYPHIM VI vaccine 1 week ago and then was given another dose on 23 July 2013 by mistake. No information was provided regarding the patients. No adverse event was reported. List of documents held by sender: none.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, hard lump, and pain at injection site. Took Aleve to alleviate pain.
Age: 50.0
Sex: F
Vaccine: HEPA, IPV, TDAP, TYP, YF
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Initial report received on 23 September 2013 from a health care professional. A female patient whose medical history included hypothyroidism and gastro esophageal reflux disease (GERD), concomitant medications were not reported, received a dose of YF-VAX (lot number UH667AA) at left subcutaneous, IPOL (lot number H1340-1) at right SQ arm, TYPHIM Co (lot number G1541-1) at right delt, ADACEL (lot number C4426AA) at right delt and hepatitis A vaccine (lot number AHAVB672AA) at left delt from 09-Sep-2013. After vaccination, on 16-Sep-2013 patient experienced a silver dollar sized area of redness and induration, hot to the touch, tender, that has lasted 2 weeks. The event was ongoing. List of documents held by sender: none.
Sex: M
Vaccine: TDAP, TYP
Symptoms: Back pain, Body temperature increased, Neck pain, Pain in extremity
Clinical narrative: Initial information was received from a consumer on 19 September 2013. A adult male patient (age not reported), had no medical history reported, received a dose of ADACEL vaccine (route, Dose, site of administration and batch number were not reported) and TYPHIM VI (route, Dose, Site of administration and batch number were not reported) on 17 September 2013. Patient had no concomitant medication reported. It was reported that the on 19 September 2013 patient had experienced sore arm, neck and back as well as a temperature was recorded of 100.4. At the time of report the outcome of event was unknown. List of document reported was none. Company Comment: Lab Tests: Test Name Coll. Date Result Unit Low Value High Value. Body temperature 19-SEP-2013 100.4 Unknown Unknown Unknown. Confirmatory Tests:
Age: 54.0
Sex: F
Vaccine: TDAP, TYP, YF
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Initial misuse report received on 25 October 2013 from a health care professional. A 54-year-old female adult whose medical history and concomitant medications were not reported, received at unspecified site dose of YF-VAX (lot number UH668AA, expiry date unknown and site of vaccination left upper arm SQ), received at intramuscular dose above YF site of TYPHIM VI (lot number J0501-1, expiry date unknown and site of vaccination left arm SQ) and received at unspecified site dose of BOOSTRIX (lot number AC52B110CA, expiry date unknown and site of vaccination right upper arm) on 18 October 2013, IM. Nurse reported that a patient, a week after she received the vaccine, developed redness and induration, at the injection site of the YF-VAX, 5cm area, getting bigger. No testing, treatment. No reaction was reported. List of documents held by sender: none.
Sex: U
Vaccine: TYP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 14 November 2013. It was reported that TYPHIM VI was inadvertently administered to a 14-month-old patient thinking that the patient was a 2 year-old. No adverse event was reported. List of documents held by sender: none.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Blood creatinine, Blood immunoglobulin G, Blood thyroid stimulating hormone, Brain natriuretic peptide, C-reactive protein
Clinical narrative: On 11/26/2014 was light headed, dizzy and began experiencing bilateral lower extremity weakness.  On 12/01/20147 symptoms worsened and additional symptoms of tachycardia, chest pain, shortness of breath, and unsteady gait noted. Appointment on 12/03/2014 with PCP labs obtained. Referred to Neurology. 12/12/2014 - Emergency room visit due to worsening symptoms as per neurology recommendations. MRI, performed. 12/16/2014-Neurology clinic visit. 12/19/2014 - Lumbar puncture. 12/30/2014 - cardiology evaluation (Holter monitor ordered).
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: CSF culture, Chest pain, Cytomegalovirus test, Dizziness, Dyspnoea
Clinical narrative: On 11/26/2014 was light headed, dizzy and began experiencing bilateral lower extremity weakness.  On 12/01/20147 symptoms worsened and additional symptoms of tachycardia, chest pain, shortness of breath, and unsteady gait noted. Appointment on 12/03/2014 with PCP labs obtained. Referred to Neurology. 12/12/2014 - Emergency room visit due to worsening symptoms as per neurology recommendations. MRI, performed. 12/16/2014-Neurology clinic visit. 12/19/2014 - Lumbar puncture. 12/30/2014 - cardiology evaluation (Holter monitor ordered).
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Electrocardiogram ambulatory, Full blood count, Gait disturbance, Metabolic function test, Muscular weakness
Clinical narrative: On 11/26/2014 was light headed, dizzy and began experiencing bilateral lower extremity weakness.  On 12/01/20147 symptoms worsened and additional symptoms of tachycardia, chest pain, shortness of breath, and unsteady gait noted. Appointment on 12/03/2014 with PCP labs obtained. Referred to Neurology. 12/12/2014 - Emergency room visit due to worsening symptoms as per neurology recommendations. MRI, performed. 12/16/2014-Neurology clinic visit. 12/19/2014 - Lumbar puncture. 12/30/2014 - cardiology evaluation (Holter monitor ordered).
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Red blood cell sedimentation rate, Tachycardia, Thyroid function test
Clinical narrative: On 11/26/2014 was light headed, dizzy and began experiencing bilateral lower extremity weakness.  On 12/01/20147 symptoms worsened and additional symptoms of tachycardia, chest pain, shortness of breath, and unsteady gait noted. Appointment on 12/03/2014 with PCP labs obtained. Referred to Neurology. 12/12/2014 - Emergency room visit due to worsening symptoms as per neurology recommendations. MRI, performed. 12/16/2014-Neurology clinic visit. 12/19/2014 - Lumbar puncture. 12/30/2014 - cardiology evaluation (Holter monitor ordered).
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Thyroxine free, Troponin
Clinical narrative: On 11/26/2014 was light headed, dizzy and began experiencing bilateral lower extremity weakness.  On 12/01/20147 symptoms worsened and additional symptoms of tachycardia, chest pain, shortness of breath, and unsteady gait noted. Appointment on 12/03/2014 with PCP labs obtained. Referred to Neurology. 12/12/2014 - Emergency room visit due to worsening symptoms as per neurology recommendations. MRI, performed. 12/16/2014-Neurology clinic visit. 12/19/2014 - Lumbar puncture. 12/30/2014 - cardiology evaluation (Holter monitor ordered).
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Urticaria, Vomiting
Clinical narrative: Vomiting and diarrhea, hives starting that evening and going through the next morning.
Age: 0.14
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Abdominal discomfort, Abdominal distension, Decreased eye contact, Dermatitis, Diarrhoea
Clinical narrative: She slept almost continuously for about 18 hours following the vaccines, we had to wake her to eat (which had never happened before). She then began to wake for about an hour and sleep for about an hour for the next 4 days.  When she woke up on day two, she had a few hours where she didn't/couldn't make eye contact with anyone, something very strange for her.  Also, for about 3 days her hearing abilities were reduced, and then they began to come back.  On about day 3 after the vaccines her arms began to shake for about a day and a half. Her eyes were glassy and the whites of her eyes slightly off-colour for about a week and a half.  Digestion upset even now (one month after the vaccines).  She began to spit up very frequently, and large amounts, and had (especially the first two weeks after the vaccines) very painful gas and bowel movements.  One week after the vaccines, she had severe diarrhea and skin from her bottom seemed to have burnt off - with no change in mom's diet other than a reduction in soy around the same time (she is breastfed exclusively).  Two weeks after the vaccines, she had blood in her stool.  It took her three weeks to socialize as she did before the vaccines.  She remains much fussier than before the vaccines and with a much more sensitive digestive system.  We have decided to see natural doctors to help her digestion improve and to help her detox.  Probiotics have been recommended, we will start them tomorrow, and diluted apple cider vinegar.  We will also give her homeopathy to help her detox.  We will not vaccinate again due to these reactions.  We will continue to monitor to determine whether there are any other lasting reactions.  (Also noteworthy is that we called the pediatrician's office on three separate occasions with concerns in particular about the vomiting and digestive issues but were always told to continue waiting, that if she were moving her bowels and urinating that she would be fine.  At one point a nurse recommended that we go to the emergency room (after the blood in the stool), but we decided not to add more trauma to the situation and instead sought alternative doctors to help us.
Age: 0.14
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Glassy eyes, Haematochezia, Hypersomnia, Hypoacusis, Incomplete course of vaccination
Clinical narrative: She slept almost continuously for about 18 hours following the vaccines, we had to wake her to eat (which had never happened before). She then began to wake for about an hour and sleep for about an hour for the next 4 days.  When she woke up on day two, she had a few hours where she didn't/couldn't make eye contact with anyone, something very strange for her.  Also, for about 3 days her hearing abilities were reduced, and then they began to come back.  On about day 3 after the vaccines her arms began to shake for about a day and a half. Her eyes were glassy and the whites of her eyes slightly off-colour for about a week and a half.  Digestion upset even now (one month after the vaccines).  She began to spit up very frequently, and large amounts, and had (especially the first two weeks after the vaccines) very painful gas and bowel movements.  One week after the vaccines, she had severe diarrhea and skin from her bottom seemed to have burnt off - with no change in mom's diet other than a reduction in soy around the same time (she is breastfed exclusively).  Two weeks after the vaccines, she had blood in her stool.  It took her three weeks to socialize as she did before the vaccines.  She remains much fussier than before the vaccines and with a much more sensitive digestive system.  We have decided to see natural doctors to help her digestion improve and to help her detox.  Probiotics have been recommended, we will start them tomorrow, and diluted apple cider vinegar.  We will also give her homeopathy to help her detox.  We will not vaccinate again due to these reactions.  We will continue to monitor to determine whether there are any other lasting reactions.  (Also noteworthy is that we called the pediatrician's office on three separate occasions with concerns in particular about the vomiting and digestive issues but were always told to continue waiting, that if she were moving her bowels and urinating that she would be fine.  At one point a nurse recommended that we go to the emergency room (after the blood in the stool), but we decided not to add more trauma to the situation and instead sought alternative doctors to help us.
Age: 0.14
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Infantile spitting up, Insomnia, Irritability, Painful defaecation, Scleral discolouration
Clinical narrative: She slept almost continuously for about 18 hours following the vaccines, we had to wake her to eat (which had never happened before). She then began to wake for about an hour and sleep for about an hour for the next 4 days.  When she woke up on day two, she had a few hours where she didn't/couldn't make eye contact with anyone, something very strange for her.  Also, for about 3 days her hearing abilities were reduced, and then they began to come back.  On about day 3 after the vaccines her arms began to shake for about a day and a half. Her eyes were glassy and the whites of her eyes slightly off-colour for about a week and a half.  Digestion upset even now (one month after the vaccines).  She began to spit up very frequently, and large amounts, and had (especially the first two weeks after the vaccines) very painful gas and bowel movements.  One week after the vaccines, she had severe diarrhea and skin from her bottom seemed to have burnt off - with no change in mom's diet other than a reduction in soy around the same time (she is breastfed exclusively).  Two weeks after the vaccines, she had blood in her stool.  It took her three weeks to socialize as she did before the vaccines.  She remains much fussier than before the vaccines and with a much more sensitive digestive system.  We have decided to see natural doctors to help her digestion improve and to help her detox.  Probiotics have been recommended, we will start them tomorrow, and diluted apple cider vinegar.  We will also give her homeopathy to help her detox.  We will not vaccinate again due to these reactions.  We will continue to monitor to determine whether there are any other lasting reactions.  (Also noteworthy is that we called the pediatrician's office on three separate occasions with concerns in particular about the vomiting and digestive issues but were always told to continue waiting, that if she were moving her bowels and urinating that she would be fine.  At one point a nurse recommended that we go to the emergency room (after the blood in the stool), but we decided not to add more trauma to the situation and instead sought alternative doctors to help us.
Age: 0.14
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Tremor, Vomiting
Clinical narrative: She slept almost continuously for about 18 hours following the vaccines, we had to wake her to eat (which had never happened before). She then began to wake for about an hour and sleep for about an hour for the next 4 days.  When she woke up on day two, she had a few hours where she didn't/couldn't make eye contact with anyone, something very strange for her.  Also, for about 3 days her hearing abilities were reduced, and then they began to come back.  On about day 3 after the vaccines her arms began to shake for about a day and a half. Her eyes were glassy and the whites of her eyes slightly off-colour for about a week and a half.  Digestion upset even now (one month after the vaccines).  She began to spit up very frequently, and large amounts, and had (especially the first two weeks after the vaccines) very painful gas and bowel movements.  One week after the vaccines, she had severe diarrhea and skin from her bottom seemed to have burnt off - with no change in mom's diet other than a reduction in soy around the same time (she is breastfed exclusively).  Two weeks after the vaccines, she had blood in her stool.  It took her three weeks to socialize as she did before the vaccines.  She remains much fussier than before the vaccines and with a much more sensitive digestive system.  We have decided to see natural doctors to help her digestion improve and to help her detox.  Probiotics have been recommended, we will start them tomorrow, and diluted apple cider vinegar.  We will also give her homeopathy to help her detox.  We will not vaccinate again due to these reactions.  We will continue to monitor to determine whether there are any other lasting reactions.  (Also noteworthy is that we called the pediatrician's office on three separate occasions with concerns in particular about the vomiting and digestive issues but were always told to continue waiting, that if she were moving her bowels and urinating that she would be fine.  At one point a nurse recommended that we go to the emergency room (after the blood in the stool), but we decided not to add more trauma to the situation and instead sought alternative doctors to help us.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Convulsion, Dizziness postural, Extremity contracture, Fall, Fatigue
Clinical narrative: Patient received Menactra injection in R deltoid, tolerated well; then Gardasil injection in L deltoid, which she tolerated, but became tearful after injection stating that it hurt. Approximately 1 minute after injection, while seated, she appeared tired as her eyelids began to close, her head started to roll forward (chin dropping towards chest), and she became floppy. She was immediately supported and laid supine on the exam table, legs were extended & then lifted. Momentarily after being supine her arms became tonic, in flexed position from elbows (to approx 45 degrees, not tightly or fully flexed), and her legs also had tonic extension. There was no clonic activity or eye-rolling, no facial activity. This lasted for 25 seconds, after which she opened her eyes fully, and a moment later became tearful, realizing that she'd "fallen" & needed support. She had no recollection of being helped to supine or of seizure. She was tired & felt nauseous afterwards, then hungry after ~30-45min. She was kept supine for at least 20min, not feeling like sitting up. When she did sit up, she felt "dizzy" and was laid supine again for another 20min at least, she was given some candy & felt better. When she was slowly moved into sitting upright her bp was 84/58 with heartrate 100, though her heartrate during the syncopal/seizure episode was closer to 60. There was never any central cyanosis. She was able to tolerate sitting upright shortly thereafter, close to 1h after injections.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hypotonia, Nausea, Pain, Posture abnormal, Syncope
Clinical narrative: Patient received Menactra injection in R deltoid, tolerated well; then Gardasil injection in L deltoid, which she tolerated, but became tearful after injection stating that it hurt. Approximately 1 minute after injection, while seated, she appeared tired as her eyelids began to close, her head started to roll forward (chin dropping towards chest), and she became floppy. She was immediately supported and laid supine on the exam table, legs were extended & then lifted. Momentarily after being supine her arms became tonic, in flexed position from elbows (to approx 45 degrees, not tightly or fully flexed), and her legs also had tonic extension. There was no clonic activity or eye-rolling, no facial activity. This lasted for 25 seconds, after which she opened her eyes fully, and a moment later became tearful, realizing that she'd "fallen" & needed support. She had no recollection of being helped to supine or of seizure. She was tired & felt nauseous afterwards, then hungry after ~30-45min. She was kept supine for at least 20min, not feeling like sitting up. When she did sit up, she felt "dizzy" and was laid supine again for another 20min at least, she was given some candy & felt better. When she was slowly moved into sitting upright her bp was 84/58 with heartrate 100, though her heartrate during the syncopal/seizure episode was closer to 60. There was never any central cyanosis. She was able to tolerate sitting upright shortly thereafter, close to 1h after injections.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Tearfulness
Clinical narrative: Patient received Menactra injection in R deltoid, tolerated well; then Gardasil injection in L deltoid, which she tolerated, but became tearful after injection stating that it hurt. Approximately 1 minute after injection, while seated, she appeared tired as her eyelids began to close, her head started to roll forward (chin dropping towards chest), and she became floppy. She was immediately supported and laid supine on the exam table, legs were extended & then lifted. Momentarily after being supine her arms became tonic, in flexed position from elbows (to approx 45 degrees, not tightly or fully flexed), and her legs also had tonic extension. There was no clonic activity or eye-rolling, no facial activity. This lasted for 25 seconds, after which she opened her eyes fully, and a moment later became tearful, realizing that she'd "fallen" & needed support. She had no recollection of being helped to supine or of seizure. She was tired & felt nauseous afterwards, then hungry after ~30-45min. She was kept supine for at least 20min, not feeling like sitting up. When she did sit up, she felt "dizzy" and was laid supine again for another 20min at least, she was given some candy & felt better. When she was slowly moved into sitting upright her bp was 84/58 with heartrate 100, though her heartrate during the syncopal/seizure episode was closer to 60. There was never any central cyanosis. She was able to tolerate sitting upright shortly thereafter, close to 1h after injections.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal
Clinical narrative: On 12/23/14, patient received inactivated influenza vaccine 1:34 pm (right deltoid), and pneumo23 vaccine ~5:30pm (left deltoid).  On 12/24/14 ~1am, woke up with severe 10/10 new left shoulder pain, morning vitals temp 100.4, HR 112, BP 147/107. 12/25/14 Fever resolved ~3am.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood creatine phosphokinase normal, Blood culture negative, C-reactive protein increased, Electrocardiogram normal, Full blood count normal
Clinical narrative: On 12/23/14, patient received inactivated influenza vaccine 1:34 pm (right deltoid), and pneumo23 vaccine ~5:30pm (left deltoid).  On 12/24/14 ~1am, woke up with severe 10/10 new left shoulder pain, morning vitals temp 100.4, HR 112, BP 147/107. 12/25/14 Fever resolved ~3am.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Metabolic function test normal, Pyrexia, Red blood cell sedimentation rate increased, Staphylococcus test negative
Clinical narrative: On 12/23/14, patient received inactivated influenza vaccine 1:34 pm (right deltoid), and pneumo23 vaccine ~5:30pm (left deltoid).  On 12/24/14 ~1am, woke up with severe 10/10 new left shoulder pain, morning vitals temp 100.4, HR 112, BP 147/107. 12/25/14 Fever resolved ~3am.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Thyroid function test normal, Troponin normal, X-ray limb normal
Clinical narrative: On 12/23/14, patient received inactivated influenza vaccine 1:34 pm (right deltoid), and pneumo23 vaccine ~5:30pm (left deltoid).  On 12/24/14 ~1am, woke up with severe 10/10 new left shoulder pain, morning vitals temp 100.4, HR 112, BP 147/107. 12/25/14 Fever resolved ~3am.
Age: 22.0
Sex: M
Vaccine: ANTH, FLUX, HEPA, YF
Symptoms: Anxiety, Arthritis, Blood testosterone decreased, Craniocerebral injury, Diverticulum
Clinical narrative: 2004 tuberculosis; 2009 neuro cardiovascular genic syncope; 2009 PTSD; 2009-current multiple TBI's; 2010 anxiety and stress disorder; 2010 arthritis in spine; 2010 degenerative disk disease; 2010 eroded duodenum; 2010 IBS; 2010 3in part of muscle /tendons pulled off spine; 2010 extremely low testosterone still ongoing; 2010 has a large pocket in intestines; 2010-current low immune system; 2009 clinically mutated foot; 2010 unexplained hives.
Age: 22.0
Sex: M
Vaccine: ANTH, FLUX, HEPA, YF
Symptoms: Immune system disorder, Intervertebral disc degeneration, Irritable bowel syndrome, Muscle strain, Musculoskeletal disorder
Clinical narrative: 2004 tuberculosis; 2009 neuro cardiovascular genic syncope; 2009 PTSD; 2009-current multiple TBI's; 2010 anxiety and stress disorder; 2010 arthritis in spine; 2010 degenerative disk disease; 2010 eroded duodenum; 2010 IBS; 2010 3in part of muscle /tendons pulled off spine; 2010 extremely low testosterone still ongoing; 2010 has a large pocket in intestines; 2010-current low immune system; 2009 clinically mutated foot; 2010 unexplained hives.
Age: 22.0
Sex: M
Vaccine: ANTH, FLUX, HEPA, YF
Symptoms: Peptic ulcer, Post-traumatic stress disorder, Stress, Syncope, Tuberculosis
Clinical narrative: 2004 tuberculosis; 2009 neuro cardiovascular genic syncope; 2009 PTSD; 2009-current multiple TBI's; 2010 anxiety and stress disorder; 2010 arthritis in spine; 2010 degenerative disk disease; 2010 eroded duodenum; 2010 IBS; 2010 3in part of muscle /tendons pulled off spine; 2010 extremely low testosterone still ongoing; 2010 has a large pocket in intestines; 2010-current low immune system; 2009 clinically mutated foot; 2010 unexplained hives.
Age: 22.0
Sex: M
Vaccine: ANTH, FLUX, HEPA, YF
Symptoms: Urticaria
Clinical narrative: 2004 tuberculosis; 2009 neuro cardiovascular genic syncope; 2009 PTSD; 2009-current multiple TBI's; 2010 anxiety and stress disorder; 2010 arthritis in spine; 2010 degenerative disk disease; 2010 eroded duodenum; 2010 IBS; 2010 3in part of muscle /tendons pulled off spine; 2010 extremely low testosterone still ongoing; 2010 has a large pocket in intestines; 2010-current low immune system; 2009 clinically mutated foot; 2010 unexplained hives.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients was vaccinated with VAQTA (doses and lot numbers not reported), intramuscularly. The nurse noted that unspecified number of patients were administered the booster dose of VAQTA "several days too early" (earlier than 6 to 18 months after the primary dose) on unspecified dates. No adverse effects were reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: FLUX, HEPAB, TYP
Symptoms: Vaccination complication
Clinical narrative: This case concerns a legal case. Initial report received from a non-healthcare professional on 04 December 2013. A patient of unspecified demographics, whose medical history and concomitant medications were not reported, had received a dose of TYPHIM, Influenza vaccine from other manufacturer and Hepatitis A+B vaccine from other manufacturer (route, dose number, batch number and anatomical site of vaccination of all vaccines was not reported) on an unspecified date. On an unspecified date, the patient had developed unspecified adverse reaction after receiving vaccines. The corrective treatments and laboratory investigations were not reported. The outcome of the event was not reported. List of documents held by the sender is none.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Fall
Clinical narrative: Patient received GARDASIL injection with no initial problem. Patient stood-up, put on coat and stood in hallway for a minute and then felt dizzy an fell backwards onto floor.
Sex: U
Vaccine: TYP
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a Healthcare professional on 27 January 2014. The case was received on 21 March 2014 at GPV. This is an invalid case as individual patient identifiers are not reported. A TYPHIM VI was given subcutaneously. (No information was provided regarding the patients). No adverse event was reported. List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: TYP
Symptoms: Oropharyngeal pain, Pharyngeal disorder, Pharyngeal oedema
Clinical narrative: Initial report received from a healthcare professional on 08 May 2014. A 16-year-old female patient had received a dose of TYPHIM, (batch number, dose number, route and site of vaccination not reported) on 07 May 2014. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. On 07 May 2014, same day after vaccination, the patient's throat was sore, swollen and had brown and yellow stripes in the back of the throat. The patient reported not feeling well the last few days before injection with throat soreness. Laboratory details were not reported. The patient received BENADRYL as treatment. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow up information received from the healthcare professional on 30 June 2014. A 17-years-old patient had received an intramuscular dose of 0.5 ml of TYPHIM vaccine (batch number: J1631-1 and expiry date: 26 October 2015) in the left deltoid. On an unspecified date the patient was recovered.
Age: 13.0
Sex: M
Vaccine: TYP
Symptoms: Epistaxis
Clinical narrative: Initial report received from a health care professional on 30 April 2014. A 13-years-old male patient, had received a dose of TYPHIM VI (Lot number: K1183-1) intramuscularly in the left deltoid on 25 April 2014. The patient does not have any illness at the time of vaccination and pre-existing physician diagnosed allergie, birth defects, medical conditions was unknown. The patient's mother reported that the patient had nose bleeds on 26 April 2014 and was told that it was unrelated to vaccine. Corrective treatment and laboratory details were not reported. At the time of this report, the event was not recovered. Documents held by sender: None.
Sex: U
Vaccine: ANTH, TYP
Symptoms: Adverse event
Clinical narrative: Initial report received from a non-health care professional on 17 April 2014. A patient whose demographic details including initials, age, gender and date of birth not reported had received a dose of TYPHIM VI (Lot number, dose number, route and site of vaccination not reported) on an unspecified date. A patient had received ANTHRAX and Typhoid vaccine and experienced adverse event. It was also reported that three patients were vaccinated with ANTHRAX and Varicella and the fifth person was vaccinated with just ANTHRAX. The laboratory details and corrective treatment were unknown. At the time of this report the outcome of the adverse event was unknown. Documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: HEP, TDAP, TYP, YF
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Initial report received from a healthcare professional on 06 February 2014. A 69-years-old female patient, whose medical history and concomitant medications were not reported, had received subcutaneous dose of YF-VAX (batch number: UH674AA) in the right deltoid and received intramuscular dose of TYPHIM Vi (batch number: J0520-1) in left deltoid and received intramuscular dose of Hepatitis B (manufacturer: unknown, batch number: AHBUC104AA) in right deltoid, all on 23 January 2014. On 23 January 2014, the patient presented red area at injection site approximately 3 cm, tender at site. Corrective treatment and laboratory data were not reported. As of 06 February 2014, the patient had not recovered from the event. Documents held by sender: None. Follow-up information received from healthcare professional on 03 April 2014. It was reported that, the patient received YF-VAX in right upper arm. On 23 January 2014, the patient also received TDAP, batch number: C4347AA (route and anatomical site of administration were not reported) in right deltoid. The patient did not receive any other vaccination within 4weeks prior to vaccination. It was reported that, the arm was recovered within 2 weeks to normal appearance.
Age: 28.0
Sex: F
Vaccine: TYP, YF
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial report received from a Healthcare professional on 06 February 2014. A 28-years-old female patient, whose medical history and concomitant medications were not reported, had received subcutaneous dose of YF-VAX (batch number: UH674AA) in right deltoid on 30 January 2014, had received VIVOTIF (manufacture: Other, batch number: 3000691) orally, on 30 January 2014. On 30 January 2014, the patient presented injection site soreness, redness and swelling. Corrective treatment and laboratory data were not reported. As of 06 February 2014, the patient had not recovered from the event. Documents held by sender: none. Follow up information was received on 03 April 2014: The patient received YF-VAX in to the right upper arm and not in to the deltoid right as reported as earlier. It was updated that the event was informed on a phone call. This case is linked with the case number 2014SA016136 and 2014SA016153.
Age: 52.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Injection site erythema, Injection site pain, Tenderness
Clinical narrative: Initial report received from a Healthcare professional on 06 February 2014. A 52-years-old female patient, whose medical history and concomitant medications were not reported, had received subcutaneous dose of YF-VAX (batch number: UH674AA) in right deltoid on 30 January 2014, had received VIVOTIF (manufacture: other, batch number: 3000691, route and site of administration was not reported) and received intramuscular dose of Hepatitis A (manufacture: Unknown, batch number: AHAVB566AN) in left deltoid on 30 January 2014. On 30 January 2014, the patient presented injection site pain, redness described as about 3 cm in diameter. Corrective treatment and laboratory data were not reported. As of 06 February 2014, the patient had not recovered from the event. Documents held by sender: none. Follow-up information received from healthcare professional on 03 April 2014. The patient's initial were updated. The YF-VAX vaccine lot number was UH674AA and expiry date was 11 February 2015. Patient's upper arm remained red and tender for approximately 10 days and on an unspecified date (within 2 weeks) the arm required to normal appearance. Follow-up information received from healthcare professional on 06 May 2014: No laboratory tests were performed.
Sex: F
Vaccine: HEPAB, PPV, RAB, TYP
Symptoms: Injection site erythema
Clinical narrative: Initial report received from healthcare professional on 19 December 2013. A female patient whose age, medical history and concomitant medications were not reported, received IMOVAX intramuscularly in right deltoid, TYPHIM VI in left deltoid, PNEUMOVAX in right deltoid and TWINRIX in right deltoid (lot number, expiration date unknown) on 16 December 2013. On 17 December 2013, Patient reported that redness on the right arm from injection site up to shoulder. Laboratory investigations and corrective treatment were not reported. As of this report, the patient was recovered from the events. Documents held by sender: none.
Sex: U
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received on 13-Dec-2013 from a health care professional. An unknown patient whose medical history and concomitant medications were not reported, received TUBERSOL (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that the expired TYPHIM VI vaccine was given to the patient thus, expired vaccine was used. No reaction was reported. List of documents held by sender: none.
Sex: F
Vaccine: HEP, TYP
Symptoms: Fatigue, Malaise
Clinical narrative: Initial report received from healthcare professional on 12 December 2013. A female patient, who age, medical history and concomitant medications were not reported, received TYPHIM VI (lot number, expiration date, route and site of administration were unknown) on an unknown date. Patient also received Hepatitis B on an unknown date. On an unknown date, patient experienced malaise and fatigue. Laboratory investigation and corrective treatment were not reported. As of this report, the patient was not recovered from the events. Documents held by sender: none.
Sex: U
Vaccine: TYP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a health care professional on 11 July 2014. A patient whose age, gender, medical history and concomitant medication were not reported received a dose of TYPHIM VI (lot number, expiration date, route, site of vaccination were not reported) on 11 July (year unspecified). It was reported that the patient received TYPHIM VI on 19 June (year unspecified) and also on 11 July (1 year unspecified) hence received an extra dose of the vaccine. No adverse event were reported. Documents held by the sender were none.
Sex: F
Vaccine: PPV, TYP, YF
Symptoms: Vaginal discharge
Clinical narrative: Initial report received from healthcare professional on 20 June 2014. A female patient, whose age, medical history and concomitant medications not reported, had received a subcutaneous dose of YF VAX (batch number, dose, dose number, and site of vaccination not reported), a dose of pneumococcal vaccine (batch number, dose, dose number, route and site of vaccination not reported) and a dose of VIVOTIF (manufacturer: Crucell, batch number, dose, dose number and site of vaccination not reported) on an unspecified day in June 2014. It was reported that one day after vaccination, patient had a black colored discharge from the vaginal area. She stated the amount of discharge is enough to saturate a tampon. She reported that it was not her monthly menses, which already occurred that month. Lab investigations and corrective treatments were not reported. Outcome of the event was reported as unknown. Documents held by sender: None.