chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia, Streptococcus test, Urine analysis, Vomiting
Clinical narrative: Started out with a sore throat, turned into what felt like the full blown flu. Headache, shortness of breath, vomiting, dehydration, dizziness, bodyaches, chills, fever, muscle aches.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a 59 years old female patient. The patient was vaccinated with ZOSTAVAX (lot# unspecified) on 10-OCT-2012. No other co-suspects were reported. Concomitant medications included acetaminophen, VICODIN, "fish oil" and probenecid. On 25-OCT-2012, the patient was in the doctor's office with a rash that started on her left breast and wrapped around to her back. It was reported that the patient had a burning sensation. The patient was given gabapentin. The outcome of burning sensation and rash was unknown. The events were considered to be other medically significant events by the reporter. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Injection site cellulitis, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 43 years old female patient with pertinent medical history of rheumatoid arthritis. The patient had unspecified drug reactions or allergies. The patient was vaccinated with dose the first dose of PNEUMOVAX 23 (lot number reported as H009826; expired date 11-FEB-2014) intramuscularly for the patient was immunosuppressed on 06-NOV-2012 on unknown injection site. No other co-suspects were reported. Concomitant medications included methotrexate, hydroxychloroquine sulfate and HUMIRA. On 07-NOV-2012 the patient developed cellulitis at the injection site after receiving a first dose of PNEUMOVAX 23. The reporter mentioned the patient came into the pharmacy the day after receiving PNEUMOVAX 23 and had a rash at the injection site and was later admitted to the hospital for worsening symptoms. Treatment information BENADRYL, ice and unspecified antibiotics were given for adverse events. Unspecified blood work performed, and the result was not reported. The patient was not recovered at the time of report. The patient had sought unspecified medical attention. Pharmacist requested a lot check for PNEUMOVAX 23 (lot number H009826; expired date 11-FEB-2014). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Activities of daily living impaired, Central nervous system lesion, Dizziness, Fatigue, Hypoaesthesia
Clinical narrative: 6 days after rec FLUMIST, student c/o nausea and later on developed vomiting - dizziness as reported by his mother. Dx - Bell's palsy & now being worked up by neurology - (+) MRI for brain lesions again as reported to me by his mother. She said the doctor is r/o ADEM or MS. Has numbness Rt hand residual & still out of school to date, fatigue, & light-headed. Hospitalized - IV steroids per mother. Has been out of school since Nov 1 2012.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Laboratory test, Lumbar puncture, Nausea, Nuclear magnetic resonance imaging brain abnormal, VIIth nerve paralysis
Clinical narrative: 6 days after rec FLUMIST, student c/o nausea and later on developed vomiting - dizziness as reported by his mother. Dx - Bell's palsy & now being worked up by neurology - (+) MRI for brain lesions again as reported to me by his mother. She said the doctor is r/o ADEM or MS. Has numbness Rt hand residual & still out of school to date, fatigue, & light-headed. Hospitalized - IV steroids per mother. Has been out of school since Nov 1 2012.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: 6 days after rec FLUMIST, student c/o nausea and later on developed vomiting - dizziness as reported by his mother. Dx - Bell's palsy & now being worked up by neurology - (+) MRI for brain lesions again as reported to me by his mother. She said the doctor is r/o ADEM or MS. Has numbness Rt hand residual & still out of school to date, fatigue, & light-headed. Hospitalized - IV steroids per mother. Has been out of school since Nov 1 2012.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Idiopathic thrombocytopenic purpura, Mumps antibody test negative
Clinical narrative: This spontaneous report was received from a physician regarding an approximately 2 years old female patient. No medical history, drug allergies or reactions were reported. In approximately November 2009 (3 years ago), the patient was vaccinated with a dose of M-M-R II (lot # and route not reported). No concomitant medications were reported. In approximately November 2009 (3 years ago), the patient developed idiopathic thrombocytopenic purpura (ITP) (medically significant). The patient's mumps titer was negative when a titer was taken last month approximately in October 2012. No treatment was given for the adverse events. The patient's present status was reported as recovered. The patient had sought medical attention (unspecified). Upon internal review the event idiopathic thrombocytopenic purpura (ITP) was considered to be medically significant. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: Patient with nausea/vomiting and headache for days after injection. Spike fever on day 4, injection site erythematous and warm, WBC 18, transferred from mental health to inpatient unit to receive empiric antibiotics. Symptoms: Cellulitis. Treatment: Diphenhydramine, Ibuprofen.
Age: 22.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: Patient with nausea/vomiting and headache for days after injection. Spike fever on day 4, injection site erythematous and warm, WBC 18, transferred from mental health to inpatient unit to receive empiric antibiotics. Symptoms: Cellulitis. Treatment: Diphenhydramine, Ibuprofen.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Body temperature increased, Confusional state, Dysstasia, Insomnia
Clinical narrative: Symptoms began the evening of vaccination, unable to sleep, very restless. When he did sleep, very hard to wake up, out of it. Next morning very weak, could hardly stand. Slightly confused. Temp 100.8 on admission to hospital. Given IV fluids and monitored. Hospital stay was one day. Has recovered completely.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Restlessness, Somnolence
Clinical narrative: Symptoms began the evening of vaccination, unable to sleep, very restless. When he did sleep, very hard to wake up, out of it. Next morning very weak, could hardly stand. Slightly confused. Temp 100.8 on admission to hospital. Given IV fluids and monitored. Hospital stay was one day. Has recovered completely.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Amnesia, Confusional state, Electroencephalogram, Lumbar puncture, Nausea
Clinical narrative: Mental confusion-memory loss. Nausea/vomiting. Rt sided facial paralysis. 6 -> 12 hrs til onset. Increased WBC.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: VIIth nerve paralysis, Vomiting, White blood cell count increased
Clinical narrative: Mental confusion-memory loss. Nausea/vomiting. Rt sided facial paralysis. 6 -> 12 hrs til onset. Increased WBC.
Age: 0.51
Sex: M
Vaccine: DTAP, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Appendicectomy, Explorative laparotomy, Intussusception
Clinical narrative: 01/28/12 hospitalization with pyloric stenosis. 1/29/12 laparoscopic pyloromyotomy. 07/05/12 hospitalization with "recurrent intussusception". 7/06/12 exploratory laparotomy, appendectomy.
Age: 85.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Inflammation, Pyrexia, Skin warm, Tenderness
Clinical narrative: ADACEL given 10/30/12 to (L) arm per MD orders. <24 hours - below elbow to upper shoulder red/hot/inflamed, tender. MD ordered SEPTRA DS BID x10 days prior to knowledge of Rx. Then Dc'd and change to ROCEPHIN IV QD x10 days. Fever 100.8 10/31/12.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Laboratory test normal
Clinical narrative: Pt rec'd flu shot at employer hosted worksite event on 10-4-12. Within 3 days, pt experienced seizure, went to ER, adm x1d, all tests WNL.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram head, Computerised tomogram normal, Dyskinesia, Eyelid function disorder, Hypoaesthesia
Clinical narrative: Rt. side of mouth drooping slightly and rt. side of rt eyebrow didn't seem to move. Pt had INR that morning of 3.3 so PA suspected a hemorrhage in brain so did a CAT scan which was negative. The next 3 days symptoms much more pronounced - difficulty in blinking, numbness in rt. cheek & bottom lip & much more paralysis of rt. side of face. REFRESH gel drops & LACRI-LUBE ointment for eye.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, International normalised ratio increased, VIIth nerve paralysis
Clinical narrative: Rt. side of mouth drooping slightly and rt. side of rt eyebrow didn't seem to move. Pt had INR that morning of 3.3 so PA suspected a hemorrhage in brain so did a CAT scan which was negative. The next 3 days symptoms much more pronounced - difficulty in blinking, numbness in rt. cheek & bottom lip & much more paralysis of rt. side of face. REFRESH gel drops & LACRI-LUBE ointment for eye.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Guillain-Barre Syndrome. Vaccination 10/18/12, symptoms began 10/31/12.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Chest pain, Dysphagia, Immediate post-injection reaction, Injection site rash
Clinical narrative: This consumer report (initial receipt: 31-Oct-2012) concerns a 49-year-old male patient. Concomitant medication included testosterone. On 08-Oct-2012 the patient received AFLURIA (batch number was not provided) injection intramuscularly. Within minutes after vaccination, the patient started immediately with a small rash at the injection. He got extremely sick and developed a sore throat that lasted 5 - 6 days. His throat was so sore that he could not swallow his own saliva. On 15-Oct-2012 he saw his NP (nurse practitioner), was tested for Strep throat and blood work and put on unspecified antibiotics. Later he felt like spikes were being driven through his shoulders and chest. On 25-Oct-2012 he went to the ER (Emergency Room) because the pain was so severe that he could not sleep. At the ER he was given PERCOCET and VALIUM. He had the shakes but no fever. His neck now had the spikes of pain and he could not move his neck. He still had a nerve problem with tremors and shakes every now and then. The events improved slowly. The event outcome was not recovered.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Insomnia, Malaise, Mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: This consumer report (initial receipt: 31-Oct-2012) concerns a 49-year-old male patient. Concomitant medication included testosterone. On 08-Oct-2012 the patient received AFLURIA (batch number was not provided) injection intramuscularly. Within minutes after vaccination, the patient started immediately with a small rash at the injection. He got extremely sick and developed a sore throat that lasted 5 - 6 days. His throat was so sore that he could not swallow his own saliva. On 15-Oct-2012 he saw his NP (nurse practitioner), was tested for Strep throat and blood work and put on unspecified antibiotics. Later he felt like spikes were being driven through his shoulders and chest. On 25-Oct-2012 he went to the ER (Emergency Room) because the pain was so severe that he could not sleep. At the ER he was given PERCOCET and VALIUM. He had the shakes but no fever. His neck now had the spikes of pain and he could not move his neck. He still had a nerve problem with tremors and shakes every now and then. The events improved slowly. The event outcome was not recovered.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Nervous system disorder, Oropharyngeal pain, Streptococcus test, Tremor
Clinical narrative: This consumer report (initial receipt: 31-Oct-2012) concerns a 49-year-old male patient. Concomitant medication included testosterone. On 08-Oct-2012 the patient received AFLURIA (batch number was not provided) injection intramuscularly. Within minutes after vaccination, the patient started immediately with a small rash at the injection. He got extremely sick and developed a sore throat that lasted 5 - 6 days. His throat was so sore that he could not swallow his own saliva. On 15-Oct-2012 he saw his NP (nurse practitioner), was tested for Strep throat and blood work and put on unspecified antibiotics. Later he felt like spikes were being driven through his shoulders and chest. On 25-Oct-2012 he went to the ER (Emergency Room) because the pain was so severe that he could not sleep. At the ER he was given PERCOCET and VALIUM. He had the shakes but no fever. His neck now had the spikes of pain and he could not move his neck. He still had a nerve problem with tremors and shakes every now and then. The events improved slowly. The event outcome was not recovered.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal discomfort, Crohn's disease, Incorrect dose administered, Injection site cellulitis, Lymphadenopathy
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 02 November 2012, which also involved misuse (extra dose administered). A 14-year-old male patient had received an "inadvertent" dose two injection of "probably" a MENINGOCOCCAL VACCINE, Sanofi Pasteur (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced swollen lymph nodes, cellulitis at injection site, "stomach problems", and developed Crohn's disease. The patient received a meningococcal vaccine at age 12, which was believed to be MENACTRA. The patient had no illness at the time of vaccination and no known allergies. The patient's outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Biopsy, Culture negative, Drug administration error, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Initial report was received from a healthcare professional on 26 October 2012. A female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of ADACEL vaccine (lot number: unknown by reporter, dose, dose number not reported) in Right Deltoid on 14 July 2012. The reporter stated that, on unspecified date the patient experienced pain in arm and decreased range of motion. The reporter states that, on an unspecified date a biopsy was done and culture was negative. Complementary diagnostic tests and laboratory data were not reported. The patient was not recovered at the time of report. Follow-up information was received on 26 October 2012 by a company representative from a health care professional who reported that an MRI revealed osteomyelitis. Based upon this new information, the case which also involved misuse (given ADACEL "incorrectly" in the arm) has been upgraded to serious. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Osteomyelitis, Pain in extremity
Clinical narrative: Initial report was received from a healthcare professional on 26 October 2012. A female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of ADACEL vaccine (lot number: unknown by reporter, dose, dose number not reported) in Right Deltoid on 14 July 2012. The reporter stated that, on unspecified date the patient experienced pain in arm and decreased range of motion. The reporter states that, on an unspecified date a biopsy was done and culture was negative. Complementary diagnostic tests and laboratory data were not reported. The patient was not recovered at the time of report. Follow-up information was received on 26 October 2012 by a company representative from a health care professional who reported that an MRI revealed osteomyelitis. Based upon this new information, the case which also involved misuse (given ADACEL "incorrectly" in the arm) has been upgraded to serious. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Cold sweat, Eye swelling, Lip swelling
Clinical narrative: SWELLING OF LIPS AND EYES CHILLS COLD SWEAT.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Injection site painful, decreased ROM in arm.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Angioedema, Chest discomfort
Clinical narrative: Chest tightness without shortness of breath followed by angioedema of the lips and tongue -- symptoms progressed from 3:00 PM to 6:00 PM.  50 mg of diphenhydramine resolved symptoms 30 minutes after administration.  Symptoms resolved by 6:30 PM.
Age: 28.0
Sex: M
Vaccine: MMR
Symptoms: Food allergy, Gastrointestinal disorder, Rash
Clinical narrative: Large rash in groin and face and arm pits.  Lots of food reactions.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Depression, Food allergy, Learning disorder, Milk allergy
Clinical narrative: Food allergies to milk and other things.  Learning problems.  Depression.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Disability, Guillain-Barre syndrome, Mechanical ventilation
Clinical narrative: Progressive weakness later diagnosed as Guillain-Barre.  Patient has been on ventilator since 10/31/2012 and is expected to remain on a ventilator for 6 months to 2 years.  She is expected to have a permanent disability.
Age: 0.55
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Blood electrolytes, C-reactive protein, Decreased appetite
Clinical narrative: 6 month 23 day old male began with c/o diarrhea for 2-3 days, began on 11/11/2012 in middle of night, mixed with blood, associated with abdominal cramping, intermittent.  C/o abdominal pain for 2-3 days started suddenly on Saturday night, not sleeping well due to abdominal pain, cramping draws legs up.  C/o fever 100.5, taking Tylenol.  C/o poor appetite decreased since this morning, did not want to bottle feed this am.  C/o blood in stool mixed with stool dark red in color.  C/o fussy constantly.  Denies: spitting up, vomiting, nausea, sick contacts, abdominal distension, gassy.
Age: 0.55
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Diarrhoea haemorrhagic, Differential white blood cell count, Enema administration, Feeding disorder neonatal, Full blood count
Clinical narrative: 6 month 23 day old male began with c/o diarrhea for 2-3 days, began on 11/11/2012 in middle of night, mixed with blood, associated with abdominal cramping, intermittent.  C/o abdominal pain for 2-3 days started suddenly on Saturday night, not sleeping well due to abdominal pain, cramping draws legs up.  C/o fever 100.5, taking Tylenol.  C/o poor appetite decreased since this morning, did not want to bottle feed this am.  C/o blood in stool mixed with stool dark red in color.  C/o fussy constantly.  Denies: spitting up, vomiting, nausea, sick contacts, abdominal distension, gassy.
Age: 0.55
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Haematochezia, Intussusception, Irritability, Poor quality sleep, Pyrexia
Clinical narrative: 6 month 23 day old male began with c/o diarrhea for 2-3 days, began on 11/11/2012 in middle of night, mixed with blood, associated with abdominal cramping, intermittent.  C/o abdominal pain for 2-3 days started suddenly on Saturday night, not sleeping well due to abdominal pain, cramping draws legs up.  C/o fever 100.5, taking Tylenol.  C/o poor appetite decreased since this morning, did not want to bottle feed this am.  C/o blood in stool mixed with stool dark red in color.  C/o fussy constantly.  Denies: spitting up, vomiting, nausea, sick contacts, abdominal distension, gassy.
Age: 0.55
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Ultrasound abdomen
Clinical narrative: 6 month 23 day old male began with c/o diarrhea for 2-3 days, began on 11/11/2012 in middle of night, mixed with blood, associated with abdominal cramping, intermittent.  C/o abdominal pain for 2-3 days started suddenly on Saturday night, not sleeping well due to abdominal pain, cramping draws legs up.  C/o fever 100.5, taking Tylenol.  C/o poor appetite decreased since this morning, did not want to bottle feed this am.  C/o blood in stool mixed with stool dark red in color.  C/o fussy constantly.  Denies: spitting up, vomiting, nausea, sick contacts, abdominal distension, gassy.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Received vaccine, arm immediately painful, arm still painful when reported on 10/28/2012.
Age: 72.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Chills, Muscle spasms
Clinical narrative: Extreme chills, severe muscle cramps in both legs.
Age: 72.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Chills, Muscle spasms, Nocturia
Clinical narrative: Extreme chills, severe muscle cramps in both legs.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Stated neck stopped hurting but arm vaccine was given in started hurting about 2 days after receiving vaccine and still hurting.  Hurts from shoulder down to elbow.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Cardiac function test, Cardiac monitoring, Dizziness, Echocardiogram
Clinical narrative: Minor symptoms happened within an hour like red face, body aches, low energy. More severe reactions on 11/01/12 with dizziness, body aches and fatigue all day. Almost passed out a couple of times while being dizzy. 11/02/12 major severe reactions had all symptoms as noted above with severe dizziness, heart palpitations and racing of the heart.  Several times of near passing out.  Started with an irregular heart beat that I haven't ever had before.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Electrocardiogram, Erythema, Fatigue, Heart rate irregular, Laboratory test
Clinical narrative: Minor symptoms happened within an hour like red face, body aches, low energy. More severe reactions on 11/01/12 with dizziness, body aches and fatigue all day. Almost passed out a couple of times while being dizzy. 11/02/12 major severe reactions had all symptoms as noted above with severe dizziness, heart palpitations and racing of the heart.  Several times of near passing out.  Started with an irregular heart beat that I haven't ever had before.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Pain, Palpitations, X-ray
Clinical narrative: Minor symptoms happened within an hour like red face, body aches, low energy. More severe reactions on 11/01/12 with dizziness, body aches and fatigue all day. Almost passed out a couple of times while being dizzy. 11/02/12 major severe reactions had all symptoms as noted above with severe dizziness, heart palpitations and racing of the heart.  Several times of near passing out.  Started with an irregular heart beat that I haven't ever had before.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Pt reports next day arm sore and unable to lift arm. She took NSAIDs and rested it and it seemed not to help. She seen our clinic provider who dx it as nerve pain and was given more NSAIDs. She still is having problem lifting arm and is painful.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Dry eye, Erythema, Eye pruritus, Eyelid oedema
Clinical narrative: Itchy dry eyes that turned red on lids, lids started to swell slightly but by following day eyelids were very swollen. 3rd day eyelid swelling going down, but not fully recovered as of this report.
Age: 13.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site nodule, Pain in extremity, Vaccination complication
Clinical narrative: Client received vaccines on 10-10-12. Father called on 10-12-12 and states client has had a reaction to the vaccines. Father states that client has a small knot and redness the size of a baseball on the fatty part of his right arm. Father denies client experience of fever, SOB, DIB. Father states client c/o a lot of pain in his R arm. Father called back on 10-19-12 asking for school excuse and states prior symtoms have resolved.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibiotic resistant Staphylococcus test negative, Blood test normal, Culture negative, Injection site discharge, Injection site erythema
Clinical narrative: On 11/06/2012 the injection site was raised and hot at 7:00 AM by 4:00 PM his whole upper arm was red and very hot, the injection site was the size of a golf ball, swollen, and draining. He had a 100 degree fever. We took him to the Union hospital ER. They cultured it and sent us home with antibiotics and told us to give him Benadryl and said for him to not return to school until the culture results came back. On 11/07/2012 He woke up and the injection site was worse. I took him to an infectious disease doctor who then sent us to a pediatric infectious disease doctor. She examined him and hosptalized him at Regional hospital. He was given IV antibiotics and Benadryl and Ibuprofen. On 11/8/2012 he was released after the test results came back. His culture tested negative for MRSA, Staph, and Strep and his blood work was normal. He was sent home with antibiotics, steroids, and given Benadryl. On 11/12/2012 he was seen again as a follow with the first infectious disease doctor. He was released back to school 11/13/2012 and has another follow up 11/14/2012 with the pediatric doctor.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth, Pyrexia, Staphylococcus test negative, Streptococcus test negative
Clinical narrative: On 11/06/2012 the injection site was raised and hot at 7:00 AM by 4:00 PM his whole upper arm was red and very hot, the injection site was the size of a golf ball, swollen, and draining. He had a 100 degree fever. We took him to the Union hospital ER. They cultured it and sent us home with antibiotics and told us to give him Benadryl and said for him to not return to school until the culture results came back. On 11/07/2012 He woke up and the injection site was worse. I took him to an infectious disease doctor who then sent us to a pediatric infectious disease doctor. She examined him and hosptalized him at Regional hospital. He was given IV antibiotics and Benadryl and Ibuprofen. On 11/8/2012 he was released after the test results came back. His culture tested negative for MRSA, Staph, and Strep and his blood work was normal. He was sent home with antibiotics, steroids, and given Benadryl. On 11/12/2012 he was seen again as a follow with the first infectious disease doctor. He was released back to school 11/13/2012 and has another follow up 11/14/2012 with the pediatric doctor.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling hot, Inflammation, Injection site pain, Weight bearing difficulty
Clinical narrative: Pain developed in left bicep after injection. First day felt like inflammation and heat running down left arm. For two plus weeks pain still remains in left bicep and have not been able to lift anything with any kind of weight without pain associated with it.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Electrocardiogram, Flushing, Full blood count
Clinical narrative: Weakness, flushing of skin, shortness of breath, Hydration with 1 liter of normal saline, Decadron IV, Benadryl IV and Pepcid IV.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Liver function test, Troponin
Clinical narrative: Weakness, flushing of skin, shortness of breath, Hydration with 1 liter of normal saline, Decadron IV, Benadryl IV and Pepcid IV.
Age: 63.0
Sex: M
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Musculoskeletal stiffness, Oedema peripheral, Pain, Rash, Secretion discharge
Clinical narrative: No rxn at site of injection bi-lateral rash, painful oozing sores, stiff swollen hands, went to MD tmt-acyclovir 800 5x/day, amox 500 tid x10d, gabapentin 300 tid.
Age: 63.0
Sex: M
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Skin ulcer
Clinical narrative: No rxn at site of injection bi-lateral rash, painful oozing sores, stiff swollen hands, went to MD tmt-acyclovir 800 5x/day, amox 500 tid x10d, gabapentin 300 tid.
Age: 63.0
Sex: M
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Blister, Pain, Rash generalised, Secretion discharge, Varicella
Clinical narrative: No rxn at site of injection bi-lateral rash, painful oozing sores, stiff swollen hands, went to MD tmt-acyclovir 800 5x/day, amox 500 tid x10d, gabapentin 300 tid.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient states that as of 11/13/12 (19 days post-vaccination) she is still having signficant arm pain and stiffness at injection site.
Sex: U
Vaccine: FLU3, PNC
Symptoms: Febrile convulsion
Clinical narrative: Initial report was received from a consumer through another manufacturer under manufacturer report number 2012215588 on 31 October 2012. A patient (age, gender and date of birth not reported) had received an injection of FLUZONE, Sanofi Pasteur Inc., (lot number, route, site, and date of administration not reported) and an injection of PREVNAR 13, Pfizer, (lot number, route, site, and date of administration not reported) and an unspecified amount of time later experienced a febrile seizure. No additional information was available. Outcome was not reported. Documents held by sender: None.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Initial report was received from a consumer through another manufacturer on 31 October 2012 under service request number 1-5680231899. A 78-year-old female patient had received an injection of Influenza Vaccine manufactured by Sanofi Pasteur (lot number, route, site and date of administration not reported) and two days later developed shingles. Treatment included Prednisone and an antiviral medication. No additional information was available. Outcome was not reported. Documents held by sender: None.
Age: 1.54
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 29 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 2-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 4 doses of PENTACEL: lot number C3294AA on 10 December 2009, lot number C3541AA on 26 January 2010, lot number C3555AA on 30 April 2010, and lot number C3815AA on 12 April 2011 (routes and sites of administration not reported). The subject developed a cough on 27 August 2012, approximately 16 months after the last dose. Nine days later, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and apnea (onset dates not reported). Laboratory testing included positive PCR on 12 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 12 September 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.54
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting
Clinical narrative: Initial report received on 29 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 2-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 4 doses of PENTACEL: lot number C3294AA on 10 December 2009, lot number C3541AA on 26 January 2010, lot number C3555AA on 30 April 2010, and lot number C3815AA on 12 April 2011 (routes and sites of administration not reported). The subject developed a cough on 27 August 2012, approximately 16 months after the last dose. Nine days later, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and apnea (onset dates not reported). Laboratory testing included positive PCR on 12 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 12 September 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Dry skin, Erythema, Herpes zoster, Pruritus
Clinical narrative: After adverse reaction 9-10 inch redness, temperature, rough skin, itching) to actual vaccination an extremely itchy, bumpy/uneven and scaly area developed at base of scalp on same side as vaccination.  It has lasted 1 1/2 months until I went to the doctor on Monday, 11/06/2012 and it was diagnosed as Shingles.  I was given generic Valtrex and an antibiotic to prevent infection (where I had badly scratched the area).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin exfoliation
Clinical narrative: After adverse reaction 9-10 inch redness, temperature, rough skin, itching) to actual vaccination an extremely itchy, bumpy/uneven and scaly area developed at base of scalp on same side as vaccination.  It has lasted 1 1/2 months until I went to the doctor on Monday, 11/06/2012 and it was diagnosed as Shingles.  I was given generic Valtrex and an antibiotic to prevent infection (where I had badly scratched the area).
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Headache, Hot flush, Nausea
Clinical narrative: PATIENT BECAME NAUSEOUS, ACQUIRED AN INSTANT HEADACHE, HER LIPS WERE TINGLING, SHE HAD A BURNING FLUSH THAT STARTED IN HER CHEST AND ROSE UP TO THE TOP OF HER HEAD, AND SHE WAS LIGHT HEADED AND WEAK, WHICH ALL BEGAN WITHIN FIVE MINUTES OF RECEIVING THE VACCINE.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral
Clinical narrative: PATIENT BECAME NAUSEOUS, ACQUIRED AN INSTANT HEADACHE, HER LIPS WERE TINGLING, SHE HAD A BURNING FLUSH THAT STARTED IN HER CHEST AND ROSE UP TO THE TOP OF HER HEAD, AND SHE WAS LIGHT HEADED AND WEAK, WHICH ALL BEGAN WITHIN FIVE MINUTES OF RECEIVING THE VACCINE.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Hypoaesthesia, Nuclear magnetic resonance imaging, Urine analysis
Clinical narrative: All of a sudden my arm and hands went numb. Traveled up my face.  Could not gain control of myself.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Chills, fever of 101.8, entire upper arm became swollen and red, painful.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Wrong drug administered
Clinical narrative: Pediatric Influenza was administered instead of the required Pediarix.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal discomfort, Dyspnoea, Hypoaesthesia, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient developed shortness of breath about 4:30 pm. Both she and her sister who also had the shot complained of sore throat and upset stomach about 6:30PM.  Both developed fevers by 9:PM.  Patient's reached 103 by midnight and by 4:30 her hands were numb and she was short of breath.  She then vomited and went back to sleep.  She has been sleeping with a 102 temp. since then and it is 3:40 PM 11/13/2012.  These are all reactions listed on the HPV handout.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Vomiting
Clinical narrative: Patient developed shortness of breath about 4:30 pm. Both she and her sister who also had the shot complained of sore throat and upset stomach about 6:30PM.  Both developed fevers by 9:PM.  Patient's reached 103 by midnight and by 4:30 her hands were numb and she was short of breath.  She then vomited and went back to sleep.  She has been sleeping with a 102 temp. since then and it is 3:40 PM 11/13/2012.  These are all reactions listed on the HPV handout.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Pain
Clinical narrative: Temp of 103.4 body aches and lasted 24 hours then felt just fine.
Age: 1.05
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Decreased appetite, Dermatitis diaper, Irritability, Pyrexia
Clinical narrative: Fever started on 10/29/2012, peaked at 102.5 at 10:00PM.  Our son continued to have a low fever for two days, was very fussy and lost his appetite.  He continued to drink a lot of water.  He developed blisters on his fingers and toes over the next few days.  He developed a bad diaper rash.  By 11/2/2012, he had no fever and his appetite returned.  The blisters are now dried up.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: VERY severe arm pain, fever, aches, severe fatigue and exhaustion, disturbed sleep.
Age: 39.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site rash, Rash
Clinical narrative: Client said she got red bumps at the site where she received chicken pox shot and 1 bump also in her mouth. Client said she took Advil and stayed home until the area went away. Client said this lasted for about 10 days and also stated she didn't seek medical attention.
Age: 49.0
Sex: F
Vaccine: TTOX
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in Lt hand and Lt foot. Last approx 15-20 minutes.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster, Pain, Rash, Rash erythematous
Clinical narrative: Sore red spots on left side of abdomen and back.  Diagnosed several days later with shingles.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site streaking, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Red stripes, raised hot to touch extending across upper arm near injection site, approx. 1.5 inches wide. Muscles sore to touch, extending under arm into upper chest. Tx with ibuprofen 600 mg q6h.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Extrasystoles, Heart rate increased
Clinical narrative: Increase in HR and skipping beats.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Headache, Influenza A virus test negative
Clinical narrative: Fever of 102 degrees, extreme dizziness, body weakness, headache, chills.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza B virus test, Influenza virus test negative, Pyrexia
Clinical narrative: Fever of 102 degrees, extreme dizziness, body weakness, headache, chills.
Age: 26.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Mobility decreased, Oedema peripheral
Clinical narrative: Arm swelled up, got really red, and couldn't move it.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Fatigue, Mobility decreased, Myalgia
Clinical narrative: 11/8: affected arm had: sore tricep/bicep, limited movement range, swelling, redness from elbow to armpit of affected tricep, tiredness, 1 hour of chills that night.  11/9: swelling, itching, redness like one large hive over bicep and tricep area, painful muscles, limited movement without pain, tiredness.  11/11 swelling, itching, redness slightly reduced, sore muscles improving but now extending into elbow and upper forearm, less tired.  11/12 pain, redness, itching reduced. 11/13 symptoms 95% gone.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain, Pruritus
Clinical narrative: 11/8: affected arm had: sore tricep/bicep, limited movement range, swelling, redness from elbow to armpit of affected tricep, tiredness, 1 hour of chills that night.  11/9: swelling, itching, redness like one large hive over bicep and tricep area, painful muscles, limited movement without pain, tiredness.  11/11 swelling, itching, redness slightly reduced, sore muscles improving but now extending into elbow and upper forearm, less tired.  11/12 pain, redness, itching reduced. 11/13 symptoms 95% gone.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: NO ADVERSE EVENT. Vaccine was accidentally administered IM instead of SC.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Large red warm bump at injection site. Came to work my charge nurse looked at site, had me fill out incident report with shift manager. Was then sent to ER to have Dr. on duty to look at, the Dr. looked told me to rub the site so the tissue and muscle would absorb vaccine. Since time the bump is still there and are is steadily getting worse.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose, Dizziness, Dyspnoea, Malaise, Oropharyngeal pain
Clinical narrative: The young man the patient came in with came back to the pharmacy and said patient was feeling not feeling well. He said she was having difficulty breathing and feeling like she was going to pass out. She was sitting on a bench and conscious. I had my team call 911. Upon speaking with her, she said her throat was hurting. I checked the injection site for signs of swelling or a rash and there did not appear to be anything there. She was also leaning on the wall and her friend for support. I continued speaking with her and her friend. She appeared to have labored breathing. The paramedics arrived by 6:24 PM. The patient never lost consciousness that I saw. They ran some tests on her and she checked out okay according to them. They recommened she go to the emergency room, but she refused saying she was feeling better. About 10 minutes after they left and her friend was finished filling out some paperwork for pharmacy, they left. She was able to walk out on her own.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Antibody test negative, Electromyogram normal, Immunoglobulin therapy, Immunology test normal, Laboratory test normal
Clinical narrative: This case was reported in a literature article and described the occurrence of myeloradiculitis in a 70-year-old male subject who was vaccinated with Influenza vaccine (GlaxoSmithKline). No preceding illness. On an unspecified date, the subject received an unspecified dose of Influenza vaccine (intramuscular, administration site unknown, batch number not provided). 14 days after vaccination with Influenza vaccine, the subject experienced a rapidly progressive ascending acute flaccid paralysis with urinary retention. This case was assessed as medically serious by GSK. The magnetic resonance imaging lumbar spine showed longitudinally extensive T2 hyperintensity with no enhancement. The electromyogram was normal. The subject was diagnosed lumbar longitudinally extensive transverse myelitis. The subject was treated with high dose IV steroids. 2 months later, he again had acute flaccid paralysis with urinary retention. Magnetic resonance imaging of the lumbar spine showed longitudinally extensive T2 hyperintensity with anterior root enhancement. Magnetic resonance imaging thoracic spine showed longitudinally extensive T2 hyperintensity as well. He was diagnosed with thoraco-lumbar longitudinally extensive myeloradiculitis and treated with high dose of steroids and IVIG. Extensive toxic, metabolic, inflammatory, autoimmune, NMO antibody, multiple sclerosis, infectious, neoplastic, paraneoplastic work-up repeated multiple times have remained negative. At the time of reporting, the outcome of the events was unspecified. The author's conclusion stated that vaccine associated myeloradiculitis is an extremely uncommon entity. Further studies are needed to establish a causal link between vaccines and simultaneous demyelinating lesions involving the central and peripheral nervous system.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Metabolic function test normal, Myelitis, Myelitis transverse, Nuclear magnetic resonance imaging spinal cord abnormal, Paralysis flaccid
Clinical narrative: This case was reported in a literature article and described the occurrence of myeloradiculitis in a 70-year-old male subject who was vaccinated with Influenza vaccine (GlaxoSmithKline). No preceding illness. On an unspecified date, the subject received an unspecified dose of Influenza vaccine (intramuscular, administration site unknown, batch number not provided). 14 days after vaccination with Influenza vaccine, the subject experienced a rapidly progressive ascending acute flaccid paralysis with urinary retention. This case was assessed as medically serious by GSK. The magnetic resonance imaging lumbar spine showed longitudinally extensive T2 hyperintensity with no enhancement. The electromyogram was normal. The subject was diagnosed lumbar longitudinally extensive transverse myelitis. The subject was treated with high dose IV steroids. 2 months later, he again had acute flaccid paralysis with urinary retention. Magnetic resonance imaging of the lumbar spine showed longitudinally extensive T2 hyperintensity with anterior root enhancement. Magnetic resonance imaging thoracic spine showed longitudinally extensive T2 hyperintensity as well. He was diagnosed with thoraco-lumbar longitudinally extensive myeloradiculitis and treated with high dose of steroids and IVIG. Extensive toxic, metabolic, inflammatory, autoimmune, NMO antibody, multiple sclerosis, infectious, neoplastic, paraneoplastic work-up repeated multiple times have remained negative. At the time of reporting, the outcome of the events was unspecified. The author's conclusion stated that vaccine associated myeloradiculitis is an extremely uncommon entity. Further studies are needed to establish a causal link between vaccines and simultaneous demyelinating lesions involving the central and peripheral nervous system.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Toxicologic test normal, Urinary retention
Clinical narrative: This case was reported in a literature article and described the occurrence of myeloradiculitis in a 70-year-old male subject who was vaccinated with Influenza vaccine (GlaxoSmithKline). No preceding illness. On an unspecified date, the subject received an unspecified dose of Influenza vaccine (intramuscular, administration site unknown, batch number not provided). 14 days after vaccination with Influenza vaccine, the subject experienced a rapidly progressive ascending acute flaccid paralysis with urinary retention. This case was assessed as medically serious by GSK. The magnetic resonance imaging lumbar spine showed longitudinally extensive T2 hyperintensity with no enhancement. The electromyogram was normal. The subject was diagnosed lumbar longitudinally extensive transverse myelitis. The subject was treated with high dose IV steroids. 2 months later, he again had acute flaccid paralysis with urinary retention. Magnetic resonance imaging of the lumbar spine showed longitudinally extensive T2 hyperintensity with anterior root enhancement. Magnetic resonance imaging thoracic spine showed longitudinally extensive T2 hyperintensity as well. He was diagnosed with thoraco-lumbar longitudinally extensive myeloradiculitis and treated with high dose of steroids and IVIG. Extensive toxic, metabolic, inflammatory, autoimmune, NMO antibody, multiple sclerosis, infectious, neoplastic, paraneoplastic work-up repeated multiple times have remained negative. At the time of reporting, the outcome of the events was unspecified. The author's conclusion stated that vaccine associated myeloradiculitis is an extremely uncommon entity. Further studies are needed to establish a causal link between vaccines and simultaneous demyelinating lesions involving the central and peripheral nervous system.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Vaccinated at flu clinic held at hospital infection prevention office. Complained of vomiting one hour after getting vaccination. BP 113/61 Pulse 59. No further vomiting - only once. Stated he had a GI bug one week prior. ED at 1154. Left without instructions 1513.