chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity, Paraesthesia, Tracheostomy
Clinical narrative: Started upon awakening with feet and hands feeling numb and tingly.  Also started with headache described as behind his eyes.  Seen in ED on 10/11/13 with parasthesias.  Stated numbness and tingling had progressed to his entire body. Sent home with diagnosis of paresthesias, anxiety.  10/13/2013 to ED with increasing numbness, tingling arms, legs accompanied by pain, chills.  Gradual onset weakness - reported as severe by patient.  Bilateral face affected, unable to swallow.  Patient hospitalized and required intensive care treatment.  On ventilator and ended up with tracheostomy.  Tube feedings and eventual PEG tube.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Anxiety, Arterial catheterisation, Asthenia, Blood pressure increased, CSF test abnormal
Clinical narrative: Started upon awakening with feet and hands feeling numb and tingly.  Also started with headache described as behind his eyes.  Seen in ED on 10/11/13 with parasthesias.  Stated numbness and tingling had progressed to his entire body. Sent home with diagnosis of paresthesias, anxiety.  10/13/2013 to ED with increasing numbness, tingling arms, legs accompanied by pain, chills.  Gradual onset weakness - reported as severe by patient.  Bilateral face affected, unable to swallow.  Patient hospitalized and required intensive care treatment.  On ventilator and ended up with tracheostomy.  Tube feedings and eventual PEG tube.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Central venous catheterisation, Chills, Decubitus ulcer, Dysphagia, Gastrostomy
Clinical narrative: Started upon awakening with feet and hands feeling numb and tingly.  Also started with headache described as behind his eyes.  Seen in ED on 10/11/13 with parasthesias.  Stated numbness and tingling had progressed to his entire body. Sent home with diagnosis of paresthesias, anxiety.  10/13/2013 to ED with increasing numbness, tingling arms, legs accompanied by pain, chills.  Gradual onset weakness - reported as severe by patient.  Bilateral face affected, unable to swallow.  Patient hospitalized and required intensive care treatment.  On ventilator and ended up with tracheostomy.  Tube feedings and eventual PEG tube.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: General physical health deterioration, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Mechanical ventilation
Clinical narrative: Started upon awakening with feet and hands feeling numb and tingly.  Also started with headache described as behind his eyes.  Seen in ED on 10/11/13 with parasthesias.  Stated numbness and tingling had progressed to his entire body. Sent home with diagnosis of paresthesias, anxiety.  10/13/2013 to ED with increasing numbness, tingling arms, legs accompanied by pain, chills.  Gradual onset weakness - reported as severe by patient.  Bilateral face affected, unable to swallow.  Patient hospitalized and required intensive care treatment.  On ventilator and ended up with tracheostomy.  Tube feedings and eventual PEG tube.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain, Paraesthesia, Pneumonia, Tracheostomy
Clinical narrative: Started upon awakening with feet and hands feeling numb and tingly.  Also started with headache described as behind his eyes.  Seen in ED on 10/11/13 with parasthesias.  Stated numbness and tingling had progressed to his entire body. Sent home with diagnosis of paresthesias, anxiety.  10/13/2013 to ED with increasing numbness, tingling arms, legs accompanied by pain, chills.  Gradual onset weakness - reported as severe by patient.  Bilateral face affected, unable to swallow.  Patient hospitalized and required intensive care treatment.  On ventilator and ended up with tracheostomy.  Tube feedings and eventual PEG tube.
Age: 56.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Nodule, Pruritus, Tenderness
Clinical narrative: Pt developed a knot in her left arm along with extreme itching, redness and tenderness 12/4, the day after receiving vaccinations. Symptoms reported 12/5. Treated with ice and ibuprofen. Symptoms improved.
Age: 40.0
Sex: F
Vaccine: FLUN4
Symptoms: Accidental exposure to product, Bronchospasm, Chest pain, Cough, Dizziness
Clinical narrative: I did not receive FluMist, but was the administrator of FluMist at an elementary school based clinic. The clinic started at approximately 9:00 am. While I administered FluMist, the other nurses noted that my face and neck were very red at approximately 10:00 am I stopped administering FluMist and left the clinic area. Symptoms progressed to include itching, wheezing, coughing, bronchospasms, chest pain, dizziness, and fatigue.  6 hours were spent in the emergency department.  Auto injectable epinephrine was administered in the emergency department.
Age: 40.0
Sex: F
Vaccine: FLUN4
Symptoms: Erythema, Fatigue, Occupational exposure to product, Pruritus, Wheezing
Clinical narrative: I did not receive FluMist, but was the administrator of FluMist at an elementary school based clinic. The clinic started at approximately 9:00 am. While I administered FluMist, the other nurses noted that my face and neck were very red at approximately 10:00 am I stopped administering FluMist and left the clinic area. Symptoms progressed to include itching, wheezing, coughing, bronchospasms, chest pain, dizziness, and fatigue.  6 hours were spent in the emergency department.  Auto injectable epinephrine was administered in the emergency department.
Age: 32.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Oropharyngeal pain, Pyrexia, Rash generalised, Viral titre decreased
Clinical narrative: Fever and sore throat.  Took Tylenol and Ibuprofen.  Fever got up to 102.4.  12/3 I had a rash all over my body.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Reported on 12/8/13 at 2pm. Pt had fever for 2 days. Followed by pain in the arm ever since. Pt showed up on 12/8/13 at 2 pm saying he had pain in the arm. Had it ever since shot. Had Dr visit 12/5/13 on Naproxen. Pt reported the symptoms not until 12/8/13 at 2 pm to pharmacist.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Patient called Saturday about 7 p.m. and said her right arm was sore. She was advised to ice area of vaccine. Sunday, 12-8, she called and said her arm was sore and swollen and she was going to emergency room for treatment.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Wrong drug administered
Clinical narrative: Patient was injected with MMR, even though an MMRV (PROQUAD) was ordered.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Tingling sensation in arm that radiated down the hand for days.
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Pt said his arm "itched" for 11 months, but never had reaction before.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: After administration of vaccine pt. developed swelling in (L) upper arm and warm to touch, with pain radiating to her neck. Swelling is beginning to go down.
Age: 69.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Lymphadenitis
Clinical narrative: Patient with lymphadenitis under (L) arm where vaccine administered.
Age: 1.0
Sex: F
Vaccine: FLU3, MMRV, PNC13
Symptoms: Otitis media, Otitis media acute, Rash, Rash morbilliform, Screaming
Clinical narrative: On 12/3/13 pt. developed rash; at night screaming x 4 hrs - evaluated in the ER on 12/4/13 at 1 am, diagnosed with AOM; azithromycin. On F/U in the office pt. had morbilliform exanthem on both extremities; only serum fluid on examination of middle ear (12/6/13).
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Muscle twitching, Mydriasis, Nausea, Pallor
Clinical narrative: At time of injection, pt had extremity twitch, eye dilation and became pale - after 3rd injection felt nauseous, had pulse of 60. Was kept supine and given juice. By 5 min felt improved.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Rash
Clinical narrative: Approximately 10 inch by 8 inch superficial rash noted on the mid to upper back. Localized redness also noted at the left arm injection site (approximately 0.5 cm x 0.5 cm). Client asymptomatic.
Age: 0.51
Sex: M
Vaccine: DTAP, HEP, HIBV, RVX
Symptoms: Vomiting
Clinical narrative: Throwing up 2 times already.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling, Lymph node pain, Lymphadenopathy, Muscular weakness
Clinical narrative: Pain and swelling at injection site, weakness in injected arm, slight pain and some swelling of under-arm lymph nodes.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Pain
Clinical narrative: Excessive sorenes, per patient, not able to fully use arm, waiting on patient to visit physician.
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Gave Varivax instead of Zostavax, no adverse reactions by patient.
Age: 18.0
Sex: M
Vaccine: HEP, HEPA, HPV4, IPV, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No reaction noted.  Patient was given a varicella shot that was not required.  He had already met the requirement for the two varicella vaccines.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Eyelid oedema, Fatigue, Injection site bruising, Injection site pain
Clinical narrative: Local site reaction with swelling, pain, bruising, then joint aches, then lip and eyelid swelling, myalgias, fatigue.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Lip swelling, Local reaction, Myalgia
Clinical narrative: Local site reaction with swelling, pain, bruising, then joint aches, then lip and eyelid swelling, myalgias, fatigue.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient said she felt like she would pass out.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test, Central nervous system inflammation, Computerised tomogram, Convulsion, Electrocardiogram
Clinical narrative: Seizures, inflammation on the brain, paralyze all body functions.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Electroencephalogram, Nuclear magnetic resonance imaging, Paralysis
Clinical narrative: Seizures, inflammation on the brain, paralyze all body functions.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: Constipation, Eye movement disorder, Flatulence, Movement disorder
Clinical narrative: No bowel movements, foul smelling flatulence, panicky latch on at the breast, rapid head and eye movements left to right, grasping fists quickly.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Injection site urticaria, Pain, Rash
Clinical narrative: Started with Hive at injection site.  Next day swollen and sore.  Next day VERY swollen, sore, hot to touch, started rash all over trunk and arms, a little on face, upset stomach, headache.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Started with Hive at injection site.  Next day swollen and sore.  Next day VERY swollen, sore, hot to touch, started rash all over trunk and arms, a little on face, upset stomach, headache.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Headache, Heart rate increased, Pain
Clinical narrative: Fast heartbeat, dizziness, weakness, fever, body aches, and headache.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fast heartbeat, dizziness, weakness, fever, body aches, and headache.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Dizziness, Headache, Insomnia
Clinical narrative: Saturday morning I woke up with high fever, terrible head cold, headache, dizziness,very weak, and no appetite. I was unable to rest my head where I pleased because the pain was excruciating to make simple movement. I wasn't able to sleep comfortable for several nights because it hurt the back of my neck and spine when I tried to move my neck. I was left to nursing a stiff neck after the fever went and hot pads to move my neck again and sleep.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Nasopharyngitis, Neck pain, Pain, Pyrexia
Clinical narrative: Saturday morning I woke up with high fever, terrible head cold, headache, dizziness,very weak, and no appetite. I was unable to rest my head where I pleased because the pain was excruciating to make simple movement. I wasn't able to sleep comfortable for several nights because it hurt the back of my neck and spine when I tried to move my neck. I was left to nursing a stiff neck after the fever went and hot pads to move my neck again and sleep.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Spinal pain
Clinical narrative: Saturday morning I woke up with high fever, terrible head cold, headache, dizziness,very weak, and no appetite. I was unable to rest my head where I pleased because the pain was excruciating to make simple movement. I wasn't able to sleep comfortable for several nights because it hurt the back of my neck and spine when I tried to move my neck. I was left to nursing a stiff neck after the fever went and hot pads to move my neck again and sleep.
Sex: F
Vaccine: HPV4
Symptoms: Paralysis
Clinical narrative: This spontaneous report as received from a journalist refers to a young female patient of unknown age. On an unknown date, the patient was vaccinated with a dose or doses of GARDASIL (route, dose and lot # not reported). On an unknown date, the patient experienced paralyzed from the waist down after receiving GARDASIL. At the time of the report, the patient's outcome was unknown. The reporter considered paralyzed from the waist down to be disabling. Upon internal review paralyzed from the waist down was considered to be medically significant. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse via a company representative refers to a patient of unknown age. On 02-DEC-2013 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # H012521, expiration date 09-OCT-2013, dose, route indications not reported). No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of unknown age gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On 27-NOV-2013, at an unspecified nursing home, a patient received an expired dose of ZOSTAVAX (Lot # not provided and exact expiration date were not provided, but it was told by the nurse that the vaccine dose expired in September 2013). Co-suspect therapy and concomitant medications were not provided. No adverse effect was reported. Additional information is not expected.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: This spontaneous report as received from Medical Assistant refers to a 2 day old female patient. On 11-JAN-2013 the patient was vaccinated with RECOMBIVAX HB dose 1. The reporter noticed the Hepatitis B vaccine (recombinant) (manufacturer unknown) syringe was leaking of the patient as the first dose was administered. On 19-MAR-2013 the patient received second dose of RECOMBIVAX HB at the physician's office with no issues reported. The reporter stated she noticed the RECOMBIVAX HB lot # reported as J007329 exp date: 27-MAR-2013 syringe was leaking into the thigh of the patient as she was administering the third dose of patient on 30-OCT-2013. A PQC was filed. No additional dose was administered. The reporter stated the physician, planned to do titer testing when the patient would be two-years-old. No AE symptoms were reported. The patient did not seek medical attention. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial pain, Herpes zoster, Neck pain, Rash
Clinical narrative: Initial and follow up information has been received from a pharmacy student and a physician respectively, refers to a 61 year old male patient with medical history of chicken pox as a child, high blood pressure and hyperthyroidism. Drug allergies/reactions included: LIPITOR caused elevated liver function tests, simvastatin (manufacturer unknown) caused felt poorly, CRESTOR caused muscle and headaches and LIVALO caused felt poorly aches. On 12-FEB-2010, the patient was vaccinated with ZOSTAVAX lot # 665521/1226Y expiracy date 27-FEB-2011, 0.65 ml, subcutaneous in the left arm. No rash occurred at the site of injection post-vaccination. Concomitant therapies included fenofibrate (manufacturer unknown), lansoprazole (manufacturer unknown), fluocinonide (manufacturer unknown), ergocalciferol (manufacturer unknown), multivitamins (manufacturer unknown), compounded testosterone (manufacturer unknown), LEVITRA, LEVOXYL, aspirin (manufacturer unknown), VALTREX, fish oil (manufacturer unknown), DIOVAN and ADVAIR Diskus. In 2011, the patient experienced herpes zoster outbreak every three to four months, lasting through 2012. The patient was treated with VALTREX. On 19-NOV-2013, the patient was diagnosed with another zoster outbreak and would begin therapy with VALTREX. On 21-NOV-2013, the patient experienced rash on the left side of his neck, one lesion (also reported as patient experienced pain in the neck going up towards the facial region and was followed by the ras on the neck). The patient sought for medical attention (saw primary health care provider). VZVIP specimen sample was collected from a vesicle/lesion (no results were given). The patient had no recent exposure to chickenpox or shingles. The outcome of another zoster outbreak was reported as not recovered. This is one of two reports from the same patient (MARRS # 1312USA004011). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age and gender. The consumer reported that she heard of a patient who got shingles after receiving ZOSTAVAX. Vaccination date, dose, route and lot number of ZOSTAVAX were not reported. Treatment and outcome of shingles were unknown. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Diplopia, Eye inflammation, Immune system disorder, Visual acuity reduced
Clinical narrative: This consumer report (initial receipt 25-Nov-2013) concerns a 66 year old male patient who had a medical history of vertigo. Concomitant medications included a multivitamin. On the 05-Nov-2013, the patient received an unspecified influenza virus vaccine injection (manufacturer and batch number not reported) one dose because it was recommended. The patient also received an unspecified pneumococcal virus vaccine (manufacturer and batch number not reported). On the 09-Nov-2013, the patient developed inflammation of the eyes, poor vision, double vision and his immune system was stirred up. The patient sought medical attention from a doctor. Treatment included acyclovir, PRED FORTE and cyclopentolate hydrochloride. Outcome was reported as recovering.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash generalised
Clinical narrative: Varicella-like rash on trunk and limbs.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Varicella-like rash on trunk and limbs.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site vesicles, Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The pharmacist reported that on an unknown date, the patient developed the shingles later after receiving ZOSTAVAX. Acyclovir, Triamcinolone cream and Medrol dose pack were given as a treatment for the experience. At the time of the report, the patient was recovering. The relatedness for shingles and ZOSTAVAX was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The pharmacist reported that on an unknown date, the patient developed the shingles later after receiving ZOSTAVAX. Acyclovir, Triamcinolone cream and Medrol dose pack were given as a treatment for the experience. At the time of the report, the patient was recovering. The relatedness for shingles and ZOSTAVAX was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The pharmacist reported that on an unknown date, the patient developed the shingles later after receiving ZOSTAVAX. Acyclovir, Triamcinolone cream and Medrol dose pack were given as a treatment for the experience. At the time of the report, the patient was recovering. The relatedness for shingles and ZOSTAVAX was unknown. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Anxiety, Asthenia, CSF test, Chills, Computerised tomogram
Clinical narrative: A 35 year-old presented to the office on December 6, 2013 complaining that the clinic is responsible for his diagnosis of Guillain-Barré Syndrome (GBS); therefore, the Infection Control Specialist conducted an in-depth review of his electronic medical record which revealed the following: On August 30, 2013, the patient consented to receive an influenza vaccination at his primary care appointment. The patient was provided with appropriate educational information, per protocol, prior to consent. Approximately six weeks later, the patient presented to the Emergency Department with a chief complaint of numbness and tingling that started in his hands and feet but progressed to his entire body. He was subsequently discharged with a diagnosis of paresthesia's and anxiety and instructed to follow-up with his primary care provider or return to the emergency department if there was no improvement. On October 13, 2013, two days after his Emergency Department visit, the patient was seen at the Emergency Department where he reported increased numbness and tingling accompanied by pain, chills, and weakness. He was admitted with a diagnosis of rule-out Guillain-Barre Syndrome, which was confirmed with cerebrospinal fluid studies. His condition deteriorated and he became unable to swallow. He required respiratory ventilation support along with a gastric tube for nutrition. He subsequently developed pneumonia during his inpatient stay as well as pressure ulcers. The patient required an arterial line, Shiley line, percutaneous endoscopic gastrostomy (PEG), and tracheostomy. He was treated with two cycles of intravenous immunoglobulin (IVIG) for five days each along with intravenous antibiotics for pneumonia. On November 12, 2013, the patient was transferred from one hospital to another for aggressive inpatient physical and supportive therapy. On November 25, 2013, he was discharged to a rehab center where he received care for his tracheostomy, pressure ulcers, and improved GBS condition. With continued improvement in his health condition, he was discharged from the rehab center on December 6, 2013, and is currently receiving home health care. He is scheduled to follow-up with his primary care provider in December 10, 2013. Actions, Progress and Resolution Date: The Infection Control Specialist consulted with school and determined that this GBS diagnosis was not reported to the Center for Disease Control (CDC). Therefore, per CDC guidelines, the event has now been reported through the Vaccine Adverse Events Reporting System.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Dysphagia, Eye pain, Gastrointestinal tube insertion, Gastrostomy
Clinical narrative: A 35 year-old presented to the office on December 6, 2013 complaining that the clinic is responsible for his diagnosis of Guillain-Barré Syndrome (GBS); therefore, the Infection Control Specialist conducted an in-depth review of his electronic medical record which revealed the following: On August 30, 2013, the patient consented to receive an influenza vaccination at his primary care appointment. The patient was provided with appropriate educational information, per protocol, prior to consent. Approximately six weeks later, the patient presented to the Emergency Department with a chief complaint of numbness and tingling that started in his hands and feet but progressed to his entire body. He was subsequently discharged with a diagnosis of paresthesia's and anxiety and instructed to follow-up with his primary care provider or return to the emergency department if there was no improvement. On October 13, 2013, two days after his Emergency Department visit, the patient was seen at the Emergency Department where he reported increased numbness and tingling accompanied by pain, chills, and weakness. He was admitted with a diagnosis of rule-out Guillain-Barre Syndrome, which was confirmed with cerebrospinal fluid studies. His condition deteriorated and he became unable to swallow. He required respiratory ventilation support along with a gastric tube for nutrition. He subsequently developed pneumonia during his inpatient stay as well as pressure ulcers. The patient required an arterial line, Shiley line, percutaneous endoscopic gastrostomy (PEG), and tracheostomy. He was treated with two cycles of intravenous immunoglobulin (IVIG) for five days each along with intravenous antibiotics for pneumonia. On November 12, 2013, the patient was transferred from one hospital to another for aggressive inpatient physical and supportive therapy. On November 25, 2013, he was discharged to a rehab center where he received care for his tracheostomy, pressure ulcers, and improved GBS condition. With continued improvement in his health condition, he was discharged from the rehab center on December 6, 2013, and is currently receiving home health care. He is scheduled to follow-up with his primary care provider in December 10, 2013. Actions, Progress and Resolution Date: The Infection Control Specialist consulted with school and determined that this GBS diagnosis was not reported to the Center for Disease Control (CDC). Therefore, per CDC guidelines, the event has now been reported through the Vaccine Adverse Events Reporting System.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Headache, Hypoaesthesia, Intensive care, Mechanical ventilation, Nuclear magnetic resonance imaging
Clinical narrative: A 35 year-old presented to the office on December 6, 2013 complaining that the clinic is responsible for his diagnosis of Guillain-Barré Syndrome (GBS); therefore, the Infection Control Specialist conducted an in-depth review of his electronic medical record which revealed the following: On August 30, 2013, the patient consented to receive an influenza vaccination at his primary care appointment. The patient was provided with appropriate educational information, per protocol, prior to consent. Approximately six weeks later, the patient presented to the Emergency Department with a chief complaint of numbness and tingling that started in his hands and feet but progressed to his entire body. He was subsequently discharged with a diagnosis of paresthesia's and anxiety and instructed to follow-up with his primary care provider or return to the emergency department if there was no improvement. On October 13, 2013, two days after his Emergency Department visit, the patient was seen at the Emergency Department where he reported increased numbness and tingling accompanied by pain, chills, and weakness. He was admitted with a diagnosis of rule-out Guillain-Barre Syndrome, which was confirmed with cerebrospinal fluid studies. His condition deteriorated and he became unable to swallow. He required respiratory ventilation support along with a gastric tube for nutrition. He subsequently developed pneumonia during his inpatient stay as well as pressure ulcers. The patient required an arterial line, Shiley line, percutaneous endoscopic gastrostomy (PEG), and tracheostomy. He was treated with two cycles of intravenous immunoglobulin (IVIG) for five days each along with intravenous antibiotics for pneumonia. On November 12, 2013, the patient was transferred from one hospital to another for aggressive inpatient physical and supportive therapy. On November 25, 2013, he was discharged to a rehab center where he received care for his tracheostomy, pressure ulcers, and improved GBS condition. With continued improvement in his health condition, he was discharged from the rehab center on December 6, 2013, and is currently receiving home health care. He is scheduled to follow-up with his primary care provider in December 10, 2013. Actions, Progress and Resolution Date: The Infection Control Specialist consulted with school and determined that this GBS diagnosis was not reported to the Center for Disease Control (CDC). Therefore, per CDC guidelines, the event has now been reported through the Vaccine Adverse Events Reporting System.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity, Paraesthesia, Tracheostomy
Clinical narrative: A 35 year-old presented to the office on December 6, 2013 complaining that the clinic is responsible for his diagnosis of Guillain-Barré Syndrome (GBS); therefore, the Infection Control Specialist conducted an in-depth review of his electronic medical record which revealed the following: On August 30, 2013, the patient consented to receive an influenza vaccination at his primary care appointment. The patient was provided with appropriate educational information, per protocol, prior to consent. Approximately six weeks later, the patient presented to the Emergency Department with a chief complaint of numbness and tingling that started in his hands and feet but progressed to his entire body. He was subsequently discharged with a diagnosis of paresthesia's and anxiety and instructed to follow-up with his primary care provider or return to the emergency department if there was no improvement. On October 13, 2013, two days after his Emergency Department visit, the patient was seen at the Emergency Department where he reported increased numbness and tingling accompanied by pain, chills, and weakness. He was admitted with a diagnosis of rule-out Guillain-Barre Syndrome, which was confirmed with cerebrospinal fluid studies. His condition deteriorated and he became unable to swallow. He required respiratory ventilation support along with a gastric tube for nutrition. He subsequently developed pneumonia during his inpatient stay as well as pressure ulcers. The patient required an arterial line, Shiley line, percutaneous endoscopic gastrostomy (PEG), and tracheostomy. He was treated with two cycles of intravenous immunoglobulin (IVIG) for five days each along with intravenous antibiotics for pneumonia. On November 12, 2013, the patient was transferred from one hospital to another for aggressive inpatient physical and supportive therapy. On November 25, 2013, he was discharged to a rehab center where he received care for his tracheostomy, pressure ulcers, and improved GBS condition. With continued improvement in his health condition, he was discharged from the rehab center on December 6, 2013, and is currently receiving home health care. He is scheduled to follow-up with his primary care provider in December 10, 2013. Actions, Progress and Resolution Date: The Infection Control Specialist consulted with school and determined that this GBS diagnosis was not reported to the Center for Disease Control (CDC). Therefore, per CDC guidelines, the event has now been reported through the Vaccine Adverse Events Reporting System.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Anxiety, Arterial catheterisation, Asthenia, Blood pressure increased, CSF test abnormal
Clinical narrative: A 35 year-old presented to the office on December 6, 2013 complaining that the clinic is responsible for his diagnosis of Guillain-Barré Syndrome (GBS); therefore, the Infection Control Specialist conducted an in-depth review of his electronic medical record which revealed the following: On August 30, 2013, the patient consented to receive an influenza vaccination at his primary care appointment. The patient was provided with appropriate educational information, per protocol, prior to consent. Approximately six weeks later, the patient presented to the Emergency Department with a chief complaint of numbness and tingling that started in his hands and feet but progressed to his entire body. He was subsequently discharged with a diagnosis of paresthesia's and anxiety and instructed to follow-up with his primary care provider or return to the emergency department if there was no improvement. On October 13, 2013, two days after his Emergency Department visit, the patient was seen at the Emergency Department where he reported increased numbness and tingling accompanied by pain, chills, and weakness. He was admitted with a diagnosis of rule-out Guillain-Barre Syndrome, which was confirmed with cerebrospinal fluid studies. His condition deteriorated and he became unable to swallow. He required respiratory ventilation support along with a gastric tube for nutrition. He subsequently developed pneumonia during his inpatient stay as well as pressure ulcers. The patient required an arterial line, Shiley line, percutaneous endoscopic gastrostomy (PEG), and tracheostomy. He was treated with two cycles of intravenous immunoglobulin (IVIG) for five days each along with intravenous antibiotics for pneumonia. On November 12, 2013, the patient was transferred from one hospital to another for aggressive inpatient physical and supportive therapy. On November 25, 2013, he was discharged to a rehab center where he received care for his tracheostomy, pressure ulcers, and improved GBS condition. With continued improvement in his health condition, he was discharged from the rehab center on December 6, 2013, and is currently receiving home health care. He is scheduled to follow-up with his primary care provider in December 10, 2013. Actions, Progress and Resolution Date: The Infection Control Specialist consulted with school and determined that this GBS diagnosis was not reported to the Center for Disease Control (CDC). Therefore, per CDC guidelines, the event has now been reported through the Vaccine Adverse Events Reporting System.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Central venous catheterisation, Chills, Decubitus ulcer, Dysphagia, Gastrostomy
Clinical narrative: A 35 year-old presented to the office on December 6, 2013 complaining that the clinic is responsible for his diagnosis of Guillain-Barré Syndrome (GBS); therefore, the Infection Control Specialist conducted an in-depth review of his electronic medical record which revealed the following: On August 30, 2013, the patient consented to receive an influenza vaccination at his primary care appointment. The patient was provided with appropriate educational information, per protocol, prior to consent. Approximately six weeks later, the patient presented to the Emergency Department with a chief complaint of numbness and tingling that started in his hands and feet but progressed to his entire body. He was subsequently discharged with a diagnosis of paresthesia's and anxiety and instructed to follow-up with his primary care provider or return to the emergency department if there was no improvement. On October 13, 2013, two days after his Emergency Department visit, the patient was seen at the Emergency Department where he reported increased numbness and tingling accompanied by pain, chills, and weakness. He was admitted with a diagnosis of rule-out Guillain-Barre Syndrome, which was confirmed with cerebrospinal fluid studies. His condition deteriorated and he became unable to swallow. He required respiratory ventilation support along with a gastric tube for nutrition. He subsequently developed pneumonia during his inpatient stay as well as pressure ulcers. The patient required an arterial line, Shiley line, percutaneous endoscopic gastrostomy (PEG), and tracheostomy. He was treated with two cycles of intravenous immunoglobulin (IVIG) for five days each along with intravenous antibiotics for pneumonia. On November 12, 2013, the patient was transferred from one hospital to another for aggressive inpatient physical and supportive therapy. On November 25, 2013, he was discharged to a rehab center where he received care for his tracheostomy, pressure ulcers, and improved GBS condition. With continued improvement in his health condition, he was discharged from the rehab center on December 6, 2013, and is currently receiving home health care. He is scheduled to follow-up with his primary care provider in December 10, 2013. Actions, Progress and Resolution Date: The Infection Control Specialist consulted with school and determined that this GBS diagnosis was not reported to the Center for Disease Control (CDC). Therefore, per CDC guidelines, the event has now been reported through the Vaccine Adverse Events Reporting System.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: General physical health deterioration, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Mechanical ventilation
Clinical narrative: A 35 year-old presented to the office on December 6, 2013 complaining that the clinic is responsible for his diagnosis of Guillain-Barré Syndrome (GBS); therefore, the Infection Control Specialist conducted an in-depth review of his electronic medical record which revealed the following: On August 30, 2013, the patient consented to receive an influenza vaccination at his primary care appointment. The patient was provided with appropriate educational information, per protocol, prior to consent. Approximately six weeks later, the patient presented to the Emergency Department with a chief complaint of numbness and tingling that started in his hands and feet but progressed to his entire body. He was subsequently discharged with a diagnosis of paresthesia's and anxiety and instructed to follow-up with his primary care provider or return to the emergency department if there was no improvement. On October 13, 2013, two days after his Emergency Department visit, the patient was seen at the Emergency Department where he reported increased numbness and tingling accompanied by pain, chills, and weakness. He was admitted with a diagnosis of rule-out Guillain-Barre Syndrome, which was confirmed with cerebrospinal fluid studies. His condition deteriorated and he became unable to swallow. He required respiratory ventilation support along with a gastric tube for nutrition. He subsequently developed pneumonia during his inpatient stay as well as pressure ulcers. The patient required an arterial line, Shiley line, percutaneous endoscopic gastrostomy (PEG), and tracheostomy. He was treated with two cycles of intravenous immunoglobulin (IVIG) for five days each along with intravenous antibiotics for pneumonia. On November 12, 2013, the patient was transferred from one hospital to another for aggressive inpatient physical and supportive therapy. On November 25, 2013, he was discharged to a rehab center where he received care for his tracheostomy, pressure ulcers, and improved GBS condition. With continued improvement in his health condition, he was discharged from the rehab center on December 6, 2013, and is currently receiving home health care. He is scheduled to follow-up with his primary care provider in December 10, 2013. Actions, Progress and Resolution Date: The Infection Control Specialist consulted with school and determined that this GBS diagnosis was not reported to the Center for Disease Control (CDC). Therefore, per CDC guidelines, the event has now been reported through the Vaccine Adverse Events Reporting System.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain, Paraesthesia, Pneumonia, Tracheostomy
Clinical narrative: A 35 year-old presented to the office on December 6, 2013 complaining that the clinic is responsible for his diagnosis of Guillain-Barré Syndrome (GBS); therefore, the Infection Control Specialist conducted an in-depth review of his electronic medical record which revealed the following: On August 30, 2013, the patient consented to receive an influenza vaccination at his primary care appointment. The patient was provided with appropriate educational information, per protocol, prior to consent. Approximately six weeks later, the patient presented to the Emergency Department with a chief complaint of numbness and tingling that started in his hands and feet but progressed to his entire body. He was subsequently discharged with a diagnosis of paresthesia's and anxiety and instructed to follow-up with his primary care provider or return to the emergency department if there was no improvement. On October 13, 2013, two days after his Emergency Department visit, the patient was seen at the Emergency Department where he reported increased numbness and tingling accompanied by pain, chills, and weakness. He was admitted with a diagnosis of rule-out Guillain-Barre Syndrome, which was confirmed with cerebrospinal fluid studies. His condition deteriorated and he became unable to swallow. He required respiratory ventilation support along with a gastric tube for nutrition. He subsequently developed pneumonia during his inpatient stay as well as pressure ulcers. The patient required an arterial line, Shiley line, percutaneous endoscopic gastrostomy (PEG), and tracheostomy. He was treated with two cycles of intravenous immunoglobulin (IVIG) for five days each along with intravenous antibiotics for pneumonia. On November 12, 2013, the patient was transferred from one hospital to another for aggressive inpatient physical and supportive therapy. On November 25, 2013, he was discharged to a rehab center where he received care for his tracheostomy, pressure ulcers, and improved GBS condition. With continued improvement in his health condition, he was discharged from the rehab center on December 6, 2013, and is currently receiving home health care. He is scheduled to follow-up with his primary care provider in December 10, 2013. Actions, Progress and Resolution Date: The Infection Control Specialist consulted with school and determined that this GBS diagnosis was not reported to the Center for Disease Control (CDC). Therefore, per CDC guidelines, the event has now been reported through the Vaccine Adverse Events Reporting System.
Age: 45.0
Sex: F
Vaccine: FLU3, HEPAB, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to left posterior upper arm onset Friday morning. Was seen at Hospital Emergency Room, given KEFLEX to take 4 times a day for 7 days.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swollen upper arm, larger than a quarter knot at injection site, redness approximately 2.5 inches in diameter, excessive soreness, itching, and condition remains basically unchanged 4 days later.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Mother stated that patient complained of itchiness to her left lateral thigh which improved overnight. Patient reported to the clinic the following day 10DEC13 will an approximate 60mm erythemic induration to injection site. No other signs or symptoms of allergic reaction observed or expressed by mother.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injection site pain
Clinical narrative: Continued soreness in left arm at injection site.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain, Pain, Pain in extremity
Clinical narrative: Continued soreness in left arm at injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Breast pain, Disability, Hyperaesthesia, Hypersensitivity
Clinical narrative: This spontaneous report as received from a 60 year old female retired nurse refers to herself with no drug reactions/allergies. The patient's medical history included rosacea. On 19-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot# not reported). Concomitant therapy included METROLOTION, 80 mg aspirin and ESTHEDERM patch. Sometime during the first week or second week of October, 2013, she developed pain in an area approximately the size of a half dollar that was very sensitive, "as if was a sting from a hornet". There was no redness or evident skin involvement and the pain moved from her back to her front, involving her left breast. She had burning pain on her skin surface, with excruciating sensitivity, stabbing pain in her left breast, excruciating pain in left nipple and in the ganglion under her left armpit. She further stated she couldn't wear a bra due to extreme sensitivity. At this time, the pain had mostly diminished with occasional burning pain at the original site on her back and stinging pain in left nipple. However, there was numbness under armpit and continuing neuropathy from her nipple line to above her pubic area on her left side. Patient sought medical attention by seeing her physician for further consultation. She stated she had information that she might need to have a spinal tap done for verification of disease involvement. TYLENOL and MOTRIN was given as treatment. And there was no lab diagnostics studies performed. The reporter considered the adverse events to be disability. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Neuropathy peripheral, Nipple pain, Pain, Pain of skin
Clinical narrative: This spontaneous report as received from a 60 year old female retired nurse refers to herself with no drug reactions/allergies. The patient's medical history included rosacea. On 19-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot# not reported). Concomitant therapy included METROLOTION, 80 mg aspirin and ESTHEDERM patch. Sometime during the first week or second week of October, 2013, she developed pain in an area approximately the size of a half dollar that was very sensitive, "as if was a sting from a hornet". There was no redness or evident skin involvement and the pain moved from her back to her front, involving her left breast. She had burning pain on her skin surface, with excruciating sensitivity, stabbing pain in her left breast, excruciating pain in left nipple and in the ganglion under her left armpit. She further stated she couldn't wear a bra due to extreme sensitivity. At this time, the pain had mostly diminished with occasional burning pain at the original site on her back and stinging pain in left nipple. However, there was numbness under armpit and continuing neuropathy from her nipple line to above her pubic area on her left side. Patient sought medical attention by seeing her physician for further consultation. She stated she had information that she might need to have a spinal tap done for verification of disease involvement. TYLENOL and MOTRIN was given as treatment. And there was no lab diagnostics studies performed. The reporter considered the adverse events to be disability. Additional information has been requested.