chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Vitamin B12 decreased, Vitamin D decreased
Clinical narrative: Within just a couple short weeks of being vaccinated patient now has significant issues ranging from low vitamin D, zinc, B12, magnesium and behavior issues that are autistic in nature. She has obsessions and outbursts that were not present prior to receiving so many vaccines at once. We are now spending a fortune to correct these things by diet, supplements, and multiple therapies.
Age: 4.0
Sex: M
Vaccine: DTPIPV, MMRV
Symptoms: Expired product administered
Clinical narrative: Vaccine PROQUAD was given on 4/19/17, it had expired on 4/5/17.
Age: 25.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Death, Encephalitis autoimmune, Toxic epidermal necrolysis
Clinical narrative: Anti-NMDA receptor encephalitis after anthrax/typhoid vaccines.
Age: 1.08
Sex: M
Vaccine: DTAP, HIBV, MMR, PPV, VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction positive, Rash, Varicella virus test positive
Clinical narrative: Herpes Zoster in a vaccinated individual. Painful unilateral rash, unknown duration. Given Acyclovir as treatment.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema
Clinical narrative: REDDENED RAISED AREA NOTED ON L ARM THE SIZE OF A SILVER DOLLAR. PCM MADE AWARE AND ASSESSED AREA. PLAN OF CARE DISCUSSED WITH MOTHER OF PATIENT. MOTHER OF PATIENT IS TO CONTINUE WITH COOL COMPRESSES AND GIVE PATIENT MOTRIN FOR PAIN OR DISCOMFORT INSTRUCTIONS GIVEN PER PROVIDER.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMR, VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction positive, Rash, Varicella virus test positive
Clinical narrative: Herpes Zoster in a vaccinated individual. Painful unilateral rash lasting less than 4 weeks. Not given treatment.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Blood test, Electromyogram, Gait disturbance
Clinical narrative: Woke up with no movement of left hand/wrist. one week later numbness and tingling of left foot with inability to toe walk. Unable to do simple daily life activities (ie. unable to tie my own shoes) EMG done on 12/5/2016 followed by immediate admit to the hospital for GBS. MRI of brain and neck followed by LP.  IVIG was given over the next 5 days. as of today 4/19/2017 I am still having residual weakness and pain in left wrist.  I am unable to resume working due to weakness.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: Woke up with no movement of left hand/wrist. one week later numbness and tingling of left foot with inability to toe walk. Unable to do simple daily life activities (ie. unable to tie my own shoes) EMG done on 12/5/2016 followed by immediate admit to the hospital for GBS. MRI of brain and neck followed by LP.  IVIG was given over the next 5 days. as of today 4/19/2017 I am still having residual weakness and pain in left wrist.  I am unable to resume working due to weakness.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Lumbar puncture, Mobility decreased, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: Woke up with no movement of left hand/wrist. one week later numbness and tingling of left foot with inability to toe walk. Unable to do simple daily life activities (ie. unable to tie my own shoes) EMG done on 12/5/2016 followed by immediate admit to the hospital for GBS. MRI of brain and neck followed by LP.  IVIG was given over the next 5 days. as of today 4/19/2017 I am still having residual weakness and pain in left wrist.  I am unable to resume working due to weakness.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Patient had the anthrax vaccine on 4/10/2017 and experiencing itchiness and soreness on left arm 4/12/2017.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring a patient of unknown age or gender. The patient's concurrent conditions, medical history or concomitant medication were not provided. On 12-JUL-2012 and on 27-JUL-2013, the patient was vaccinated with GARDASIL 9 (strength, dose, route of administration, lot number and expiration date were not reported) both for prophylaxis, respectively. On 30-MAR-2017, the patient was in the office for her third dose of GARDASIL 9. No adverse symptoms reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 31-MAR-2017 from a physician via a company employee regarding a 60 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. The physician, currently 67 years old and who is also the patient, reported to the company employee that he was vaccinated with ZOSTAVAX (lot number and expiration not reported) subcutaneous for prophylaxis when he was 60 years old. The physician reported that ever since he received the vaccine, once or twice a year he gets a mild case of shingles somewhere on his body, usually on his torso. The physician has not sought medical attention and has not been hospitalized. The physician reported that it always resolves on its own.   No further information has been provided. The causality of shingles was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certificated medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M009378 with expiration date of 23-APR-2018 and lot # M016193 with expiration date of 24-APR-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses with the lot # M009378 and expiration date of 23-APR-2018 and with the lot # M016193 and expiration date of 24-APR-2018, experienced a temperature excursion during 119 hours 30 minutes at a temperature between 32 degrees Fahrenheit and 35 degrees Fahrenheit (0 degrees Celsius and 1 degrees Celsius) (# cycles: 30) from 15-DEC-2016 to 13-JAN-2017, and a temperature excursion during 04 hours at a temperature between 32 degrees Fahrenheit and 35 degrees Fahrenheit (0 degrees Celsius and 1 degrees Celsius) (# cycles: 30) from 23-FEB-2017 to 24-MAR-2017. A data logger issue was involved. No previous temperature excursion and no adverse effects were reported. Additional information has been requested.; Sender's Comments: US-009507513-1704USA008690: US-009507513-1704USA008691:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certificated medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # M025194 with expiration date of 22-MAR-2019, lot # M036057 with expiration date of 18-MAY-2019 and lot # L014427 with expiration date of 09-MAR-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses with the lot # M025194 and expiration date of 22-MAR-2019, lot # M036057 and expiration date of 18-MAY-2019 and lot # L014427 with expiration date of 09-MAR-2018, experienced a temperature excursion during 119 hours 30 minutes at a temperature between 32 degrees Fahrenheit and 35 degrees Fahrenheit (0 degrees Celsius and 1 degrees Celsius) (# cycles: 30) from 15-DEC-2016 to 13-JAN-2017, and a temperature excursion during 04 hours at a temperature between 32 degrees Fahrenheit and 35 degrees Fahrenheit (0 degrees Celsius and 1 degrees Celsius) (# cycles: 30) from 23-FEB-2017 to 24-MAR-2017. A data logger issue was involved. No previous temperature excursion and no adverse effects were reported. Additional information has been requested.; Sender's Comments: US-009507513-1704USA008691: US-009507513-1704USA002259:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certificated medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot # M000592 with expiration date of 12-OCT-2017; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 119 hours 30 minutes at a temperature between 32 degrees Fahrenheit and 35 degrees Fahrenheit (0 degrees Celsius and 1 degrees Celsius) (# cycles: 30) from 15-DEC-2016 to 13-JAN-2017, and a temperature excursion during 04 hours at a temperature between 32 degrees Fahrenheit and 35 degrees Fahrenheit (0 degrees Celsius and 1 degrees Celsius) (# cycles: 30) from 23-FEB-2017 to 24-MAR-2017. A data logger issue was involved. No previous temperature excursion and no adverse effects were reported.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA002259: US-009507513-1704USA008690:
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer Company representative. This nurse reported similar events for two patients. This is the first of two reports. Only this case is serious. A 52 year-old female patient of an unspecified race/ethnicity received PREVNAR 13 via an unspecified route of administration in the arm on an unspecified date at 0.5 ml single for immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced local cellulitis (red and tender like at the area where she got the shot). The nurse reported that when the doctor reviewed the patient there were not swollen lymph nodes or soreness or anything like that, it was just this tender to touch the part, the patient was able to move her arm and hand without any problems. The doctor gave to the patient cephalexin (KEFLEX) 500 mg four times a day for 5 days and 6 tablets of prednisone 20 mg, then 1 tablet of prednisone twice a day for 3 days. Outcome of the event was unknown. Event was considered related to pneumococcal 13-val conj vac (dipht crm197 protein).; Sender's Comments: The reported event vaccination site cellulitis is possibly related to PREVNAR 13. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Limb mass, Pain in extremity, Pyrexia
Clinical narrative: Initial unsolicited report received from other non-healthcare professional on 06-APR-2017. This case is linked with 2017SA062460. This case involves a female patient (onset age unknown) who was vaccinated with a first dose of ADACEL (batch number: U5561AB, expiry date: 18-FEB-2019, dose was not reported) intramuscularly in the left deltoid on 03-APR-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as unknown. Illness at the time of vaccination was reported as none. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 03-APR-2017, same day of following the vaccination, the patient had developed fever and then sore in the left arm with redness the size of a baseball with a hard lump under it. The patient required emergency room (ER) or doctor visit on an unknown date. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Pain, Pain in jaw, Pyrexia
Clinical narrative: Customer reported fever of 101 degrees F 24 hours after receiving the vaccines. She also has reported that both her jaws are hurting along with body aches.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: ZOSTAVAX was administered in left deltoid of the arm instead of in sub Q fat of arm. Pt. did not experience any adverse event.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Affect lability, Aggression, Disturbance in social behaviour, Gait disturbance, Head banging
Clinical narrative: Regression of speech, walking. Regressed from walking to being fearful of taking steps. Emotional labile - temper outburst, banging head not as interactive with siblings.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Speech disorder developmental
Clinical narrative: Regression of speech, walking. Regressed from walking to being fearful of taking steps. Emotional labile - temper outburst, banging head not as interactive with siblings.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Flushing, Nausea
Clinical narrative: After administration, C/O lightheaded, flushed, nauseated. Lasted approximately 10 min. Relieved by lying down.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Burning sensation, Injection site urticaria, Pruritus, Urticaria
Clinical narrative: 4/18/2017 went to health department to get my MMR vaccination my appointment was at 100pm. Got home at 200pm and noticed I had hives on my left arm where I recieved the vaccination. It progressed onto me face hairline and thighs on both legs. Called my Physician and they said take Benadryl and follow up with appointment on 4/19/2017 at 230pm. Went to them today because my face was on fire and the left arm was still very itchie. The physician gave me a prednisone shot as well got a prescription. I follow up in three days with doctor again 4/24/2017.
Age: 65.0
Sex: U
Vaccine: PNC13
Symptoms: Chills, Injection site rash, Local swelling, Pyrexia, Skin warm
Clinical narrative: Patient experienced fever, chills and rash (4 inches) on arm at site of injection. Arm was warm and area was swollen.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Bruised area on left tricep (Immunization given in left deltoid). Bruise roughly 3 x 12", appears to be resolving. Was somewhat painful.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Croup infectious, Pyrexia
Clinical narrative: Varicella vaccine given yesterday (4/6/17). Croup and fever same night.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Report of (R) anterior shoulder pain 2 days 4-14-17 after receiving Hepatitis B vaccine 4-12-17 - evaluated 4-18-17 and 4-19-17. Cool pack, gentle pendulum exercises and follow up appointment scheduled 4-26-17.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Flecks of blood in stool 7 days after ROTATEQ. No irritability, lethargy, emesis. Will observe. No treatment recommended.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Doctor ordered Zoster and PPV23 for patient. They were both given but patient had previous Zoster 9-24-15. No adverse reactions 20 minutes following. Patient notified and left appt.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Upper arm became very red, swollen and painful. Also itchy. Most of the right upper arm is involved.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Abdominal pain, Crying, Culture stool, Decreased appetite, Diarrhoea
Clinical narrative: After receiving shots on 03/02/17, in the evening, patients cried for more than three hours -inconsolable, started having diarrhea - bloody stool and mucus with abdominal pain. Decreased appetite. Not moving left leg, fever greater than 102 degrees F. Seen on 03/07/17.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Emotional distress, Haematochezia, Injected limb mobility decreased, Mucous stools, Pyrexia
Clinical narrative: After receiving shots on 03/02/17, in the evening, patients cried for more than three hours -inconsolable, started having diarrhea - bloody stool and mucus with abdominal pain. Decreased appetite. Not moving left leg, fever greater than 102 degrees F. Seen on 03/07/17.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Ultrasound abdomen
Clinical narrative: After receiving shots on 03/02/17, in the evening, patients cried for more than three hours -inconsolable, started having diarrhea - bloody stool and mucus with abdominal pain. Decreased appetite. Not moving left leg, fever greater than 102 degrees F. Seen on 03/07/17.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying, Eye movement disorder, Seizure, Staring, Tremor
Clinical narrative: Seizure 6:45 AM 4/4/17 woke with intense cry, shaking of extremities, extended limbs, then eyes deviating to right without blinking for 30 seconds, unresponsive when name called, occurred every few minutes for 2 hours.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Unresponsive to stimuli
Clinical narrative: Seizure 6:45 AM 4/4/17 woke with intense cry, shaking of extremities, extended limbs, then eyes deviating to right without blinking for 30 seconds, unresponsive when name called, occurred every few minutes for 2 hours.
Age: 27.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dizziness, Pallor, Posture abnormal
Clinical narrative: After patient received both injections, she got light headed and slid out of chair to floor. She was "white" complexion but never passed out. After 5 minutes and a glass of water she was fine.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Paraesthesia
Clinical narrative: 4/10/2017 upper arm sore became swollen began having tingling and pain in in arm and hands. Has put warm pack on arm and is taking Ibuprofen.
Age: 1.58
Sex: M
Vaccine: HIBV
Symptoms: Injection site discomfort, Injection site haematoma
Clinical narrative: Hematoma to upper left thigh. Discomfort to injection site x 1 week.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Syncope
Clinical narrative: Patient fainted after given immunization, closed eyes laid down, fluids, sugar, cool cloth applied to forehead, start to finish 20 minutes.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Syncope
Clinical narrative: Patient fainted after immunization given, closed eyes, laid down, fluids, sugar, cool cloth applied to forehead, crackers with peanut butter. Start to finish 20 min.
Age: 11.0
Sex: U
Vaccine: TDAP
Symptoms: Erythema, Immediate post-injection reaction
Clinical narrative: Pt given ADACEL - immediate reaction, redness size from shoulder above elbow.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives at the site and on bilateral legs.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Immunoglobulin therapy, Knee operation, Platelet count decreased, Sports injury, Thrombocytopenia
Clinical narrative: GARDASIL received in 8/15. Seen 9/21/15 for football injury and platelets 81K. Platelet count has varied between 12K on 11/30/15 and 146K 5/27/16 after IVIgG to treat count 43K prior to knee surgery. At diagnosis also EBV (+).
Age: 33.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Pain in extremity
Clinical narrative: PATIENT REPORTED TO PHARMACY THAT SHE HAD A SORE RIGHT ARM IN THE MORNING ON 4/18/17. THE SORENESS CONTINUED AND ON 4/19/17 IT WAS WORSE. HER DOCTOR RECOMMENDED THAT SHE SEE A DOCTOR TO GET EVALUATED. THEY ARE SUSPECTING CELLULITIS, BUT THEY ARE RUNNING MORE TESTS AS OF 4/19/17 at 3PM.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Patient reports itchy rash that started at site of injection and has spread to other areas such as under breast.  I recommended that the patient call the Dr. so that the Dr. can evaluate and suggest treatments.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal pain, Blood test, Laboratory test, Lymphadenopathy, Ocular hyperaemia
Clinical narrative: Fever over 7 days....blood red eyes, abdominal pain, swelling tongue, swollen glands.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Respiratory syncytial virus test, Swollen tongue, Urine analysis, X-ray
Clinical narrative: Fever over 7 days....blood red eyes, abdominal pain, swelling tongue, swollen glands.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Alanine aminotransferase normal, Blood albumin normal, Blood culture negative, C-reactive protein increased, Conjunctivitis
Clinical narrative: Fever over 7 days....blood red eyes, abdominal pain, swelling tongue, swollen glands.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cough, Culture urine negative, Cytomegalovirus test negative, Echocardiogram normal, Epstein-Barr virus test negative
Clinical narrative: Fever over 7 days....blood red eyes, abdominal pain, swelling tongue, swollen glands.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Full blood count, Gamma-glutamyltransferase normal, Hypophagia, Immunoglobulin therapy, Irritability
Clinical narrative: Fever over 7 days....blood red eyes, abdominal pain, swelling tongue, swollen glands.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Kawasaki's disease, Mycoplasma test negative, Nasal disorder, Pleocytosis, Poor quality sleep
Clinical narrative: Fever over 7 days....blood red eyes, abdominal pain, swelling tongue, swollen glands.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Respiratory tract congestion, Respiratory viral panel, Thrombocytosis
Clinical narrative: Fever over 7 days....blood red eyes, abdominal pain, swelling tongue, swollen glands.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urine analysis normal, Viral infection, White blood cell count increased
Clinical narrative: Fever over 7 days....blood red eyes, abdominal pain, swelling tongue, swollen glands.
Age: 11.0
Sex: F
Vaccine: FLU4, HEPA, HPVX, MNQ, TDAP, VARCEL
Symptoms: Death, Generalised tonic-clonic seizure
Clinical narrative: First Grand Mal Tonic-Clonic Seizure (3/28/2016). Second Grand Mal Tonic-Clonic Seizure 1/20/2017. Third/Fourth Grand Mal Tonic-Clonic Seizure 3/10/2017. Fifth/Final Grand Mal Tonic-Clonic Seizure leading to death: 4/8/2017.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Anaemia, Asthenia, Autoimmune haemolytic anaemia, Blood test, Decreased appetite
Clinical narrative: Patient lethargy, no energy, not eating. Rush to ER where was given blood transfusion because acute anemia. More test were performed and later diagnosed with idiopathic autoimmune hemolytic anemia. She was given Ranitidine 15 mg take 1.5 ml by mouth twice a day for six month.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Lethargy, Transfusion
Clinical narrative: Patient lethargy, no energy, not eating. Rush to ER where was given blood transfusion because acute anemia. More test were performed and later diagnosed with idiopathic autoimmune hemolytic anemia. She was given Ranitidine 15 mg take 1.5 ml by mouth twice a day for six month.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Presyncope, Vomiting
Clinical narrative: Pt had vasovagal response, but then had vomiting, treatment - rest, lying down.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pruritus, Skin warm, Tenderness
Clinical narrative: Patient came in the pharmacy 4/19/17 at 8:30 PM to report an adverse reaction that he experienced the date after being vaccinated.  Patient stated that he experienced itchiness, redness, tender to touch and warm. He did not seek medication help.  He did not take any OTC medication to relief itchiness. He stated that the adverse reaction went away after about 2 week. All the symptoms went away after 2 weeks.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Full blood count, Influenza virus test negative, Pyrexia, Urine analysis, Viral upper respiratory tract infection
Clinical narrative: Vaccines admin. 03/31/17 at 4pm. 4/1/17 child slept most of day. Woke at 9pm w/104.7 fever. Over the course of the next week made 3-4 trips to Dr office for tests (urine, blood, check for flu) as fever continued. No for sure cause identified. Gave antibiotic 4/5 for 10 days for possible/unsure UTI. Fever last had on Thurs 4/6 at 7am of 102.0. No fever since. Still on antibiotic. Child now also has cold symptoms. (cough runny congested none)
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Epistaxis
Clinical narrative: Nosebleed. No treatment. Happened 1 day after 4 mo and 6 mo shots. Pt's mother report this to me on 4/12/2017.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Arm swollen at site of injection, significantly - mid humorous to top of shoulder with pain, warmth, redness onset less than 12 hours post administration.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site nodule, Injection site pain, Pain
Clinical narrative: (R) deltoid pain-always aware of it being sore has a knot in deep tissues has stabbing pain. Achiness.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Induration, Injection site reaction, Rash erythematous, Rash macular, Skin lesion
Clinical narrative: Patient was seen on 4/4/17. She received BEXSERO 1st dose and also was put on BACTRIM for abscess. Noticed blotchy rashes on Rt. upper arm on Friday 4/7/17. Has one large circular erythematous lesion 1.5 x 1.5 cm with central induration seen on Rt. forearm. No other rashes in the body.
Age: 64.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Oropharyngeal pain, Paraesthesia, Visual impairment
Clinical narrative: Dizziness, lightheaded, tingling in arm, vision going white, sore throat - within minutes of injection - propped feet up, - pt improved. Called 911, just in case.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness, Muscle twitching, Seizure
Clinical narrative: Patient passed out and had mild seizure or twitching after receiving BOOSTRIX vaccine. Called 911 everything ok - gave patient food since no breakfast - Left - called him at home 2 hours later - everything ok.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Confusional state, Nausea, Pain in extremity, Pyrexia
Clinical narrative: 03/25/17 I got up at 1:00 AM. Pain in arm, fever, nauseous, weak, confuse, but I took a nap at 4:30 PM for two weeks after that day. Still I feel nauseous.
Age: 26.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Rash over abdomen, back, thighs, neck, arms. Red flat rash. Temp 98.2.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Erythema, Pruritus, Pyrexia
Clinical narrative: Patient had vaccine on 4/13/17. Had rash/itching/redness/swelling on 4/14/17. She said on 4/15/17 she had 103 fever and chills, continued swelling and redness. She went to the doctor on 4/18/17 and he said she had cellulitis. He gave her cephalexin. He tried to give her steroid - she refused. On 4/19 - she said it was much better.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling
Clinical narrative: Patient had vaccine on 4/13/17. Had rash/itching/redness/swelling on 4/14/17. She said on 4/15/17 she had 103 fever and chills, continued swelling and redness. She went to the doctor on 4/18/17 and he said she had cellulitis. He gave her cephalexin. He tried to give her steroid - she refused. On 4/19 - she said it was much better.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Erythema of eyelid, Eyelid rash, Fatigue, Measles antibody negative, Mumps antibody test negative
Clinical narrative: MMR given 4/14/17. Onset 4/16/17 PM of rash on back, eye lids (white center with red around it). Itching. Low grade fever (100 degrees), nausea and fatigue. Employee Health notified of symptoms 4/19/17. Referred to PCP who felt this was a vaccine reaction.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Pruritus, Pyrexia, Rash
Clinical narrative: MMR given 4/14/17. Onset 4/16/17 PM of rash on back, eye lids (white center with red around it). Itching. Low grade fever (100 degrees), nausea and fatigue. Employee Health notified of symptoms 4/19/17. Referred to PCP who felt this was a vaccine reaction.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Fatigue, Fungal infection, Injection site pain, Injection site swelling
Clinical narrative: 4/4-date of vaccine. 4/6-symptoms feeling very tired, pain at site red/swelling, warm. (MD not seen). 4/7-feeling ok but site of injection red/swollen/warm. Pt had placed ice, and went to ER and confirmed to be cellulitis, 6 inches and raised. 4/8-Cephalexin given for 7 days - [4/10]- PCP- to put heat= 4/17. 4/10- Pt. has a rash on hand/calf -feeling itching. 4/17-Pt being treated for yeast infection.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pruritus, Rash
Clinical narrative: 4/4-date of vaccine. 4/6-symptoms feeling very tired, pain at site red/swelling, warm. (MD not seen). 4/7-feeling ok but site of injection red/swollen/warm. Pt had placed ice, and went to ER and confirmed to be cellulitis, 6 inches and raised. 4/8-Cephalexin given for 7 days - [4/10]- PCP- to put heat= 4/17. 4/10- Pt. has a rash on hand/calf -feeling itching. 4/17-Pt being treated for yeast infection.
Age: 1.25
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site vesicles
Clinical narrative: Mom noticed spots on Left thigh 4-12-17 pm. Office visit 4-14-17:Left thigh with a red 2.5cm diameter area with mild induration, not warm, no drainage, nonfluctuant. Several healed over areas that look like small vesicles that had broken open and then healed over.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: About 24h after vaccine had large local swelling and redness and warmth.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient has redness, swelling, and warmth to area of arm where vaccination was given. She went to the doctor and they gave her antibiotics in case of cellulitis.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood thyroid stimulating hormone, Full blood count, Metabolic function test, Nausea
Clinical narrative: Evening of 12/31/15 Complained of nausea and vomiting. Seen in ED on 1/1/16 for bilateral leg and left arm tingling with weakness and pain. Continuing to have symptoms.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Nerve conduction studies normal, Nuclear magnetic resonance imaging brain normal, Pain, Paraesthesia, Thyroxine free
Clinical narrative: Evening of 12/31/15 Complained of nausea and vomiting. Seen in ED on 1/1/16 for bilateral leg and left arm tingling with weakness and pain. Continuing to have symptoms.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Vitamin B12, Vomiting
Clinical narrative: Evening of 12/31/15 Complained of nausea and vomiting. Seen in ED on 1/1/16 for bilateral leg and left arm tingling with weakness and pain. Continuing to have symptoms.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MEN, TDAP
Symptoms: Urticaria
Clinical narrative: After 20 minutes later of being immunized, patient developed urticarial (small wheal and flare) on his cheeks and right arm.  He had no trouble breathing. Recommended that he take Cetirizine (Zyrtec, already prescribed for his itching with eczema) when he got home.
Age: 68.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Fatigue, Nasopharyngitis, Respiration abnormal
Clinical narrative: This spontaneous report was received from a male patient of currently 69 years old reporting on himself. In his concurrent conditions was reported diabetes (low level) and he had not any drug reactions/allergies. The patient did not provide any pertinent medical history. His concomitant medications included: metformin, JANUVIA, ramipril (also reported as ramapril), telmisartan (also reported as telesmartin) and bisoprolol (also reported as bisperol); these last three were for high blood pressure. On 14-DEC-2016, the patient was vaccinated with PNEUMOVAX 23 1 injection, intravenously (strength, Lot # and expiration date were not provided) for prevention. On an unknown date, reported as "several weeks" after the shot of PNEUMOVAX 23 was given, the patient  began complaining of respiratory symptoms which he believed were a result of the vaccine. He experienced heavy "labored" breathing/shortness of breath, excess phlegm (productive cough) and difficulty walking. On 08-AUG-2017, the patient went to see a Pulmonary specialist who given him unspecified antibiotics. After this, the patient stated that he was feeling better overall but he still had some remaining effects and he corroborated again that he believed the effects were from the vaccine. The patient performed a chest scan, on an unknown date, but the results were not provided. The outcome of dyspnoea, gait disturbance and productive cough was reported as not improved (previously reported as "feeling better overall"). Additional information is not expected as there was no consent to be contacted.
Age: 68.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chest scan, Dyspnoea, Gait disturbance, Productive cough, Respiratory symptom
Clinical narrative: This spontaneous report was received from a male patient of currently 69 years old reporting on himself. In his concurrent conditions was reported diabetes (low level) and he had not any drug reactions/allergies. The patient did not provide any pertinent medical history. His concomitant medications included: metformin, JANUVIA, ramipril (also reported as ramapril), telmisartan (also reported as telesmartin) and bisoprolol (also reported as bisperol); these last three were for high blood pressure. On 14-DEC-2016, the patient was vaccinated with PNEUMOVAX 23 1 injection, intravenously (strength, Lot # and expiration date were not provided) for prevention. On an unknown date, reported as "several weeks" after the shot of PNEUMOVAX 23 was given, the patient  began complaining of respiratory symptoms which he believed were a result of the vaccine. He experienced heavy "labored" breathing/shortness of breath, excess phlegm (productive cough) and difficulty walking. On 08-AUG-2017, the patient went to see a Pulmonary specialist who given him unspecified antibiotics. After this, the patient stated that he was feeling better overall but he still had some remaining effects and he corroborated again that he believed the effects were from the vaccine. The patient performed a chest scan, on an unknown date, but the results were not provided. The outcome of dyspnoea, gait disturbance and productive cough was reported as not improved (previously reported as "feeling better overall"). Additional information is not expected as there was no consent to be contacted.
Age: 19.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Eye swelling, Injection site swelling, Local reaction, Pruritus, Swelling face
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a 19-year-old male patient who received BEXSERO (batch number 166801A, expiry date 31st May 2017). On 13th March 2017, the patient received the 2nd dose of BEXSERO (intramuscular) .5 ml. On 13th March 2017, less than a day after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling. The patient was treated with prednisone. On an unknown date, the outcome of the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling were unknown. It was unknown if the reporter considered the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on the left deltoid. On 13th March 2017, in the evening, the patient began to have a reaction which began initially as hives, then progressed to an anaphylactic reaction. The patient had swelling of the tongue, lips, eyes and face. The patient also had swelling, hardness, and hives at the injection site. On the same date, the patient was seen in the emergency room, treated with Prednisone, and discharged. Follow up information (targeted follow up questionnaire) was received from a nurse on 12th April 2017: The patient demographics details were updated. The patient had received 2 doses of BEXSERO before the hypersensitivity reaction occurred. The VAERS details were updated. On 13th March 2017, less than a day after vaccination, the patient also experienced laryngeal edema and urticaria. The events were resolved after 48 hours. The patient went to the emergency department for management. The details of diagnostics test and full drug history were not provided. It was unknown if the reporter considered the laryngeal edema and urticaria to be related to BEXSERO.
Age: 19.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a 19-year-old male patient who received BEXSERO (batch number 166801A, expiry date 31st May 2017). On 13th March 2017, the patient received the 2nd dose of BEXSERO (intramuscular) .5 ml. On 13th March 2017, less than a day after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling. The patient was treated with prednisone. On an unknown date, the outcome of the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling were unknown. It was unknown if the reporter considered the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on the left deltoid. On 13th March 2017, in the evening, the patient began to have a reaction which began initially as hives, then progressed to an anaphylactic reaction. The patient had swelling of the tongue, lips, eyes and face. The patient also had swelling, hardness, and hives at the injection site. On the same date, the patient was seen in the emergency room, treated with Prednisone, and discharged. Follow up information (targeted follow up questionnaire) was received from a nurse on 12th April 2017: The patient demographics details were updated. The patient had received 2 doses of BEXSERO before the hypersensitivity reaction occurred. The VAERS details were updated. On 13th March 2017, less than a day after vaccination, the patient also experienced laryngeal edema and urticaria. The events were resolved after 48 hours. The patient went to the emergency department for management. The details of diagnostics test and full drug history were not provided. It was unknown if the reporter considered the laryngeal edema and urticaria to be related to BEXSERO.
Age: 19.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Anaphylactic reaction, Eye swelling, Injection site induration, Injection site swelling, Injection site urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a 19-year-old male patient who received BEXSERO (batch number 166801A, expiry date 31st May 2017). On 13th March 2017, the patient received the 2nd dose of BEXSERO (intramuscular) .5 ml. On 13th March 2017, less than a day after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling. The patient was treated with prednisone. On an unknown date, the outcome of the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling were unknown. It was unknown if the reporter considered the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on the left deltoid. On 13th March 2017, in the evening, the patient began to have a reaction which began initially as hives, then progressed to an anaphylactic reaction. The patient had swelling of the tongue, lips, eyes and face. The patient also had swelling, hardness, and hives at the injection site. On the same date, the patient was seen in the emergency room, treated with Prednisone, and discharged. Follow up information (targeted follow up questionnaire) was received from a nurse on 12th April 2017: The patient demographics details were updated. The patient had received 2 doses of BEXSERO before the hypersensitivity reaction occurred. The VAERS details were updated. On 13th March 2017, less than a day after vaccination, the patient also experienced laryngeal edema and urticaria. The events were resolved after 48 hours. The patient went to the emergency department for management. The details of diagnostics test and full drug history were not provided. It was unknown if the reporter considered the laryngeal edema and urticaria to be related to BEXSERO.
Age: 19.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Lip swelling, Swelling face, Swollen tongue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a 19-year-old male patient who received BEXSERO (batch number 166801A, expiry date 31st May 2017). On 13th March 2017, the patient received the 2nd dose of BEXSERO (intramuscular) .5 ml. On 13th March 2017, less than a day after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling. The patient was treated with prednisone. On an unknown date, the outcome of the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling were unknown. It was unknown if the reporter considered the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on the left deltoid. On 13th March 2017, in the evening, the patient began to have a reaction which began initially as hives, then progressed to an anaphylactic reaction. The patient had swelling of the tongue, lips, eyes and face. The patient also had swelling, hardness, and hives at the injection site. On the same date, the patient was seen in the emergency room, treated with Prednisone, and discharged. Follow up information (targeted follow up questionnaire) was received from a nurse on 12th April 2017: The patient demographics details were updated. The patient had received 2 doses of BEXSERO before the hypersensitivity reaction occurred. The VAERS details were updated. On 13th March 2017, less than a day after vaccination, the patient also experienced laryngeal edema and urticaria. The events were resolved after 48 hours. The patient went to the emergency department for management. The details of diagnostics test and full drug history were not provided. It was unknown if the reporter considered the laryngeal edema and urticaria to be related to BEXSERO.
Age: 19.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Anaphylactic reaction, Eye swelling, Hypersensitivity, Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a 19-year-old male patient who received BEXSERO (batch number 166801A, expiry date 31st May 2017). On 13th March 2017, the patient received the 2nd dose of BEXSERO (intramuscular) .5 ml. On 13th March 2017, less than a day after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling. The patient was treated with prednisone. On an unknown date, the outcome of the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling were unknown. It was unknown if the reporter considered the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on the left deltoid. On 13th March 2017, in the evening, the patient began to have a reaction which began initially as hives, then progressed to an anaphylactic reaction. The patient had swelling of the tongue, lips, eyes and face. The patient also had swelling, hardness, and hives at the injection site. On the same date, the patient was seen in the emergency room, treated with Prednisone, and discharged. Follow up information (targeted follow up questionnaire) was received from a nurse on 12th April 2017: The patient demographics details were updated. The patient had received 2 doses of BEXSERO before the hypersensitivity reaction occurred. The VAERS details were updated. On 13th March 2017, less than a day after vaccination, the patient also experienced laryngeal edema and urticaria. The events were resolved after 48 hours. The patient went to the emergency department for management. The details of diagnostics test and full drug history were not provided. It was unknown if the reporter considered the laryngeal edema and urticaria to be related to BEXSERO.