chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Swelling face
Clinical narrative: per patient reports facial swelling after meningitis b was given on 07/20/2017
Age: 18.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Loss of consciousness, Posture abnormal
Clinical narrative: An 18 year old female received 5 vaccines on 8-10-19 at our Shots clinic at the Fire Station.  Upon completion of the last vaccine ( MMR) she then slouched over and proceeded to lose consciousness for a total of 5-10 seconds.  She was then lowered to the floor and was given a cold compress and alcohol swab to sniff. She was given a juice box before the shots were administered and was instructed to keep sipping on the juice. Paramedics then stepped in and monitored her status.  They were able to get her off the ground and onto the stretcher where they moved her head up gradually.  Pt stated no SOB and or nausea. She recovered within 15 minutes and was escorted out to her mothers car to be transported home.  VAERS COMPLETED 8/13/2019 Pt stated she did not eat breakfast that morning, therefore a juice was given to her before shots were administered. She drank about half before passing out with the last vaccine.  It was also very warm where the shots were being administered.   Mom stated after the incident that her other child passes out as well..... and that they do not like needles. Education was provided to the parent and patient to always eat breakfast before getting shots. They were also instructed for future visits to always let the nurse know that the patient has a history of passing out and that we can give the shots laying down if needed .
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Fatigue, Hypoaesthesia, Influenza like illness
Clinical narrative: Extreme periods of fatigue starting early evening of Day 1. Continued into Day 2, then increasing localized pain around injection site ( from none, initially) and flu- like ache in lower back. Evening of Day 2 noticed red " welts" and inflammation about 3-4 inches across at injection site. Some swelling, but intense burning/itching. During the night felt like left arm to fingers was numb/ tingling. Day 3 this is persisting.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site reaction, Paraesthesia
Clinical narrative: Extreme periods of fatigue starting early evening of Day 1. Continued into Day 2, then increasing localized pain around injection site ( from none, initially) and flu- like ache in lower back. Evening of Day 2 noticed red " welts" and inflammation about 3-4 inches across at injection site. Some swelling, but intense burning/itching. During the night felt like left arm to fingers was numb/ tingling. Day 3 this is persisting.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Extreme periods of fatigue starting early evening of Day 1. Continued into Day 2, then increasing localized pain around injection site ( from none, initially) and flu- like ache in lower back. Evening of Day 2 noticed red " welts" and inflammation about 3-4 inches across at injection site. Some swelling, but intense burning/itching. During the night felt like left arm to fingers was numb/ tingling. Day 3 this is persisting.
Age: 11.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Cold sweat, Dizziness, Eye movement disorder, Fatigue, Headache
Clinical narrative: Patient was sitting in my office following vaccinations and his face went pale.  He then said he felt dizzy, became clammy, and his eyes rolled back in his head.  He passed out for approximately 5 seconds and woke complaining of headache, nausea, and seeing black.  Patient's feet were elevated, cool rags placed on forehead and neck.  After about 5 minutes patient reported he could see okay but his head was still hurting, he was nauseated, and felt really tired.  He was given a few sips of a cold cola and monitored.  After about 15-20 minutes the patient was back to normal skin color and his only complaints were mild headache and feeling tired.  He was alert and oriented x 3 upon discharge.  He was able to ambulate out of building supervised by his mother and was stable at discharge.
Age: 11.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Loss of consciousness, Nausea, Pallor, Visual impairment
Clinical narrative: Patient was sitting in my office following vaccinations and his face went pale.  He then said he felt dizzy, became clammy, and his eyes rolled back in his head.  He passed out for approximately 5 seconds and woke complaining of headache, nausea, and seeing black.  Patient's feet were elevated, cool rags placed on forehead and neck.  After about 5 minutes patient reported he could see okay but his head was still hurting, he was nauseated, and felt really tired.  He was given a few sips of a cold cola and monitored.  After about 15-20 minutes the patient was back to normal skin color and his only complaints were mild headache and feeling tired.  He was alert and oriented x 3 upon discharge.  He was able to ambulate out of building supervised by his mother and was stable at discharge.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient was seen in clinic today for back to school immunizations. She was administered Boostrix and Menactra IM to her Left Deltoid and then Gardasil 9 IM to her Right Deltoid. Patient remained seated in the nurses office for 5-10 minutes afterwards and was given a snack. Patient and parent then stated that they were ready to leave and were asked to wait in the front lobby for patient's printed certificate of immunization.  Per front staff - patient and her mother were standing at the front window waiting on her certificate of immunization when patient told her mother she was feeling dizzy. Patient's mother lowered her to the floor (she did not fall or hit her head). Nursing staff were then called to assess patient she was conscious by the time nursing got to her and mother reported patient only lost consciousness for about 5-10 seconds.  Patient was assisted into chair, cool cloth applied to neck and head, and some soda was given. Patient was monitored by nursing staff for 15-25 minutes. Patient and mother reported that patient was feeling much better and they left (mother was instructed to contact 911 if patient started to display any s/s of distress and she voiced understanding).
Age: 66.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt reported red, swollen, painful, hot area around injection site 6 days after receiving shingrix vaccine.  Pt was advised to see PCP to rule out infection.  MD determined it was an vaccine reaction and ruled out infection, pt was prescribed steroid cream.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Dry mouth, Ear pain, Muscle spasms, Pruritus, Pyrexia
Clinical narrative: Slight ear pain lasting only a few seconds and happening about 5 times, brief itching on the neck, shakiness, dry mouth, severe cramps (felt like something between period cramps and bowel movements, but more intense) that lasted about 40 minutes (subsided about 20-30 minutes after I took 2 ibuprofen pills), followed by a rash on the head, neck, ears, back, stomach, arms, and wrists and a slight fever.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Tremor
Clinical narrative: Slight ear pain lasting only a few seconds and happening about 5 times, brief itching on the neck, shakiness, dry mouth, severe cramps (felt like something between period cramps and bowel movements, but more intense) that lasted about 40 minutes (subsided about 20-30 minutes after I took 2 ibuprofen pills), followed by a rash on the head, neck, ears, back, stomach, arms, and wrists and a slight fever.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Lymph node pain in armpit area of injected arm (left); chills; fatigue; swelling, redness, and pain at incision site (upper left arm); skin hot to touch at incision site (left arm).  Onset of these symptoms: early evening on the day of the Shingrix injection. Symptoms have persisted for approximately 24 hours.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Lymph node pain
Clinical narrative: Lymph node pain in armpit area of injected arm (left); chills; fatigue; swelling, redness, and pain at incision site (upper left arm); skin hot to touch at incision site (left arm).  Onset of these symptoms: early evening on the day of the Shingrix injection. Symptoms have persisted for approximately 24 hours.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram head, Gastritis, Headache, Hypertension
Clinical narrative: Severe headache, n/v, neck pain, high blood pressure. Lasted almost 4 weeks, had 6 ED visits and 3 hospital admissions. The only thing that helped was IV steroids.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Lumbar puncture, Nausea, Neck pain, Vomiting
Clinical narrative: Severe headache, n/v, neck pain, high blood pressure. Lasted almost 4 weeks, had 6 ED visits and 3 hospital admissions. The only thing that helped was IV steroids.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: pt received both fluarix and pnemovax 23 (merck and co inc lot s012246, exp 02/10/21) in left arm and had severe reaction (arm swelling and redness)--enough to go to ER and be prescribed Doxycycline
Age: 18.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: there is no adverse event. MMR was given instead of Menactra
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Insomnia, Middle insomnia
Clinical narrative: Woke up in middle of night with headache, chills, muscle aches, a bit nauseous.  These symptoms were worse than I have experienced for other vaccines ( for example flu vaccines).  I could not get back to sleep, so I took 2 tylenol, still could not sleep, and symptoms persisted all day and next night.  I took 2 tylenol everey 8 hours , and finally tried taking 2 advil also in the evening.  The Advil seemed to help some to relieve chills and headache.  I got some sleep that night.  The next morning 8/11/2019 was the first time in over 24 hours that I felt good enough to get up and eat normally and start to resume normal activities.  By noon, I was feeling much better,  and I hadn?t taken Tylenol or Advil for 12 hours.  My Arm is still sore ate injection site, but I am fine now.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: Woke up in middle of night with headache, chills, muscle aches, a bit nauseous.  These symptoms were worse than I have experienced for other vaccines ( for example flu vaccines).  I could not get back to sleep, so I took 2 tylenol, still could not sleep, and symptoms persisted all day and next night.  I took 2 tylenol everey 8 hours , and finally tried taking 2 advil also in the evening.  The Advil seemed to help some to relieve chills and headache.  I got some sleep that night.  The next morning 8/11/2019 was the first time in over 24 hours that I felt good enough to get up and eat normally and start to resume normal activities.  By noon, I was feeling much better,  and I hadn?t taken Tylenol or Advil for 12 hours.  My Arm is still sore ate injection site, but I am fine now.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Oral mucosal blistering, Pain
Clinical narrative: Nausea, exhaustion, headache , body aches for 10 days and not resolving. Rash on arm and on foot, day 4-10  Blisters in mouth day7-8.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Nausea, exhaustion, headache , body aches for 10 days and not resolving. Rash on arm and on foot, day 4-10  Blisters in mouth day7-8.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Malaise
Clinical narrative: Intense shivering. Chills. Malaise. Fatigue. I don't have a thermometer. Normal injection site soreness.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Rash
Clinical narrative: rash, redness, painful, no breathing problems.
Age: 19.0
Sex: F
Vaccine: CHOL, JEV1
Symptoms: Blood culture negative, Blood iron abnormal, Blood lactic acid, Blood magnesium, Chest X-ray normal
Clinical narrative: per pt caseworker: pt c/o chest pain within about 1 hr post vaccinations but resolved spontaneously.  The night following vaccinations pt reported chills, fever (103.5 F), H/A, body aches, and blurred vision.   No reports of rash, swelling, or difficulty breathing.  Caseworker reported taking pt to ED for care.  Pt discharge 8/12/19 on oral antibiotics and iron pills.  Pt rec'd blood transfusion during course of stay due to low hemoglobin per caseworker report.
Age: 19.0
Sex: F
Vaccine: CHOL, JEV1
Symptoms: Chest pain, Chills, Computerised tomogram normal, Differential white blood cell count abnormal, Full blood count abnormal
Clinical narrative: per pt caseworker: pt c/o chest pain within about 1 hr post vaccinations but resolved spontaneously.  The night following vaccinations pt reported chills, fever (103.5 F), H/A, body aches, and blurred vision.   No reports of rash, swelling, or difficulty breathing.  Caseworker reported taking pt to ED for care.  Pt discharge 8/12/19 on oral antibiotics and iron pills.  Pt rec'd blood transfusion during course of stay due to low hemoglobin per caseworker report.
Age: 19.0
Sex: F
Vaccine: CHOL, JEV1
Symptoms: Haemoglobin decreased, Headache, Human chorionic gonadotropin negative, Lipase, Metabolic function test abnormal
Clinical narrative: per pt caseworker: pt c/o chest pain within about 1 hr post vaccinations but resolved spontaneously.  The night following vaccinations pt reported chills, fever (103.5 F), H/A, body aches, and blurred vision.   No reports of rash, swelling, or difficulty breathing.  Caseworker reported taking pt to ED for care.  Pt discharge 8/12/19 on oral antibiotics and iron pills.  Pt rec'd blood transfusion during course of stay due to low hemoglobin per caseworker report.
Age: 19.0
Sex: F
Vaccine: CHOL, JEV1
Symptoms: Pain, Procalcitonin, Pyrexia, Serum ferritin abnormal, Transfusion
Clinical narrative: per pt caseworker: pt c/o chest pain within about 1 hr post vaccinations but resolved spontaneously.  The night following vaccinations pt reported chills, fever (103.5 F), H/A, body aches, and blurred vision.   No reports of rash, swelling, or difficulty breathing.  Caseworker reported taking pt to ED for care.  Pt discharge 8/12/19 on oral antibiotics and iron pills.  Pt rec'd blood transfusion during course of stay due to low hemoglobin per caseworker report.
Age: 19.0
Sex: F
Vaccine: CHOL, JEV1
Symptoms: Troponin, Urine analysis normal, Vision blurred
Clinical narrative: per pt caseworker: pt c/o chest pain within about 1 hr post vaccinations but resolved spontaneously.  The night following vaccinations pt reported chills, fever (103.5 F), H/A, body aches, and blurred vision.   No reports of rash, swelling, or difficulty breathing.  Caseworker reported taking pt to ED for care.  Pt discharge 8/12/19 on oral antibiotics and iron pills.  Pt rec'd blood transfusion during course of stay due to low hemoglobin per caseworker report.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: A few hours after the vaccination patients left arm got red, painful and swollen. After 24 hours it seemed worse and the redness had spread down to her forearm. Patient spoke to her doctor and they prescribed azithromycin (500mg on day 1 and 250 mg on days 2-5) in case this was cellulitis. As of 8/13 her arm is improving but still has some swelling.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness, Nausea
Clinical narrative: Client complained of nausea, dizziness, and passed out for few seconds after receiving 1st HPV9 immunization
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site warmth, Malaise
Clinical narrative: Patient experienced redness and soreness that radiated from the injection site down her arm almost to her elbow. The red, irritated area was hot to the touch. She did not complain of fever, but she did say she did not feel well the day after receiving the vaccine. Patient was referred to her doctor, and was informed that she should be seen as soon as possible. Patient stated that her doctor informed her that she had a fever of 99 degrees F. She was given a seven day supply of Keflex by her primary care physician, Dr.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Paraesthesia
Clinical narrative: Patient is experiencing chills and tingling in her fingers and toes.
Age: 39.0
Sex: F
Vaccine: HEP, PPV, HEP, PPV
Symptoms: Blood magnesium, Borrelia test, Chills, Condition aggravated, Culture urine
Clinical narrative: WOKE UP WITH MIGRAINE FOLLOWING DAY,THEN PROGRESS TO FEVER AND BODY ACHES,FEVER CONTINUE FOR A 24 HOUR PERIOD WITH CHILLS AND BURNING EYE FATIGUE,DIZZINESS AND RAPID HEART BEAT.WENT TO EMERGENCY ROOM ON 8/7 WAS ADMITTED TILL 8/9 WAS GIVEN IV FLUIDS AND ANTIBIOTICS VIA IV CBC COUNT WAS OVER 20 THOUSAND MD DIAGNOSIS HIGH FEVER,SEPSIS INFECTION AND CELLULITIS  WHERE VACCINE WAS ADMINISTERED
Age: 39.0
Sex: F
Vaccine: HEP, PPV, HEP, PPV
Symptoms: Differential white blood cell count, Dizziness, Drug level, Eye irritation, Fatigue
Clinical narrative: WOKE UP WITH MIGRAINE FOLLOWING DAY,THEN PROGRESS TO FEVER AND BODY ACHES,FEVER CONTINUE FOR A 24 HOUR PERIOD WITH CHILLS AND BURNING EYE FATIGUE,DIZZINESS AND RAPID HEART BEAT.WENT TO EMERGENCY ROOM ON 8/7 WAS ADMITTED TILL 8/9 WAS GIVEN IV FLUIDS AND ANTIBIOTICS VIA IV CBC COUNT WAS OVER 20 THOUSAND MD DIAGNOSIS HIGH FEVER,SEPSIS INFECTION AND CELLULITIS  WHERE VACCINE WAS ADMINISTERED
Age: 39.0
Sex: F
Vaccine: HEP, PPV, HEP, PPV
Symptoms: Fibrin D dimer, Full blood count, Heart rate increased, Liver function test, Metabolic function test
Clinical narrative: WOKE UP WITH MIGRAINE FOLLOWING DAY,THEN PROGRESS TO FEVER AND BODY ACHES,FEVER CONTINUE FOR A 24 HOUR PERIOD WITH CHILLS AND BURNING EYE FATIGUE,DIZZINESS AND RAPID HEART BEAT.WENT TO EMERGENCY ROOM ON 8/7 WAS ADMITTED TILL 8/9 WAS GIVEN IV FLUIDS AND ANTIBIOTICS VIA IV CBC COUNT WAS OVER 20 THOUSAND MD DIAGNOSIS HIGH FEVER,SEPSIS INFECTION AND CELLULITIS  WHERE VACCINE WAS ADMINISTERED
Age: 39.0
Sex: F
Vaccine: HEP, PPV, HEP, PPV
Symptoms: Migraine, Pain, Polymerase chain reaction, Pyrexia, Respiratory viral panel
Clinical narrative: WOKE UP WITH MIGRAINE FOLLOWING DAY,THEN PROGRESS TO FEVER AND BODY ACHES,FEVER CONTINUE FOR A 24 HOUR PERIOD WITH CHILLS AND BURNING EYE FATIGUE,DIZZINESS AND RAPID HEART BEAT.WENT TO EMERGENCY ROOM ON 8/7 WAS ADMITTED TILL 8/9 WAS GIVEN IV FLUIDS AND ANTIBIOTICS VIA IV CBC COUNT WAS OVER 20 THOUSAND MD DIAGNOSIS HIGH FEVER,SEPSIS INFECTION AND CELLULITIS  WHERE VACCINE WAS ADMINISTERED
Age: 39.0
Sex: F
Vaccine: HEP, PPV, HEP, PPV
Symptoms: Sepsis, Staphylococcus test, Urine analysis, Vaccination site cellulitis, Vaccination site infection
Clinical narrative: WOKE UP WITH MIGRAINE FOLLOWING DAY,THEN PROGRESS TO FEVER AND BODY ACHES,FEVER CONTINUE FOR A 24 HOUR PERIOD WITH CHILLS AND BURNING EYE FATIGUE,DIZZINESS AND RAPID HEART BEAT.WENT TO EMERGENCY ROOM ON 8/7 WAS ADMITTED TILL 8/9 WAS GIVEN IV FLUIDS AND ANTIBIOTICS VIA IV CBC COUNT WAS OVER 20 THOUSAND MD DIAGNOSIS HIGH FEVER,SEPSIS INFECTION AND CELLULITIS  WHERE VACCINE WAS ADMINISTERED
Age: 39.0
Sex: F
Vaccine: HEP, PPV, HEP, PPV
Symptoms: White blood cell count increased
Clinical narrative: WOKE UP WITH MIGRAINE FOLLOWING DAY,THEN PROGRESS TO FEVER AND BODY ACHES,FEVER CONTINUE FOR A 24 HOUR PERIOD WITH CHILLS AND BURNING EYE FATIGUE,DIZZINESS AND RAPID HEART BEAT.WENT TO EMERGENCY ROOM ON 8/7 WAS ADMITTED TILL 8/9 WAS GIVEN IV FLUIDS AND ANTIBIOTICS VIA IV CBC COUNT WAS OVER 20 THOUSAND MD DIAGNOSIS HIGH FEVER,SEPSIS INFECTION AND CELLULITIS  WHERE VACCINE WAS ADMINISTERED
Age: 39.0
Sex: F
Vaccine: HEP, PPV, HEP, PPV
Symptoms: Infection, Influenza like illness, Malaise
Clinical narrative: WOKE UP WITH MIGRAINE FOLLOWING DAY,THEN PROGRESS TO FEVER AND BODY ACHES,FEVER CONTINUE FOR A 24 HOUR PERIOD WITH CHILLS AND BURNING EYE FATIGUE,DIZZINESS AND RAPID HEART BEAT.WENT TO EMERGENCY ROOM ON 8/7 WAS ADMITTED TILL 8/9 WAS GIVEN IV FLUIDS AND ANTIBIOTICS VIA IV CBC COUNT WAS OVER 20 THOUSAND MD DIAGNOSIS HIGH FEVER,SEPSIS INFECTION AND CELLULITIS  WHERE VACCINE WAS ADMINISTERED
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Influenza like illness, Pain, Somnolence
Clinical narrative: Patient complains of headache, feeling lightheaded, and general ache. Symptoms similar to flu-like symptoms. Patient also complains of falling in and out of sleep.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Immediate post-injection reaction, Injection site pain, Injection site rash
Clinical narrative: pt had transient stinging during administration. Tenderness and hotness at injection site remained but gradually dissipated, but not completely, over the following 6 days.  The rash around the site reached about 2.5 inches and was slightly swollen during the 1st 24 hours.  On the 4th day after administration, patient experienced one day of nausea and diarrhea with some chills.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Nausea
Clinical narrative: pt had transient stinging during administration. Tenderness and hotness at injection site remained but gradually dissipated, but not completely, over the following 6 days.  The rash around the site reached about 2.5 inches and was slightly swollen during the 1st 24 hours.  On the 4th day after administration, patient experienced one day of nausea and diarrhea with some chills.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Pain in extremity
Clinical narrative: Sore painful arm with significant bruising from shoulder to hand
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Injection site pain, Pain
Clinical narrative: This was my second course of  Shingrix vaccine. Approximately 24 hours after injection felt shivery and achy all over. Feel warm but prefer to be under covers than to shiver.   Injection site hurts but not anything to report about. Very similar to pain from first injection.  I don?t have the vaccine info to add above.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea, Urticaria
Clinical narrative: Hive like rash on chest, back, and face that would come and go for a couple of days. Diarrhea for 3 days so far.
Age: 1.08
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Developmental regression, Diarrhoea, Ear discomfort, Emotional distress
Clinical narrative: After receiving the shot on 7/23 a round solid bump formed at the injection site. Two inches in diameter. Baby did not want his leg touched. On 8/8 baby developed fever of 104, followed the next day by lower 100 and vomiting and diarrhea. Baby was screaming continuously, and louder than he ever had prior. Unable to console. Screaming would go on and off for several hours until he was exhausted. Loss of appetite, regression in motor skills (walking stopped), less verbal.  8/13 slight body rash.
Age: 1.08
Sex: M
Vaccine: DTAP
Symptoms: Eye irritation, Fatigue, Gait inability, Head discomfort, Injection site pain
Clinical narrative: After receiving the shot on 7/23 a round solid bump formed at the injection site. Two inches in diameter. Baby did not want his leg touched. On 8/8 baby developed fever of 104, followed the next day by lower 100 and vomiting and diarrhea. Baby was screaming continuously, and louder than he ever had prior. Unable to console. Screaming would go on and off for several hours until he was exhausted. Loss of appetite, regression in motor skills (walking stopped), less verbal.  8/13 slight body rash.
Age: 1.08
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Lethargy, Pyrexia, Rash, Roseola
Clinical narrative: After receiving the shot on 7/23 a round solid bump formed at the injection site. Two inches in diameter. Baby did not want his leg touched. On 8/8 baby developed fever of 104, followed the next day by lower 100 and vomiting and diarrhea. Baby was screaming continuously, and louder than he ever had prior. Unable to console. Screaming would go on and off for several hours until he was exhausted. Loss of appetite, regression in motor skills (walking stopped), less verbal.  8/13 slight body rash.
Age: 1.08
Sex: M
Vaccine: DTAP
Symptoms: Screaming, Speech disorder, Urinary tract infection, Vomiting
Clinical narrative: After receiving the shot on 7/23 a round solid bump formed at the injection site. Two inches in diameter. Baby did not want his leg touched. On 8/8 baby developed fever of 104, followed the next day by lower 100 and vomiting and diarrhea. Baby was screaming continuously, and louder than he ever had prior. Unable to console. Screaming would go on and off for several hours until he was exhausted. Loss of appetite, regression in motor skills (walking stopped), less verbal.  8/13 slight body rash.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Heart rate increased, Tachycardia
Clinical narrative: Tachycardia / increased heart rate to 209 bpm
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Heart rate increased
Clinical narrative: Shivering, elevated heart rate
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Injection site cellulitis
Clinical narrative: localized cellulitis at site. site marked, Benadryl dose amount provided to mom oral steroid x 1 day, topical antibiotic
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: Gave the patient and expired  Hep A vaccine on 8/13/19 in LT Deltoid  HEP A expiration 6-12-19 LOT R013858 NDC 006-4831-41
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eyelid rash, Ophthalmic herpes zoster
Clinical narrative: Shingles rash on (L) eyelid
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Shingles rash on (L) eyelid
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial infection, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient came in on 8/10/19 with Approx. 9cm in diameter circular erythematic, swollen Rash no left upper arm. She went to local urgent care and was diagnosed with bacterial infection And given antibiotics for a 7 day course. Pt is doing Better.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Pt had chest tightness and difficulty breathing. Pt was given Epi pen IM and followed by another in 1 minute later. After no relief. Albuterol HFA 3 puffs were given sequentially 1 min later 911 was called and pt was picked up by EMT.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: felt dizzy; immediately felt dizzy; This report was identified from a line listing obtained on request by the Company from the FDA (Agency# 725130) under the Freedom of Information Act, referring to 11 year old male patient. The patient had no other medication, historical condition and current illness. Information about prior vaccination was unknown.  On 31-OCT-2017 the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot # N000326)I intramuscularly in the right arm for prophylaxis. Other suspect therapies included the sixth dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) (lot#393D9) (indication and expiration date was not reported) intramuscularly in a left arm and the first dose of meningococcal acyw conj vaccine (dip toxoid)(MENACTRA)(lot#U5712AA)(indication and expiration date was not reported) intramuscularly in the right arm.  On the same day, after the vaccinations, the patient immediately felt dizzy (dizziness and immediate post-injection reaction). The patient was laid down on exam table for 5-10 minutes and the patient began to feel better. The blood pressure was 125/59 (units unknown). The patient sat up and stated that he felt fine. The patient then stood up with the blood pressure of 116/75 (units unknown). The patient walked to car and was notified if he got any worse to go to emergency room.  The outcome of the events was reported as recovered. The agency did not provide the causality between the events with the suspect therapies.  Follow up information has been received from a health professional on 19-JUN-2019. The patient had no prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination, no allergies to medications, food or other products, no other illnesses at the time of vaccination and up to one month prior and no chronic or long-standing health conditions. The date and time of vaccination was 31-OCT-2017 15:00. The adverse event started at 15:00 on 31-OCT-2017. The patient never had an adverse event following any previous vaccine.  Follow up information was received from the health professional on 25-JUL-2019 regarding 11-year old (also reported as 12) male patient. The patient's demographics were updated.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received shot on stated date and 2 days later had redness, swelling, and tenderness at injection site. Redness and swelling were roughly 10 inches in duration. Patient did not complain of difficulty breathing or any other symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: itchy; rash on her stomach; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number HB2B2, expiry date unknown) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix with an associated reaction of rash pruritic (1st dose received on 24th April 2019, refer case US2019079806 ). Concurrent medical conditions included chronic lymphoid leukemia and post herpetic neuralgia (pre-vaccination). Concomitant products included thyroxine sodium (Levothyroxine), allergy medication {nos} (Allergy Pill), silver (Silver Solution), gabapentin, losartan and oxcarbazepine.   On 26th June 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced itchy rash and rash. The patient was treated with hydrocortisone, avena sativa (Aveeno), loratadine and cetirizine. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the itchy rash and rash were unknown.   It was unknown if the reporter considered the itchy rash and rash to be related to Shingrix.  Additional details were provided as follows:  After receiving the 2nd dose of Shingrix, the patient experienced itchy rash intermittently itchy rash on her entire left arm and a rash on her stomach of unknown cause.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bedridden, Blister, Herpes zoster, Pain, Peripheral swelling
Clinical narrative: Worst shingles/ shingles on his head; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 21 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. The batch number was not available. Three weeks after receiving 2nd dose of Shingrix, the patient developed worst shingles of his life and also experienced shingles on his head. The reporter and the pharmacy consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash generalised
Clinical narrative: Worst shingles/ shingles on his head; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 21 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. The batch number was not available. Three weeks after receiving 2nd dose of Shingrix, the patient developed worst shingles of his life and also experienced shingles on his head. The reporter and the pharmacy consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Worst shingles/ shingles on his head; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 21 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. The batch number was not available. Three weeks after receiving 2nd dose of Shingrix, the patient developed worst shingles of his life and also experienced shingles on his head. The reporter and the pharmacy consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphagia, Headache, Hyperhidrosis, Pain, Throat irritation
Clinical narrative: felt like she had a cold; sneezing; runny nose; sweating; chills; headache; body ache; sore throat; trouble swallowing; sore arm at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of cold in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   Concurrent medical conditions included allergy to plants (allergy to pine and balsum).   On 30th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 31st July 2019, 1 days after receiving Shingrix, the patient experienced cold, sneezing, runny nose, sweating, chills, headache, general body pain, sore throat, swallowing difficult and injection site pain. The patient was treated with methylprednisolone (Medrol). On an unknown date, the outcome of the cold, sneezing, runny nose, sweating, chills, headache, general body pain, sore throat, swallowing difficult and injection site pain were unknown.   It was unknown if the reporter considered the cold, sneezing, runny nose, sweating, chills, headache, general body pain, sore throat, swallowing difficult and injection site pain to be related to Shingrix.  Additional information received were as follows: The caller was a pharmacist who reported a day after receiving Shingrix, the patient experienced felt like she had a cold, sneezing, runny nose, sweating, chills, headache, body ache, sore throat, trouble swallowing and sore arm at injection site. The caller reported that the patient was eventually seen by her doctor and was prescribed Medrol dose pack to help with the symptoms.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dysphagia, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: felt like she had a cold; sneezing; runny nose; sweating; chills; headache; body ache; sore throat; trouble swallowing; sore arm at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of cold in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   Concurrent medical conditions included allergy to plants (allergy to pine and balsum).   On 30th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 31st July 2019, 1 days after receiving Shingrix, the patient experienced cold, sneezing, runny nose, sweating, chills, headache, general body pain, sore throat, swallowing difficult and injection site pain. The patient was treated with methylprednisolone (Medrol). On an unknown date, the outcome of the cold, sneezing, runny nose, sweating, chills, headache, general body pain, sore throat, swallowing difficult and injection site pain were unknown.   It was unknown if the reporter considered the cold, sneezing, runny nose, sweating, chills, headache, general body pain, sore throat, swallowing difficult and injection site pain to be related to Shingrix.  Additional information received were as follows: The caller was a pharmacist who reported a day after receiving Shingrix, the patient experienced felt like she had a cold, sneezing, runny nose, sweating, chills, headache, body ache, sore throat, trouble swallowing and sore arm at injection site. The caller reported that the patient was eventually seen by her doctor and was prescribed Medrol dose pack to help with the symptoms.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain, Rhinorrhoea, Sneezing
Clinical narrative: felt like she had a cold; sneezing; runny nose; sweating; chills; headache; body ache; sore throat; trouble swallowing; sore arm at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of cold in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   Concurrent medical conditions included allergy to plants (allergy to pine and balsum).   On 30th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 31st July 2019, 1 days after receiving Shingrix, the patient experienced cold, sneezing, runny nose, sweating, chills, headache, general body pain, sore throat, swallowing difficult and injection site pain. The patient was treated with methylprednisolone (Medrol). On an unknown date, the outcome of the cold, sneezing, runny nose, sweating, chills, headache, general body pain, sore throat, swallowing difficult and injection site pain were unknown.   It was unknown if the reporter considered the cold, sneezing, runny nose, sweating, chills, headache, general body pain, sore throat, swallowing difficult and injection site pain to be related to Shingrix.  Additional information received were as follows: The caller was a pharmacist who reported a day after receiving Shingrix, the patient experienced felt like she had a cold, sneezing, runny nose, sweating, chills, headache, body ache, sore throat, trouble swallowing and sore arm at injection site. The caller reported that the patient was eventually seen by her doctor and was prescribed Medrol dose pack to help with the symptoms.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Blood test normal, Headache, Influenza like illness, Malaise
Clinical narrative: his urine has changed in color to a dark brown; nausea; fever; aches; lower back pain; chills; dry mouth; soreness in the injection arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2019, the patient received the 2nd dose of Shingrix. On 19th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 20th July 2019, the patient experienced fever, pain, low back pain, chills, dry mouth and nausea. On an unknown date, the patient experienced urine discoloration. On an unknown date, the outcome of the fever, pain, low back pain, chills, dry mouth, urine discoloration and nausea were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the fever, pain, low back pain, chills, dry mouth, urine discoloration, nausea and injection site pain to be related to Shingrix.  Additional information received were as follows: The caller was a patient. The patient received Shingrix on an unknown arm. On the same day of vaccination, the patient experienced soreness in the injection arm. 1 day after receiving the vaccine, the patient experienced fever, aches, chills, lower back pain, dry mouth and nausea. Less than 3 weeks after receiving Shingrix, the patient stated that his urine has changed in color to a dark brown. The patient had been to the local quick care, and 2 different emergency room. The reporter consented to follow up. Emergency room visit required. The patient did not provide any additional details.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: his urine has changed in color to a dark brown; nausea; fever; aches; lower back pain; chills; dry mouth; soreness in the injection arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2019, the patient received the 2nd dose of Shingrix. On 19th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 20th July 2019, the patient experienced fever, pain, low back pain, chills, dry mouth and nausea. On an unknown date, the patient experienced urine discoloration. On an unknown date, the outcome of the fever, pain, low back pain, chills, dry mouth, urine discoloration and nausea were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the fever, pain, low back pain, chills, dry mouth, urine discoloration, nausea and injection site pain to be related to Shingrix.  Additional information received were as follows: The caller was a patient. The patient received Shingrix on an unknown arm. On the same day of vaccination, the patient experienced soreness in the injection arm. 1 day after receiving the vaccine, the patient experienced fever, aches, chills, lower back pain, dry mouth and nausea. Less than 3 weeks after receiving Shingrix, the patient stated that his urine has changed in color to a dark brown. The patient had been to the local quick care, and 2 different emergency room. The reporter consented to follow up. Emergency room visit required. The patient did not provide any additional details.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Chills, Chromaturia, Dry mouth, Injection site pain
Clinical narrative: his urine has changed in color to a dark brown; nausea; fever; aches; lower back pain; chills; dry mouth; soreness in the injection arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2019, the patient received the 2nd dose of Shingrix. On 19th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 20th July 2019, the patient experienced fever, pain, low back pain, chills, dry mouth and nausea. On an unknown date, the patient experienced urine discoloration. On an unknown date, the outcome of the fever, pain, low back pain, chills, dry mouth, urine discoloration and nausea were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the fever, pain, low back pain, chills, dry mouth, urine discoloration, nausea and injection site pain to be related to Shingrix.  Additional information received were as follows: The caller was a patient. The patient received Shingrix on an unknown arm. On the same day of vaccination, the patient experienced soreness in the injection arm. 1 day after receiving the vaccine, the patient experienced fever, aches, chills, lower back pain, dry mouth and nausea. Less than 3 weeks after receiving Shingrix, the patient stated that his urine has changed in color to a dark brown. The patient had been to the local quick care, and 2 different emergency room. The reporter consented to follow up. Emergency room visit required. The patient did not provide any additional details.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: his urine has changed in color to a dark brown; nausea; fever; aches; lower back pain; chills; dry mouth; soreness in the injection arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2019, the patient received the 2nd dose of Shingrix. On 19th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 20th July 2019, the patient experienced fever, pain, low back pain, chills, dry mouth and nausea. On an unknown date, the patient experienced urine discoloration. On an unknown date, the outcome of the fever, pain, low back pain, chills, dry mouth, urine discoloration and nausea were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the fever, pain, low back pain, chills, dry mouth, urine discoloration, nausea and injection site pain to be related to Shingrix.  Additional information received were as follows: The caller was a patient. The patient received Shingrix on an unknown arm. On the same day of vaccination, the patient experienced soreness in the injection arm. 1 day after receiving the vaccine, the patient experienced fever, aches, chills, lower back pain, dry mouth and nausea. Less than 3 weeks after receiving Shingrix, the patient stated that his urine has changed in color to a dark brown. The patient had been to the local quick care, and 2 different emergency room. The reporter consented to follow up. Emergency room visit required. The patient did not provide any additional details.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Blood test, Blood test normal, Breast pain, Chest X-ray normal
Clinical narrative: heart pain; shingles; pain; pain went from back to left breast; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of cardiac pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd July 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms. On 1st August 2019, the patient experienced cardiac pain (serious criteria GSK medically significant), shingles, back pain and breast pain. On 24th July 2019, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the cardiac pain, shingles, back pain and breast pain were not recovered/not resolved.   It was unknown if the reporter considered the cardiac pain, shingles, back pain, breast pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient reported that the pain went from her back to her left breast.   The patient planned to continue follow up with her physician on an unknown date. The patient required emergency room visit due to these events. The patient consented to follow up. There was a discrepancy in the reported outcomes of the events cardiac pain, shingles, back pain and breast pain. In XML, outcome was mentioned as recovering/resolving and in the database, it was autoloaded as recovered/resolved. However outcome of all these events is captured as autoloaded in database.