chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received on 29-JUN-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 29-JUN-2017 the patient was vaccinated with an expired dose of VAQTA, (lot number unknown) expiration date 26-MAY-2017 intramuscular for prophylaxis. No adverse effects reported. No additional information was provided. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Within 15 minutes of receiving vacation in upper right arm, area started to itch. Then the area started to burn, internally, not on outside. The itching is bothersome and concerning. The area surrounding injection site is warm to the touch and also starting to turn bright pink. I'm not happy at all about this reaction; especially the itching and burning.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, MNQ
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Burning sensation, Decreased appetite, Differential white blood cell count
Clinical narrative: Ever since he had shots in both arms he has been having burning in his muscles and in the axilla. Last night upper thighs were hurting and very sensitive. Says both legs and thighs are numb. Today hurting a little lower than the thighs. No headache or fever. Had anorexia over the past weekend and continued on Monday and Tuesday.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, MNQ
Symptoms: Full blood count, Hypoaesthesia, Metabolic function test, Pain in extremity, Sensory disturbance
Clinical narrative: Ever since he had shots in both arms he has been having burning in his muscles and in the axilla. Last night upper thighs were hurting and very sensitive. Says both legs and thighs are numb. Today hurting a little lower than the thighs. No headache or fever. Had anorexia over the past weekend and continued on Monday and Tuesday.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, MNQ
Symptoms: Burning sensation, Hyperaesthesia, Hypoaesthesia, Myalgia, Pain
Clinical narrative: Ever since he had shots in both arms he has been having burning in his muscles and in the axilla. Last night upper thighs were hurting and very sensitive. Says both legs and thighs are numb. Today hurting a little lower than the thighs. No headache or fever. Had anorexia over the past weekend and continued on Monday and Tuesday.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, MNQ
Symptoms: Hyperaesthesia, Hypoaesthesia, Myalgia, Pain in extremity
Clinical narrative: Ever since he had shots in both arms he has been having burning in his muscles and in the axilla. Last night upper thighs were hurting and very sensitive. Says both legs and thighs are numb. Today hurting a little lower than the thighs. No headache or fever. Had anorexia over the past weekend and continued on Monday and Tuesday.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Condition aggravated, Cough, Fungal infection, Headache
Clinical narrative: About 8 or so hours after injection: sore throat headache and nausea. About 20 hours later injection site extremely red, sore and swollen. Also noted severe rash under breasts; mainly right sided but also left. Asthma symptoms developed within 24 hours. Coughing, wheezing. Symptoms continued through weekend (had vaccine on Thursday; symptoms developed Friday.) Self medication....creams, Pro-air inhaler, OTC Nyquil. Saw doctor on Monday July 10 9:45 a.m.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Oropharyngeal pain
Clinical narrative: About 8 or so hours after injection: sore throat headache and nausea. About 20 hours later injection site extremely red, sore and swollen. Also noted severe rash under breasts; mainly right sided but also left. Asthma symptoms developed within 24 hours. Coughing, wheezing. Symptoms continued through weekend (had vaccine on Thursday; symptoms developed Friday.) Self medication....creams, Pro-air inhaler, OTC Nyquil. Saw doctor on Monday July 10 9:45 a.m.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin infection, Wheezing
Clinical narrative: About 8 or so hours after injection: sore throat headache and nausea. About 20 hours later injection site extremely red, sore and swollen. Also noted severe rash under breasts; mainly right sided but also left. Asthma symptoms developed within 24 hours. Coughing, wheezing. Symptoms continued through weekend (had vaccine on Thursday; symptoms developed Friday.) Self medication....creams, Pro-air inhaler, OTC Nyquil. Saw doctor on Monday July 10 9:45 a.m.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Mobility decreased, Musculoskeletal pain
Clinical narrative: Shoulder pain, hard to move the arm, pain 8/10, red raised spots on arm in area of injection site.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Pt received Hep A around noon time 7/7/17-Mom called 3:30 that pt had red hives itchy rash to full body. No fever. Tx w/BENADRYL helped. Last 36 hrs.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) thigh redness, slight swelling, hot to touch. Tx: oral BENADRYL as needed for itchy skin.
Age: 0.58
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray, Pyrexia, Tachycardia, Tachypnoea, Urine analysis
Clinical narrative: tachycardia (180s-200) x 2 days; tachypnea x 2 days; fever 103 x 2 days
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Haematoma, Injection site warmth, Pain
Clinical narrative: Patient had soreness for 2 days after vaccination, then injection site felt a little warm, 4 days post injection developed hematoma. Patient went to Emergency Department 7 days post vaccination.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Crying, Pyrexia, Skin warm, Vomiting
Clinical narrative: Got the MMR at 11am, fine all day until 5pm she complained and was crying about a lower stomach ache and felt warm. At 6pm she vomitied, her temperature was 100.3 and 9pm she feel asleep and then vomited again at 12am. Called the 24 hour nurse. The fever stayed around 99.8-100.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, Culture urine negative, Diarrhoea haemorrhagic, Full blood count, Metabolic function test
Clinical narrative: Fever X 7 days starting night vaccinations received, TYLENOL given; bloody diarrhea X 2, 5 days after vaccinations, rash starting 6 days after vaccinations- not resolved as of yet.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Polymerase chain reaction, Pyrexia, Rash, Stool analysis, Urine analysis
Clinical narrative: Fever X 7 days starting night vaccinations received, TYLENOL given; bloody diarrhea X 2, 5 days after vaccinations, rash starting 6 days after vaccinations- not resolved as of yet.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Erythema
Clinical narrative: RED SOFTBALL SIZE MARK  ON LEFT ARM TEMPERATURE OF 100 DEGREES.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Hot red welt on child's thigh that lasted 2 days.
Age: 1.08
Sex: F
Vaccine: MMR, PNC13
Symptoms: Amblyopia, Blindness unilateral, Corrective lens user
Clinical narrative: Ok so I just found out about this website and it was a long time ago so I'm not exactly sure of date and time or which shots were all given at once but I believe it was her MMR. Right around the time she was almost one. Within one month after being given her shots my daughter developed a permanent lazy eye that is now developing into permanent vision loss. We are in the process of trying to save her vision loss that resulted as a result of her lazy eye! She was perfectly healthy before and her eyes were totally normal before this shot.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Fluid retention
Clinical narrative: Patient reports a pocket of fluid in arm that traveled to his elbow, he went to the hospital and they gave him a steriod shot which helped.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: Patient states she started to develop a bumpy, chickenpox-like rash on her lower extremities two days after vaccination. Within two weeks she developed another rash on her arm and side. She saw Dr. and he diagnosed this rash as shingles.
Age: 32.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Pruritus, Rash generalised
Clinical narrative: Generalized rash (itching), and diarrhea x3
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: I received a call from the manager of the MD office, at 4:45 pm on July 12th, the day my son received the MMR vaccine. She informed me that patient may have received a vaccine incorrectly. She said that instead of using the proper diluent for the MMR, the person preparing the vaccine used a DTaP vaccine. She said they noticed the discrepancy when they counted their doses and diluents. There were three children who received the MMR during that time span and patient was one of them. They already called Poison Control and she informed me the results of that. The office also reported it to the health department. I also spoke with Poison Control, the health department, and the CDC and learned to watch for a local reaction. They advised close monitoring but didn't expect a significant reaction. They also informed me the vaccine needs to be repeated no sooner than a month from now as this injection is considered invalid. As of today, two days after the injection, my son seems fine. The injection site was warm for the first day, there was a small red area over a lump, and now the redness has disappeared and a lump remains. His mood and temperament is unchanged. He has not had a fever.
Age: 24.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Sensory disturbance
Clinical narrative: Right after injection of the BOOSTRIX and PNEUMOVAX vaccines on the left arm, patient mentioned that she needed a moment before receiving the third vaccine. She reported feeling nauseated and dizzy. I asked if there was anything I could get for her and she asked for water. After drinking some water and taking time to sit and relax, patient felt better and was able to continue with the final vaccine. Patient described to me that the catalyst to her feeling nauseated was injection of the PNEUMOVAX, which seemed to have caused an irritatin nerve sensation to run through her arm.
Age: 75.0
Sex: M
Vaccine: HEPAB, MMR, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Patient called 7/14/17 to report that his left arm was swollen and red from just above the elbow all the way to his wrist. He wanted to know which vaccinations he had received in his left arm and was going to see his provider. He was given amoxicillin and diflucan by his provider.
Age: 15.0
Sex: F
Vaccine: MENB, MNQ, MENB
Symptoms: Culture, Erythema, Headache, Musculoskeletal stiffness, Oropharyngeal pain
Clinical narrative: Two hours after receiving the TRUMENBA vaccine, patient complained of body aches, sore throat, headache, and fever. Came to primary care physician's office the next morning for an evaluation. Had a fever of 101.1 at that time along with stiffness and pain in the right arm. 1.5 cm x 1.5 cm redness on r. arm, 1 x 1 cm also on arm.
Age: 15.0
Sex: F
Vaccine: MENB, MNQ, MENB
Symptoms: Pain, Pain in extremity, Pyrexia, Streptococcus test negative
Clinical narrative: Two hours after receiving the TRUMENBA vaccine, patient complained of body aches, sore throat, headache, and fever. Came to primary care physician's office the next morning for an evaluation. Had a fever of 101.1 at that time along with stiffness and pain in the right arm. 1.5 cm x 1.5 cm redness on r. arm, 1 x 1 cm also on arm.
Age: 15.0
Sex: F
Vaccine: MENB, MNQ, MENB
Symptoms: Injection site rash, Oropharyngeal pain
Clinical narrative: Two hours after receiving the TRUMENBA vaccine, patient complained of body aches, sore throat, headache, and fever. Came to primary care physician's office the next morning for an evaluation. Had a fever of 101.1 at that time along with stiffness and pain in the right arm. 1.5 cm x 1.5 cm redness on r. arm, 1 x 1 cm also on arm.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Feeling abnormal, Neck pain, Pain, Skin warm
Clinical narrative: 2 hrs after-hurting, swollen 2.5-3 in diameter-took TYLENOL/IBU overnight pain went up to neck. Blister today almost around arm top to bottom of arm and hurts, hot to touch. Also reported feeling "Wonky" or out of sorts.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: 2 hrs after-hurting, swollen 2.5-3 in diameter-took TYLENOL/IBU overnight pain went up to neck. Blister today almost around arm top to bottom of arm and hurts, hot to touch. Also reported feeling "Wonky" or out of sorts.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, MMRV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, tender, warm to touch on the left thigh. Given MOTRIN at time of onset; Instructed to administer BENADRYL, MOTRIN and TYLENOL as needed and to apply cool compresses to relieve discomfort.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site mass, Injection site pruritus
Clinical narrative: Redness at injection site, open sore, and small bump.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Skin ulcer, Swelling
Clinical narrative: Redness at injection site, open sore, and small bump.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Vaccination site swelling
Clinical narrative: Patient had a swollen right arm in the area of the Vaccination.  Also there was redness present in the lower forearm area.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Depression, Fatigue, Irritability, Pain
Clinical narrative: I received the vaccine in middle school, recently I heard about the averse affects people have been reporting. Toward the end of middle school and beginning of high school I became very depressed, always fatigued, my body was achey and I became irritable with behavioral issues. I had numerous fainting spells and upon standing would nearly faint which still sometimes happens. I figured it was due to my age, maybe it was.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope, Syncope
Clinical narrative: I received the vaccine in middle school, recently I heard about the averse affects people have been reporting. Toward the end of middle school and beginning of high school I became very depressed, always fatigued, my body was achey and I became irritable with behavioral issues. I had numerous fainting spells and upon standing would nearly faint which still sometimes happens. I figured it was due to my age, maybe it was.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient's arm became red and swollen. She was seen at her primary care doctor's office and given a topical cream and instructed to follow up if condition worsened. By 7/14/17, patient had improved and swelling was reducing.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Heart rate increased
Clinical narrative: Fever. Fatigue. Fast heart beat. Weakness. Chills. Dizziness.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Fever. Fatigue. Fast heart beat. Weakness. Chills. Dizziness.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Confusional state, Dizziness, Dysgeusia, Feeling abnormal
Clinical narrative: Started to feel lousy around 3 PM on day of shot. Sort of expected that. Arm did not hurt when given shot but began to hurt. Feeling body aches (expected that too). Second day, awoke feeling pretty lousy but thought if I took IBUPROFEN throughout the day it would decrease symptoms. Had little effect on how bad I felt and I was driving a 300 mile route for work. As day progressed I felt worse. Started getting severe chills and the 93 degree weather felt good. Felt feverish, arm swelled a lot and was extremely hot to touch and ached something terrible Not just the site but my whole arm. Swelling was size of my whole hand. I felt dizzy, sleepy, and had a bad headache. Felt like an arrow through my head and that a tomahawk had smashed  the top of my head. I was a bit queasy too. Went home, ate small supper and went to bed. Did not get out of bed the third day. Even 3 doses of 800 milligrams of IBUPROFEN di not make me feel any better. Symptoms continued all day. Food tasted terrible. Dizzy and confused feeling when I  got up to use the bathroom. Arm swelling did not dissipate and keep cool packs on it all day on and off. Head felt terrible. Body ached. Symptoms subsided forth day and about 3 PM began to feel normal again.. ARM is still swollen 5 th day.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site pain, Nausea, Pain, Pain in extremity
Clinical narrative: Started to feel lousy around 3 PM on day of shot. Sort of expected that. Arm did not hurt when given shot but began to hurt. Feeling body aches (expected that too). Second day, awoke feeling pretty lousy but thought if I took IBUPROFEN throughout the day it would decrease symptoms. Had little effect on how bad I felt and I was driving a 300 mile route for work. As day progressed I felt worse. Started getting severe chills and the 93 degree weather felt good. Felt feverish, arm swelled a lot and was extremely hot to touch and ached something terrible Not just the site but my whole arm. Swelling was size of my whole hand. I felt dizzy, sleepy, and had a bad headache. Felt like an arrow through my head and that a tomahawk had smashed  the top of my head. I was a bit queasy too. Went home, ate small supper and went to bed. Did not get out of bed the third day. Even 3 doses of 800 milligrams of IBUPROFEN di not make me feel any better. Symptoms continued all day. Food tasted terrible. Dizzy and confused feeling when I  got up to use the bathroom. Arm swelling did not dissipate and keep cool packs on it all day on and off. Head felt terrible. Body ached. Symptoms subsided forth day and about 3 PM began to feel normal again.. ARM is still swollen 5 th day.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia, Skin warm, Somnolence
Clinical narrative: Started to feel lousy around 3 PM on day of shot. Sort of expected that. Arm did not hurt when given shot but began to hurt. Feeling body aches (expected that too). Second day, awoke feeling pretty lousy but thought if I took IBUPROFEN throughout the day it would decrease symptoms. Had little effect on how bad I felt and I was driving a 300 mile route for work. As day progressed I felt worse. Started getting severe chills and the 93 degree weather felt good. Felt feverish, arm swelled a lot and was extremely hot to touch and ached something terrible Not just the site but my whole arm. Swelling was size of my whole hand. I felt dizzy, sleepy, and had a bad headache. Felt like an arrow through my head and that a tomahawk had smashed  the top of my head. I was a bit queasy too. Went home, ate small supper and went to bed. Did not get out of bed the third day. Even 3 doses of 800 milligrams of IBUPROFEN di not make me feel any better. Symptoms continued all day. Food tasted terrible. Dizzy and confused feeling when I  got up to use the bathroom. Arm swelling did not dissipate and keep cool packs on it all day on and off. Head felt terrible. Body ached. Symptoms subsided forth day and about 3 PM began to feel normal again.. ARM is still swollen 5 th day.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: Pt got ZOSTAVAX shot on 07/12/17, pt discovered red bloches/rash-like (no itch) on face on 07/14/17 morning. bloches/redness is about the same since pt discover the reactions.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Erythema, Peripheral swelling, Rash
Clinical narrative: Patient woke up the next day with a swollen red burning sensation in her arm. She had a rash on the arm also. She went to the emergency room  and received Keflex and Motrin.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Peripheral swelling, Rash, Skin warm
Clinical narrative: Patient woke up with red swollen arm hot to the touch with burning sensation in arm and a rash on the arm. She received the ADACEL shot also in the same arm She went to the ER 7/13/2017 and received Keflex and Motrin.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Lip swelling, Urticaria
Clinical narrative: Patient develops hives on the legs, back and both sides of the back of the forearm on July 14 2017. When patient call back in the afternoon at around 3pm the same day, patient reported his lower lip was swollen. Patient went to ER and was given a steroid shot in the hospital. For discharge medications, patient has prednisone, Benadryl and Nexium.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Acoustic stimulation tests abnormal, Blood test normal, Deafness unilateral, Diarrhoea
Clinical narrative: Severe stomach cramping/diarrhea lasting several hours, uncontrollable full body tremors, shaking lasting approx 3 hours, went to sleep and woke up with no hearing in left ear.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging, Tremor
Clinical narrative: Severe stomach cramping/diarrhea lasting several hours, uncontrollable full body tremors, shaking lasting approx 3 hours, went to sleep and woke up with no hearing in left ear.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pain, Vaccination site cellulitis, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Presents on 7/16/17 with one day history of redness, swelling, pain, on right thigh where vaccine was provided. There was no redness swelling on the day the vaccine was provided. Some pain with walking. No fever. Treated today with antibiotic for secondary cellulitis.
Age: 0.17
Sex: M
Vaccine: DTAP, RV1
Symptoms: Activated partial thromboplastin time, Culture stool negative, Culture urine negative, Differential white blood cell count normal, Faeces discoloured
Clinical narrative: Within 2 days of receiving the rotavirus vaccine, the color of patient's stool began to change, from brown to reddish brown to frank red blood. We had already seen a gastroenterologist due to what they thought had been a dairy allergy a month or so prior to this, so we went back to their office. I explained my fear of intussusception, to which the Nurse Practitioner told me that patient was too young. However, that's a false statement because intussusception is actually listed as a serious problem following the rotavirus vaccine right on the CDC website, and the first dose of the vaccine is recommended at 2 months old. Moving forward, I asked that their office order an abdominal ultrasound. The soonest I could get patient in for the US at Medical Center was the following week. In the meantime, I asked Dr. to order an US as well and called Medical Center to see if they could get us in any sooner. They were able to get us in 2 days sooner, so we went there. The results ruled out intussusception, however, were still mostly inconclusive. At this point, the blood was so bad, the next day, August 18th, 2016, Dr. referred us to the Emergency room. So now, my 2 month old baby, who has already been through open heart surgery, has to go through a multitude of testing, including IV sticks, IV fluids, stool tests, urine tests, and blood draws... all negative besides a  low hemoglobin, due to the bleeding, but not low enough to transfuse as well as a slightly decreased kidney function. The Medical Center emergency room did not complete an ultrasound, so we brought him back for his originally scheduled appointment, which showed an essentially negative ultrasound. Finally, after several weeks to months, the frank blood stopped, but to this day, almost 1 year later, patient's stool still shows microscopic blood when tested with an occult stool card.
Age: 0.17
Sex: M
Vaccine: DTAP, RV1
Symptoms: Full blood count abnormal, Gastrointestinal haemorrhage, Haematochezia, Haemoglobin decreased, Metabolic function test
Clinical narrative: Within 2 days of receiving the rotavirus vaccine, the color of patient's stool began to change, from brown to reddish brown to frank red blood. We had already seen a gastroenterologist due to what they thought had been a dairy allergy a month or so prior to this, so we went back to their office. I explained my fear of intussusception, to which the Nurse Practitioner told me that patient was too young. However, that's a false statement because intussusception is actually listed as a serious problem following the rotavirus vaccine right on the CDC website, and the first dose of the vaccine is recommended at 2 months old. Moving forward, I asked that their office order an abdominal ultrasound. The soonest I could get patient in for the US at Medical Center was the following week. In the meantime, I asked Dr. to order an US as well and called Medical Center to see if they could get us in any sooner. They were able to get us in 2 days sooner, so we went there. The results ruled out intussusception, however, were still mostly inconclusive. At this point, the blood was so bad, the next day, August 18th, 2016, Dr. referred us to the Emergency room. So now, my 2 month old baby, who has already been through open heart surgery, has to go through a multitude of testing, including IV sticks, IV fluids, stool tests, urine tests, and blood draws... all negative besides a  low hemoglobin, due to the bleeding, but not low enough to transfuse as well as a slightly decreased kidney function. The Medical Center emergency room did not complete an ultrasound, so we brought him back for his originally scheduled appointment, which showed an essentially negative ultrasound. Finally, after several weeks to months, the frank blood stopped, but to this day, almost 1 year later, patient's stool still shows microscopic blood when tested with an occult stool card.
Age: 0.17
Sex: M
Vaccine: DTAP, RV1
Symptoms: Renal impairment, Respiratory viral panel, Rotavirus test negative, Stool analysis normal, Ultrasound abdomen normal
Clinical narrative: Within 2 days of receiving the rotavirus vaccine, the color of patient's stool began to change, from brown to reddish brown to frank red blood. We had already seen a gastroenterologist due to what they thought had been a dairy allergy a month or so prior to this, so we went back to their office. I explained my fear of intussusception, to which the Nurse Practitioner told me that patient was too young. However, that's a false statement because intussusception is actually listed as a serious problem following the rotavirus vaccine right on the CDC website, and the first dose of the vaccine is recommended at 2 months old. Moving forward, I asked that their office order an abdominal ultrasound. The soonest I could get patient in for the US at Medical Center was the following week. In the meantime, I asked Dr. to order an US as well and called Medical Center to see if they could get us in any sooner. They were able to get us in 2 days sooner, so we went there. The results ruled out intussusception, however, were still mostly inconclusive. At this point, the blood was so bad, the next day, August 18th, 2016, Dr. referred us to the Emergency room. So now, my 2 month old baby, who has already been through open heart surgery, has to go through a multitude of testing, including IV sticks, IV fluids, stool tests, urine tests, and blood draws... all negative besides a  low hemoglobin, due to the bleeding, but not low enough to transfuse as well as a slightly decreased kidney function. The Medical Center emergency room did not complete an ultrasound, so we brought him back for his originally scheduled appointment, which showed an essentially negative ultrasound. Finally, after several weeks to months, the frank blood stopped, but to this day, almost 1 year later, patient's stool still shows microscopic blood when tested with an occult stool card.
Age: 0.17
Sex: M
Vaccine: DTAP, RV1
Symptoms: Urine analysis normal, Viral test negative
Clinical narrative: Within 2 days of receiving the rotavirus vaccine, the color of patient's stool began to change, from brown to reddish brown to frank red blood. We had already seen a gastroenterologist due to what they thought had been a dairy allergy a month or so prior to this, so we went back to their office. I explained my fear of intussusception, to which the Nurse Practitioner told me that patient was too young. However, that's a false statement because intussusception is actually listed as a serious problem following the rotavirus vaccine right on the CDC website, and the first dose of the vaccine is recommended at 2 months old. Moving forward, I asked that their office order an abdominal ultrasound. The soonest I could get patient in for the US at Medical Center was the following week. In the meantime, I asked Dr. to order an US as well and called Medical Center to see if they could get us in any sooner. They were able to get us in 2 days sooner, so we went there. The results ruled out intussusception, however, were still mostly inconclusive. At this point, the blood was so bad, the next day, August 18th, 2016, Dr. referred us to the Emergency room. So now, my 2 month old baby, who has already been through open heart surgery, has to go through a multitude of testing, including IV sticks, IV fluids, stool tests, urine tests, and blood draws... all negative besides a  low hemoglobin, due to the bleeding, but not low enough to transfuse as well as a slightly decreased kidney function. The Medical Center emergency room did not complete an ultrasound, so we brought him back for his originally scheduled appointment, which showed an essentially negative ultrasound. Finally, after several weeks to months, the frank blood stopped, but to this day, almost 1 year later, patient's stool still shows microscopic blood when tested with an occult stool card.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Headache, Pyrexia
Clinical narrative: 48 Hours - Fever, Headache, Stomach ache.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swelling and redness of upper left arm, may have been allergic or cellulitis.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Asthenia, Decreased appetite, Heart rate increased, Hypotension, Loss of consciousness
Clinical narrative: Two days after receiving the Gardasil 9 vaccine (shot 1) our daughter started blacking out completely  and having seizures that are very multiple through out the day and night.  She has no energy, no appetite, cannot get up to do anything without either stopping and sitting back down or blacking out simple task like putting away the dishes.  Taking a shower is a HUGE task she blacks out ever time. Her heart rate staying in the high upper 100's and her b/p is very low.  She wants to sleep all the time.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Loss of personal independence in daily activities, Seizure, Somnolence
Clinical narrative: Two days after receiving the Gardasil 9 vaccine (shot 1) our daughter started blacking out completely  and having seizures that are very multiple through out the day and night.  She has no energy, no appetite, cannot get up to do anything without either stopping and sitting back down or blacking out simple task like putting away the dishes.  Taking a shower is a HUGE task she blacks out ever time. Her heart rate staying in the high upper 100's and her b/p is very low.  She wants to sleep all the time.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Amnesia, Arthralgia, Autonomic nervous system imbalance, Confusional state, Loss of consciousness
Clinical narrative: Two days after receiving the Gardasil 9 vaccine (shot 1) our daughter started blacking out completely  and having seizures that are very multiple through out the day and night.  She has no energy, no appetite, cannot get up to do anything without either stopping and sitting back down or blacking out simple task like putting away the dishes.  Taking a shower is a HUGE task she blacks out ever time. Her heart rate staying in the high upper 100's and her b/p is very low.  She wants to sleep all the time.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Migraine, Myalgia, Postural orthostatic tachycardia syndrome, Seizure, Syncope
Clinical narrative: Two days after receiving the Gardasil 9 vaccine (shot 1) our daughter started blacking out completely  and having seizures that are very multiple through out the day and night.  She has no energy, no appetite, cannot get up to do anything without either stopping and sitting back down or blacking out simple task like putting away the dishes.  Taking a shower is a HUGE task she blacks out ever time. Her heart rate staying in the high upper 100's and her b/p is very low.  She wants to sleep all the time.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Tachycardia
Clinical narrative: Two days after receiving the Gardasil 9 vaccine (shot 1) our daughter started blacking out completely  and having seizures that are very multiple through out the day and night.  She has no energy, no appetite, cannot get up to do anything without either stopping and sitting back down or blacking out simple task like putting away the dishes.  Taking a shower is a HUGE task she blacks out ever time. Her heart rate staying in the high upper 100's and her b/p is very low.  She wants to sleep all the time.
Age: 13.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Malaise, Nausea, Pyrexia, Rash
Clinical narrative: Fever, malaise, nausea, severe headache, upper trunk body rash.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: After receiving his pneumonia shot (PPv23) patient arrived at the pharmacy on the next day in the morning to report that he could not move his left arm.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Choking, Cough, Lethargy, Pyrexia, Rash generalised
Clinical narrative: High fever lasting for 3 days followed by a full body rash. Also experiencing lethargy and choking cough. Have treated with Tylenol and ibuprofen.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site inflammation, Injection site irritation, Injection site pain, Injection site rash
Clinical narrative: The patient returned to the pharmacy in the afternoon of the day following the injection. A four inch area surrounding the injection site was inflamed with a rash that appeared to be shingles. The patient complained of pain, heat and irritation in the affected area. I recommended hydrocortisone cream, warm compresses and pain relievers.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: The patient returned to the pharmacy in the afternoon of the day following the injection. A four inch area surrounding the injection site was inflamed with a rash that appeared to be shingles. The patient complained of pain, heat and irritation in the affected area. I recommended hydrocortisone cream, warm compresses and pain relievers.
Age: 60.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Musculoskeletal pain, Pain
Clinical narrative: By the night that I got the shots, I could not lift either arm, and all night I woke up from shoulder pain (either pressure lying on the shoulder and also whenever I tried to lift my arm to turn over). I had to have my husband help me dress. This acute stage lasted a week, and I called the nurse on 11/3/16 to report that the pain was still out of control!
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: Patient's arm is red and hot. Redness extends about 4 inches on upper arm in a circle. I called the patient's doctor, but it is Sunday and the receptionist gave me a nurse's line to call to report this. Once I contacted the nurse's line, patient spoke with nurse who instructed her to apply cold packs and contact her prescriber on Monday.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: MoP states that there is swelling at the injection site; Erythema; Hot to the touch.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Autopsy, Death
Clinical narrative: DEATH.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Rash erythematous, Vomiting
Clinical narrative: Pt. vomited 7/13/17 the evening she had the vaccine. She began to have small red rashes on lower back and back of legs and on foot. Injection site had same redness and swelling.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling, Urticaria
Clinical narrative: Pt states "Large lemon sized welt". "Extreme itchiness." "Swollen, red, painful." (Observed this personally).
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Back pain, Computerised tomogram, Electromyogram, Nuclear magnetic resonance imaging
Clinical narrative: Patient stated her arm hurt where the injection was starting 2 weeks after the vaccine was given. Described it as pain like a blood pressure cuff being too tight.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity, Ultrasound Doppler, X-ray
Clinical narrative: Patient stated her arm hurt where the injection was starting 2 weeks after the vaccine was given. Described it as pain like a blood pressure cuff being too tight.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Laboratory test, Nerve stimulation test, Nuclear magnetic resonance imaging
Clinical narrative: Patient stated her arm hurt where the injection was starting 2 weeks after the vaccine was given. Described it as pain like a blood pressure cuff being too tight.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest X-ray normal, Chills, Electrocardiogram normal, Fatigue, Headache
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 year old female patient. On 01-JUL-2017, the patient was vaccinated with ZOSTAVAX for prophylaxis. On 01-JUL-2017, 1 day after onset of therapy, the patient experienced nausea, injection site erythema, fatigue and pyrexia. The outcome of fatigue, injection site erythema, pyrexia and nausea was reported as recovering/resolving. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Nausea, Pyrexia, Urine analysis normal
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 year old female patient. On 01-JUL-2017, the patient was vaccinated with ZOSTAVAX for prophylaxis. On 01-JUL-2017, 1 day after onset of therapy, the patient experienced nausea, injection site erythema, fatigue and pyrexia. The outcome of fatigue, injection site erythema, pyrexia and nausea was reported as recovering/resolving. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site erythema, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 year old female patient. On 01-JUL-2017, the patient was vaccinated with ZOSTAVAX for prophylaxis. On 01-JUL-2017, 1 day after onset of therapy, the patient experienced nausea, injection site erythema, fatigue and pyrexia. The outcome of fatigue, injection site erythema, pyrexia and nausea was reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker referring to two unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On 22-JAN-2016 and on 09-MAR-2016 the patients were vaccinated with improperly stored injections of RECOMBIVAX HB, lot # K021444 and expiration date 17-SEP-2016 (strength, dose number and route of administration were not provided) for prophylaxis. The patients' concomitant therapies were not reported. The vaccines were exposed to two different temperature excursion, first on 29-DEC-2015, exposed to temperature ranges between 32° Fahrenheit (F) and 35°F  (34.3° F) during a time frame of 22 hours 30 minutes, and on 04-FEB-2016, exposed to temperature ranges between 47°F and 77°F (50°F) during a time frame of 1 hour 30 minutes. The temperature excursions were called by a data logger, there was not previous temperature excursion. Adverse effects were not reported. This is one of two reports received from the same source.; Sender's Comments: US-009507513-1706USA005017:
Age: 0.08
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 8 week old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On approximately 15-JUN-2017, the patient was vaccinated with GARDASIL 9 lot # reported as M004798 and expiration date on 31-OCT-2019 (dose and route of administration were not provided) for prophylaxis. The reporter stated that the patient was inadvertently administered the vaccine, due to human error and no adverse effects were reported.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a physician via a company representative referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history. On an unspecified date (reported as many years ago), the patient was vaccinated with two doses of GARDASIL (doses, lot # and expiration dates were not reported) for prophylaxis.  The patient's concomitant medications were not reported. In addition, the reporter stated that a dose of GARDASIL or GARDASIL 9 would be administered on an unspecified date. No adverse effects have been reported. No  PQC was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy, drug and allergy history were not reported. On 16-JUN-2017, the patient was vaccinated by a medical assistant with an expired dose of VAQTA intramuscularly, lot number M022556, expiration date 26-MAY-2017, for prophylaxis (dose number was not reported). The physician stated that the medical assistant did not check the expiration date on vial prior to the administration. No adverse effects were reported and no additional information was given.
Age: 22.0
Sex: M
Vaccine: HEP, HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 22 year old male patient. The patient's medical history, concomitant therapies and concurrent conditions were not reported. On 20-JUN-2017, the patient was vaccinated with an expired dose of VAQTA lot # M003025, expiration date: 26-MAY-2017 (dose and route of administration were not provided). There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a multiple unspecified patients of unknown age and gender. The patients' current conditions and medical history were not provided. On an unknown dates, the patients were vaccinated with VARIVAX, dose and route of administration were not reported (lot # L042266 with expiration date 27-OCT-2017 and lot # M034583 with expiration date 27-JUL-2018). The VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown). No adverse effects were reported. VARIVAX was stored between 15 Fahrenheit degrees (F) and 46 F for 2 hours and 12 minutes. There was previous temperature excursion temperatures between 15 F and 46 F for 1 hour and 12 minutes. The digital data logger was involved in recording the excursion. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA001487:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from medical assistant and refers to unspecified number of patients' of unknown demographics. On unknown date(s), the patients' were vaccinated with improperly stored doses of VARIVAX (lot # M047662, expiry date: 02-DEC-2018) for prophylaxis (incorrect product storage). Temperature Excursion details were as follows: Temperature and Time frame: Between 32 degree Fahrenheit (°F) to 35°F for 8 hours and between 47 °F to 77 °F for 9 hours. Previous temperature excursion included 32°F to 35°F for 9 hours. The call was because of a data logger. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report received from the nurse practitioner referred to a 56 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. Nurse Practitioner reported that patient started PNEUMOVAX 23 (lot: M003027) at a dose of 0.5 ml injected subcutaneously (also reported as intramuscular) on 24-JUN-2017 to vaccinate against pneumococcal. On 24-JUN-2017, after administration it was realized that the PNEUMOVAX 23 expired on 21-JUN-2017 (expired product administered). The patient had reported no adverse events. As of 24-JUN-2017 it was unknown if the patient would receive another dose of PNEUMOVAX 23 in the future. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. Approximately on April 2015, the patient received first dose of RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 12-JUN-2017, the patient received second dose of RECOMBIVAX HB lot# M027339, expiration date 31-MAY-2017 (dose and route of administration were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative refers to an unspecified child patient of an unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017 the patient was vaccinated with a dose of VARIVAX, subcutaneous (dose, frequency unknown) (lot number N014366, expiry date May 2019) to prevent chicken pox. On an unknown date in 2017 the patient received a dose of VARIVAX, subcutaneous (dose, frequency unknown) to prevent chicken pox. It was reported that both the vaccines were given out of temperature range inadvertently. The action taken and outcome of the event was unknown. No further information provided.  This case is linked to case number 1707USA003667 via same reporter link. Additional information has been requested.; Sender's Comments: US-009507513-1707USA003667: