chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Within 24 hours - fever, body aches, nausea, fatigue, injection site pain and redness, headache - Form being completed 3 days after injection + Sx persist. Chills and sweats, Deltoid and axillary pain.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Myalgia, Nausea, Pain
Clinical narrative: Within 24 hours - fever, body aches, nausea, fatigue, injection site pain and redness, headache - Form being completed 3 days after injection + Sx persist. Chills and sweats, Deltoid and axillary pain.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Within 24 hours - fever, body aches, nausea, fatigue, injection site pain and redness, headache - Form being completed 3 days after injection + Sx persist. Chills and sweats, Deltoid and axillary pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Arm pain and limited range of motion.
Age: 13.0
Sex: M
Vaccine: TYP, YF
Symptoms: Loss of personal independence in daily activities, Lymph node pain, Lymphadenopathy
Clinical narrative: Within 48 hours post Typhoid vaccine administration the patient developed lymphadenopathy one side - R axilla and R cervical. The nodes were painful - child did not attend school. By day 3 the nodes were improving. No systemic SXS. No fever
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature, Chills, Pain
Clinical narrative: Chills, temp, body aches 3 days took aspirin.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Rash, redness x 9 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Skin lesion
Clinical narrative: Approx. 7 x 7 cm, red, itchy lesion at site of injection.
Age: 1.17
Sex: U
Vaccine: FLU4
Symptoms: Abasia, Balance disorder, Gait disturbance, Pyrexia
Clinical narrative: Loss of balance, unable to walk/hard time walking Fever.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Pyrexia
Clinical narrative: Bad cough lasting 5 days. Fever.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Adult Hep A vac. given to 18 y/o. No adverse event noted.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Differential white blood cell count, Full blood count, Injection site bruising, Injection site discolouration, Injection site rash
Clinical narrative: Mom noted bruising and purple dots from knee down to foot. No swelling No fevers. Received 2 injections (L) thigh (where reaction noted) Hep B and PENTACEL.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Platelet count
Clinical narrative: Mom noted bruising and purple dots from knee down to foot. No swelling No fevers. Received 2 injections (L) thigh (where reaction noted) Hep B and PENTACEL.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Local reaction, Skin warm
Clinical narrative: Redness and swelling of (upper) left arm (with sm. area redness below left axilla). Redness 14 1/2 cm long and extended approx. 8 cm wide. It felt warm to touch. (Local Reaction).
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Developed 4 itchy bumps on left side of back a few days after vaccines. Resolved after approx week.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm upper left arm.
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Large, angry welts-red and very itchy-appear alternately on face, back, legs, arms, throat. No response to BENADRYL, ZYRTEC, ALLEGRA or oral steroids. No response to anti-itch cream. A month has passed and it still continues.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Developed erythematous rash to (L) arm within hours of receiving vaccines.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal X-ray, Abdominal pain, Abdominal pain upper, Alopecia, Autonomic nervous system imbalance
Clinical narrative: The next day started to throw up, had fever, felt achiness. Thought that pt was getting a cold but stomach pains began 4-5 days after shot. Had a doctor appt. Strep testing was negative. Improved a bit but stomach pain did not go away. Went to GI specialist, started pt on elimination diet, took stool samples, treated with LEVSIN/PREVACID/ZANTAC, tried for awhile. Stomach x rays showed that pt was backed up diagnosis was small intestinal bacterial overgrowth. Also put on triple antibiotic therapy. FLAGYL/omeprazole/doxycycline. Neurology testing was done for leg and arm and overall body pain. Dizziness got worse so GI doctor tested for POTS (postural orthostatic tachycardia syndrome). Neuropathy, not able to sweat, nerve dysfunction. Unable to go to school normally; can only go for a couple of hours. Unable to walk for prolonged time or distance. Suffers from headaches, severe abdominal pain, nausea daily. Sore throat and hair loss; loss eyebrow. Diagnosed with dysautonomia.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Constipation, Dizziness, Gait disturbance, Gastrointestinal bacterial overgrowth, Headache
Clinical narrative: The next day started to throw up, had fever, felt achiness. Thought that pt was getting a cold but stomach pains began 4-5 days after shot. Had a doctor appt. Strep testing was negative. Improved a bit but stomach pain did not go away. Went to GI specialist, started pt on elimination diet, took stool samples, treated with LEVSIN/PREVACID/ZANTAC, tried for awhile. Stomach x rays showed that pt was backed up diagnosis was small intestinal bacterial overgrowth. Also put on triple antibiotic therapy. FLAGYL/omeprazole/doxycycline. Neurology testing was done for leg and arm and overall body pain. Dizziness got worse so GI doctor tested for POTS (postural orthostatic tachycardia syndrome). Neuropathy, not able to sweat, nerve dysfunction. Unable to go to school normally; can only go for a couple of hours. Unable to walk for prolonged time or distance. Suffers from headaches, severe abdominal pain, nausea daily. Sore throat and hair loss; loss eyebrow. Diagnosed with dysautonomia.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of personal independence in daily activities, Nausea, Neuropathy peripheral, Oropharyngeal pain, Pain
Clinical narrative: The next day started to throw up, had fever, felt achiness. Thought that pt was getting a cold but stomach pains began 4-5 days after shot. Had a doctor appt. Strep testing was negative. Improved a bit but stomach pain did not go away. Went to GI specialist, started pt on elimination diet, took stool samples, treated with LEVSIN/PREVACID/ZANTAC, tried for awhile. Stomach x rays showed that pt was backed up diagnosis was small intestinal bacterial overgrowth. Also put on triple antibiotic therapy. FLAGYL/omeprazole/doxycycline. Neurology testing was done for leg and arm and overall body pain. Dizziness got worse so GI doctor tested for POTS (postural orthostatic tachycardia syndrome). Neuropathy, not able to sweat, nerve dysfunction. Unable to go to school normally; can only go for a couple of hours. Unable to walk for prolonged time or distance. Suffers from headaches, severe abdominal pain, nausea daily. Sore throat and hair loss; loss eyebrow. Diagnosed with dysautonomia.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Pyrexia, Streptococcus test negative, Vomiting, X-ray abnormal
Clinical narrative: The next day started to throw up, had fever, felt achiness. Thought that pt was getting a cold but stomach pains began 4-5 days after shot. Had a doctor appt. Strep testing was negative. Improved a bit but stomach pain did not go away. Went to GI specialist, started pt on elimination diet, took stool samples, treated with LEVSIN/PREVACID/ZANTAC, tried for awhile. Stomach x rays showed that pt was backed up diagnosis was small intestinal bacterial overgrowth. Also put on triple antibiotic therapy. FLAGYL/omeprazole/doxycycline. Neurology testing was done for leg and arm and overall body pain. Dizziness got worse so GI doctor tested for POTS (postural orthostatic tachycardia syndrome). Neuropathy, not able to sweat, nerve dysfunction. Unable to go to school normally; can only go for a couple of hours. Unable to walk for prolonged time or distance. Suffers from headaches, severe abdominal pain, nausea daily. Sore throat and hair loss; loss eyebrow. Diagnosed with dysautonomia.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling over (R) upper arm with redness, warmth, tenderness. Site: 7x13 cm of erythema.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Mobility decreased, Skin tightness
Clinical narrative: Received PPSV23. The next day pt. reported that he woke up in the morning with redness and tightness. Erythema noted at injection site spreading to under arm. Pt. had difficulty raising arm greater than shoulder height. BENADRYL 50 mg and warm compresses were recommended by MD.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTP, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swollen red itchy bilateral arms, provider will give benedryl.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Nausea. Half dollar sized red bump shot location.
Age: 0.17
Sex: M
Vaccine: RVX
Symptoms: Haematochezia
Clinical narrative: Blood in stool.
Age: 50.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Patient given IM injection to R deltoid.  Within 3 minutes patient developed significant itching at the injection site and upper arm of same extremity.  Minutes later patient developed itching to L upper arm followed by the development of itching to upper back.  No respiratory distresss occured.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Vaccination site swelling
Clinical narrative: Patient returned to our pharmacy, where vaccine was administered, the day following the injection. The vaccination site was swollen from deltoid down to the elbow, though not extremely red or uncomfortable.  Patient was given a dose of liquid benadryl, and cold compress applied.  Was contacted the next morning and reported that he had visited his physician just to make sure things were ok, and they had applied more cold compress and symptoms were getting much better.
Age: 1.0
Sex: M
Vaccine: HPVX, MMR, VARCEL
Symptoms: Fatigue, Injection site induration, Injection site reaction, Rash erythematous
Clinical narrative: Child was very tired for a week after vaccines, also got very large, hard, red bumps where they were injected that stayed for two weeks.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Baseball size rash at the site of injection that is slightly raised. It does not itch and is not hot when touching it.
Age: 0.67
Sex: M
Vaccine: DTAP, HEP, HIBV, PPV, RV5
Symptoms: Autoimmune disorder, Blood test, Crying, Decreased appetite, Diarrhoea
Clinical narrative: DESPITE repeatedly questioning the risks of administering so many vaccinations at once, including live Rotavirus, we were repeatedly assured that this was customary so that our 7 month old son could "catch up" with on inoculation schedule as the vaccines had not been available for months. Within two day of receiving his shots, patient stopped eating solid foods. Over the next couple of days our son began having episodes of inconsolable crying; refused to drink his breast milk and developed a persistent fever. We took him back at our pediatrician's office on the 7th July and were assured by Dr that patient simply had a sore throat or was teething! When our son's fever rose to 104.9F (41.6C) he started projectile vomiting and little red lines appeared on his hands and feet (which she informed us it wasn't Meningitis but we know to be petechiae) we took back to his pediatrics office who said he has a virus and instructed us to rotate giving him COPOL and Ibuprofen and go the hospital for a blood test. The next day the doctor called and said he bloods were not that bad. Saturday night he started having severe diarrhea and his temperature soared to 107.1F. We placed him in an ice bath and head straight to the Emergency Room. The ER team informed us that his platelets had crashed; he was neutropenia and needed an immediate blood transfusion in order to survive. As our son's condition deteriorated rapidly, over the next 3 days and patient was placed into Pediatric ICU. As doctors were stumped we decided to air- ambulance him to another Hospital. Within 4 hours, Dr diagnosed with an often fatal, blood autoimmune disease HH; and, he began an aggressive treatment protocol for his condition.
Age: 0.67
Sex: M
Vaccine: DTAP, HEP, HIBV, PPV, RV5
Symptoms: Diet refusal, Erythema, General physical health deterioration, Histiocytosis haematophagic, Intensive care
Clinical narrative: DESPITE repeatedly questioning the risks of administering so many vaccinations at once, including live Rotavirus, we were repeatedly assured that this was customary so that our 7 month old son could "catch up" with on inoculation schedule as the vaccines had not been available for months. Within two day of receiving his shots, patient stopped eating solid foods. Over the next couple of days our son began having episodes of inconsolable crying; refused to drink his breast milk and developed a persistent fever. We took him back at our pediatrician's office on the 7th July and were assured by Dr that patient simply had a sore throat or was teething! When our son's fever rose to 104.9F (41.6C) he started projectile vomiting and little red lines appeared on his hands and feet (which she informed us it wasn't Meningitis but we know to be petechiae) we took back to his pediatrics office who said he has a virus and instructed us to rotate giving him COPOL and Ibuprofen and go the hospital for a blood test. The next day the doctor called and said he bloods were not that bad. Saturday night he started having severe diarrhea and his temperature soared to 107.1F. We placed him in an ice bath and head straight to the Emergency Room. The ER team informed us that his platelets had crashed; he was neutropenia and needed an immediate blood transfusion in order to survive. As our son's condition deteriorated rapidly, over the next 3 days and patient was placed into Pediatric ICU. As doctors were stumped we decided to air- ambulance him to another Hospital. Within 4 hours, Dr diagnosed with an often fatal, blood autoimmune disease HH; and, he began an aggressive treatment protocol for his condition.
Age: 0.67
Sex: M
Vaccine: DTAP, HEP, HIBV, PPV, RV5
Symptoms: Leukaemia, Neutropenia, Platelet count decreased, Pyrexia, Transfusion
Clinical narrative: DESPITE repeatedly questioning the risks of administering so many vaccinations at once, including live Rotavirus, we were repeatedly assured that this was customary so that our 7 month old son could "catch up" with on inoculation schedule as the vaccines had not been available for months. Within two day of receiving his shots, patient stopped eating solid foods. Over the next couple of days our son began having episodes of inconsolable crying; refused to drink his breast milk and developed a persistent fever. We took him back at our pediatrician's office on the 7th July and were assured by Dr that patient simply had a sore throat or was teething! When our son's fever rose to 104.9F (41.6C) he started projectile vomiting and little red lines appeared on his hands and feet (which she informed us it wasn't Meningitis but we know to be petechiae) we took back to his pediatrics office who said he has a virus and instructed us to rotate giving him COPOL and Ibuprofen and go the hospital for a blood test. The next day the doctor called and said he bloods were not that bad. Saturday night he started having severe diarrhea and his temperature soared to 107.1F. We placed him in an ice bath and head straight to the Emergency Room. The ER team informed us that his platelets had crashed; he was neutropenia and needed an immediate blood transfusion in order to survive. As our son's condition deteriorated rapidly, over the next 3 days and patient was placed into Pediatric ICU. As doctors were stumped we decided to air- ambulance him to another Hospital. Within 4 hours, Dr diagnosed with an often fatal, blood autoimmune disease HH; and, he began an aggressive treatment protocol for his condition.
Age: 0.67
Sex: M
Vaccine: DTAP, HEP, HIBV, PPV, RV5
Symptoms: Viral infection, Vomiting projectile
Clinical narrative: DESPITE repeatedly questioning the risks of administering so many vaccinations at once, including live Rotavirus, we were repeatedly assured that this was customary so that our 7 month old son could "catch up" with on inoculation schedule as the vaccines had not been available for months. Within two day of receiving his shots, patient stopped eating solid foods. Over the next couple of days our son began having episodes of inconsolable crying; refused to drink his breast milk and developed a persistent fever. We took him back at our pediatrician's office on the 7th July and were assured by Dr that patient simply had a sore throat or was teething! When our son's fever rose to 104.9F (41.6C) he started projectile vomiting and little red lines appeared on his hands and feet (which she informed us it wasn't Meningitis but we know to be petechiae) we took back to his pediatrics office who said he has a virus and instructed us to rotate giving him COPOL and Ibuprofen and go the hospital for a blood test. The next day the doctor called and said he bloods were not that bad. Saturday night he started having severe diarrhea and his temperature soared to 107.1F. We placed him in an ice bath and head straight to the Emergency Room. The ER team informed us that his platelets had crashed; he was neutropenia and needed an immediate blood transfusion in order to survive. As our son's condition deteriorated rapidly, over the next 3 days and patient was placed into Pediatric ICU. As doctors were stumped we decided to air- ambulance him to another Hospital. Within 4 hours, Dr diagnosed with an often fatal, blood autoimmune disease HH; and, he began an aggressive treatment protocol for his condition.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Diarrhoea, Injection site pain, Nausea, Pyrexia
Clinical narrative: Fever, Nausea, Diarrhea, Chills, Right Arm Pain at injection site.
Age: 18.0
Sex: M
Vaccine: HPVX
Symptoms: Full blood count normal, Laboratory test normal, Nausea, Pain, Pain in extremity
Clinical narrative: Pt reports arm hurt more than any other vaccine (this was HPV #3) and today 5/3/17 has progressively worsening general body aches and nausea.
Age: 23.0
Sex: M
Vaccine: HEPAB, MMR, TD, VARCEL
Symptoms: No adverse event
Clinical narrative: No problems.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient dropped phone complaining of L arm pain and not being able to move it. On exam, pt was able to move it, but did have decreased (but improving) ROM.
Age: 0.5
Sex: M
Vaccine: RVX
Symptoms: Crying, Hypotonia, Opisthotonus, Pyrexia, Respiratory arrest
Clinical narrative: Fever, sleepiness, crying lasting 48 hours after vaccinations. Then on April 24, 2017 child stopped breathing, arched back, went limp, and was rushed to the ER.
Age: 0.5
Sex: M
Vaccine: RVX
Symptoms: Somnolence
Clinical narrative: Fever, sleepiness, crying lasting 48 hours after vaccinations. Then on April 24, 2017 child stopped breathing, arched back, went limp, and was rushed to the ER.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Decreased appetite, Diarrhoea, Dysgeusia, Erythema
Clinical narrative: Severe frontal headache, fever, vomiting, pain at injection site. 4/27 same as previous day with taste of metal in mouth, lt arm hard, swollen, hot and red size 6"x 2" very painful to touch. Diarrhea started around 7 AM. Loss of appetite with extreme fatigue. 4/27 around 05:00 PM, I started having copious amounts of clear mucus with congestion in the right middle lobe with expiratory wheeze with a duration of seven hours. The mucus returned with a repeat of the previous night scenario with a six hour duration. On 4/29 around 05:00 AM, my temperature returned to normal and the vomiting ceased. All of my large joints ached and the pain at the injection site reached its peak. On 4/30, only the diarrhea, joint pain, loss of appetite with the taste of metal continued.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Induration, Injection site pain, Local swelling
Clinical narrative: Severe frontal headache, fever, vomiting, pain at injection site. 4/27 same as previous day with taste of metal in mouth, lt arm hard, swollen, hot and red size 6"x 2" very painful to touch. Diarrhea started around 7 AM. Loss of appetite with extreme fatigue. 4/27 around 05:00 PM, I started having copious amounts of clear mucus with congestion in the right middle lobe with expiratory wheeze with a duration of seven hours. The mucus returned with a repeat of the previous night scenario with a six hour duration. On 4/29 around 05:00 AM, my temperature returned to normal and the vomiting ceased. All of my large joints ached and the pain at the injection site reached its peak. On 4/30, only the diarrhea, joint pain, loss of appetite with the taste of metal continued.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Respiratory tract congestion, Secretion discharge, Skin warm
Clinical narrative: Severe frontal headache, fever, vomiting, pain at injection site. 4/27 same as previous day with taste of metal in mouth, lt arm hard, swollen, hot and red size 6"x 2" very painful to touch. Diarrhea started around 7 AM. Loss of appetite with extreme fatigue. 4/27 around 05:00 PM, I started having copious amounts of clear mucus with congestion in the right middle lobe with expiratory wheeze with a duration of seven hours. The mucus returned with a repeat of the previous night scenario with a six hour duration. On 4/29 around 05:00 AM, my temperature returned to normal and the vomiting ceased. All of my large joints ached and the pain at the injection site reached its peak. On 4/30, only the diarrhea, joint pain, loss of appetite with the taste of metal continued.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting, Wheezing
Clinical narrative: Severe frontal headache, fever, vomiting, pain at injection site. 4/27 same as previous day with taste of metal in mouth, lt arm hard, swollen, hot and red size 6"x 2" very painful to touch. Diarrhea started around 7 AM. Loss of appetite with extreme fatigue. 4/27 around 05:00 PM, I started having copious amounts of clear mucus with congestion in the right middle lobe with expiratory wheeze with a duration of seven hours. The mucus returned with a repeat of the previous night scenario with a six hour duration. On 4/29 around 05:00 AM, my temperature returned to normal and the vomiting ceased. All of my large joints ached and the pain at the injection site reached its peak. On 4/30, only the diarrhea, joint pain, loss of appetite with the taste of metal continued.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Abnormal behaviour, Abnormal faeces, Bowel movement irregularity, Condition aggravated, Constipation
Clinical narrative: The evening of the twins vaccinations (1-3pm appts), our daughter went into a shock-like state. She wouldn't respond to loud noises, talking, or movement. She just stared at the wall and would or could not make eye contact. No more smiles or cooing. She was a completely different baby. This lasted for 4 days. It was very scary. Also, her stool went from a normal, yellow, regular consistency baby stool (multiple times a day) to a very foul, black, thick (paste like) stool. It smelled very foul, almost chemical- like. It burned my nose to smell it. Her skin on her buttocks and female genitalia was very red and inflamed from the abnormal stool. Her stool stayed that way for months. She also experienced constipation and irregularity for several months following. Her eczema also worsened by quite a bit and will not go back to the state in was in prior to vaccines (on cheeks). I told 2 drs about it and neither said was vaccine related, although these reactions are listed as adverse in vaccine inserts. No treatment was recommended or provided.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Decreased eye contact, Dermatitis, Eczema, Erythema, Faeces discoloured
Clinical narrative: The evening of the twins vaccinations (1-3pm appts), our daughter went into a shock-like state. She wouldn't respond to loud noises, talking, or movement. She just stared at the wall and would or could not make eye contact. No more smiles or cooing. She was a completely different baby. This lasted for 4 days. It was very scary. Also, her stool went from a normal, yellow, regular consistency baby stool (multiple times a day) to a very foul, black, thick (paste like) stool. It smelled very foul, almost chemical- like. It burned my nose to smell it. Her skin on her buttocks and female genitalia was very red and inflamed from the abnormal stool. Her stool stayed that way for months. She also experienced constipation and irregularity for several months following. Her eczema also worsened by quite a bit and will not go back to the state in was in prior to vaccines (on cheeks). I told 2 drs about it and neither said was vaccine related, although these reactions are listed as adverse in vaccine inserts. No treatment was recommended or provided.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Shock symptom, Staring, Unresponsive to stimuli
Clinical narrative: The evening of the twins vaccinations (1-3pm appts), our daughter went into a shock-like state. She wouldn't respond to loud noises, talking, or movement. She just stared at the wall and would or could not make eye contact. No more smiles or cooing. She was a completely different baby. This lasted for 4 days. It was very scary. Also, her stool went from a normal, yellow, regular consistency baby stool (multiple times a day) to a very foul, black, thick (paste like) stool. It smelled very foul, almost chemical- like. It burned my nose to smell it. Her skin on her buttocks and female genitalia was very red and inflamed from the abnormal stool. Her stool stayed that way for months. She also experienced constipation and irregularity for several months following. Her eczema also worsened by quite a bit and will not go back to the state in was in prior to vaccines (on cheeks). I told 2 drs about it and neither said was vaccine related, although these reactions are listed as adverse in vaccine inserts. No treatment was recommended or provided.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Abdominal discomfort, Abdominal pain, Abnormal faeces, Bowel movement irregularity, Condition aggravated
Clinical narrative: The evening of the twins vaccinations (1-3pm appts), our son's stool went from a normal, yellow, regular consistency baby stool (multiple times a day) to a very foul, black, thick (paste like) stool. It smelled very foul, almost chemical- like. It burned my nose to smell it. The skin on his buttocks and male genitalia was very red and inflamed from the abnormal stool. His stool stayed that way for months. His twin sister also experienced this same exact abnormal stool change the same night. In addition, he also experienced constipation and irregularity for several months following. Along with long periods of crying (2-4 hrs at a time) and the sudden development of colic. Colic lasted for several months, as well as crying. His eczema also worsened by quite a bit and will not go back to the state it was in prior to vaccines (on face and periodically on arms and legs). He does not do well with foods and seems to have digestive discomfort still, almost 10 months later. I told 2 drs about it shortly after vaccination and neither said it was vaccine related. Although these reactions are listed as adverse in vaccine inserts. No treatment was recommended or provided.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Constipation, Crying, Dermatitis, Eczema, Erythema
Clinical narrative: The evening of the twins vaccinations (1-3pm appts), our son's stool went from a normal, yellow, regular consistency baby stool (multiple times a day) to a very foul, black, thick (paste like) stool. It smelled very foul, almost chemical- like. It burned my nose to smell it. The skin on his buttocks and male genitalia was very red and inflamed from the abnormal stool. His stool stayed that way for months. His twin sister also experienced this same exact abnormal stool change the same night. In addition, he also experienced constipation and irregularity for several months following. Along with long periods of crying (2-4 hrs at a time) and the sudden development of colic. Colic lasted for several months, as well as crying. His eczema also worsened by quite a bit and will not go back to the state it was in prior to vaccines (on face and periodically on arms and legs). He does not do well with foods and seems to have digestive discomfort still, almost 10 months later. I told 2 drs about it shortly after vaccination and neither said it was vaccine related. Although these reactions are listed as adverse in vaccine inserts. No treatment was recommended or provided.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Faeces discoloured
Clinical narrative: The evening of the twins vaccinations (1-3pm appts), our son's stool went from a normal, yellow, regular consistency baby stool (multiple times a day) to a very foul, black, thick (paste like) stool. It smelled very foul, almost chemical- like. It burned my nose to smell it. The skin on his buttocks and male genitalia was very red and inflamed from the abnormal stool. His stool stayed that way for months. His twin sister also experienced this same exact abnormal stool change the same night. In addition, he also experienced constipation and irregularity for several months following. Along with long periods of crying (2-4 hrs at a time) and the sudden development of colic. Colic lasted for several months, as well as crying. His eczema also worsened by quite a bit and will not go back to the state it was in prior to vaccines (on face and periodically on arms and legs). He does not do well with foods and seems to have digestive discomfort still, almost 10 months later. I told 2 drs about it shortly after vaccination and neither said it was vaccine related. Although these reactions are listed as adverse in vaccine inserts. No treatment was recommended or provided.
Age: 11.0
Sex: M
Vaccine: MENB, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV, VARZOS, FLU4, PPV, VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Denies any reactions or adverse events.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV, VARZOS, FLU4, PPV, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Denies any reactions or adverse events.
Age: 0.5
Sex: F
Vaccine: PNC13, RV5
Symptoms: Constipation, Speech disorder
Clinical narrative: On 7/14/16 mom says she had not had a bowel movement for a week and constipation continued. On 8/4/16 she says she is not talking as much as she used to.
Age: 1.58
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None. Patient was given KINRIX to a 19 month old on 3/9/17.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Patient with hives and swollen hands that started 3 days after vaccine given and was intermittent and lasted for 4-5 days. relief with BENADRYL.
Age: 39.0
Sex: F
Vaccine: ANTH, RAB
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Arthralgia, Hypoaesthesia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Developed migrating episodic wrist, finger hand shoulder hips and knee pain, finger numbness 7 days after receipt of rabies #2 and anthrax #3. Diagnosis Feb 2017 Palindromic rheumatism. Serology shows (+) RF and (+) CCP prior to vaccine receipt.
Age: 39.0
Sex: F
Vaccine: ANTH, RAB
Symptoms: Palindromic rheumatism, Rheumatoid factor positive
Clinical narrative: Developed migrating episodic wrist, finger hand shoulder hips and knee pain, finger numbness 7 days after receipt of rabies #2 and anthrax #3. Diagnosis Feb 2017 Palindromic rheumatism. Serology shows (+) RF and (+) CCP prior to vaccine receipt.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chemotherapy, Herpes zoster
Clinical narrative: L had shingles - left hip along leg of panty to rear. I was undergoing chemo treatment when they appeared.
Age: 31.0
Sex: F
Vaccine: HEP, VARCEL, HEP, VARCEL
Symptoms: Dizziness, Pharyngeal oedema, Throat tightness
Clinical narrative: Pt's husband reported on 5/1/17 that pt, shortly after leaving clinic, reported "feeling faint, light headed, throat closing up, swelling up" pt went to clinic where she was given Epi shot, and later taken to ER.
Age: 31.0
Sex: F
Vaccine: HEP, VARCEL, HEP, VARCEL
Symptoms: Allergy test negative, Blood pressure increased, Dizziness, Dyspnoea, Paraesthesia
Clinical narrative: Pt's husband reported on 5/1/17 that pt, shortly after leaving clinic, reported "feeling faint, light headed, throat closing up, swelling up" pt went to clinic where she was given Epi shot, and later taken to ER.
Age: 31.0
Sex: F
Vaccine: HEP, VARCEL, HEP, VARCEL
Symptoms: Throat irritation, Throat tightness
Clinical narrative: Pt's husband reported on 5/1/17 that pt, shortly after leaving clinic, reported "feeling faint, light headed, throat closing up, swelling up" pt went to clinic where she was given Epi shot, and later taken to ER.
Age: 0.17
Sex: F
Vaccine: DTAPIPV, HEP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Initially had some warmth and redness on the injection site which as now resolved. <1cm subcutaneous nodule palpable in (L) anterior thigh remains.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Angioedema, Erythema, Peripheral swelling
Clinical narrative: Redness and swelling to L/Arm.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Listless, Pyrexia, Somnolence
Clinical narrative: At 10:15 4/27/17 mom called MD on call to report fever 102.9, listlessness, and difficulty to awaken. Mom gave TYLENOL and sponge bath. After sponge bath and TYLENOL, patient was alert and attentive. Temp resolved by morning of 4/28/17 to 98.3. Patient was back to baseline.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Rt thigh 1/2 cm area of redness, firm nodule at the PEDIARIX site - no peri tenderness.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, C-reactive protein, Erythema, Malaise, Musculoskeletal stiffness
Clinical narrative: Local pain/stiffness x 2d - general malaise with arthralgia x 2d. Erythematous coalescent macular rash with tenderness. RUE involuntary deltoid muscle and extending down soft tissue to elbow. No fever. No axillary LAD.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Rash macular, Tenderness
Clinical narrative: Local pain/stiffness x 2d - general malaise with arthralgia x 2d. Erythematous coalescent macular rash with tenderness. RUE involuntary deltoid muscle and extending down soft tissue to elbow. No fever. No axillary LAD.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Muscle spasms
Clinical narrative: Symptoms from first dose of HPV9 continued - see Box 18. By November severe leg cramping started in both legs and numbness. Called doctor for phone consultation who recommended heat/ice packs and massages which helped a little bit but it was just temporary relief. Doctor said it was growing pains.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Fatigue, Headache, Pain in extremity, Slow response to stimuli
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 586452) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 18 year old female patient. The patient's concomitant medications, pertinent medical history, current illnesses and prior vaccinations were not reported. Other medication included LOESTRIN 1/20. On 17-JUL-2015, the patient was vaccinated with GARDASIL 9 dose number 1, lot # L001312, (dose and lot expiration date unknown intramuscularly in the right arm) for prophylaxis. Other suspect therapies included MENACTRA (Vaccinated date: 17-JUL-2015, dose number 2, lot # U4846BA, intramuscularly in the left arm, dose and lot expiration date unknown) for prophylaxis. On the same day, the patient experienced severe pain in right hand after injection in the right arm, throat tightening 2 hours post-vaccination. Patient also experienced headache, dizziness, fatigue, slow mental response time for 48 hours after the vaccination and reactions still persisted. The patient also had facial swelling 60 hours post vaccination. The patient was taken to emergency room. The outcome of dizziness, throat tightness, swelling face, slow response to stimuli, Pain in extremity, headache and fatigue was reported as not recovered. Causality assessment was not reported. Additional information is not expected from  the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Swelling face, Throat tightness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 586452) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 18 year old female patient. The patient's concomitant medications, pertinent medical history, current illnesses and prior vaccinations were not reported. Other medication included LOESTRIN 1/20. On 17-JUL-2015, the patient was vaccinated with GARDASIL 9 dose number 1, lot # L001312, (dose and lot expiration date unknown intramuscularly in the right arm) for prophylaxis. Other suspect therapies included MENACTRA (Vaccinated date: 17-JUL-2015, dose number 2, lot # U4846BA, intramuscularly in the left arm, dose and lot expiration date unknown) for prophylaxis. On the same day, the patient experienced severe pain in right hand after injection in the right arm, throat tightening 2 hours post-vaccination. Patient also experienced headache, dizziness, fatigue, slow mental response time for 48 hours after the vaccination and reactions still persisted. The patient also had facial swelling 60 hours post vaccination. The patient was taken to emergency room. The outcome of dizziness, throat tightness, swelling face, slow response to stimuli, Pain in extremity, headache and fatigue was reported as not recovered. Causality assessment was not reported. Additional information is not expected from  the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Blood bilirubin abnormal, Blood creatine phosphokinase, C-reactive protein, Cytomegalovirus test negative
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 591497) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient's medical history included recurrent oral HSV, not active at time of vaccination, acne with BACTRIM prescribed day of vaccination and tonsillectomy. Other medications included initial HPV and GARDASIL 4. The patient had no concurrent illnesses. On 13-AUG-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # K026246, dose 1, intramuscularly in the left arm for prophylaxis. On 15-AUG-2015, the events abdominal pain, ultrasound pelvis, ultrasound abdomen, red blood cell sedimentation rate, myalgia, metabolic function test, liver function test, hepatitis viral test, full blood count, Epstein-Barr virus antibody negative, differential white blood cell count, cytomegalovirus test negative, cytomegalovirus test, C-reactive protein, blood creatine phosphokinase and blood bilirubin abnormal were reported. The patient had sudden onset of severe body muscle aches with abdominal pain, no rash and fever. There was no treatment given. The outcome of abdominal pain, ultrasound pelvis, ultrasound abdomen, red blood cell sedimentation rate, myalgia, metabolic function test, liver function test, hepatitis viral test, full blood count, Epstein-Barr virus antibody negative, differential white blood cell count, cytomegalovirus test negative, cytomegalovirus test, C-reactive protein, blood creatine phosphokinase and blood bilirubin abnormal were reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Differential white blood cell count, Epstein-Barr virus antibody negative, Full blood count, Hepatitis viral test, Liver function test
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 591497) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient's medical history included recurrent oral HSV, not active at time of vaccination, acne with BACTRIM prescribed day of vaccination and tonsillectomy. Other medications included initial HPV and GARDASIL 4. The patient had no concurrent illnesses. On 13-AUG-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # K026246, dose 1, intramuscularly in the left arm for prophylaxis. On 15-AUG-2015, the events abdominal pain, ultrasound pelvis, ultrasound abdomen, red blood cell sedimentation rate, myalgia, metabolic function test, liver function test, hepatitis viral test, full blood count, Epstein-Barr virus antibody negative, differential white blood cell count, cytomegalovirus test negative, cytomegalovirus test, C-reactive protein, blood creatine phosphokinase and blood bilirubin abnormal were reported. The patient had sudden onset of severe body muscle aches with abdominal pain, no rash and fever. There was no treatment given. The outcome of abdominal pain, ultrasound pelvis, ultrasound abdomen, red blood cell sedimentation rate, myalgia, metabolic function test, liver function test, hepatitis viral test, full blood count, Epstein-Barr virus antibody negative, differential white blood cell count, cytomegalovirus test negative, cytomegalovirus test, C-reactive protein, blood creatine phosphokinase and blood bilirubin abnormal were reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Metabolic function test, Myalgia, Red blood cell sedimentation rate, Ultrasound abdomen, Ultrasound pelvis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 591497) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient's medical history included recurrent oral HSV, not active at time of vaccination, acne with BACTRIM prescribed day of vaccination and tonsillectomy. Other medications included initial HPV and GARDASIL 4. The patient had no concurrent illnesses. On 13-AUG-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # K026246, dose 1, intramuscularly in the left arm for prophylaxis. On 15-AUG-2015, the events abdominal pain, ultrasound pelvis, ultrasound abdomen, red blood cell sedimentation rate, myalgia, metabolic function test, liver function test, hepatitis viral test, full blood count, Epstein-Barr virus antibody negative, differential white blood cell count, cytomegalovirus test negative, cytomegalovirus test, C-reactive protein, blood creatine phosphokinase and blood bilirubin abnormal were reported. The patient had sudden onset of severe body muscle aches with abdominal pain, no rash and fever. There was no treatment given. The outcome of abdominal pain, ultrasound pelvis, ultrasound abdomen, red blood cell sedimentation rate, myalgia, metabolic function test, liver function test, hepatitis viral test, full blood count, Epstein-Barr virus antibody negative, differential white blood cell count, cytomegalovirus test negative, cytomegalovirus test, C-reactive protein, blood creatine phosphokinase and blood bilirubin abnormal were reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9, PNC13
Symptoms: Amnesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 592004). This spontaneous report refers to a 15 year old male patient. with prophylaxis. The patient had no concurrent illnesses and other medications. Information on the patient's medical history was not reported. On 04-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # K006960 dose 1, intramuscular route for prophylaxis (dosage and site of administration unspecified). On the same day, the patient was also vaccinated with VAQTA lot# J015882, dose 2, intramuscular route (dosage and site of administration unspecified) and PREVNAR 13 batch/lot# L13523, dose 1, intramuscular route in the right arm for prophylaxis (dosage unspecified). On 04-AUG-2015, the patient experienced amnesia. The patient's mother states that the patient had immunizations and had a loss of memory for 12 hours. The patient could not remember taking a driving test. The patient's mother took the patient to emergency room (ER) but left after being told the wait would be about 4 hours. The patient recovered the next day but per the patient's mother, the patient still could not remember the day of vaccines. The patient's mother had previously declined the GARDASIL 9 vaccine for the patient and believes that the patient's reaction was due to the GARDASIL 9 vaccine. The outcome of amnesia was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 and VAQTA was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.