chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor, Presyncope, Vomiting
Clinical narrative: Client states she feels lightheaded and that she feels like she is going to pass out.  Pt sitting in chair in lobby, pale looking.  Encouraged slow deep breaths in her nose and out her mouth while fanning then pt.  Assisted by RN w/ a cool wash cloth to forehead and garbage can b/c pt state she feels like she is going to vomit.  Pt vomits large amount of undigested food.  Sstate she is feeling a little better.  Color improving to a light pink.  Client given juice to drink.  Client assisted back to clinic room laying down on table for 10 minutes w a cool fan on her.  After 10 min client states she is feeling better.  Cont to drink juice. Pt goes back out to waiting room and instructed to sit for 10 more minutes and to notify us if she feels lightheaded again.  Verbalized understanding.  After sitting for 10 minutes pt states she feels good enough to leave.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lethargy, Pallor, Vomiting projectile
Clinical narrative: Projectile vomiting x 1, lethargy, paleness
Age: 0.16
Sex: F
Vaccine: HEP, MEN, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site rash, Rash, Rash erythematous
Clinical narrative: Client developed a large blotchy red rash on her upper chest, upper right arm immediately after receiving VZV, no S.O.B Epinephrine 0.3 mg Auto-Injector SC STAT R thigh. Fire rescue arrived @ 10:20 AM. Paramedics team recommended client's parents to observe the child and see the child's private doctor.
Age: 0.16
Sex: F
Vaccine: HEP, MEN, VARCEL
Symptoms: Rash macular
Clinical narrative: Client developed a large blotchy red rash on her upper chest, upper right arm immediately after receiving VZV, no S.O.B Epinephrine 0.3 mg Auto-Injector SC STAT R thigh. Fire rescue arrived @ 10:20 AM. Paramedics team recommended client's parents to observe the child and see the child's private doctor.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Arthralgia, Joint swelling
Clinical narrative: swelling of left knee, minimal pain
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Parotid gland enlargement
Clinical narrative: Bilateral parotid gland swelling. Not tender, no redness.
Age: 1.28
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Immediately had swelling at site within five minutes of vaccination, nurse immediately applied ice to site, physician observe and recommended Benadryl and continue to apply ice PRN.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Arthralgia, Burning sensation, Chest pain, Fatigue
Clinical narrative: Initial: Vaccine was administered on June 2, 2011 during the course of patient's routine annual physical.  Up to this point in time, she was very healthy.   Began with stomach pain, fever and rash across torso and arm, and around mouth within 48 hrs of vaccination.  Symptoms progressed over the course of the following weeks to include fatigue, headaches, sore throat, swollen glands, sores in mouth, swollen hands, abnormal menstrual flow (black colored),  painful joints, intermittent blurred vision in one eye, chest pain, tachycardia, diffuse muscular pain, diminished reflexes, burning and pressure sensations in back of head and neck. Patient has been examined multiple times by her pediatrician, and has been evaluated by physicians in the following specialties: infectious disease, cardiology, rheumatology, and neurology.  All tests conducted to date have come back normal.  Physicians cannot explain this course of events.  Patient continues to live with pain and symptoms each day.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hyporeflexia, Laboratory test normal, Lymphadenopathy, Menstrual disorder
Clinical narrative: Initial: Vaccine was administered on June 2, 2011 during the course of patient's routine annual physical.  Up to this point in time, she was very healthy.   Began with stomach pain, fever and rash across torso and arm, and around mouth within 48 hrs of vaccination.  Symptoms progressed over the course of the following weeks to include fatigue, headaches, sore throat, swollen glands, sores in mouth, swollen hands, abnormal menstrual flow (black colored),  painful joints, intermittent blurred vision in one eye, chest pain, tachycardia, diffuse muscular pain, diminished reflexes, burning and pressure sensations in back of head and neck. Patient has been examined multiple times by her pediatrician, and has been evaluated by physicians in the following specialties: infectious disease, cardiology, rheumatology, and neurology.  All tests conducted to date have come back normal.  Physicians cannot explain this course of events.  Patient continues to live with pain and symptoms each day.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Oedema peripheral, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Initial: Vaccine was administered on June 2, 2011 during the course of patient's routine annual physical.  Up to this point in time, she was very healthy.   Began with stomach pain, fever and rash across torso and arm, and around mouth within 48 hrs of vaccination.  Symptoms progressed over the course of the following weeks to include fatigue, headaches, sore throat, swollen glands, sores in mouth, swollen hands, abnormal menstrual flow (black colored),  painful joints, intermittent blurred vision in one eye, chest pain, tachycardia, diffuse muscular pain, diminished reflexes, burning and pressure sensations in back of head and neck. Patient has been examined multiple times by her pediatrician, and has been evaluated by physicians in the following specialties: infectious disease, cardiology, rheumatology, and neurology.  All tests conducted to date have come back normal.  Physicians cannot explain this course of events.  Patient continues to live with pain and symptoms each day.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Sensation of pressure, Stomatitis, Tachycardia, Vision blurred
Clinical narrative: Initial: Vaccine was administered on June 2, 2011 during the course of patient's routine annual physical.  Up to this point in time, she was very healthy.   Began with stomach pain, fever and rash across torso and arm, and around mouth within 48 hrs of vaccination.  Symptoms progressed over the course of the following weeks to include fatigue, headaches, sore throat, swollen glands, sores in mouth, swollen hands, abnormal menstrual flow (black colored),  painful joints, intermittent blurred vision in one eye, chest pain, tachycardia, diffuse muscular pain, diminished reflexes, burning and pressure sensations in back of head and neck. Patient has been examined multiple times by her pediatrician, and has been evaluated by physicians in the following specialties: infectious disease, cardiology, rheumatology, and neurology.  All tests conducted to date have come back normal.  Physicians cannot explain this course of events.  Patient continues to live with pain and symptoms each day.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Chills, Computerised tomogram, Feeling abnormal, Headache
Clinical narrative: I starting having pain in my left hand then I felt it tingling.  By 10/13/2011 I was foggy.  Had a headache and chills that night.  The next day I awoke with a loss of sensation all over my body.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Paraesthesia, Sensory loss, Ultrasound scan, Viral infection
Clinical narrative: I starting having pain in my left hand then I felt it tingling.  By 10/13/2011 I was foggy.  Had a headache and chills that night.  The next day I awoke with a loss of sensation all over my body.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Pt. received flu shot on 8/25/11.  That night at 1:15 am he wokeup and was shivering uncontrollably and running a fever of 101.7. He has body aches.   Took Tylenol and called nurse hotline who told him to go to ER or call doctor.  Was able to go back to sleep around 3am and when he woke  fever and chills were gone but had a pounding headache. He called the Nurse Clinic to report the adverse event. Told to treat symptomatically with Tylenol and Ibuprofen.  He stayed home from work but stated he felt better.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Sensation of pressure
Clinical narrative: Patient was fine immediately after vaccination. Appropriately 2 & 1/2 hours after vaccination, the patient returned to the pharmacy and complained of "pressure" in her throat. Patient stated that she could breathe through her nose, but she felt the need to cough. She was in no apparent physical distress. There were no signs of injection-site reactions. No treatment was administered. Patient was told to sit & relax. She inquired about taking diphenhydramine, and she was told that would be okay. She was told to return if symptoms worsened while at the pharmacy. She was told to report to the ER or call 911 if symptoms worsened or in distress once she left the pharmacy. She left work and went home.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Patient presented with a rash
Age: 0.32
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV1
Symptoms: Rash
Clinical narrative: Pt. received DTaP, Hib, PCV13, Rotavirus. 5 minutes after receiving vaccines had a rash on face-arms-trunk-not on legs. Dr. here to check patient instructed to wait twenty minutes. Rash less, mom instructed to watch rash area.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Patient received ZOSTAVAX vaccine on 8/15/11. She developed symptoms of shingles around 7 days later. She was diagnosed with shingles on 8/25/11. Her symptoms do include pain!
Age: 14.0
Sex: U
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: At site of injection edema, erythema and pruritus. No SOB, pain, H/A, dizziness. No trouble with vision, senses. Tx: BENADRYL, ice pack & TYLENOL.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Muscle spasms
Clinical narrative: Muscle spasm in arm, headaches. FIORICET, Tizanidine prescribed.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Pt's rt arm where vaccine was given, warm to touch, 8" diameter redness area. No other side effects noted. 2 " hard lump at injection site. Recommended ice , elevation, Ibuprofen age appropriate, and BENADRYL. Return to clinic prn.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site infection
Clinical narrative: DTAP injection site became infected requiring oral antibiotic administration. No fever reported.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Choking, Drooling, Erythema, Pruritus, Rash erythematous
Clinical narrative: 17:10 child received vaccines, did not cry and then a few minutes later he turned red in face and started drooling and not talking. I was called into the room to assess patient and patient was quiet without any changed to baseline assessment. Left room to as Dr. to evaluate the patient and when we entered the room he told mom that his feet were itching. Upon re-assessment the child was noted to have splotchy red rash to right side of posterior neck and the bottoms of feet were red. As we continued to observe the child had additional redness to right and left side of legs, but nothing specific to injection sites. See immunization record for administration of vaccines to site. Attempt was made to administer oral BENADRYL to patient which he did not tolerate and vomited a large amount of fluid after choking, suctioning performed via bulb, tolerated well. Child cleaned and wet clothing removed. No oral BENADRYL administered. SaO2 94% and child clear bilaterally and regular heart rate. BENADRYL 15 mg IM and Epinephrine (1:1000) 0.15mg IM. With continued observation child decreased rash and redness and SaO2 return to 96%. Child transported via ambulance to ER for further evaluation and management. Clinic summary provided to parent to assist in continuation of care.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash macular, Speech disorder, Vomiting
Clinical narrative: 17:10 child received vaccines, did not cry and then a few minutes later he turned red in face and started drooling and not talking. I was called into the room to assess patient and patient was quiet without any changed to baseline assessment. Left room to as Dr. to evaluate the patient and when we entered the room he told mom that his feet were itching. Upon re-assessment the child was noted to have splotchy red rash to right side of posterior neck and the bottoms of feet were red. As we continued to observe the child had additional redness to right and left side of legs, but nothing specific to injection sites. See immunization record for administration of vaccines to site. Attempt was made to administer oral BENADRYL to patient which he did not tolerate and vomited a large amount of fluid after choking, suctioning performed via bulb, tolerated well. Child cleaned and wet clothing removed. No oral BENADRYL administered. SaO2 94% and child clear bilaterally and regular heart rate. BENADRYL 15 mg IM and Epinephrine (1:1000) 0.15mg IM. With continued observation child decreased rash and redness and SaO2 return to 96%. Child transported via ambulance to ER for further evaluation and management. Clinic summary provided to parent to assist in continuation of care.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Electroencephalogram normal, Tic
Clinical narrative: Baby developed facial tics after 3rd hep B injection.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Patient received ZOSTAVAX vaccine on 06/30/2011. On 08/22/2011, she called pharmacy and reported that day after receiving vaccine she developed red blistery rash under her armpit. The same arm. She followed with MD & was prescribed antibacterial wipes. Rash is still there, purplish and little residual.
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Presyncope
Clinical narrative: Pt was given MENACTRA and had a vasovagal reaction 5 minutes after shot was administered.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: 08/26/2011 Severe anaphylactic reaction. Patient loss airway with flu vaccine. Loses airway when in certain buildings.
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: After MENACTRA, Tdap, Hep A and HPV, fainted while sitting on mom's lap; 2 beats of arms seizure activity. Self-resolved all lasted approximately 5 sec.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: At the noted time for adverse onset, vomiting, fever, diarrhea, extreme headache. Lasted until midnight. The headache lasted through the 25th but not severe; leg aches have continued through the 26th.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site rash, Rash
Clinical narrative: 4 month old getting 2nd set of vaccines - today has rash both thighs and abdomen.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Food poisoning, Gastrointestinal disorder, Guillain-Barre syndrome, Intensive care, Mechanical ventilation
Clinical narrative: This case was reported by a physician and described the occurrence of Guillain-Barre in a 23-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject experienced a gastrointestinal illness (due to food poisoning) 2 months before the Guillain-Barre surfaced. On 23 September 2009 the subject received a dose of FLULAVAL in an unknown arm. On 25 November 2009, 63 days after vaccination with FLULAVAL, the subject experienced tingling in her legs. Guillain-Barre was officially diagnosed in December 2009. At that time, the subject was hospitalized for one month in the intensive care unit. She received a tracheotomy and was on a ventilator. Complete paralysis was reported. The physician considered the events were disabling, life threatening and clinically significant (or requiring intervention). The physician reporting (an oral maxillofacial surgeon) stated that he did not feel that the vaccine was related to the Guillain-Barre at all. It was reported that the subject had experienced a gastrointestinal illness (due to food poisoning) 2 months before the Guillain-Barre surfaced. The physician felt that the food poisoning provided the vehicle for contraction of the Guillain-Barre. The physician was unaware of the subject's physical state at the time of reporting or if all of the events had resolved.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Paralysis, Tracheostomy
Clinical narrative: This case was reported by a physician and described the occurrence of Guillain-Barre in a 23-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject experienced a gastrointestinal illness (due to food poisoning) 2 months before the Guillain-Barre surfaced. On 23 September 2009 the subject received a dose of FLULAVAL in an unknown arm. On 25 November 2009, 63 days after vaccination with FLULAVAL, the subject experienced tingling in her legs. Guillain-Barre was officially diagnosed in December 2009. At that time, the subject was hospitalized for one month in the intensive care unit. She received a tracheotomy and was on a ventilator. Complete paralysis was reported. The physician considered the events were disabling, life threatening and clinically significant (or requiring intervention). The physician reporting (an oral maxillofacial surgeon) stated that he did not feel that the vaccine was related to the Guillain-Barre at all. It was reported that the subject had experienced a gastrointestinal illness (due to food poisoning) 2 months before the Guillain-Barre surfaced. The physician felt that the food poisoning provided the vehicle for contraction of the Guillain-Barre. The physician was unaware of the subject's physical state at the time of reporting or if all of the events had resolved.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Injection site swelling, Muscle swelling, Myalgia
Clinical narrative: Day of injection I informed the HCP that the injection site was burning and painful at the time of injection. Woke up next morning with slight facial edema, painful and swelling of injection site with hard, large induration.  That night facial swelling increased. On 05/29/20011 increase of facial swelling with my eyes shut.  Increase pain, red, hard, large induration of injection site.  Lower part of my extremities were painful, hard to bend and painful to walk.  That eve. I went to the ER, in which they confirmed I had an Adverse reaction to the vaccination.  I went back to facility on June 30, 2011 to refuse the second dose,  The Nurse felt the induration on my arm which was still there and painful and I explained to her my symptons.  My pain and induration didn't fade away until the first or second week of Aug.  The pain in my lower extremities eventually subsided but moved to my Right upper thigh and is excruciating.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Eyelid oedema, Face oedema, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Day of injection I informed the HCP that the injection site was burning and painful at the time of injection. Woke up next morning with slight facial edema, painful and swelling of injection site with hard, large induration.  That night facial swelling increased. On 05/29/20011 increase of facial swelling with my eyes shut.  Increase pain, red, hard, large induration of injection site.  Lower part of my extremities were painful, hard to bend and painful to walk.  That eve. I went to the ER, in which they confirmed I had an Adverse reaction to the vaccination.  I went back to facility on June 30, 2011 to refuse the second dose,  The Nurse felt the induration on my arm which was still there and painful and I explained to her my symptons.  My pain and induration didn't fade away until the first or second week of Aug.  The pain in my lower extremities eventually subsided but moved to my Right upper thigh and is excruciating.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Injection site swelling, Pain, Pain in extremity, Swelling face, Vaccination complication
Clinical narrative: Day of injection I informed the HCP that the injection site was burning and painful at the time of injection. Woke up next morning with slight facial edema, painful and swelling of injection site with hard, large induration.  That night facial swelling increased. On 05/29/20011 increase of facial swelling with my eyes shut.  Increase pain, red, hard, large induration of injection site.  Lower part of my extremities were painful, hard to bend and painful to walk.  That eve. I went to the ER, in which they confirmed I had an Adverse reaction to the vaccination.  I went back to facility on June 30, 2011 to refuse the second dose,  The Nurse felt the induration on my arm which was still there and painful and I explained to her my symptons.  My pain and induration didn't fade away until the first or second week of Aug.  The pain in my lower extremities eventually subsided but moved to my Right upper thigh and is excruciating.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Foreign travel, Rash generalised, Rash pustular, Vaccinia virus infection
Clinical narrative: Pt received the vaccine in the states during the predeployment process. Arrived 5 days ago. Rash started below breast and has since spread considerably. Presents with severe widespread vaccinia with small pustules covering back chest and right ankle. Referred to dermatologist here in country to confirm. Received the Varicella vaccine on 7/8/2011.
Age: 64.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Headache, Pallor, Rash, Urticaria
Clinical narrative: Rash and hives on my extremities and back, pale, Abdominal pain, headache
Age: 1.13
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Convulsion, Cyanosis, Pyrexia, Vomiting
Clinical narrative: Fever began around 3PM on August 24th. On August 25th around 8AM the patient had a seizure, turned blue, and vomited. He was transported by ambulance to the pediatric emergency room.
Age: 1.13
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Anaemia, Blood culture negative, C-reactive protein increased, Culture throat negative, Grand mal convulsion
Clinical narrative: Fever began around 3PM on August 24th. On August 25th around 8AM the patient had a seizure, turned blue, and vomited. He was transported by ambulance to the pediatric emergency room.
Age: 1.13
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Lymphocyte count, Mean cell haemoglobin increased, Mean cell volume decreased, Metabolic function test normal, Neutrophil count
Clinical narrative: Fever began around 3PM on August 24th. On August 25th around 8AM the patient had a seizure, turned blue, and vomited. He was transported by ambulance to the pediatric emergency room.
Age: 1.13
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Postictal state, Pyrexia, Red cell distribution width increased, Streptococcus test negative, Vomiting
Clinical narrative: Fever began around 3PM on August 24th. On August 25th around 8AM the patient had a seizure, turned blue, and vomited. He was transported by ambulance to the pediatric emergency room.
Age: 69.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Aphonia, Dysphagia, Dyspnoea, Pharyngeal oedema, Throat tightness
Clinical narrative: Symptoms included: swelling of throat, constriction of airway, difficulty swallowing and breathing, and loss of voice
Age: 26.0
Sex: F
Vaccine: HPVX
Symptoms: Smear cervix abnormal, Therapeutic procedure
Clinical narrative: Since receiving shots, I had a pap smear and was told I had abnormal cells. I have never had an abnormal pap. During above date I was at mild risk for cervical cancer and had the cells removed. As of 24 Aug 2011 I am now at high risk.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: chills, fever, weak, chills so bad I couldn't stop shivering
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Upon injection patient stated itching at site of injection. Became very red and began to spread. Applied ice and redness was reduced to only injection site. Within 30 min only minimal swelling & redness at that location.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Heart rate increased, Pyrexia, Tremor
Clinical narrative: Per pt - extreme chills, shakes, fever, increased heart rate (heart was racing per pt) a few hours after receiving vaccination. He ended up going to ER to get treatment. Was released approx. midnight.
Age: 23.0
Sex: U
Vaccine: FLU3
Symptoms: Dizziness, Hypotension, Nausea, Syncope
Clinical narrative: Fainted, dizziness, low BP 100/50, nausea.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dry mouth, Fatigue, Feeling abnormal, Headache
Clinical narrative: Received BOOSTRIX at 945 AM. Called agency at 2 pm with headache, nausea, no fever, no vomiting. Felt wiped out, weakness and fatigue, dry mouth.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Received BOOSTRIX at 945 AM. Called agency at 2 pm with headache, nausea, no fever, no vomiting. Felt wiped out, weakness and fatigue, dry mouth.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hot flush, Musculoskeletal stiffness, Nausea, Salivary hypersecretion
Clinical narrative: sx-hot flashes, lightheaded, stiff tounge, watery mouth, nauseous  tx-rest
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Activities of daily living impaired, Rash, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Woke up with a few bumps on arms that I thought were bug bites. Throughout the day she developed bumps that covered her whole body. Some were as large as 5 inches in diameter. By noon her face was swelling and body was covered in raised red itchy bumps. I called Dr. and she said it was due to the MMR vaccine and I needed to give her Benadryl every 6 hours until the symptoms go away.   My poor daughter has been very drowsy and not able to participate in normal activities because of this. I am fearful that she will have long term damage because of this vaccine.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Somnolence, Swelling face
Clinical narrative: Woke up with a few bumps on arms that I thought were bug bites. Throughout the day she developed bumps that covered her whole body. Some were as large as 5 inches in diameter. By noon her face was swelling and body was covered in raised red itchy bumps. I called Dr. and she said it was due to the MMR vaccine and I needed to give her Benadryl every 6 hours until the symptoms go away.   My poor daughter has been very drowsy and not able to participate in normal activities because of this. I am fearful that she will have long term damage because of this vaccine.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever, administered baby pedia care
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain upper, Decreased appetite, Immediate post-injection reaction, Injection site pain, Injection site rash
Clinical narrative: Severe pain immediately following vaccination. A "bubble" formed just beneath skin at vaccination site at 6:10 PM. Complaints of muscle/arm stiffness at 7:00 PM. Loss of appetite and mild stomach cramps evening of 08/24/2011 & morning (6:15 AM) of 08/25/2011. By 1:00 PM 08/25/2011 swelling in injection site was the size of a quarter with continuous pain and fever at injection site. 08/26/2011 6:30 AM injection site had swelled to just larger than a Kennedy half-dollar with tightness. Visited pediatrician and was told to administer Benadryl, Tylenol, and ice packs. 08/27/2011 9:00 AM swelling had increased to approximately 3 1/2 inches diameter with a rash covering entire area and feels warm to touch with tightness. Complaints of extreme itching and shoulder muscle soreness. 08/28/2011 rash, warmth, itching, muscle soreness in shoulder, tightness in injection site. Swelling is now approximately 4 inches in diameter.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site reaction, Injection site swelling, Injection site vesicles, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Severe pain immediately following vaccination. A "bubble" formed just beneath skin at vaccination site at 6:10 PM. Complaints of muscle/arm stiffness at 7:00 PM. Loss of appetite and mild stomach cramps evening of 08/24/2011 & morning (6:15 AM) of 08/25/2011. By 1:00 PM 08/25/2011 swelling in injection site was the size of a quarter with continuous pain and fever at injection site. 08/26/2011 6:30 AM injection site had swelled to just larger than a Kennedy half-dollar with tightness. Visited pediatrician and was told to administer Benadryl, Tylenol, and ice packs. 08/27/2011 9:00 AM swelling had increased to approximately 3 1/2 inches diameter with a rash covering entire area and feels warm to touch with tightness. Complaints of extreme itching and shoulder muscle soreness. 08/28/2011 rash, warmth, itching, muscle soreness in shoulder, tightness in injection site. Swelling is now approximately 4 inches in diameter.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Myalgia, Pain, Pruritus, Skin tightness
Clinical narrative: Severe pain immediately following vaccination. A "bubble" formed just beneath skin at vaccination site at 6:10 PM. Complaints of muscle/arm stiffness at 7:00 PM. Loss of appetite and mild stomach cramps evening of 08/24/2011 & morning (6:15 AM) of 08/25/2011. By 1:00 PM 08/25/2011 swelling in injection site was the size of a quarter with continuous pain and fever at injection site. 08/26/2011 6:30 AM injection site had swelled to just larger than a Kennedy half-dollar with tightness. Visited pediatrician and was told to administer Benadryl, Tylenol, and ice packs. 08/27/2011 9:00 AM swelling had increased to approximately 3 1/2 inches diameter with a rash covering entire area and feels warm to touch with tightness. Complaints of extreme itching and shoulder muscle soreness. 08/28/2011 rash, warmth, itching, muscle soreness in shoulder, tightness in injection site. Swelling is now approximately 4 inches in diameter.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Erythema, Injection site swelling, Oedema, Oedema peripheral, Rash macular
Clinical narrative: Swollen left arm under injection site.  Warm and slightly blotchy red.  Much redder the next day and arm still swollen. Swelling looks like edema.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Skin warm
Clinical narrative: Swollen left arm under injection site.  Warm and slightly blotchy red.  Much redder the next day and arm still swollen. Swelling looks like edema.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Cough, Dyspnoea, Headache
Clinical narrative: I TO GET THE CHILLS AND WENT INTO BED AND STARTED TO COUGH, MUSCLE ACHE, SORE THROAT, HEADACHE, FELT WEAK, DIFFICULTY BREATHING, WHEEZING, PALENESS, FAST HEART BEAT AND VOMITING
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Myalgia, Oropharyngeal pain, Pallor, Vaccination complication
Clinical narrative: I TO GET THE CHILLS AND WENT INTO BED AND STARTED TO COUGH, MUSCLE ACHE, SORE THROAT, HEADACHE, FELT WEAK, DIFFICULTY BREATHING, WHEEZING, PALENESS, FAST HEART BEAT AND VOMITING
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting, Wheezing
Clinical narrative: I TO GET THE CHILLS AND WENT INTO BED AND STARTED TO COUGH, MUSCLE ACHE, SORE THROAT, HEADACHE, FELT WEAK, DIFFICULTY BREATHING, WHEEZING, PALENESS, FAST HEART BEAT AND VOMITING
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient states warm, red area around injection site that started as 2x2" and over 2 days has increased to 5x3 to 4" area. The area is raised and warm with a soft outside area and hard inside area. Pt also reports fever but no temperature taken.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Motor dysfunction
Clinical narrative: Patient called pharmacy the following day, said she had some loss of motor control of face and increased back pain 20 minutes after injection. Lasted till 5AM. OK today 8/28/11 approximately 2:45PM.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Contusion, Oedema peripheral
Clinical narrative: Arm swollen. She was not too concerned about it. I called to check up on her and she said she was fine. Her main complaint was bruising due to COUMADIN.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure immeasurable, Electrocardiogram, Laboratory test normal, Syncope
Clinical narrative: Information has been received from a physician's assistant (PA) concerning a 19 year old female patient with a history of fainting who on 23-APR-2010, was vaccinated with the first 0.5 ml dose of GARDASIL. The physician's assistant reported that the patient received her first dose of GARDASIL and fainted. The PA stated that the patient was fasting because she wanted to do her blood work as well and her blood pressure was 94/54 before receiving the vaccine. After she fainted, the office could not get a read on her blood pressure and her pulse was 40, oxygen was 98. The PA also mentioned that 5 minutes later she fainted again while she was laying down and after that they did EKG (read 38) and took blood pressure again and it was at 88/48. After that the patient went to emergency room (ER), however she was released and all other lab work came back normal. The patient recovered the same day. The patient sought unspecified medical attention. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Biopsy kidney abnormal, Blood creatinine increased, Glomerulonephritis membranous, Hypertension, Nephrotic syndrome
Clinical narrative: This literature report (initial receipt: 06-May-2011) concerns a 60-year old female patient. The patient had been refusing influenza vaccine in the past as her father died from Guillain-Barre syndrome after receiving influenza vaccination. On an unknown date the patient received influenza vaccine. The patient presented with a one week history of abrupt onset lower extremity edema which developed five days after receiving influenza vaccine. Her exam was significant for lower extremity pitting edema and hypertension. Her laboratory data revealed acute kidney injury (AKI) with serum creatinine (Scr) of 10.2. Her spot urine total protein to creatinine ratio (TP/CR) was 23. Serological workup was negative. She underwent kidney biopsy which showed stage 1 membranous nephropathy (MN) with acute interstitial nephritis (AIN). She was started on daily oral prednisolone (0.75 mg/kg) with tapering doses over the next two months. Her renal function normalised (Scr 0.9) five weeks later after initiation of oral prednisolone. Her spot urine TP/CR decreased to 1.3. After one week of completion of therapy, the patient was found to have elevated Scr of 2.3. Her spot urine TP/CR increased to 28. At this time, the patient underwent repeat kidney biopsy which showed MN with resolution of AIN. The patient was restarted on daily oral prednisone (0.75 mg/kg) which was tapered over the next 4 months. One month after initiation of oral prednisone, her Scr decreased to 0.9. Her spot urine TP/CR decreased to 0.2 upon completion of therapy. The patient continued to be in remission, six months after completion of oral corticosteroid therapy. The reporter concluded that abrupt onset of nephrotic syndrome after influenza vaccine was suggestive that there was activation of the immune system which was triggered by the vaccination. Based on the reporter's experience, a course of oral corticosteroid should be considered in patients who develop nephrotic syndrome with AKI after influenza vaccine.
Age: 60.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Oedema, Renal failure acute, Tubulointerstitial nephritis, Urine protein/creatinine ratio increased
Clinical narrative: This literature report (initial receipt: 06-May-2011) concerns a 60-year old female patient. The patient had been refusing influenza vaccine in the past as her father died from Guillain-Barre syndrome after receiving influenza vaccination. On an unknown date the patient received influenza vaccine. The patient presented with a one week history of abrupt onset lower extremity edema which developed five days after receiving influenza vaccine. Her exam was significant for lower extremity pitting edema and hypertension. Her laboratory data revealed acute kidney injury (AKI) with serum creatinine (Scr) of 10.2. Her spot urine total protein to creatinine ratio (TP/CR) was 23. Serological workup was negative. She underwent kidney biopsy which showed stage 1 membranous nephropathy (MN) with acute interstitial nephritis (AIN). She was started on daily oral prednisolone (0.75 mg/kg) with tapering doses over the next two months. Her renal function normalised (Scr 0.9) five weeks later after initiation of oral prednisolone. Her spot urine TP/CR decreased to 1.3. After one week of completion of therapy, the patient was found to have elevated Scr of 2.3. Her spot urine TP/CR increased to 28. At this time, the patient underwent repeat kidney biopsy which showed MN with resolution of AIN. The patient was restarted on daily oral prednisone (0.75 mg/kg) which was tapered over the next 4 months. One month after initiation of oral prednisone, her Scr decreased to 0.9. Her spot urine TP/CR decreased to 0.2 upon completion of therapy. The patient continued to be in remission, six months after completion of oral corticosteroid therapy. The reporter concluded that abrupt onset of nephrotic syndrome after influenza vaccine was suggestive that there was activation of the immune system which was triggered by the vaccination. Based on the reporter's experience, a course of oral corticosteroid should be considered in patients who develop nephrotic syndrome with AKI after influenza vaccine.
Age: 60.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Oedema, Oedema peripheral, Renal failure acute, Renal impairment, Serology negative
Clinical narrative: This literature report (initial receipt: 06-May-2011) concerns a 60-year old female patient. The patient had been refusing influenza vaccine in the past as her father died from Guillain-Barre syndrome after receiving influenza vaccination. On an unknown date the patient received influenza vaccine. The patient presented with a one week history of abrupt onset lower extremity edema which developed five days after receiving influenza vaccine. Her exam was significant for lower extremity pitting edema and hypertension. Her laboratory data revealed acute kidney injury (AKI) with serum creatinine (Scr) of 10.2. Her spot urine total protein to creatinine ratio (TP/CR) was 23. Serological workup was negative. She underwent kidney biopsy which showed stage 1 membranous nephropathy (MN) with acute interstitial nephritis (AIN). She was started on daily oral prednisolone (0.75 mg/kg) with tapering doses over the next two months. Her renal function normalised (Scr 0.9) five weeks later after initiation of oral prednisolone. Her spot urine TP/CR decreased to 1.3. After one week of completion of therapy, the patient was found to have elevated Scr of 2.3. Her spot urine TP/CR increased to 28. At this time, the patient underwent repeat kidney biopsy which showed MN with resolution of AIN. The patient was restarted on daily oral prednisone (0.75 mg/kg) which was tapered over the next 4 months. One month after initiation of oral prednisone, her Scr decreased to 0.9. Her spot urine TP/CR decreased to 0.2 upon completion of therapy. The patient continued to be in remission, six months after completion of oral corticosteroid therapy. The reporter concluded that abrupt onset of nephrotic syndrome after influenza vaccine was suggestive that there was activation of the immune system which was triggered by the vaccination. Based on the reporter's experience, a course of oral corticosteroid should be considered in patients who develop nephrotic syndrome with AKI after influenza vaccine.
Age: 60.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Tubulointerstitial nephritis, Urine protein/creatinine ratio increased
Clinical narrative: This literature report (initial receipt: 06-May-2011) concerns a 60-year old female patient. The patient had been refusing influenza vaccine in the past as her father died from Guillain-Barre syndrome after receiving influenza vaccination. On an unknown date the patient received influenza vaccine. The patient presented with a one week history of abrupt onset lower extremity edema which developed five days after receiving influenza vaccine. Her exam was significant for lower extremity pitting edema and hypertension. Her laboratory data revealed acute kidney injury (AKI) with serum creatinine (Scr) of 10.2. Her spot urine total protein to creatinine ratio (TP/CR) was 23. Serological workup was negative. She underwent kidney biopsy which showed stage 1 membranous nephropathy (MN) with acute interstitial nephritis (AIN). She was started on daily oral prednisolone (0.75 mg/kg) with tapering doses over the next two months. Her renal function normalised (Scr 0.9) five weeks later after initiation of oral prednisolone. Her spot urine TP/CR decreased to 1.3. After one week of completion of therapy, the patient was found to have elevated Scr of 2.3. Her spot urine TP/CR increased to 28. At this time, the patient underwent repeat kidney biopsy which showed MN with resolution of AIN. The patient was restarted on daily oral prednisone (0.75 mg/kg) which was tapered over the next 4 months. One month after initiation of oral prednisone, her Scr decreased to 0.9. Her spot urine TP/CR decreased to 0.2 upon completion of therapy. The patient continued to be in remission, six months after completion of oral corticosteroid therapy. The reporter concluded that abrupt onset of nephrotic syndrome after influenza vaccine was suggestive that there was activation of the immune system which was triggered by the vaccination. Based on the reporter's experience, a course of oral corticosteroid should be considered in patients who develop nephrotic syndrome with AKI after influenza vaccine.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Influenza like illness, Oedema peripheral
Clinical narrative: Vaccine Tdap (ADACEL) given in split dose with 0.25ml on 8-8-11 (R) deltoid & 0.25ml given on 8-9-11 (L) deltoid. No Rxn after each shot. Patient woke up on 8-11-11 with flu like sx and afternoon of same day (L) arm became red & swollen. Used BENADRYL and Ibuprofen.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Abdominal wall abscess, Appendiceal abscess, Appendicitis perforated
Clinical narrative: Information has been received from a registered nurse regarding her granddaughter who is a 18 year old patient with allergies to peanuts who on 18-JUL-2011 was vaccinated with a 0.5 ml dose of GARDASIL (Lot # not reported). Concomitant therapy included meningococcal A polysaccharide vaccine (manufacturer not reported). On 26-Jul-2011 (also reported as one week after receiving the first dose of GARDASIL in the administration series), the nurse reported that the patient developed stomach pain, low grade fever and constipation. The nurse reported one week later the patient went to a local emergency room on two separate occasions and on one visit the patient was given an enema. The patient was not admitted on either visits. The nurse reported that the patient visited her pediatrician and received no specific treatment. On 10-Aug-2011, the patient developed a 102 degrees Fahrenheit temperature and severe abdominal pain and went to the emergency room. She was admitted to the hospital with a 19,000 white blood cell count, and a CAT scan that showed a ruptured appendix with an "abscessed wall with appendiceal phlegmon." The patient had a complete blood cell count and an X-ray. The patient was treated with intravenous antibiotics and fluids. The patient's status at the time of the report was not recovered. Action taken in relation to therapy was not reported at the time of the report. Information received from a telephone call on 16-Aug-2011 with the nurse, who reported the patient's treatment with antibiotics had worked and her abscess was "cured" and that the patient should be home within the next couple of days. The reporter felt that the events of stomach pain, low grade fever, constipation, "went to a local emergency room on 2 separate occasions and on one visit was given on enema", 102 Fahrenheit temperature, severe abdominal pain, white blood cell count of 19,000, ruptured appendix with an abscessed wall with appendiceal phlegmon were disabling and life threatening. The reporting registered nurse contacted during telephone follow-up would not supply the patient's name, date of birth, lot number, and healthcare provider's name and contact information. No additional information provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram abnormal, Constipation, Enema administration, Full blood count, Pyrexia
Clinical narrative: Information has been received from a registered nurse regarding her granddaughter who is a 18 year old patient with allergies to peanuts who on 18-JUL-2011 was vaccinated with a 0.5 ml dose of GARDASIL (Lot # not reported). Concomitant therapy included meningococcal A polysaccharide vaccine (manufacturer not reported). On 26-Jul-2011 (also reported as one week after receiving the first dose of GARDASIL in the administration series), the nurse reported that the patient developed stomach pain, low grade fever and constipation. The nurse reported one week later the patient went to a local emergency room on two separate occasions and on one visit the patient was given an enema. The patient was not admitted on either visits. The nurse reported that the patient visited her pediatrician and received no specific treatment. On 10-Aug-2011, the patient developed a 102 degrees Fahrenheit temperature and severe abdominal pain and went to the emergency room. She was admitted to the hospital with a 19,000 white blood cell count, and a CAT scan that showed a ruptured appendix with an "abscessed wall with appendiceal phlegmon." The patient had a complete blood cell count and an X-ray. The patient was treated with intravenous antibiotics and fluids. The patient's status at the time of the report was not recovered. Action taken in relation to therapy was not reported at the time of the report. Information received from a telephone call on 16-Aug-2011 with the nurse, who reported the patient's treatment with antibiotics had worked and her abscess was "cured" and that the patient should be home within the next couple of days. The reporter felt that the events of stomach pain, low grade fever, constipation, "went to a local emergency room on 2 separate occasions and on one visit was given on enema", 102 Fahrenheit temperature, severe abdominal pain, white blood cell count of 19,000, ruptured appendix with an abscessed wall with appendiceal phlegmon were disabling and life threatening. The reporting registered nurse contacted during telephone follow-up would not supply the patient's name, date of birth, lot number, and healthcare provider's name and contact information. No additional information provided. Additional information has been requested.