chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female patient with hyperlipidaemia, osteopenia and rosacea, with no drug reactions or allergies who on 18-MAY-2010 received for the first time a 0.5 ml dose of PNEUMOVAX 23 IM ( lot number 665270/1398Y).  Concomitant medication included "many unnamed medications".  Nurse reported that the patient experienced redness, swelling and tenderness of the left arm with streaking to the breast.  On 20-MAY-2010, she was sent to the emergency room with diagnosis of cellulitis.  Patient started on oral AUGMENTIN.  The next day, she called the office stating the area was warm to touch and the redness was wider.  She was advised to return to the emergency room if symptoms became worse.  At the time of reporting, the patient had not recovered from cellulitis.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a patient with blood pressure check at the time of vaccination and no known allergies or medical conditions who on 15-MAR-2010 at 8:30 a.m. was vaccinated with a first dose of PNEUMOVAX 23 vaccine in the right arm (lot# 664476/1190Y).  On 16-MAR-2010 the patient experienced cellulitis.  The patient was treated with clindamycin for 7 days.  It was unknown if the patient sought medical attention.  Subsequently, the patient recovered from cellulitis.  No laboratory or diagnostic studies were performed.  A standard lot check investigation has been finalized.  All in-process quality checks for the lot number 664476/1190Y were satisfactory.  The lot met the requirements of the Research Center and was released.  This is one of several reports received from the same source.  Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not provided).  Subsequently the patient experienced an unspecified adverse event.  At the time of this report, the patient's outcome was unknown.  It was unknown if the patient sought medical attention.  Additional information has been requested.
Age: 1.91
Sex: F
Vaccine: MMR, MMR
Symptoms: Blood glucose, Catheter placement, Chest X-ray, Culture urine, Diarrhoea
Clinical narrative: I was woken up by patient shaking uncontrollably and crying beside me in bed. She began throwing up over and over and I called 911 for an ambulance right away. Later at her follow-up with RN, I was told her febrile seizure was probably due to the MMR shot since my daughter has had high fevers before with no previous history of seizures. Since this event, my daughter still has higher temperatures than she used to, unusual fussiness, and some muscle twitching.
Age: 1.91
Sex: F
Vaccine: MMR, MMR
Symptoms: Feeling hot, Pyrexia, Tremor, Urine analysis, Vomiting
Clinical narrative: I was woken up by patient shaking uncontrollably and crying beside me in bed. She began throwing up over and over and I called 911 for an ambulance right away. Later at her follow-up with RN, I was told her febrile seizure was probably due to the MMR shot since my daughter has had high fevers before with no previous history of seizures. Since this event, my daughter still has higher temperatures than she used to, unusual fussiness, and some muscle twitching.
Age: 1.91
Sex: F
Vaccine: MMR, MMR
Symptoms: Crying, Febrile convulsion, Irritability, Muscle twitching, Pyrexia
Clinical narrative: I was woken up by patient shaking uncontrollably and crying beside me in bed. She began throwing up over and over and I called 911 for an ambulance right away. Later at her follow-up with RN, I was told her febrile seizure was probably due to the MMR shot since my daughter has had high fevers before with no previous history of seizures. Since this event, my daughter still has higher temperatures than she used to, unusual fussiness, and some muscle twitching.
Age: 1.91
Sex: F
Vaccine: MMR, MMR
Symptoms: Tremor, Vomiting
Clinical narrative: I was woken up by patient shaking uncontrollably and crying beside me in bed. She began throwing up over and over and I called 911 for an ambulance right away. Later at her follow-up with RN, I was told her febrile seizure was probably due to the MMR shot since my daughter has had high fevers before with no previous history of seizures. Since this event, my daughter still has higher temperatures than she used to, unusual fussiness, and some muscle twitching.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: RIGHT LEG RED SPOT 1IN BY 3/4IN THEN SWOLLEN ALL AROUND AND HOT TO TOUCH.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Asthenia, Blood test, Immune system disorder, Injection site pain
Clinical narrative: On (09/24/2008) Dr. gave our daughter the Hep. A shot which is not required by the state to take. The doctor on the day of her annual physical check-up told us that she was "fine" and can play sports. A few days later she became weak, had stomach pain, and was losing a lot weight this leads us to believe that Hep. A caused this to happen. Still up to this day the right arm where the shot was injected causes her pain. We believe that this shot attack her organs and damaged her immune system resulting in her having mass, losing a part of her kidney, and undergo multiple treatments. At first we were told that this is curable but now a doctor has admitted to us that the cure rate is only twenty-five percent. She is now living day to day for survival.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Mass, Renal disorder, Weight decreased
Clinical narrative: On (09/24/2008) Dr. gave our daughter the Hep. A shot which is not required by the state to take. The doctor on the day of her annual physical check-up told us that she was "fine" and can play sports. A few days later she became weak, had stomach pain, and was losing a lot weight this leads us to believe that Hep. A caused this to happen. Still up to this day the right arm where the shot was injected causes her pain. We believe that this shot attack her organs and damaged her immune system resulting in her having mass, losing a part of her kidney, and undergo multiple treatments. At first we were told that this is curable but now a doctor has admitted to us that the cure rate is only twenty-five percent. She is now living day to day for survival.
Age: 1.02
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Pyrexia, Rash generalised, Urticaria
Clinical narrative: Persistent high fever lasting until present time. Hives on cheeks beginning 08/05/2010 at 6 PM lasting until present time. Also accompanied by rash on trunk, legs, feet and genitals.
Age: 0.17
Sex: F
Vaccine: DTAP, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Gaze palsy, Hypersomnia, Musculoskeletal stiffness, Pyrexia, Unresponsive to stimuli
Clinical narrative: Patient slept for the first 24 hours, ran a slight fever (all normal reactions). When she woke up, she began to cycle through episodes of shrieking, then like a light switch she would stop, and appear vacant and non-responsive. Her eyes glassed over. At one point (at about 5 pm) I was holding her and her body stiffened and shot upwards. I called my pediatrician and talked to Dr. who was on call. I assumed they had filed this report, but upon asking, they had not filed a VAERS.
Age: 0.17
Sex: F
Vaccine: DTAP, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Hypersomnia, Screaming, Staring, Vaccine positive rechallenge
Clinical narrative: Patient slept for the first 24 hours, ran a slight fever (all normal reactions). When she woke up, she began to cycle through episodes of shrieking, then like a light switch she would stop, and appear vacant and non-responsive. Her eyes glassed over. At one point (at about 5 pm) I was holding her and her body stiffened and shot upwards. I called my pediatrician and talked to Dr. who was on call. I assumed they had filed this report, but upon asking, they had not filed a VAERS.
Age: 0.34
Sex: F
Vaccine: DTAP, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Abnormal behaviour, Crying, Emotional distress, Fatigue, Gaze palsy
Clinical narrative: Patient became glassy eyed and pale. She was completely non-responsive. She lost muscle control in her body (like a ragdoll). This time I video taped her reaction. I decided to continue to vaccinate given the current whooping cough outbreak and because my pediatrician said there are no CDC reports of a child who had an adverse reaction having subsequent reactions to vaccines!!!!!!  She also said there are no reports of permanent damage, but since her vaccines she has lost skills, particularly motor-planning and imitation skills such as being able to stick her tongue out (motor planning and imitation). I can see that she tries to move her tongue inside her mouth but is no longer able to stick it out. She was doing this consistently before the vaccines. She is now waking up every 2 hours at night (previously woke up once at 4 am and 6:30 am and then slept until 9). Now will shriek and not be able to self-soothe and put herself back to sleep. She also is overly active and fussy. I can only describe it like she is driven by a motor for the past 5 days. Her heart beats fast and she literally pants out of exhaustion from kicking and moving. She no longer is consolable and pleasant. She cries most of her waking hours and seems unhappy. This is a different child than what she was before these vaccines. Dr. spent almost an hour with her and SAW what a pleasant happy baby she WAS!!!!
Age: 0.34
Sex: F
Vaccine: DTAP, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Heart rate increased, Hypotonia, Irritability, Pallor, Psychomotor skills impaired
Clinical narrative: Patient became glassy eyed and pale. She was completely non-responsive. She lost muscle control in her body (like a ragdoll). This time I video taped her reaction. I decided to continue to vaccinate given the current whooping cough outbreak and because my pediatrician said there are no CDC reports of a child who had an adverse reaction having subsequent reactions to vaccines!!!!!!  She also said there are no reports of permanent damage, but since her vaccines she has lost skills, particularly motor-planning and imitation skills such as being able to stick her tongue out (motor planning and imitation). I can see that she tries to move her tongue inside her mouth but is no longer able to stick it out. She was doing this consistently before the vaccines. She is now waking up every 2 hours at night (previously woke up once at 4 am and 6:30 am and then slept until 9). Now will shriek and not be able to self-soothe and put herself back to sleep. She also is overly active and fussy. I can only describe it like she is driven by a motor for the past 5 days. Her heart beats fast and she literally pants out of exhaustion from kicking and moving. She no longer is consolable and pleasant. She cries most of her waking hours and seems unhappy. This is a different child than what she was before these vaccines. Dr. spent almost an hour with her and SAW what a pleasant happy baby she WAS!!!!
Age: 0.34
Sex: F
Vaccine: DTAP, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Respiratory rate increased, Unresponsive to stimuli
Clinical narrative: Patient became glassy eyed and pale. She was completely non-responsive. She lost muscle control in her body (like a ragdoll). This time I video taped her reaction. I decided to continue to vaccinate given the current whooping cough outbreak and because my pediatrician said there are no CDC reports of a child who had an adverse reaction having subsequent reactions to vaccines!!!!!!  She also said there are no reports of permanent damage, but since her vaccines she has lost skills, particularly motor-planning and imitation skills such as being able to stick her tongue out (motor planning and imitation). I can see that she tries to move her tongue inside her mouth but is no longer able to stick it out. She was doing this consistently before the vaccines. She is now waking up every 2 hours at night (previously woke up once at 4 am and 6:30 am and then slept until 9). Now will shriek and not be able to self-soothe and put herself back to sleep. She also is overly active and fussy. I can only describe it like she is driven by a motor for the past 5 days. Her heart beats fast and she literally pants out of exhaustion from kicking and moving. She no longer is consolable and pleasant. She cries most of her waking hours and seems unhappy. This is a different child than what she was before these vaccines. Dr. spent almost an hour with her and SAW what a pleasant happy baby she WAS!!!!
Age: 0.34
Sex: F
Vaccine: DTAP, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Abnormal behaviour, Depressed mood, Drooling, Hypotonia, Psychomotor hyperactivity
Clinical narrative: Patient became glassy eyed and pale. She was completely non-responsive. She lost muscle control in her body (like a ragdoll). This time I video taped her reaction. I decided to continue to vaccinate given the current whooping cough outbreak and because my pediatrician said there are no CDC reports of a child who had an adverse reaction having subsequent reactions to vaccines!!!!!!  She also said there are no reports of permanent damage, but since her vaccines she has lost skills, particularly motor-planning and imitation skills such as being able to stick her tongue out (motor planning and imitation). I can see that she tries to move her tongue inside her mouth but is no longer able to stick it out. She was doing this consistently before the vaccines. She is now waking up every 2 hours at night (previously woke up once at 4 am and 6:30 am and then slept until 9). Now will shriek and not be able to self-soothe and put herself back to sleep. She also is overly active and fussy. I can only describe it like she is driven by a motor for the past 5 days. Her heart beats fast and she literally pants out of exhaustion from kicking and moving. She no longer is consolable and pleasant. She cries most of her waking hours and seems unhappy. This is a different child than what she was before these vaccines. Dr. spent almost an hour with her and SAW what a pleasant happy baby she WAS!!!!
Age: 0.34
Sex: F
Vaccine: DTAP, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Respiratory rate increased, Restlessness, Somnolence, Staring, Unresponsive to stimuli
Clinical narrative: Patient became glassy eyed and pale. She was completely non-responsive. She lost muscle control in her body (like a ragdoll). This time I video taped her reaction. I decided to continue to vaccinate given the current whooping cough outbreak and because my pediatrician said there are no CDC reports of a child who had an adverse reaction having subsequent reactions to vaccines!!!!!!  She also said there are no reports of permanent damage, but since her vaccines she has lost skills, particularly motor-planning and imitation skills such as being able to stick her tongue out (motor planning and imitation). I can see that she tries to move her tongue inside her mouth but is no longer able to stick it out. She was doing this consistently before the vaccines. She is now waking up every 2 hours at night (previously woke up once at 4 am and 6:30 am and then slept until 9). Now will shriek and not be able to self-soothe and put herself back to sleep. She also is overly active and fussy. I can only describe it like she is driven by a motor for the past 5 days. Her heart beats fast and she literally pants out of exhaustion from kicking and moving. She no longer is consolable and pleasant. She cries most of her waking hours and seems unhappy. This is a different child than what she was before these vaccines. Dr. spent almost an hour with her and SAW what a pleasant happy baby she WAS!!!!
Age: 15.0
Sex: F
Vaccine: DTOX, UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Both arms at injection sites became very swollen, red, hot to the touch, and painful.
Age: 32.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Arthralgia, Balance disorder, Blood test, Fatigue, Gait disturbance
Clinical narrative: My fingers have reduced feeling and complete numbness all of the time.  Hands, forearm, bicep and shoulder are weak intermittently.  Weakness in hands and legs. Balance is off quite a bit. Buckling at the knees in both legs. Intermittently have intense pain and pressure in the joints of my fingers. Have much difficulty traveling up or down stairs. General fatigue.  Cannot follow my normal exercise regimen at all.  Saw primary care physician and was referred to a neurologist to follow up with the next day. Neurologist conducted several tests.  Latest blood work showed inflammation.  It has been 6 weeks and my symptoms have not yet improved.
Age: 32.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Hypoaesthesia, Inflammation, Muscular weakness, Nerve conduction studies
Clinical narrative: My fingers have reduced feeling and complete numbness all of the time.  Hands, forearm, bicep and shoulder are weak intermittently.  Weakness in hands and legs. Balance is off quite a bit. Buckling at the knees in both legs. Intermittently have intense pain and pressure in the joints of my fingers. Have much difficulty traveling up or down stairs. General fatigue.  Cannot follow my normal exercise regimen at all.  Saw primary care physician and was referred to a neurologist to follow up with the next day. Neurologist conducted several tests.  Latest blood work showed inflammation.  It has been 6 weeks and my symptoms have not yet improved.
Age: 77.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Abasia, Dysstasia, Glossodynia, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: The following paragraphs will outline an adverse reaction, Guillain Barre Syndrome, which my husband has following an H1N1 vaccination received at your clinic.   On June 23, 2010 at 12:30.  My husband had an appointment with Dr. and received the H1N1 vaccination. Shortly after receiving the vaccination he began feeling ill with pain and numbness in his hands and feet and tongue.  He returned to the clinic on July 14th and saw a chiropractor at 9:00 am.  The chiropractor instructed him to see a neurologist.  He was informed that a Cat Scan would be scheduled but no appointment date was given, nor has there been any follow up from the clinic. Patient tried to schedule an appointment on the 15th but was denied, so he went to Urgent Care.  His illness was progressing and the pain was getting worse as well as the numbness.  Dr. prescribed him Vicodin and Soma and he returned home. On July 16th, my husband phoned Dr. as the prescriptions gave him no relief and his illness was progressing.  Dr. instructed patient to go to the ER.   Since that time my husband has been to the ER twice, once on the 16th and a second time the 18th when he was finally admitted and diagnosed with Guillain Barre Syndrome.  He was hospitalized until July 27th when he was transferred to Rehab where his still is today.  He is improving slowly and receives help from a speech therapist and physical therapist.  He can not yet walk, but is talking and beginning to stand.
Age: 77.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia oral, Malaise, Pain in extremity, Speech disorder
Clinical narrative: The following paragraphs will outline an adverse reaction, Guillain Barre Syndrome, which my husband has following an H1N1 vaccination received at your clinic.   On June 23, 2010 at 12:30.  My husband had an appointment with Dr. and received the H1N1 vaccination. Shortly after receiving the vaccination he began feeling ill with pain and numbness in his hands and feet and tongue.  He returned to the clinic on July 14th and saw a chiropractor at 9:00 am.  The chiropractor instructed him to see a neurologist.  He was informed that a Cat Scan would be scheduled but no appointment date was given, nor has there been any follow up from the clinic. Patient tried to schedule an appointment on the 15th but was denied, so he went to Urgent Care.  His illness was progressing and the pain was getting worse as well as the numbness.  Dr. prescribed him Vicodin and Soma and he returned home. On July 16th, my husband phoned Dr. as the prescriptions gave him no relief and his illness was progressing.  Dr. instructed patient to go to the ER.   Since that time my husband has been to the ER twice, once on the 16th and a second time the 18th when he was finally admitted and diagnosed with Guillain Barre Syndrome.  He was hospitalized until July 27th when he was transferred to Rehab where his still is today.  He is improving slowly and receives help from a speech therapist and physical therapist.  He can not yet walk, but is talking and beginning to stand.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site inflammation
Clinical narrative: 7/8 cm of inflammation noted to LAT.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: 7/8 cm of inflammation/swelling (L) upper thigh both anterior and lateral aspect.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood culture positive, Electroencephalogram normal, Muscle twitching, Nuclear magnetic resonance imaging normal, Pyrexia
Clinical narrative: Pt developed fever and had left arm twitching in the evening of 8/1/2010.  He was admitted to the hospital the next day to r/o partial complex seizure with fever.  Initial blood cx positive but was determined to be a contaminant.  He was discharged from hospital on 8/7/2010.  He had no seizure -like events in hospital and appeared well the entire time.  MRI and EEG were normal.  Repeat Blood cx negative and he defervesced.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Member states that he had the following symptoms on/off for two weeks:  High fever, headaches, nausea, vomiting, minimal current erythema to arm.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Alopecia
Clinical narrative: Member states he has recently noticed his hair is falling out.
Age: 1.03
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Slight skin rash on belly.  30 minutes later, developed into hives on belly, legs and face.
Age: 5.0
Sex: F
Vaccine: UNK, DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The following day after vaccine, pt. developed large amount of swelling, erythema and pain at site. Now this is subsiding.
Age: 14.0
Sex: M
Vaccine: DTAP, HPV4, MNQ, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient received MENACTRA, DTAP and HPV vaccinations. He fainted promptly afterwards and struck his (L) frontal orbital area of face, causing bruising, regained consciousness within 2 minutes after fainting, but continued headache and lethargy and felt faint again when sitting up. Paramedics were called for transport to E.R.
Age: 14.0
Sex: M
Vaccine: DTAP, HPV4, MNQ, HPV4, MNQ, TDAP
Symptoms: Contusion, Dizziness, Face injury, Headache, Immediate post-injection reaction
Clinical narrative: Patient received MENACTRA, DTAP and HPV vaccinations. He fainted promptly afterwards and struck his (L) frontal orbital area of face, causing bruising, regained consciousness within 2 minutes after fainting, but continued headache and lethargy and felt faint again when sitting up. Paramedics were called for transport to E.R.
Age: 14.0
Sex: M
Vaccine: DTAP, HPV4, MNQ, HPV4, MNQ, TDAP
Symptoms: Lethargy, Syncope
Clinical narrative: Patient received MENACTRA, DTAP and HPV vaccinations. He fainted promptly afterwards and struck his (L) frontal orbital area of face, causing bruising, regained consciousness within 2 minutes after fainting, but continued headache and lethargy and felt faint again when sitting up. Paramedics were called for transport to E.R.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Immediate post-injection reaction, Tonic clonic movements, Urinary incontinence, Vomiting
Clinical narrative: Immediately post vaccine pt slumped to floor, had tonic clonic movement of arms and legs and was incontinent of urine - After 10 minutes she had improved somewhat but upon trying to ambulate she vomited x 2.  She was then transported to the ER by ambulance.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Patient reported localized inflammation around injection site described as red and warm, but not painful. This occurred 2-3 days following administration of a ZOSTAVAX immunization.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Rash
Clinical narrative: Redness around injection site. Rash on stomach and upper thighs.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Convulsion, Pyrexia
Clinical narrative: Child had a fever of 100 to 100.6 after vaccines. At 430 am child had a seizure and was taken to the ER.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Fever and large amount of swelling to injection site.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Back pain, Heart rate decreased, Hyperhidrosis, Pallor, Sensation of heaviness
Clinical narrative: Became diaphoretic and pale, pulse rate 50 pt reclined, examined by MD. BP 100/62 Pulse-68 @ 3:25 pm. Oral fluids given. Patient states she had not eaten this day-12 oz Pedialyte, glucose tab 4 gm x 2 given. No further diaphoresis 4:35 pm c/o heaviness in left arm & mid thoracic back pain 4:45 pm BP 110/80 Pulse 72
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Blood test normal, Borrelia test negative, Fatigue, Headache, Inflammation
Clinical narrative: Symptoms: Stiff neck, severe headache, fever of 101.4, fatigue.  Treatment: Outpatient ER Visit for 2 IV's and Toradol for pain and inflammation.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Musculoskeletal stiffness, Pain, Pyrexia, Urine analysis normal
Clinical narrative: Symptoms: Stiff neck, severe headache, fever of 101.4, fatigue.  Treatment: Outpatient ER Visit for 2 IV's and Toradol for pain and inflammation.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 5 x 4 cm erythema surrounding injection site some swelling. Non tender, not warm left vastus lateralis.
Age: 0.53
Sex: F
Vaccine: HEP, HIBV, IPV, PNC13
Symptoms: Dyskinesia, Pallor, Similar reaction on previous exposure to drug
Clinical narrative: Mom described child had jerky movements on left side of body. No fever. No breathing difficulties. Child became pale 24 hours after administration of PREVNAR 13, HBV, HIB. DTAP withheld because of similar reaction at 4 months of age. Possible family hx of seizure disorder in mother and maternal grandmother.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Blood culture, Full blood count normal, Hyperpyrexia, Urine analysis, Urine analysis normal
Clinical narrative: Hyperpyrexia (102.4) 12-18 hrs post admin 2 mo vaccines including Rotavirus.
Age: 1.31
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Condition aggravated, Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizures (he does have hx) fever x 2 days max 103.5 sz x 1 min.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, HIV infection, Pyrexia, Vomiting
Clinical narrative: Pt. states had fever to touch, vomiting and diarrhea X 3 days. Pt states took "anti-diarrhea" medication.
Age: 0.24
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Wrong drug administered
Clinical narrative: Mother brought her 2 mth daughter into Clinic for immunizations - nurse, administered the vaccines one of which was a HIBERIX (a brand of HIB authorized for the booster dose only).
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Wrong drug administered
Clinical narrative: Mom brought her 2 mth old son for immunizations at clinic. Nurse administered the vaccines, one of which was a HIBERIX (a brand of HIB authorized for the booster dose only).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Hard red area swollen. Mother took pt. to ER, since reaction happen on Saturday. ER doctor prescribed steroid and BENADRYL.
Age: 67.0
Sex: F
Vaccine: DT, PPV
Symptoms: Erythema, Fluid retention, Immediate post-injection reaction, Pain, Pruritus
Clinical narrative: Pain, swelling, redness and itching immediately after received it. "Pooling of fluid", left arm.  Any outdoor air made it worse.  (Saw Dr. several weeks after). May 2010 - pain, swelling, redness and itching continues. Consulted MD once again.
Age: 67.0
Sex: F
Vaccine: DT, PPV
Symptoms: Sensory disturbance, Swelling
Clinical narrative: Pain, swelling, redness and itching immediately after received it. "Pooling of fluid", left arm.  Any outdoor air made it worse.  (Saw Dr. several weeks after). May 2010 - pain, swelling, redness and itching continues. Consulted MD once again.
Age: 73.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt presented to center with c/o redness, soreness (R) deltoid/arm.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Patient seen for cellulitis due to a laceration on his L forearm that occurred approx 1 week earlier on 8/2/2010. Patient's last TD was 9 years ago, therefore the ADACEL was administered in his L deltoid. Patient was also given a 2 scripts, 1) BACTROBAN to apply to the affected area TID 2) ZITHROMAX (Z-Pak) use as directed. Patient was seen 8/3 due to a c/o of low-grade fever and generalized achiness that started the evening before. Patient was taking SAVELLA for his fibromyalgia that he discontinued 2 days earlier due to GI upset. Patient temp today is 100 degrees F. Cellulitis has improved. Z-pak was discontinued. Patient is to call with status in 24hrs and go to the ED if symptoms worsen, patient voiced understanding.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: 7CM X 7CM SHOT REACTION SWOLLEN AND HOT TO TOUCH, RED RIGHT TIGHT. STARTED FRI NIGHT.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Agitation, Generalised erythema, Heart rate increased, Pulse abnormal
Clinical narrative: Generalised body redness, fast and thready pulse and agitation I/M epi pen Jr stat Benadryl 12.5mg  Prednisone 1mg/kg Symptoms resolved within 3 hours, patient returned to baseline and has been stable
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Left leg is red and hard, about the size of baseball.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling hot, Headache, Influenza like illness, Injection site rash, Nausea
Clinical narrative: Mom called and said pt. got Tdap here (clinic) yesterday about 3p. Almost 1 hr. later pt. c/o heaviness in legs, achiness, headache, pain in back neck, hands, feet, nausea- no vomiting, feels hot, claw marks on legs- no itching- Around noon today pt. said head, neck, back, hurt the most. Fever elevated 101.6- advised mom to take child to ER. About 6p yesterday mom took pt. to ER- no test done. They gave 1 dose of steroids in ER. Told mom to continue Benadryl, Tylenol, Motrin. Mom was told it was an allergy to something, had flu like symptoms, red bumps about 1-2 1/2 inches in diameter at inj. site.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain, Pain in extremity, Pyrexia, Sensation of heaviness
Clinical narrative: Mom called and said pt. got Tdap here (clinic) yesterday about 3p. Almost 1 hr. later pt. c/o heaviness in legs, achiness, headache, pain in back neck, hands, feet, nausea- no vomiting, feels hot, claw marks on legs- no itching- Around noon today pt. said head, neck, back, hurt the most. Fever elevated 101.6- advised mom to take child to ER. About 6p yesterday mom took pt. to ER- no test done. They gave 1 dose of steroids in ER. Told mom to continue Benadryl, Tylenol, Motrin. Mom was told it was an allergy to something, had flu like symptoms, red bumps about 1-2 1/2 inches in diameter at inj. site.
Age: 9.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, Unevaluable event
Clinical narrative: Pt, given KINRIX at age 9 yrs (licensed for 4-6 y.o.).
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix abnormal, Cervical dysplasia, Colposcopy abnormal, Papilloma viral infection, Precancerous cells present
Clinical narrative: Information has been received from a physician concerning a 22 year old female with allergic reaction to CECLOR, tetracycline, penicillin and sulfa who on 09-AUG-2007 was vaccinated with the first dose of GARDASIL (0.5ml, IM), the second dose (0.5ml, IM) was on 06-DEC-2007 and the date of third dose (0.5ml, IM) was unknown. Concomitant therapy included unspecified "birth control" medication. In July 2010 PAP results indicated the patient had high risk HPV. The patient had a colposcopy and biopsy and the results that showed high dysplasia and severe dysplasia. The patient's results showed "precancerous". the patient had routine office visit and would have surgery in the office. The patient had not recovered at time of report. High risk HPV and precancerous dysplasia were considered to be other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 22 year old female with allergic reaction to CECLOR, tetracycline, penicillin and sulfa who on 09-AUG-2007 was vaccinated with the first dose of GARDASIL (0.5ml, IM), the second dose (0.5ml, IM) was on 06-DEC-2007 and the date of third dose (0.5ml, IM) was unknown. Concomitant therapy included unspecified "birth control" medication. In July 2010 PAP results indicated the patient had high risk HPV. The patient had a colposcopy and biopsy and the results that showed high dysplasia and severe dysplasia. The patient's results showed "precancerous". the patient had routine office visit and would have surgery in the office. The patient had not recovered at time of report. High risk HPV and precancerous dysplasia were considered to be other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning an 18 year old female patient who on an unspecified date was vaccinated in the arm with a second dose of GARDASIL (lot number not provided). The nurse reported that on 23-JUL-2010 the patient passed out and suffered a chronic seizure. On an unspecified date the patient recovered. The patient sought unspecified medical attention. The reporting physician considered the chronic seizure to be an other important medical event. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Erythema of immunization area with (Right thigh) warmth and mild soreness.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Erythema of immunization area (right thigh) with warmth and mild soreness.
Sex: F
Vaccine: VARZOS
Symptoms: Leukaemia
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # unknown) prior to learning the patient had leukemia. Upon internal review, Leukemia was considered to be another important medical event. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Viral titre
Clinical narrative: Information has been received from a consumer, concerning her 13 year old daughter, who in December 1998, was vaccinated with the first dose of VARIVAX (Merck) (Lot # unknown). The patient's mother reported that her daughter "was not immune to chickenpox" after receiving one dose of VARIVAX (Merck) based on an "recent" titer. The mother stated that pediatrician informed that children were getting chickenpox despite having two doses of VARIVAX (Merck) (Waes # 1008USA00530). No immune to chickenpox was considered to be disabling. The patient sought unspecified medical attention. This is one of several reports received from the same source. No further information is available.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Vaccine had expired by 8 days, no reaction noted.
Age: 0.51
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: 2 1/2 X 2 1/2 inch raised area left deltoid.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Blood test, Condition aggravated, Gout, Immune system disorder, Influenza
Clinical narrative: Subject reports that he is frequently sick and feels like he may have a compromised immune system since 2007. He recently (July 2010) had flu symptoms and was taking Doxycycline. The subject reports that he has gout in both feet since 2006. He was recently in the hospital ER for pain in his feet (subject reports the pain in his feet began in 2006 as well). He was given TORADOL IM and was prescribed indomethacin 50mg every 8 hours for the gout symptoms. He has pain in his shoulder (which began in 2002 during push-ups), knees (since 2002) and back (since 1997). He had surgery on his right shoulder at the hospital in December 2009 for a torn rotator cuff and biceps tendon tear. He reports hospitalization for one day. He reportedly has patellofemoral syndrome which began in 2002 and was taking CELEBREX for a while. The subject reports that he has plantar fasciitis in both feet (since 2001), tendonitis in his left elbow (since 2001), and a herniated disc at L4-L5 (since 1997). The subject states that he takes TYLENOL, FLEXARIL, Ibuprofen and VICODIN for the pain in his shoulder, back and knees. The subject states he was physically active during his time in the military. He does not have a history of participating in sports during school or as an adult.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Malaise, Pain in extremity, Rotator cuff syndrome, Shoulder operation, Tendon rupture
Clinical narrative: Subject reports that he is frequently sick and feels like he may have a compromised immune system since 2007. He recently (July 2010) had flu symptoms and was taking Doxycycline. The subject reports that he has gout in both feet since 2006. He was recently in the hospital ER for pain in his feet (subject reports the pain in his feet began in 2006 as well). He was given TORADOL IM and was prescribed indomethacin 50mg every 8 hours for the gout symptoms. He has pain in his shoulder (which began in 2002 during push-ups), knees (since 2002) and back (since 1997). He had surgery on his right shoulder at the hospital in December 2009 for a torn rotator cuff and biceps tendon tear. He reports hospitalization for one day. He reportedly has patellofemoral syndrome which began in 2002 and was taking CELEBREX for a while. The subject reports that he has plantar fasciitis in both feet (since 2001), tendonitis in his left elbow (since 2001), and a herniated disc at L4-L5 (since 1997). The subject states that he takes TYLENOL, FLEXARIL, Ibuprofen and VICODIN for the pain in his shoulder, back and knees. The subject states he was physically active during his time in the military. He does not have a history of participating in sports during school or as an adult.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: X-ray
Clinical narrative: Subject reports that he is frequently sick and feels like he may have a compromised immune system since 2007. He recently (July 2010) had flu symptoms and was taking Doxycycline. The subject reports that he has gout in both feet since 2006. He was recently in the hospital ER for pain in his feet (subject reports the pain in his feet began in 2006 as well). He was given TORADOL IM and was prescribed indomethacin 50mg every 8 hours for the gout symptoms. He has pain in his shoulder (which began in 2002 during push-ups), knees (since 2002) and back (since 1997). He had surgery on his right shoulder at the hospital in December 2009 for a torn rotator cuff and biceps tendon tear. He reports hospitalization for one day. He reportedly has patellofemoral syndrome which began in 2002 and was taking CELEBREX for a while. The subject reports that he has plantar fasciitis in both feet (since 2001), tendonitis in his left elbow (since 2001), and a herniated disc at L4-L5 (since 1997). The subject states that he takes TYLENOL, FLEXARIL, Ibuprofen and VICODIN for the pain in his shoulder, back and knees. The subject states he was physically active during his time in the military. He does not have a history of participating in sports during school or as an adult.
Age: 33.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Alpha 1 foetoprotein, Drug exposure during pregnancy, Premature labour, Premature rupture of membranes, Twin pregnancy
Clinical narrative: Information has been received from a medical assistant on 27-JUL-2010. A 33 year old pregnant female (twin gestation with EDD: 23-DEC-2009) was vaccinated with single dose of flu vaccine (manufacturer unknown) at 17 weeks gestation on 15-SEP-2009. At that time, alpha feto protein was drawn (no results provided). On 12-OCT-2009, the pregnant female experienced pre-term, pre-labor rupture of membranes (twins) at 29 weeks gestation. Specific outcomes were not reported. On 24-NOV-2009, the patient received the H1N1 shot. This case was originally reported to Merck (case# 0909USA01988). Additional information has been requested. The company considered event serious due to medical significance. The company considered event 'pre-term, pre-labor rupture of membrane (twins) at 29 weeks gestation' possibly related to Flu shot, however the brand name is unknown. Information derived from this AE report does not change the current safety profile of the product.
Age: 33.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Alpha 1 foetoprotein, Drug exposure during pregnancy, Premature labour, Premature rupture of membranes
Clinical narrative: Information has been received from a medical assistant on 27-JUL-2010. A 33 year old pregnant female (twin gestation with EDD: 23-DEC-2009) was vaccinated with single dose of flu vaccine (manufacturer unknown) at 17 weeks gestation on 15-SEP-2009. At that time, alpha feto protein was drawn (no results provided). On 12-OCT-2009, the pregnant female experienced pre-term, pre-labor rupture of membranes (twins) at 29 weeks gestation. Specific outcomes were not reported. On 24-NOV-2009, the patient received the H1N1 shot. This case was originally reported to Merck (case# 0909USA01988). Additional information has been requested. The company considered event serious due to medical significance. The company considered event 'pre-term, pre-labor rupture of membrane (twins) at 29 weeks gestation' possibly related to Flu shot, however the brand name is unknown. Information derived from this AE report does not change the current safety profile of the product.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who developed cellulitis. The patient received a dose on an unspecified date. On an unknown date, the patient developed cellulitis. The outcome was not specified. No additional information was available at the time of this report.
Age: 17.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Blood pressure decreased, Pallor, Unresponsive to stimuli
Clinical narrative: 10:55 vaccines administered - 11:00 Pt stated "I'm going to pass out. 11:01 pt out unresponsive, moved from chair to floor, elevated legs, B/P 68/40 pulse 48, EMS called, very pale. 11:05 BP: 98/62, repirations 26, responsive, alert, oriented, EMS arrived 11:18 B/P 104/78 11:30 left clinic via personal car with mother.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Pallor, Tremor
Clinical narrative: 1400 - HPV (GARDASIL administered), 1415 Pt reported shaking and sweating, tremors noted, skin pale, sweating noted.  EMS called by RN.  Pt. remains alert and oriented.  1440 Pt transported to Medical Center via ambulance.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Mild tenderness LAT and pain.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Malaise, Pyrexia
Clinical narrative: Intense pain at injection site!! Malaise, fever to 102 debility > 24 hrs.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, pain across anterior thigh, dusky coloring at vaccination site.
Age: 3.0
Sex: F
Vaccine: FLUN3, PNC13
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Tennis ball size inflammation/swelling at injection site.
Age: 45.0
Sex: U
Vaccine: HEP
Symptoms: Abdominal discomfort, Chills, Cold sweat, Diarrhoea, Dizziness
Clinical narrative: Lightheaded, sick to stomach. Later on the day had chills, fever, cold sweats, vomiting, diarrhea, hard time breathing. Was to sick to go to work.
Age: 45.0
Sex: U
Vaccine: HEP
Symptoms: Dyspnoea, Impaired work ability, Pyrexia, Vomiting
Clinical narrative: Lightheaded, sick to stomach. Later on the day had chills, fever, cold sweats, vomiting, diarrhea, hard time breathing. Was to sick to go to work.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Blister, Discomfort, Erythema, Swelling
Clinical narrative: #2 Varicella vaccine given SQ RA. 7/27/10 client presented to HD with 3" x 4" circular swelling with approx. 2" erythema/blistering in center. Discomfort only with palpation - Advised local reaction - use cool compress/TYLENOL/MOTRIN/BENADRYL. To return if not better 48 hours.
Age: 11.0
Sex: M
Vaccine: FLU(H1N1), HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Client received HPV and H1N1 about 1:30p.m. He was sitting up in a chair as per protocol after shots and was observed with his head down, not responding to verbal commands. He was assisted to the floor. VS WNL. He responded to command to squeeze hand, but could not open eyes or raise hand. O2 2L/NC applied. ? and arrived at 1:42p.m. Client then opened his eyes and became responsive. He left with his mother - no hospitalization.
Age: 1.03
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever 103F onset 08/08/2010. T 103F 08/9/2010.
Age: 25.0
Sex: F
Vaccine: YF
Symptoms: Abdominal pain, Blister, Chills, Dizziness, Erythema
Clinical narrative: 8/4/10 Fever, chills, myalgia, blisters on fingers, some swelling x 6 days; woke up Sunday with abd. pain in middle of the night, felt like was going to pass out. Red, painful lines on left upper ext.
Age: 25.0
Sex: F
Vaccine: YF
Symptoms: Myalgia, Pain in extremity, Pyrexia, Swelling
Clinical narrative: 8/4/10 Fever, chills, myalgia, blisters on fingers, some swelling x 6 days; woke up Sunday with abd. pain in middle of the night, felt like was going to pass out. Red, painful lines on left upper ext.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Urticaria
Clinical narrative: Patient noticed a hive like outbreak in left armpit.  Denies itchy, pain, no fevers.  Area was warm to touch.
Age: 2.0
Sex: M
Vaccine: FLUN3, PNC13
Symptoms: Injected limb mobility decreased, Injection site swelling, Irritability
Clinical narrative: Vaccine administered Thursday - Friday became very fussy and Saturday morning mother removed pajamas and noticed leg swollen from knee to groin and unable to bend leg - parents out of town and called clinic.  Sxs resolved by Monday.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh swelling and redness at the site felt warm.