chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: DTAP, FLUX, HPVX, MEN, DTAP, FLUX, HPVX, MEN
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reporting systems (VAERS ID: 683516) on May-2017 was reported by other non-healthcare professional and concerns a 11-year-old male patient. The patient's current condition included mild cold. Administration of Company suspect drug: On 20-Feb-2016, the patient was administered with influenza virus vaccine polyvalent, (anatomical location: right arm, dose, route of administration, batch number, expiration date: not reported). Indication was not reported. Administration of non company suspect drug: On 20-Feb-2016, the patient was administered with Dtap (anatomical location: left arm, dose, route of administration, batch number, expiration date: not reported). Indication was not reported. On 20-Feb-2016, the patient was administered with Papillomavirus vaccines, (anatomical location: right arm, dose, route of administration, batch number, expiration date: not reported). Indication was not reported. On 20-Feb-2016, the patient was administered with Meningococcal vaccine, (anatomical location: left arm, dose, route of administration, batch number, expiration date: not reported). Indication was not reported. Adverse events/reactions and outcomes: On 20-Feb-2016, after administration of influenza virus vaccine polyvalent, the patient experienced large red raised welt that is hot to touch at injection site on the left side extending through about half the length of top portion of the arm. And characterised by vaccine administered at inappropriate site. Treatment medication: The patient's treatment medication included antibiotics. Action taken with influenza virus vaccine polyvalent was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality between influenza virus vaccine polyvalent and event. This case report was non serious.
Age: 11.0
Sex: M
Vaccine: DTAP, FLUX, HPVX, MEN, DTAP, FLUX, HPVX, MEN
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reporting systems (VAERS ID: 683516) on May-2017 was reported by other non-healthcare professional and concerns a 11-year-old male patient. The patient's current condition included mild cold. Administration of Company suspect drug: On 20-Feb-2016, the patient was administered with influenza virus vaccine polyvalent, (anatomical location: right arm, dose, route of administration, batch number, expiration date: not reported). Indication was not reported. Administration of non company suspect drug: On 20-Feb-2016, the patient was administered with Dtap (anatomical location: left arm, dose, route of administration, batch number, expiration date: not reported). Indication was not reported. On 20-Feb-2016, the patient was administered with Papillomavirus vaccines, (anatomical location: right arm, dose, route of administration, batch number, expiration date: not reported). Indication was not reported. On 20-Feb-2016, the patient was administered with Meningococcal vaccine, (anatomical location: left arm, dose, route of administration, batch number, expiration date: not reported). Indication was not reported. Adverse events/reactions and outcomes: On 20-Feb-2016, after administration of influenza virus vaccine polyvalent, the patient experienced large red raised welt that is hot to touch at injection site on the left side extending through about half the length of top portion of the arm. And characterised by vaccine administered at inappropriate site. Treatment medication: The patient's treatment medication included antibiotics. Action taken with influenza virus vaccine polyvalent was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality between influenza virus vaccine polyvalent and event. This case report was non serious.
Age: 42.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Blood test, Dysstasia, Hyperhidrosis, Hypopnoea, Laboratory test
Clinical narrative: Between 5-7 hrs after the influenza shot was administered-my left leg started to go paralyzed, I was unable to walk, couldn't breathe, I was shaking profusely. My husband carried me to the car and went to emergency (hospital).
Age: 42.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Mobility decreased, Paralysis, Tremor
Clinical narrative: Between 5-7 hrs after the influenza shot was administered-my left leg started to go paralyzed, I was unable to walk, couldn't breathe, I was shaking profusely. My husband carried me to the car and went to emergency (hospital).
Age: 42.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Abasia, Dyspnoea, Monoplegia, Tremor
Clinical narrative: Between 5-7 hrs after the influenza shot was administered-my left leg started to go paralyzed, I was unable to walk, couldn't breathe, I was shaking profusely. My husband carried me to the car and went to emergency (hospital).
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, HPV9, MENB
Symptoms: Body temperature increased, Fatigue, Haemoglobin decreased, Pain, Pyrexia
Clinical narrative: Pt presented to clinic with fever, chills, generalized body ache, fatigue. Pt advised to go to ER.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, HPV9, MENB
Symptoms: White blood cell count increased
Clinical narrative: Pt presented to clinic with fever, chills, generalized body ache, fatigue. Pt advised to go to ER.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, HPV9, MENB
Symptoms: Chills, Fatigue, Full blood count, Pain, Pyrexia
Clinical narrative: Pt presented to clinic with fever, chills, generalized body ache, fatigue. Pt advised to go to ER.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Bone pain, Chills, Extra dose administered, Haemoptysis
Clinical narrative: Pt called today, 6/19/17, and was complaining of the follow symptoms: fever, chills, head-ache, joint and muscles pain, blood in phlegm in AM, lumps on top of head, 4-5 small, painful, and feet and toes are red.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Headache, Mass, Myalgia, Pain, Pyrexia
Clinical narrative: Pt called today, 6/19/17, and was complaining of the follow symptoms: fever, chills, head-ache, joint and muscles pain, blood in phlegm in AM, lumps on top of head, 4-5 small, painful, and feet and toes are red.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Chills, Erythema, Haemoptysis, Headache
Clinical narrative: Pt called today, 6/19/17, and was complaining of the follow symptoms: fever, chills, head-ache, joint and muscles pain, blood in phlegm in AM, lumps on top of head, 4-5 small, painful, and feet and toes are red.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Mass, Myalgia, Productive cough, Pyrexia
Clinical narrative: Pt called today, 6/19/17, and was complaining of the follow symptoms: fever, chills, head-ache, joint and muscles pain, blood in phlegm in AM, lumps on top of head, 4-5 small, painful, and feet and toes are red.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Injection site reaction, Pruritus, Skin warm
Clinical narrative: Vaccine given in left arm. Arm became warm and red. The redness spread further down her arm over 5 days when she reported on 6/20/17. Her arm was visibly red and swollen. Also itchy/warm.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Vaccine given in left arm. Arm became warm and red. The redness spread further down her arm over 5 days when she reported on 6/20/17. Her arm was visibly red and swollen. Also itchy/warm.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pruritus, Injection site swelling, Injection site warmth, Lethargy
Clinical narrative: Pain in left arm at site of vaccine. A half dollar sized knot and swelling at site noted by evening. Lethargy noted same night. Itching and warmness at site noticed on 6/28/2017. All symptoms continuing at time of reporting at 11pm 6/28/2017.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site pain
Clinical narrative: Pain in left arm at site of vaccine. A half dollar sized knot and swelling at site noted by evening. Lethargy noted same night. Itching and warmness at site noticed on 6/28/2017. All symptoms continuing at time of reporting at 11pm 6/28/2017.
Age: 1.58
Sex: M
Vaccine: DTAP, DTAP, DTAP
Symptoms: Autopsy, Death, Laboratory test normal, Lethargy, Pathology test
Clinical narrative: My son received his 4th DTAP vaccine on 4/25/17 and within 24 hours developed cold like symptoms...this was very common after almost all vaccines...but never related it to vaccine injury until now...on 05/07/17 he developed a fever and was very lethargic...on 05/08/17 he seemed to be completely back to himself...on 05/12/17 I found him in his crib at 08:30 AM...he passed away that prior evening...
Age: 1.58
Sex: M
Vaccine: DTAP, DTAP, DTAP
Symptoms: Pyrexia, Sudden death, Viral upper respiratory tract infection
Clinical narrative: My son received his 4th DTAP vaccine on 4/25/17 and within 24 hours developed cold like symptoms...this was very common after almost all vaccines...but never related it to vaccine injury until now...on 05/07/17 he developed a fever and was very lethargic...on 05/08/17 he seemed to be completely back to himself...on 05/12/17 I found him in his crib at 08:30 AM...he passed away that prior evening...
Age: 1.58
Sex: M
Vaccine: DTAP, DTAP, DTAP
Symptoms: Abnormal behaviour, Death, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: My son received his 4th DTAP vaccine on 4/25/17 and within 24 hours developed cold like symptoms...this was very common after almost all vaccines...but never related it to vaccine injury until now...on 05/07/17 he developed a fever and was very lethargic...on 05/08/17 he seemed to be completely back to himself...on 05/12/17 I found him in his crib at 08:30 AM...he passed away that prior evening...
Age: 1.58
Sex: M
Vaccine: DTAP, DTAP, DTAP
Symptoms: Unresponsive to stimuli, Viral upper respiratory tract infection
Clinical narrative: My son received his 4th DTAP vaccine on 4/25/17 and within 24 hours developed cold like symptoms...this was very common after almost all vaccines...but never related it to vaccine injury until now...on 05/07/17 he developed a fever and was very lethargic...on 05/08/17 he seemed to be completely back to himself...on 05/12/17 I found him in his crib at 08:30 AM...he passed away that prior evening...
Age: 1.58
Sex: M
Vaccine: DTAP, DTAP, DTAP
Symptoms: Autopsy, Death, Pyrexia, Unresponsive to stimuli
Clinical narrative: My son received his 4th DTAP vaccine on 4/25/17 and within 24 hours developed cold like symptoms...this was very common after almost all vaccines...but never related it to vaccine injury until now...on 05/07/17 he developed a fever and was very lethargic...on 05/08/17 he seemed to be completely back to himself...on 05/12/17 I found him in his crib at 08:30 AM...he passed away that prior evening...
Age: 1.58
Sex: M
Vaccine: DTAP, DTAP, DTAP
Symptoms: Autopsy, Death, Laboratory test normal, Lethargy, Pathology test
Clinical narrative: On April 25th patient got his DTaP shot, he had a rash for a day or so after, had a little cold and runny nose on and off, Sunday May 7th had a fever wasn't himself most the day. Monday May 8th woke up fine with no fever back to himself for the next 4 days happy, playing, eating running around with his sister then Friday May 12th patient did not wake up.
Age: 1.58
Sex: M
Vaccine: DTAP, DTAP, DTAP
Symptoms: Pyrexia, Sudden death, Viral upper respiratory tract infection
Clinical narrative: On April 25th patient got his DTaP shot, he had a rash for a day or so after, had a little cold and runny nose on and off, Sunday May 7th had a fever wasn't himself most the day. Monday May 8th woke up fine with no fever back to himself for the next 4 days happy, playing, eating running around with his sister then Friday May 12th patient did not wake up.
Age: 1.58
Sex: M
Vaccine: DTAP, DTAP, DTAP
Symptoms: Abnormal behaviour, Death, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: On April 25th patient got his DTaP shot, he had a rash for a day or so after, had a little cold and runny nose on and off, Sunday May 7th had a fever wasn't himself most the day. Monday May 8th woke up fine with no fever back to himself for the next 4 days happy, playing, eating running around with his sister then Friday May 12th patient did not wake up.
Age: 1.58
Sex: M
Vaccine: DTAP, DTAP, DTAP
Symptoms: Unresponsive to stimuli, Viral upper respiratory tract infection
Clinical narrative: On April 25th patient got his DTaP shot, he had a rash for a day or so after, had a little cold and runny nose on and off, Sunday May 7th had a fever wasn't himself most the day. Monday May 8th woke up fine with no fever back to himself for the next 4 days happy, playing, eating running around with his sister then Friday May 12th patient did not wake up.
Age: 1.58
Sex: M
Vaccine: DTAP, DTAP, DTAP
Symptoms: Autopsy, Death, Pyrexia, Unresponsive to stimuli
Clinical narrative: On April 25th patient got his DTaP shot, he had a rash for a day or so after, had a little cold and runny nose on and off, Sunday May 7th had a fever wasn't himself most the day. Monday May 8th woke up fine with no fever back to himself for the next 4 days happy, playing, eating running around with his sister then Friday May 12th patient did not wake up.
Age: 0.75
Sex: F
Vaccine: DTAP
Symptoms: Emotional distress, Immediate post-injection reaction, Lethargy, Posture abnormal, Pyrexia
Clinical narrative: Immediately became lethargic and fell asleep while being put in the car -she couldn't hold her head up or respond. Within a few hours, she developed a high fever which reached 104 within the next 24 hours and lasted a few days. She remained lethargic, less responsive, and upset for those 3 days.
Age: 0.75
Sex: F
Vaccine: DTAP
Symptoms: Somnolence, Unresponsive to stimuli
Clinical narrative: Immediately became lethargic and fell asleep while being put in the car -she couldn't hold her head up or respond. Within a few hours, she developed a high fever which reached 104 within the next 24 hours and lasted a few days. She remained lethargic, less responsive, and upset for those 3 days.
Age: 52.0
Sex: M
Vaccine: HEPA
Symptoms: Hypoaesthesia, Muscle tightness, Pain in jaw
Clinical narrative: Patient described soreness/numbness/tightness along left jaw line extending toward ear. Patient elected to try an ice pack and rest.
Sex: U
Vaccine: HIBV, PNC13
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program Pfizer RXPathways from a contactable consumer (patient). A patient of an unspecified age, gender and ethnicity received PREVNAR 13 (lot number and expiration date not reported) at single dose and ACT HIB (lot number and expiration date not reported; Sanofi Pasteur) at unknown dose, both via unspecified routes of administration on 22Jun2017 for immunization. Patient medical history included allergy to egg. Concomitant medications were not reported. It was reported that the patient received the two vaccines on 22Jun2017 (reported as yesterday from the time of the report) and went into an allergic reaction on unspecified date. The patient stated "I need to know if these vaccines have egg in them. No one could find where they did or did contain egg, Egg is my major allergy but I have another one no one can pinpoint." Outcome of the event was unknown.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Pain in extremity, Sensation of foreign body, Swelling face, Tonsillar hypertrophy, Vomiting
Clinical narrative: Patient complained to nurse that he vomited after eating macaroni salad around 1700. Nurse noted he had facial and tonsil swelling. Stated he felt like something was in his throat. Nurse gave him 50mg of Benadryl and took him to the ER. Upon arrival to ER pt c/o right lower leg pain over his tibia/fibula, pt given ibuprofen.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Dry skin, Erythema, Joint swelling, Myalgia, Pain in extremity
Clinical narrative: Patient presented to clinic on 6/28/2017 with concerns for possible reaction. Patient states that she did not have any reaction after receiving the vaccine. Patient states that she has some redness , swelling and muscle soreness afterwards. Patient states that later that evening she notice that she had some swelling around the elbow area. Patient states that it seems to be getting worse and she has notice that he swelling has radiated up the arm. Patient states that she began to have itching and rough skin on 6/27/2017 along with lower right arm pain.(Vaccine given L deltoid PCV13). Patient states that she was ordered new medication on the day the vaccine was given but states that she did not start the medication until 6/26/2017. Patient denies having elevated temperatures. Patient was not in any distress and was informed by care coordination to go to PCM or ER for evaluation . Patient verbalized understanding.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Pruritus, Swelling
Clinical narrative: Patient presented to clinic on 6/28/2017 with concerns for possible reaction. Patient states that she did not have any reaction after receiving the vaccine. Patient states that she has some redness , swelling and muscle soreness afterwards. Patient states that later that evening she notice that she had some swelling around the elbow area. Patient states that it seems to be getting worse and she has notice that he swelling has radiated up the arm. Patient states that she began to have itching and rough skin on 6/27/2017 along with lower right arm pain.(Vaccine given L deltoid PCV13). Patient states that she was ordered new medication on the day the vaccine was given but states that she did not start the medication until 6/26/2017. Patient denies having elevated temperatures. Patient was not in any distress and was informed by care coordination to go to PCM or ER for evaluation . Patient verbalized understanding.
Age: 15.0
Sex: F
Vaccine: HPV9, HEPA
Symptoms: Bipolar disorder, Headache, Lethargy, Nausea, Pain in jaw
Clinical narrative: Phone call from stepmom early June 2017 stating that the HPV vaccine had given patient a lot of symptoms including hand tremors, nausea, lethargy, personality changes, bipolar symptoms as well as hives, weight gain, jaw pain, nausea, vomiting and headaches. Patient did not present for medical evaluation.  Patient's current status is undocumented.
Age: 15.0
Sex: F
Vaccine: HPV9, HEPA
Symptoms: Personality change, Tremor, Urticaria, Vomiting, Weight increased
Clinical narrative: Phone call from stepmom early June 2017 stating that the HPV vaccine had given patient a lot of symptoms including hand tremors, nausea, lethargy, personality changes, bipolar symptoms as well as hives, weight gain, jaw pain, nausea, vomiting and headaches. Patient did not present for medical evaluation.  Patient's current status is undocumented.
Age: 15.0
Sex: F
Vaccine: HPV9, HEPA
Symptoms: Lethargy, Nausea, Pain in jaw, Somatic symptom disorder, Tremor
Clinical narrative: Phone call from stepmom early June 2017 stating that the HPV vaccine had given patient a lot of symptoms including hand tremors, nausea, lethargy, personality changes, bipolar symptoms as well as hives, weight gain, jaw pain, nausea, vomiting and headaches. Patient did not present for medical evaluation.  Patient's current status is undocumented.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Eye movement disorder, Eye swelling, Ocular hyperaemia, Pruritus
Clinical narrative: Sneezing, vomited, eyes darting back and forth, red eyes (then swelling), itchy feet, red cheeks, some redness (spots on abdomen - rash already present on arms turned red). BENADRYL, ZOFRAN, dexamethasone. No redness or swelling at injection site. No wheezing.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash, Rash erythematous, Sneezing, Vomiting
Clinical narrative: Sneezing, vomited, eyes darting back and forth, red eyes (then swelling), itchy feet, red cheeks, some redness (spots on abdomen - rash already present on arms turned red). BENADRYL, ZOFRAN, dexamethasone. No redness or swelling at injection site. No wheezing.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Varicella
Clinical narrative: Red raised bumps down torso and extremities. Patient denies itching, denies pain. Patient came to clinic 08:37AM. Patient was seen by provider. Ok'd to discharge. Patient to call with worsening symptoms. Dr. diagnosed patient with chicken pox.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Confusional state, Pyrexia, Syncope
Clinical narrative: Fever, syncopy, confusion.
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable Nurse Practitioner via Pfizer's sales representative. A male patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at 0.5ml, single on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced cellulitis on most of his arm on an unspecified date with outcome of unknown.; Sender's Comments: The current information is very limited and does not allow a full medically meaningful assessment, especially lack of the following: complete medical history and location site of vaccination, concomitant medications, and event detailed description including onset date.  Assessment is postponed after receipt of a more complete case report.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Blood test, Cardiovascular examination, Computerised tomogram, Depression
Clinical narrative: Our son has had and still have many issues after receiving the FLUZONE shot. Dizziness, sleeping at school, not being able to sleep at night, hallucinate, muscle fatigue, fainting, depression, can't compete in physical sports, weight gain, nervousness, anxiety. He was the fastest runner in his class, now he can't keep up with his peers. Very disheartening. I have taken him to specialist with no answers to date, 06/27/2017.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Electroencephalogram, Exercise tolerance decreased, Hallucination, Insomnia
Clinical narrative: Our son has had and still have many issues after receiving the FLUZONE shot. Dizziness, sleeping at school, not being able to sleep at night, hallucinate, muscle fatigue, fainting, depression, can't compete in physical sports, weight gain, nervousness, anxiety. He was the fastest runner in his class, now he can't keep up with his peers. Very disheartening. I have taken him to specialist with no answers to date, 06/27/2017.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of personal independence in daily activities, Muscle fatigue, Nervousness, Neurological examination, Nuclear magnetic resonance imaging
Clinical narrative: Our son has had and still have many issues after receiving the FLUZONE shot. Dizziness, sleeping at school, not being able to sleep at night, hallucinate, muscle fatigue, fainting, depression, can't compete in physical sports, weight gain, nervousness, anxiety. He was the fastest runner in his class, now he can't keep up with his peers. Very disheartening. I have taken him to specialist with no answers to date, 06/27/2017.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Somnolence, Specialist consultation, Syncope, Weight increased
Clinical narrative: Our son has had and still have many issues after receiving the FLUZONE shot. Dizziness, sleeping at school, not being able to sleep at night, hallucinate, muscle fatigue, fainting, depression, can't compete in physical sports, weight gain, nervousness, anxiety. He was the fastest runner in his class, now he can't keep up with his peers. Very disheartening. I have taken him to specialist with no answers to date, 06/27/2017.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Autoimmune thyroiditis, Loss of personal independence in daily activities, Malaise, Postural orthostatic tachycardia syndrome
Clinical narrative: My 15 year old daughter received two doses of GARDASIL. Within 2 months she went from being an athletic to being too sick to function on a daily basis. She has been diagnosed with Hashimoto's thyroiditis and POTS. Prior to receiving the 2nd vaccine, she was on the high school volleyball team. She is now under the care of a cardiologist and an endocrinologist. I am pro-vaccine but I am very afraid that the GARDASIL initiated an immune response to her system that caused the Hashimoto's and the POTS.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Acute disseminated encephalomyelitis, Asthenia, Bacterial test negative, CSF glucose normal, CSF lymphocyte count abnormal
Clinical narrative: Patient initially developed a fever to Tmax 102F. She was seen by urgent care on 6/23/17 and diagnosed with a UTI by dipstick, given ceftriaxone. The next day, 6/24/17, she was noted to have difficulty ambulating and speaking, with a droopy face. She was taken to Medical Center on 6/24/17, and discharged on amoxicillin for presumptive UTI (culture ultimately negative). She was noted to have decreased energy on 6/26/17, seen by PMD, given ceftriaxone and oral meds changed to cephalexin. Patient had received MMR vaccine on 6/2/2017 and had traveled 3 weeks prior to presentation.  She was brought to the ED on 6/27/17, where she was febrile to 100.8F, patient tired appearing, exam benign except for slow ambulation, CT of the head within normal limits, full sepsis workup initiated. CBC with a white count of 20 and LEFT shift neutrophils of 78, stabs 8. CSF Gram stain showed no organisms, CSF WBCs 19, normal glucose and protein. Patient had a brain MRI with and without contrast with bilateral cerebral signal abnormality most prominently affecting both thalami, with focal Left cerebellar white matter involvement. Viral encephalitis and acute disseminated encephalomyelitis were the primary diagnostic considerations. A routine EEG showed intermittent generalized moderate to high amplitude rhythmic slowing. Patient was transferred from inpatient floor to pediatric intensive care unit for hourly neurological checks and intravenous immunoglobulin therapy.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: CSF monocyte count decreased, CSF neutrophil count increased, CSF protein normal, CSF red blood cell count positive, CSF white blood cell count increased
Clinical narrative: Patient initially developed a fever to Tmax 102F. She was seen by urgent care on 6/23/17 and diagnosed with a UTI by dipstick, given ceftriaxone. The next day, 6/24/17, she was noted to have difficulty ambulating and speaking, with a droopy face. She was taken to Medical Center on 6/24/17, and discharged on amoxicillin for presumptive UTI (culture ultimately negative). She was noted to have decreased energy on 6/26/17, seen by PMD, given ceftriaxone and oral meds changed to cephalexin. Patient had received MMR vaccine on 6/2/2017 and had traveled 3 weeks prior to presentation.  She was brought to the ED on 6/27/17, where she was febrile to 100.8F, patient tired appearing, exam benign except for slow ambulation, CT of the head within normal limits, full sepsis workup initiated. CBC with a white count of 20 and LEFT shift neutrophils of 78, stabs 8. CSF Gram stain showed no organisms, CSF WBCs 19, normal glucose and protein. Patient had a brain MRI with and without contrast with bilateral cerebral signal abnormality most prominently affecting both thalami, with focal Left cerebellar white matter involvement. Viral encephalitis and acute disseminated encephalomyelitis were the primary diagnostic considerations. A routine EEG showed intermittent generalized moderate to high amplitude rhythmic slowing. Patient was transferred from inpatient floor to pediatric intensive care unit for hourly neurological checks and intravenous immunoglobulin therapy.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Computerised tomogram head normal, Culture urine negative, Electroencephalogram abnormal, Encephalitis viral, Enterovirus test negative
Clinical narrative: Patient initially developed a fever to Tmax 102F. She was seen by urgent care on 6/23/17 and diagnosed with a UTI by dipstick, given ceftriaxone. The next day, 6/24/17, she was noted to have difficulty ambulating and speaking, with a droopy face. She was taken to Medical Center on 6/24/17, and discharged on amoxicillin for presumptive UTI (culture ultimately negative). She was noted to have decreased energy on 6/26/17, seen by PMD, given ceftriaxone and oral meds changed to cephalexin. Patient had received MMR vaccine on 6/2/2017 and had traveled 3 weeks prior to presentation.  She was brought to the ED on 6/27/17, where she was febrile to 100.8F, patient tired appearing, exam benign except for slow ambulation, CT of the head within normal limits, full sepsis workup initiated. CBC with a white count of 20 and LEFT shift neutrophils of 78, stabs 8. CSF Gram stain showed no organisms, CSF WBCs 19, normal glucose and protein. Patient had a brain MRI with and without contrast with bilateral cerebral signal abnormality most prominently affecting both thalami, with focal Left cerebellar white matter involvement. Viral encephalitis and acute disseminated encephalomyelitis were the primary diagnostic considerations. A routine EEG showed intermittent generalized moderate to high amplitude rhythmic slowing. Patient was transferred from inpatient floor to pediatric intensive care unit for hourly neurological checks and intravenous immunoglobulin therapy.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Facial paralysis, Fatigue, Gait disturbance, Herpes simplex test negative, Immunoglobulin therapy
Clinical narrative: Patient initially developed a fever to Tmax 102F. She was seen by urgent care on 6/23/17 and diagnosed with a UTI by dipstick, given ceftriaxone. The next day, 6/24/17, she was noted to have difficulty ambulating and speaking, with a droopy face. She was taken to Medical Center on 6/24/17, and discharged on amoxicillin for presumptive UTI (culture ultimately negative). She was noted to have decreased energy on 6/26/17, seen by PMD, given ceftriaxone and oral meds changed to cephalexin. Patient had received MMR vaccine on 6/2/2017 and had traveled 3 weeks prior to presentation.  She was brought to the ED on 6/27/17, where she was febrile to 100.8F, patient tired appearing, exam benign except for slow ambulation, CT of the head within normal limits, full sepsis workup initiated. CBC with a white count of 20 and LEFT shift neutrophils of 78, stabs 8. CSF Gram stain showed no organisms, CSF WBCs 19, normal glucose and protein. Patient had a brain MRI with and without contrast with bilateral cerebral signal abnormality most prominently affecting both thalami, with focal Left cerebellar white matter involvement. Viral encephalitis and acute disseminated encephalomyelitis were the primary diagnostic considerations. A routine EEG showed intermittent generalized moderate to high amplitude rhythmic slowing. Patient was transferred from inpatient floor to pediatric intensive care unit for hourly neurological checks and intravenous immunoglobulin therapy.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Intensive care, Nuclear magnetic resonance imaging brain abnormal, Polymerase chain reaction, Pyrexia, Scan with contrast abnormal
Clinical narrative: Patient initially developed a fever to Tmax 102F. She was seen by urgent care on 6/23/17 and diagnosed with a UTI by dipstick, given ceftriaxone. The next day, 6/24/17, she was noted to have difficulty ambulating and speaking, with a droopy face. She was taken to Medical Center on 6/24/17, and discharged on amoxicillin for presumptive UTI (culture ultimately negative). She was noted to have decreased energy on 6/26/17, seen by PMD, given ceftriaxone and oral meds changed to cephalexin. Patient had received MMR vaccine on 6/2/2017 and had traveled 3 weeks prior to presentation.  She was brought to the ED on 6/27/17, where she was febrile to 100.8F, patient tired appearing, exam benign except for slow ambulation, CT of the head within normal limits, full sepsis workup initiated. CBC with a white count of 20 and LEFT shift neutrophils of 78, stabs 8. CSF Gram stain showed no organisms, CSF WBCs 19, normal glucose and protein. Patient had a brain MRI with and without contrast with bilateral cerebral signal abnormality most prominently affecting both thalami, with focal Left cerebellar white matter involvement. Viral encephalitis and acute disseminated encephalomyelitis were the primary diagnostic considerations. A routine EEG showed intermittent generalized moderate to high amplitude rhythmic slowing. Patient was transferred from inpatient floor to pediatric intensive care unit for hourly neurological checks and intravenous immunoglobulin therapy.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Shift to the left, Speech disorder, Urinary tract infection, White blood cell count increased
Clinical narrative: Patient initially developed a fever to Tmax 102F. She was seen by urgent care on 6/23/17 and diagnosed with a UTI by dipstick, given ceftriaxone. The next day, 6/24/17, she was noted to have difficulty ambulating and speaking, with a droopy face. She was taken to Medical Center on 6/24/17, and discharged on amoxicillin for presumptive UTI (culture ultimately negative). She was noted to have decreased energy on 6/26/17, seen by PMD, given ceftriaxone and oral meds changed to cephalexin. Patient had received MMR vaccine on 6/2/2017 and had traveled 3 weeks prior to presentation.  She was brought to the ED on 6/27/17, where she was febrile to 100.8F, patient tired appearing, exam benign except for slow ambulation, CT of the head within normal limits, full sepsis workup initiated. CBC with a white count of 20 and LEFT shift neutrophils of 78, stabs 8. CSF Gram stain showed no organisms, CSF WBCs 19, normal glucose and protein. Patient had a brain MRI with and without contrast with bilateral cerebral signal abnormality most prominently affecting both thalami, with focal Left cerebellar white matter involvement. Viral encephalitis and acute disseminated encephalomyelitis were the primary diagnostic considerations. A routine EEG showed intermittent generalized moderate to high amplitude rhythmic slowing. Patient was transferred from inpatient floor to pediatric intensive care unit for hourly neurological checks and intravenous immunoglobulin therapy.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Acute disseminated encephalomyelitis, CSF white blood cell count increased, Culture urine negative, Dysarthria, Encephalitis
Clinical narrative: Patient initially developed a fever to Tmax 102F. She was seen by urgent care on 6/23/17 and diagnosed with a UTI by dipstick, given ceftriaxone. The next day, 6/24/17, she was noted to have difficulty ambulating and speaking, with a droopy face. She was taken to Medical Center on 6/24/17, and discharged on amoxicillin for presumptive UTI (culture ultimately negative). She was noted to have decreased energy on 6/26/17, seen by PMD, given ceftriaxone and oral meds changed to cephalexin. Patient had received MMR vaccine on 6/2/2017 and had traveled 3 weeks prior to presentation.  She was brought to the ED on 6/27/17, where she was febrile to 100.8F, patient tired appearing, exam benign except for slow ambulation, CT of the head within normal limits, full sepsis workup initiated. CBC with a white count of 20 and LEFT shift neutrophils of 78, stabs 8. CSF Gram stain showed no organisms, CSF WBCs 19, normal glucose and protein. Patient had a brain MRI with and without contrast with bilateral cerebral signal abnormality most prominently affecting both thalami, with focal Left cerebellar white matter involvement. Viral encephalitis and acute disseminated encephalomyelitis were the primary diagnostic considerations. A routine EEG showed intermittent generalized moderate to high amplitude rhythmic slowing. Patient was transferred from inpatient floor to pediatric intensive care unit for hourly neurological checks and intravenous immunoglobulin therapy.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Febrile convulsion, Gait disturbance, Immunoglobulin therapy, Lethargy, Neutrophil percentage increased
Clinical narrative: Patient initially developed a fever to Tmax 102F. She was seen by urgent care on 6/23/17 and diagnosed with a UTI by dipstick, given ceftriaxone. The next day, 6/24/17, she was noted to have difficulty ambulating and speaking, with a droopy face. She was taken to Medical Center on 6/24/17, and discharged on amoxicillin for presumptive UTI (culture ultimately negative). She was noted to have decreased energy on 6/26/17, seen by PMD, given ceftriaxone and oral meds changed to cephalexin. Patient had received MMR vaccine on 6/2/2017 and had traveled 3 weeks prior to presentation.  She was brought to the ED on 6/27/17, where she was febrile to 100.8F, patient tired appearing, exam benign except for slow ambulation, CT of the head within normal limits, full sepsis workup initiated. CBC with a white count of 20 and LEFT shift neutrophils of 78, stabs 8. CSF Gram stain showed no organisms, CSF WBCs 19, normal glucose and protein. Patient had a brain MRI with and without contrast with bilateral cerebral signal abnormality most prominently affecting both thalami, with focal Left cerebellar white matter involvement. Viral encephalitis and acute disseminated encephalomyelitis were the primary diagnostic considerations. A routine EEG showed intermittent generalized moderate to high amplitude rhythmic slowing. Patient was transferred from inpatient floor to pediatric intensive care unit for hourly neurological checks and intravenous immunoglobulin therapy.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Pyrexia, Somnolence, White blood cell count increased, White blood cells urine positive
Clinical narrative: Patient initially developed a fever to Tmax 102F. She was seen by urgent care on 6/23/17 and diagnosed with a UTI by dipstick, given ceftriaxone. The next day, 6/24/17, she was noted to have difficulty ambulating and speaking, with a droopy face. She was taken to Medical Center on 6/24/17, and discharged on amoxicillin for presumptive UTI (culture ultimately negative). She was noted to have decreased energy on 6/26/17, seen by PMD, given ceftriaxone and oral meds changed to cephalexin. Patient had received MMR vaccine on 6/2/2017 and had traveled 3 weeks prior to presentation.  She was brought to the ED on 6/27/17, where she was febrile to 100.8F, patient tired appearing, exam benign except for slow ambulation, CT of the head within normal limits, full sepsis workup initiated. CBC with a white count of 20 and LEFT shift neutrophils of 78, stabs 8. CSF Gram stain showed no organisms, CSF WBCs 19, normal glucose and protein. Patient had a brain MRI with and without contrast with bilateral cerebral signal abnormality most prominently affecting both thalami, with focal Left cerebellar white matter involvement. Viral encephalitis and acute disseminated encephalomyelitis were the primary diagnostic considerations. A routine EEG showed intermittent generalized moderate to high amplitude rhythmic slowing. Patient was transferred from inpatient floor to pediatric intensive care unit for hourly neurological checks and intravenous immunoglobulin therapy.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Blood pressure decreased, Dry mouth, Nausea, Vomiting
Clinical narrative: PATIENT REPORTS MOUTH DRYNESS, NAUSEA, VOMITING, PAIN NEAR RIGHT HIP, BLOOD PRESSURE DROPPED.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Arthropathy, Conversion disorder, Dysstasia, Fall, Gait disturbance
Clinical narrative: Falling, difficulty standing and walking, knees and hips give out periodically. Symptoms still going on as of this report 06/29/2017. Diagnosed with Conversion Disorder 05/27/2017, physical therapy ordered.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Arthroscopy, Asthenia, Nerve conduction studies, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Left arm pain, weakness, onset with injection; worse that night. Steroid injection, physical therapy, arthroscopy on 5/11/17.
Age: 42.0
Sex: F
Vaccine: DTAP
Symptoms: Paraesthesia oral, Rash maculo-papular
Clinical narrative: Mild tingling in mouth and around lips fine macular papular rash on upper chest.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Pt states that 2 hours after getting her 2nd GARDASIL injection she experienced 20 minutes of sweating, dizziness, and stomachache. She also had a headache, which continued into the next day, but Tylenol helped.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dysphagia, Headache, Hyperhidrosis, Nausea
Clinical narrative: Nausea, perspiration, syncope, tightness in her chest, couldnt swallow, head shooting x3.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Nausea, perspiration, syncope, tightness in her chest, couldnt swallow, head shooting x3.
Age: 13.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Alopecia, Glucose tolerance impaired, Hair growth abnormal, Menstruation irregular, Ovarian cyst
Clinical narrative: Irregular menstruation, uterine pain, ovarian cysts, loss of hair on head, increase of hair on upper lip and chin, diagnosis of Polycystic Ovarian Syndrome in October of 2014 and prediabetic condition from the PCOS.
Age: 13.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Polycystic ovaries, Uterine pain
Clinical narrative: Irregular menstruation, uterine pain, ovarian cysts, loss of hair on head, increase of hair on upper lip and chin, diagnosis of Polycystic Ovarian Syndrome in October of 2014 and prediabetic condition from the PCOS.
Age: 1.75
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site pain, Injection site rash, Pyrexia, Rash
Clinical narrative: Developed a fever, rash beginning on the right thigh at injection site, complained of pain. Rash moved up into the trunk and face. As of 06/29/17 rash is beginning to recede in the opposite manner as it appeared. Patient seen in the clinic on 06/29/17.
Age: 17.0
Sex: F
Vaccine: HEPA, MMRV, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: PATIENT WAS ADMINISTERED MMRV BUT IT IS ONLY LICENSED THROUGH AGE 12.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT WAS ADMINISTERED PEDIATRIC DOSE OF HEPATITIS A VACCINE.
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Fatigue, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient's parent). A female patient of an unspecified age and ethnicity received the 2nd dose of TRUMENBA via an unspecified route of administration at single dose on 23Jun2017 at around 2 O'clock for immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the 1st dose of TRUMENBA on an unknown date for immunisation. Starting on 24Jun2017 morning she did not had much energy, she was a kind of swollen around the vaccination site and she was just really tired. The reporter was concerned because the patient was actually leaving for 3 weeks of school tomorrow. The reporter was going to call the Pediatrician. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Rash maculo-papular
Clinical narrative: Initial unsolicited report received from a physician on 09-Jun-2017 and additional information received on 27-Jun-2017. This case involves a 25-months-old female patient, who was vaccinated with MENACTRA (batch number, expiration date, dose, route and site of administration was not reported) on an unknown date of Jun-2017 (around 07-Jun-2017) at 10 AM. Patient's medical history included infantile roseola. She received a dose of NEISVAC when she was 1 year-old, in 2016. The family moved end of February-2017. 10 days after arrival (in March-2017), the girl experienced a strong rotavirus gastroenteritis which led to hospitalization due to diarrhea, vomiting and loss of appetite. Rotavirus was identified by laboratory exam. No specific reaction after primo-vaccinations. Patient's concomitant medication was not reported. On an unknown date of Jun-2017 (around 07-Jun-2017) in the evening, few hours after the vaccination, patient developed high fever (40 degree C) that lasted 3 days, together with reactions on her legs and arms for 48 hours/rash on the body (mainly forearm, legs, bottom and slightly on the face). Rashes were made of red and round plates that appeared and disappeared; It looked like maculo-papulous rash or could make think about multiforme erythema (according to pictures received from the parents) but without clear center in the middle. Patient's other lab test was not reported. Patient received DOLIPRANE as corrective treatment. At the time of the report, the patient was recovered. Upon internal review the case was considered as serious because of important medical events' erythema multiform-like eruption, generalised rash and maculopapular rash. List of the documents held by sender none. Sender's Comments: Sanofi company comment dated 29-Jun-2017: Erythema multiforme with generalised rash and Maculopapular rash is unlisted and high fever is listed following MENACTRA vaccine. Time to onset is compatible with the vaccine. Erythema multiforme is autoimmune is self-limited disease which can be trigger by any viral, bacterial, fungal, parasitic infection, any drug reaction and neoplastic disorder. Based on available information with presence of alternative cause as concurrent viral infection, rule out role of vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Received KINRIX vaccine in left thigh. Redness and knot at site on day after vaccines. Mild reaction to left thigh per Dr. Pt. was started on Cefdinir 125 mg/5ml BID x 10 days.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient had BEXSERO 6-26-17 left deltoid. Pain to left arm that night and swelling. Warm to touch today.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: He began developing a vesicular rash on his anterior thighs and forearms.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: REDNESS WITH MILD ITCHING AT THE SITE. THE REDNESS AND SWELLING IS THE SIZE OF A MASON JAR LID. THERE IS A KNOT IN THE MIDDLE OF THE REDNESS WHERE THE INJECTION WAS GIVEN. ALL REPORTED BY THE PATIENT OVER THE PHONE.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: Pallor and diaphoresis.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left upper deltoid with significant swelling, warm to touch, tender to palpation. Area of induration 4.5cmx6cm. Temp 100.3. Treated with Ibuprofen, icing.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Pruritus
Clinical narrative: Patient complains that his arm still itches in that area.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: Extreme soreness and numbness in the arm, unable to move arm.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Delayed onset swelling and rash at injection site.