chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: FLUN4, FLUN4, FLUN4
Symptoms: Gait disturbance, Gastrointestinal tube insertion, Head discomfort, Hypophagia, Intensive care
Clinical narrative: The patient was in his usual state of excellent health until approximately October 14th when he received the live attenuated influenza vaccine, FluMist.  Approximately one day later, he began having fevers of 100.5 degrees.  Subsequently, he became increasingly lethargic.  His mother noted that he was not as active as usual.  He was not able to fully participate in soccer practice.  On approximately October 19th, he developed fever to 101.3 degrees.  That evening, he began having nausea and vomiting. On October 20th, he continued to have fever as well as the persistent nausea and vomiting.  She also noted that he had enlarged lymph nodes in his neck. On approximately October 22nd, he developed a fever to 104.9 degrees.  He was seen by his pediatrician, who performed a rapid strep test that was positive. He was then started on amoxicillin.  On October 23rd, the fevers persisted. He became increasingly weak and lethargic.  At one point, he told his mother he was too weak to walk and asked her to take him to the bathroom.  She did this twice.  Subsequently, he became incontinent of urine.  He went back to his pediatrician's office where he was noted to have persistent nausea and vomiting as well as urinary incontinence.  At that point, he was referred to the emergency room. On arrival in the emergency room, he was initially afebrile.  Subsequently, he developed fever to 38.5 degrees.  His other vital signs were unremarkable.  He became increasingly agitated while in the emergency room.  He demonstrated aggression and restlessness.  He was, therefore, admitted to the intensive care unit. He had a CT scan of the brain performed that was unremarkable.  He then underwent a lumbar puncture; which showed 37 white cells, 7% of which were neutrophils, 93% were mononuclear. The glucose of 52 with a protein of nearly 60.  He was thought to have meningitis or meningoencephalitis.  He was started on empiric antibiotic therapy consisting of ceftriaxone and acyclovir.  An MRI was obtained on October 24th, which was completely unremarkable.  Throughout the day of October 25th, he became less and less responsive and became comatose.  On the evening of October 25th, he developed abnormal pattern respiration.  He is thought to be having seizures and was started on Keppra. Subsequently, his respiratory status improved.
Age: 7.0
Sex: M
Vaccine: FLUN4, FLUN4, FLUN4
Symptoms: Irritability, Laboratory test, Lethargy, Limb discomfort, Lumbar puncture abnormal
Clinical narrative: The patient was in his usual state of excellent health until approximately October 14th when he received the live attenuated influenza vaccine, FluMist.  Approximately one day later, he began having fevers of 100.5 degrees.  Subsequently, he became increasingly lethargic.  His mother noted that he was not as active as usual.  He was not able to fully participate in soccer practice.  On approximately October 19th, he developed fever to 101.3 degrees.  That evening, he began having nausea and vomiting. On October 20th, he continued to have fever as well as the persistent nausea and vomiting.  She also noted that he had enlarged lymph nodes in his neck. On approximately October 22nd, he developed a fever to 104.9 degrees.  He was seen by his pediatrician, who performed a rapid strep test that was positive. He was then started on amoxicillin.  On October 23rd, the fevers persisted. He became increasingly weak and lethargic.  At one point, he told his mother he was too weak to walk and asked her to take him to the bathroom.  She did this twice.  Subsequently, he became incontinent of urine.  He went back to his pediatrician's office where he was noted to have persistent nausea and vomiting as well as urinary incontinence.  At that point, he was referred to the emergency room. On arrival in the emergency room, he was initially afebrile.  Subsequently, he developed fever to 38.5 degrees.  His other vital signs were unremarkable.  He became increasingly agitated while in the emergency room.  He demonstrated aggression and restlessness.  He was, therefore, admitted to the intensive care unit. He had a CT scan of the brain performed that was unremarkable.  He then underwent a lumbar puncture; which showed 37 white cells, 7% of which were neutrophils, 93% were mononuclear. The glucose of 52 with a protein of nearly 60.  He was thought to have meningitis or meningoencephalitis.  He was started on empiric antibiotic therapy consisting of ceftriaxone and acyclovir.  An MRI was obtained on October 24th, which was completely unremarkable.  Throughout the day of October 25th, he became less and less responsive and became comatose.  On the evening of October 25th, he developed abnormal pattern respiration.  He is thought to be having seizures and was started on Keppra. Subsequently, his respiratory status improved.
Age: 7.0
Sex: M
Vaccine: FLUN4, FLUN4, FLUN4
Symptoms: Lymphadenopathy, Meningitis viral, Nuclear magnetic resonance imaging, Pain, Pyrexia
Clinical narrative: The patient was in his usual state of excellent health until approximately October 14th when he received the live attenuated influenza vaccine, FluMist.  Approximately one day later, he began having fevers of 100.5 degrees.  Subsequently, he became increasingly lethargic.  His mother noted that he was not as active as usual.  He was not able to fully participate in soccer practice.  On approximately October 19th, he developed fever to 101.3 degrees.  That evening, he began having nausea and vomiting. On October 20th, he continued to have fever as well as the persistent nausea and vomiting.  She also noted that he had enlarged lymph nodes in his neck. On approximately October 22nd, he developed a fever to 104.9 degrees.  He was seen by his pediatrician, who performed a rapid strep test that was positive. He was then started on amoxicillin.  On October 23rd, the fevers persisted. He became increasingly weak and lethargic.  At one point, he told his mother he was too weak to walk and asked her to take him to the bathroom.  She did this twice.  Subsequently, he became incontinent of urine.  He went back to his pediatrician's office where he was noted to have persistent nausea and vomiting as well as urinary incontinence.  At that point, he was referred to the emergency room. On arrival in the emergency room, he was initially afebrile.  Subsequently, he developed fever to 38.5 degrees.  His other vital signs were unremarkable.  He became increasingly agitated while in the emergency room.  He demonstrated aggression and restlessness.  He was, therefore, admitted to the intensive care unit. He had a CT scan of the brain performed that was unremarkable.  He then underwent a lumbar puncture; which showed 37 white cells, 7% of which were neutrophils, 93% were mononuclear. The glucose of 52 with a protein of nearly 60.  He was thought to have meningitis or meningoencephalitis.  He was started on empiric antibiotic therapy consisting of ceftriaxone and acyclovir.  An MRI was obtained on October 24th, which was completely unremarkable.  Throughout the day of October 25th, he became less and less responsive and became comatose.  On the evening of October 25th, he developed abnormal pattern respiration.  He is thought to be having seizures and was started on Keppra. Subsequently, his respiratory status improved.
Age: 7.0
Sex: M
Vaccine: FLUN4, FLUN4, FLUN4
Symptoms: Speech disorder, Streptococcus test positive, Urinary incontinence, Vomiting, White blood cell count increased
Clinical narrative: The patient was in his usual state of excellent health until approximately October 14th when he received the live attenuated influenza vaccine, FluMist.  Approximately one day later, he began having fevers of 100.5 degrees.  Subsequently, he became increasingly lethargic.  His mother noted that he was not as active as usual.  He was not able to fully participate in soccer practice.  On approximately October 19th, he developed fever to 101.3 degrees.  That evening, he began having nausea and vomiting. On October 20th, he continued to have fever as well as the persistent nausea and vomiting.  She also noted that he had enlarged lymph nodes in his neck. On approximately October 22nd, he developed a fever to 104.9 degrees.  He was seen by his pediatrician, who performed a rapid strep test that was positive. He was then started on amoxicillin.  On October 23rd, the fevers persisted. He became increasingly weak and lethargic.  At one point, he told his mother he was too weak to walk and asked her to take him to the bathroom.  She did this twice.  Subsequently, he became incontinent of urine.  He went back to his pediatrician's office where he was noted to have persistent nausea and vomiting as well as urinary incontinence.  At that point, he was referred to the emergency room. On arrival in the emergency room, he was initially afebrile.  Subsequently, he developed fever to 38.5 degrees.  His other vital signs were unremarkable.  He became increasingly agitated while in the emergency room.  He demonstrated aggression and restlessness.  He was, therefore, admitted to the intensive care unit. He had a CT scan of the brain performed that was unremarkable.  He then underwent a lumbar puncture; which showed 37 white cells, 7% of which were neutrophils, 93% were mononuclear. The glucose of 52 with a protein of nearly 60.  He was thought to have meningitis or meningoencephalitis.  He was started on empiric antibiotic therapy consisting of ceftriaxone and acyclovir.  An MRI was obtained on October 24th, which was completely unremarkable.  Throughout the day of October 25th, he became less and less responsive and became comatose.  On the evening of October 25th, he developed abnormal pattern respiration.  He is thought to be having seizures and was started on Keppra. Subsequently, his respiratory status improved.
Age: 7.0
Sex: M
Vaccine: FLUN4, FLUN4, FLUN4
Symptoms: X-ray
Clinical narrative: The patient was in his usual state of excellent health until approximately October 14th when he received the live attenuated influenza vaccine, FluMist.  Approximately one day later, he began having fevers of 100.5 degrees.  Subsequently, he became increasingly lethargic.  His mother noted that he was not as active as usual.  He was not able to fully participate in soccer practice.  On approximately October 19th, he developed fever to 101.3 degrees.  That evening, he began having nausea and vomiting. On October 20th, he continued to have fever as well as the persistent nausea and vomiting.  She also noted that he had enlarged lymph nodes in his neck. On approximately October 22nd, he developed a fever to 104.9 degrees.  He was seen by his pediatrician, who performed a rapid strep test that was positive. He was then started on amoxicillin.  On October 23rd, the fevers persisted. He became increasingly weak and lethargic.  At one point, he told his mother he was too weak to walk and asked her to take him to the bathroom.  She did this twice.  Subsequently, he became incontinent of urine.  He went back to his pediatrician's office where he was noted to have persistent nausea and vomiting as well as urinary incontinence.  At that point, he was referred to the emergency room. On arrival in the emergency room, he was initially afebrile.  Subsequently, he developed fever to 38.5 degrees.  His other vital signs were unremarkable.  He became increasingly agitated while in the emergency room.  He demonstrated aggression and restlessness.  He was, therefore, admitted to the intensive care unit. He had a CT scan of the brain performed that was unremarkable.  He then underwent a lumbar puncture; which showed 37 white cells, 7% of which were neutrophils, 93% were mononuclear. The glucose of 52 with a protein of nearly 60.  He was thought to have meningitis or meningoencephalitis.  He was started on empiric antibiotic therapy consisting of ceftriaxone and acyclovir.  An MRI was obtained on October 24th, which was completely unremarkable.  Throughout the day of October 25th, he became less and less responsive and became comatose.  On the evening of October 25th, he developed abnormal pattern respiration.  He is thought to be having seizures and was started on Keppra. Subsequently, his respiratory status improved.
Age: 7.0
Sex: M
Vaccine: FLUN4, FLUN4, FLUN4
Symptoms: Back pain, Meningoencephalitis viral, Pyrexia, Streptococcus test positive, Vomiting
Clinical narrative: The patient was in his usual state of excellent health until approximately October 14th when he received the live attenuated influenza vaccine, FluMist.  Approximately one day later, he began having fevers of 100.5 degrees.  Subsequently, he became increasingly lethargic.  His mother noted that he was not as active as usual.  He was not able to fully participate in soccer practice.  On approximately October 19th, he developed fever to 101.3 degrees.  That evening, he began having nausea and vomiting. On October 20th, he continued to have fever as well as the persistent nausea and vomiting.  She also noted that he had enlarged lymph nodes in his neck. On approximately October 22nd, he developed a fever to 104.9 degrees.  He was seen by his pediatrician, who performed a rapid strep test that was positive. He was then started on amoxicillin.  On October 23rd, the fevers persisted. He became increasingly weak and lethargic.  At one point, he told his mother he was too weak to walk and asked her to take him to the bathroom.  She did this twice.  Subsequently, he became incontinent of urine.  He went back to his pediatrician's office where he was noted to have persistent nausea and vomiting as well as urinary incontinence.  At that point, he was referred to the emergency room. On arrival in the emergency room, he was initially afebrile.  Subsequently, he developed fever to 38.5 degrees.  His other vital signs were unremarkable.  He became increasingly agitated while in the emergency room.  He demonstrated aggression and restlessness.  He was, therefore, admitted to the intensive care unit. He had a CT scan of the brain performed that was unremarkable.  He then underwent a lumbar puncture; which showed 37 white cells, 7% of which were neutrophils, 93% were mononuclear. The glucose of 52 with a protein of nearly 60.  He was thought to have meningitis or meningoencephalitis.  He was started on empiric antibiotic therapy consisting of ceftriaxone and acyclovir.  An MRI was obtained on October 24th, which was completely unremarkable.  Throughout the day of October 25th, he became less and less responsive and became comatose.  On the evening of October 25th, he developed abnormal pattern respiration.  He is thought to be having seizures and was started on Keppra. Subsequently, his respiratory status improved.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Chest pain, Chills, Headache, Hypertension
Clinical narrative: First very high blood pressure a few days later, chest pains aching of all bones, headache, fever, chills, nausea.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pneumonia, Pyrexia
Clinical narrative: First very high blood pressure a few days later, chest pains aching of all bones, headache, fever, chills, nausea.
Age: 1.07
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Abnormal behaviour, Electroencephalogram normal, Gaze palsy, Nuclear magnetic resonance imaging normal, Otitis media acute
Clinical narrative: On morning of 10/14/15 began having episodes of eye deviation (up and to left) lasting ~ 2 seconds, occurred twice on 10/14/15, then several times per day (4-25) every day since. (mom provided video recording of the episodes of eye deviation at visit on 10/20/15). On 10/21/15 had fever 101 and 3-4 episodes of staring, lasting 5-10 secsonds each (and seemed "out of it" during the staring episodes). Seen 10/22/15 for fever and treated with amoxicillin for left acute otitis media.  MRI and EEG negative.
Age: 1.07
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Staring
Clinical narrative: On morning of 10/14/15 began having episodes of eye deviation (up and to left) lasting ~ 2 seconds, occurred twice on 10/14/15, then several times per day (4-25) every day since. (mom provided video recording of the episodes of eye deviation at visit on 10/20/15). On 10/21/15 had fever 101 and 3-4 episodes of staring, lasting 5-10 secsonds each (and seemed "out of it" during the staring episodes). Seen 10/22/15 for fever and treated with amoxicillin for left acute otitis media.  MRI and EEG negative.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness
Clinical narrative: Dizziness.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Gait disturbance, Vomiting
Clinical narrative: Within 2 hours of receiving the vaccine, the patient reported that he became very dizzy and began vomiting, which he assumed was due to the overwhelming dizziness.  He had trouble staying upright and could not walk in a straight line and had a stumbling gait due to the dizziness.  The patient was luckily on his way home and went to bed as soon as he reached his home.  He slept the rest of the day and reported feeling normal once he woke up the next morning.
Age: 11.0
Sex: M
Vaccine: DTAP, MEN, VARCEL
Symptoms: Erythema, Injection site pain, Injection site swelling, Musculoskeletal stiffness, Pruritus
Clinical narrative: Pain and significant swelling at injection site lasting 9 days. Stiffness, redness and itchiness.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient reports some pain and swelling at the site of injection.  Patient Used some ice on the site of injection and took some Benadryl.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Discomfort, Erythema, Hyperhidrosis, Laboratory test, Lethargy
Clinical narrative: On the 6th day post vaccination, my daughter had some hives on her body, later in the day they spread from head to toe as an itchy rash.  Hives were multiple sizes and shapes.  Skin was red surrounding the hives.  For this I gave her Benadryl and hives subsided.  Soon after, I noticed a raised dark red dots on her torso and chest which resembled the measles.  These spots lasted for a few days. and hives came and went periodically.  For the next 4 days, she had a constant fever and was lethargic.  Fever was treated with alternating Tylenol and Motrin every there hours, but a fever of 102-103 always lingered. She went to the pediatrician to be seen and I was consulted numerous times over the phone with them as to what to do to help her.  By the third day the fever reached 104, by the fourth day in the afternoon, fever went up to 105.6 and my daughter was convulsing and was very uncomfortable.  An ambulance came and took her to the hospital where multiple tests were done to rule out anything else that may be causing this reaction.  It was concluded with my pediatricians and ER doctors that this was a reaction to the MMR vaccine.  Later that night my daughter's fever broke, she was sweating and felt warm to the touch and rectal temperature was 96.7.  I kept her warm all night with blankets so that her temperature would rise.  By the fifth day she was symptom free and started to recover after this agonizing and scary episode.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash morbilliform, Rash pruritic, Seizure, Skin warm
Clinical narrative: On the 6th day post vaccination, my daughter had some hives on her body, later in the day they spread from head to toe as an itchy rash.  Hives were multiple sizes and shapes.  Skin was red surrounding the hives.  For this I gave her Benadryl and hives subsided.  Soon after, I noticed a raised dark red dots on her torso and chest which resembled the measles.  These spots lasted for a few days. and hives came and went periodically.  For the next 4 days, she had a constant fever and was lethargic.  Fever was treated with alternating Tylenol and Motrin every there hours, but a fever of 102-103 always lingered. She went to the pediatrician to be seen and I was consulted numerous times over the phone with them as to what to do to help her.  By the third day the fever reached 104, by the fourth day in the afternoon, fever went up to 105.6 and my daughter was convulsing and was very uncomfortable.  An ambulance came and took her to the hospital where multiple tests were done to rule out anything else that may be causing this reaction.  It was concluded with my pediatricians and ER doctors that this was a reaction to the MMR vaccine.  Later that night my daughter's fever broke, she was sweating and felt warm to the touch and rectal temperature was 96.7.  I kept her warm all night with blankets so that her temperature would rise.  By the fifth day she was symptom free and started to recover after this agonizing and scary episode.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria, Vaccination complication
Clinical narrative: On the 6th day post vaccination, my daughter had some hives on her body, later in the day they spread from head to toe as an itchy rash.  Hives were multiple sizes and shapes.  Skin was red surrounding the hives.  For this I gave her Benadryl and hives subsided.  Soon after, I noticed a raised dark red dots on her torso and chest which resembled the measles.  These spots lasted for a few days. and hives came and went periodically.  For the next 4 days, she had a constant fever and was lethargic.  Fever was treated with alternating Tylenol and Motrin every there hours, but a fever of 102-103 always lingered. She went to the pediatrician to be seen and I was consulted numerous times over the phone with them as to what to do to help her.  By the third day the fever reached 104, by the fourth day in the afternoon, fever went up to 105.6 and my daughter was convulsing and was very uncomfortable.  An ambulance came and took her to the hospital where multiple tests were done to rule out anything else that may be causing this reaction.  It was concluded with my pediatricians and ER doctors that this was a reaction to the MMR vaccine.  Later that night my daughter's fever broke, she was sweating and felt warm to the touch and rectal temperature was 96.7.  I kept her warm all night with blankets so that her temperature would rise.  By the fifth day she was symptom free and started to recover after this agonizing and scary episode.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Injection site reaction, Nausea, Pain
Clinical narrative: INJECTION SITE REACTION, BODY ACHE, FLU LIKE SYMPTOMS, SICK TO STOMACH.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: RIGHT ARM RED FROM DELTOID TO ELBOW, SLIGHT SWELLING WITH SORENESS, NECK PAIN AND HEADACHE.
Age: 66.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Activities of daily living impaired, Dyspnoea, Inappropriate schedule of drug administration
Clinical narrative: Tried to exercise as usual by running a four mile distance, but almost immediately discovered that my lungs were unable to process oxygen deeply.  Feeling was similar to extreme altitude sickness, and while I usually can run four miles at a moderate pace without stopping at all, I found that I had to stop every few hundred yards and gasp for breath.  Even going up stairs caused me to be short of breath.  These symptoms worsened until about 09/20/2015, and have very gradually improved since.  However, as of today (six weeks after injection) lung capacity under physical stress/moderate exercise is still no greater than about 90% by approximate feeling of patient, and for now seems to have leveled without recent further improvement.  It is still impossible for me to exercise as I did pre-Prevnar 13 injection without stopping at least four or five times during a four mile run to walk and catch my breath, and even while running there is a constant feeling as though my lungs are not very deeply utilizing oxygen as they should be. It's noted that the Prevnar 13 injection was given at the Pharmacy, about a half hour after receiving a seasonal flu shot, and after discussion between the employee providing the injection and the head pharmacist.  After experiencing symptoms I've read the cautions by the Prevnar 13 manufacturer which appears to warn against doing these at the same time.  Although the Prevnar 13 was suggested by Dr at the same Clinic during an annual physical earlier that day, neither he nor his immediate staff were responsible for actually performing the injections, nor were they in the decision-making process of the advisability to give both the Prevnar 13 and seasonal flu serums at the same time.  Unknown now whether full lung capacity will return.
Age: 0.31
Sex: F
Vaccine: DTP
Symptoms: Crying, Injection site swelling, Pyrexia, Seizure
Clinical narrative: High-pitched crying for 8+ hours, fever 105, severe swelling of leg, seizure.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cheilitis, Oral mucosal erythema, Stomatitis, Tenderness
Clinical narrative: Patient said he developed sores and redness inside of mouth and on lips and around lips. He said it was tender to the touch.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Nausea, aches and fever started around 6:30pm and lasted throughout the night.  Symptoms continued with temperature around 100 through the following day until 5:30pm.  Tylenol taken 10/21 around 5pm (dose unknown).
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Erythema, Fatigue, Headache, Influenza like illness
Clinical narrative: Headache, joints achy, tired, arm very sore, flu like symptoms. Took an anti histamine and an aspirin and went to bed. Very tired. Arm swollen and red, still is very sore 6" below injection site.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Headache, joints achy, tired, arm very sore, flu like symptoms. Took an anti histamine and an aspirin and went to bed. Very tired. Arm swollen and red, still is very sore 6" below injection site.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Area around injection site became red, warm, and slightly inflamed.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Nausea, Vomiting
Clinical narrative: 30 minutes after vaccine administered patient's supervisor called and spoke w/RN and said patient was diaphoretic, nauseous and vomiting. RN advised patient be taken to the Emergency Dept.
Age: 0.82
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives within minutes of receiving flu vaccine - BENADRYL given.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Injection site swelling, Pruritus, Skin warm
Clinical narrative: Client reported within 1-2 hours - swelling at site - progressed to size of palm of her hd. with bluish discoloration, hot to touch and itching - no SOB - saw MD 10/23/15. No treatment other than BENADRYL PRN.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Headache, Influenza, Myalgia
Clinical narrative: Felt head was about to explode. Settled in chest. Muscle aches. Worst flu ever.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Insomnia
Clinical narrative: All the fingers felt numb at the left hand the first day. Three fingers still felt numb after 2 days. Right now, still two fingers fell numb. Event can't sleep.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Malaise
Clinical narrative: Arm still bruised, on aspirin, a little  5x4 feeling malaise, no fever, after 3 or 3 days, symptoms stopped, but came back a little while later. Told pt to see doc.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Injection site inflammation
Clinical narrative: Patient got FLUZONE HD shot on Oct. 22, 2015 and complained on Oct. 23, 2015 of inflamed arm and at site on injection.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site pruritus
Clinical narrative: Patient last got the FLUZONE HD shot on Oct. 20, 2015. Today patient still complained of an inflamed arm at site of injection and itchiness.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Mobility decreased, Rash, Skin warm, Tenderness
Clinical narrative: Pt states when changing shirt that she notice red, warm to touch, rash from upper arm to elbow (approx 15 cm). Painful to touch and difficulty raising arm. MD notified and prescribed pt. steroids.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Lump (L) arm injection site red, hot, lump. Redness for a couple days.
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of muscle pain in a male patient who received FLUARIX QUADRIVALENT. On 29th September 2015, the patient received FLUARIX QUADRIVALENT. On an unknown date, 7 days after receiving FLUARIX QUADRIVALENT, the patient experienced muscle pain and joint pain. On an unknown date, the outcome of the muscle pain and joint pain were not recovered/not resolved. It was unknown if the reporter considered the muscle pain and joint pain to be related to FLUARIX QUADRIVALENT. Additional details provide were as follows: The patient experienced muscle aches and joint pain one week after receiving the vaccination in October 2015. The reporter did not provide any further details because he did not have time. He stated that someone can call him back and speak to one of his nurses regarding the adverse event.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Awakened with an unusual type of headache. Different from usual headaches. Felt better later.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Malaise, Nausea
Clinical narrative: Abdominal discomfort, nausea, sick feeling after vaccination. Went home slept for 6 hours and felt better.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received FLUARIX quadrivalent. In 2015, the patient received FLUARIX quadrivalent. On an unknown date, less than a month after receiving FLUARIX quadrivalent, the patient experienced injection site pain was unknown. The reporter considered the injection site pain to be related to FLUARIX quadrivalent. Additional details were received as follows: This case was previously reported to a manufacturer. The reporter was Director of Pharmacy and was asked to contact GlaxoSmithKline by employee health department to saw if there were any reports of extreme arm pain. The reporter stated that, their hospital changed FLUARIX trivalent to FLUARIX quadrivalent this year. The reporter stated that, last 2 weeks ago from reporting date, the patient had received FLUARIX quadrivalent and experienced severe arm pain (injection site pain). The reporter did not have the further information about patient and vaccine. The reporter did not know when the arm pain began or resolved. This case has been linked with case US2015149594 reported by the same reporter.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Injection site pain, Injection site paraesthesia, Nausea, Paraesthesia
Clinical narrative: Burning, tingling sensation on injection site (left deltoid) went to neck back, arms and fingers. Nausea, took TYLENOL and felt better.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 28-year-old female patient who received FLUARIX (batch number 97X92, expiry date 30th June 2016). On 15th October 2015, the patient received FLUARIX (intramuscular) .5 ml. On 15th October 2015, 2 hrs after receiving FLUARIX, the patient experienced fever, rigors, fatigue, weakness and headache. On 15th October 2015, the outcome of the rigors and headache were recovered/resolved. On 16th October 2015, the outcome of the fever, fatigue and weakness were recovered/resolved. The reporter considered the fever, rigors, fatigue, weakness and headache to be probably related to FLUARIX.  Additional details provided were as follows: On 15th October 2015, at 16:00, the patient received a dose of FLUARIX season vaccine in right deltoid. Same day 2 hours after vaccination, the patient experienced fever, chills, rigors, fatigue, weakness, could not hold anything and headache. The reporter described the patient's rigors as severe shaking almost to point of convulsions. She could not have anything due to this shaking. The reporter noted that the patient did not experience any vomiting with these events and that the patient is small in size.
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received FLUARIX Quadrivalent. In 2015, the patient received FLUARIX Quadrivalent. On an unknown date, less than a month after receiving FLUARIX Quadrivalent, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. The reporter considered the pain in arm to be related to FLUARIX Quadrivalent. Additional details were received as follows: This case was previously reported to manufacturer. The reporter was Director of Pharmacy and was asked to contact GlaxoSmithKline by employee health department to saw if there were any reports of extreme arm pain. The reporter stated that, their hospital changed FLUARIX Trivalent to FLUARIX Quadrivalent this year. The reporter stated that, last 2 weeks ago from reporting date, the patient had received FLUARIX Quadrivalent and experienced severe arm pain. The patient was nurse and after severe arm pain she had to miss time from her work. The reporter did not have the further information about patient and vaccine. The reporter did not know when the arm pain began or resolved. This case was linked to case US2015149595 reported by the same reporter.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Vomiting
Clinical narrative: At 2:30 pm received flu shot - off from work at 5:30 - when arrived home - 5:30. Started vomiting and diarrhea - lasted almost 3 days.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 1/3 or the (L) arm injection site warm, red, swollen.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Pruritus generalised, Rash, Rash erythematous
Clinical narrative: Burning sensation during administration (L) deltoid. Red rash circular center of chest - 4 to 5 inches. Took antihistamine which relieved itching. Took BENADRYL 9:30 pm 10-8-15, 10-9-15 5am. Chest, sides, back, armpits, base of neck with itching. Took antihistamine and came to work. Saw PMD 10-9-15 and recv'd treatment with steroids and antihistamines and improved.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Injection site red, warm with induration.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness, warmth and induration (approx 3x3 inch) at injection site.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Left upper arm became hot and swollen 12 hours following administration of immunization. Over next 24 hours, reaction became more localized. Now central clearing around injection with reddened, swollen area approximately 3" in diameter. BENADRYL 1/2 tsp qid prescribed.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Rotator cuff syndrome
Clinical narrative: Pt says arm is hurting and now she is having trouble with her rotator cuff.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Face injury, Fall, Haemorrhage, Hyperhidrosis, Loss of consciousness
Clinical narrative: Patient was bleeding after shot was administered. As I started to clean it up she stated she felt nauseous and laid her head on her knees and fell forward. She hit her chin on the ground. I kept her talking while the tech called 911. She lost consciousness for a split second and came right back. She stated she still nauseous and was sweating.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Patient was bleeding after shot was administered. As I started to clean it up she stated she felt nauseous and laid her head on her knees and fell forward. She hit her chin on the ground. I kept her talking while the tech called 911. She lost consciousness for a split second and came right back. She stated she still nauseous and was sweating.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness
Clinical narrative: Pt felt dizzy after receiving immunizations and PPD placement. Had patient lie down, gave ice pack, juice and snack. BP taken. Patient's sx resolved, cleared to leave by RN and MD.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Areflexia, Asthenia, Nuclear magnetic resonance imaging spinal abnormal, Spinal disorder
Clinical narrative: Progressive weakness, areflexia 3 weeks ?.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Culture urine, Decreased appetite, Full blood count, Injection site oedema
Clinical narrative: On-going lethargy, low-grade fever, chills, edema of injection site, poor appetite for five (5) weeks.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Lethargy, Pyrexia, Urine analysis
Clinical narrative: On-going lethargy, low-grade fever, chills, edema of injection site, poor appetite for five (5) weeks.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Fever of 101-102.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Contusion, Induration
Clinical narrative: Pt came in 10/24 and reported arm still bruised from immunization give 10/9/15. It also is a little hard. Was concerned. Let him know bruising should go away at seeing his MD Monday 10/29. Anyway so have him look at it.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Noticed softball sized swelling at injection site. Itchy, hot, painful at 10/26. Only local reaction. Pt taking BENADRYL, using ice on site.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased
Clinical narrative: Severe limitation of movement in left arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropod bite, Infected bite
Clinical narrative: Patient was fine after vaccine. 10 days later noticed 2 bug bites at same site of injection. They were infected due to scratching. MD asked us to report.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Pt came in at 1:30 pm on 10/21/15 to report local reaction to ZOSTAVAX. He developed a raised, red, warm, and painful bump the size of baseball on injection site. No systemic effects reported. Instructed pt to follow up with PCP.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 60 mm round area of erythema surrounding injection site, warm to touch, and tender to palpation. No drainage or lesions noted, no fever.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching for 3 weeks.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Body temperature increased, Drug administered to patient of inappropriate age, White blood cell count increased, Wrong drug administered
Clinical narrative: When she was 4, patient was given the wrong vaccination. She was given Adult Hep A, instead of childrens. The error was not reported to us until recently. Patient was in the triage getting treated for 8 hours with a WBC of 29,000+ temp 104.7.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Swollen left upper arm, below injection site, and pain in left arm and left leg. No fever.
Age: 1.25
Sex: F
Vaccine: MMR, PNC13
Symptoms: Nasal congestion, Rash
Clinical narrative: Rash on R/L face, nare with swelling, couple breaths. H/O egg allergy. ZYRTEC/BENADRYL and allergy referred with EPI PEN Jr. Rx for use with anaphylaxis.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Rash
Clinical narrative: Developed rash 10/7/15. Had varicella vaccine 9/22/15.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a certificated medical assistant referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 03-AUG-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K006117, expiration date 14-JAN-2017, dose and route were not reported). Concomitant drug was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from an office administrator referring to a female patient of unknown age. The patients medical history or concurrent condition were not reported. On an unknown date, a dose of M-M-R II (lot#, expiration date, dose, dose number, route were unspecified was inadvertently administered to the patient who was currently pregnant (last menstrual period (LMP) and estimated due date (EDD) was not provided). No adverse events were reported at the time of the call. The pregnancy outcome was pending. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a certificated medical assistant referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 09-JUL-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K006117, expiration date 14-JAN-2017, dose and route were not reported). Concomitant drug was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 08-JUN-2015, the patients were vaccinated with improperly stored doses of Liquid PEDVAXHIB (lot # was reported as J009051, expiration date was reported as 26-MAR-2016; lot # was reported as K026666, expiration date was reported as 22-OCT-2016, route and dose were not reported. Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No concomitant medications or medical history was reported. On 15-OCT-2015 the patient was vaccinated with PROQUAD (Merck) lot # L005292 with expiry date-17-AUG-2015, which was improperly stored. No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. The events were considered to be not related to PROQUAD (Merck). Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown aye and gender. Pertinent medical history and drug reactions/allergies were not reported. On 01-JUNJ-2015, 08-JUN-2015, 22-JUN-2015 and 20-JUL-2015 the patients were vaccinated with improperly stored doses of M-M-R II (lot # K024038, expiration date 26-NOV-2016, route dose and therapy type were not reported). Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a certificated medical assistant referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 09-JUL-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K006117, expiration date 14-JAN-2017, dose and route were not reported). On 09-JUL-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K006117, expiration date 14-JAN-2017, dose and route were not reported). Concomitant drug was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a certificated medical assistant referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 03-JUL-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K006117, expiration date 14-JAN-2017, dose and route were not reported). Concomitant drug was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information hs been received from a pharmacist referring to an approximately 64 years old patient of unknown gender. The patient had undiagnosed breathing problem and meperidine related allergy. On 19-OCT-2015 the patient was vaccinated with ZOSTAVAX (lot# L028281 with expiration date of 28-OCT-2015, 065 ml once, subcutaneous . Concomitant therapies included SINGULAIR. On 21-OCT-2015, the patient contacted pharmacy complaining of redness at injection site with area "about 6 inches, the size of a smaller" which happened on an unspecified date in October 2015. Pharmacist stated the patient did not report any itching at the injection site. For treatment, the patient was taking BENADRYL and applying ice to the reported injection site. No lab diagnostic studies were performed. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to "about 25" patients of unknown age and gender. The patient's medical history or concurrent condition were not provided. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (lot#, dose, dose number were unspecified) orally. No adverse effects were reported. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65 year old patient of unknown gender. The patient did not have pertinent medical history. The patient had no know allergies. On 13-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX23, lot # K008927 (dose not reported), expiration date 17-MAR-2016, intramuscularly. The patient did not take concomitant therapy. On an unknown date in October 2015, the patient experienced unspecified rash at injection site, red, tender and diagnosed as cellulitis. The patient contacted the office to seek medical attention on 15-OCT-2015 (today), and was seen by a clinician in the office. The patient started on doxycycline for the event. No lab diagnostics studies were performed. The outcome of the event was unknown. This is one of three reports received from the same source. Additional information has been requested.