chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Wheezing
Clinical narrative: Patient returned to office 30-45 mins after vaccines given, complaining of itching, facial swelling, no difficulty breathing. Exam positive flushing, urticaria and slight wheezing, swollen lips. Treated with BENADRYL, Prednisone and Epinephrine.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site urticaria
Clinical narrative: Soreness and erythema with edema at injection site that started 10/30/2011. Presented to office on 10/31/2011 - wheal measuring 17 x 10 x 0 cm to right posterior upper arm.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Oral herpes
Clinical narrative: On 10/26/11 pt had cold sore in mouth. On 10/29/11 pt had reoccurrence of shingles lower back.
Age: 7.0
Sex: F
Vaccine: DTAP, FLU3, PNC13, PPV
Symptoms: Body temperature increased, Injection site pain
Clinical narrative: C/O sight pain shortly after receiving shot and awoke around 2AM with Temp of 103.1.
Age: 1.0
Sex: U
Vaccine: FLU3, HEP, MMR, VARCEL
Symptoms: Croup infectious
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 20-Oct-2011) concerns a 12 month old patient. On 19-Oct-2011 the patient received influenza virus vaccine. On the same day the patient also received MMR II, VARIVAX and Hep B. The patient subsequently developed croup. The patient received dexamethasone on 20-Oct-2011. The event outcome was not reported.
Age: 0.66
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Computerised tomogram normal, Cyanosis, Dyspnoea, Metabolic function test
Clinical narrative: Received vaccination Friday morning, at around 10pm she started having a twitch in her face and limbs, then her lips turned blue, then her whole face turned blue and her limbs were white and motionless. This lasted a couple of min then she gasped for air for 30 sec, then she returned to normal. No prodromal signs or symptoms.
Age: 0.66
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscle twitching, Skin discolouration
Clinical narrative: Received vaccination Friday morning, at around 10pm she started having a twitch in her face and limbs, then her lips turned blue, then her whole face turned blue and her limbs were white and motionless. This lasted a couple of min then she gasped for air for 30 sec, then she returned to normal. No prodromal signs or symptoms.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Swelling noticed in am, redness, hives on entire body noticed in pm. Treated with BENADRYL 12.5mg po x1 with resolution of symptoms.
Age: 11.0
Sex: F
Vaccine: FLUX, MNQ, TDAP
Symptoms: VIIth nerve paralysis
Clinical narrative: 10/26/11. Abrupt onset of facial droop. Increasing 10/27/11. Seen at E.R., dx. w/ Bells Palsy. Rx'd Prednisone 20mg. F/u neurology.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Per mom, after being vaccinated pt was in the car & mom said she had a seizure. She was sure it was because she has had them in the past. Mom will be making an appointment with pt's neurologist for further evaluation.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Red, warm swelling around injection site (R thigh). Rash spreading up to hip and down to knee.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: After receiving multiple vaccines client was advised to wait in waiting area for 10-15 minutes. Mother noticed client slumping in chair - noted client appeared to have fainted. Assisted by several staff to being placed in prone position and client color improved, and became conscious.
Sex: M
Vaccine: PNC13
Symptoms: Otitis media, Pneumonia necrotising, Polymerase chain reaction, Speech disorder developmental
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer Sales representative. A 13-month-old male patient (race unknown) received the third dose of PREVNAR 13 on an unknown date. Relevant medical history and concomitant medications were unknown. It was reported that on an unknown date, the patient experienced otitis media which lead to necrotizing pneumonia. It was noted that the patient also had a speech delay. A polymerase chain reaction (PCR) test was performed on an unknown date (results unknown). Therapeutic measures taken as a result of the events were unknown. The outcome of the event was unknown at time of report.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Rash maculo-papular
Clinical narrative: Patient developed a maculopapular rash (painless) on arms, chest, and back shortly after receiving the flu shot.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Urticaria
Clinical narrative: Developed urticaria 2 1/2 hrs after receiving vaccines in the office: KINRIX and Flu shot.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pruritus, Pain in extremity
Clinical narrative: Patient came in for a flu shot and pneumonia shot on 10-26-11. She received the flu shot in her left arm and PNEUMOVAX in her right arm. She came back on 10-27-11 & said her right shoulder started itching the night of 10-26-11 & her arm was sore. She said she would take some BENADRYL & see her Dr. if it persisted.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Urticaria
Clinical narrative: Vaccine administered 10/27/11, the next day patient started w/ general body aches and hives. Hives were over about 40% of body. Took BENADRYL w/ relief of symptoms over a couple of days.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Saturday evening patient noticed red itchy area on her right cheek (face) feels like getting more intense.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills
Clinical narrative: Patient received vaccine at 10:00 AM. At 3:00 pm that same day he began experiencing aches from head to toe in all joints and began shivering. Wife called pharmacy, was advised to see MD. The MD sent him to the E.R. was given TORADOL injection (per wife) and sxs resolved in 1/2 hour.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA, PNC13
Symptoms: Abasia, Arthralgia, Groin pain, Hypotonia, Pyrexia
Clinical narrative: Please see attached. About 2 hrs after vaccinations were administered, pt woke up screaming and was not able to walk. I gave him MOTRIN at 5:00pm, he received the vaccinations at 5:30pm. I carried him to the car, he then fell asleep. At about 7pm, he woke up screaming, I picked him up and tried to stand up so I could look at his legs and his legs would fall out to the sides, both legs were limp. I could touch his legs, even squeeze them and he had no pain/feeling in his legs. He would scream and grasp his groin/hips from what I assume was cramping in that area. His fever stayed about 102 for the entire 4 days. He would grasp the groin area and just scream. This went on for about 4 days, and after the 5th day he could walk, but it appeared his legs were in braces, he walked straight legged, with a swinging motion. It took about 8 days for him to be able to walk normal and not complain of the pain in his groin/hips.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA, PNC13
Symptoms: Screaming
Clinical narrative: Please see attached. About 2 hrs after vaccinations were administered, pt woke up screaming and was not able to walk. I gave him MOTRIN at 5:00pm, he received the vaccinations at 5:30pm. I carried him to the car, he then fell asleep. At about 7pm, he woke up screaming, I picked him up and tried to stand up so I could look at his legs and his legs would fall out to the sides, both legs were limp. I could touch his legs, even squeeze them and he had no pain/feeling in his legs. He would scream and grasp his groin/hips from what I assume was cramping in that area. His fever stayed about 102 for the entire 4 days. He would grasp the groin area and just scream. This went on for about 4 days, and after the 5th day he could walk, but it appeared his legs were in braces, he walked straight legged, with a swinging motion. It took about 8 days for him to be able to walk normal and not complain of the pain in his groin/hips.
Age: 8.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Decreased appetite, Headache, Pain in extremity, Vomiting
Clinical narrative: Headache, arm soreness, loss of appetite. Starting at 2100 on 10/28/11 vomiting q 20min. for 30 hours, started arm cellulitis. Visited ER 10/29/11.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Blood culture, C-reactive protein, Clostridium test, Decreased appetite, Full blood count
Clinical narrative: 10/27/11 Patient presented to MD office for blood in stool & decreased appetite. Patient was examined and sent to ER where diagnosis of intussusception was made, surgery follow diagnosis.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Haematochezia, Intussusception, Metabolic function test, Microscopy, Surgery
Clinical narrative: 10/27/11 Patient presented to MD office for blood in stool & decreased appetite. Patient was examined and sent to ER where diagnosis of intussusception was made, surgery follow diagnosis.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Ultrasound abdomen abnormal, Urinary system X-ray
Clinical narrative: 10/27/11 Patient presented to MD office for blood in stool & decreased appetite. Patient was examined and sent to ER where diagnosis of intussusception was made, surgery follow diagnosis.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Heart rate increased, Heart rate irregular, Palpitations
Clinical narrative: Went to bed - no problems. Woke with extreme discomfort around 430PM. My heart was racing, tool BP reading 151/113 pulse 135! Machine beeping irregular heartbeat. This continued over an hour. My normal pulse between 64-67. I take two BP medicines.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Activities of daily living impaired, Joint swelling, Mobility decreased, Oedema peripheral
Clinical narrative: My arm & shoulder swelled, very sore, could not move arm well, had to have help getting clothes on. Doctor gave Prednisone 5 mg 6 day pak plus refill.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient started experiencing signs and symptoms the next morning. Patient's left upper arm was red, swollen, hot, and itchy.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Blood aluminium increased, Blood heavy metal test, Dizziness, Fatigue
Clinical narrative: In 2009 I began to have severe headaches and also began to have hand tremors so bad that I could not raise a fork to my mouth without spilling food. I have continued dizziness and after HPV vaccine I had a papilloma growing inside nostril that was surgically removed. I have also become B-12 deficient since receiving HPV vaccines that require monthly B-12 shots. I am extremely fatigued with leg and arm pain. Before these vaccines I was a very athletic student and outgoing. My life is forever changed. How could this Pharmaceutical Industry allow this terrible vaccines approval. Do you at the CDC know how it feels to have your entire life changed by vaccination that the system told you was safe? And in some cases forced on the female population!!! I am trying to get through college as best as I can function but each passing day I never know if I will be so fatigued that I will remain in bed. This is as close to genocide as I've witnessed in my short 21 years. God help this evil system!
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pain in extremity, Papilloma excision, Sinonasal papilloma, Tremor
Clinical narrative: In 2009 I began to have severe headaches and also began to have hand tremors so bad that I could not raise a fork to my mouth without spilling food. I have continued dizziness and after HPV vaccine I had a papilloma growing inside nostril that was surgically removed. I have also become B-12 deficient since receiving HPV vaccines that require monthly B-12 shots. I am extremely fatigued with leg and arm pain. Before these vaccines I was a very athletic student and outgoing. My life is forever changed. How could this Pharmaceutical Industry allow this terrible vaccines approval. Do you at the CDC know how it feels to have your entire life changed by vaccination that the system told you was safe? And in some cases forced on the female population!!! I am trying to get through college as best as I can function but each passing day I never know if I will be so fatigued that I will remain in bed. This is as close to genocide as I've witnessed in my short 21 years. God help this evil system!
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Vitamin B12 deficiency
Clinical narrative: In 2009 I began to have severe headaches and also began to have hand tremors so bad that I could not raise a fork to my mouth without spilling food. I have continued dizziness and after HPV vaccine I had a papilloma growing inside nostril that was surgically removed. I have also become B-12 deficient since receiving HPV vaccines that require monthly B-12 shots. I am extremely fatigued with leg and arm pain. Before these vaccines I was a very athletic student and outgoing. My life is forever changed. How could this Pharmaceutical Industry allow this terrible vaccines approval. Do you at the CDC know how it feels to have your entire life changed by vaccination that the system told you was safe? And in some cases forced on the female population!!! I am trying to get through college as best as I can function but each passing day I never know if I will be so fatigued that I will remain in bed. This is as close to genocide as I've witnessed in my short 21 years. God help this evil system!
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Joint swelling, Paraesthesia
Clinical narrative: 10/13 Injection to top of left shoulder. 10/19 Increasing pain and swelling in shoulder joint. 10/23 Tingling and numbness side of hand and two fingers. 10/24 Tingling and numbness entire hand. 10/24 GP prescribed METHYLPRED 4mg.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Arrhythmia, Autopsy, Blood culture positive, Body fluid analysis, Cardiac failure
Clinical narrative: Company from the FDA under the Freedom of Information Act. A 14 year old female patient was vaccinated on 28-MAR-2011 with the third dose of GARDASIL (lot # 666162/0565Z) (site and route not reported). Concomitant vaccine included first dose of FLUZONE (lot # U3741AA), (site and route not reported) on 28-MAR-2011. Patient was found dead in bed in the morning by family. Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy. Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death. The following information was obtained through follow-up and/or provided by the government. 25-AUG-2011 Autopsy report received. Cause of death consistent with cardiac insufficiency due to cardiac arrhythmia due to probable early cardiomyopathy. Autopsy, including microscopy slides. Heart blood culture showed alpha streptococcus (not Strep. pneumoniae, not enterococcus sp., not Strep. bovis). Femoral blood and vitreous humor samples showed no drugs on complete drug screen. Vitreous panel (Glucose - 32 mg/dL, Sodium - 137 mmol/L, Potassium -15.2 mmol/L, Chloride  -124 mmol/L, Urea nitrogen 13 mg/dL and Creatinine - 1.3 mg/dL). Mildly overweight; concern for idiopathic scoliosis. The following information was obtained through follow-up and or provided by the government. PMH: Previously healthy, Scoliosis, slightly elevated cholesterol. Patient found deceased at home. The VAERS ID # is 430780. The original reporting source was not provided. This report was considered serious due to death by the agency. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Cardiomyopathy, Death, Drug screen negative, Microscopy, Streptococcus test positive
Clinical narrative: Company from the FDA under the Freedom of Information Act. A 14 year old female patient was vaccinated on 28-MAR-2011 with the third dose of GARDASIL (lot # 666162/0565Z) (site and route not reported). Concomitant vaccine included first dose of FLUZONE (lot # U3741AA), (site and route not reported) on 28-MAR-2011. Patient was found dead in bed in the morning by family. Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy. Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death. The following information was obtained through follow-up and/or provided by the government. 25-AUG-2011 Autopsy report received. Cause of death consistent with cardiac insufficiency due to cardiac arrhythmia due to probable early cardiomyopathy. Autopsy, including microscopy slides. Heart blood culture showed alpha streptococcus (not Strep. pneumoniae, not enterococcus sp., not Strep. bovis). Femoral blood and vitreous humor samples showed no drugs on complete drug screen. Vitreous panel (Glucose - 32 mg/dL, Sodium - 137 mmol/L, Potassium -15.2 mmol/L, Chloride  -124 mmol/L, Urea nitrogen 13 mg/dL and Creatinine - 1.3 mg/dL). Mildly overweight; concern for idiopathic scoliosis. The following information was obtained through follow-up and or provided by the government. PMH: Previously healthy, Scoliosis, slightly elevated cholesterol. Patient found deceased at home. The VAERS ID # is 430780. The original reporting source was not provided. This report was considered serious due to death by the agency. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Sudden cardiac death
Clinical narrative: Company from the FDA under the Freedom of Information Act. A 14 year old female patient was vaccinated on 28-MAR-2011 with the third dose of GARDASIL (lot # 666162/0565Z) (site and route not reported). Concomitant vaccine included first dose of FLUZONE (lot # U3741AA), (site and route not reported) on 28-MAR-2011. Patient was found dead in bed in the morning by family. Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy. Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death. The following information was obtained through follow-up and/or provided by the government. 25-AUG-2011 Autopsy report received. Cause of death consistent with cardiac insufficiency due to cardiac arrhythmia due to probable early cardiomyopathy. Autopsy, including microscopy slides. Heart blood culture showed alpha streptococcus (not Strep. pneumoniae, not enterococcus sp., not Strep. bovis). Femoral blood and vitreous humor samples showed no drugs on complete drug screen. Vitreous panel (Glucose - 32 mg/dL, Sodium - 137 mmol/L, Potassium -15.2 mmol/L, Chloride  -124 mmol/L, Urea nitrogen 13 mg/dL and Creatinine - 1.3 mg/dL). Mildly overweight; concern for idiopathic scoliosis. The following information was obtained through follow-up and or provided by the government. PMH: Previously healthy, Scoliosis, slightly elevated cholesterol. Patient found deceased at home. The VAERS ID # is 430780. The original reporting source was not provided. This report was considered serious due to death by the agency. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Arrhythmia, Autopsy, Blood chloride increased, Blood creatinine increased, Blood culture positive
Clinical narrative: Company from the FDA under the Freedom of Information Act. A 14 year old female patient was vaccinated on 28-MAR-2011 with the third dose of GARDASIL (lot # 666162/0565Z) (site and route not reported). Concomitant vaccine included first dose of FLUZONE (lot # U3741AA), (site and route not reported) on 28-MAR-2011. Patient was found dead in bed in the morning by family. Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy. Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death. The following information was obtained through follow-up and/or provided by the government. 25-AUG-2011 Autopsy report received. Cause of death consistent with cardiac insufficiency due to cardiac arrhythmia due to probable early cardiomyopathy. Autopsy, including microscopy slides. Heart blood culture showed alpha streptococcus (not Strep. pneumoniae, not enterococcus sp., not Strep. bovis). Femoral blood and vitreous humor samples showed no drugs on complete drug screen. Vitreous panel (Glucose - 32 mg/dL, Sodium - 137 mmol/L, Potassium -15.2 mmol/L, Chloride  -124 mmol/L, Urea nitrogen 13 mg/dL and Creatinine - 1.3 mg/dL). Mildly overweight; concern for idiopathic scoliosis. The following information was obtained through follow-up and or provided by the government. PMH: Previously healthy, Scoliosis, slightly elevated cholesterol. Patient found deceased at home. The VAERS ID # is 430780. The original reporting source was not provided. This report was considered serious due to death by the agency. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Blood glucose decreased, Blood potassium increased, Blood sodium normal, Blood urea normal, Body fluid analysis
Clinical narrative: Company from the FDA under the Freedom of Information Act. A 14 year old female patient was vaccinated on 28-MAR-2011 with the third dose of GARDASIL (lot # 666162/0565Z) (site and route not reported). Concomitant vaccine included first dose of FLUZONE (lot # U3741AA), (site and route not reported) on 28-MAR-2011. Patient was found dead in bed in the morning by family. Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy. Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death. The following information was obtained through follow-up and/or provided by the government. 25-AUG-2011 Autopsy report received. Cause of death consistent with cardiac insufficiency due to cardiac arrhythmia due to probable early cardiomyopathy. Autopsy, including microscopy slides. Heart blood culture showed alpha streptococcus (not Strep. pneumoniae, not enterococcus sp., not Strep. bovis). Femoral blood and vitreous humor samples showed no drugs on complete drug screen. Vitreous panel (Glucose - 32 mg/dL, Sodium - 137 mmol/L, Potassium -15.2 mmol/L, Chloride  -124 mmol/L, Urea nitrogen 13 mg/dL and Creatinine - 1.3 mg/dL). Mildly overweight; concern for idiopathic scoliosis. The following information was obtained through follow-up and or provided by the government. PMH: Previously healthy, Scoliosis, slightly elevated cholesterol. Patient found deceased at home. The VAERS ID # is 430780. The original reporting source was not provided. This report was considered serious due to death by the agency. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Cardiac failure, Cardiomyopathy, Death, Drug screen negative, Microscopy
Clinical narrative: Company from the FDA under the Freedom of Information Act. A 14 year old female patient was vaccinated on 28-MAR-2011 with the third dose of GARDASIL (lot # 666162/0565Z) (site and route not reported). Concomitant vaccine included first dose of FLUZONE (lot # U3741AA), (site and route not reported) on 28-MAR-2011. Patient was found dead in bed in the morning by family. Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy. Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death. The following information was obtained through follow-up and/or provided by the government. 25-AUG-2011 Autopsy report received. Cause of death consistent with cardiac insufficiency due to cardiac arrhythmia due to probable early cardiomyopathy. Autopsy, including microscopy slides. Heart blood culture showed alpha streptococcus (not Strep. pneumoniae, not enterococcus sp., not Strep. bovis). Femoral blood and vitreous humor samples showed no drugs on complete drug screen. Vitreous panel (Glucose - 32 mg/dL, Sodium - 137 mmol/L, Potassium -15.2 mmol/L, Chloride  -124 mmol/L, Urea nitrogen 13 mg/dL and Creatinine - 1.3 mg/dL). Mildly overweight; concern for idiopathic scoliosis. The following information was obtained through follow-up and or provided by the government. PMH: Previously healthy, Scoliosis, slightly elevated cholesterol. Patient found deceased at home. The VAERS ID # is 430780. The original reporting source was not provided. This report was considered serious due to death by the agency. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Streptococcus test positive, Sudden cardiac death
Clinical narrative: Company from the FDA under the Freedom of Information Act. A 14 year old female patient was vaccinated on 28-MAR-2011 with the third dose of GARDASIL (lot # 666162/0565Z) (site and route not reported). Concomitant vaccine included first dose of FLUZONE (lot # U3741AA), (site and route not reported) on 28-MAR-2011. Patient was found dead in bed in the morning by family. Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy. Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death. The following information was obtained through follow-up and/or provided by the government. 25-AUG-2011 Autopsy report received. Cause of death consistent with cardiac insufficiency due to cardiac arrhythmia due to probable early cardiomyopathy. Autopsy, including microscopy slides. Heart blood culture showed alpha streptococcus (not Strep. pneumoniae, not enterococcus sp., not Strep. bovis). Femoral blood and vitreous humor samples showed no drugs on complete drug screen. Vitreous panel (Glucose - 32 mg/dL, Sodium - 137 mmol/L, Potassium -15.2 mmol/L, Chloride  -124 mmol/L, Urea nitrogen 13 mg/dL and Creatinine - 1.3 mg/dL). Mildly overweight; concern for idiopathic scoliosis. The following information was obtained through follow-up and or provided by the government. PMH: Previously healthy, Scoliosis, slightly elevated cholesterol. Patient found deceased at home. The VAERS ID # is 430780. The original reporting source was not provided. This report was considered serious due to death by the agency. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Convulsion, Faeces discoloured, Flatulence, Injection site eczema, Injection site rash
Clinical narrative: Please see attached clinic note with description of event. Child was not brought in for medical attention at that time nor was contact made by phone.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Irritability
Clinical narrative: Please see attached clinic note with description of event. Child was not brought in for medical attention at that time nor was contact made by phone.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Unevaluable event
Clinical narrative: Please see attached clinic note with description of event. Child was not brought in for medical attention at that time nor was contact made by phone.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: I developed instantaneous pain in left upper arm after flu shot. Has impaired my daily activities, not able to rotate left arm at shoulder without pain. Visited MD - 10-17-11 - referred me to. Visited another MD - 10/20/11 - prescription for therapy.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injection site joint movement impairment, Injection site pain, Pain
Clinical narrative: I developed instantaneous pain in left upper arm after flu shot. Has impaired my daily activities, not able to rotate left arm at shoulder without pain. Visited MD - 10-17-11 - referred me to. Visited another MD - 10/20/11 - prescription for therapy.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypersensitivity, Injection site pruritus, Pruritus generalised, Wheezing
Clinical narrative: Itching, ? audible wheeze 10:47AM took Benadryl 50 mg po, EMS called 10:54AM epinephrine 0.3cc (1:1000) IM 11:00AM EMS arrived
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pruritus
Clinical narrative: Itching, ? audible wheeze 10:47AM took Benadryl 50 mg po, EMS called 10:54AM epinephrine 0.3cc (1:1000) IM 11:00AM EMS arrived
Age: 7.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Biopsy skin abnormal, Blood test normal, Pityriasis lichenoides et varioliformis acuta, Rash generalised
Clinical narrative: Initial report was received on 21 October 2011 from a consumer who is also the patient's father. A seven year-old male patient had received in the AM on 22 September 2011 an intramuscular right deltoid injection of FLUZONE, lot number UH460AA and an unspecified amount of time later in the PM, experienced a red rash "like chicken pox" on his chest, back, neck and groin area. The patient was referred to a dermatologist. A biopsy revealed a diagnosis of Pityriasis lichenoides et varioliformis acuta (PLEVA). Other diagnostic tests included blood tests (results not reported). No further information was available at the time of the report. Outcome was not recovered but slowly improving. Documents held by sender: none.
Age: 7.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Biopsy site unspecified abnormal, Blood test, Pityriasis lichenoides et varioliformis acuta, Rash erythematous, Rash vesicular
Clinical narrative: Initial report was received on 21 October 2011 from a consumer who is also the patient's father. A seven year-old male patient had received in the AM on 22 September 2011 an intramuscular right deltoid injection of FLUZONE, lot number UH460AA and an unspecified amount of time later in the PM, experienced a red rash "like chicken pox" on his chest, back, neck and groin area. The patient was referred to a dermatologist. A biopsy revealed a diagnosis of Pityriasis lichenoides et varioliformis acuta (PLEVA). Other diagnostic tests included blood tests (results not reported). No further information was available at the time of the report. Outcome was not recovered but slowly improving. Documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Extreme pain in the muscle where vaccine was administered. Got worse each day. The vaccine was given very high up on the arm. Patient has been on a six day course of steroids. Now one month later prescribed meloxicam. It is very difficult to do daily chores.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Injection site reaction, Myalgia
Clinical narrative: Extreme pain in the muscle where vaccine was administered. Got worse each day. The vaccine was given very high up on the arm. Patient has been on a six day course of steroids. Now one month later prescribed meloxicam. It is very difficult to do daily chores.
Age: 54.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received Tdap Vaccination 10/18/11. On 10/21/11, patients presented to ER with fever, and erythema, swelling, and redness at injection site. Patient was diagnosed with cellulitis secondary to Tdap IM injection and sent home on outpatient antibiotics.
Age: 54.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient received Tdap Vaccination 10/18/11. On 10/21/11, patients presented to ER with fever, and erythema, swelling, and redness at injection site. Patient was diagnosed with cellulitis secondary to Tdap IM injection and sent home on outpatient antibiotics.
Age: 57.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Headache, Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: 10/23/11, 2 weeks after vaccine was administered, progressive severe muscle pain in left upper-arm extending across shoulder leading to inability to raise arm or move backward accompanied by headache and slight nausea. Area looked normal and felt normal on palpation. 10/28/11 symptoms began to subside. No treatment. This same scenario occured after vaccine received in 2010 but was unreported.
Age: 57.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Nausea
Clinical narrative: 10/23/11, 2 weeks after vaccine was administered, progressive severe muscle pain in left upper-arm extending across shoulder leading to inability to raise arm or move backward accompanied by headache and slight nausea. Area looked normal and felt normal on palpation. 10/28/11 symptoms began to subside. No treatment. This same scenario occured after vaccine received in 2010 but was unreported.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt. had flu shot on 10/4/11. Called pharmacy on 10/27/11 to let us know that she has had a prolonged sore arm. Went to see the doctor on 10/21/11 and has started physical therapy on 10/26/11. Her arm has been very sore and has been having decreased range of motion.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Pt. had flu shot on 10/4/11. Called pharmacy on 10/27/11 to let us know that she has had a prolonged sore arm. Went to see the doctor on 10/21/11 and has started physical therapy on 10/26/11. Her arm has been very sore and has been having decreased range of motion.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling
Clinical narrative: Red raised area about 1/2 dollar in size.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: Went to ER and was diagnosed with Arterial Fibrillation.  First time event.
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Injection site reaction, Rash papular, Rash pruritic
Clinical narrative: Rash at injection site - papular, itchy persists > 3 days.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody positive, Arthralgia, Breast pain, Full blood count, Joint stiffness
Clinical narrative: Multiple joint aches knee/ankles. Breast pain on side of (arm vaccine site). No arm pain - joint stiffness continues.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate, Vitamin D
Clinical narrative: Multiple joint aches knee/ankles. Breast pain on side of (arm vaccine site). No arm pain - joint stiffness continues.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: 9/19/11 sharp shooting pain, feels like getting another shot in area.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dyspepsia, Nausea, Ocular hyperaemia
Clinical narrative: Patient received a flu shot 10/26/11 in the AM at her place of work by H.D nurse. School nurse called H.D when patient came to her c/o eyes being blood shot red, nausea, indigestion, pain in back between shoulder blades.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Pt experienced immediate severe pain of the entire arm after receiving injection. Limited movement and significant pain without improvement to present. Ice/heat provide no relief. A few doses of Ibuprofen were helpful but pt instructed not to take Ibuprofen due to hx of gastric bypass. Pt saw walk in clinic provider 10/31/11 & was told "issues with her rotator cuff" and given a cortisone injection.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain, Blood test, Ear infection, Pain, Pyrexia
Clinical narrative: Pain in upper left side, spleen enlarged, ear infection, fever on and off two weeks, vomiting, severe abdominal pain that is still persistent almost two months later.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Splenomegaly, Stool analysis, Ultrasound scan, Vomiting, X-ray
Clinical narrative: Pain in upper left side, spleen enlarged, ear infection, fever on and off two weeks, vomiting, severe abdominal pain that is still persistent almost two months later.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Joint soreness in ankles, feet, knees and hips, inability to move. Persists to this day.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: VIIth nerve paralysis
Clinical narrative: The afternoon of the day after receiving Flumist, mother and speech therapist noticed that patient's left side of his face was drawn up (in actuality, the right side was drooping).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: TREATMENT: PREDNISOLONE AND CLINDAMYCIN SUSPENSIONS.  SITE WHERE INJ. WAS GIVEN WAS RED, PAINFUL AND WARM.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Abdominal pain upper, Diarrhoea, Headache, Pain
Clinical narrative: Very watery diarrhea with stomach cramps and headache.  Very achy.  This lasted till mid afternoon and the sore tummy lasted till next day.  Had another loose bowel on 11/1/2011.  Also have runny nose but that is probably due to seasonal allergies.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Rhinorrhoea, Seasonal allergy
Clinical narrative: Very watery diarrhea with stomach cramps and headache.  Very achy.  This lasted till mid afternoon and the sore tummy lasted till next day.  Had another loose bowel on 11/1/2011.  Also have runny nose but that is probably due to seasonal allergies.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Croup infectious, X-ray
Clinical narrative: Severe sudden onset of croup. Racemic epi neb give, decadron in office.  Transferred by ambulance to hospital for overnight observation.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injection site pain, Pain, Pain in extremity
Clinical narrative: Injection site pain immediate and severe.  Pain started at the time needle inserted and increased as Vaccine was administered.  Severe Pain diminished somewhat in first 72 hours but moderate to severe pain remains in L arm around and adjacent to injection site.  Pain exacerbates with motion of the arm.  No injection site erythema, edema or rash was ever noted.  At present, I am experiencing constant pain wich exacerbates upon movement of my arm and have difficulty performing activities of daily living.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Pain
Clinical narrative: Injection site pain immediate and severe.  Pain started at the time needle inserted and increased as Vaccine was administered.  Severe Pain diminished somewhat in first 72 hours but moderate to severe pain remains in L arm around and adjacent to injection site.  Pain exacerbates with motion of the arm.  No injection site erythema, edema or rash was ever noted.  At present, I am experiencing constant pain wich exacerbates upon movement of my arm and have difficulty performing activities of daily living.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching, scattered hives on bother arms.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry mouth, Feeling abnormal, Lip swelling
Clinical narrative: Pt came back to the pharmacy a short while after receiveing the vaccine with symptoms of dry mouth and swollen lips. Pt said she just didn't feel like herself.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: 1-2 days after injection was administered patient experienced inflammation/redness at site of injection - soreness, warm feverish knot around injection site. All symptoms have subsided at area around injection site still slightly red.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Erythema, Rash macular, Somnolence
Clinical narrative: Redness to skin - splotchy, non tender more sleepy than normal.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Balance disorder, Chills, Confusional state, Depressed mood
Clinical narrative: See other sheet. The next day after receiving my flu shot, I experienced hyperventilation and had to breath into a small brown paper bag. I also had a fever of 102-103 F with cold chills. I had nausea for 1 wk along with diarrhea. I had severe aching and pain in my muscles and stiffness in my joints. I had severe back pain esp in flank areas. I was told to call the doctor until the 3rd day after receiving the flu shot. I experiencing severe dizziness - my equilibrium was off and my gait was very unsteady - so much that I fell down 2 times I was pale, lethargic & depressed. I felt confused & disoriented. I developed severe sinus infections and fever blisters all over my upper & lower lips. My neck was very stiff and I had severe headaches, when I was finally able to go to the doctor, I was put on antibiotics, acyclovir and PHENERGAN. My flu test was negative. I was more sick than if I had the flu itself. I had no URI or congestion. I was told that I had a rare and severe reaction to the flu vaccine. I will never get another one. This was as sick as I have ever been. Thank you for the vaccine adverse effect form. It has been 1 wk now after receiving the vaccine, and I still don't feel well.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Disorientation, Dizziness, Fall, Gait disturbance
Clinical narrative: See other sheet. The next day after receiving my flu shot, I experienced hyperventilation and had to breath into a small brown paper bag. I also had a fever of 102-103 F with cold chills. I had nausea for 1 wk along with diarrhea. I had severe aching and pain in my muscles and stiffness in my joints. I had severe back pain esp in flank areas. I was told to call the doctor until the 3rd day after receiving the flu shot. I experiencing severe dizziness - my equilibrium was off and my gait was very unsteady - so much that I fell down 2 times I was pale, lethargic & depressed. I felt confused & disoriented. I developed severe sinus infections and fever blisters all over my upper & lower lips. My neck was very stiff and I had severe headaches, when I was finally able to go to the doctor, I was put on antibiotics, acyclovir and PHENERGAN. My flu test was negative. I was more sick than if I had the flu itself. I had no URI or congestion. I was told that I had a rare and severe reaction to the flu vaccine. I will never get another one. This was as sick as I have ever been. Thank you for the vaccine adverse effect form. It has been 1 wk now after receiving the vaccine, and I still don't feel well.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hyperventilation, Influenza virus test negative, Joint stiffness, Lethargy
Clinical narrative: See other sheet. The next day after receiving my flu shot, I experienced hyperventilation and had to breath into a small brown paper bag. I also had a fever of 102-103 F with cold chills. I had nausea for 1 wk along with diarrhea. I had severe aching and pain in my muscles and stiffness in my joints. I had severe back pain esp in flank areas. I was told to call the doctor until the 3rd day after receiving the flu shot. I experiencing severe dizziness - my equilibrium was off and my gait was very unsteady - so much that I fell down 2 times I was pale, lethargic & depressed. I felt confused & disoriented. I developed severe sinus infections and fever blisters all over my upper & lower lips. My neck was very stiff and I had severe headaches, when I was finally able to go to the doctor, I was put on antibiotics, acyclovir and PHENERGAN. My flu test was negative. I was more sick than if I had the flu itself. I had no URI or congestion. I was told that I had a rare and severe reaction to the flu vaccine. I will never get another one. This was as sick as I have ever been. Thank you for the vaccine adverse effect form. It has been 1 wk now after receiving the vaccine, and I still don't feel well.