chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pharyngeal oedema, Pyrexia, Wheezing
Clinical narrative: Immunized at 1245 pm. Within a few minutes, my throat was swollen.(no prob breathing) Within 2-3 hours, I felt like there was water in my lungs. At about 4 hours, I couldn't stop coughing, wheezing. It sounded like I was barking. My eyes were very swollen and became very inflamed with discharge. My was swelling as well to a little lesser degree. I had a low grade fever, 99.9 and in the next hours had chills, and nausea-no vomiting. The following day, I felt achy and cold,I took an antihistamine and my eyes became less swollen by evening. Most of symptoms disappeared within 48 hours except for intermittent intense headaches, mild nausea in the evenings and intermittent pain on my rt side and general malaise. (I've taken the flu shot on many occasions with no adverse reactions)
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Dyspnoea, Face oedema, Ocular hyperaemia, Pain
Clinical narrative: Immunized at 1245 pm. Within a few minutes, my throat was swollen.(no prob breathing) Within 2-3 hours, I felt like there was water in my lungs. At about 4 hours, I couldn't stop coughing, wheezing. It sounded like I was barking. My eyes were very swollen and became very inflamed with discharge. My was swelling as well to a little lesser degree. I had a low grade fever, 99.9 and in the next hours had chills, and nausea-no vomiting. The following day, I felt achy and cold,I took an antihistamine and my eyes became less swollen by evening. Most of symptoms disappeared within 48 hours except for intermittent intense headaches, mild nausea in the evenings and intermittent pain on my rt side and general malaise. (I've taken the flu shot on many occasions with no adverse reactions)
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pharyngeal oedema, Pruritus, Pulmonary congestion, Pyrexia
Clinical narrative: Immunized at 1245 pm. Within a few minutes, my throat was swollen.(no prob breathing) Within 2-3 hours, I felt like there was water in my lungs. At about 4 hours, I couldn't stop coughing, wheezing. It sounded like I was barking. My eyes were very swollen and became very inflamed with discharge. My was swelling as well to a little lesser degree. I had a low grade fever, 99.9 and in the next hours had chills, and nausea-no vomiting. The following day, I felt achy and cold,I took an antihistamine and my eyes became less swollen by evening. Most of symptoms disappeared within 48 hours except for intermittent intense headaches, mild nausea in the evenings and intermittent pain on my rt side and general malaise. (I've taken the flu shot on many occasions with no adverse reactions)
Age: 0.65
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Crying
Clinical narrative: Constant, uncontrollable crying.
Age: 1.31
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Drug ineffective, Laboratory test abnormal, Malaise, Parotitis, Pyrexia
Clinical narrative: Vaccine Failure - child was diagnosed with mumps 10/15/05.  Symptoms - fever (onset=10/13/05), malaise (onset-10/13/05), unilater parotitis (10/15/05)
Age: 1.31
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Viral infection
Clinical narrative: Vaccine Failure - child was diagnosed with mumps 10/15/05.  Symptoms - fever (onset=10/13/05), malaise (onset-10/13/05), unilater parotitis (10/15/05)
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Faeces pale, Urticaria, Vomiting
Clinical narrative: Vaccine administered on 10/20/05 @0745 Per notes in chart: pt vomiting thick mucous & large amount of big yellow stool; Sats decreased to 93-94% and BP 80-90's/50-60's on 10/20/05 @0845 Solu-medrol 20mg IV and Benadryl 10mg IV given @0930 Hives noted by nurse
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Muscle spasticity
Clinical narrative: Patient reported increased spasticity and some increased shortness of breath 1 week after receiving immunization.
Age: 40.0
Sex: M
Vaccine: RAB
Symptoms: Chills, Hot flush, Pain, Pyrexia
Clinical narrative: On the evening after the second Rabavert was received, pt. complained of chills, whole body ache, hot flashes, Temp 99. He called the oncall doctor who did not return his call. Episode lasted 24 - 36 hours. Pt. started feeling better after that and is back to work.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Headache, Injection site rash, Pyrexia
Clinical narrative: Developed a rash (approximately 3 inches in size)at the injection site.  Also suffered from fever, headaches, and lightheadedness.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Dyspnoea, Hyperhidrosis, Nausea
Clinical narrative: Approximately 3 hours after injection I had the following symptoms: difficulty breathing, cold sweat, body aches and weakness. Then in another two hours turned into severe nausea, dizziness. Symptoms lasted 12 to 15 hours. Was very close to going to the emergency room when I fell asleep.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Approximately 3 hours after injection I had the following symptoms: difficulty breathing, cold sweat, body aches and weakness. Then in another two hours turned into severe nausea, dizziness. Symptoms lasted 12 to 15 hours. Was very close to going to the emergency room when I fell asleep.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site reaction
Clinical narrative: Patient had Flu vaccine and Pneumonia vaccination in same arm on 10/11/2005 at a local grocery store. Seen my office 10/13/2005 with severe reaction at site of injection. Treated with steroid orally and local measures
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Anorexia, Headache, Influenza, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: had flu shot on Oct 19, became sick with flu on Oct 22, rather severe, sore throat, fever, headache, unable to eat for 24 hours.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Client experienced facial tingling - 5 minuest after immunization - predominently on the right side. Given 50mg Benedrly P.O. 10 minutes after immunization. Vital signs stable. Hx: allergy to iodine - anaphylaxis. Tingling decreased by 30 minutes following the event. Client's vital signs remained stable. Client instructed to follow-up in the ER if client experienced difficulty breathing or tingling returned.
Age: 57.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Confusional state, Neurological symptom
Clinical narrative: Pt 18 hrs after vaccine and Avonex shot, became confused and began having neurologic changes. He wanted to go to the hospital.
Age: 57.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Abdominal pain, Bacterial infection, Disorientation, Injection site pain, Laboratory test abnormal
Clinical narrative: Pt 18 hrs after vaccine and Avonex shot, became confused and began having neurologic changes. He wanted to go to the hospital.
Age: 57.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Muscle spasms, Sepsis
Clinical narrative: Pt 18 hrs after vaccine and Avonex shot, became confused and began having neurologic changes. He wanted to go to the hospital.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Shot administered on 10/22/05. Redness at injection site on posterior upper L arm began next day. Diagnosed with cellulitis on 10/27/05. Started on oral cef..  Recheck on 10/31/05 showed vast improvement. Will complete 7-day course
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on neck, back, arms, within 18 hours. Then progressed to torso and thighs within 5 days. 12/04 shows mild rash.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dysphagia
Clinical narrative: Developed inability to swallow solid food 10/28/05 which worsened by 10/27/05 and is now having trouble swallowing liquids. Went to hospital walk in 10/27/05. Given prednisone 20 mg TID for 3 days and Pepcid. Not started as of this writing.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Injection site reaction, Paraesthesia, Pruritus
Clinical narrative: Injection site felt like "Bee Sting" while driving home. Upper arm was tingly, warm to touch. Red, swollen and itchy 15 minutes after injection. Eventually redness went from shoulder  to elbow. Seen at hospital and given prednisone and Atarax at 9:30 am
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Insomnia, Oedema, Pain, Vision blurred
Clinical narrative: Swelling, redness of right arm 7 hours after shot. Arm very painful, unable to sleep. Blurry vision. To P.C.P in am of 10/27 - ordered ice pack only. Went to hospital 10 am 10/27/05 was given prednisone taper pack
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema, Pyrexia
Clinical narrative: Red swollen area on arm less than 4 inches. Low grade fever 99 degrees F.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Tremor
Clinical narrative: Had flu immunization 10/28/05 next day her RUE shakes when she extends her arm. Also complained pain R deltoid and antecubital area, no numbness no area change. No febrile
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Cough, Diarrhoea
Clinical narrative: Developed chronic rhinitis, gastritis, and fatigue after AVA. Symptoms: epigastric pain, nasal drainage, fatigue, malaise > 60 days.  I have stomach pain and lots of episodes of cough and mucous that started after I had the Anthrax shot. In Dec. 2000 he began to have stomach pain intermittently as well as episodes of cough. He did not seek treatment for the gastrointestinal symptoms but did seek care for the respiratory problem. He states he received antibiotics and other unknown medications. He states he "didn't feel like himself" after receiving each Anthrax injection. He says he "was not sick but felt a burning all over his body" and had a headache that lasted a couple of days then resolved. States he also developed fatigue after the 3-4th shot.  In 2003 he reports that he experienced an acute illness for several days and had a fever to 104 f. He was given an antibiotic and the acute symptoms resolved. However, he states his symptoms of intermittent productive cough, gastric pain, diarrhea, headache and having some generalized joint pain and dizzy spells. he sought medical treatment after he left the military but symptoms have continued. He states his life has been profoundly effected by this condition. He does not have the energy to play sports or to go out with his family. He is continually tired. States he sleeps well but does not awaken refreshed. There have been multiple reports to the VAERS center of fibromyalgia-like and chronic fatigue symptoms temporally associated to receipt of the anthrax vaccine. The etiology of fibromyalgia and chronic fatigue syndrome remains poorly understood. Endocrinolgic and neurologic findings in patients suggest that disturbances in the autonomic and endocrine stress response systems may underlie the etiology. How these pathophysiologic processes are set in motion is not understood, but studies have shown that genetic factors may contribute. The prevalence of pre-morbid physical and psychological trauma is high in these patients as well as environmental factors such as infections, emotional stress, catastrophic events (war) autoimmune disease, and other pain conditions. Symptomatology began 8 months after receipt of the last Anthrax vaccine dose on 4/4/00. He also contracted a significant viral illness in 2003 after which his symptoms worsened. Based on the knowledge that we currently have, vaccine adverse events characteristically develop between 1-60 days after vaccine receipt. We will place this service member in our database and contact him if new information evolves regarding the association of these symptom complexes and immunizations.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Fatigue, Gastritis, Headache, Malaise
Clinical narrative: Developed chronic rhinitis, gastritis, and fatigue after AVA. Symptoms: epigastric pain, nasal drainage, fatigue, malaise > 60 days.  I have stomach pain and lots of episodes of cough and mucous that started after I had the Anthrax shot. In Dec. 2000 he began to have stomach pain intermittently as well as episodes of cough. He did not seek treatment for the gastrointestinal symptoms but did seek care for the respiratory problem. He states he received antibiotics and other unknown medications. He states he "didn't feel like himself" after receiving each Anthrax injection. He says he "was not sick but felt a burning all over his body" and had a headache that lasted a couple of days then resolved. States he also developed fatigue after the 3-4th shot.  In 2003 he reports that he experienced an acute illness for several days and had a fever to 104 f. He was given an antibiotic and the acute symptoms resolved. However, he states his symptoms of intermittent productive cough, gastric pain, diarrhea, headache and having some generalized joint pain and dizzy spells. he sought medical treatment after he left the military but symptoms have continued. He states his life has been profoundly effected by this condition. He does not have the energy to play sports or to go out with his family. He is continually tired. States he sleeps well but does not awaken refreshed. There have been multiple reports to the VAERS center of fibromyalgia-like and chronic fatigue symptoms temporally associated to receipt of the anthrax vaccine. The etiology of fibromyalgia and chronic fatigue syndrome remains poorly understood. Endocrinolgic and neurologic findings in patients suggest that disturbances in the autonomic and endocrine stress response systems may underlie the etiology. How these pathophysiologic processes are set in motion is not understood, but studies have shown that genetic factors may contribute. The prevalence of pre-morbid physical and psychological trauma is high in these patients as well as environmental factors such as infections, emotional stress, catastrophic events (war) autoimmune disease, and other pain conditions. Symptomatology began 8 months after receipt of the last Anthrax vaccine dose on 4/4/00. He also contracted a significant viral illness in 2003 after which his symptoms worsened. Based on the knowledge that we currently have, vaccine adverse events characteristically develop between 1-60 days after vaccine receipt. We will place this service member in our database and contact him if new information evolves regarding the association of these symptom complexes and immunizations.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Paraesthesia, Rhinitis, Rhinorrhoea
Clinical narrative: Developed chronic rhinitis, gastritis, and fatigue after AVA. Symptoms: epigastric pain, nasal drainage, fatigue, malaise > 60 days.  I have stomach pain and lots of episodes of cough and mucous that started after I had the Anthrax shot. In Dec. 2000 he began to have stomach pain intermittently as well as episodes of cough. He did not seek treatment for the gastrointestinal symptoms but did seek care for the respiratory problem. He states he received antibiotics and other unknown medications. He states he "didn't feel like himself" after receiving each Anthrax injection. He says he "was not sick but felt a burning all over his body" and had a headache that lasted a couple of days then resolved. States he also developed fatigue after the 3-4th shot.  In 2003 he reports that he experienced an acute illness for several days and had a fever to 104 f. He was given an antibiotic and the acute symptoms resolved. However, he states his symptoms of intermittent productive cough, gastric pain, diarrhea, headache and having some generalized joint pain and dizzy spells. he sought medical treatment after he left the military but symptoms have continued. He states his life has been profoundly effected by this condition. He does not have the energy to play sports or to go out with his family. He is continually tired. States he sleeps well but does not awaken refreshed. There have been multiple reports to the VAERS center of fibromyalgia-like and chronic fatigue symptoms temporally associated to receipt of the anthrax vaccine. The etiology of fibromyalgia and chronic fatigue syndrome remains poorly understood. Endocrinolgic and neurologic findings in patients suggest that disturbances in the autonomic and endocrine stress response systems may underlie the etiology. How these pathophysiologic processes are set in motion is not understood, but studies have shown that genetic factors may contribute. The prevalence of pre-morbid physical and psychological trauma is high in these patients as well as environmental factors such as infections, emotional stress, catastrophic events (war) autoimmune disease, and other pain conditions. Symptomatology began 8 months after receipt of the last Anthrax vaccine dose on 4/4/00. He also contracted a significant viral illness in 2003 after which his symptoms worsened. Based on the knowledge that we currently have, vaccine adverse events characteristically develop between 1-60 days after vaccine receipt. We will place this service member in our database and contact him if new information evolves regarding the association of these symptom complexes and immunizations.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site rash, Injection site warmth
Clinical narrative: Rash and warm on injection site down to elbow. 2 red streaks. Treated with amox.
Sex: U
Vaccine: PPV
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Warm and red rash from injection site to elbow. Hot compress
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Laboratory test abnormal
Clinical narrative: 10/28/05 Lt thigh with 3cmX1 3/4 red indurated, warm with central injection site: + ?? + range ??.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Injection site rash, Injection site swelling, Muscular weakness, Myalgia
Clinical narrative: On 10/24/05 client called our clinic and stated she believes she had some kind of reaction to td immunization she received 8/30/05. States she has muscular pain arm was sore since beginning and got worse. She developed a rash for 11 days around injection site with gold ball size swelling. Called client 11/1/05 and stated her muscle ?? weakens at times and arm sore when she lays on her Left side and moves it at times
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Pain, Pyrexia, Red blood cell abnormality
Clinical narrative: This case was reported by a pharmacist and described the occurrence of elevated red blood cell count in a 76 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On Oct 20 2005 the subject received a dose of Fluarix (lot AFLUA1200AA). the pharmacist did not report a previous history of vaccination to influenza virus. On Oct 21 2005, one day following vaccination with Fluarix, the subject experienced an elevated red blood cell count, leg weakness, a high fever and pain throughout her body. The subject was hospitalized on Oct 24 2005 for testing. The events were ongoing at the time of initial reporting, Oct 31 2005. The pharmacist considered the events to possibly be related to vaccination with Fluarix, The pharmacist also stated that , no cause has been determined for her symptoms other than the patient had received the flu vaccine the previous day.
Age: 0.17
Sex: M
Vaccine: HIBV, HIBV
Symptoms: Agitation, Irritability, Opisthotonus, Photophobia, Pyrexia
Clinical narrative: Inconsolable and arching back off and on for 7-8 hours starting 1 1/2 hours after the vaccine, felt warm. (temperature not taken) X 24 hours, slept fitfully X 24 hours, sensitive to light and touch.
Age: 0.17
Sex: M
Vaccine: HIBV, HIBV
Symptoms: Agitation, Feeling hot, Hyperaesthesia, Opisthotonus, Photophobia
Clinical narrative: Inconsolable and arching back off and on for 7-8 hours starting 1 1/2 hours after the vaccine, felt warm. (temperature not taken) X 24 hours, slept fitfully X 24 hours, sensitive to light and touch.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ, FLU3, MNQ
Symptoms: Facial palsy, Headache, Hypoaesthesia, Tongue paralysis
Clinical narrative: Pt vaccinated 10/21/05 without difficulty with Flu and Menactra. returned to office 10/25/05 with Bell's palsy.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ, FLU3, MNQ
Symptoms: Facial palsy
Clinical narrative: Pt vaccinated 10/21/05 without difficulty with Flu and Menactra. returned to office 10/25/05 with Bell's palsy.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Influenza Vaccine given SQ.  Local reaction w/ 10 cm of indurated erythema developed around injection site.  This reaction persisted for ~ 7 days.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Feeling hot, Rash papular, Tenderness
Clinical narrative: Influenza Vaccine given SQ.  Local reaction w/ 10 cm of indurated erythema developed around injection site.  This reaction persisted for ~ 7 days.
Age: 24.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Call received day after receiving above vaccines re: nausea/vomiting and diarrhea, 10-15 hours after receiving above vaccines.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Erythema multiforme
Clinical narrative: Erythema multif head to toe starting 5 day after vaccine administered.
Age: 0.78
Sex: M
Vaccine: PNC
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Cellulitis, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: Left thigh edema, warm, red, fever.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Pain
Clinical narrative: 10 cm rash over site of injection. R deltoid with body aches.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Pt was given pneumococcal in R deltoid IM, 1 day later return to office with cellulitis and itchiness red hot arm with some slight swelling.
Age: 5.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: Patient's mother called and stated that the patient had a very hot, hard and red arm on left side, between shoulder and elbow some puss coming out. Patient was going to the doctor for treatment.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Agitation, Cough, Crying, Erythema, Feeling hot
Clinical narrative: Area of left deltoid very warm to touch, and firm with redness about 3" in length and 2" in width. Mother of client reports crying and lots of coughing about 4:00 am on 10/27/2005.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site induration
Clinical narrative: Area of left deltoid very warm to touch, and firm with redness about 3" in length and 2" in width. Mother of client reports crying and lots of coughing about 4:00 am on 10/27/2005.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Blood pressure increased, Cardiac disorder, Dizziness, Headache, Nausea
Clinical narrative: Initial report received from a patients parent who is a health care provider on Oct 19 2005. An 18 year old male patient with a medical history of decreased heart rate, attributed to an athletic history and determined by a cardiologist, received an injection of Meningococcal vaccine identified as Menomune, lot number 41675AA (not a valid lot number), in July 2005. The route and site of administration were not reported. Illness at the time of vaccination was unsure and other medications were none. Around the time of vaccination, the patient experienced headache, dizziness and nausea. At an unspecified time later, the patient experienced elevated blood pressure and decreased heart rate. The patient was seen in an ER two weeks prior to the initial report date and referred to a neurologist for follow up. The patient had an MRI (scheduled for Oct 18 2005) and was seen by a neurologist on Oct 20 2005. Per the reporter, the neurologist did not feel the patients symptoms were related to the vaccine, and the patient continues to be monitored and evaluated. He continues to experience dizziness at times during the day and has occasional headache and nausea. At the time of this report, the patient had not recovered. although the product was reported to have been Menomune, the lot number was not a valid manufacture lot number as indicated above. The lot number provided was very similar to a Menactra lot number and the decision was made to enter the suspect product as Menactra at this time.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site vesicles, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 year old female who on 9/28/05 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (lot # 649274/0896P). On 10/11/05, the patient presented with a vesicular rash at the injection site that the CMA reported might have been shingles. The patient was treated with valacyclovir hydrochloride. Subsequently, the patient fully recovered. No product quality complaint was involved. The reporter considered the adverse event to be an other important medical event (OMIC). Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Dyspnoea, Hypersensitivity
Clinical narrative: Information has been received from a physician concerning a patient with an egg allergy who between January and May of 2005 was vaccinated subcutaneously with a 0.5 ml dose of varicella virus vaccine live (date unspecified). Concomitant suspect vaccination given on that same day included a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently, on the same evening thee patient experienced an trouble breathing also reported as allergic reaction and was taken to the hospital for possible adverse reaction following vaccination. It was reported that the patient was hospitalized for 1-2 days for further testing. The outcome was reported as recovered. No further information was available. No product quality complaint was involved. Additional information is not expected.
Age: 0.3
Sex: M
Vaccine: PNC
Symptoms: Meningitis, White blood cell count increased
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a nurse regarding a 4 month old male patient who received a second dose of Prevnar on Oct 5 2005. On Oct 23 2005, the child developed viral meningitis. No allergies or previous drug reactions reported, medical record unremarkable. Indication for Prevnar was immunization. Product was administered on Oct 5 2005. Dose regimen was 0.5 ml 1 time per day intramuscular. Concomitant medication were not reported. On Oct 5 2005, the patient received a second dose of Prevnar. On Oct 23 2005, the patient developed viral meningitis. On an unspecified date in Oct 2005, a spinal fluid culture was performed that showed no growth for 72 hours. On Oct 24 2005, the patient was hospitalized. His white count on admission was noted to be 42,000. The child was treated with Ampicillin and Rocephin. On an unspecified date the reporter noted that the child's white count had dropped. As of Oct 26 2005 the patient recovered. No additional information was available at the time of this report.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU3, HBHEPB, PNC
Symptoms: Febrile convulsion
Clinical narrative: Febrile Seizure lasting about 5 min evaluated in ER then DCd. No known family hx of seizure. Given Motrin in ER and seizure info in office.
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Back pain, Face oedema, Rash papular
Clinical narrative: A non serious spontaneous case from a nurse involving Papular rash around eyes. The reporter causality is possibly related to FluMist. This case is submitted according to the VAERS safety surveillance accelerated reporting agreement with FluMist. A nurse practitioner reported that a 38 year old female patient experienced non pruritic papular rash around both eyes, back pain and maxillofacial edema, one day after she received FluMist on Oct 6 2005. No accompanying shortness of breath was noted. per the reporter, symptoms presented were not consistent with angioedema. She went back to the clinic ans was prescribed with oral Benadryl (Diphenhydramine), ranitidine, Motrin (ibuprofen) and Percocet (acetaminophen/oxycodone). Complete blood count and urinalysis were done, both of which were within normal. As of Oct 21 2005, the patient has completely recovered from adverse events reported. The reporter assessed the events as possibly related to FluMist.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Localized reaction to flu vaccine: redness 3 1/2 cm and swelling, slightly warm to the area. To ice area and return if symptoms become worse.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site induration, Pain
Clinical narrative: Vaccine given 10:00 am on 10/21/2005 began with pain in left elbow about 4 hours after injection. Took Tylenol deltoid area became hot, hard and painful at some time as the elbow started hurting waited 4 hours took Motrin. Next day pain continued. On Sunday used compresses went to ER on Sunday did EKG, lab test, all test were normal. Given antiinflammatory (Motrin) and Percocet.
Age: 12.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Oedema, Pain
Clinical narrative: Patient received vaccines on10/28/2005 right arm swollen to quarter size, left arm swollen to about soft ball size. Denies any redness , soreness on and off with movement. Mom called office 10/31/2005 to report symptoms that started on 10/29/2005
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Urticaria
Clinical narrative: Hives all over body starting Sat Oct 29 , blisters left wrist area Sat Oct 29am, Sun night took antihistamine call info MD await return.
Age: 1.01
Sex: F
Vaccine: FLU3, HBHEPB, MMR, VARCEL
Symptoms: Irritability, Rash morbilliform
Clinical narrative: Unusual fussiness for 1 week, then measle type rash.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, pruritus left arm 2 days after injection treated with cool compress, Benadryl, lotrisone cream.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Hyperhidrosis, Muscle spasms
Clinical narrative: Received vaccine at approximately 11am. At 7pm that same night, employee c/o sweating profusely with uncontrollable chills along with muscle cramps (legs and feet). C/o feeling extremely weak and felt he would pass out. At midnight, he felt a migrating heat from chest to back and down to scrotum. He fell asleep at 2am.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Received vaccine at approximately 11am. At 7pm that same night, employee c/o sweating profusely with uncontrollable chills along with muscle cramps (legs and feet). C/o feeling extremely weak and felt he would pass out. At midnight, he felt a migrating heat from chest to back and down to scrotum. He fell asleep at 2am.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Erythema, warmth,edema in 10cm x 13cm area around injection site.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Medication error
Clinical narrative: Administered Pneumococcal vaccine which expired 06/04/2005. No adverse event.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Medication error
Clinical narrative: Administered Pneumococcal vaccine which expired on June 04 2005, no adverse events.
Age: 13.0
Sex: M
Vaccine: HEP, TD
Symptoms: Medication error
Clinical narrative: Pt received any adult Hep B as third dose instead of Child/adolescent dose. No adverse reaction reported.
Age: 17.0
Sex: F
Vaccine: YF
Symptoms: Bronchospasm
Clinical narrative: Per father approx 25 - 30 min after leaving our office. Pt developed bronchospasms requiring epinephrine per Pts father. Pts father notified us at 1pm twin sister also received vaccine with no reactions reported.
Age: 28.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Coma, Convulsion, Dizziness, Heart rate decreased, Hypotension
Clinical narrative: Pt. got his Hepatitis A, Yellow fever, and Typhoid vaccines in Travel Health center on the date mentioned in the form. Pt. became lightheaded initially after the first shot and was asked to lie down on the table. He said he is o.k and put his head between his knees. After getting the subsequent vaccinations, he went "blank" as per the MA. As per his wife who was in the room with him, he had a tonic-clonic seizure and left eye gaze. MA called for help. By the time I saw the pt. he is unresponsive. With the help of his wife, I got him out of the chair on to the floor. After being on the floor for 15 seconds and repeatedly calling his name and tapping on his face he became responsive. Travel Health coordinator called the operator at the hospital for help. His BP is was initially in the 80's and PR in 40's. An Internist who works in the same suite came to help us. After the pt. became responsive, he said he is totally aware of everything that happened and refused our recommendations to go to the ER. He lied down on the floor for 15 minutes. His BP eventually improved to 110/80, PR to 66 and his oxygen saturation was 96% on Room air. His Blood glucose by finger stick was 99. Pt. left the travel health center fine.
Age: 17.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Hot flush, Nausea, Pruritus, Rash
Clinical narrative: At 11:45 ct. developed rash on arms, neck and inside of mouth near back of throat. Went to school nurse who told her to wash up and return to class.  Rash described as itching badly, red raised spots with white bump in middle.  Hot flashes no fever.  Ct's mother called writer at 3:40 PM and described SX. Writer advised her to take Benydryl (ct. states itching was somewhat relieved and rash improved) and take ct. to ED and if any breathing difficulties call 911.  Ct. saw pediatrician who examined her and sent home.  At 11:00 PM ct. developed severe headache and severe nausea. Pediatrician sent to local ED.   Itching relieved w/ Benydryl 25 mg.  at home 4:00 PM.  Emergency Dept. - Ultraset for HA, Phenegren for nausea and more Benydryl. 11/2, 10:00 AM - rash resolved, slight HA, slight nausea, resting comfortably.
Age: 17.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash erythematous
Clinical narrative: At 11:45 ct. developed rash on arms, neck and inside of mouth near back of throat. Went to school nurse who told her to wash up and return to class.  Rash described as itching badly, red raised spots with white bump in middle.  Hot flashes no fever.  Ct's mother called writer at 3:40 PM and described SX. Writer advised her to take Benydryl (ct. states itching was somewhat relieved and rash improved) and take ct. to ED and if any breathing difficulties call 911.  Ct. saw pediatrician who examined her and sent home.  At 11:00 PM ct. developed severe headache and severe nausea. Pediatrician sent to local ED.   Itching relieved w/ Benydryl 25 mg.  at home 4:00 PM.  Emergency Dept. - Ultraset for HA, Phenegren for nausea and more Benydryl. 11/2, 10:00 AM - rash resolved, slight HA, slight nausea, resting comfortably.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Asthenia, Blister, Coma, Depressed level of consciousness, Flushing
Clinical narrative: Within 10 min. of injection, he became nauseated and weak.Another min. or 2 and he fell asleep. He was difficult to rouse only a min. later and he broke out into a sweat, his cheeks flushed and his eyes were red and very glassy. We rushed to ER. Breathing was very shallow, he was non-responsive and within 15 min, he was broken out in hives all over body, soon hives looked like blisters. Dr. administered Benadryl and Tylenol with no effect. Injection of steroids showed results within minutes. Hives were no longer apparent but he was agitated and crying the rest of the day. Next day, he seems in good health as he was previously.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Hyperhidrosis, Hypoventilation, Nausea, Ocular hyperaemia, Staring
Clinical narrative: Within 10 min. of injection, he became nauseated and weak.Another min. or 2 and he fell asleep. He was difficult to rouse only a min. later and he broke out into a sweat, his cheeks flushed and his eyes were red and very glassy. We rushed to ER. Breathing was very shallow, he was non-responsive and within 15 min, he was broken out in hives all over body, soon hives looked like blisters. Dr. administered Benadryl and Tylenol with no effect. Injection of steroids showed results within minutes. Hives were no longer apparent but he was agitated and crying the rest of the day. Next day, he seems in good health as he was previously.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Within 10 min. of injection, he became nauseated and weak.Another min. or 2 and he fell asleep. He was difficult to rouse only a min. later and he broke out into a sweat, his cheeks flushed and his eyes were red and very glassy. We rushed to ER. Breathing was very shallow, he was non-responsive and within 15 min, he was broken out in hives all over body, soon hives looked like blisters. Dr. administered Benadryl and Tylenol with no effect. Injection of steroids showed results within minutes. Hives were no longer apparent but he was agitated and crying the rest of the day. Next day, he seems in good health as he was previously.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Swelling, Urticaria
Clinical narrative: Patient complained of "puffed up" arm night of flu shot (10/20/05).  Patient used frozen vegetables as cold compress.  No meds taken for pain.  Next AM on 10/21, patient checked arm for swelling.  None noted. patient then noticed red, raised areas/whelps on upper 1-2 inches of palm of right hand and 3-4 inches of right.  10/22/05 and 10/23/05:  The whelps continued to spread up right forearm from palm of right hand to 6 inches below armpit. No pain or itching.  Patient states that most recent whelps burn and are hot.  Patient has used rubbing alcohol topically but denies any meds just for pain.  Patient denies any new medications, foods, contact with plants or recent yardwork.  Patient has approximate 10 year history of flu vaccination without problems.  RN encouraged patient to see PMD and to use Benadryl and cool compresses for relief at present time. NOTE:  RN followed up with patient on 10/28/05.  Patient stated he saw MD on 10/25/05.  Initial diagnosis from MD was allergic reaction?  After conferring with 2nd MD, the first MD changed diagnosis to ?shingles?  Patient was prescribed Famvir, Benadryl, and Caldyphen.  patient was instructed to return 11/01/05 if no relief with meds.  Patient stated as of 10/28, no symptom relief.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Fatigue, Hypertension, Vertigo
Clinical narrative: Employee states she started to experience fatigue, positional vertigo within 24 hours of vaccination. Continued to feel dizzy and was seen by her PMD. Employee states doctor feels that the "flu vaccine exacerbated previous condition of vertigo." Employee was diagnosed with HTN (consistant with finding in exam by NP in employee health office: see section 9 of this form) and was given a Rx for Hydrochlorothiazide.
Age: 33.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Heart rate increased, Nausea, Pyrexia, Vomiting
Clinical narrative: Six hours after vaccine administered, patient started with high fever 102, nausea,vomitting, diarrhea, rapid heart beat.  Lost 11 lbs due to diarrhea/vomitting overnight.  Only treatment was bedrest.
Age: 1.78
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site reaction
Clinical narrative: given vaccine with local reaction  - 3" red spot on left leg.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Insomnia, Nasal congestion, Pharyngolaryngeal pain
Clinical narrative: SLEEPLESSNESS SINCE INJECTION WAS GIVEN. SORE THROAT CONGESTION
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Diabetes mellitus, Hyperglycaemia, Hypoglycaemia
Clinical narrative: Patient vaccinated between 10am-1 Pm on October 30, 2005. Found dead in bed next morning at home by parents. Pt had type 1 diabetes with AC1 of 7.0 but having hypoglycemic episodes  1-2 times per week and not wanting to treat the symptoms per endocrinlogist.  Term of DM removed from symtom list as per autopsy report rec'd 12/28/2005/sr This is tag-2 report.
Age: 1.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Viral infection
Clinical narrative: more than 50 pox on back, lower stomach, and upper thighs
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm swelling and redness at injection site and extending distally. Discomfort and warmth at the site.Seen by own Md who suggested she show to health dept staff.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Pain
Clinical narrative: Received Pneumovax vaccine 10/28/05.  Approximately 4 hours after vaccination, she noticed redness and soreness in arm.  By morning of 10/29/05 - she noted redness from injection site (right deltoid) up her shoulder and down to her wrist. Self-treated with Benadryl and warm compresses and ibuprofen.  By morning of 11/1/01, all redness and soreness had resolved.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Pruritus
Clinical narrative: Onset 5x7 erythematous raised urticarial lesion to left deltoid around injection site.  Received FLUARIX Lot AFLU145AA 10-31-05 IM to LD.  Developed swelling at injection site within 24 hours.  No fever, chills, purulent drainage or axillary LAD present.  C/o mild itching.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Fatigue, Headache, Pharyngolaryngeal pain, Sinus congestion
Clinical narrative: Sore throat, headache, sinus drainage, tired, chronic aches, chronic cough. Similar to Flu.  Treatment: OTC Sinus medicine, cough syrup. Doctor prescribed 3 day script of 500MG Zithromax on 10/31/05.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Headache, Injection site reaction, Leukocytosis
Clinical narrative: Pt. was hospitalized for cellulitis in arm that both the flu and the PPV vaccinations were administered. Right arm started hurting within a few hours of the injections.  Client woke up next a.m. with chills and had a fever of 103 degrees, headache, nausea and severe pain in right arm.  Client on Vancomycin, Unisyn and Amoxicillin.  Cultures are pending at this time. 1/24/06 Review of 1-page d/c summary confirms diagnosis of cellulitis of R arm with associated fever, and leukocytosis.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Pt. was hospitalized for cellulitis in arm that both the flu and the PPV vaccinations were administered. Right arm started hurting within a few hours of the injections.  Client woke up next a.m. with chills and had a fever of 103 degrees, headache, nausea and severe pain in right arm.  Client on Vancomycin, Unisyn and Amoxicillin.  Cultures are pending at this time. 1/24/06 Review of 1-page d/c summary confirms diagnosis of cellulitis of R arm with associated fever, and leukocytosis.
Age: 82.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Fall, Muscular weakness
Clinical narrative: Became dizzy at approximately 12:00 noon, fell on sidewalk. Weakness in legs.
Age: 27.0
Sex: M
Vaccine: FLU3, SMALL
Symptoms: Injection site vesicles
Clinical narrative: Pt with disseminated vaccinia lesions in periphery of initial vaccination site. No intervention.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Sudden infant death syndrome
Clinical narrative: On June 21 2005 I was called (as coroner) to the local hospital emergency room. A baby born Jan 30 2005, had died suddenly. She was a white, female, and appeared to be in good physical health. During the course of my investigation, I learned that the baby had been vaccinated one week earlier. The baby was immunized on June 16 2005 and according to the mother, been a little cranky. The mother of the baby had treated the baby with children's Tylenol. When the child review panel discussed this babies death, there was a lot of concern about the number of blankets, stuffed animals, and general lack of air flow in the babies crib. Enclosed is the autopsy report and a copy of the death certificate. Call me if you need further information. All child deaths under the age of 18 are reviewed. All coroners and medical examiners meet once a year for the purpose of updates and continuing education. Until you called, I like many coroners, was unaware of your organization. If you would like to get some information to us as an organization, I can let you know the dates of our next training session. I think it will be in March of 2006. Autopsy Report received which stated COD as SIDS.
Age: 0.67
Sex: F
Vaccine: FLU3
Symptoms: Congenital anomaly, Convulsion, Cough, Electroencephalogram abnormal, Laboratory test abnormal
Clinical narrative: Vaccine received 10/26/05. Had brief URI with low grade fever 1 week prior with normal exam. 10/27/05 Began with recurrent lip smacking and drowsiness. EEG consistent with focal seizures. Information from 60 day report states: Ongoing seizure disorder controlled with medication. Felt due to cerebral malformation and not due to influenza vaccine. As per follow up report, reproter wrote to correct pts last name and provided the following information. MRI revealed developmental abnormality on left temporal cortex in hospital, thus neurological conclusion is that is a congenital condition not vaccine related. Medical records state cough. msv
Age: 0.67
Sex: F
Vaccine: FLU3
Symptoms: Neurodevelopmental disorder, Pyrexia, Somnolence, Tardive dyskinesia, Upper respiratory tract infection
Clinical narrative: Vaccine received 10/26/05. Had brief URI with low grade fever 1 week prior with normal exam. 10/27/05 Began with recurrent lip smacking and drowsiness. EEG consistent with focal seizures. Information from 60 day report states: Ongoing seizure disorder controlled with medication. Felt due to cerebral malformation and not due to influenza vaccine. As per follow up report, reproter wrote to correct pts last name and provided the following information. MRI revealed developmental abnormality on left temporal cortex in hospital, thus neurological conclusion is that is a congenital condition not vaccine related. Medical records state cough. msv
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site pain
Clinical narrative: Left upper arm redness, warmth and soreness.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: Pt was given flu mist yesterday then he broke out in hives that night the hives were not itchy and would move to different parts of body.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Pyrexia, Rash, Tongue disorder, Tongue oedema
Clinical narrative: Swollen glands in neck, rash all over body, fever, tongue burned, swollen. Went to private doctor 10/9/05 put on steroid, received injection - pt not subjection has had flu shots in the past w/out reaction.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal dreams, Feeling hot, Injection site hypersensitivity, Injection site induration, Injection site oedema
Clinical narrative: took immunization about 11:30am 10/28/2005 when took nap that afternoon had bizarre dreams, that evening began to swell get red and hot, through next day continued swelling maximum size tennis ball was hot, hard, tender, did not ever take temp, talked with someone on 10/31/2005 3 days after injection. Site has went from size to tennis ball to current size of egg, cont red, hard tender and itching, is still having crazy dreams. 01/01/2005 talked to someone again, no itching today, did not have strange dreams 2st time last night and swelling almost gone, historically had a reaction like this 1x with TD immunization, but took Hep A x2 with no problems at all.