chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site discomfort, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: 60mm circle around the injection site. Hard warm/hot bump. Stiff and very tender, itchy, very uncomfortable. Took Tylenol and Benedryl and my Alegra for the itching. Went back to the cllinic to see what was going on and was told I was having a reaction to the injection. Today is the 15th and I still have the itching and tenderness, but the redness seems to be going away.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site reaction, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: 60mm circle around the injection site. Hard warm/hot bump. Stiff and very tender, itchy, very uncomfortable. Took Tylenol and Benedryl and my Alegra for the itching. Went back to the cllinic to see what was going on and was told I was having a reaction to the injection. Today is the 15th and I still have the itching and tenderness, but the redness seems to be going away.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Entire lateral upper arm is bruised from the injection point on the left deltoid down to approximately 1 inch above elbow.
Age: 0.24
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Convulsion, Hydrocephalus, Hypersomnia, Oral intake reduced, Scan brain
Clinical narrative: pARENT CALLED ON 10/10/2008 STATING PATIENT NOT EATING WELL AND SLEEPING ALOT. ON 10/11/2008 PATIENT HAD SEIZURE AND TAKEN TO HOSPITAL.  10/23/08-records received for DOS 10/11-10/17/08-presented with fever and seizure activity on 10/9/08, increased somnolence and decreased feeding and decreased urine output. Unable to perform LP. 1/27/2010 Patient under care of neurologist for seizures and hydrocephalus.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cold sweat, Cough, Eye discharge, Myalgia
Clinical narrative: Recieved Flu Vaccine at around 2:00 pm, by 5:00 pm of the same day I had a high fever 101.6, muscle aches, cough, stuffed up nose (so severe everytime I swalled my tongue was sucked up to the back of my throat), red blood shot eyes with yellowish discharge, sore/scrathcy throat, chills/ cold sweat.  When I got up the next morning both eyes were matted shut with a yellowish discharge.  By 12:30 pm the next day I still have a fever, aches, red blood shot eyes, with a yellow discharge and cold chills.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Nasal congestion, Ocular hyperaemia, Oropharyngeal pain, Pyrexia
Clinical narrative: Recieved Flu Vaccine at around 2:00 pm, by 5:00 pm of the same day I had a high fever 101.6, muscle aches, cough, stuffed up nose (so severe everytime I swalled my tongue was sucked up to the back of my throat), red blood shot eyes with yellowish discharge, sore/scrathcy throat, chills/ cold sweat.  When I got up the next morning both eyes were matted shut with a yellowish discharge.  By 12:30 pm the next day I still have a fever, aches, red blood shot eyes, with a yellow discharge and cold chills.
Age: 15.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Erythema, Pain in extremity
Clinical narrative: ARM RED AND SORE DUE TO VARICELLA SHOT
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching and mild errythema around injection site within 5 minn of administration.  No other problems.  Given 1 tsp Benadryl and observed x30 minn.  Itching and redness resolved.
Age: 14.0
Sex: F
Vaccine: FLUN3, MEN, TDAP
Symptoms: Activities of daily living impaired, Dizziness, Dry throat, Hypersomnia, Malaise
Clinical narrative: On the way home from the doctors office she complained of feeling nausea. We thought it was the heat along with being in the car as she is suceptiable to migraine headaches, or that she may have been hungry, because she hadn't eaten much in the morning. She had a little something to eat, came home and went to sleep. Woke up in the evening had a little dinner did some homework and went back to bed. All this time complaining of not feeling well. When she woke the next day and tried to get ready for school she felt dizzy, and right before we were to leave to take her to school, she vommited. She stayed home from school not feeling well throught the day. Having dry heaves, afraid to eat or drink much. Also complaining of body aches, continued dizziness. We are now into the next day and she is still not feeling well. Sleeping alot, body aches, dizzy, a bit of a dry/sore throat, and having a slight fever.
Age: 14.0
Sex: F
Vaccine: FLUN3, MEN, TDAP
Symptoms: Nausea, Oropharyngeal pain, Pain, Pyrexia, Retching
Clinical narrative: On the way home from the doctors office she complained of feeling nausea. We thought it was the heat along with being in the car as she is suceptiable to migraine headaches, or that she may have been hungry, because she hadn't eaten much in the morning. She had a little something to eat, came home and went to sleep. Woke up in the evening had a little dinner did some homework and went back to bed. All this time complaining of not feeling well. When she woke the next day and tried to get ready for school she felt dizzy, and right before we were to leave to take her to school, she vommited. She stayed home from school not feeling well throught the day. Having dry heaves, afraid to eat or drink much. Also complaining of body aches, continued dizziness. We are now into the next day and she is still not feeling well. Sleeping alot, body aches, dizzy, a bit of a dry/sore throat, and having a slight fever.
Age: 14.0
Sex: F
Vaccine: FLUN3, MEN, TDAP
Symptoms: Vomiting
Clinical narrative: On the way home from the doctors office she complained of feeling nausea. We thought it was the heat along with being in the car as she is suceptiable to migraine headaches, or that she may have been hungry, because she hadn't eaten much in the morning. She had a little something to eat, came home and went to sleep. Woke up in the evening had a little dinner did some homework and went back to bed. All this time complaining of not feeling well. When she woke the next day and tried to get ready for school she felt dizzy, and right before we were to leave to take her to school, she vommited. She stayed home from school not feeling well throught the day. Having dry heaves, afraid to eat or drink much. Also complaining of body aches, continued dizziness. We are now into the next day and she is still not feeling well. Sleeping alot, body aches, dizzy, a bit of a dry/sore throat, and having a slight fever.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Blood culture, Bone scan, Erythema, Pain, Pyrexia
Clinical narrative: redness, fever, aches 10/16/08-records received for DOS 9/28-10/2/08-DC DX: Cellulitis to right arm. Presented to ED with C/O right arm pain, redness at injection site that began 3-4 days ago. C/O chills, sweats and increased redness. Day of vaccines C/O sinus infection, diagnosed with sinusitis.
Age: 29.0
Sex: M
Vaccine: FLUN3, SMALL
Symptoms: Latex allergy, Pharyngeal oedema, Urticaria
Clinical narrative: SM. RECEIVED SMALLPOX ON 2OCT2008. SM. DID NOT KNOW AT THIS TIME HE WAS ALLERGIC TO LATEX. WAS ASKED PRIOR TO VACCINATION. SM. DEVELOPED HIVES ON ARMS, CHEST, STOMACH, AND ARMPITS.ALSO SWELLING OF THE THROAT 1 TO 2 DAYS AFTER VACCINATION.  SM. FOUND OUT ABOUT ALLERGY TO LATEX IN ANOTHER PROCEDURE BY A DIFFERENT CLINIC. WAS GIVEN ANTIBIOTICS, BENADRYL, AND NEW ALLERGY TAGS WITH LATEX ADDED TO THEM.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Patient had pale pink macular rash on the inner aspects of both arms.  No evidence of rash, redness, swelling, or itching at site of injection which was Right upper arm.Loradamed was given.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, No reaction on previous exposure to drug, Oxygen supplementation, Pallor
Clinical narrative: Received flu vaccine in left arm by nurse.  About 5-10 minutes later was itchy and red blotches appeared on his face. Red blotches were on his forehead, cheeks, and around mouth.  He appeared pale.  He stated his throat was also itchy.  He stated trouble breathing. Parents states no previous problems with shots and no allergies. 911 called. Received oxygen and vitals were taken by paramedic.  After about 15 minutes he was getting better.  Parents did not think it was necessary for him to be taken to the hospital.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash macular, Throat irritation
Clinical narrative: Received flu vaccine in left arm by nurse.  About 5-10 minutes later was itchy and red blotches appeared on his face. Red blotches were on his forehead, cheeks, and around mouth.  He appeared pale.  He stated his throat was also itchy.  He stated trouble breathing. Parents states no previous problems with shots and no allergies. 911 called. Received oxygen and vitals were taken by paramedic.  After about 15 minutes he was getting better.  Parents did not think it was necessary for him to be taken to the hospital.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Mass, Rash, Tenderness
Clinical narrative: 10/14/2008: Pt. called stating she had a low grade temp, rash along left flank and 2 "lumps" around the left posterior side of scalp localized described as "sensitive to touch" noted on 10/11 with rash and low grade temp resolved by 10/13. Pt. stated that she did not go to ER or MD upon noting symptoms. Pt. continues to have sentivity and 2 "lumps" on scalp. States that "lumps" are intact, no drainage or scabbing or spreading noted. Pt. encouragd to seek care with PMD or Urgent Care center for f/u.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Computerised tomogram normal, Dizziness, Headache, Vomiting
Clinical narrative: CLIENT RECEIVED INFLUENZA VACCINATION ON OCTOBER 11TH, 2008.  CLIENT REPORTS THAT SHE EXPERIENCED SYMPTOMS THAT SHE REPORTS WAS RELATED TO THE VACCINE ABOUT 1.5 HOURS LATER.  CLIENT STATES SHE EXPEREINCED " A SEVERE HEADACHE", "FELT CLAMMY", AND HAD DIZZINESS AND VOMITING. CALLED EMERGENCY MEDICAL SERVICES.  BLOOD PRESSURE WAS 160/118.  TAKEN TO EMERGENCY DEPARTMENT AND RECEIVED A CT SCAN WHICH WAS NEGATIVE.  GIVEN DARVOCET FOR HEADACHE AND PAIN.
Age: 0.8
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt. had six month well check 06/25/08. Mom elected not to do immunizations that day related to having "plans" for the weekend, but agreed to return in one week.  Pt. did not return until 9 month appt., but was not feeling well. Physician suggested returning to clinic in one week for immunizations.  Parent returned to clinic 10/08/08 for a "nurse care visit only" for vaccinations.  A new hire looked up last well visit to try and find order for immunizations.  Something wrong with computer system and 9 month well visit was not displayed.  She looked at the 6 month well visit and saw the recommendation to return for Pediarix, Hib, Prevnar and Rotateq.  She went ahead and gave all the mentioned and entered them into the system.  When they appeared on Dr.  workload to be signed off on, Dr. realized the child had exceeded the recommended age for the Rotateq vaccine.  She refused to sign off on the order.  I contacted Merck for direction on any concerns, have not heard of any yet.  Still awaiting final answer. To contact Parent to let them know this was given, should not experience adverse effects and they will not be charged for this.  I will file report to Risk Management/ Quality Safety. Discussed with new hire.  Will implement new policy for patients returning for vaccinations only (nurse care visits).  We will not give vaccinations without an order, either written and signed or entered in scheduler notes as an order.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Convulsion, Gaze palsy, Hyperhidrosis, Muscle rigidity
Clinical narrative: Patient had seizure following gardasil injection. BP 156/86, pale, eyes rolling, rigid, diaphoretic, EMT called, blood sugar 82, refused transport to ER, appointment made with primary doctor for evaluation same day.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor
Clinical narrative: Patient had seizure following gardasil injection. BP 156/86, pale, eyes rolling, rigid, diaphoretic, EMT called, blood sugar 82, refused transport to ER, appointment made with primary doctor for evaluation same day.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Myalgia, Pyrexia, Respiratory tract congestion, Vision blurred
Clinical narrative: Within 4-6 hours of the flu shot, started with high fever, muscle soreness, blurred vision, headache and lung congestion.  It lasted a good part of 24 hours.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Injection site pain, Lymphadenopathy
Clinical narrative: Pt. c/o chills & pain @ injection site 4 hrs after vaccination, then noticed L axillary lymphadenopathy (grapefruit sized) approx. 8 hrs after injection. Pt took 600mg Motrin without effect. Pt to see his primary MD for follow up.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Urticaria
Clinical narrative: Hives in hairline and forehead...itchy around the eyes.  Took oral antihistamine.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Vision blurred
Clinical narrative: Dizziness, blurred vision and nausea for 5 hours the day following the immunization
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Nausea, Pain, Pharyngeal oedema
Clinical narrative: Fever 102, Chills, body aches, blurred vision, nausea, headache, swelling in throat.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Fever 102, Chills, body aches, blurred vision, nausea, headache, swelling in throat.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site pain, Laboratory test normal, Pain in extremity
Clinical narrative: Within 6 hours of injection client complained of severe pain at upper right arm. At 3:00am went to ER with complaint of 10/10 pain at right arm. No redness or edema. Was admitted on observation from 3am-9:30am, 10/14/08, then discharged. Was given one Lortab for pain and blood was also drawn. Provider states blood work was WNL. By 4:00pm, 10/14, husband states she is resting with only a soreness at arm.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Laboratory test normal, Pain in extremity
Clinical narrative: Within 6 hours of injection client complained of severe pain at upper right arm. At 3:00am went to ER with complaint of 10/10 pain at right arm. No redness or edema. Was admitted on observation from 3am-9:30am, 10/14/08, then discharged. Was given one Lortab for pain and blood was also drawn. Provider states blood work was WNL. By 4:00pm, 10/14, husband states she is resting with only a soreness at arm.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site vesicles
Clinical narrative: Vaccine administered on 10/13/08, in Left thigh, on 10/15/08 MOC brought baby to clinic because he had developed a fluid filled blister on the outer aspect of the left thigh, approx 1 cm in length, 1mm in width.  Vaccine was given on the front of the thigh approx 2 inchies from the blister.
Age: 37.0
Sex: F
Vaccine: HEPAB
Symptoms: Drug exposure during pregnancy, Pregnancy
Clinical narrative: Patient was pregnant when vaccine administered (this was the second dose in the 3 dose series)
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Anorexia, Chills, Diarrhoea, Nausea, Pyrexia
Clinical narrative: within one hour, felt nausea, loss of appetite.  After 4 hours, developed 102 fever, chills, vomiting, severe diaharrea, lasted several hours
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: within one hour, felt nausea, loss of appetite.  After 4 hours, developed 102 fever, chills, vomiting, severe diaharrea, lasted several hours
Age: 0.33
Sex: M
Vaccine: HIBV, IPV, PNC, RV5, TDAP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse event, patient was re-immunized with dTaP on 10-15-08
Age: 1.0
Sex: M
Vaccine: HIBV, IPV, PNC, TDAP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse reaction
Age: 21.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Facial palsy, Hypoaesthesia, Injection site pain, Nausea, Pain
Clinical narrative: She experienced pain in right arm where shot was administered. Also had nausea, soreness, and numbness on R side of body. She was diagnosed with Bell's Palsy and given Medrol and Valtrex.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, MMRV
Symptoms: Ear infection, Pyrexia, Rash generalised, Rash vesicular
Clinical narrative: 4 days after ear infection with med. grade fever. Fever and ear treated with over counter childrens motrin. Symptoms seemed to subside. Fever returened on 10/15/08 along with severe chicken pox type rash covering entire body including head, neck, and face. No treatment yet. Going to doctor first thing in the morning 10/16/08
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Fatigue, Hyperhidrosis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of diaphoresis in a 20-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline).  Concurrent medical conditions included asthma and smoker.  There were no concurrent medications.  On 10 October 2008 at 10:00 the subject received a dose of FLULAVAL at 0.5 ml in the left arm.  On 10 October 2008, 45 minutes after vaccination with FLULAVAL, the subject experienced diaphoresis, chest pain, shortness of breath and fatigue.  The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention).  The subject was taken to the emergency room and treated with epinephrine.  Approximately four hours and fifteen minutes following onset, the symptoms were improved.  The health professional reported that she had five other subjects with similar, but less severe symptoms.  She did not have specific information regarding these subjects at the time of reporting.  Linked cases include: A0751890A, A0751892A, A0751893A, A0751894A and A0751895A.
Sex: U
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Fatigue, Hyperhidrosis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of diaphoresis in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced diaphoresis, chest pain, shortness of breath and fatigue. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. Four additional subjects had similar symptoms. Linked case include: A0751892A, A0751893A, A0751894A and A0751895A. Linked case A0751880A was more severe and included subject and event specifics.
Sex: U
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Fatigue, Hyperhidrosis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of diaphoresis in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced diaphoresis, chest pain, shortness of breath and fatigue. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. Four additional subjects had similar symptoms. Linked cases include: A0751890A, A0751893A, A0751894A and A0751895A. Linked case A0751880A was more severe and included subject and event specifics.
Sex: U
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Fatigue, Hyperhidrosis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of diaphoresis in a subject of unspecified age and gender who was vaccinated with FLULAVAL, GlaxoSmithKline.  On an unspecified date the subject received unspecified dose of FLULAVAL (unknown).  At an unspecified time after vaccination with FLULAVAL, the subject experienced diaphoresis, chest pain, shortness of breath and fatigue.  The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention).  At the time of reporting the outcome of the events was unspecified.  Four additional subjects had similar symptoms.  Linked cases include: A0751890A, A0751892A, A0751894A and A0751895A.  Linked case A0751880A was more severe and included subject and event specifics.
Sex: U
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Fatigue, Hyperhidrosis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of diaphoresis in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced diaphoresis, chest pain, shortness of breath and fatigue. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. Four additional subjects had similar symptoms. Linked cases include: A0751890A, A0751892A, A0751893A and A0751895A. Linked case A0751880A was more severe and included subject and event specifics.
Sex: U
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Fatigue, Hyperhidrosis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of diaphoresis in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced diaphoresis, chest pain, shortness of breath and fatigue. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. Four additional subjects had similar symptoms. Linked cases include: A0751890A, A0751892A, A0751893A and A0751894A. Linked case A0751880A was more severe and included subject and event specifics.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic shock, Blood pressure decreased, Cough, Hyperhidrosis, Intensive care
Clinical narrative: Anaphylactic shock following administration of flu vaccine at physician's office. Patient became diaphoretic, hypotensive following injection. Sent to ER, where she received epinephrine and methylprednisolone with some improvement. Complaints of coughing and wheezing. BP again dropped, retreated with epinephrine and steroid. Admitted to ICU. 10/22/08-records received for DOS 10/7-10/10/08- DC DX: Anaphylactic shock to flu shot. Presented to ED with after becoming diaphoretic, hypotensive following flu shot. C/O cough and wheezing. Blood pressure dropped to 60/40.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Oxygen saturation decreased, Wheezing
Clinical narrative: Anaphylactic shock following administration of flu vaccine at physician's office. Patient became diaphoretic, hypotensive following injection. Sent to ER, where she received epinephrine and methylprednisolone with some improvement. Complaints of coughing and wheezing. BP again dropped, retreated with epinephrine and steroid. Admitted to ICU. 10/22/08-records received for DOS 10/7-10/10/08- DC DX: Anaphylactic shock to flu shot. Presented to ED with after becoming diaphoretic, hypotensive following flu shot. C/O cough and wheezing. Blood pressure dropped to 60/40.
Age: 58.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Body temperature increased, Erythema, Fatigue, Feeling hot, Pain in extremity
Clinical narrative: Patient received flu and pneumonia vaccine at our pharmacy flu clinic on 10/11/08 from me. The patient states that Saturday evening she started to feel very warm and fatigued. She ran a temperature of approximately 103 F and took four 200mg tablets of ibuprofen. She has continued to take ibuprofen daily because her arm is still very sore, red, and warm to the touch. To her knowledge she has not continued to run a fever but her arm is still bothering her she is still feeling fatigued.
Age: 58.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Patient received flu and pneumonia vaccine at our pharmacy flu clinic on 10/11/08 from me. The patient states that Saturday evening she started to feel very warm and fatigued. She ran a temperature of approximately 103 F and took four 200mg tablets of ibuprofen. She has continued to take ibuprofen daily because her arm is still very sore, red, and warm to the touch. To her knowledge she has not continued to run a fever but her arm is still bothering her she is still feeling fatigued.
Age: 58.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Pyrexia, Rash, Skin warm
Clinical narrative: Patient received flu and pneumonia vaccine at our pharmacy flu clinic on 10/11/08 from me. The patient states that Saturday evening she started to feel very warm and fatigued. She ran a temperature of approximately 103 F and took four 200mg tablets of ibuprofen. She has continued to take ibuprofen daily because her arm is still very sore, red, and warm to the touch. To her knowledge she has not continued to run a fever but her arm is still bothering her she is still feeling fatigued.
Age: 58.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Swelling
Clinical narrative: Patient received flu and pneumonia vaccine at our pharmacy flu clinic on 10/11/08 from me. The patient states that Saturday evening she started to feel very warm and fatigued. She ran a temperature of approximately 103 F and took four 200mg tablets of ibuprofen. She has continued to take ibuprofen daily because her arm is still very sore, red, and warm to the touch. To her knowledge she has not continued to run a fever but her arm is still bothering her she is still feeling fatigued.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Abdominal pain lower, Blood test, Computerised tomogram, Hypoaesthesia, Nuclear magnetic resonance imaging
Clinical narrative: Abdominal pain (R) lower, (L) arm numbness. 10/27/08-records received-office visit 1/15/08-C/O stomach ache times 2 days with nausea. Abdomen tender. 3/28/08-no complaints. 10/14/08-left wrist numbness, neuro exam normal.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Urinary tract infection, Urine analysis
Clinical narrative: Abdominal pain (R) lower, (L) arm numbness. 10/27/08-records received-office visit 1/15/08-C/O stomach ache times 2 days with nausea. Abdomen tender. 3/28/08-no complaints. 10/14/08-left wrist numbness, neuro exam normal.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient woke up with hives and itching. Says she gets hives about once a year, but this was from the zoster vaccine. Took some BENADRYL. The hives she gets once a year go away with BENADRYL and sometimes needs prednisone.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort
Clinical narrative: -Chest tightness approximately 45 minutes after vaccine. -Received 0.30 ml Epinephrine 1:1000, 14:22 PM. -Symptoms improved 14:30 PM. -Seen by provider 15:15 PM. -Prednisone tapering dose prescribed.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient was given vaccine around 10:00 am and developed nausea, diarrhea and vomiting in the afternoon. Those symptoms resolved by the next morning.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Cough, Ear pain, Pharyngolaryngeal pain, Respiratory tract congestion
Clinical narrative: Approx. 24 hr after vaccination, developed congested cough, sore throat (mild) and mild ear ache; followed by profound bone pain in long bones (humerus x 2 femurs x 2 tibias x 2).
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site anaesthesia, Paraesthesia
Clinical narrative: Tingling/numbness in right arm where injection given (patient states PNEUMOVAX given in right arm).
Age: 78.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Burning sensation, Rash
Clinical narrative: Patient received ZOSTAVAX on 10/8/08. 2 days later - 10/10/08 she developed a rash on her thighs - no shortness of breath or other adverse reaction. On 10/13/08 she noticed a rash on her arms. She went into her hot tub and felt like her arms were "on fire." burning, today - better
Age: 78.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Erythema, Rash pruritic
Clinical narrative: Patient received ZOSTAVAX on 10/8/08. 2 days later - 10/10/08 she developed a rash on her thighs - no shortness of breath or other adverse reaction. On 10/13/08 she noticed a rash on her arms. She went into her hot tub and felt like her arms were "on fire." burning, today - better
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Malaise
Clinical narrative: Patient experienced extreme dizziness about 36 hours after receiving shot. In addition, she stated she just didn't feel 100% all over, dizziness was somewhat better on day 4; and she was starting to feel like herself again by day 5.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Convulsion, Incontinence
Clinical narrative: Pt. received MCV4 and VARIVAX today 10/14/08: after about 2 sec., pt. started with seizures and incontinence. I quickly took control of the situation and gave her 0.3 ml Ammonia inhalant, raised pt. foot and called RN as well as Dr. Pt. reacted well w/Ammonia. Pt. was seen w/provider and sent to ER.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Approximately 1 1/2 hours after patient received FLUVIRIN he broke out in hives. I told mom to give him BENADRYL and keep an eye on him. Take to ER if trouble breathing. BENADRYL helped and hives were gone within a few hours.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Right deltoid redness at injection sight measuring 9.5 cm vertically, 11 cm horizontal
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 4 CM erythema at inj site (R upper arm) with tenderness/warmth/swelling. Rec observation/ice/motrin prn.
Age: 6.0
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Warm to touch area of redness 5 in x 4.5 in. Areas of swelling 4 in x 4 in. Prescribed BENADRYL 12.5 ml/5 cc
Age: 34.0
Sex: M
Vaccine: HEPAB, TDAP, TYP
Symptoms: Mydriasis, Visual acuity tests normal
Clinical narrative: Patient presented to opthamologist with one dilated pupil. Vision test returned normal (20/20).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt. had swollen red area on (L) arm at Varicella vaccine injection site, starting PM on 10/14/08. Area still swollen, warm to touch, red, tender on 10/15/08. BENADRYL prescribed. Redness/edema, 6cm x 7cm in size.
Age: 0.6
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, DTAPIPVHIB, HEP, PNC
Symptoms: Pyrexia, Rash, Screaming
Clinical narrative: Inconsolable screaming lasting 3 hours. Fever 102 degrees Fahrenheit. Rash. As reported by parent.
Age: 0.6
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, DTAPIPVHIB, HEP, PNC
Symptoms: Crying, Pyrexia
Clinical narrative: Inconsolable screaming lasting 3 hours. Fever 102 degrees Fahrenheit. Rash. As reported by parent.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Oct. 3 - vaccine given hurt on shoulders, Right side of neck
Age: 45.0
Sex: F
Vaccine: FLUN3, PPV
Symptoms: Hypoaesthesia, Loss of consciousness, Pain in extremity
Clinical narrative: Client contacted health department to report extreme pain in (L) upper extremity with numbness; client also states that she had "passed out" secondary to extreme pain. Client had received PNEUMOVAX vaccine 10/14/08. Client was instructed and present to the medical clinic to be observed by her primary care provider. Client called HD @ 8:30 AM. Client was scheduled in clinic @ 8:45.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Throat irritation, Urticaria
Clinical narrative: HIVES, ITCHY THROAT, PUFFY FACE - 1 hour after receiving vaccine. Previous flu vaccine 10/07. Went to ER - given1m BENEDRYL and then recovered and went back to work.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: LD swelling, redness, pain, warm to touch. Onset 10-13-8 @ 8:00 PM. L 3 1/2" W 2" C 6 1/2".
Sex: F
Vaccine: HEPAB
Symptoms: Induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Client reported stinging at injection site at time of injection. Followed later that PM with tenderness and swelling - slight warm to touch. Tenderness till today with induration. No fever. Advised to continue with warm compress, and anti-inflammatory and ibuprofen.
Age: 46.0
Sex: F
Vaccine: PPV, VARCEL
Symptoms: Burning sensation, Erythema, Pain
Clinical narrative: Reddened area right upper arm burning pain no itching induration and 9 x 4 cm redness
Age: 1.4
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Convulsion, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: One hour after administration of VARIVAX and Hep A. Pt. experienced seizure-like activity. Squad was called and taken to Children Hospital - PC was negative.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt has redness, swelling and heat on (R) deltoid at injection site.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia, Wheezing
Clinical narrative: A non-serious spontaneous report of wheezing and fever has been received from a nurse concerning a four-year-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient had no history of wheezing. The patient received the first dose of FLUMIST on 01-Sep-2008. Approximately nine to ten hours after receiving FLUMIST, the patient developed a fever and wheezing. The patient was given acetaminophen. The outcome was not reported.
Age: 58.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of given expired vaccine was received from a registered nurse concerning a 58-month-old male. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received his first dose of FluMist on 11-Sep-2008. The FluMist had expired on 03-Apr-2008. The reporter stated that FluMist was given by one of the nurses helping out the clinic on 11-Sep-2008 and not by the nurse in-charge of the immunization. the incident regarding the expired FluMist was noted when the immunization record was being updated. As of 24-Sep-2008, there was no adverse event reported; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the vent is considered resolved. 09/11/2008 Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information received on 24-Mar-2009 included Product Complaint Investigation results.
Age: 1.7
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of a 20-month-old male child who was administered FluMist, and developed runny nose and fever had been received from a consumer. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Medical history and concomitant medications were not reported. The patient received FluMist on 11-Sep-2008. On 12-Sep-2008, the patient developed a runny nose, and on 14-Sep-2008, eh developed a fever of 101 degrees Fahrenheit. The outcome of the events was not reported.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, Medication error, No adverse event
Clinical narrative: A non serious spontaneous report of inadvertent administration of expired FLUMIST was received from a nurse concerning a patient of unknown age in a pediatrician's office. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error at the time of the report, nor when contact was made with the site approximately two weeks later; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. 10/07/08 Follow-up received 07-Oct-2008: No adverse events had been reported. Follow-up information received on 20-Mar-2009 included Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a nurse concerning a patient of unknown age in a pediatrician's office. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error at the time of the report, nor when contact was made with the site approximately two weeks later; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medications errors that occurred shortly after the product expired. Follow-up received 07-Oct-2008. No adverse events had been reported. Follow-up received 20 Mar-2009: added product complaint investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a nurse concerning a patient of unknown age in a pediatricians office. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Follow-up received 17-Oct-2008. No adverse events had been reported. Follow-up information received on 20-Mar-2009 included Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a nurse in the USA concerning a patient of unknown age in a pediatrician's office. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up received 17-Oct-2008. no adverse events had been reported. Follow-up information received on 20-Mar-2009 included Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired flumist was received from a nurse concerning a patient of unknown age in a pediatrician's office. This case is submitted in accordance with MedImmune  post-market commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error at the time of the report, nor when contact was made with the site approximately two weeks later, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication error were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occured shortly after the product expired. Follow-up received 07-Oct-2008. No adverse events had been reported. Follow-up information received on 20-Mar-2009 included Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a nurse concerning a patient of unknown age in a pediatricians office. This case is submitted in accordance with Medimmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error at the time of the report, nor when contact was made with the site approximately two weeks later, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up received on 17-Oct-2008. No adverse events had been reported. Follow-up information received on 20-Mar-2009 included Product Compliant Invetigation Products.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired Flumist was received from a nurse concerning a patient of unknown age in a pediatrician's office. This case is submitted in accordance with Medimmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error at the time of the report, nor when contact was made with the site approximately two weeks later; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medications errors that occurred shortly after the product expired. Follow-up received 07-Oct-2008. No adverse events had been reported. Follow-up information received on 20 Mar-2009 included Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a nurse concerning a patient of unknown age in a pediatricians office. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error at the time of the report, when contact was made with the site approximately two weeks later; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the real cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up received 02-Oct-2008: No adverse events had been reported. Follow-up information received on 20-Mar-2009 included Product Complaint Investigative results. 10/07/08 Follow-up received 07-Oct-2008: No adverse events had been reported.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired FluMist was received from a nurse concerning a patient of unknown age in a pediatricians office.  This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Follow-up received 07-Oct-2000. No adverse event had been reported. Based on the results of the investigation, the root cause for the medication were caused by 1) customer not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occuured shortly after teh product expired. Follow-up received 30-Mar-2000: added product complaint investigation results.
Age: 1.9
Sex: U
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST was received from a mother in the USA concerning a 23-month-old patient who received FLUMIST.  This case is submitted in accordance with organization's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The patient's medical history and concomitant medications were not reported.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 0.9
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious, spontaneous report of administration of FLUMIST to a nine-month-old male infant was received from a physician. The patient's medical history includes seizures and developmental delay. Concomitant medications included Phenobarbital and oral steroids. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments not applicable and the event is considered resolved. This case is submitted in accordance with agencies post-mareketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.