chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Tachycardia, Tachypnoea, Tongue biting, Unresponsive to stimuli, White blood cell count normal
Clinical narrative: 12/7/2009 1940 hours-Nurse called to patient's room. Patient's roommate witnessed seizure type activity lasting 2-3 minutes. Nurse stated grand-mal activity. Nonresponsive with labored respirations BP 176/100, P143, R26, Pulse OX 99%. Patient transferred to Emergency Department for evaluation. Patient reported to have bitten tongue and was incontinent (type not specified). Symptoms: 1. Seizures 2. Tachypnea; 3 Hypertension; 4. Tachycardia.
Age: 59.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Blood chloride decreased, Blood lactic acid decreased, Blood sodium decreased, Computerised tomogram abnormal, Dyspnoea
Clinical narrative: 12/7/2009 1940 hours-Nurse called to patient's room. Patient's roommate witnessed seizure type activity lasting 2-3 minutes. Nurse stated grand-mal activity. Nonresponsive with labored respirations BP 176/100, P143, R26, Pulse OX 99%. Patient transferred to Emergency Department for evaluation. Patient reported to have bitten tongue and was incontinent (type not specified). Symptoms: 1. Seizures 2. Tachypnea; 3 Hypertension; 4. Tachycardia.
Age: 59.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Grand mal convulsion, Unresponsive to stimuli
Clinical narrative: 12/7/2009 1940 hours-Nurse called to patient's room. Patient's roommate witnessed seizure type activity lasting 2-3 minutes. Nurse stated grand-mal activity. Nonresponsive with labored respirations BP 176/100, P143, R26, Pulse OX 99%. Patient transferred to Emergency Department for evaluation. Patient reported to have bitten tongue and was incontinent (type not specified). Symptoms: 1. Seizures 2. Tachypnea; 3 Hypertension; 4. Tachycardia.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: Patient received the seasonal Influenza injection (CSL BIOTHERAPIES 075491HA Exp 6/20/2010) as outpatient 09/29/09, 0.5cc influenza vaccine was administered IM to the left deltoid. Immediately after, patient experienced shortness of breath and redness and itching at injection site. Patient was then sent to urgent care and was examined. Patient did not want medication, but nurse recommended diphenhydramine OTC, and ice to swollen area if symptoms worsened.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Anxiety, Convulsion, Headache, Impaired work ability
Clinical narrative: My granddaughter had the 3 shot series of GARDASIL approximately 2-3 yrs ago. She was a perfectly healthy normal teenager. Then you had the GARDASIL. Since then she continues to suffer from debilitating headaches and has seizures - she had been seen by a neurologist and there tests show no signs of Epilepsy, just some sort of "seizure disorder". This has made a drastic change in her lifestyle. She no longer goes out with her friends for fear of having a seizure, finds it impossible to hold a job because of these problems, and lives with constant anxiety over what will happen next. Also, she has a younger sister who had two of the shots and ever since has had problems with dizziness and blacking out. These were both perfectly healthy young girls before these shots.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills
Clinical narrative: H1N1 Flu a mono 2009 after injection, in 30 minutes later, felt mild chilling for 30 minute. Just mild side effect, but not serious
Age: 9.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood electrolytes normal, Computerised tomogram normal, Dizziness, Dysstasia, Full blood count normal
Clinical narrative: Began with dizziness, lightheaded, difficulty with balance, progressing to difficulty walking and standing in 24 hours. Over 72 hours, unable to stand unsupported or walk unaided, vision changes.
Age: 9.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Gait disturbance, Lumbar puncture normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Began with dizziness, lightheaded, difficulty with balance, progressing to difficulty walking and standing in 24 hours. Over 72 hours, unable to stand unsupported or walk unaided, vision changes.
Age: 10.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Asthma, Chest discomfort, Cough, Retching, Sinusitis
Clinical narrative: Dry, barking cough within hours of the nasal mist.  Cough continued and progressively got worse.  Pediatrician diagnosed asthma and began Albuterol treatments and Prednisone.  1 week later, still coughing, now also gagging and vomiting when coughing.  We went back to Pediatrician and she diagnosed him with a sinus infection and put him on a round of Zithromax and said to continue Albuterol.  Also, added an albuterol inhaler.  Six days after staring Z-pack he is a little better but still coughing and gagging about 50% of the time.  We will return to the doctor to have pulmonary function tests. He has tightness in his chest.
Age: 10.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Vomiting
Clinical narrative: Dry, barking cough within hours of the nasal mist.  Cough continued and progressively got worse.  Pediatrician diagnosed asthma and began Albuterol treatments and Prednisone.  1 week later, still coughing, now also gagging and vomiting when coughing.  We went back to Pediatrician and she diagnosed him with a sinus infection and put him on a round of Zithromax and said to continue Albuterol.  Also, added an albuterol inhaler.  Six days after staring Z-pack he is a little better but still coughing and gagging about 50% of the time.  We will return to the doctor to have pulmonary function tests. He has tightness in his chest.
Age: 11.0
Sex: F
Vaccine: FLUN(H1N1), HEP, HPV4, VARCEL
Symptoms: Syncope
Clinical narrative: Patient received vaccines; shortly after ~2-5 mins. fainted to floor; immediately arousable; no injury; patient laying supine with legs elevated over heart level; patient oriented x4 reports did not have breakfast. Received graham crackers with peanut butter observed for ~20 minutes; Vital Signs stable; Neuro checks WNL; reports no pain; walked out with steady gait with Mother of Child.
Age: 86.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Malaise, Rhinorrhoea
Clinical narrative: Woke up morning of 1/22/2010 with runny nose and dizziness. Symptoms lasted through 1/23/2010. During the week preceding 1/22, client felt "like she was coming down with something". Took Tylenol. No fever, no redness or swelling at injection site.
Age: 47.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Headache, Nasopharyngitis, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Severe headache for 9 days and head cold symptoms, runny nose, congestion, feeling run down.
Age: 63.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Chills, Fatigue
Clinical narrative: Felt extreme tiredness about 5:00 p.m.  By 5:30 chills began and lasted approximately 1 hour 30 minutes.  No fever, no other symptoms.  Once chills ended, normal energy level returned quickly.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Decreased appetite, Injection site erythema, Irritability, Pallor
Clinical narrative: Shortly after her 2 month old shots she had a reaction.  Her father describes the reaction as her had paleness over the whole body.  This lasted for about 3 hours and started about 10 hours after the shot.  She was a little fussy and ate poorly during that time.  She was crying a lot at the time.  The episode went away on its own.  She has since received the HIB vaccine and had no problems except for just a little redness at the site of injection.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Skin test
Clinical narrative: Shortly after her 2 month old shots she had a reaction.  Her father describes the reaction as her had paleness over the whole body.  This lasted for about 3 hours and started about 10 hours after the shot.  She was a little fussy and ate poorly during that time.  She was crying a lot at the time.  The episode went away on its own.  She has since received the HIB vaccine and had no problems except for just a little redness at the site of injection.
Age: 20.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Hypoaesthesia, Oedema peripheral
Clinical narrative: Right hand swelling with some right hand numbness that seemed to travel up the right arm, denied any respiratory complaints
Age: 11.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dyspnoea, Oropharyngeal pain, Urticaria
Clinical narrative: 1 - 2 minutes after child recieved the H1N1 vaccine she began rubbing her throat and arms she stated she felt like ants were biting her all over, note on permission slip child has had hives with PCN,  observed child closely after 30 minutes no further s/s such as difficulty breathing or hives/welts etc.  She stated the feeling of ants biting her all over had subsided.  Mother called and child released to care of grandparent home.  No hives, itching or s/s on release from school.
Age: 60.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Headache, Urticaria
Clinical narrative: 2 hives by Left eye Headache.
Age: 66.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Itching all over, hives
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Chills, Dysphagia, Feeling abnormal, Feeling cold, Myalgia
Clinical narrative: I would like to report that I had a reaction to my flu vaccination that I received on January 12, 2010. I tried to report this on the internet and found the website to be most awkward and unusable. So I am contacting you the old fashion way and hope that it works. I had this same reaction last year when I received a flu shot...told my physician and told the administrator at the place that I got the flu shot. Both looked at me as if I were speaking a foreign language. But when I got the same reaction this year I made a point of noticing the exact timing of the reaction. In exactly 2.5 to 3 hours after the shots (Regular and H1N1) I began to have a tiny grain of sand feel in the back of my throat. Within the hour my throat felt large and it was hard to swallow. Not sore, just very hard to swallow. I looked into my throat and the uvula was swollen and elongated to about an inch long 3/8 inch wide. It lay across and along the tongue making it hard to swallow. At the same time I began to have chills and aches feeling generally lousy all over my body. I took my temperature, but I had no temperature, just chills. The tongue swelling lasted about 6 to 7 hours and the chills about the same amount of time. I could feel a very rapid heart beat in my ears as well as my chest. I did not take my pulse as I was cold and miserable. Feared knowing what it was. I am now sorry that I did not get up and take a reading! Before the shots were administrated I was asked if I was allergic to egg, chicken, formaldehyde and a list of others that were unfamiliar to me. I did ask if they were associated to molds, yeast, or sulfa or sulfites of any kind as I have very bad allergic reactions to them. The person did not think so...so I took the shots. I would very much like to know for sure what preservatives are put into the vaccine formula. I am certain that there is something I am allergic to in those formulas. Can a vaccine be administrated without preservatives?? I noted that on the patient receipt flu vaccine with preservative is listed! Please, if you would...give a response to my letter. Thank You!
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Palpitations, Pharyngeal oedema, Swollen tongue, Throat irritation, Vaccine positive rechallenge
Clinical narrative: I would like to report that I had a reaction to my flu vaccination that I received on January 12, 2010. I tried to report this on the internet and found the website to be most awkward and unusable. So I am contacting you the old fashion way and hope that it works. I had this same reaction last year when I received a flu shot...told my physician and told the administrator at the place that I got the flu shot. Both looked at me as if I were speaking a foreign language. But when I got the same reaction this year I made a point of noticing the exact timing of the reaction. In exactly 2.5 to 3 hours after the shots (Regular and H1N1) I began to have a tiny grain of sand feel in the back of my throat. Within the hour my throat felt large and it was hard to swallow. Not sore, just very hard to swallow. I looked into my throat and the uvula was swollen and elongated to about an inch long 3/8 inch wide. It lay across and along the tongue making it hard to swallow. At the same time I began to have chills and aches feeling generally lousy all over my body. I took my temperature, but I had no temperature, just chills. The tongue swelling lasted about 6 to 7 hours and the chills about the same amount of time. I could feel a very rapid heart beat in my ears as well as my chest. I did not take my pulse as I was cold and miserable. Feared knowing what it was. I am now sorry that I did not get up and take a reading! Before the shots were administrated I was asked if I was allergic to egg, chicken, formaldehyde and a list of others that were unfamiliar to me. I did ask if they were associated to molds, yeast, or sulfa or sulfites of any kind as I have very bad allergic reactions to them. The person did not think so...so I took the shots. I would very much like to know for sure what preservatives are put into the vaccine formula. I am certain that there is something I am allergic to in those formulas. Can a vaccine be administrated without preservatives?? I noted that on the patient receipt flu vaccine with preservative is listed! Please, if you would...give a response to my letter. Thank You!
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: 2 hives in aspect of L arm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: right deltoid 8 - 10 cm redness, swelling
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Lip swelling, Pruritus generalised, Urticaria
Clinical narrative: The patient stated that 36 hrs after receiving shingles vax he developed severe itching with red whelps all over his body. The patient also had a swollen lip and a red circle around the injection site. The patient went to the ER and was prescribed BENADRYL 30 mg and MEDROL dose pack. Patient still has not recovered.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: The patient stated that 36 hrs after receiving shingles vax he developed severe itching with red whelps all over his body. The patient also had a swollen lip and a red circle around the injection site. The patient went to the ER and was prescribed BENADRYL 30 mg and MEDROL dose pack. Patient still has not recovered.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: The patient stated that 36 hrs after receiving shingles vax he developed severe itching with red whelps all over his body. The patient also had a swollen lip and a red circle around the injection site. The patient went to the ER and was prescribed BENADRYL 30 mg and MEDROL dose pack. Patient still has not recovered.
Age: 50.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Mobility decreased, Pain in extremity
Clinical narrative: Initial report received on 15 December 2009 from a consumer who is a health care professional. A 50 year old female patient with seasonal allergies and a prior history of "local red, hot, swollen" with prior seasonal influenza and tetanus vaccinations complained of pain in her arm immediately after she received Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP020AA) intramuscular in the left deltoid in November 2009 on an unspecified day. The patient also complained of pain at and around the site. The patient did not note any redness or swelling, but did have decreased mobility and limited range of motion. The patient denied numbness and tingling. The patient also received a seasonal influenza vaccine (manufacturer and lot number not provided) within four weeks of receiving the Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative vaccine. The date was no specified. At the time of the report, which was closed to 4 weeks after the time of onset, the patient's symptoms persisted. Follow-up information was received on 11 January 2010 from the patient who reported that each symptom had started on the same date she received Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative. The vaccine administrator was unable to provide the patient with the exact date of the H1N1 vaccination. The patient indicated that as of 06 January 2010, her symptoms still persisted. At the time of the report, the patient reported continued limited range of motion and pain. No further details were provided. Based on follow-up information, this case was upgraded from non-serious to serious. List of Documents held by Sender: none. The patient has another event which is captured in case number 2009-05565.
Age: 50.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Reaction to previous exposure to any vaccine
Clinical narrative: Initial report received on 15 December 2009 from a consumer who is a health care professional. A 50 year old female patient with seasonal allergies and a prior history of "local red, hot, swollen" with prior seasonal influenza and tetanus vaccinations complained of pain in her arm immediately after she received Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP020AA) intramuscular in the left deltoid in November 2009 on an unspecified day. The patient also complained of pain at and around the site. The patient did not note any redness or swelling, but did have decreased mobility and limited range of motion. The patient denied numbness and tingling. The patient also received a seasonal influenza vaccine (manufacturer and lot number not provided) within four weeks of receiving the Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative vaccine. The date was no specified. At the time of the report, which was closed to 4 weeks after the time of onset, the patient's symptoms persisted. Follow-up information was received on 11 January 2010 from the patient who reported that each symptom had started on the same date she received Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative. The vaccine administrator was unable to provide the patient with the exact date of the H1N1 vaccination. The patient indicated that as of 06 January 2010, her symptoms still persisted. At the time of the report, the patient reported continued limited range of motion and pain. No further details were provided. Based on follow-up information, this case was upgraded from non-serious to serious. List of Documents held by Sender: none. The patient has another event which is captured in case number 2009-05565.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Nuclear magnetic resonance imaging abnormal, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: fever,swelling and soreness of arm with pain in arm.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: fever,swelling and soreness of arm with pain in arm.
Age: 52.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Diarrhoea, Pain, Pyrexia, Retching, Vomiting
Clinical narrative: Saturday 1/9/2010 at 1130 Am he received the injection, he had dinner at home, did not eat out. The next morning at 0600 he began vomiting, until 1230 pm on 1/10, he also had dry heaves and diarrhea.  He did not initially have a fever but that afternoon he developed a fever, it broke Monday afternoon.  By Tuesday he was up and moving but was achy.  Everyone else in the family remained asymptomatic.  He states he did not need to see a Doctor. Everyone in his family ate the same foods but he was the only one ill.
Age: 49.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Dyspnoea, Dysstasia, Fatigue, Hypertension
Clinical narrative: nausea/dizziness, eye redness, extreme fatigue (inability to stand) hypertension, sob
Age: 49.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nausea, Ocular hyperaemia
Clinical narrative: nausea/dizziness, eye redness, extreme fatigue (inability to stand) hypertension, sob
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt was given shots on 1/20/10-mother took pt to ER. Pt c/o pain in R leg and swelling. Pt was given BENADRYL, MOTRIN and KEFLEX (antibiotic).
Age: 1.25
Sex: M
Vaccine: FLU(H1N1), HIBV, MMR, VARCEL
Symptoms: Grand mal convulsion, Hypoventilation, Pyrexia
Clinical narrative: Noted to have shallow breathing, trouble sitting up. Had generalized tonic-clonic seizures over 8 minutes. Noted to have fever 37.7 in ER.
Age: 14.0
Sex: U
Vaccine: MNQ
Symptoms: Chills, Myalgia
Clinical narrative: Chills, soreness
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Pain in extremity, Somnolence
Clinical narrative: 6:41 PM left arm very sore and patient very sleepy.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling, Insomnia, Swelling
Clinical narrative: Tender, swelling and redness in injection site. Patient returned today complaining of the sudden onset of selling, tenderness, and redness in his left deltoid muscle. This began about 4 hours after receiving a Pneumovax in the shoulder. his most recent Pneumovax was 5 years ago. He denies fevers, chills, or seats. The pain was significant enough that he didn't sleep very well last night.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Tender, swelling and redness in injection site. Patient returned today complaining of the sudden onset of selling, tenderness, and redness in his left deltoid muscle. This began about 4 hours after receiving a Pneumovax in the shoulder. his most recent Pneumovax was 5 years ago. He denies fevers, chills, or seats. The pain was significant enough that he didn't sleep very well last night.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Fatigue, Hypersensitivity, Insomnia
Clinical narrative: Around Oct 17th 2009 started feeling weakness, tiredness, short of breath, sleepless nights; thought it was just cold related symptoms - took NYQUIL-DAYQUIL-TYLENOL.
Age: 29.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Urticaria
Clinical narrative: Client began breaking out in hives 545 minutes after vaccine administered on legs and buttocks with itching. She applied Desonide 05% on areas (Prescription cream given to her father for itching). It provided relief but the next morning she broke out in hives again in same areas as well as under arms. Cream reapplied without relief. Benadryl cream applied PO min later with no relief. Took 25mg Benadryl PO and slept rest of day. January 22nd she broke out again and took Zyrtec. Hives resolved. No hives on January 23 but January 24th she broke out in hives again. Resolved with Zyrtec. So far no other outbreaks.
Sex: U
Vaccine: FLUX(H1N1)
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Oesophageal disorder
Clinical narrative: 1/4/10 1) Diarrhea. 2) Head throb. 3) Esophagus and stomach disruption.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest pain, Hypoaesthesia facial, Paraesthesia oral
Clinical narrative: H1N1 shot administered; complained of tingling around lips. No shortness of breath. No hives. 0.5mL epinephrine administered. 911 called and transported to hospital - still complaining of chest pain and facial numbness.
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Choking sensation, Computerised tomogram abnormal, Convulsion, Electroencephalogram abnormal, Gaze palsy
Clinical narrative: On 12/20/09 Pt had approximately 20 second episode of head twitching and "making noises like he was choking", per mother. Eyes were 1/2 open and somewhat "rolled back in his head", per mom. Taken to ER; CT showed seizure, as did EEG of neurology consult. Further evaluation pending. Client had been on "cold medicine" several days before H1N1 vaccine but not given on 12/16.
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Muscle twitching
Clinical narrative: On 12/20/09 Pt had approximately 20 second episode of head twitching and "making noises like he was choking", per mother. Eyes were 1/2 open and somewhat "rolled back in his head", per mom. Taken to ER; CT showed seizure, as did EEG of neurology consult. Further evaluation pending. Client had been on "cold medicine" several days before H1N1 vaccine but not given on 12/16.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: Cellulitis of skin/arm erythema/swelling AUGMENTIN/ice.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 12/23/09 TC from patient-received ZOSTAVAX 12/16. On 12/17/09 notified reddened area right arm, bigger than an egg (oval shaped). No raised area or soreness. States itching of the area, area decreasing in size. On 12/23/09 is smaller than a golf ball.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Hypokinesia, Skin warm
Clinical narrative: 1/6/10 warm to the touch hard to extend the arm, right arm.
Age: 23.0
Sex: M
Vaccine: FLU(H1N1), FLU3, PPV
Symptoms: Erythema, Headache, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: swelling of arm and redness, hot to touch. headaches, fever, (left arm) lasted three days. called my doctor and he told me to go to the emergency room.
Age: 1.55
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Gait disturbance, Lethargy, Musculoskeletal stiffness, Pain
Clinical narrative: 2 -3 hours after receiving DTaP, patient became lethargic, not wanting to move, acting stiff and in pain, needed to be carried. Went to ER - no tx resolved 6-8 hours.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling at site of injection from upper right arm to almost bend of arm. Red raised are approx. 1" over same area, lasted 3 days.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: L arm - area became red, warm to touch and painful when lifted or moved.
Age: 55.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Nausea, Vomiting
Clinical narrative: She received H1N1 injectible vaccine from Health department, they came to her apartment buliding and administered the shot in her right arm on 1/8/2010. The next morning she woke up with nausea and vomiting, she took her temperature with a thermometer but she had no fever.  The vomiting lasted in her words for "a DAY OR TWO , THEN WENT AWAY".  She did not contact her private doctor about these symptoms.
Age: 62.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Arthralgia, Injection site pain, Malaise, Oropharyngeal pain, Pain
Clinical narrative: Sore and scratchy throat; low-grade fever; pronounced soreness in arm at shot site.
Age: 62.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Pyrexia, Rhinorrhoea, Throat irritation
Clinical narrative: Sore and scratchy throat; low-grade fever; pronounced soreness in arm at shot site.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: REDNESS AND SWELLING TO LEFT ARM, SPREADING OVER UPPER ARM AND PAIN SPREADING UP NECK
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Influenza serology negative, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Fever, aches, chills, pain in left arm, red and swollen at injection site (left arm). Patient went to doctor's office Thursday 1/21/10. Given antibiotics and told to take Ibuprofen and antihistamines at Dr. office. 1/25/2010 left arm red at injection site, warm to touch, redness spreading over other parts of upper arm.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Streptococcal identification test negative
Clinical narrative: Fever, aches, chills, pain in left arm, red and swollen at injection site (left arm). Patient went to doctor's office Thursday 1/21/10. Given antibiotics and told to take Ibuprofen and antihistamines at Dr. office. 1/25/2010 left arm red at injection site, warm to touch, redness spreading over other parts of upper arm.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN(H1N1), IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: SWELLING OF L ARM, ERYTHEMA, AND ITCHING
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient received Zostavax vaccine on Wednesday, 1/20/2010. She started experiencing a rash, slight swelling, redness, and change in texture (rough) at injection site (left arm) on Thursday 1/21/2010. Patient did not seek treatment since reaction was not severe and did not self medicate/treat to relieve symptoms. Today, 1/25/2010, patient states symptoms are improving and not bothersome.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Blister, Blood blister, Burning sensation, Cough, Feeling hot
Clinical narrative: 12/23 @ 6:00 PM:  "lungs felt like they were filling up", had a little hacking cough and feeling of heat on chest area.  She went to bed. 12/24 @ 2:00 AM:  Hands from wrists to fingertips were "throbbing, burning terribly and were swollen". 12/25:  Palms of hands "OK" but had little blisters on them.  Had a feeling of pressure from the second knuckle to the tip of each finger 12/26:  Pain was gone but had a "blood blister" on the tip of each finger and they were "tender to the touch" 12/28:  Went to doctor's office for B/P check.  Mentioned aforemention to nurse who told PAC. Since: Hands have peeled, bloodblisters healed but have marks on hands where affected.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Lung disorder, Oedema peripheral, Pain, Sensation of pressure, Skin exfoliation
Clinical narrative: 12/23 @ 6:00 PM:  "lungs felt like they were filling up", had a little hacking cough and feeling of heat on chest area.  She went to bed. 12/24 @ 2:00 AM:  Hands from wrists to fingertips were "throbbing, burning terribly and were swollen". 12/25:  Palms of hands "OK" but had little blisters on them.  Had a feeling of pressure from the second knuckle to the tip of each finger 12/26:  Pain was gone but had a "blood blister" on the tip of each finger and they were "tender to the touch" 12/28:  Went to doctor's office for B/P check.  Mentioned aforemention to nurse who told PAC. Since: Hands have peeled, bloodblisters healed but have marks on hands where affected.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Tenderness
Clinical narrative: 12/23 @ 6:00 PM:  "lungs felt like they were filling up", had a little hacking cough and feeling of heat on chest area.  She went to bed. 12/24 @ 2:00 AM:  Hands from wrists to fingertips were "throbbing, burning terribly and were swollen". 12/25:  Palms of hands "OK" but had little blisters on them.  Had a feeling of pressure from the second knuckle to the tip of each finger 12/26:  Pain was gone but had a "blood blister" on the tip of each finger and they were "tender to the touch" 12/28:  Went to doctor's office for B/P check.  Mentioned aforemention to nurse who told PAC. Since: Hands have peeled, bloodblisters healed but have marks on hands where affected.
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Fall, Gaze palsy, Head injury, Immediate post-injection reaction, Mydriasis
Clinical narrative: Student fell off chair immediately after receiving H1N1 vaccine IM and hit head on bookcase.  Student eyes rolled back and did not respond for 3-5 seconds.  Color pale, pupils dilated but left pupil reacted sluggishly: weak pulse-92 and BP-82/50. First aid squad present and administered oxygen 8LPM via mask.  Student responsive and oriented but color remained pale and pulse weak.  Benadryl 25mg. given po as per standing order.  Transported via ambulance with first aid squad to Hospital.  Parents were notified and met student at hospital.  Medical Physician from Health Department notified.  Triage nurse from Hospital notified and report given on status of student.
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pallor, Pulse pressure decreased
Clinical narrative: Student fell off chair immediately after receiving H1N1 vaccine IM and hit head on bookcase.  Student eyes rolled back and did not respond for 3-5 seconds.  Color pale, pupils dilated but left pupil reacted sluggishly: weak pulse-92 and BP-82/50. First aid squad present and administered oxygen 8LPM via mask.  Student responsive and oriented but color remained pale and pulse weak.  Benadryl 25mg. given po as per standing order.  Transported via ambulance with first aid squad to Hospital.  Parents were notified and met student at hospital.  Medical Physician from Health Department notified.  Triage nurse from Hospital notified and report given on status of student.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Mother reports that on 1/12/10-the site where the Dtap was given became red, warm to touch about the size of a "50 cent piece" and progressively got more inflamed. Took to MD and was diagnosed with cellulitis. Mom called 01/14/2010 and reports the site looks a lot better after antibiotics.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Angiogram, Antibody test, Blindness, Borrelia burgdorferi serology, Chest X-ray
Clinical narrative: It was reported in a published article, title as stated above that a 17 year old female who was vaccinated with GARDASIL. The patient was referred for new onset vision loss in both eyes 3 weeks after being vaccine. A standard dose of 0.5 ml was injected intramuscularly into the left deltoid without any resulting skin reaction. Her medical history was significant for depression treated with quetiapine. Three weeks following vaccination, she developed painless vision loss in the left eye followed 2 days later with painless vision loss of the right eye. The patient denied any viral prodrome. On examination, visual acuity measured 20/60 in the right eye and 20/100 in the left eye. Intraocular pressure measured 14 mm Hg in both eyes, and there was no conjunctival injection, no anterior chamber cells and no anterior vitreous inflammation on dilated fundus exam she was found to have multiple creamy chorioretinal infiltrates in the macula extending into the id-periphery, left eye greater than right. On fluorescein angiography, the lesions demonstrated early hypofluorescence and late hyperfluorescence. Systemic evaluation was within normal limits and included a complete blood count with differential, tuberculin skin test, chest radiograph, lyme titres, rapid plasma regain and fluorescent treponemal antibody. There was no family history of autoimmune disease. The patient was diagnosed as having acute posterior multifocal placoid pigment epitheliopathy (APMPPE) and observed. After 5 days, the patient's vision deteriorated to 20/400 in the right eye and count fingers at six feet in the left eye, and fundus exam demonstrated chorioretinal scarring in the macula with persistent activity of the lesion margins. At this time, because of the scarring, the diagnosis shifted to ampiginous choroiditis, and oral prednisone 1 mg/kg/day was initiated. The prednisone was successfully tapered off within 3 months without recurrence of the choroiditis, but extensive macular scarring remained. The final visual acuity was 20/50 in the right eye and 20/60 in the left eye. The authors stated that this case does not prove causation but the temporal relationship between GARDASIL and onset of an aggressive ampiginous choroiditis is intriguing and may shed light on the immunological triggers involved in posterior non infectious uveitis. Upon internal review, vision loss was considered to be an other important medical event. Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Chorioretinal scar, Choroiditis, Differential white blood cell count, Full blood count, Fundoscopy abnormal
Clinical narrative: It was reported in a published article, title as stated above that a 17 year old female who was vaccinated with GARDASIL. The patient was referred for new onset vision loss in both eyes 3 weeks after being vaccine. A standard dose of 0.5 ml was injected intramuscularly into the left deltoid without any resulting skin reaction. Her medical history was significant for depression treated with quetiapine. Three weeks following vaccination, she developed painless vision loss in the left eye followed 2 days later with painless vision loss of the right eye. The patient denied any viral prodrome. On examination, visual acuity measured 20/60 in the right eye and 20/100 in the left eye. Intraocular pressure measured 14 mm Hg in both eyes, and there was no conjunctival injection, no anterior chamber cells and no anterior vitreous inflammation on dilated fundus exam she was found to have multiple creamy chorioretinal infiltrates in the macula extending into the id-periphery, left eye greater than right. On fluorescein angiography, the lesions demonstrated early hypofluorescence and late hyperfluorescence. Systemic evaluation was within normal limits and included a complete blood count with differential, tuberculin skin test, chest radiograph, lyme titres, rapid plasma regain and fluorescent treponemal antibody. There was no family history of autoimmune disease. The patient was diagnosed as having acute posterior multifocal placoid pigment epitheliopathy (APMPPE) and observed. After 5 days, the patient's vision deteriorated to 20/400 in the right eye and count fingers at six feet in the left eye, and fundus exam demonstrated chorioretinal scarring in the macula with persistent activity of the lesion margins. At this time, because of the scarring, the diagnosis shifted to ampiginous choroiditis, and oral prednisone 1 mg/kg/day was initiated. The prednisone was successfully tapered off within 3 months without recurrence of the choroiditis, but extensive macular scarring remained. The final visual acuity was 20/50 in the right eye and 20/60 in the left eye. The authors stated that this case does not prove causation but the temporal relationship between GARDASIL and onset of an aggressive ampiginous choroiditis is intriguing and may shed light on the immunological triggers involved in posterior non infectious uveitis. Upon internal review, vision loss was considered to be an other important medical event. Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inflammation, Intraocular pressure test normal, Ophthalmological examination abnormal, Retinal pigment epitheliopathy, Syphilis test
Clinical narrative: It was reported in a published article, title as stated above that a 17 year old female who was vaccinated with GARDASIL. The patient was referred for new onset vision loss in both eyes 3 weeks after being vaccine. A standard dose of 0.5 ml was injected intramuscularly into the left deltoid without any resulting skin reaction. Her medical history was significant for depression treated with quetiapine. Three weeks following vaccination, she developed painless vision loss in the left eye followed 2 days later with painless vision loss of the right eye. The patient denied any viral prodrome. On examination, visual acuity measured 20/60 in the right eye and 20/100 in the left eye. Intraocular pressure measured 14 mm Hg in both eyes, and there was no conjunctival injection, no anterior chamber cells and no anterior vitreous inflammation on dilated fundus exam she was found to have multiple creamy chorioretinal infiltrates in the macula extending into the id-periphery, left eye greater than right. On fluorescein angiography, the lesions demonstrated early hypofluorescence and late hyperfluorescence. Systemic evaluation was within normal limits and included a complete blood count with differential, tuberculin skin test, chest radiograph, lyme titres, rapid plasma regain and fluorescent treponemal antibody. There was no family history of autoimmune disease. The patient was diagnosed as having acute posterior multifocal placoid pigment epitheliopathy (APMPPE) and observed. After 5 days, the patient's vision deteriorated to 20/400 in the right eye and count fingers at six feet in the left eye, and fundus exam demonstrated chorioretinal scarring in the macula with persistent activity of the lesion margins. At this time, because of the scarring, the diagnosis shifted to ampiginous choroiditis, and oral prednisone 1 mg/kg/day was initiated. The prednisone was successfully tapered off within 3 months without recurrence of the choroiditis, but extensive macular scarring remained. The final visual acuity was 20/50 in the right eye and 20/60 in the left eye. The authors stated that this case does not prove causation but the temporal relationship between GARDASIL and onset of an aggressive ampiginous choroiditis is intriguing and may shed light on the immunological triggers involved in posterior non infectious uveitis. Upon internal review, vision loss was considered to be an other important medical event. Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Tuberculin test, Visual acuity reduced, Visual acuity tests abnormal
Clinical narrative: It was reported in a published article, title as stated above that a 17 year old female who was vaccinated with GARDASIL. The patient was referred for new onset vision loss in both eyes 3 weeks after being vaccine. A standard dose of 0.5 ml was injected intramuscularly into the left deltoid without any resulting skin reaction. Her medical history was significant for depression treated with quetiapine. Three weeks following vaccination, she developed painless vision loss in the left eye followed 2 days later with painless vision loss of the right eye. The patient denied any viral prodrome. On examination, visual acuity measured 20/60 in the right eye and 20/100 in the left eye. Intraocular pressure measured 14 mm Hg in both eyes, and there was no conjunctival injection, no anterior chamber cells and no anterior vitreous inflammation on dilated fundus exam she was found to have multiple creamy chorioretinal infiltrates in the macula extending into the id-periphery, left eye greater than right. On fluorescein angiography, the lesions demonstrated early hypofluorescence and late hyperfluorescence. Systemic evaluation was within normal limits and included a complete blood count with differential, tuberculin skin test, chest radiograph, lyme titres, rapid plasma regain and fluorescent treponemal antibody. There was no family history of autoimmune disease. The patient was diagnosed as having acute posterior multifocal placoid pigment epitheliopathy (APMPPE) and observed. After 5 days, the patient's vision deteriorated to 20/400 in the right eye and count fingers at six feet in the left eye, and fundus exam demonstrated chorioretinal scarring in the macula with persistent activity of the lesion margins. At this time, because of the scarring, the diagnosis shifted to ampiginous choroiditis, and oral prednisone 1 mg/kg/day was initiated. The prednisone was successfully tapered off within 3 months without recurrence of the choroiditis, but extensive macular scarring remained. The final visual acuity was 20/50 in the right eye and 20/60 in the left eye. The authors stated that this case does not prove causation but the temporal relationship between GARDASIL and onset of an aggressive ampiginous choroiditis is intriguing and may shed light on the immunological triggers involved in posterior non infectious uveitis. Upon internal review, vision loss was considered to be an other important medical event. Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dyskinesia, Immediate post-injection reaction, Laboratory test
Clinical narrative: Information has been received from a physician concerning a patient's little sister (age unspecified) with unspecified medical history, drug reactions or allergies, who on an unspecified date was vaccinated with a 0.5 mL dose of GARDASIL (route and lot # unknown). Concomitant medication was unspecified. The physician reported that on an unspecified date, a patient's little sister experienced seizure like activity and jerking for a couple of minutes after receiving GARDASIL. Lab diagnostic studies performed were unspecified. It was unspecified if the patient sought medical attention. At the time of the report the patient's outcome was reported as improved. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 58 year old female with hypersensitivity, osteoarthritis, intervertebral disc degeneration, anxiety and frequent bronchitis and a history of lap band surgery who on 28-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included BENICAR, MOBIC, XANAX, LORCET, SOMA and ALLEGRA. On 30-OCT-2009 the patient experienced erythema and swelling at the injection site. On 03-NOV-2009 they had also developed a fever. The physician prescribed doxycycline (manufacturer unspecified) for treatment. On 09-NOV-2009 the swelling and tenderness were reduced and as of 11-NOV-2009 the fever was gone. No lot number was provided. At the reporting time the patient was recovering. Follow up information has been received from the physician concerning a 58 year old female patient with no known allergies who on 28-OCT-2009 was vaccinated with the second dose of PNEUMOVAX 23 (lot #664864/1365Y) in her left deltoid. On 29-OCT-2009 (previously reported as 30-OCT-2009) the patient experienced pain and tenderness over the left deltoid area. Redness + 4 cm warm tender mass over the left deltoid. The patient was treated with doxycycline 100 mg BID x10 days #20. At the time of the report, the patient had recovered on unspecified dates. Erythema and tenderness at the injection site and 4 cm warm tender mass were considered to be other important medical events by the physician. No further information is available.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 58 year old female with hypersensitivity, osteoarthritis, intervertebral disc degeneration, anxiety and frequent bronchitis and a history of lap band surgery who on 28-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included BENICAR, MOBIC, XANAX, LORCET, SOMA and ALLEGRA. On 30-OCT-2009 the patient experienced erythema and swelling at the injection site. On 03-NOV-2009 they had also developed a fever. The physician prescribed doxycycline (manufacturer unspecified) for treatment. On 09-NOV-2009 the swelling and tenderness were reduced and as of 11-NOV-2009 the fever was gone. No lot number was provided. At the reporting time the patient was recovering. Follow up information has been received from the physician concerning a 58 year old female patient with no known allergies who on 28-OCT-2009 was vaccinated with the second dose of PNEUMOVAX 23 (lot #664864/1365Y) in her left deltoid. On 29-OCT-2009 (previously reported as 30-OCT-2009) the patient experienced pain and tenderness over the left deltoid area. Redness + 4 cm warm tender mass over the left deltoid. The patient was treated with doxycycline 100 mg BID x10 days #20. At the time of the report, the patient had recovered on unspecified dates. Erythema and tenderness at the injection site and 4 cm warm tender mass were considered to be other important medical events by the physician. No further information is available.