chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: She first started feeling numbness in her feet and hands and by 03/12/2010 she started to having numbness in her lips and tongue.  On 03/12/2010 she was admitted to hospital and diagnosed with Guillain-Barre Syndrome. She is currently still in the hospital and they are estimating she can be discharged on 05/28/2010
Age: 3.0
Sex: F
Vaccine: FLU(H1N1), FLUX
Symptoms: Blood electrolytes normal, Eyelid function disorder, Facial palsy, Full blood count normal
Clinical narrative: Family brought patient to ER for "droopy left side of face" and that the left eyelid would not close.  ER diagnosis: Bells Palsy
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Local injection site erythema and edema which increased in size.
Age: 1.35
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Onset of low grade temp and rash on trunk on day 7 after immunization.  Worsening each day with fever 103 and rash entire body. Patient had MMR and VARIVAX vaccine on March 30, 2010. She broke out in rash 6 or 7 days later. It is now 3 weeks since the rash started and it is worsening. Fever is up again to 102 with no obvious source of infection. Plan another visit to pediatrician.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Injection site erythema, Injection site swelling, Lymphadenopathy, Otitis media
Clinical narrative: mother reported redness and swelling of the left upper arm (site of administration)
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever, Redness and swelling at injection site.
Age: 0.97
Sex: M
Vaccine: DTAPIPVHIB, HEP, MNQ
Symptoms: Wrong drug administered
Clinical narrative: NP ordered PCV vaccine; MCV vaccine given
Age: 16.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Activities of daily living impaired, Blood test normal, Computerised tomogram normal, Fatigue, Feeling abnormal
Clinical narrative: Patient developed a severe headache in her forehead on the evening of Saturday, Nov. 14th.  A few hours after patient was vaccinated on Nov. 12th, she said she did not feel "the best".  The next afternoon (Friday, Nov. 13th) she felt achey and tired.  After some rest she felt a little better.  However, on Saturday, Nov. 14th, she progressively felt worse until that night when she went to bed with a headache.  Other than a couple of days following hospitalization and IV meds, patient has suffered a headache every second of every day since November 14th.  She has missed approximately 2/3 of the school days since the headache started.
Age: 16.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Nuclear magnetic resonance imaging normal, Pain
Clinical narrative: Patient developed a severe headache in her forehead on the evening of Saturday, Nov. 14th.  A few hours after patient was vaccinated on Nov. 12th, she said she did not feel "the best".  The next afternoon (Friday, Nov. 13th) she felt achey and tired.  After some rest she felt a little better.  However, on Saturday, Nov. 14th, she progressively felt worse until that night when she went to bed with a headache.  Other than a couple of days following hospitalization and IV meds, patient has suffered a headache every second of every day since November 14th.  She has missed approximately 2/3 of the school days since the headache started.
Age: 0.21
Sex: M
Vaccine: RV5, RV5
Symptoms: Abnormal faeces, Decreased appetite, Diarrhoea haemorrhagic, Intussusception, Irritability
Clinical narrative: Poor appetite began after 9 PM feeding on 4/11.  She became more sleepy and irritable.  Emesis began in the AM on 4/12 with a large foul smeling stool.  She was initially seen in the office.  However, the emesis evolved into bloody diarrhea.  She was then seen in the Hospital and Medical Center ED and was diagnosed with an intussusception.
Age: 0.21
Sex: M
Vaccine: RV5, RV5
Symptoms: Somnolence, Vomiting
Clinical narrative: Poor appetite began after 9 PM feeding on 4/11.  She became more sleepy and irritable.  Emesis began in the AM on 4/12 with a large foul smeling stool.  She was initially seen in the office.  However, the emesis evolved into bloody diarrhea.  She was then seen in the Hospital and Medical Center ED and was diagnosed with an intussusception.
Age: 0.21
Sex: M
Vaccine: RV5, RV5
Symptoms: Barium double contrast, Barium enema, Decreased appetite, Diarrhoea haemorrhagic, Intussusception
Clinical narrative: Poor appetite began after 9 PM feeding on 4/11.  She became more sleepy and irritable.  Emesis began in the AM on 4/12 with a large foul smeling stool.  She was initially seen in the office.  However, the emesis evolved into bloody diarrhea.  She was then seen in the Hospital and Medical Center ED and was diagnosed with an intussusception.
Age: 0.21
Sex: M
Vaccine: RV5, RV5
Symptoms: Pallor, Somnolence, Vomiting, X-ray
Clinical narrative: Poor appetite began after 9 PM feeding on 4/11.  She became more sleepy and irritable.  Emesis began in the AM on 4/12 with a large foul smeling stool.  She was initially seen in the office.  However, the emesis evolved into bloody diarrhea.  She was then seen in the Hospital and Medical Center ED and was diagnosed with an intussusception.
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Child complained of pain and itching yesterday. Noticed redness yesterday and has not changed - per dad. Left arm lateral aspect from deltoid to elbow reddened, swelling and warm to touch.
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR
Symptoms: Pruritus
Clinical narrative: Child complained of pain and itching yesterday. Noticed redness yesterday and has not changed - per dad. Left arm lateral aspect from deltoid to elbow reddened, swelling and warm to touch.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Pt states redness and pain on site noted 4/10/10 at AM. Pt kept bandage on until 4/10/10. Pt states had fever 103.0 and took Tylenol for 2 day. Pt walk in today 4/12/10 AM.
Sex: F
Vaccine: FLUN(H1N1), HPV4, HPV4, FLUN(H1N1), HPV4
Symptoms: Computerised tomogram normal, Electroencephalogram abnormal, Feeling abnormal, Staring, Tunnel vision
Clinical narrative: Patient developed partial left temporal lobe seizures in Jan 2010 after completing third GARDASIL in Dec 2008. MRI revealed single area of abnormal signal in right hemisphere white matter. Leg left temporal seizure activity. Unknown if vaccine causative or related. Vaccine administered by pediatrician.
Sex: F
Vaccine: FLUN(H1N1), HPV4, HPV4, FLUN(H1N1), HPV4
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Partial seizures
Clinical narrative: Patient developed partial left temporal lobe seizures in Jan 2010 after completing third GARDASIL in Dec 2008. MRI revealed single area of abnormal signal in right hemisphere white matter. Leg left temporal seizure activity. Unknown if vaccine causative or related. Vaccine administered by pediatrician.
Sex: F
Vaccine: FLUN(H1N1), HPV4, HPV4, FLUN(H1N1), HPV4
Symptoms: Computerised tomogram normal, Convulsion, Deja vu
Clinical narrative: Patient developed partial left temporal lobe seizures in Jan 2010 after completing third GARDASIL in Dec 2008. MRI revealed single area of abnormal signal in right hemisphere white matter. Leg left temporal seizure activity. Unknown if vaccine causative or related. Vaccine administered by pediatrician.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase increased, Blood albumin normal, Blood bicarbonate decreased, Blood calcium decreased
Clinical narrative: Describes low-grade fever with malaise which began 3d after vaccine. Eventually evaluated in Urgent Care clinic on 4/3/10...labs drawn but no tx given....f/u on 4/6 with repeat labs and eventually given Cipro 500mg bid x 7d. Seen on 4/12 by PCP for f/u with approx 85% recovery.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood chloride increased, Blood creatinine normal, Blood glucose increased, Blood iron decreased, Blood potassium normal
Clinical narrative: Describes low-grade fever with malaise which began 3d after vaccine. Eventually evaluated in Urgent Care clinic on 4/3/10...labs drawn but no tx given....f/u on 4/6 with repeat labs and eventually given Cipro 500mg bid x 7d. Seen on 4/12 by PCP for f/u with approx 85% recovery.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood sodium normal, Blood urea normal, Haematocrit normal, Haemoglobin decreased, Malaise
Clinical narrative: Describes low-grade fever with malaise which began 3d after vaccine. Eventually evaluated in Urgent Care clinic on 4/3/10...labs drawn but no tx given....f/u on 4/6 with repeat labs and eventually given Cipro 500mg bid x 7d. Seen on 4/12 by PCP for f/u with approx 85% recovery.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Platelet count decreased, Protein total increased, Pyrexia, Red cell distribution width increased, Reticulocyte count normal
Clinical narrative: Describes low-grade fever with malaise which began 3d after vaccine. Eventually evaluated in Urgent Care clinic on 4/3/10...labs drawn but no tx given....f/u on 4/6 with repeat labs and eventually given Cipro 500mg bid x 7d. Seen on 4/12 by PCP for f/u with approx 85% recovery.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Serum ferritin normal, Transferrin saturation decreased, Vitamin B12 increased, White blood cell count decreased
Clinical narrative: Describes low-grade fever with malaise which began 3d after vaccine. Eventually evaluated in Urgent Care clinic on 4/3/10...labs drawn but no tx given....f/u on 4/6 with repeat labs and eventually given Cipro 500mg bid x 7d. Seen on 4/12 by PCP for f/u with approx 85% recovery.
Age: 1.01
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Cyanosis, Erythema multiforme, Urticaria
Clinical narrative: On 3/26/10 pt presented with a rash that looked like urticaria. He was on Amoxicillin and it was stopped. Pt returned on 3/07/10 with blue hands and feet and erythema multiforme rash. Over the next week the rash faded away but intermittently came and went. Mom concerned this was due to Varicella shot. I thought it was more likely due to Amoxicillin.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Condition aggravated, Convulsion, Decreased eye contact, Facial asymmetry, Gastroenteritis rotavirus
Clinical narrative: Information has been received from a consumer concerning her son, a 15 to 18 month old patient with a mild form of cerebral palsy who was vaccinated with the first dose of MMR II. One hour post vaccination, the patient experienced "like seizure activity with left side of his face lowered". The child also experienced fever and rash and had a hard time to maintain eye contact. The patient's mother stated that she worked very hard with her child's "mild form of cerebral palsy" and his delays, but after being vaccinated with MMR II the child regressed. The reporter stated that the adverse effects continued on and off form many months after the MMR II vaccination. The patient's mother wanted to take her son to the doctor's office for follow up but then he would get better. It was reported that the patient was also hospitalized with rotavirus for 5 days, right before he was 3 years of age. Which she thought was due to the patient's weakened immune system because of the MMR II that was administered when the patient was younger. The patient did not receive the rotavirus vaccine because his doctor did not think it was good for him to get it. The mother stated that he "child's immune system was back to normal". The outcome for fever, rash, cerebral palsy regressed and rotavirus was unknown. Upon internal review seizure like activity was considered to be an other important medical event. No further information is available.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Immune system disorder, Pyrexia, Rash
Clinical narrative: Information has been received from a consumer concerning her son, a 15 to 18 month old patient with a mild form of cerebral palsy who was vaccinated with the first dose of MMR II. One hour post vaccination, the patient experienced "like seizure activity with left side of his face lowered". The child also experienced fever and rash and had a hard time to maintain eye contact. The patient's mother stated that she worked very hard with her child's "mild form of cerebral palsy" and his delays, but after being vaccinated with MMR II the child regressed. The reporter stated that the adverse effects continued on and off form many months after the MMR II vaccination. The patient's mother wanted to take her son to the doctor's office for follow up but then he would get better. It was reported that the patient was also hospitalized with rotavirus for 5 days, right before he was 3 years of age. Which she thought was due to the patient's weakened immune system because of the MMR II that was administered when the patient was younger. The patient did not receive the rotavirus vaccine because his doctor did not think it was good for him to get it. The mother stated that he "child's immune system was back to normal". The outcome for fever, rash, cerebral palsy regressed and rotavirus was unknown. Upon internal review seizure like activity was considered to be an other important medical event. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Neonatal disorder
Clinical narrative: Information has been received from a physician and a consumer concerning her male baby, who in February 2008, was exposed through his mother to a dose of GARDASIL (lot number 659435/1265U) administered on 26-OCT-2007. Concomitant medication included (ORTHO TRI-CYCLEN). On 13-NOV-2008 the patient was born with a weight of 5 pounds/7 ounces and had anemia at birth. The infant was born with only one kidney and duodenal atresia which were considered congenital anomalies. In follow-up, the patient's mother mentioned that her "boy was born with a bunch of birth defects". The patient's outcome was unknown at the time of reporting. The mother's experiences were captured in WAES# 0812USA01616. The infant's experience was previously reported in WAES 0812USA01616. No further information is available.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Patient recieved pneumococcal 23-valent vaccine at an outpatient clinic. He returned to the clinic the next day complaining of pain and erythematous area around where the vaccination was given without fever. It was described as cellulitis and the patient was admitted to the hospital for intravenous antibiotic administration.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Oedema peripheral, Pain in extremity
Clinical narrative: Pt called on 4/7/10 to report he went to ER on 4/6/10 (evening) stating his arms was red, sore and swollen. He had limited ROM. Seen in ER and given prednisone and BENADRYL in ER. Given prednisone to take as an outpatient and advised to return for f/u.
Age: 12.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Headache, Syncope
Clinical narrative: Patient fainted after administration of vaccine last for 30 second. No injury happen due to fainting after 30 second. Patient alert, oriented with mild headache x 2-3minute. BP=117/60 HR=78 RR=26 SO2=100%. Pt observed for 10 minute. Asymptomatic. Discharged.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Balance disorder, Excoriation, Gait disturbance, Injection site erythema, Injection site haematoma
Clinical narrative: Pt was seen by healthcare provider on 4/8/10 with c/o redness, swelling, bruising of (R) shoulder + (R) arm above elbow. Per husband report pt  will be receiving follow-up treatment. Pt was noted to have unsteady gait + required assistance with ambulation. Pt noted to have new abrasion on nose. Clerical staff reports pt stated that she felt. Pt reports nx of balance problems and unsteady gait.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Pt was seen by healthcare provider on 4/8/10 with c/o redness, swelling, bruising of (R) shoulder + (R) arm above elbow. Per husband report pt  will be receiving follow-up treatment. Pt was noted to have unsteady gait + required assistance with ambulation. Pt noted to have new abrasion on nose. Clerical staff reports pt stated that she felt. Pt reports nx of balance problems and unsteady gait.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Eye rolling, Loss of consciousness, Pallor, Tremor
Clinical narrative: Few second after given Menactra vaccine. Patient tried to stand up and walk but suddenly passed out and according to mother patient developed shaking of extremities and eyes rolling to the back, skin pulled for almost one minutes. When paramedic came patient already awake alert and oriented. Subsequently patient was brought to E.R.
Age: 0.65
Sex: F
Vaccine: DTAPHEPBIP, FLU(H1N1), FLU3, PNC, RV5
Symptoms: Blood culture negative, Chest X-ray normal, Culture urine negative, Full blood count normal, Pyrexia
Clinical narrative: Fever to 104.8.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site haematoma
Clinical narrative: Pt. presented to pharmacy 1 week after injection asking about bruising at injection site. Discovered the bruising and phoned his physician. Nurse stated if pt. experiencing pain or it was bothering to come in to be seen. Pt stated would wait to be seen only if gets worse.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Per mother pain, swelling bil legs. Using MOTRIN, intermittent ice. Brought to clinic - Rt thigh 7cm area of redness/edema, Lt thigh 2cm area slight redness.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Wrong drug administered
Clinical narrative: None, Rotavirus given in the form of ROTARIX while vaccine was still suspended.
Age: 1.59
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Dermatitis, Rash pruritic
Clinical narrative: 3/24/10 one day after immunization - Rash on back, neck, face with itching. Dx: Dermatitis - Tx: PRELONE syrup 15 mg/5ml PO 3.75 ml 1 time a day for 5 days; Hydrochloride 10 mg/5 ml PO 4 x day 10 days. 3/31/10 Pt seen in ER for rash. 4/1/10 Rash - Tx: PEDIAPRED liquid, sodium phosphate 5 mg/5 ml 10 ml 1 time a day 4 days.
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Blood pressure normal, Dizziness, Oxygen saturation normal, Syncope
Clinical narrative: After PPD - Pt felt lightheaded and had syncope episode - no LOC - Vasovagal V/S stable. See f/u - 4/5/10.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site urticaria
Clinical narrative: A welt formed at the location of the injection. It was approx. 6mm x 6mm in size. No redness or bruising noted. Pt instructed to apply ice.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt given Varicella vaccine to right upper arm on 3/29/10. Yesterday he noticed swelling and pain on the site of injection. This morning (3/31/10) when he woke up he saw a big area of involvement, tenderness noted. Increase warmth. He took MOTRIN last night for pain only.
Age: 0.34
Sex: F
Vaccine: DTAP, PNC, RV5
Symptoms: Convulsion, Exaggerated startle response, Gaze palsy
Clinical narrative: Seizure like activity. Daughter has a prolonged startle and her eyes roll up into her head you can not get her to stop while the event is taking place
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Body temperature increased, Decreased appetite, Gait disturbance
Clinical narrative: Report received from mother who reports child has an elevated temperature of 103-104 accompanied by poor appetite and refusal to walk.
Sex: U
Vaccine: RV1
Symptoms: Vaccination failure
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of vaccination failure in an unspecified number of subjects of unspecified ages and gender who were vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ROTARIX (unknown) and experienced vaccination failure. The physician reported "problems with ROTARIX, to include ROTARIX failures". This case was assessed as medically serious by GSK. Follow-up information was received on 26 April 2010, via physician who reported I did not have a patient who suffered an adverse event". No other information was provided.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: Patch of erythema with itchy left leg approx. 8x10cm sized patch.
Age: 48.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site atrophy
Clinical narrative: Lipoatrophy at injection site. Pt reports this has slowly increased. Reporter has not seen this so no other data available.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Rash vesicular, Tenderness
Clinical narrative: multiple tight tender vesicular lesions on hands, elbows, knees, and feet.  Treated with motrin and was excused from work x3 days because it was uncomfortable for him to wear his work boots
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Culture stool negative, Diarrhoea, Parasite stool test, Rotavirus test negative
Clinical narrative: This case was reported by a healthcare professional via a representative and described the occurrence of diarrhea in a female subject of unspecified age who was vaccinated with ROTARIX (GlaxoSmithKline). On 9 June 2009 the subject received 1st dose of ROTARIX (oral). On 10 June 2009, 1 day after vaccination with ROTARIX, the subject experienced severe diarrhea. She was seen in the doctor's office. Stool cultures were taken, including rotavirus, on 19 June 2009. When the child returned on 24 June 2009, all specimens were reported to be negative and the diarrhea was getting better. Four months later, the child was not given a second dose of ROTARIX. Follow-up information was received on 02 April 2010. The subject was a 2 month old female. Diarrhea occurred on 10 June 2009, one day after receiving ROTARIX. The event completely resolved by 30 June 2009. No further doses of ROTARIX were given.
Age: 40.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Asthma, Chills, Cough, Headache
Clinical narrative: Joint pain, headaches, congestion, fever, chills, coughing, asthmatic symptoms.
Age: 40.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Joint pain, headaches, congestion, fever, chills, coughing, asthmatic symptoms.
Age: 38.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Alopecia areata
Clinical narrative: sometime within 2-4 weeks following vaccination developed alopecia areata
Age: 41.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site vesicles
Clinical narrative: Large tender indurated area on right deltoid 7 days post vaccination 10 cm induration 3 cm erythema 1 1/2 cm bubble.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 1.05
Sex: M
Vaccine: DTAPHEPBIP, MMR, PNC, VARCEL
Symptoms: Body temperature increased, Cyanosis, Febrile convulsion, Respiratory arrest
Clinical narrative: Pt. taken to hospital via EMS. "Turning blue and stopped breathing" arrived @ 1206. Diagnosed at hospital : Febrile Seizures. Temp of 102. Discharged with 1/2 hrs in ER. Patient afebrile and taking fluids well.
Age: 1.53
Sex: M
Vaccine: UNK
Symptoms: Muscle twitching
Clinical narrative: Pt started twitching 1 1/2-2 hrs after vaccine was given.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: She received ZOSTAVAX on 4/6. She called today and said she had redness, swelling and itching in the area of the shot. She was told to take Benadryl.
Age: 37.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Hypokinesia, Injection site pain, Limb discomfort, Pain in extremity
Clinical narrative: Pt reports that he began experiencing (L) arm discomfort at 48 degrees after injection of H1N1 vaccine. It has continued to date with pain on lifting arm above shoulder in any position and involve (L) shoulder front and back; no noticeable swelling at site of injection or underarm today.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site became red and swollen.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Red, warm, hard 4 cm x 6 cm around injection site, the day after vaccination. On 3/18/10 had fever (not recorded by pt.). On 3/19/10 no fever but red, painful.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Drug dispensing error
Clinical narrative: ROTARIX given to patient while vaccine was still suspended.
Age: 21.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: SM received AVA #3 on 3/22/10 and found she was pregnant on 4/4/10.
Age: 21.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure before pregnancy
Clinical narrative: SM received AVA #3 on 3/22/10 and found she was pregnant on 4/4/10.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: Episode abdominal pain with nausea and vomiting on the following dates: 11-5-09, 12-30-09, 1-17-09, 3-06-10, 4-05-10.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Pyrexia
Clinical narrative: Pt's Mother reported the child cried the rest of the day and carried a fever of 103-104 x 24 hours. No local reaction.
Age: 55.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Hypoaesthesia, Lymphadenopathy, Pain, Swelling
Clinical narrative: Client called today on Friday 4/2/10 client developed pain and swelling in (L) foot and ankle; (L) knee and (L) hand and writs with numbness in (L) hand. She states she had a golf ball size node behind (L) ear also. Denies fever and other illness.
Age: 0.18
Sex: M
Vaccine: DTAP, IPV
Symptoms: Immediate post-injection reaction, Infantile spitting up
Clinical narrative: Immediately following administration of the Rota the pt spit up the vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Initial case was received on 31 March 2010 from a healthcare professional. The reporter stated she had a patient in the practice, who was inquiring if she was at an increased risk of GBS (GUILLAIN-BARRE Syndrome) following a H1N1 vaccination. The concern was because her mother, a female patient (age not specified), received an injection (route and site not reported) of INFLUENZA VACCINE (manufacturer and lot number not reported) on an unspecified date last year and experienced GBS (onset date not reported). The mother was not a patient in that practice. Outcome was not reported. The reporter had no further information and did not want to be contacted. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Convulsion, Nausea, Pyrexia, Vomiting
Clinical narrative: Initial case was received on 31 March 2010 from a consumer/parent. A 5 year old male patient received an injection (route and site unknown) of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number unknown) on 06 February 2010. The patient experienced an unspecified fever, nausea and weakness on 21 February 2010. He had no vaccines within the last year. He had no pre-existing medical conditions, no known allergies and no concomitant medications. As of this report he continued to be weak. Subsequently, on 06 March 2010 the patient received an injection (route and site unknown) of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number unknown). Post vaccination between 06 March 2010 and 17 March 2010 he experienced nausea, vomiting and a seizure, reported in case number 2010-01914. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Convulsion, Fear, Nausea, Similar reaction on previous exposure to drug
Clinical narrative: Initial case was received on 31 March 2010 from a consumer/parent. A 5 year old male patient received an injection (route and site unknown) of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number unknown) on 06 March 2010. Post vaccination, between 06 March 2010 and 17 March 2010, the patient experienced nausea, vomiting and a seizure. Had no pre-existing medical conditions, no known allergies and no concomitant medications. As of this report he continued to be weak and fearful. The outcome status of the nausea, vomiting and seizure was not reported. The patient had previously received an injection (route and site unknown) of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number unknown) on 06 February 2010 and he experienced unspecified fever, nausea and weakness on 21 February 2010, reported in case number 2010-01913. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Vomiting
Clinical narrative: Initial case was received on 31 March 2010 from a consumer/parent. A 5 year old male patient received an injection (route and site unknown) of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number unknown) on 06 March 2010. Post vaccination, between 06 March 2010 and 17 March 2010, the patient experienced nausea, vomiting and a seizure. Had no pre-existing medical conditions, no known allergies and no concomitant medications. As of this report he continued to be weak and fearful. The outcome status of the nausea, vomiting and seizure was not reported. The patient had previously received an injection (route and site unknown) of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number unknown) on 06 February 2010 and he experienced unspecified fever, nausea and weakness on 21 February 2010, reported in case number 2010-01913. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Fever, redness, swelling at site of injection, induration and tenderness. Area was 5 inches x 3 1/2 in, and purple!
Age: 11.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Pyrexia
Clinical narrative: Fever, redness, swelling at site of injection, induration and tenderness. Area was 5 inches x 3 1/2 in, and purple!
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling - localized to injection site - 10x13cm area of erythema on left upper extremity - treated with oral steroids.
Age: 5.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Body temperature increased, Discomfort, Injection site erythema, Injection site warmth
Clinical narrative: Left thigh with red, warm area at site of injections. Immunization received on 4/12/10 school nurse called mom on 4-13-10 with symptoms temp 98.8 degrees F @ appt on 4-13. Seen in clinic - treatment of warm packs for comfort and MOTRIN for discomfort.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: (L) arm to hand / fingers swollen, and painful. Symptoms began within 3hr post injection per pt, sling, ice, Vicodan PRN for pain.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Immediate post-injection reaction, Pain, Skin warm
Clinical narrative: Pt developed redness, soreness, warmth beginning shortly after immunization; increased the first 48 hours and now is improving.
Age: 1.35
Sex: M
Vaccine: MMR, PNC
Symptoms: Rash papular, Skin lesion, Vaccination failure, Varicella
Clinical narrative: Patient seen in office with papular vesicular lesions. Received vaccine at age 15mo. Suspected Varicella. Varicella Vaccine breakthrough.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Balance disorder, Dizziness, Nausea
Clinical narrative: nausea, dizziness, dysequilibrium starting on evening of shot, and continuing the next day
Age: 32.0
Sex: F
Vaccine: FLU3, FLU(H1N1)
Symptoms: Activated partial thromboplastin time prolonged, Alanine aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal
Clinical narrative: From the neurology consultation notes 3/26/10: Upon waking on 3/20/2010, felt numbness in the left and right toes; toes felt heavy and with decreased sensation but no tingling. No motor symptoms. On 3/21/10, numbness moved to mid-foot. On 3/22/10, numbness moved to first part of her calf bilaterally. On 3/23/10, numbness moved to mid-calf. On 3/24/10 and 3/25/10, numbness moved to below the knees and on the evening of 3/25/10, numbness to the thigh.  On 3/26/10, mid-thigh numbness bilaterally. Had some proprioception difficulty on exam (exam 3/26/10). Decreased sensation in the mid-thigh down. Denied any recent upper respiratory tract infection, denied gastroenteritis, denied diarrhea, denied exposure to Campylobacter. Denied HIV history. Denied fevers, chills, myalgias. She did receive H1N1 and seasonal flu vaccines in fall. The patient was admitted to Hospital on 3/26/10, discharged 3/30/10. LP was done 3/26/10, showed elevated CSF protein (33).
Age: 32.0
Sex: F
Vaccine: FLU3, FLU(H1N1)
Symptoms: Blood calcium normal, Blood chloride normal, Blood creatine decreased, Blood glucose decreased, Blood potassium normal
Clinical narrative: From the neurology consultation notes 3/26/10: Upon waking on 3/20/2010, felt numbness in the left and right toes; toes felt heavy and with decreased sensation but no tingling. No motor symptoms. On 3/21/10, numbness moved to mid-foot. On 3/22/10, numbness moved to first part of her calf bilaterally. On 3/23/10, numbness moved to mid-calf. On 3/24/10 and 3/25/10, numbness moved to below the knees and on the evening of 3/25/10, numbness to the thigh.  On 3/26/10, mid-thigh numbness bilaterally. Had some proprioception difficulty on exam (exam 3/26/10). Decreased sensation in the mid-thigh down. Denied any recent upper respiratory tract infection, denied gastroenteritis, denied diarrhea, denied exposure to Campylobacter. Denied HIV history. Denied fevers, chills, myalgias. She did receive H1N1 and seasonal flu vaccines in fall. The patient was admitted to Hospital on 3/26/10, discharged 3/30/10. LP was done 3/26/10, showed elevated CSF protein (33).
Age: 32.0
Sex: F
Vaccine: FLU3, FLU(H1N1)
Symptoms: Blood sodium normal, Blood test, Blood urea increased, CSF glucose decreased, CSF protein normal
Clinical narrative: From the neurology consultation notes 3/26/10: Upon waking on 3/20/2010, felt numbness in the left and right toes; toes felt heavy and with decreased sensation but no tingling. No motor symptoms. On 3/21/10, numbness moved to mid-foot. On 3/22/10, numbness moved to first part of her calf bilaterally. On 3/23/10, numbness moved to mid-calf. On 3/24/10 and 3/25/10, numbness moved to below the knees and on the evening of 3/25/10, numbness to the thigh.  On 3/26/10, mid-thigh numbness bilaterally. Had some proprioception difficulty on exam (exam 3/26/10). Decreased sensation in the mid-thigh down. Denied any recent upper respiratory tract infection, denied gastroenteritis, denied diarrhea, denied exposure to Campylobacter. Denied HIV history. Denied fevers, chills, myalgias. She did receive H1N1 and seasonal flu vaccines in fall. The patient was admitted to Hospital on 3/26/10, discharged 3/30/10. LP was done 3/26/10, showed elevated CSF protein (33).
Age: 32.0
Sex: F
Vaccine: FLU3, FLU(H1N1)
Symptoms: CSF white blood cell count increased, Carbon dioxide normal, Globulin, Gram stain negative, HIV antibody negative
Clinical narrative: From the neurology consultation notes 3/26/10: Upon waking on 3/20/2010, felt numbness in the left and right toes; toes felt heavy and with decreased sensation but no tingling. No motor symptoms. On 3/21/10, numbness moved to mid-foot. On 3/22/10, numbness moved to first part of her calf bilaterally. On 3/23/10, numbness moved to mid-calf. On 3/24/10 and 3/25/10, numbness moved to below the knees and on the evening of 3/25/10, numbness to the thigh.  On 3/26/10, mid-thigh numbness bilaterally. Had some proprioception difficulty on exam (exam 3/26/10). Decreased sensation in the mid-thigh down. Denied any recent upper respiratory tract infection, denied gastroenteritis, denied diarrhea, denied exposure to Campylobacter. Denied HIV history. Denied fevers, chills, myalgias. She did receive H1N1 and seasonal flu vaccines in fall. The patient was admitted to Hospital on 3/26/10, discharged 3/30/10. LP was done 3/26/10, showed elevated CSF protein (33).
Age: 32.0
Sex: F
Vaccine: FLU3, FLU(H1N1)
Symptoms: Haematocrit decreased, Haemoglobin normal, Hypoaesthesia, International normalised ratio normal, Loss of proprioception
Clinical narrative: From the neurology consultation notes 3/26/10: Upon waking on 3/20/2010, felt numbness in the left and right toes; toes felt heavy and with decreased sensation but no tingling. No motor symptoms. On 3/21/10, numbness moved to mid-foot. On 3/22/10, numbness moved to first part of her calf bilaterally. On 3/23/10, numbness moved to mid-calf. On 3/24/10 and 3/25/10, numbness moved to below the knees and on the evening of 3/25/10, numbness to the thigh.  On 3/26/10, mid-thigh numbness bilaterally. Had some proprioception difficulty on exam (exam 3/26/10). Decreased sensation in the mid-thigh down. Denied any recent upper respiratory tract infection, denied gastroenteritis, denied diarrhea, denied exposure to Campylobacter. Denied HIV history. Denied fevers, chills, myalgias. She did receive H1N1 and seasonal flu vaccines in fall. The patient was admitted to Hospital on 3/26/10, discharged 3/30/10. LP was done 3/26/10, showed elevated CSF protein (33).
Age: 32.0
Sex: F
Vaccine: FLU3, FLU(H1N1)
Symptoms: Neutrophil count, Platelet count normal, Protein total normal, Prothrombin time prolonged, Red blood cells CSF positive
Clinical narrative: From the neurology consultation notes 3/26/10: Upon waking on 3/20/2010, felt numbness in the left and right toes; toes felt heavy and with decreased sensation but no tingling. No motor symptoms. On 3/21/10, numbness moved to mid-foot. On 3/22/10, numbness moved to first part of her calf bilaterally. On 3/23/10, numbness moved to mid-calf. On 3/24/10 and 3/25/10, numbness moved to below the knees and on the evening of 3/25/10, numbness to the thigh.  On 3/26/10, mid-thigh numbness bilaterally. Had some proprioception difficulty on exam (exam 3/26/10). Decreased sensation in the mid-thigh down. Denied any recent upper respiratory tract infection, denied gastroenteritis, denied diarrhea, denied exposure to Campylobacter. Denied HIV history. Denied fevers, chills, myalgias. She did receive H1N1 and seasonal flu vaccines in fall. The patient was admitted to Hospital on 3/26/10, discharged 3/30/10. LP was done 3/26/10, showed elevated CSF protein (33).
Age: 32.0
Sex: F
Vaccine: FLU3, FLU(H1N1)
Symptoms: Rheumatoid factor negative, Sensation of heaviness, Sensory loss, Urine analysis normal, White blood cell count normal
Clinical narrative: From the neurology consultation notes 3/26/10: Upon waking on 3/20/2010, felt numbness in the left and right toes; toes felt heavy and with decreased sensation but no tingling. No motor symptoms. On 3/21/10, numbness moved to mid-foot. On 3/22/10, numbness moved to first part of her calf bilaterally. On 3/23/10, numbness moved to mid-calf. On 3/24/10 and 3/25/10, numbness moved to below the knees and on the evening of 3/25/10, numbness to the thigh.  On 3/26/10, mid-thigh numbness bilaterally. Had some proprioception difficulty on exam (exam 3/26/10). Decreased sensation in the mid-thigh down. Denied any recent upper respiratory tract infection, denied gastroenteritis, denied diarrhea, denied exposure to Campylobacter. Denied HIV history. Denied fevers, chills, myalgias. She did receive H1N1 and seasonal flu vaccines in fall. The patient was admitted to Hospital on 3/26/10, discharged 3/30/10. LP was done 3/26/10, showed elevated CSF protein (33).
Age: 32.0
Sex: F
Vaccine: FLU3, FLU(H1N1)
Symptoms: CSF protein increased, Guillain-Barre syndrome, Hypoaesthesia, Loss of proprioception, Sensory loss
Clinical narrative: From the neurology consultation notes 3/26/10: Upon waking on 3/20/2010, felt numbness in the left and right toes; toes felt heavy and with decreased sensation but no tingling. No motor symptoms. On 3/21/10, numbness moved to mid-foot. On 3/22/10, numbness moved to first part of her calf bilaterally. On 3/23/10, numbness moved to mid-calf. On 3/24/10 and 3/25/10, numbness moved to below the knees and on the evening of 3/25/10, numbness to the thigh.  On 3/26/10, mid-thigh numbness bilaterally. Had some proprioception difficulty on exam (exam 3/26/10). Decreased sensation in the mid-thigh down. Denied any recent upper respiratory tract infection, denied gastroenteritis, denied diarrhea, denied exposure to Campylobacter. Denied HIV history. Denied fevers, chills, myalgias. She did receive H1N1 and seasonal flu vaccines in fall. The patient was admitted to Hospital on 3/26/10, discharged 3/30/10. LP was done 3/26/10, showed elevated CSF protein (33).
Age: 1.45
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Unevaluable event
Clinical narrative: There were no adverse events observed. The child remained in the clinic approximately 30 min after the vaccines were given.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Oral herpes
Clinical narrative: EXTREMELY LARGE WELT AT SITE OF INJECTION WITH SEVERE ITCHING AND THE FORMATION OF COLD SORES ON UPPER LIP
Age: 46.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Asthenia, Blood test normal, Computerised tomogram normal, Convulsion, Cough
Clinical narrative: weak, decrease appetite, cough, not sure if had fever. got worse and on 4/4/10 felt nauseated and fainted x 2 that morning with 1 episode of vomiting. denies gross body movements. taken to Hospital. W/u included blood test, CT scan brain WNL Diagnosis was Seizure. Referred to a neurologist. Pt was told everything was normal.
Age: 46.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Decreased appetite, Nausea, Scan brain, Syncope, Vomiting
Clinical narrative: weak, decrease appetite, cough, not sure if had fever. got worse and on 4/4/10 felt nauseated and fainted x 2 that morning with 1 episode of vomiting. denies gross body movements. taken to Hospital. W/u included blood test, CT scan brain WNL Diagnosis was Seizure. Referred to a neurologist. Pt was told everything was normal.
Age: 15.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Arthralgia, Blood test, Borrelia test negative, Fatigue, Influenza like illness
Clinical narrative: joint pain and swelling in wrists, knuckles, knees, ankles and some pain in back accompanied with rash (hives), severe fatigue, and just over all not feeling well. 5/14/10 Follow up: Temporary #E-42978 report filled out in regards to my son. Additional information to support my report. In the month following the meningitis vaccine he began having flu like symptoms but tested negative for flu. Had rash, hives, strep like symptoms. Treated with antibiotics on several occasions over the last 15 months. I have taken him to 5 different doctors with symptoms and most recent being an arthritis doctor. I have suggested this vaccine from the very beginning and was told no this was no the cause. After being tested for so many different possibilities I feel this vaccine has contributed to my, prior to vaccine, "healthy" sons medical problems. He has been tested for the following: strep, flu, mono, lupus, arthritis, lyme disease, and had white blood count checked. He was 15 at the time he was given this vaccine "WITHOUT MY REQUEST OR CONSENT", and at this point I am ready to find out if something has happened with this vaccine.
Age: 15.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Malaise, Mononucleosis heterophile test negative, Rash, Sinusitis, Streptococcal infection
Clinical narrative: joint pain and swelling in wrists, knuckles, knees, ankles and some pain in back accompanied with rash (hives), severe fatigue, and just over all not feeling well. 5/14/10 Follow up: Temporary #E-42978 report filled out in regards to my son. Additional information to support my report. In the month following the meningitis vaccine he began having flu like symptoms but tested negative for flu. Had rash, hives, strep like symptoms. Treated with antibiotics on several occasions over the last 15 months. I have taken him to 5 different doctors with symptoms and most recent being an arthritis doctor. I have suggested this vaccine from the very beginning and was told no this was no the cause. After being tested for so many different possibilities I feel this vaccine has contributed to my, prior to vaccine, "healthy" sons medical problems. He has been tested for the following: strep, flu, mono, lupus, arthritis, lyme disease, and had white blood count checked. He was 15 at the time he was given this vaccine "WITHOUT MY REQUEST OR CONSENT", and at this point I am ready to find out if something has happened with this vaccine.
Age: 15.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Swelling, Urticaria, White blood cell count normal
Clinical narrative: joint pain and swelling in wrists, knuckles, knees, ankles and some pain in back accompanied with rash (hives), severe fatigue, and just over all not feeling well. 5/14/10 Follow up: Temporary #E-42978 report filled out in regards to my son. Additional information to support my report. In the month following the meningitis vaccine he began having flu like symptoms but tested negative for flu. Had rash, hives, strep like symptoms. Treated with antibiotics on several occasions over the last 15 months. I have taken him to 5 different doctors with symptoms and most recent being an arthritis doctor. I have suggested this vaccine from the very beginning and was told no this was no the cause. After being tested for so many different possibilities I feel this vaccine has contributed to my, prior to vaccine, "healthy" sons medical problems. He has been tested for the following: strep, flu, mono, lupus, arthritis, lyme disease, and had white blood count checked. He was 15 at the time he was given this vaccine "WITHOUT MY REQUEST OR CONSENT", and at this point I am ready to find out if something has happened with this vaccine.
Age: 0.17
Sex: M
Vaccine: 6VAX-F, PPV, RVX
Symptoms: Blood test normal, Convulsion, Crying, Dyskinesia, Electroencephalogram normal
Clinical narrative: He had a stiffening, seizure like episode that lasted for about 4-5 seconds.  His whole body tightened, his face got bright red, it looked involuntary, and he cried afterward like he was scared and didn't know what had just happened.  This happened two times on 1/10 in the morning, one time on 1/12 in the late afternoon and two times on 1/14 in the evening.  Patient was hospitalized on 1/15 to 1/16 due to these episodes.  There was no fever and he did not have any more of these episodes after 1/14.  They did an EEG while sleeping and awake and did not find any irregular brain activity.  A neurologist saw him and thought it might be a reaction to his immunizations.
Age: 0.17
Sex: M
Vaccine: 6VAX-F, PPV, RVX
Symptoms: Erythema, Inappropriate schedule of drug administration, Musculoskeletal stiffness
Clinical narrative: He had a stiffening, seizure like episode that lasted for about 4-5 seconds.  His whole body tightened, his face got bright red, it looked involuntary, and he cried afterward like he was scared and didn't know what had just happened.  This happened two times on 1/10 in the morning, one time on 1/12 in the late afternoon and two times on 1/14 in the evening.  Patient was hospitalized on 1/15 to 1/16 due to these episodes.  There was no fever and he did not have any more of these episodes after 1/14.  They did an EEG while sleeping and awake and did not find any irregular brain activity.  A neurologist saw him and thought it might be a reaction to his immunizations.