chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: ANTH, FLU(H1N1), SMALL, TYP, ANTH, FLU(H1N1), SMALL, TYP
Symptoms: Resuscitation, Syncope, Troponin, Unresponsive to stimuli
Clinical narrative: 22 y/o male who collapsed after a prolonged high intensity exercise run wearing about 30-40 lbs of gear on field run for > 1 hour; felt "unwell" at the end of 4 mile run; walked around about 1 1/2 laps and then collapsed. Does not recall any events following collapse until about 8 days later while hospitalized. Pt felt well prior to run - "near 100%". Reports he was well hydrated. When patient transported by ambulance, he experienced an altered mental status (initially unresponsive, then agitated, combative) and his temperature was 109 degrees F, rectally, which was confirmed at ER as >107 degrees F, rectally. Efforts to cool and sedate (received ATIVAN and HALDOL --> intubated). Temp down to 103 degrees F --> transferred to another Hospital. Temp down to 101 on admission; given additional fentanyl and versed for agitation. Hemodynamically stable with HRs 80-90 and SBP 100-20s; O2 stats > 97%. Loose green stools. HOSPITAL COURSE: Agitated, febrile to 102 rectally despite cooling blanket, fan and ice packs. Given Librium d/t concern for DTs with ETOH intake of about 30 beers/week (last ETOH intake around 3/14/2010); given VERSED as needed for agitation. Concern for cerebral edema (per CT with concern for herniation; episode in scanner where he was unresponsive, sluggish small pupils, heart rate in 30s, requiring resuscitation -->MICU). Given Mannitol with improvement. F/u MRI w/o evidence of elevated ICP. Received coverage for infections (doxy, vancomycin, ceftriaxzone, and acyclovir). After consultation with CDC and VHC, VIG (X1) administered IV (6000 units per kg) and pat also received IV methylprednisolone. Over hospital course, temperature returned to normal after several days, LFTS improved and mental status improved to near baseline. By 24 March, patient was extubated. He was following commands and answering questions, but no recall of previous 7 days. He was discharged on 28 March 2010. 13 April, Follow up visit, problems with motor skills (difficulty using fork and pen) and continues to report memory lapses ( -- > repair MRI and Neurology follow-up appt). 26 April, Follow Up, problems with mild memory lapses with forgetting what he is doing and at time how to do simple things such as tie his shoes. Problems falling asleep with sleep initiation taking anywhere from 2-3 hours. Also, admits to increased mood swings but he admits to being under some pressure from all this going on.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: C-reactive protein, Full blood count, Herpes zoster, Lip pain, Pain in extremity
Clinical narrative: Dx - shingles - painful (R) leg (R) hip. Not bearing wt. x2d then zoster like rash noted only on (R) leg.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Red blood cell sedimentation rate, X-ray
Clinical narrative: Dx - shingles - painful (R) leg (R) hip. Not bearing wt. x2d then zoster like rash noted only on (R) leg.
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Barium enema, Blood test, Intussusception, Ultrasound abdomen, Vomiting
Clinical narrative: Intussusception, emesis went to hospital ER on 4/28/2010. Treatment: IV hydration, ZOFRAN, PEPCID.
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: X-ray
Clinical narrative: Intussusception, emesis went to hospital ER on 4/28/2010. Treatment: IV hydration, ZOFRAN, PEPCID.
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Intussusception, emesis went to hospital ER on 4/28/2010. Treatment: IV hydration, ZOFRAN, PEPCID.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness and swelling and itching since 4/26/10 when he received immunes. Was instructed to use warm compresses and see if the redness will disperse and was prescribed medication as well.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, CSF cell count normal, CSF protein increased, Electromyogram abnormal, Endotracheal intubation
Clinical narrative: Profound weakness initially attributed to viral illness.  Required intubation on 11/11/2009 secondary to respiratory failure.  Subsequently diagnosed with GBS with significant morbidity and prolonged recovery time.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Polyneuropathy, Radiculopathy, Respiratory failure
Clinical narrative: Profound weakness initially attributed to viral illness.  Required intubation on 11/11/2009 secondary to respiratory failure.  Subsequently diagnosed with GBS with significant morbidity and prolonged recovery time.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Pt had right arm hot and it was swollen.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Abasia, Gait disturbance, Guillain-Barre syndrome, Lumbar puncture, Muscular weakness
Clinical narrative: Per mother, child started having nausea off and on 2 and 1/2 to 3 weeks ago. Child sent home from school a couple of days. Started having R and L leg weakness which worsened a few days later. Saw family physician, then Inf Disease MD, then Neuro. Eventually child unable to walk. Hospitalized for 8 days. Diagnosed with Guillain Barre. On Homebound re school for the rest of this year. Child used wheel chair and walker in hospital. Walking without assistance at home but gait still far from normal per mother. Child will be getting PT and OT per mom.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Nausea, Nuclear magnetic resonance imaging, Walking aid user, Wheelchair user
Clinical narrative: Per mother, child started having nausea off and on 2 and 1/2 to 3 weeks ago. Child sent home from school a couple of days. Started having R and L leg weakness which worsened a few days later. Saw family physician, then Inf Disease MD, then Neuro. Eventually child unable to walk. Hospitalized for 8 days. Diagnosed with Guillain Barre. On Homebound re school for the rest of this year. Child used wheel chair and walker in hospital. Walking without assistance at home but gait still far from normal per mother. Child will be getting PT and OT per mom.
Age: 62.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: CSF test abnormal, Electromyogram abnormal, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Burning pain experienced in thighs on 11/10/2009 followed by bilateral lower extremity weakness on 11/11/2009.  Admitted to hospital on 11/15/2009 where he was treated with IVIG.
Age: 62.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pain
Clinical narrative: Burning pain experienced in thighs on 11/10/2009 followed by bilateral lower extremity weakness on 11/11/2009.  Admitted to hospital on 11/15/2009 where he was treated with IVIG.
Age: 1.29
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, raised area, warm to the touch on left thigh. Measured 3cm x 3cm.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Blood test, Decreased appetite, Disturbance in attention, Dry mouth, Endocrine test
Clinical narrative: Extreme Exhaustion, Inability to think clearly, dry mouth, tongue swelling, severe headaches, fevers, loss of appetite, insomnia, skin infections, extreme feeling of having the flu every day.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Headache, Influenza, Insomnia, Pyrexia
Clinical narrative: Extreme Exhaustion, Inability to think clearly, dry mouth, tongue swelling, severe headaches, fevers, loss of appetite, insomnia, skin infections, extreme feeling of having the flu every day.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Saliva analysis, Skin infection, Swollen tongue
Clinical narrative: Extreme Exhaustion, Inability to think clearly, dry mouth, tongue swelling, severe headaches, fevers, loss of appetite, insomnia, skin infections, extreme feeling of having the flu every day.
Age: 0.19
Sex: F
Vaccine: DTAPIPV, HIBV, MEN, RVX
Symptoms: Pyrexia
Clinical narrative: Rising fever uncontrolled with Tylenol.  Fever continued to rise until approximately 11:30 pm.  Fever reached 103 degrees even with Tylenol therapy.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eyelid oedema, Oedema peripheral, Oral herpes, Pruritus
Clinical narrative: ARM RED AND SWOLLEN THE SIZE OF A TENNIS BALL, AND ITCHING, 4/30/2010 1:00 PM, COLD SORE ON UPPER LIP, HAD NOT HAD A COLD SORE IN 2 YEARS, 5/1/2010 ARM HOT AND ITCHING, RIGHT EYE SWOLLEN SHUT, DON'T KNOW IF THIS WAS ALL RELATED TO SHINGLES VACCINE OR JUST A COINCIDENCE.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: ARM RED AND SWOLLEN THE SIZE OF A TENNIS BALL, AND ITCHING, 4/30/2010 1:00 PM, COLD SORE ON UPPER LIP, HAD NOT HAD A COLD SORE IN 2 YEARS, 5/1/2010 ARM HOT AND ITCHING, RIGHT EYE SWOLLEN SHUT, DON'T KNOW IF THIS WAS ALL RELATED TO SHINGLES VACCINE OR JUST A COINCIDENCE.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, OPV, RVX
Symptoms: Crying, Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Unconsolable crying, fever, red swollen injection site and surrounding area. Vomiting.
Age: 64.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Blood test, Chest X-ray abnormal, Chills, Cough
Clinical narrative: General malaise Tuesay evening. Wednesday morning fever, chills, weakness, fatigue. Wednesday evening - High fever 103 degrees. Wheezing, heavy cough with congestion, shortness of breath, extreme dizziness, unsteady on feet.
Age: 64.0
Sex: M
Vaccine: TD
Symptoms: Dizziness, Dyspnoea, Fatigue, Gait disturbance, Malaise
Clinical narrative: General malaise Tuesay evening. Wednesday morning fever, chills, weakness, fatigue. Wednesday evening - High fever 103 degrees. Wheezing, heavy cough with congestion, shortness of breath, extreme dizziness, unsteady on feet.
Age: 64.0
Sex: M
Vaccine: TD
Symptoms: Pneumonia, Pyrexia, Respiratory tract congestion, Wheezing
Clinical narrative: General malaise Tuesay evening. Wednesday morning fever, chills, weakness, fatigue. Wednesday evening - High fever 103 degrees. Wheezing, heavy cough with congestion, shortness of breath, extreme dizziness, unsteady on feet.
Age: 1.72
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Pyrexia, Skin lesion, Urticaria, Vomiting
Clinical narrative: Given vaccines at 20 month WCC on 4/8/10 - MMR #1, Varicella #1, Hepatitis A #1. Had several chicken pox-like lesions the next day with low grade fever, some vomiting/diarrhea. These symptoms resolved in 2-3 days followed by classic hives for 2-3 weeks.
Age: 2.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Condition aggravated, Convulsion, Tremor
Clinical narrative: Seizure and now ongoing tremors everyday.
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Body temperature normal, Cardio-respiratory arrest, Condition aggravated, Glycosylated haemoglobin increased, Low density lipoprotein normal
Clinical narrative: Initial report received from a healthcare professional via vaccine adverse event reporting system on 30 Apr 2010: This polymedicated patient had medical history of myocardial infarction (1998), obesity, diabetes mellitus, coronary artery disease, hypertension, hyperlipidemia, chronic mechanical low back pain (2006), herniated disc surgery (2006), peripheral edema (Aug 2007), angina (Aug 2007). Both diabetes and cholesterol were poorly controlled before vaccination. During the last medical visit on 29 Oct 2007, physical examination was within normal limits. The patient was vaccinated with FLUVIRIN 2007/08  (batch number 79898) On 29 Oct 2007. Same day, the patient was also vaccinated with ZOSTAVAX (batch number 658209/1085U). The patient expired suddenly on 10 Dec 2007. Immediate cause of death was reported as cardiopulmonary arrest. 10 year history of coronary artery disease was reported as secondary cause of death. Diabetes mellitus was reported to be a significant contributor. The patient expired in own home and no autopsy was done.
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Sudden death
Clinical narrative: Initial report received from a healthcare professional via vaccine adverse event reporting system on 30 Apr 2010: This polymedicated patient had medical history of myocardial infarction (1998), obesity, diabetes mellitus, coronary artery disease, hypertension, hyperlipidemia, chronic mechanical low back pain (2006), herniated disc surgery (2006), peripheral edema (Aug 2007), angina (Aug 2007). Both diabetes and cholesterol were poorly controlled before vaccination. During the last medical visit on 29 Oct 2007, physical examination was within normal limits. The patient was vaccinated with FLUVIRIN 2007/08  (batch number 79898) On 29 Oct 2007. Same day, the patient was also vaccinated with ZOSTAVAX (batch number 658209/1085U). The patient expired suddenly on 10 Dec 2007. Immediate cause of death was reported as cardiopulmonary arrest. 10 year history of coronary artery disease was reported as secondary cause of death. Diabetes mellitus was reported to be a significant contributor. The patient expired in own home and no autopsy was done.
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Cardio-respiratory arrest, Death
Clinical narrative: Initial report received from a healthcare professional via vaccine adverse event reporting system on 30 Apr 2010: This polymedicated patient had medical history of myocardial infarction (1998), obesity, diabetes mellitus, coronary artery disease, hypertension, hyperlipidemia, chronic mechanical low back pain (2006), herniated disc surgery (2006), peripheral edema (Aug 2007), angina (Aug 2007). Both diabetes and cholesterol were poorly controlled before vaccination. During the last medical visit on 29 Oct 2007, physical examination was within normal limits. The patient was vaccinated with FLUVIRIN 2007/08  (batch number 79898) On 29 Oct 2007. Same day, the patient was also vaccinated with ZOSTAVAX (batch number 658209/1085U). The patient expired suddenly on 10 Dec 2007. Immediate cause of death was reported as cardiopulmonary arrest. 10 year history of coronary artery disease was reported as secondary cause of death. Diabetes mellitus was reported to be a significant contributor. The patient expired in own home and no autopsy was done.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Guillain-Barre syndrome, Mechanical ventilation
Clinical narrative: Symptoms began with a low grade temperature with generalized malaise with achiness along with burning while urinating. On 4/19 she developed numbness and tingling of the feet and hands. On 4/21 she had weakness and difficulty climbing stairs.  By 4/22 she could not stand up or walk independently.  Areflexic and significant weakness bilaterally in both upper and lower extremities. Some perioral numbness and lower facial numbness and tingling. EMG indicated Guillain Barre syndrome and she was treated with IVIG, intubated, and admitted to ICU.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Areflexia, Asthenia, Body temperature increased, Dysstasia, Dysuria
Clinical narrative: Symptoms began with a low grade temperature with generalized malaise with achiness along with burning while urinating. On 4/19 she developed numbness and tingling of the feet and hands. On 4/21 she had weakness and difficulty climbing stairs.  By 4/22 she could not stand up or walk independently.  Areflexic and significant weakness bilaterally in both upper and lower extremities. Some perioral numbness and lower facial numbness and tingling. EMG indicated Guillain Barre syndrome and she was treated with IVIG, intubated, and admitted to ICU.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Electromyogram abnormal, Endotracheal intubation, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Symptoms began with a low grade temperature with generalized malaise with achiness along with burning while urinating. On 4/19 she developed numbness and tingling of the feet and hands. On 4/21 she had weakness and difficulty climbing stairs.  By 4/22 she could not stand up or walk independently.  Areflexic and significant weakness bilaterally in both upper and lower extremities. Some perioral numbness and lower facial numbness and tingling. EMG indicated Guillain Barre syndrome and she was treated with IVIG, intubated, and admitted to ICU.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia facial, Hypoaesthesia oral, Immunoglobulin therapy, Intensive care, Malaise
Clinical narrative: Symptoms began with a low grade temperature with generalized malaise with achiness along with burning while urinating. On 4/19 she developed numbness and tingling of the feet and hands. On 4/21 she had weakness and difficulty climbing stairs.  By 4/22 she could not stand up or walk independently.  Areflexic and significant weakness bilaterally in both upper and lower extremities. Some perioral numbness and lower facial numbness and tingling. EMG indicated Guillain Barre syndrome and she was treated with IVIG, intubated, and admitted to ICU.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Muscular weakness, Pain, Paraesthesia
Clinical narrative: Symptoms began with a low grade temperature with generalized malaise with achiness along with burning while urinating. On 4/19 she developed numbness and tingling of the feet and hands. On 4/21 she had weakness and difficulty climbing stairs.  By 4/22 she could not stand up or walk independently.  Areflexic and significant weakness bilaterally in both upper and lower extremities. Some perioral numbness and lower facial numbness and tingling. EMG indicated Guillain Barre syndrome and she was treated with IVIG, intubated, and admitted to ICU.
Age: 51.0
Sex: F
Vaccine: HEP, TDAP, HEP, TDAP
Symptoms: Lymphadenopathy, Pain, Rash
Clinical narrative: Pt. had shot at 1:15Pm on the 04/14/2010 at 2:35 am Pt. noticed a rash on her arms, days following she has been feeling fatigue, extreme abdominal pain, nausea, and Pt. looks jaundice.
Age: 51.0
Sex: F
Vaccine: HEP, TDAP, HEP, TDAP
Symptoms: Abdominal pain, Fatigue, Jaundice, Liver function test, Nausea
Clinical narrative: Pt. had shot at 1:15Pm on the 04/14/2010 at 2:35 am Pt. noticed a rash on her arms, days following she has been feeling fatigue, extreme abdominal pain, nausea, and Pt. looks jaundice.
Age: 51.0
Sex: F
Vaccine: HEP, TDAP, HEP, TDAP
Symptoms: Rash
Clinical narrative: Pt. had shot at 1:15Pm on the 04/14/2010 at 2:35 am Pt. noticed a rash on her arms, days following she has been feeling fatigue, extreme abdominal pain, nausea, and Pt. looks jaundice.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning an 18 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on an unspecified date was vaccinated with a dose of GARDASIL (Lot # not reported). There was no concomitant medication reported. It was reported that the patient was vaccinated with GARDASIL during pregnancy. The patient was seen at the practice. On an unspecified date a home pregnancy test and an ultrasound were performed (results not provided). The date of the last menstrual period was on 25-MAR-2009 and the estimated delivery date was 30-DEC-2009. Follow up information was received from a health professional. It was reported that they saw this patient only twice. The first time was in May 2009 and then on 08-JUN-2009 in the emergency room (ER). The patient was seen in the ER due to miscarriage. They have not seen the patients since that time. The reporter mentioned that the patient did not receive the HPV in their office. The patient had reported receiving it in April 2009. Upon internal review, miscarriage was considered to be an other important medical event. No further information is available.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Emotional distress, Haematochezia, Intussusception, Mucous stools
Clinical narrative: Initial and follow-up information has been received from a physician and a front office employee concerning an 18 weeks old male with no pertinent medical history or allergies who on 22-APR-2010 was vaccinated orally with the first dose of ROTATEQ (lot# 664883/1523Y). Concomitant therapy included PENTACEL (lot# SPC#3469AA) and PREVNAR (lot# E44520) which were both vaccinated on 22-APR-2010. On 25-APR-2010 the patient had an inconsolable episode for 3-4 hours in the early afternoon. Then at 1:00 am the patient's mother opened the patient's diaper and there was a string of mucus with blood. The physician believed the patient may have had intussusception episode on the afternoon of 25-APR-2010 that self resolved by the time the patient's mother contacted him around 1:00 am through phone call. It was reported that the patient was not experiencing any known symptoms. The physician also reported that no testing were done, so it was unknown if the patient experienced intussusception. Based on symptoms of the child being inconsolable along with the tiny amount of bloody mucus in diaper, the physician suspected that it was self-resolving intussusception. These adverse events were not considered to be disabling or life threatening by the physician. Upon internal review, intussusception was determined to be an other important medical event. No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Bacterial test, Haematochezia, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning an infant patient with no illness at time of vaccination or pre-existing allergies, birth defects and medical conditions who on 05-APR-2010 was vaccinated orally with the first dose of ROTATEQ (Lot# 664076/0768Y) at 19:00. On 06-APR-2010 the patient developed blood in the stool which persisted > 10 days. Lab data: rotavirus antigen positive in stool and bacterial culture was pending. At the time of report the patient's status was unknown. Upon internal review, blood in the stool was considered to be an other important medical event. Additional information has been requested.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Autopsy, Bronchopneumonia, Death, Respiratory failure
Clinical narrative: Initial report received from a physician via health authority on 03 May 2010: This patient was vaccinated with S-OIV FLUVIRIN (batch number 107522P1) on 29 Apr 2010. 24 hours after vaccination, the patient presented with sudden respiratory failure on 30 Apr 2010 and two hours later, the patient died. Medical history of the patient was unknown. Autopsy was performed and cause of death was stated as bronchopneumonia.
Age: 1.75
Sex: F
Vaccine: HEPA, MMR
Symptoms: Computerised tomogram head, Electroencephalogram abnormal, Febrile convulsion, Full blood count, Laboratory test
Clinical narrative: Child given MMR + Hep A #2 and 1 week later developed febrile seizure and had RML Pneumonia.
Age: 1.75
Sex: F
Vaccine: HEPA, MMR
Symptoms: Lobar pneumonia
Clinical narrative: Child given MMR + Hep A #2 and 1 week later developed febrile seizure and had RML Pneumonia.
Sex: F
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: None. Pt. came in for flu immunization was unaware before.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: BEGAN INITIALLY AS PAIN @ SITE & ITCHING & REDNESS @ INJECTION SITE/PROGRESSED TO RED WARM TO TOUCH AREA 5CM X3 CM OVER INJECTION SITE/ NOTED 1CM BRUISE TO R OF REDDENED AREA.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Area on arm where shot given swollen, red and painful.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Dyspnoea, Eyelid oedema, Lip swelling, Upper respiratory tract congestion
Clinical narrative: Pt. rec'd HepA, varicella and meningococcal vaccines in few minutes mother brought pt back - Pt. was having SOB, swollen eyelids and lips, congestion: consulted DON and NP - Epi given 0.5 cc x 2 - 15 min apart per attending EMS order called. Pt transported to hospital.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Redness, swelling, pain in Left arm, radiating up into neck. Treatment on 04/26/2010: Rx for Bactrim DS 1 b.i.d x 10 days, told to apply ice.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Pain in left bicep and tricep. Redness, swelling, and warmness, in area.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Neuralgia
Clinical narrative: Severe pain, in the left Pudental nerve, affecting all normal functions. Various treatments, to no good effect. Unremmitting, and still severe, 15 months later.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site pain, Irritability, Nausea
Clinical narrative: Pain at injection site, chills, fever, headache, body ache, irritability, and nausea.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Pain at injection site, chills, fever, headache, body ache, irritability, and nausea.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pain, Pruritus, Swelling
Clinical narrative: Area became red swollen hard and hot plus itchy.  By 2 days after shot it had spread over entire upper arm.  ER doc prescribed hydroxine for itching and hydrocodone 325mg for pain.  As of today, 5/5/2010, redness and hardness has decreased some, but still large area affected and still hot and itchy and painful.  Only relief is with cold pack applied.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: 10 cm erythematous patch of skin surrounding vaccine site with swelling. Temperature to 101.  Resolved over 12 hours.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Burning sensation, Lymphadenopathy, Paraesthesia, Rash
Clinical narrative: Rash, burning and prickling sensation above left eye. Lymph node behind left ear swollen.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Day after receiving VZV and Hep A vaccine site where VZV was administrated became red and swollen.  Parent states gave Benadryl and applied cold compress.  Came to Health Dept. on 5/5 and was referred to PCP.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: LUMP SIZE OF QUARTER AT INJECTION SITE.  NO PAIN OR FEVER.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: Local reaction ( L ) arm. Tx - ibuprofen 300 mg q 6 hours x 48 hours. BENADRYL 25-50 mg q 6 hours prn x 48 hours.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Immediate post-injection reaction
Clinical narrative: Pt. states c/o pain in joints immediately following vaccination. Presents with MD 10/31/10 too Rheumatologist in January.
Age: 64.0
Sex: F
Vaccine: TD
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Rash and swelling at the sight.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Muscular weakness, Nausea, Palpitations
Clinical narrative: Completely healthy teenager developed muscle weakness, severe nausea and heart palpitations after about 5-6 weeks of receiving second shot. Symptoms lasted for about 4 weeks and mild persistent nausea and some muscle weakness for about 8 weeks. Called night nurse and went to physician.
Age: 29.0
Sex: M
Vaccine: MMR, TTOX
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pain and stiffness on the left upper arm, around the vaccination area.
Sex: U
Vaccine: DTAPIPV
Symptoms: Cellulitis
Clinical narrative: This case was reported by a healthcare professional via a representative and described the occurrence of cellulitis in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown). At an unspecified time after vaccination with KINRIX, the subject  experienced cellulitis. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. The sales representative reported that there has been 4 cases of cellulitis at this doctor's office recently. They have increased their doses of KINRIX during this time and were questioning whether it may have been a cause. The sales representative had no additional information.
Sex: U
Vaccine: DTAPIPV
Symptoms: Cellulitis
Clinical narrative: This case was reported by a healthcare professional via a representative and described the occurrence of cellulitis in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown). At an unspecified time after vaccination with KINRIX, the subject experienced cellulitis. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. The sales representative reported that there has been 4 cases of cellulitis at this doctor's office recently. They have increased their doses of KINRIX during this time and were questioning whether it may have been a cause. The sales representative had no additional information.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Per MD has shingles.
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site rash, Similar reaction on previous exposure to drug
Clinical narrative: Small bumps around circumference of upper left arm around where the site of injection (Hep A) was; member had similar response following H1N1 Injection in same arm in Jan 2010.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site swelling, Pain
Clinical narrative: Patient developed swelling at injection site on 5/4/10 soreness/redness. Patient went to emergency room tx with Keflex 125mg/5ml. Rx given to take T.I.D. x7 days. Patient seen in doctor's office on 5/5/10. Rx given - Benadryl liq. 12.5/5ml. Instructed to apply ice.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.6
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised
Clinical narrative: Broke out in a rash 2 days after immunization (Flu). Rash spread all over arm then to stomach arms & legs. Family doctor said it was not hives. Never had flu shot before - prescribed steroids for itching. Had given blood 1-1 1/2 wks prior to flu shot. Also took BENADRYL.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen and red at site. Gave 2 tsp BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Red, induration at left shoulder.  Treated w/ TYLENOL PRN & cool compresses.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Injection site swelling
Clinical narrative: Severe headache which lasted until evening, injection site pain and swelling.
Age: 0.52
Sex: F
Vaccine: DTAPH, DTAPHEPBIP, HBHEPB
Symptoms: Choking, Drooling, Dyspnoea, Oedema mouth, Staring
Clinical narrative: Mouth swelling and drooling, choking, trouble breathing, staring.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Pyrexia
Clinical narrative: Fever up to 104 degrees for 2 days.
Age: 1.56
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Injection site erythema, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: On 4/30/10, immunization given was PENTACEL ( L ) leg, HAVRIX ( R ) leg. Mom said (+) redness like before w/immun. Then woke up next day size > grapefruit.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: DEVELOPED URTICARIA/HIVES ON 4/30/10 AND WAS INTERMITTENT X 5 DAYS ON FACE, NECK AND ABDOMEN
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site urticaria, Pruritus, Pyrexia, Rash erythematous
Clinical narrative: Vaccine given on 4/26/10, on 4/28 patient presents with red welts on arm, thigh and back. They are itchy and hot to the touch. Also present on injection site, approx size of silver dollar. Also fever, headache, she was restricted to bed on 4/28. 4/29-patient felt better. 5/5/10- feels better, very small red spots still present. Cortisone cream, Zyrtec and Tylenol.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: Vaccine given on 4/26/10, on 4/28 patient presents with red welts on arm, thigh and back. They are itchy and hot to the touch. Also present on injection site, approx size of silver dollar. Also fever, headache, she was restricted to bed on 4/28. 4/29-patient felt better. 5/5/10- feels better, very small red spots still present. Cortisone cream, Zyrtec and Tylenol.
Age: 1.27
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Despite mom giving ibuprofen at the visit and 6 hrs. later, patient still developed at temp of 102.8F and has continued to be febrile with
Age: 1.27
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Body temperature increased, Injection site swelling, Pyrexia
Clinical narrative: Despite mom giving ibuprofen at the visit and 6 hrs. later, patient still developed at temp of 102.8F and has continued to be febrile with
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Convulsion, Dizziness, Dyskinesia, Fall, Pallor
Clinical narrative: 11:30 AM, a few minutes after administering shots Tdap, MCV4 & varicella, she was sitting down waiting and she fainted. Fell to floor, had a seizure type jerking for about 10 seconds, we helped her up and she was alert & talking, had pallor to face & little dizziness. After sitting for about 10 min. Mom took her home.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: 11:30 AM, a few minutes after administering shots Tdap, MCV4 & varicella, she was sitting down waiting and she fainted. Fell to floor, had a seizure type jerking for about 10 seconds, we helped her up and she was alert & talking, had pallor to face & little dizziness. After sitting for about 10 min. Mom took her home.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Large localized vaccine reaction-swollen, red, mild tenderness and itching. Treating symptomatically with Benadryl and Motrin. Marked borders of erythema. Return to clinic if symptoms persist or worsen. Left upper arm is site of reaction.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, slightly swollen 2 x 3 cm area at injection site.
Age: 4.0
Sex: M
Vaccine: IPV, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Approximately 12 x 12 cm warm, red area left deltoid. Child OK looks fully healthy. On 5/4/10 pm symptoms almost completely recovered.
Age: 65.0
Sex: F
Vaccine: PPV, TD, VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Neck pain, Pain in extremity, Spinal X-ray abnormal
Clinical narrative: Left deltoid region pain that may be leading to left shoulder and neck and upper arm pain that has persisted for approx 2 mos.
Age: 65.0
Sex: F
Vaccine: PPV, TD, VARZOS
Symptoms: X-ray normal
Clinical narrative: Left deltoid region pain that may be leading to left shoulder and neck and upper arm pain that has persisted for approx 2 mos.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Redness, swelling, fever.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching, and pain, at injection site, areas of redness 35mm.
Age: 1.09
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Skin lesion
Clinical narrative: Swelling, warmth and erythema in the left thigh that resolved the next day.  "Wavy" rash on both legs on 4/30/2010 that resolved within a few hours.  Varicella lesions on the face that began on 5/5/10.
Age: 1.09
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC13, VARCEL
Symptoms: Varicella
Clinical narrative: Swelling, warmth and erythema in the left thigh that resolved the next day.  "Wavy" rash on both legs on 4/30/2010 that resolved within a few hours.  Varicella lesions on the face that began on 5/5/10.
Age: 50.0
Sex: F
Vaccine: DTAP
Symptoms: Flushing, Hot flush, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pain and swelling at site of IM injection in right deltoid. Burning/flushing of skin. Reports feels "burning to the core." Has used ice and ibuprofen without relief. Face hot/flushed. Low fever.
Age: 50.0
Sex: F
Vaccine: DTAP
Symptoms: Skin burning sensation
Clinical narrative: Pain and swelling at site of IM injection in right deltoid. Burning/flushing of skin. Reports feels "burning to the core." Has used ice and ibuprofen without relief. Face hot/flushed. Low fever.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site urticaria
Clinical narrative: Pt. has a 2 cm red welt at the site of injection. No complaints of itchiness, or pain. Per mom, "Doesn't seem to bother her". Advised cool compresses. Follow up if not resolved or condition worsens.
Age: 36.0
Sex: M
Vaccine: TYP, YF
Symptoms: Injection site haematoma, Injection site inflammation, Injection site pain
Clinical narrative: Injection site inflammation approximately three inches in diameter.  Turning into a bruise two days after injection and remaining sore to the touch currently (five days after shot).
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Shot didn't hurt when administered.  Arm grew sore shortly after and has hurt ever since.  Throbbing pain still 4 months later.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Convulsion, Gaze palsy, Hypotension, Immediate post-injection reaction, Memory impairment
Clinical narrative: Immediately following vaccination (Tdap and MCV4) in a Health Department clinic patient experienced convulsive activity. Mom and nurse described eye-rolling with chest and arms/limbs contracting rythmically.  Health Department physician was immediately called to assess patient.  Patient was then moved from chair to an exam table.  Blood pressure rose to 90/60, then 110/70 within 5 - 10 minutes.  Pallor diasppeared and patient became more alert and conversant.  Patient could not recall all of the events.  There was no lip-biting or incontinence reported.  Neurological exam was normal.  Physician recommended follow-up with ER and/or PMD.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Muscle contractions involuntary, Pallor
Clinical narrative: Immediately following vaccination (Tdap and MCV4) in a Health Department clinic patient experienced convulsive activity. Mom and nurse described eye-rolling with chest and arms/limbs contracting rythmically.  Health Department physician was immediately called to assess patient.  Patient was then moved from chair to an exam table.  Blood pressure rose to 90/60, then 110/70 within 5 - 10 minutes.  Pallor diasppeared and patient became more alert and conversant.  Patient could not recall all of the events.  There was no lip-biting or incontinence reported.  Neurological exam was normal.  Physician recommended follow-up with ER and/or PMD.
Age: 14.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Blister, Rash papular, Rash pustular
Clinical narrative: Began with papules on 5/4/10 and developed crops of vesicles, pustules, and papules head, trunk, legs, back, abdomen.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema, Pruritus
Clinical narrative: Mild edema, erythema and slight itching began approx 24 hrs following injection. Progressed over next 24 hrs. No treatment other than topical hydrocortisone prn and oral Benadryl prn.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Vaccinated but still developed clinical and lab proven rotavirus.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Immunodeficiency, Immunoglobulin therapy, Immunoglobulins normal, Laboratory test normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under Freedom of Information Act. On 28-NOV-2007 at 8:00 AM a 16 week old male patient with no allergies or medical history was vaccinated with a second dose of ROTATEQ (Lot number 657520/0670U) orally. There was no illness at the time of vaccination. Concomitant vaccinations given the same day included a second dose of DAPTACEL (Lot number C2B57AA) given in the right anterolateral thigh, a second dose of ACTHIB (Lot number UF208AB) given in the right anterolateral thigh and a second dose of PREVNAR (Lot number B54015F) given in the left anterolateral thigh. 2 or 3 days after the second dose of ROTATEQ (on 07-DEC-2007) the baby began with vomiting and diarrhea. The patient presented to the office with prolonged diarrhea and profound peripheral edema. The patient was admitted, he was transferred to another hospital. The patient had protein losing enteropathy, immunodeficiency and was on IVIG weekly. At the time of the report the child had normal levels of immunoglobins and no hypoproteinemia. The outcome of the patient for diarrhea, vomiting and peripheral edema were unknown. The listing indicated that one or more of the events required hospitalization, and were considered to be immediately life-threatening. No further information is available. A lot check has been initiated. This was originally reported by a physician. The VAERS ID# 305257. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Oedema peripheral, Protein-losing gastroenteropathy, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under Freedom of Information Act. On 28-NOV-2007 at 8:00 AM a 16 week old male patient with no allergies or medical history was vaccinated with a second dose of ROTATEQ (Lot number 657520/0670U) orally. There was no illness at the time of vaccination. Concomitant vaccinations given the same day included a second dose of DAPTACEL (Lot number C2B57AA) given in the right anterolateral thigh, a second dose of ACTHIB (Lot number UF208AB) given in the right anterolateral thigh and a second dose of PREVNAR (Lot number B54015F) given in the left anterolateral thigh. 2 or 3 days after the second dose of ROTATEQ (on 07-DEC-2007) the baby began with vomiting and diarrhea. The patient presented to the office with prolonged diarrhea and profound peripheral edema. The patient was admitted, he was transferred to another hospital. The patient had protein losing enteropathy, immunodeficiency and was on IVIG weekly. At the time of the report the child had normal levels of immunoglobins and no hypoproteinemia. The outcome of the patient for diarrhea, vomiting and peripheral edema were unknown. The listing indicated that one or more of the events required hospitalization, and were considered to be immediately life-threatening. No further information is available. A lot check has been initiated. This was originally reported by a physician. The VAERS ID# 305257. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 23.0
Sex: M
Vaccine: ANTH, JEV, RAB, SMALL
Symptoms: Body temperature increased, Malaise, Rash generalised, Rash pruritic
Clinical narrative: This case was received by sanofi pasteur on 28 April 2009 via a QScan search on the VAERS database, under reference number 311037. A 23 year old male received smallpox vaccine (manufacturer and lot number not reported), IMOVAX (lot number not reported), J-VAX (lot number not reported) and BIOTHRAX (Emergent Bisolutions, lot number not reported) on 09 April 2008. The patient presented with a one day history of an overall rash, mild malaise and a temperature of 100.4 degrees Fahrenheit. The rash was mildly pruritic. Date of onset was not reported. The patient had been taking clindamycin for one week for treatment of a nasal fracture. He has no history of allergy to clindamycin. No additional information was provided. NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.
Age: 29.0
Sex: M
Vaccine: RAB
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous case was received from a health care professional on 04 September 2009.  It was received as one of a cluster of two patients reported by the same health care professional.  A 29-year-old patient received a fourth intramuscular right deltoid dose of IMOVAX Rabies (lot number B0662-2) on 30 August 2009.  The patient subsequently developed cellulitis at the injection site, requiring a physician visit and antibiotics.  Outcome was unknown at the time of the report.  Follow-up information was received from the health care professional on 09 November 2009.  The patient was a male.  He had received his third dose of IMOVAX (lot number B0661-2) on 23 August 2009; his second dose (lot number B0661) on 18 August 2009; and his first dose (lot number B0662) on 15 August 2009.  All doses of IMOVAX had been administered in the right deltoid.  The patient recovered.  The health care professional who reported this event also reported another adverse event following IMOVAX Rabies vaccination; the other event is captured in case number 2009-03803.
Age: 45.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous case was received from a health care professional on 04 September 2009. It was received as one of a cluster of two patients reported by this health care professional. A 45-year-old patient received a fourth intramuscular right deltoid injection of IMOVAX Rabies (lot number B0662-2) on 31 August 2009. The patient subsequently developed a 6cm x10cm red itchy area at the injection site. The patient was seen by a physician, however no treatment was required. Outcome was unknown at the time of the report. Follow-up information was received from the health care professional on 09 November 2009. The patient was a female. Previous doses of IMOVAX Rabies had been given on the following dates: dose three, left deltoid on 24 August 2009 (lot number B0661-2); dose two, right deltoid on 20 August 2009 (lot number B0662-2); and dose one, left deltoid on 17 August 2009 (lot number B0661-2). All doses were given intramuscularly. The patient was considered recovered. The other event reported by this health care professional is captured in case number 2009-03802.