chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Cellulitis, Injection site infection, Injection site irritation, Injection site pain
Clinical narrative: On 02/04/08 my daughter and I arrived at the Health Dept. arrival time around 11am, patient was given a 2nd dose of the Varicella shot in her right arm, due to the mandatory law in the county, to attend her new school. Patient went home and she began to complain around 8pm that night 02/04/2008 about burning and itching and it was a little swollen. Early the next morning 02/05/08 at 6am I woke patient up and her arm was 2x times bigger than the previous night. She was in pain and the site was hot to the touch, and very swollen, I called the health Dept at that time, but the center wasn't open yet. I took patient on to school for her first day at her new school, as we sat and waited in the school, at 8am, patient kept complaining about the tightness of her skin and the pain, I took patient to class, and told her to call me if the shot sight had gotten any bigger, and if the pain got worse. By 12pm in the afternoon the school nurse called me in a panic, saying that patient needed to be picked up, and taken to the Dr., because the shot sight didnt look good, and it was too swollen, and has gotten bigger. The nurse measured the sight (I think it was 4 inches wide at the time) and put and ice pack on the sight to control the heat and swelling. I called the health dept around 12:30pm, to explain what was happening to my daughter. The female who answered the phone, I told her what happen, and she said oh Lord, let me transfer you. The line kept ringing and the wasn't any answer at that extension. So I took patient to the nearest ER. Patient was seen by the nurse first, and she was astonished at patient arm. She gave patient a wet towel to compress on the sight for the swelling and heat. At the time 4:30pm patient temp was 100.7 and patient was in horrible pain, the Dr. came in around 5pm and told alot at the sight, he said it wasn't and allergic reaction, the sight was truly infected, due to the heat and huge swelling of the sight. At that time the Dr. order her to receive one shot of antibiotics in both of her legs the legs. Then she was observed for 20 mins. to make sure she was not allergic, and prescribed and oral dose of Augmentin 1tsp. 2x daily until gone, and ibuprofen for pain. We were release at 6:15pm on 02/5/08, patient was arm was still hot tight huge and swollen. I kept ice packs on it all night. Early 02-6-08 at 6am, patient was woken for school and her arm was smaller than the day before, but still hot and big, she wasn't able to go to school do to the pain, in her right arm.... her writing hand... still today 2/67/08 she is still trying to recover... I would like for report to be taken serious, and the batch of the varicella shot that my daughter was given to be investigated, and the lady who gave the shot question and investigated, and any reports of shot complaints of the same source investigated...
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: On 02/04/08 my daughter and I arrived at the Health Dept. arrival time around 11am, patient was given a 2nd dose of the Varicella shot in her right arm, due to the mandatory law in the county, to attend her new school. Patient went home and she began to complain around 8pm that night 02/04/2008 about burning and itching and it was a little swollen. Early the next morning 02/05/08 at 6am I woke patient up and her arm was 2x times bigger than the previous night. She was in pain and the site was hot to the touch, and very swollen, I called the health Dept at that time, but the center wasn't open yet. I took patient on to school for her first day at her new school, as we sat and waited in the school, at 8am, patient kept complaining about the tightness of her skin and the pain, I took patient to class, and told her to call me if the shot sight had gotten any bigger, and if the pain got worse. By 12pm in the afternoon the school nurse called me in a panic, saying that patient needed to be picked up, and taken to the Dr., because the shot sight didnt look good, and it was too swollen, and has gotten bigger. The nurse measured the sight (I think it was 4 inches wide at the time) and put and ice pack on the sight to control the heat and swelling. I called the health dept around 12:30pm, to explain what was happening to my daughter. The female who answered the phone, I told her what happen, and she said oh Lord, let me transfer you. The line kept ringing and the wasn't any answer at that extension. So I took patient to the nearest ER. Patient was seen by the nurse first, and she was astonished at patient arm. She gave patient a wet towel to compress on the sight for the swelling and heat. At the time 4:30pm patient temp was 100.7 and patient was in horrible pain, the Dr. came in around 5pm and told alot at the sight, he said it wasn't and allergic reaction, the sight was truly infected, due to the heat and huge swelling of the sight. At that time the Dr. order her to receive one shot of antibiotics in both of her legs the legs. Then she was observed for 20 mins. to make sure she was not allergic, and prescribed and oral dose of Augmentin 1tsp. 2x daily until gone, and ibuprofen for pain. We were release at 6:15pm on 02/5/08, patient was arm was still hot tight huge and swollen. I kept ice packs on it all night. Early 02-6-08 at 6am, patient was woken for school and her arm was smaller than the day before, but still hot and big, she wasn't able to go to school do to the pain, in her right arm.... her writing hand... still today 2/67/08 she is still trying to recover... I would like for report to be taken serious, and the batch of the varicella shot that my daughter was given to be investigated, and the lady who gave the shot question and investigated, and any reports of shot complaints of the same source investigated...
Age: 24.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Patient came in for a PPD skin test.  He came back in two days for the reading and his left arm had a blister about the size of a penny at the site that the test was placed.  Dr recommended a repeat on the opposite arm.  The PPD skin test was then placed on the right arm.  He came back in 48hrs and this time there was no blister.  The reading was negative.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Fainting and seizure.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder
Clinical narrative: The Client came in for #2 HPV. Client and mother stated that the client was having a menstrual cycle every 10 days since she received the vaccination. We went through the literature on the HPV vaccine and told her we could not find that as a side effect. But this is a new vaccine and we would report this information. We also instructed her to take her to her Dr. We did not do the #2 HPV. We told the client to talk to her Dr. before we give her the #2 dose.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Abnormal behaviour, Anxiety, Autism, Diet refusal, Musculoskeletal stiffness
Clinical narrative: Screaming for 24 hours, stiffness, extremely high fever, no eye contact, refusal to be held or comforted, refusal to eat, inconsistent responses to external stimuli. Treated with Tylenol but child never the same. From that point child had sensory issues and extreme levels of anxiety. Child diagnosed with autism at 2 years of age. Currently being treated with 20 hours of therapy a week, special diets, and medication. 2/12/08-records received-C/O speech delay, regressed in speech at age 1 year. Self stimulating behavior, spins in circles and flaps his hands. Does not socially interact. DX: Speech delay. Pervasive developmental disorcer.  1/20/2010 Anxiety, sensory issues, toxic levels of metals in system, infections, G!  problems, lack of social ability.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Pyrexia, Screaming, Sensory disturbance, Social avoidant behaviour
Clinical narrative: Screaming for 24 hours, stiffness, extremely high fever, no eye contact, refusal to be held or comforted, refusal to eat, inconsistent responses to external stimuli. Treated with Tylenol but child never the same. From that point child had sensory issues and extreme levels of anxiety. Child diagnosed with autism at 2 years of age. Currently being treated with 20 hours of therapy a week, special diets, and medication. 2/12/08-records received-C/O speech delay, regressed in speech at age 1 year. Self stimulating behavior, spins in circles and flaps his hands. Does not socially interact. DX: Speech delay. Pervasive developmental disorcer.  1/20/2010 Anxiety, sensory issues, toxic levels of metals in system, infections, G!  problems, lack of social ability.
Age: 1.1
Sex: M
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: (R) thigh DTaP, MMR sites induration, warm 2cm x 2cm 24 hr after administration -Benadryl, ice, Tylenol
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site discolouration, Injection site inflammation, Injection site vesicles, Insomnia, Irritability
Clinical narrative: Vaccine given 6 days ago.  2 days ago started having deep pink area of inflammation around varicella vaccine site.  Today, has blister there.  More fussy, less sleep last night.  Rx for Cephalexin susp given.  Epsom salts soaks recommended.  Mom to call back in 24 hrs.  Fever 101-yest.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Vaccine given 6 days ago.  2 days ago started having deep pink area of inflammation around varicella vaccine site.  Today, has blister there.  More fussy, less sleep last night.  Rx for Cephalexin susp given.  Epsom salts soaks recommended.  Mom to call back in 24 hrs.  Fever 101-yest.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Anticoagulant therapy, Haematoma
Clinical narrative: Hematoma secondary to flu shot on LVE.  Patient on coumarin therapy.  No obvious signs of infection.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Saturday 1-19-08 developed chills and low grade fever, arm swollen and sore dull ache.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: The evening of 1/24/08 patient noticed LUE to have a "sore raised hard area." Came to Dr's office on 1/25/08 at 3:45 pm 7x6 cm area of erythema and induration noted. Pt also c/o it was "itchy". Denies pain. Dr prescribed Allegra bid and hydrocortisone ointment 2.5% to affected area. Pt instructed to return to MD if Sx worsen or if not resolved by next week.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: Developed rash approx. 2 wks after receiving 3rd HPV vaccine.  Rash on arms, legs & feet.  Mother reports cl. states she had slight rash after first and 2nd shots as well, but did not tell anyone.  Was given Benadryl & mother states rash is fading.  Did not go to doctor.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Blister, Cellulitis, Culture wound negative
Clinical narrative: Cellulitis, blister, wound culture keflex, clindamycin
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Feeling cold, Hypoaesthesia, Muscle spasms, Neurological examination
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of coldness in a 45-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline). Concurrent medical conditions included asthma. Concurrent vaccination included Pneumovax (Merck) given on 26 October 2007. Concurrent medications included Nasacort, Astelin, Zyrtec, Singulair, Fluoxetine, Oral contraceptive (OCP), Advair 100/50 1 puff daily and then increased to 1 puff twice daily, Qvar, M.V.I, Maxair and Robitussin. On 26 October 2007 the subject received unspecified dose of Flulaval at 0.5 ml in the left arm. On 28 October 2007, 2 days after vaccination with Flulaval, the subject experienced coldness, spasms, numbness and decreased motor strength in her hand. The subject experienced a systemic reaction. The healthcare professional considered the events were disabling. At the time of reporting the events of coldness, spasms, numbness and decreased motor strength in her hand were improved. The healthcare professional considered these events were probably related to vaccination with Flulaval.
Age: 0.6
Sex: M
Vaccine: RV5
Symptoms: Allergy test positive, Barium enema abnormal, Biopsy intestine abnormal, Colitis, Colonoscopy abnormal
Clinical narrative: Information has been received from a health authority concerning a 7 month old male who on 31-MAY-2007 and 01-AUG-2007 was vaccinated PO with his first and second doses of Rotateq (batch# not reported, lot# not reported). On 09-AUG-2007, a week after administering the second dose, the patient was diagnosed with colitis and bloody diarrhea and was hospitalized. The patient has been diagnosed with undetermined colitis, presenting an inflammatory intestinal manifestation that affects both bowel and small intestine. Relevant diagnostic studies included: a negative stool test, abnormal barium enema test, abnormal intestinal biopsy and abnormal colonoscopy. The following lab tests were discarded: cow's milk protein intolerance and the negative coprocultives test. The patient was not recovered yet. Other business partner numbers include: E2008-00422, ES-AGEMED-122669332. Additional information has been requested.
Age: 0.6
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea haemorrhagic, Gastrointestinal inflammation, Inflammatory bowel disease, Stool analysis normal
Clinical narrative: Information has been received from a health authority concerning a 7 month old male who on 31-MAY-2007 and 01-AUG-2007 was vaccinated PO with his first and second doses of Rotateq (batch# not reported, lot# not reported). On 09-AUG-2007, a week after administering the second dose, the patient was diagnosed with colitis and bloody diarrhea and was hospitalized. The patient has been diagnosed with undetermined colitis, presenting an inflammatory intestinal manifestation that affects both bowel and small intestine. Relevant diagnostic studies included: a negative stool test, abnormal barium enema test, abnormal intestinal biopsy and abnormal colonoscopy. The following lab tests were discarded: cow's milk protein intolerance and the negative coprocultives test. The patient was not recovered yet. Other business partner numbers include: E2008-00422, ES-AGEMED-122669332. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Acute coronary syndrome, Blood creatine phosphokinase MB increased, Catheterisation cardiac normal, Chest pain, Hyperhidrosis
Clinical narrative: Early AM hours awoke with c/o chest pain and diaphoresis-taken to Hosp. ER cardiac enzymes positive for acute coronary syndrome-cardiac catherization done 1-27-08 (normal findings) Discharged eve of 29 Jan to parent's care (Parents called to bedside due to condition) transferred to another hospital 01 Feb 08 for admission and further testing. Given meds p.o. (Plavix, Toprol XL, Pendil, Zocor, ASA)
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Myocardial infarction, Myoglobin blood increased, Troponin I increased
Clinical narrative: Early AM hours awoke with c/o chest pain and diaphoresis-taken to Hosp. ER cardiac enzymes positive for acute coronary syndrome-cardiac catherization done 1-27-08 (normal findings) Discharged eve of 29 Jan to parent's care (Parents called to bedside due to condition) transferred to another hospital 01 Feb 08 for admission and further testing. Given meds p.o. (Plavix, Toprol XL, Pendil, Zocor, ASA)
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Induration, Pyrexia
Clinical narrative: 2 days after injection, area became red with induration & employee has low grade fever.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Culture, Malaise, Pyrexia, Rash
Clinical narrative: 1-30-08 developed malaise and chills.  Subsequently developed fever and rash on trunk few hours later.  Evaluated 1-31-08.  Will treat symptomatically.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcal identification test, Streptococcal identification test negative
Clinical narrative: 1-30-08 developed malaise and chills.  Subsequently developed fever and rash on trunk few hours later.  Evaluated 1-31-08.  Will treat symptomatically.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness, non-tender, 7cm x 5cm, treated with warm compresses and Motrin.
Age: 1.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (L) arm w/swelling, redness + slight tenderness.
Age: 14.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Rash, Throat tightness
Clinical narrative: According to mother, the patient developed "spots" on face & felt throat closing.  Child was advised to go to nearest ER.  Symptoms occurred ~45 mins after vaccines.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Muscular weakness, Myalgia
Clinical narrative: Muscle soreness and weakness upon certain movements especially at night.  Extreme weakness in a week or so post injection for 4-5 days.  Has abated some but still limits movement.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Lip swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: About 1 hr after Gardasil dose developed hives face, arms, neck, chest on & off x2 days.  Itchy and burning.  Also lip swelling and face swelling.  Some symptomatic relief with Benadryl on PE.  Mild lip and face swelling.  Prescribed Allegra 180 mg QD x3 d.  Events still evolving.
Age: 13.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Induration, Oedema peripheral
Clinical narrative: Redness/swelling noted with induration (L) deltoid area seen on 2/5/08 and was doing much better
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Rotavirus test negative
Clinical narrative: Diarrhea for 20 days.
Age: 18.0
Sex: F
Vaccine: HEP, HPV4, MNQ
Symptoms: Injection site erythema, Injection site inflammation, Pain
Clinical narrative: Circular, red, inflamed area 50x40 mm to L arm.  HPV and meningococcal vaccine administered in same arm.  Pain began same evening of vaccine administration.  Pt. took Aleve and hot shower, let hot water run on arm.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: Pt noted rash on trunk, spread arms, face, neck.  Went to ER at 11PM .  Seen Jan 25 by ER MD & Dermatology.  Positive erythemic macular papular rash noted on face, neck, trunk, arms.  Given Atarax 25 mg.  Referred to infectious disease & dermatology - Patient states that he received the smallpox vaccination 10 days ago as part of pre-deployment medical readiness.  He then began to develop a rash approximately 7 days after receiving the vaccine.  The rash is slightly pruritic, non-painful and involves his upper arms and thighs as well as his trunk, upper back and chest more than the abdomen and also his face along the jaw without any involvement of the eye.  He has never had this before and states that neither he nor anyone in his family have eczema or any form of dermatitis, problem list reviewed with patient, medication list reviewed with patient, and family history reviewed with patient.  NO history of skin disease and no chronic disease stated such as diabetes or HTN.  General overall feeling.  Feeling fine.
Age: 1.0
Sex: M
Vaccine: HEP, HEPA, MMRV, PNC
Symptoms: Erythema multiforme
Clinical narrative: Vaccination 1/22/08; Reaction started 2/9/08 Erythema multiforme on 2/6/08. Rx with orapred.
Age: 1.0
Sex: F
Vaccine: FLU3, IPV
Symptoms: Culture urine, Febrile convulsion, Postictal state, Pyrexia, Vomiting
Clinical narrative: High grade fever - Temperature at 104.6 F at 5:10 pm - decreased to 103.1 F in 10-15 mins.  Patient had afebrile seizure later that night - EMS called - taken to ER.  Postictal, no other abnormalities found.  Fever and vomiting started 02/05/08 daytime.
Age: 42.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Unevaluable event
Clinical narrative: No adverse events
Age: 14.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Chest X-ray normal, Full blood count normal, Lymphadenopathy, Nasopharyngitis, Pain
Clinical narrative: Received immunizations in left arm 1/30.  1/31 complained of arm soreness and noticed enlarged left supraclavicular node plus achiness.  2/2 fever and cold symptoms develop.
Age: 14.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Pain in extremity, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: Received immunizations in left arm 1/30.  1/31 complained of arm soreness and noticed enlarged left supraclavicular node plus achiness.  2/2 fever and cold symptoms develop.
Age: 68.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain, Rash
Clinical narrative: Patient began having symptoms of shingles on 1/28/08.  He had a rash under shoulder blades and pain associated with rash.  Patient under treatment.
Age: 68.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient began having symptoms of shingles on 1/28/08.  He had a rash under shoulder blades and pain associated with rash.  Patient under treatment.
Age: 1.28
Sex: M
Vaccine: DTAPHEPBIP, HEPA, PNC
Symptoms: Unevaluable event, Wrong drug administered
Clinical narrative: Pediarix given instead of DTaP.
Age: 58.0
Sex: F
Vaccine: MMR, TD
Symptoms: Activities of daily living impaired, Burning sensation, Cellulitis, Erythema, Haematoma
Clinical narrative: Five or six days after the inoculation my arm started to swell, was bright red and hot.  I went to the emergency room and was diagnosed with cellulitis which stretched from the top of my shoulder to below my elbow.  I was given strong antibiotics and within two days the swelling began to go down.  But, since then, my arm has been very painful and my doctor says a large hematoma is pressing on a nerve and that it may take a year to recover.  It doesn't seem to be improving.  It is now difficult for me to undress, I cannot straighten my arm above my head and my sleep is interrupted because it is difficult to find a position to lie in.  The pain is an intense burning sensation that lasts several seconds and is repeated scores of times a day. 2/29/08-ED records received for DOS 7/3/07-DX:cellulitis of right upper arm versus hypersensitivity reaction. Presents with redness and swelling in upper arm that started 2 days ago. Spot noted on arm that is in the area affected. PE:Diffuse area of induration encompassing region of deltoid with some overlying inflammation which extends down the upper arm to anterolateral aspect of arm.
Age: 58.0
Sex: F
Vaccine: MMR, TD
Symptoms: Injected limb mobility decreased, Mobility decreased, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Five or six days after the inoculation my arm started to swell, was bright red and hot.  I went to the emergency room and was diagnosed with cellulitis which stretched from the top of my shoulder to below my elbow.  I was given strong antibiotics and within two days the swelling began to go down.  But, since then, my arm has been very painful and my doctor says a large hematoma is pressing on a nerve and that it may take a year to recover.  It doesn't seem to be improving.  It is now difficult for me to undress, I cannot straighten my arm above my head and my sleep is interrupted because it is difficult to find a position to lie in.  The pain is an intense burning sensation that lasts several seconds and is repeated scores of times a day. 2/29/08-ED records received for DOS 7/3/07-DX:cellulitis of right upper arm versus hypersensitivity reaction. Presents with redness and swelling in upper arm that started 2 days ago. Spot noted on arm that is in the area affected. PE:Diffuse area of induration encompassing region of deltoid with some overlying inflammation which extends down the upper arm to anterolateral aspect of arm.
Age: 58.0
Sex: F
Vaccine: MMR, TD
Symptoms: Sleep disorder
Clinical narrative: Five or six days after the inoculation my arm started to swell, was bright red and hot.  I went to the emergency room and was diagnosed with cellulitis which stretched from the top of my shoulder to below my elbow.  I was given strong antibiotics and within two days the swelling began to go down.  But, since then, my arm has been very painful and my doctor says a large hematoma is pressing on a nerve and that it may take a year to recover.  It doesn't seem to be improving.  It is now difficult for me to undress, I cannot straighten my arm above my head and my sleep is interrupted because it is difficult to find a position to lie in.  The pain is an intense burning sensation that lasts several seconds and is repeated scores of times a day. 2/29/08-ED records received for DOS 7/3/07-DX:cellulitis of right upper arm versus hypersensitivity reaction. Presents with redness and swelling in upper arm that started 2 days ago. Spot noted on arm that is in the area affected. PE:Diffuse area of induration encompassing region of deltoid with some overlying inflammation which extends down the upper arm to anterolateral aspect of arm.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Burning sensation, Chest discomfort, Chills, Cough, Erythema
Clinical narrative: October 17, 2007 - Received flu shot in left arm.  Received pneumonia shot in right arm.  That evening, the injection site in my right arm was very red and the irritation was about the size of a quarter. October 18, 2007 - I woke up with a very small range of motion in my right arm without pain.  There was a orange size raised area around the injection area in the right arm.  I started having the chills.  About 1:00pm I was shaking with the chills.  I had 103.8 fever by 4pm.  I called clinic to let them know and I went to doctor.  The doctor took blood work for a CBC.  That was normal.  The raised red area had spread down and around my arm.  Still minimal range of motion without pain.  My muscles in my arm were burning.  The area was hard to the touch and hot.  The doctor concluded that my symptoms must be the result of the pneumonia inoculation.  That night my fever was 103.8-104 even though I was taking Tylenol and Motrin every 4 hours. October 19, 2007 - Irritation on my arm had spread further with pain moving down my muscles.  Fever 103.6 most of the day with 2 breaks of fever when it went down to +/-100.5 degrees.  Still very little range of motion in my arm without pain.  My arm was painful to the touch and was still raised and burning.  I tried warm compresses.  They did not help.  I was still taking Motrin and Tylenol. October 20, 2007 - Irritation on my arm was still spreading, still raised and hard.  I still had little range of motion.  My temperature was 103 in the morning and in the late afternoon.  Otherwise my temp was about 100. October 21, 2007 - Irritation on my arm looked better, some swelling had gone away.  My range of motion was increasing.  Still painful to the touch and there was a burning sensation in my muscles.  I woke up with no temperature but it went up to about 100.6 late in the afternoon.  My temp went back down after Tylenol.  My chest started feeling a little tight.  Started with a dry cough. October 22, 2007 - The raised irritation is gone on my arm.  Range of motion is almost normal.  There is a burning sensation in my muscles of my arm but the area is no longer hard and hot.  I had no fever.  I had to take some old asthma medication because of the tightness in my chest.  Blisters in mouth.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site irritation, Injection site swelling
Clinical narrative: October 17, 2007 - Received flu shot in left arm.  Received pneumonia shot in right arm.  That evening, the injection site in my right arm was very red and the irritation was about the size of a quarter. October 18, 2007 - I woke up with a very small range of motion in my right arm without pain.  There was a orange size raised area around the injection area in the right arm.  I started having the chills.  About 1:00pm I was shaking with the chills.  I had 103.8 fever by 4pm.  I called clinic to let them know and I went to doctor.  The doctor took blood work for a CBC.  That was normal.  The raised red area had spread down and around my arm.  Still minimal range of motion without pain.  My muscles in my arm were burning.  The area was hard to the touch and hot.  The doctor concluded that my symptoms must be the result of the pneumonia inoculation.  That night my fever was 103.8-104 even though I was taking Tylenol and Motrin every 4 hours. October 19, 2007 - Irritation on my arm had spread further with pain moving down my muscles.  Fever 103.6 most of the day with 2 breaks of fever when it went down to +/-100.5 degrees.  Still very little range of motion in my arm without pain.  My arm was painful to the touch and was still raised and burning.  I tried warm compresses.  They did not help.  I was still taking Motrin and Tylenol. October 20, 2007 - Irritation on my arm was still spreading, still raised and hard.  I still had little range of motion.  My temperature was 103 in the morning and in the late afternoon.  Otherwise my temp was about 100. October 21, 2007 - Irritation on my arm looked better, some swelling had gone away.  My range of motion was increasing.  Still painful to the touch and there was a burning sensation in my muscles.  I woke up with no temperature but it went up to about 100.6 late in the afternoon.  My temp went back down after Tylenol.  My chest started feeling a little tight.  Started with a dry cough. October 22, 2007 - The raised irritation is gone on my arm.  Range of motion is almost normal.  There is a burning sensation in my muscles of my arm but the area is no longer hard and hot.  I had no fever.  I had to take some old asthma medication because of the tightness in my chest.  Blisters in mouth.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Myalgia, Oral mucosal blistering, Pyrexia, Skin warm, Tremor
Clinical narrative: October 17, 2007 - Received flu shot in left arm.  Received pneumonia shot in right arm.  That evening, the injection site in my right arm was very red and the irritation was about the size of a quarter. October 18, 2007 - I woke up with a very small range of motion in my right arm without pain.  There was a orange size raised area around the injection area in the right arm.  I started having the chills.  About 1:00pm I was shaking with the chills.  I had 103.8 fever by 4pm.  I called clinic to let them know and I went to doctor.  The doctor took blood work for a CBC.  That was normal.  The raised red area had spread down and around my arm.  Still minimal range of motion without pain.  My muscles in my arm were burning.  The area was hard to the touch and hot.  The doctor concluded that my symptoms must be the result of the pneumonia inoculation.  That night my fever was 103.8-104 even though I was taking Tylenol and Motrin every 4 hours. October 19, 2007 - Irritation on my arm had spread further with pain moving down my muscles.  Fever 103.6 most of the day with 2 breaks of fever when it went down to +/-100.5 degrees.  Still very little range of motion in my arm without pain.  My arm was painful to the touch and was still raised and burning.  I tried warm compresses.  They did not help.  I was still taking Motrin and Tylenol. October 20, 2007 - Irritation on my arm was still spreading, still raised and hard.  I still had little range of motion.  My temperature was 103 in the morning and in the late afternoon.  Otherwise my temp was about 100. October 21, 2007 - Irritation on my arm looked better, some swelling had gone away.  My range of motion was increasing.  Still painful to the touch and there was a burning sensation in my muscles.  I woke up with no temperature but it went up to about 100.6 late in the afternoon.  My temp went back down after Tylenol.  My chest started feeling a little tight.  Started with a dry cough. October 22, 2007 - The raised irritation is gone on my arm.  Range of motion is almost normal.  There is a burning sensation in my muscles of my arm but the area is no longer hard and hot.  I had no fever.  I had to take some old asthma medication because of the tightness in my chest.  Blisters in mouth.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abasia, Injected limb mobility decreased, Pain, Pain in extremity, Parvovirus B19 serology positive
Clinical narrative: October 17, 2007 - Received flu shot in left arm.  Received pneumonia shot in right arm.  That evening, the injection site in my right arm was very red and the irritation was about the size of a quarter. October 18, 2007 - I woke up with a very small range of motion in my right arm without pain.  There was a orange size raised area around the injection area in the right arm.  I started having the chills.  About 1:00pm I was shaking with the chills.  I had 103.8 fever by 4pm.  I called clinic to let them know and I went to doctor.  The doctor took blood work for a CBC.  That was normal.  The raised red area had spread down and around my arm.  Still minimal range of motion without pain.  My muscles in my arm were burning.  The area was hard to the touch and hot.  The doctor concluded that my symptoms must be the result of the pneumonia inoculation.  That night my fever was 103.8-104 even though I was taking Tylenol and Motrin every 4 hours. October 19, 2007 - Irritation on my arm had spread further with pain moving down my muscles.  Fever 103.6 most of the day with 2 breaks of fever when it went down to +/-100.5 degrees.  Still very little range of motion in my arm without pain.  My arm was painful to the touch and was still raised and burning.  I tried warm compresses.  They did not help.  I was still taking Motrin and Tylenol. October 20, 2007 - Irritation on my arm was still spreading, still raised and hard.  I still had little range of motion.  My temperature was 103 in the morning and in the late afternoon.  Otherwise my temp was about 100. October 21, 2007 - Irritation on my arm looked better, some swelling had gone away.  My range of motion was increasing.  Still painful to the touch and there was a burning sensation in my muscles.  I woke up with no temperature but it went up to about 100.6 late in the afternoon.  My temp went back down after Tylenol.  My chest started feeling a little tight.  Started with a dry cough. October 22, 2007 - The raised irritation is gone on my arm.  Range of motion is almost normal.  There is a burning sensation in my muscles of my arm but the area is no longer hard and hot.  I had no fever.  I had to take some old asthma medication because of the tightness in my chest.  Blisters in mouth.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Parvovirus infection, Pyrexia
Clinical narrative: October 17, 2007 - Received flu shot in left arm.  Received pneumonia shot in right arm.  That evening, the injection site in my right arm was very red and the irritation was about the size of a quarter. October 18, 2007 - I woke up with a very small range of motion in my right arm without pain.  There was a orange size raised area around the injection area in the right arm.  I started having the chills.  About 1:00pm I was shaking with the chills.  I had 103.8 fever by 4pm.  I called clinic to let them know and I went to doctor.  The doctor took blood work for a CBC.  That was normal.  The raised red area had spread down and around my arm.  Still minimal range of motion without pain.  My muscles in my arm were burning.  The area was hard to the touch and hot.  The doctor concluded that my symptoms must be the result of the pneumonia inoculation.  That night my fever was 103.8-104 even though I was taking Tylenol and Motrin every 4 hours. October 19, 2007 - Irritation on my arm had spread further with pain moving down my muscles.  Fever 103.6 most of the day with 2 breaks of fever when it went down to +/-100.5 degrees.  Still very little range of motion in my arm without pain.  My arm was painful to the touch and was still raised and burning.  I tried warm compresses.  They did not help.  I was still taking Motrin and Tylenol. October 20, 2007 - Irritation on my arm was still spreading, still raised and hard.  I still had little range of motion.  My temperature was 103 in the morning and in the late afternoon.  Otherwise my temp was about 100. October 21, 2007 - Irritation on my arm looked better, some swelling had gone away.  My range of motion was increasing.  Still painful to the touch and there was a burning sensation in my muscles.  I woke up with no temperature but it went up to about 100.6 late in the afternoon.  My temp went back down after Tylenol.  My chest started feeling a little tight.  Started with a dry cough. October 22, 2007 - The raised irritation is gone on my arm.  Range of motion is almost normal.  There is a burning sensation in my muscles of my arm but the area is no longer hard and hot.  I had no fever.  I had to take some old asthma medication because of the tightness in my chest.  Blisters in mouth.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Nasal congestion, Nausea, Pain, Pain in extremity
Clinical narrative: Sudden onset nausea, body aches, fever 101 day after Tdap.  Nasal congestion, cough, right arm sore.  Exposed to viral septis 2 days ago in emergency room.  Medicated with Tylenol and Ibuprofen for relief.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Sudden onset nausea, body aches, fever 101 day after Tdap.  Nasal congestion, cough, right arm sore.  Exposed to viral septis 2 days ago in emergency room.  Medicated with Tylenol and Ibuprofen for relief.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Chills, Dyspnoea, Heart rate increased, Pyrexia
Clinical narrative: Patient reports waking up on 1/11/08 around 1 AM with symptoms of fever, chills, asthma or difficulty breathing, increased heart rate.  Symptoms resolved without patient seeking medical advise.  Patient does not complain of lasting adverse effects.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Paraesthesia
Clinical narrative: Prickly sensation right side of face-lasted 45min-1 hour.  Started after vaccine given-while waiting 20min after vaccine given.
Age: 9.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: L arm with swelling & redness 12.5 cm x 14.5 cm around site of Varivax injection.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Varicella
Clinical narrative: Nov 27, 2007, I was injected with either a placebo or Zostavax.  Dec. 20-21, 2007, fever.  Dec. 21 broke out with severe chickenpox lasting until Jan. 17, 2008.
Age: 13.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Left upper arm with circular 8-9cm area of redness and edema.  No sign of cellulitis.  Treatment: cool compress/Tylenol pm.
Age: 22.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Significant local reaction at injection site with significant redness, warmth, slight swelling & soreness for 2 days.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Significant local reaction at injection site with significant redness, warmth & pain for 2-3 days.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: 4" diameter, red raised itchy "hive" to injection shot.  Appeared approximately 36 hours after shot.  No treatment.  Symptoms gone in 48 hours.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Hives started 48 hrs after immunization.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Reddened area surrounds injection site 5" in diameter.
Age: 1.6
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site reaction, Skin lesion, Varicella
Clinical narrative: Definite chicken pox lesion x4 at sight of injection & on scalp.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Headache, Nausea, Vomiting
Clinical narrative: Received immunization at 1400, noticed nausea, vomiting, chills, headache at 1830 of 29Jan08.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Immunology test abnormal, Injection site erythema, Injection site induration
Clinical narrative: Pt received vaccines 1/25/08.  Had tactile fever that evening and area of swelling/redness developed at site 1/26.  Positive pruritic.  Seen in clinic 1/28/08 & noted to have 1 inch x 2 inch erythematous/indurated area on L upper arm (back) with about 8-10 overlying clear blisters (some coalesced).  Called 1/28 department of health who recommended pt stay out of school until lesions are dry/scabbed.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site swelling, Injection site vesicles, Pruritus, Pyrexia
Clinical narrative: Pt received vaccines 1/25/08.  Had tactile fever that evening and area of swelling/redness developed at site 1/26.  Positive pruritic.  Seen in clinic 1/28/08 & noted to have 1 inch x 2 inch erythematous/indurated area on L upper arm (back) with about 8-10 overlying clear blisters (some coalesced).  Called 1/28 department of health who recommended pt stay out of school until lesions are dry/scabbed.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: Patient had swelling and redness over the right deltoid area 2 hours after the vaccine is administered.  Her arm was warm and she had low grade fever.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Pain, Skin warm
Clinical narrative: Significant local reaction at injection site with significant redness, warmth & pain for 2-3 days.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Oedema peripheral, Swelling, Tremor
Clinical narrative: Day of shot erythema and swelling, shakes and chills.  Erythema and swelling in left arm, legs and elbow at night of shot injection.
Age: 53.0
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Blood pressure increased, Dizziness
Clinical narrative: Dizziness, weakness, increased BP.  Sent to hospital.  Bill generated.  See enclosed.
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: Injection site haematoma, Pyrexia
Clinical narrative: Pt came into ER with hematoma Rt leg from injection site & fever.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: L deltoid-subcutaneous skin red, hard, swollen, size 5 in by 5 in diameter area.  Provided patient with 3 day steroid burst, Orapred 15mg/5ml, 10ml PO QD x3 days and topical hydrocortisone 2.5% topical QD x7 days.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: 1/30/08 patient was given her 3rd Recombivax at 08:40.  Patient stated approximately 9pm she had small hives on bilateral arms, maybe some on inside bilateral thighs.  Denies fever.  Took Benadryl for itching with relief.  Took Benadryl this morning also.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Large local reaction with erythema and swelling from upper arm below elbow.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Feeling abnormal, Hot flush, Hyperhidrosis, Tension, Vision blurred
Clinical narrative: On way back to school, vision became blurry.  Started sweating.  Felt light and tense.  Felt hot.  Lasted few minutes.  Once she got air ok.  Didn't eat breakfast.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Angioedema, Erythema, Oedema peripheral, Rash
Clinical narrative: Pt. came to clinic with c/o of his left arm having edema and erythema from upper arm to wrist.  Area was red with some edema noted.  Pt. stated that area was better today than on yesterday.  Seen by Dr. and was advised to take Benadryl 25mg QH for the next 2 days.  PT. was advised to go to the local ER if he developed shortness of breath or wheezing.  01/25/2008 ADDENDUM Pt. received a pneumonia vaccine in this arm on 1-23-2008.  Symptoms: 1. Angioedema, 2. Skin Rash.  Treatment Drug #1 DIPHENHYDRAMINE Dose 25 Units MG Freq TID Route PO.
Age: 1.23
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Rash
Clinical narrative: Pt. had rash x24 hours. We did not give vaccine it was given at another clinic.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Blood bicarbonate decreased, Blood pH decreased, Culture stool, Diarrhoea, Hypotension
Clinical narrative: Information has been received from a physician's office administrator and a physician concerning a 9 week old previously healthy, (full-term, bottlefed) male with a history of normal delivery, no problems during pregnancy and no drug allergies who on 23-JAN-2008 was vaccinated PO with his first dose of Rotateq (lot# 659708/1621U), not 1626U as originally reported. Concomitant drug therapy on that same day included acetaminophen (reason: unknown). Other concomitant vaccinations administered on 25-JAN-2008 included a dose of TriHIBit, a dose of IPOL and a dose of Pneumovax 23 (manufacturer unknown). on 26-JAN-2008 the patient experienced pallor, was hypotensive and had massive watery, non-bloody diarrhea. The patient was intubated and was given fluid resuscitation. The patient also had a positive rotavirus ELISA test by Rotazyme result in the emergency room (prior to antibiotics). When he was stabilized the next morning, he was transferred to another medical center where he was admitted to the pediatric ICU after developing hypovolemia and respiratory failure on 27-JAN-2008. The patient received fluid resuscitation, pressor support, antibiotics and required intubation with mechanical ventilation. No fever was reported. Laboratory tests revealed a severe acidosis with an initial bicarbonate value of 14 and a pH of 7.22 after resuscitation. A repeat Rotavirus ELISA test result was performed in the pediatric ICU (post-antibiotics) which revealed a negative result. A follow-up stool sample was post-antibiotics was negative for WBCs and RBCs. Wright stain negative, and negative for enteric pathogens thus far. The physician also reported no sign of intussusception. The patient was no longer on pressor support and was extubated. At the time of this report the patient was not recovered and still remained in the pediatric ICU. There was no product quality complaint. The events were considered to be immediately life-threatening and other important medical events by the reporter. Additional information has been requested.