chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain in extremity, Vomiting
Clinical narrative: Patient reports sore arm, chills, vomiting appx. 4 hours after vaccine administered.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pain, Pruritus
Clinical narrative: Local erythema, itching, induration and pain.
Age: 0.51
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13, RV5
Symptoms: Auricular swelling, Erythema, Somnolence, Urticaria
Clinical narrative: Woke up later than usual, was sleepy all day.  Developed hives in the morning, that rapidly spread from the diaper area to the abdomen and thighs, then to the ears, with associated ear swelling and redness.  Left side of face also developed urticarial type rash.  He was taken to the Emergency Room where his symptoms began to resolve (approximately 1-2 hours).  He was given Prelone and Benadryl even though the symptoms were already improving.  Rash has not recurred.  No more medicines have been given.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Asthenia, Dyspnoea, Erythema, Full blood count
Clinical narrative: ARTHRALGIA, DROWSINESS, DYSPNEA, ERYTHEMA, FEVER, HEADACHE, MALAISE, WEAKNESS.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Headache, Malaise, Pyrexia, Somnolence
Clinical narrative: ARTHRALGIA, DROWSINESS, DYSPNEA, ERYTHEMA, FEVER, HEADACHE, MALAISE, WEAKNESS.
Age: 41.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal discomfort, Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: High fever, chills, severe muscle aches, stomach distress/ nausea for 2-3 days. Patient hasn't received a flu vaccine for over 10 years. Had received them for multiple years before then.  The reason patient stopped was because would always get the above symptoms. Because of work, patient was "highly" urged to receive a flu vaccine and again had the reactions listed above.
Age: 33.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Polymerase chain reaction, Skin lesion, Varicella virus test positive
Clinical narrative: Lesions head to toe, back and front of body.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Asthenia, Body temperature increased, Headache, Pain
Clinical narrative: Temp 102.4 (was probably higher, didn't take it until the next day), incredible body aches, weakness, headache, all these symptoms are continuing 3 days later except for temperature.  Had to call in sick to work.  If patient not better by tomorrow, will have to see the doctor.  NEVER would have gotten the flu vac if the educational information had included to wait 2 weeks after antibiotic completion.  Patient has been so adversely affected by this vaccine that they don't plan on ever taking the vaccine again and is warning other to beware!
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Feeling abnormal, Feeling hot, Pruritus generalised, Urticaria
Clinical narrative: Within one minute of AFLURIA injection - I had a severe metallic taste in my mouth, odd sensation in throat due to this taste, felt heat everywhere especially perineal area. "Felt odd" all over - several hours to 6 hours later all over itching - hives on trunk!
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Arm warm & red. Rx ice - resolved after 4 days.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema peripheral
Clinical narrative: Swollen right shoulder after Flu immunization.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Migraine, Oropharyngeal pain, Wheezing
Clinical narrative: Migraine, sore throat, then started wheezing approximately 15 min after receiving FLUMIST. Given nebulizer treatment.
Age: 78.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Diarrhoea, Dysphagia, Dyspnoea, Eructation, Gait disturbance
Clinical narrative: Case number PHEH2011US07957 is an initial spontaneous report received from a consumer (patient) on 27 Oct 2011. This report refers to a 78 year old female patient. She had concurrent condition of COPD (chronic obstructive pulmonary disease). She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on unspecified date (3-4 years ago). The patient became ill on unspecified date after vaccination. The patient could hardly walk around and remained in bed. The patient also had a fever, diarrhea, hard time breathing and flu like symptoms. The doctor treated her with ZPAK and CIPRO, but they were not effective. She was taken to a hospital and was given oxygen. Later she started treatment with alendronate (manufacturer unknown) at a dose of 70 mg for unspecified indication in Jan 2010. Further, she developed a swallowing problem, acid reflux, burping, and had shorter breaths. The outcome was not reported. Both influenza vaccine and alendronate were suspected to cause the events.
Age: 78.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Gastrooesophageal reflux disease, Influenza like illness, Malaise, Pyrexia
Clinical narrative: Case number PHEH2011US07957 is an initial spontaneous report received from a consumer (patient) on 27 Oct 2011. This report refers to a 78 year old female patient. She had concurrent condition of COPD (chronic obstructive pulmonary disease). She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on unspecified date (3-4 years ago). The patient became ill on unspecified date after vaccination. The patient could hardly walk around and remained in bed. The patient also had a fever, diarrhea, hard time breathing and flu like symptoms. The doctor treated her with ZPAK and CIPRO, but they were not effective. She was taken to a hospital and was given oxygen. Later she started treatment with alendronate (manufacturer unknown) at a dose of 70 mg for unspecified indication in Jan 2010. Further, she developed a swallowing problem, acid reflux, burping, and had shorter breaths. The outcome was not reported. Both influenza vaccine and alendronate were suspected to cause the events.
Age: 78.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Abdominal pain upper, Dyspnoea, Fatigue, Frequent bowel movements, Gastrooesophageal reflux disease
Clinical narrative: Case number PHEH2011US07957 is an initial spontaneous report received from a consumer (patient) on 27 Oct 2011. This report refers to a 78 year old female patient. She had concurrent condition of COPD (chronic obstructive pulmonary disease). She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on unspecified date (3-4 years ago). The patient became ill on unspecified date after vaccination. The patient could hardly walk around and remained in bed. The patient also had a fever, diarrhea, hard time breathing and flu like symptoms. The doctor treated her with ZPAK and CIPRO, but they were not effective. She was taken to a hospital and was given oxygen. Later she started treatment with alendronate (manufacturer unknown) at a dose of 70 mg for unspecified indication in Jan 2010. Further, she developed a swallowing problem, acid reflux, burping, and had shorter breaths. The outcome was not reported. Both influenza vaccine and alendronate were suspected to cause the events.
Age: 78.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Malaise, Respiratory tract congestion
Clinical narrative: Case number PHEH2011US07957 is an initial spontaneous report received from a consumer (patient) on 27 Oct 2011. This report refers to a 78 year old female patient. She had concurrent condition of COPD (chronic obstructive pulmonary disease). She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on unspecified date (3-4 years ago). The patient became ill on unspecified date after vaccination. The patient could hardly walk around and remained in bed. The patient also had a fever, diarrhea, hard time breathing and flu like symptoms. The doctor treated her with ZPAK and CIPRO, but they were not effective. She was taken to a hospital and was given oxygen. Later she started treatment with alendronate (manufacturer unknown) at a dose of 70 mg for unspecified indication in Jan 2010. Further, she developed a swallowing problem, acid reflux, burping, and had shorter breaths. The outcome was not reported. Both influenza vaccine and alendronate were suspected to cause the events.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Diarrhoea, Injection site cellulitis, Malaise
Clinical narrative: Pt with cellulitis (L) upper arm (inj site was (L) deltoid) and diarrhea with general malaise. Started on KEFLEX 11/3/11. Pt did have chills.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Nodule
Clinical narrative: Immediately after injection, a large knot formed about the size of a dime raised about 1/4 inch. No redness and patient says it does not hurt -- Referred patient to his primary Dr. after vaccination, patient reported being on Aspirin & PLAVIX.
Age: 15.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Patient fainted about 1 minute later after being administered vaccine MENACTRA, HPV, FLUMIST and PPD vaccines. We had him sit for 5 mints and was ok, went home.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Malaise, Muscle spasms
Clinical narrative: C/o not feeling well, leg cramps, feeling as though BP dropping, dizzy.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site infection
Clinical narrative: On 10/27/11 patient received FLUZONE vaccine Lot UT437AB exp 6/30/12 into right deltoid. On 10/29/11 called back and said that skin under bandage looks infected. Patient stated that has infection of the skin. Tried to reach pt on 10/31/11 for more info no response.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Feeling abnormal, Pain
Clinical narrative: Patient stated a few hours after receiving he started feeling "bad". He states he woke up the next morning with chest tightness and slight dyspnea. He sated he was dizzy and had body aches. They resolved by afternoon with rest.
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Dysphonia, Pain, Pyrexia
Clinical narrative: Low fever, Wheezing, Hoarsness, chills, aches, cough.
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: Low fever, Wheezing, Hoarsness, chills, aches, cough.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Acne, Rash, Rash erythematous, Rash pruritic, Vaccination site reaction
Clinical narrative: Itchy, raised, red "rash" that started around vaccination area and spread to trunk. Resembles acne.
Age: 9.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Adverse reaction, Coordination abnormal, Feeling abnormal, Impulse-control disorder, Weight increased
Clinical narrative: Patient subsequently contracted one illness after another during the following six weeks. The most egregious of these adverse reactions resulted in patient putting on 40lbs within a six-month period.  Additionally, started exhibiting impulse-control issues, lack of gross motor coordination and a general disorganization and mental fogginess.  All these issues led to patient getting into trouble at school.
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Daughter had a fever around 102 degrees and was clingy and fussy for 4 days.  After the fever broke on 11/6/11, she developed a rash.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Left anterior lymphadenopathy x 3 days. Dr prescribed Amoxicillin Caps 500mg PO TID x 7 days.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: Severe chills - uncontrolled, full body; rapid onset and rise of fever - max approx 102 degrees. Woke at 12:30am, fever rose from 99.9 degrees at 1am to 102 degrees at 1:30am. Spoke with on-call nurse at 1am, discussed ER. Shivering/chills had subsided to more controlled level by 1:30am. Took sodium naproxen and decided to wait. Fever broke approx 2pm.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node palpable, Tenderness
Clinical narrative: Tenderness in Left underarm area with palpable lymph nodes in axilla and neck.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Headache
Clinical narrative: Headache for two days 11/2 evening and 11/2..then dizzy 11/2 through 11/5 am.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left deltoid reddened, tender and slightly swollen Pt. reports worsened overnight. Erythema to upper left arm that extends to inner aspect arm halfway toward elbow. Advised to elevate and take ibuprofen for pain.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Sinus congestion, Swelling face
Clinical narrative: Fever, sinus congestion, left cheek swelling x 2 days. Dr has prescribed Amoxicillin caps 500mg PO TID x 7 days begining today, 11/07/11.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthritis, Mobility decreased, Musculoskeletal pain, Pain in extremity, Sleep disorder
Clinical narrative: Severe pain and limited movement in both arms and shoulders.  So severe cannot sleep.  Taking Tylenol and Advils.  Pain and symptoms continued thru October and still persists.  Since it persisted, patient thought it could be arthritis and went to family doctor on 10/21 and he prescribed an anti-inflammatory but it has not helped! Going back to Dr on 11/10 to request blood test and xray/MRI.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Back pain, Groin pain, Injection site pain, Insomnia
Clinical narrative: Severe pain and limited movement in both arms and shoulders.  So severe cannot sleep.  Taking Tylenol and Advils.  Pain and symptoms continued thru October and still persists.  Since it persisted, patient thought it could be arthritis and went to family doctor on 10/21 and he prescribed an anti-inflammatory but it has not helped! Going back to Dr on 11/10 to request blood test and xray/MRI.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe pain and limited movement in both arms and shoulders.  So severe cannot sleep.  Taking Tylenol and Advils.  Pain and symptoms continued thru October and still persists.  Since it persisted, patient thought it could be arthritis and went to family doctor on 10/21 and he prescribed an anti-inflammatory but it has not helped! Going back to Dr on 11/10 to request blood test and xray/MRI.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Throat tightness
Clinical narrative: Pt called reporting SOB, tightness in chest and sensation like 'throat is closing up'.  Pt was advised to go immediately to the hospital ER for evaluation. Pt verbalized understanding.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Breath sounds absent, Dysphagia, Dyspnoea, Pharyngeal oedema
Clinical narrative: Pt arrived at office stating, "My throat feels swollen." Pt presents w/ immediate difficulty breathing, difficulty swallowing, throat swelling 1 hr after eating honey bun. Pt did receive flu shot today. Pts coworker also had anaphylaxis 1 hr after eating honey bun today and was sent to ER. Pt has had flu vaccine 10 years in a row w/o a reaction. Pt has no h/o egg allergy or any known allergies.  Breath sounds absent upon auscultation.  O2 sat 89%.  Epi-Pen injected in Right thigh per order of the attending physician.  Breath sounds auscultated post epi.  4L Nasal Cannula applied for 10min until O2sat reached 98% on room air.  Pt given Claritin 10mg and prednisone 20mg po in office.  Pt sent home with extra Epi-pen.  Anaphylaxis - pt given Epi-injection immediately on arrival w/ improvement in vitals, sx, and breathing. Pt sent home w/ Epi-pen in case of recurrence. Told to take Zantac and Zyrtec as well as prednisone. Claritin 10mg given in office w/ 20mg Prednisone PO x 1. Pt to call work and notify manager of honey bun as possible culprit and have them removed as well as call health dept/CDC to notify authorities of incident. Also recommended to pt skin allergy testing to determine cause. Also will investigate possible allergy to clostridium botulinum.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Lethargy, Nasal congestion, Nausea
Clinical narrative: Patient reported start of illness in evening of 10/19/11 - received vaccination earlier in day. Complaints of possible fever (did not take temperature), soreness at injection site (left deltoid), body aches, stuffy nose, headache, nausea, lethargy. Patient had not contacted personal physician - advised to do this. Follow up call to patient early in week of 10/24/11 - symptoms persist. On 11/2/11, patient called to report left arm still sore and taking Advil for relief and has not seen physician, which was again suggested.  On 11/7/11, follow up call to patient.  No further daytime arm pain.  Arm pain hs and using Advil for relief. Has not contacted physician, but agreed to contact personal medical practice to locate new physician.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient reported start of illness in evening of 10/19/11 - received vaccination earlier in day. Complaints of possible fever (did not take temperature), soreness at injection site (left deltoid), body aches, stuffy nose, headache, nausea, lethargy. Patient had not contacted personal physician - advised to do this. Follow up call to patient early in week of 10/24/11 - symptoms persist. On 11/2/11, patient called to report left arm still sore and taking Advil for relief and has not seen physician, which was again suggested.  On 11/7/11, follow up call to patient.  No further daytime arm pain.  Arm pain hs and using Advil for relief. Has not contacted physician, but agreed to contact personal medical practice to locate new physician.
Age: 57.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Headache, Injection site erythema, Musculoskeletal stiffness, Nausea
Clinical narrative: States arm became tender that evening about 5:30. Complained of her arm throbbing and beginning to swell acc. by redness. Felt like she might have a fever. Head ache and a little nausea. States she sat in the warm bath tub with her arm submerged.  She took 2 Tylenol tablets. The next day the redness increased and swelling increased. Said "you could see the area standing out on her arm". Warm to the touch. States it became a purplish color and was very tender. She alternated moist warm and cold packs and has continued to do that daily through today. Has taken 2 Tylenol tablets daily through today. States she started taking a Z-pack for her sinus infection on 11/03/2011. Has taken tablets as directed daily. Dr. gave her Rx for 2 packages of Zpack and to take them for 10 days. When seen today patient's arm still had redness.  Injection site had a reddish brown circle about 3/4 in in diameter. Redness extended below injection site approximately 4 inches.  Redness stopped 4 fingerbreadths above elbow.  Injection site appeared to be 2 1/2 fingerbreadths from shoulder and over the deltoid muscle. When asked, patient denied loss of mobility, swollen lymph nodes or unusual tingling in arm, hand or fingers. (has been told that she has some carpal tunnel and has had some tingling in fingers before the date of her immunization). Did reply that she did have some neck stiffness, but had been sleeping with her arm elevated on a pillow and thought it might be the awkward position.
Age: 57.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Oedema peripheral, Pain, Pain in extremity, Pyrexia, Sinusitis
Clinical narrative: States arm became tender that evening about 5:30. Complained of her arm throbbing and beginning to swell acc. by redness. Felt like she might have a fever. Head ache and a little nausea. States she sat in the warm bath tub with her arm submerged.  She took 2 Tylenol tablets. The next day the redness increased and swelling increased. Said "you could see the area standing out on her arm". Warm to the touch. States it became a purplish color and was very tender. She alternated moist warm and cold packs and has continued to do that daily through today. Has taken 2 Tylenol tablets daily through today. States she started taking a Z-pack for her sinus infection on 11/03/2011. Has taken tablets as directed daily. Dr. gave her Rx for 2 packages of Zpack and to take them for 10 days. When seen today patient's arm still had redness.  Injection site had a reddish brown circle about 3/4 in in diameter. Redness extended below injection site approximately 4 inches.  Redness stopped 4 fingerbreadths above elbow.  Injection site appeared to be 2 1/2 fingerbreadths from shoulder and over the deltoid muscle. When asked, patient denied loss of mobility, swollen lymph nodes or unusual tingling in arm, hand or fingers. (has been told that she has some carpal tunnel and has had some tingling in fingers before the date of her immunization). Did reply that she did have some neck stiffness, but had been sleeping with her arm elevated on a pillow and thought it might be the awkward position.
Age: 57.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Skin discolouration, Skin warm, Tenderness
Clinical narrative: States arm became tender that evening about 5:30. Complained of her arm throbbing and beginning to swell acc. by redness. Felt like she might have a fever. Head ache and a little nausea. States she sat in the warm bath tub with her arm submerged.  She took 2 Tylenol tablets. The next day the redness increased and swelling increased. Said "you could see the area standing out on her arm". Warm to the touch. States it became a purplish color and was very tender. She alternated moist warm and cold packs and has continued to do that daily through today. Has taken 2 Tylenol tablets daily through today. States she started taking a Z-pack for her sinus infection on 11/03/2011. Has taken tablets as directed daily. Dr. gave her Rx for 2 packages of Zpack and to take them for 10 days. When seen today patient's arm still had redness.  Injection site had a reddish brown circle about 3/4 in in diameter. Redness extended below injection site approximately 4 inches.  Redness stopped 4 fingerbreadths above elbow.  Injection site appeared to be 2 1/2 fingerbreadths from shoulder and over the deltoid muscle. When asked, patient denied loss of mobility, swollen lymph nodes or unusual tingling in arm, hand or fingers. (has been told that she has some carpal tunnel and has had some tingling in fingers before the date of her immunization). Did reply that she did have some neck stiffness, but had been sleeping with her arm elevated on a pillow and thought it might be the awkward position.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt. says arm is still sore and she cannot lift it above her head. Pt. will see MD Tue 11/8.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain in extremity
Clinical narrative: 1st night chills real painful for 3 days in arm. Lingering pain for 11 days in left arm. Most intense pain in morning.
Age: 1.01
Sex: M
Vaccine: FLUX, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever in the 101 temp range; rash on back and on chest.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, CSF test abnormal, Electroencephalogram, Fall, Gait disturbance
Clinical narrative: Developed sudden onset of lower back pain radiating down the legs with significant numbness of her feet and weakness, having difficulty walking, sometime between 5 and 7 p.m. The patient today had falls times 2 (day of admission on 10/30/2011). Spinal tap done on 11/4 positive for GBS.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture, Muscular weakness, Nerve conduction studies
Clinical narrative: Developed sudden onset of lower back pain radiating down the legs with significant numbness of her feet and weakness, having difficulty walking, sometime between 5 and 7 p.m. The patient today had falls times 2 (day of admission on 10/30/2011). Spinal tap done on 11/4 positive for GBS.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Developed sudden onset of lower back pain radiating down the legs with significant numbness of her feet and weakness, having difficulty walking, sometime between 5 and 7 p.m. The patient today had falls times 2 (day of admission on 10/30/2011). Spinal tap done on 11/4 positive for GBS.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Body temperature decreased, Chills, Dizziness, Fatigue
Clinical narrative: Right arm where shot was given got extremely sore & began throbbing and began to feel very tired. Next day got chills, blood pressure 220/185 and pulse of 103. Body temperature was 93.4. Went to bed and spent all of 11/5 and most of 11/6 in bed with body aches, headache, dizziness and weakness.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: Right arm where shot was given got extremely sore & began throbbing and began to feel very tired. Next day got chills, blood pressure 220/185 and pulse of 103. Body temperature was 93.4. Went to bed and spent all of 11/5 and most of 11/6 in bed with body aches, headache, dizziness and weakness.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling on (L) arm at injection site. Cool compress applied. TYLENOL as needed recheck in 2-3 days.
Age: 23.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Fatigue, Injection site cellulitis
Clinical narrative: Chills and fatigue.  By 11/4/11 had 5 x6 cm area of cellulitis at the injection site on the R upper arm.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Pharyngeal oedema, Pruritus
Clinical narrative: Half dollar size spot with itching, some throat swelling and difficulty breathing.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Skin lesion, Varicella post vaccine
Clinical narrative: Modified Chicken Pox --Scattered Vesicular lesions on trunk.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Injection site haematoma, Paraesthesia
Clinical narrative: RECEIVED FLU SHOT ON 10/4/2011. C/O TINGLING IN LEFT ARM, STARTED ON 10/4/2011 LATE AFTERNOON. NO SWELLING AT INJECTION SITE, BUT BRUISED. TOOK ASA FOR "WEIRD FEELING IN ARM" AND RUBBED ICE ON AREA. 10/17/11 PT STILL C/O TINGLING IN ARM.
Age: 56.0
Sex: M
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: L ARM SWOLLEN AFTER RECEIVING VARICELLA ON 10/12/2011. 40 X 40 MM. RAISED AREA MEASURED ON 10/14/2011. TENDER TO TOUCH.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Immediate post-injection reaction, Mass, Pruritus
Clinical narrative: Itching and burning, immediately after administration.  Within the next few days, a warm, red, itchy lump appeared.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Itching and burning, immediately after administration.  Within the next few days, a warm, red, itchy lump appeared.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Paraesthesia, Swelling
Clinical narrative: Swelling, redness, unable to use right arm do to tingling felt on tip of the fingers.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Localized swelling, redness and pain. Area apx 1 " in diameter.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Hyperhidrosis, Nodule, Pyrexia
Clinical narrative: Fever chills sweats, nodule.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt. called to report injection site pain, swelling and redness apx 3 " diameter. Complained of "temp" unknown reading x 2 days. Improved by 11-7-11 down to quarter sized area of swelling and redness.
Age: 20.0
Sex: F
Vaccine: FLU3, HPV4, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Swelling, pain, redness at injection site.  Fever 102.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dyspnoea, Vomiting
Clinical narrative: Difficulty breathing, severe diarrhea, vomiting -- pt did not call for help.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Vomiting
Clinical narrative: Onset at 5 hours post injection, with headache (which lasted for 2-3 days), chills, and vomiting (3 times), both sxs lasted about 3-4 hours.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Hypersensitivity, Hypoaesthesia, Hypoaesthesia oral, Induration
Clinical narrative: Went on 10/25 to Employee Health for annual evaluation, was given TDaP vaccine per facility requirement.  Had an allergic reaction to the vaccine, that night, arm became swollen, achy and warm to touch, next day, had numbness of left side of face and shortness of breath, became severe and was taken by ambulance to hospital and treated for allergic reaction with steroids, Benadryl and oxygen.  Was released.  On Sunday became feverish and achy, run temp for three days, On Tuesday, 11/1/11 noted numbness of lips, face.  Went to see Dr. on Wednesday and he told me my arm was still indurated and I was continuing to have an allergic reaction to the vaccine.  I am now on Prednisone X 5 days to treat the reaction.  Fever gone and back to work on Friday, November 04, 2011.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia, Skin warm, Vaccination complication
Clinical narrative: Went on 10/25 to Employee Health for annual evaluation, was given TDaP vaccine per facility requirement.  Had an allergic reaction to the vaccine, that night, arm became swollen, achy and warm to touch, next day, had numbness of left side of face and shortness of breath, became severe and was taken by ambulance to hospital and treated for allergic reaction with steroids, Benadryl and oxygen.  Was released.  On Sunday became feverish and achy, run temp for three days, On Tuesday, 11/1/11 noted numbness of lips, face.  Went to see Dr. on Wednesday and he told me my arm was still indurated and I was continuing to have an allergic reaction to the vaccine.  I am now on Prednisone X 5 days to treat the reaction.  Fever gone and back to work on Friday, November 04, 2011.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction, Diarrhoea, Dyspnoea, Nausea, Vomiting
Clinical narrative: Vomiting and Diarrhea started about 2 hours after getting vaccine; nausea lasted about 4 days; breathing difficulties started about the same time as the vomiting, but stopped after about 30 minutes.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain, Pyrexia, Rash
Clinical narrative: Arm swelled, hot red swollen spot 6"x6". Fever 101.9, extreme body aches through early 11/5/11. 100 fever, reducing body aches 11/5. 11/7 spot reduced to 4x4, still swollen, rash looking.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Arm swelled, hot red swollen spot 6"x6". Fever 101.9, extreme body aches through early 11/5/11. 100 fever, reducing body aches 11/5. 11/7 spot reduced to 4x4, still swollen, rash looking.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster, Pruritus, Rash vesicular
Clinical narrative: Itchiness developed on left side of upper back. On 11/05/2011, a vesicular rash was noted in the area. Shingles was diagnosed by the doctor on 11/07/2011.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Induration, Skin warm, Swelling
Clinical narrative: Swelling, hard, "hot" to touch.
Age: 1.36
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: Fever, labored breathing.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Incorrect drug administration duration, Injection site pain, Joint range of motion decreased
Clinical narrative: Arm has been extremely sore in the deltoid/shoulder region since the shot was administered 3 weeks ago, with no improvement (possibly worsening).  Range of motion is limited.  Shot was administered unusually high in the deltoid.  Shot was administed at a shot clinic, and done very quickly and without much attention.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Chills, Cough, Dyspnoea, Eye irritation
Clinical narrative: Scratchy, red, swollen eyes.  Heaviness on chest with shortness of breath (difficulty breathing).  Fatigue, chills, pale, cough, sore scratchy throat.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Eye swelling, Fatigue, Ocular hyperaemia, Oropharyngeal pain, Pallor
Clinical narrative: Scratchy, red, swollen eyes.  Heaviness on chest with shortness of breath (difficulty breathing).  Fatigue, chills, pale, cough, sore scratchy throat.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Throat irritation
Clinical narrative: Scratchy, red, swollen eyes.  Heaviness on chest with shortness of breath (difficulty breathing).  Fatigue, chills, pale, cough, sore scratchy throat.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Erythema, Headache, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Arm began to hurt. Developed cough. 10:30 PM unable to move arm, swollen and red from injection site near the left shoulder to the left elbow. Extreme pain and headache lasting 3 days. Arm remains red, swollen, painful and hot.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Oedema peripheral, Pain, Pain in extremity, Skin warm
Clinical narrative: Arm began to hurt. Developed cough. 10:30 PM unable to move arm, swollen and red from injection site near the left shoulder to the left elbow. Extreme pain and headache lasting 3 days. Arm remains red, swollen, painful and hot.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site reaction, Pain in extremity
Clinical narrative: Severe muscle pain at injection site, radiating down the entire length of the arm. Pain has gradually subsided over the last 24 hours, but is still noticeable.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: 7" x 10" area of erythema.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Approx. 6 hours after vaccination fever & chills began - whole upper LA red and sore - dx cellulitis by Dr, received ceftriaxone and clindamycin.
Age: 1.5
Sex: M
Vaccine: FLU3
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme minor appeared 4 days after flu vaccine.
Age: 10.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Right arm swollen red where Varicella was given.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient developed hives over most of her body that was quite itchy the morning after shot administered. Rash lasted several days. When pt brought to our attention it decreased significantly. Pat instructed to take BENADRYL.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Nerve injury, X-ray
Clinical narrative: After administering vaccine, patient complained about administration. Site soreness. Soreness did not subside. Pt went to PCP to get examined. X-ray was performed and according to doctor a nerve was hit by vaccine.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash, Rash erythematous
Clinical narrative: Patient called the pharmacy to report that at the site of injection of PNEUMOVAX, rash appeared, patient informed that it was red, and spreading down, all over his right arm. No further reactions reported.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pt received flu shot on 11/7/11 and about 45 min later called the pharmacy to report that her forearm was throbbing. Pt did not have any accidents in the 45 min she left the pharmacy to explain the adverse reaction.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Visual acuity reduced
Clinical narrative: Decreased visual acuity per patient that started approximately 45 minutes post injection. Patient seen by the doctor and discharged home.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Dizziness, Influenza like illness, Injection site erythema
Clinical narrative: Flu-like (nausea, body aches, temp. 102 degrees F). Dizziness, joint pain - more severe on injection side of body. Injection site - itching, red, warm to touch.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site warmth, Nausea, Pain
Clinical narrative: Flu-like (nausea, body aches, temp. 102 degrees F). Dizziness, joint pain - more severe on injection side of body. Injection site - itching, red, warm to touch.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Mobility decreased, Pain, Skin warm, Swelling
Clinical narrative: Redness, swelling, throbbing pain, warmth to touch, inability to bend.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Pt reported dizziness, nausea & weakness x 2 days. He did not like the HIGH DOSE FLUZONE.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Pruritus, Rash generalised
Clinical narrative: Symptoms of rash all over the body. Very itchy! Started with just rash on arm, then went all over the main trunk area. Treatment mainly with prednisone and hydroxyzine. It is much better except for site on ribs (sore). Also using ointments.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Chills, Fatigue, Influenza like illness, Laboratory test
Clinical narrative: Evening of vaccine, had chills, fever, aches, tiredness. The following day, she still had flu-like symptoms, which were followed by severe chest pain. She then went to the emergency room. They did a cardiac work-up, then sent her home.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Evening of vaccine, had chills, fever, aches, tiredness. The following day, she still had flu-like symptoms, which were followed by severe chest pain. She then went to the emergency room. They did a cardiac work-up, then sent her home.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain in left arm from shoulder to elbow. Pain continuous. Difficulty raising arm.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Abdominal X-ray, Feeding disorder of infancy or early childhood, Full blood count normal, Haematochezia, Lethargy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 8 weeks old male patient with none preexisting illness and a history of seizure, fell out swing evening before visit-cried about 30 seconds, behaving normal, who on 14-SEP-2011 was vaccinated by mouth with the first dose of ROTATEQ (Lot number 670242/0920AA). Concomitant vaccine included the first dose of PREVNAR (Lot number 90670) administered IM (site unknown), PENTACEL (Lot number C3966AA) administered IM (site unknown) and hepatitis virus vaccine (unspecified). On 26-SEP-2011, primary care provider records were received for date of service from 14-SEP-2011 to 26-SEP-2011. On 15-SEP-2011, the patient presented with lethargy, blood in stool, "not himself", not eating well after immunization. Lab diagnostic records received from EDOS revealed blood culture negative, red blood cell count 3.79 M/mm3 (N), whole blood hematocrit 31.7% (L), red cell distribution width 14.9% (h), blood platelet count 565 K/mm3 (H), white blood cell count 11.7 K/mm3 (N), blood neutrophil count 37% (L), blood lymphocyte count 52% (H), blood monocyte count 9% (H), serum blood urea nitrogen test 3 mg/dL (L). An x-ray abdomen was abnormal, x-ray with radiolucent ring showed potential "air in belly" and skull x-ray was unremarkable. The patient was diagnosed with intussusception. On 26-SEP-2011, the patient was seen in follow up after hospitalization for intussusception. Exam was unremarkable. Ring-like lucency over right mid abdomen on x-ray. At the time of the report, the outcome of the patient was unknown. The patient required an emergency room visit and the reporter considered the events were serious. "Not himself", blood in stool, poor feeding, no eating well, lethargy and intussusception were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 435102. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 670242/0920AA 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. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: X-ray abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 8 weeks old male patient with none preexisting illness and a history of seizure, fell out swing evening before visit-cried about 30 seconds, behaving normal, who on 14-SEP-2011 was vaccinated by mouth with the first dose of ROTATEQ (Lot number 670242/0920AA). Concomitant vaccine included the first dose of PREVNAR (Lot number 90670) administered IM (site unknown), PENTACEL (Lot number C3966AA) administered IM (site unknown) and hepatitis virus vaccine (unspecified). On 26-SEP-2011, primary care provider records were received for date of service from 14-SEP-2011 to 26-SEP-2011. On 15-SEP-2011, the patient presented with lethargy, blood in stool, "not himself", not eating well after immunization. Lab diagnostic records received from EDOS revealed blood culture negative, red blood cell count 3.79 M/mm3 (N), whole blood hematocrit 31.7% (L), red cell distribution width 14.9% (h), blood platelet count 565 K/mm3 (H), white blood cell count 11.7 K/mm3 (N), blood neutrophil count 37% (L), blood lymphocyte count 52% (H), blood monocyte count 9% (H), serum blood urea nitrogen test 3 mg/dL (L). An x-ray abdomen was abnormal, x-ray with radiolucent ring showed potential "air in belly" and skull x-ray was unremarkable. The patient was diagnosed with intussusception. On 26-SEP-2011, the patient was seen in follow up after hospitalization for intussusception. Exam was unremarkable. Ring-like lucency over right mid abdomen on x-ray. At the time of the report, the outcome of the patient was unknown. The patient required an emergency room visit and the reporter considered the events were serious. "Not himself", blood in stool, poor feeding, no eating well, lethargy and intussusception were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 435102. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 670242/0920AA 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. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Abdominal X-ray, Abnormal behaviour, Blood culture negative, Blood urea decreased, Decreased appetite
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 8 weeks old male patient with none preexisting illness and a history of seizure, fell out swing evening before visit-cried about 30 seconds, behaving normal, who on 14-SEP-2011 was vaccinated by mouth with the first dose of ROTATEQ (Lot number 670242/0920AA). Concomitant vaccine included the first dose of PREVNAR (Lot number 90670) administered IM (site unknown), PENTACEL (Lot number C3966AA) administered IM (site unknown) and hepatitis virus vaccine (unspecified). On 26-SEP-2011, primary care provider records were received for date of service from 14-SEP-2011 to 26-SEP-2011. On 15-SEP-2011, the patient presented with lethargy, blood in stool, "not himself", not eating well after immunization. Lab diagnostic records received from EDOS revealed blood culture negative, red blood cell count 3.79 M/mm3 (N), whole blood hematocrit 31.7% (L), red cell distribution width 14.9% (h), blood platelet count 565 K/mm3 (H), white blood cell count 11.7 K/mm3 (N), blood neutrophil count 37% (L), blood lymphocyte count 52% (H), blood monocyte count 9% (H), serum blood urea nitrogen test 3 mg/dL (L). An x-ray abdomen was abnormal, x-ray with radiolucent ring showed potential "air in belly" and skull x-ray was unremarkable. The patient was diagnosed with intussusception. On 26-SEP-2011, the patient was seen in follow up after hospitalization for intussusception. Exam was unremarkable. Ring-like lucency over right mid abdomen on x-ray. At the time of the report, the outcome of the patient was unknown. The patient required an emergency room visit and the reporter considered the events were serious. "Not himself", blood in stool, poor feeding, no eating well, lethargy and intussusception were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 435102. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 670242/0920AA 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. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Flatulence, Full blood count normal, Haematochezia, Haematocrit decreased, Intussusception
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 8 weeks old male patient with none preexisting illness and a history of seizure, fell out swing evening before visit-cried about 30 seconds, behaving normal, who on 14-SEP-2011 was vaccinated by mouth with the first dose of ROTATEQ (Lot number 670242/0920AA). Concomitant vaccine included the first dose of PREVNAR (Lot number 90670) administered IM (site unknown), PENTACEL (Lot number C3966AA) administered IM (site unknown) and hepatitis virus vaccine (unspecified). On 26-SEP-2011, primary care provider records were received for date of service from 14-SEP-2011 to 26-SEP-2011. On 15-SEP-2011, the patient presented with lethargy, blood in stool, "not himself", not eating well after immunization. Lab diagnostic records received from EDOS revealed blood culture negative, red blood cell count 3.79 M/mm3 (N), whole blood hematocrit 31.7% (L), red cell distribution width 14.9% (h), blood platelet count 565 K/mm3 (H), white blood cell count 11.7 K/mm3 (N), blood neutrophil count 37% (L), blood lymphocyte count 52% (H), blood monocyte count 9% (H), serum blood urea nitrogen test 3 mg/dL (L). An x-ray abdomen was abnormal, x-ray with radiolucent ring showed potential "air in belly" and skull x-ray was unremarkable. The patient was diagnosed with intussusception. On 26-SEP-2011, the patient was seen in follow up after hospitalization for intussusception. Exam was unremarkable. Ring-like lucency over right mid abdomen on x-ray. At the time of the report, the outcome of the patient was unknown. The patient required an emergency room visit and the reporter considered the events were serious. "Not himself", blood in stool, poor feeding, no eating well, lethargy and intussusception were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 435102. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 670242/0920AA 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. No further information is available.