chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a 29 year old female pharmacist who is also a patient. The patient's medical history and current condition was not reported. Approximately in 1997 (reported as at the beginning of 12 years of age) the patient was vaccinated with VARIVAX (Merck) (unknown strength, dose, frequency and lot number). Other concomitant medication includes prenatal vitamins (unspecified). It was reported that initially her titers showed immunity, titers drawn in JUNE-2014 or JULY-2014 showed no immunity to varicella. Lab test includes serological testing for immunity to VARIVAX (Merck). Cancer and overdose was not reported. The outcome of the event was unknown. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 28 year old female patient. The patient's pertinent medical history was not reported. On 03-DEC-2014, a 6 months pregnant (Approximately 26 weeks and second trimester) the patient was vaccinated with M-M-R II (dose, route not reported). The patient's last menstrual period (LMP) was approximately 04-JUN-2014 and Estimated date of delivery (EDD) was 11-MAR-2015. No adverse effects were reported. The patient did not sought medical attention. No product quality complaint (PQC) was reported for M-M-R II. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 3 days of wide area of redness and swelling at site of injection. Area was warm to the touch. Patient referred to clinic. Told to use cold compresses.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pain at injection site started 12/02 at 5:40pm; fever/chills started 12/03 around 6 am; pain, swelling, erythema of injection site and entire deltoid from 12/02-12/06; tender at injection site from 12/02-current.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Cough
Clinical narrative: Cough.
Age: 67.0
Sex: M
Vaccine: FLUC3
Symptoms: Chills, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: Slight fever and chills, followed by muscle soreness and weakness in the upper arm into the neck and across the back that lasted about 7 days.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue, Throat tightness
Clinical narrative: Patient felt constriction in airway and tongue swelling-took 4 Benadryl 25mg and went to ER where she was given an epinephrine injection and steroids.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Skin warm, Urticaria
Clinical narrative: Red welt approximately 3 inches in diameter, warm to the touch, slightly raised.
Age: 0.72
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Asthenia, Feeling hot, Irritability, Pyrexia
Clinical narrative: Started acting irritable and unhappy. Started to feel a little warm and weak. It is now 12/07/2014 at 10:15 AM, and patient has been up all night with varying degrees of fever (from 100- 104 degrees).
Age: 62.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Musculoskeletal pain
Clinical narrative: Sore shoulder, muscle aches, chills, fever, fatigue, sweating, mild head ache: Lasted 12 hours but fatigue lasted two days.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Sore shoulder, muscle aches, chills, fever, fatigue, sweating, mild head ache: Lasted 12 hours but fatigue lasted two days.
Age: 1.53
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Vomiting
Clinical narrative: Vomiting for 5 hours.
Age: 43.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: Pt did not have any adverse event at the time of vaccine administration.
Age: 35.0
Sex: F
Vaccine: FLUX, MMR
Symptoms: Chills, Choking, Dyspnoea, Local swelling, Lymph node pain
Clinical narrative: Awoke to severely sore and swollen glands and neck. At 11:30 AM became unable to speak without choking and gasping for air. By 01:00 PM had fever, chills, body aches. Conditions have continued to date, and are on-going.
Age: 35.0
Sex: F
Vaccine: FLUX, MMR
Symptoms: Lymphadenopathy, Neck pain, Pain, Pyrexia, Speech disorder
Clinical narrative: Awoke to severely sore and swollen glands and neck. At 11:30 AM became unable to speak without choking and gasping for air. By 01:00 PM had fever, chills, body aches. Conditions have continued to date, and are on-going.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient reports extreme arm pain radiating from the left deltoid down length of brachi.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Pain, Pruritus generalised, Rash erythematous
Clinical narrative: Very sore and painful to touch the night after receiving the injection (more than usual after a flu shot); second day a red rash developed around and below the injection site; 4 inches by 7 inches oval; hot to the touch and itchy throughout; lasted for 3 days; for up to a week after the rash disappeared the site turned red again when exposed to heat (e.g., hot bath).
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Very sore and painful to touch the night after receiving the injection (more than usual after a flu shot); second day a red rash developed around and below the injection site; 4 inches by 7 inches oval; hot to the touch and itchy throughout; lasted for 3 days; for up to a week after the rash disappeared the site turned red again when exposed to heat (e.g., hot bath).
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: Patient claimed that her throat felt as if it was swelling up shortly after receiving vaccination.  Patient did take Benadryl and it eased up the symptoms.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature decreased, Dyspnoea, Feeling cold, Muscle spasms, Peripheral coldness
Clinical narrative: Got cold. Then had a cramp at right ankle. Then body temperature dropped. Skin got very cold then I stopped breathing and fainted. Was given CPR by husband.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Resuscitation, Syncope
Clinical narrative: Got cold. Then had a cramp at right ankle. Then body temperature dropped. Skin got very cold then I stopped breathing and fainted. Was given CPR by husband.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Injected limb mobility decreased, Tenderness
Clinical narrative: Pt reports left arm is sensitive to touch and he cannot raise his left arm over his head.
Age: 1.07
Sex: M
Vaccine: MMR
Symptoms: Lethargy, Pyrexia
Clinical narrative: Lethargic after nap, fever of 101.
Age: 1.5
Sex: M
Vaccine: DTAP, FLUX
Symptoms: Body temperature increased, Convulsion, Crying, Decreased appetite, Grunting
Clinical narrative: Today at 850 am patient had his 1.5 yr old MD appointment - he has been healthy, well, happy boy with out any illness recently was scheduled for 4 vaccines, got two - Flu and Tdap. Was very fussy and cranky tonight when I got home around 6pm, did not want dinner, very very fussy, happy to go to bed, at 8:20pm he awoke with a cry that started to build, I went in to get him out of the crib and immediately noticed he was hot to touch, consoled him but he increased in the intensity of his crying, Called for wife, she came in and we got an axillary temp of 102.7, wife had him on the the changing table and I was in the hall way when I heard two grunts and wife yell he is having a seizure, she was picking him up to bring him outside, he was in extensor pattern, minimal breathing, left lateral gaze, unresponsive for 35-55 seconds - stop watch read 27 seconds but took me 10-20 seconds to get it started. Wife stayed out side, and I got ICE to place on femoral arteries, he regained consciousness, I called Dr as he was crying hysterically in the back ground. Advised for Motrin 100mg q 6 and APAP 160mg q4 if needed, keep dosing the Mortin for 48 hours any repeat seizure or decline of condition to call back asap. With APAP and Ibu in he was much improved, did not have IBU in the house so ran to store to get some, but administered first dose of APAP 160mg at approx 8:35, first dose of Motrin at 8:55, much cooler and less fussy by 9:20pm. Set up dosing schedule - Read on internet that Flu vaccine and Dtap together raises risk of Seizures.
Age: 1.5
Sex: M
Vaccine: DTAP, FLUX
Symptoms: Irritability, Respiratory rate decreased, Skin warm, Unresponsive to stimuli
Clinical narrative: Today at 850 am patient had his 1.5 yr old MD appointment - he has been healthy, well, happy boy with out any illness recently was scheduled for 4 vaccines, got two - Flu and Tdap. Was very fussy and cranky tonight when I got home around 6pm, did not want dinner, very very fussy, happy to go to bed, at 8:20pm he awoke with a cry that started to build, I went in to get him out of the crib and immediately noticed he was hot to touch, consoled him but he increased in the intensity of his crying, Called for wife, she came in and we got an axillary temp of 102.7, wife had him on the the changing table and I was in the hall way when I heard two grunts and wife yell he is having a seizure, she was picking him up to bring him outside, he was in extensor pattern, minimal breathing, left lateral gaze, unresponsive for 35-55 seconds - stop watch read 27 seconds but took me 10-20 seconds to get it started. Wife stayed out side, and I got ICE to place on femoral arteries, he regained consciousness, I called Dr as he was crying hysterically in the back ground. Advised for Motrin 100mg q 6 and APAP 160mg q4 if needed, keep dosing the Mortin for 48 hours any repeat seizure or decline of condition to call back asap. With APAP and Ibu in he was much improved, did not have IBU in the house so ran to store to get some, but administered first dose of APAP 160mg at approx 8:35, first dose of Motrin at 8:55, much cooler and less fussy by 9:20pm. Set up dosing schedule - Read on internet that Flu vaccine and Dtap together raises risk of Seizures.
Age: 1.56
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Aphasia, Diarrhoea, Opisthotonus
Clinical narrative: Arch back, extreme diarrhea, lost her speach.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Fever, pain, redness, swelling-treated with antibiotic(s).
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist reported patient received their first dose of M-M-R II (lot#, dose and route not reported), at 9 months and received the second dose of M-M-R II (lot#, dose and route not reported), prior to elementary school entry. No adverse effects reported. No additional information to report. Additional information has been requested.
Age: 0.97
Sex: M
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from registered nurse refers to an 11 month old male patient with no drug reactions/allergies. On 07-NOV-2003 the patient was vaccinated with the first dose of VARIVAX (Merck), (0.5 ml/1 dose, lot# and route unspecified) (9 days before his first birthday)(Inappropriate schedule). On 19-DEC-2007 the patient was vaccinated with the second dose of VARIVAX (Merck), (0.5 ml/1 dose, lot# and route unspecified). The patient sought medical attention via visiting pediatrician office on an unspecified date. The outcome of the event was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Palpitations, Rheumatoid arthritis
Clinical narrative: This spontaneous report has been received from a consumer (aunt of the patient) regarding the female patient of unknown age. Pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with GARDASIL injection (dose/ dose in series/ route unknown). Concomitant medications were not reported. On an unknown date the patient experienced rheumatoid arthritis, heart palpitations and headaches. The outcome of rheumatoid arthritis, headaches and heart palpitations was reported as not resolved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Pertinent medical history was unspecified. The patient had no drug allergies. On an unknown date the patient was vaccinated with ZOSTAVAX (strength and route not reported, lot #K012923, expiration date: 29-NOV-2015). On an unknown date the patient experienced lump and redness at the injection site within a few minutes of receiving ZOSTAVAX. She took ZYRTEC to treat her symptoms. The patient sought medical attention by calling the pharmacist. The outcome of adverse event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Malaise, Nausea
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Pertinent medical history was unspecified. The patient had no drug allergies. On 28-NOV-2014, the patient was vaccinated with ZOSTAVAX (strength and route not reported, lot #K012923, expiration date: 29-NOV-2015). On an unknown date the patient experienced lump and redness at the injection site and redness that spread from the injection site "all the way to their armpit" on an unspecified date in 2014. The patient also developed malaise and nausea on an unspecified date in 2014. No treatment was given. The patient sought medical attention by calling the pharmacist. The patient's wife received ZOSTAVAX on the same date and experienced the same adverse event which was captured in MARRS # 1412USA001968. The outcome of adverse events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Malaise, Nausea
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Pertinent medical history was unspecified. The patient had no drug allergies. On 28-NOV-2014, the patient was vaccinated with ZOSTAVAX (strength and route not reported, lot #K012923, expiration date: 29-NOV-2015). On an unknown date the patient experienced lump and redness at the injection site and redness that spread from the injection site "all the way to their armpit" on an unspecified date in 2014. The patient also developed malaise and nausea on an unspecified date in 2014. No treatment was given. The patient sought medical attention by calling the pharmacist. The patient's husband received ZOSTAVAX on the same date and experienced the same adverse event which was captured in MARRS # 1412USA001968. The outcome of adverse events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLUN4
Symptoms: Eye pruritus, Nasal congestion, Rhinorrhoea, Sneezing
Clinical narrative: Sneezing, running nose, stuffy nose, feels like inside of nose is swollen and itchy eyes all throughout each day.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache
Clinical narrative: Awakened to go to the bathroom and almost fell due to extreme dizziness and headache. It lasted through 12/03/2014. Went back to clinic and advised to take Zyrtec, Ibuprofen and given meds for dizziness.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Swelling, redness, Moderate.
Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Cardiac disorder, Death
Clinical narrative: Died from cardiac disease.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Dyspnoea, Pyrexia
Clinical narrative: Joints on the pain. Shortness of breath. Fever. Weakness.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Death
Clinical narrative: Died from ??UTI/Sepsis.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report has been received from a consumer concerning 140 anonymous female patients of unknown age. On an unknown date patients were vaccinated with GARDASIL injection (dose/ dose in series/ route unknown). The reporter indicated that on an unspecified date, 140 anonymous women died after receiving GARDASIL. Cause of death was not reported. The reporter stated 'how many reported fatalities were needed for a product to be pulled from the market'. She further stated, 'with all of the side effects women experienced after receiving GARDASIL, Merck should not still be pushing the product and the product's prescribing information needed to be updated'. The reporter indicated that she was seeking an attorney because 'Merck needs to update the GARDASIL prescribing information to include the 140 who have died because they received GARDASIL'. She enquired about the address for the Office of General Counsel. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Angiogram, Angioplasty, Autoimmune disorder, Back pain, Blood test
Clinical narrative: Sustained massive headache, backache, later took daughter to emergency room, many diagnostics did not reveal anything, one week later took daughter to hospital with progressively worse symptoms, MRI performed, determined blood clot in vein in head, and intercranial pressure was off the charts, daughter spent a full month in hospital being treated, multiple scans, tests, multiple surgeries including crainotomy, 5 MRIs, six lumbar punctures to relieve building spinal pressure, angioplasty to unsuccessfully remove blot clot, as of 12/8/14 daughter still on cerebral spinal fluid medication and requires ongoing lumbar puncture, doctors diagonose as unspecificied autoimmune response.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Computerised tomogram, Craniotomy, Headache, Intracranial pressure increased, Lumbar puncture
Clinical narrative: Sustained massive headache, backache, later took daughter to emergency room, many diagnostics did not reveal anything, one week later took daughter to hospital with progressively worse symptoms, MRI performed, determined blood clot in vein in head, and intercranial pressure was off the charts, daughter spent a full month in hospital being treated, multiple scans, tests, multiple surgeries including crainotomy, 5 MRIs, six lumbar punctures to relieve building spinal pressure, angioplasty to unsuccessfully remove blot clot, as of 12/8/14 daughter still on cerebral spinal fluid medication and requires ongoing lumbar puncture, doctors diagonose as unspecificied autoimmune response.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging abnormal, Surgery, Thrombosis, Ultrasound scan, X-ray
Clinical narrative: Sustained massive headache, backache, later took daughter to emergency room, many diagnostics did not reveal anything, one week later took daughter to hospital with progressively worse symptoms, MRI performed, determined blood clot in vein in head, and intercranial pressure was off the charts, daughter spent a full month in hospital being treated, multiple scans, tests, multiple surgeries including crainotomy, 5 MRIs, six lumbar punctures to relieve building spinal pressure, angioplasty to unsuccessfully remove blot clot, as of 12/8/14 daughter still on cerebral spinal fluid medication and requires ongoing lumbar puncture, doctors diagonose as unspecificied autoimmune response.
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site atrophy
Clinical narrative: While putting lotion on my left upper arm I felt a little dimple at the injection site. Not sure when it started to dimple in but this is when I first noticed it.  As weeks went on it became worse, I lost my health insurance so I put off seeing a doctor. Went to dermatologist on Friday the 5th of December. Will have to go back for biopsy and treatment to rebuild the tissue that was lost.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Headache
Clinical narrative: Patient c/o blisters all over fingers and face x 2 mos after receiving flu vaccine. Also c/o HA the day after receiving flu shot.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Antinuclear antibody positive, Blood pressure abnormal, Blood test abnormal, Fatigue
Clinical narrative: My child's immune system became weak after the last vaccine got sick easy developed high heart rate BP problems pain chronic fatigue. Was diagnosed with POTS and chronic fatigue. Was unable to attend school doing home school. Seeing 5 specialists.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Heart rate increased, Immune system disorder, Liver function test abnormal, Malaise, Pain
Clinical narrative: My child's immune system became weak after the last vaccine got sick easy developed high heart rate BP problems pain chronic fatigue. Was diagnosed with POTS and chronic fatigue. Was unable to attend school doing home school. Seeing 5 specialists.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: My child's immune system became weak after the last vaccine got sick easy developed high heart rate BP problems pain chronic fatigue. Was diagnosed with POTS and chronic fatigue. Was unable to attend school doing home school. Seeing 5 specialists.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Malaise, Memory impairment, Muscle twitching, Nerve injury
Clinical narrative: Became sick after 3rd HPV GARDASIL vaccine was diagnosed with POTS. Waiting to see neurology has memory problems, muscle and nerve twitching and shocking headaches.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: Became sick after 3rd HPV GARDASIL vaccine was diagnosed with POTS. Waiting to see neurology has memory problems, muscle and nerve twitching and shocking headaches.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Acoustic stimulation tests, Barium enema, Decreased appetite, Differential white blood cell count, Electroencephalogram
Clinical narrative: Hypotonia, unresponsive, muscle stiffness, screaming, decreased appetite.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Full blood count, Hypotonia, Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain, Screaming
Clinical narrative: Hypotonia, unresponsive, muscle stiffness, screaming, decreased appetite.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Unresponsive to stimuli
Clinical narrative: Hypotonia, unresponsive, muscle stiffness, screaming, decreased appetite.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Patient given AFLURIA vaccine on 11-23-14, presented back at the pharmacy on 12-2-14. Had approximately 2" in diameter bruise at injection site.
Age: 1.02
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Adenovirus infection, Adenovirus test positive, Febrile convulsion, Laboratory test abnormal, Polymerase chain reaction
Clinical narrative: Febrile seizure presenting in status 8 days after vaccines.
Age: 1.02
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Rhinovirus infection, Viral test positive
Clinical narrative: Febrile seizure presenting in status 8 days after vaccines.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Client reports inside of hands and in between fingers are itching. She reports no changes other than got flu shot yesterday. She denies ever having allergies to vaccines or other allergies.
Age: 0.32
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: Electroencephalogram abnormal, Infantile spasms
Clinical narrative: Patient developed signs of Infantile Spasms that were misinterpreted as behavior due to acid reflux. Official diagnosis was made 08/11/2014 with EEG confirmation and treatment began immediately.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Headache, Hypoaesthesia oral, Nausea
Clinical narrative: Patient originally complained of "numb lips" and feeling nauseous. Later also said that she was experiencing tightness in her chest and a headache too. Never had any problems breathing or anything like that. Never emergent enough to need Epipen or Benadryl, but we called paramedics as a precaution and they ended up taking her to a hospital for observation.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red rash on both upper arms at injection sites, Also same red rash on Left forearm. Pt. And parent state not itchy.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cold sweat, Dizziness, Nausea, Pain, Pain in extremity
Clinical narrative: Influenza vaccine administered (L) electrical and pneumococcal vaccine administered (R) deltoid on 9/25/14. Approx 3 1/2 hours after administration, patient reported clammy skin, nausea light-headedness, and excruciating (L) arm pain, especially with movement. Patient saw physician on 9/29/14 and "was told to apply heat to (R) arm and take TYLENOL." Patient also saw chiropractor a couple of times. Symptoms continue to exist and patient follow-up with primary care physician on 10/28/14.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Herpes zoster
Clinical narrative: Received shingle shot 6-1-07. Received flu shot 11-14-07. Broke out shingle 11-20-14. Urgent care 11-23-14.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Decreased appetite, Fatigue, Oropharyngeal pain
Clinical narrative: Chills, aches, sore throat, fever, extremely tired, sleepy, no appetite, cough (2nd line lasted 5 1/2 weeks)! BENADRYL, acetaminophen, naproxen.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: Chills, aches, sore throat, fever, extremely tired, sleepy, no appetite, cough (2nd line lasted 5 1/2 weeks)! BENADRYL, acetaminophen, naproxen.
Age: 48.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Induration, Local swelling, Pain in extremity
Clinical narrative: Left arm swelling and pain about 1-2 days after Tdap.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood glucose increased, Dizziness, Dyspnoea, Generalised erythema, Headache
Clinical narrative: Generalized redness, difficulty breathing, headache, dizziness occurred at 3:55 pm. BP 205/110 Pulse 105.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Rash on/near the injection site pt stated it was itching - that's when she noticed the rash. Patient took BENADRYL.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt. has pain on her left arm (injection site). It is most likely mild pain but worse upon waking up and has a hard time moving it up. It is improving slowly since it started. Pt. is doing hot compress few times a day and taking TYLENOL if needed.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Laboratory test, Myalgia, Pruritus generalised, Rash erythematous
Clinical narrative: Rash across the chest (collar bone) itchy, red, itchy all over the body from head to toe, muscle aches, irritated left arm.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Rash pruritic, Skin irritation
Clinical narrative: Rash across the chest (collar bone) itchy, red, itchy all over the body from head to toe, muscle aches, irritated left arm.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Flu vaccine received 12/5/14 in early afternoon at about 2:00 pm. By Sunday morning upon awakening (R) upper arm, site of inj was itchy, swollen, red, put ice pack on with some relief. By date of report has had improvement. Redness minimal, swelling decreased, tenderness not present, no more itch.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Joint crepitation, Joint range of motion decreased, Joint swelling, Pain, Pain in extremity
Clinical narrative: On 11/10/14 received flu vaccine. About 1 day later upon awakening in a.m. felt pain in (L) thumb with snapping joints on movement and swelling in base joint with pain on movement. Has not improved over past 3 weeks. Joint ROM has decreased over that time.
Age: 1.25
Sex: M
Vaccine: FLU3, HIBV
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered, Wrong drug administered
Clinical narrative: Wrong formulation influenza vaccine given to child FLUZONE and should have been FLUZONE QUAD. Dose given 0.5 ml - should have been 0.25 ml.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Myalgia, Pyrexia
Clinical narrative: Local erythema, fever, chills, myalgia.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia, Influenza, Parosmia, Streptococcus test negative
Clinical narrative: This case was reported by a pharmacist and described the occurrence of taste altered in a 63-year-old female who received FLUARIX Quadrivalent 2014-2015 season) (batch number 7S75Y, expiry date 30th June 2015). Previously administered products included FLUARIX Quadrivalent 2013-2014 season. On 12th September 2014, the patient received FLUARIX Quadrivalent 2014-2015 season (unknown). On 12th September 2014, less than a day after receiving FLUARIX Quadrivalent 2014-2015 season, the patient experienced taste altered and smell alteration. On 27th September 2014, the outcome of the taste altered and smell alteration were recovered/resolved. It was unknown if the reporter considered  the taste altered and smell alteration to be related to FLUARIX Quadrivalent 2014-2015 season. Additional information: Patient shared she dealt with the odor for a week and then went to a doctor. Doctor told her she ha a slight touch of the Flu from the shot. He also tested her for Strep throat, which was negative. He gave her a Z-pack for 5 day therapy and the odor lasted another week.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Headache, Influenza, Insomnia
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza in a 66-year-old female patient who received Influenza vaccine. Co-suspect products included ADVAIR Diskus inhalation powder for chronic obstructive pulmonary disease and BREO ELLIPTA inhalation powder (batch number R669743, expiry date unknown) and (batch number R669743, expiry date November 2015) for chronic obstructive pulmonary disease. The patient's past medical history included smoker and pneumonia (hospitalization for 12 days). Concurrent medical conditions included chronic obstructive pulmonary disease, esophageal hernia, dyspnea, spinal fracture and cataract. Concomitant products included carvedilol, enalapril, FOSAMAX, omeprazole and Vitamin D. On 8th September 2014, the patient received Influenza vaccine. In 2006, the patient started ADVAIR Diskus (inhaled) 1 puff(s) twice daily (2 puff(s) daily). In October 2014, the patient started BREO ELLIPTA (inhaled) 1 puff(s) once daily (1 puff(s) daily). On an unknown date, the dose was changed to an unknown dose and frequency. On 10th September 2014, 2 days after receiving Influenza vaccine , 8 years after starting ADVAIR Diskus and not applicable after starting BREO ELLIPTA, the patient experienced influenza, sore throat and pain in arm. In October 2014, the patient experienced runny nose, irritability, headache, cough, difficulty sleeping, dyspnea exacerbated and productive cough. In October 2014, the outcome of the runny nose, irritability, headache, cough, difficulty sleeping, dyspnea exacerbated and productive cough were recovered/resolved. On an unknown date, the outcome of the influenza, sore throat and pain in arm were unknown. It was unknown if the reporter considered the influenza, sore throat and pain in arm to be related to influenza vaccine, ADVAIR Diskus and BREO ELLIPTA. The reporter considered the runny nose, irritability, headache, cough, difficulty sleeping, dyspnea exacerbated and productive cough to be almost certainly related to influenza vaccine, ADVAIR Diskus and BREO ELLIPTA. Additional information: When she was taking ADVAIR, she hospitalized for 12 days in 2012 for pneumonia. In October 2014, at an unspecified time after receiving Influenza vaccine, 8 years after starting ADVAIR Diskus and less than a month after starting BREO ELLIPTA, the patient experienced runny nose, irritability, headache, cough, difficulty sleeping, dyspnea exacerbated and productive cough. The patient only took the BREO ELLIPTA for 16 days and also stopped taking ADVAIR. Please refer to case US2014GSK031987 for previous tolerance to ADVAIR.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Irritability, Oropharyngeal pain, Pain in extremity, Productive cough, Rhinorrhoea
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza in a 66-year-old female patient who received Influenza vaccine. Co-suspect products included ADVAIR Diskus inhalation powder for chronic obstructive pulmonary disease and BREO ELLIPTA inhalation powder (batch number R669743, expiry date unknown) and (batch number R669743, expiry date November 2015) for chronic obstructive pulmonary disease. The patient's past medical history included smoker and pneumonia (hospitalization for 12 days). Concurrent medical conditions included chronic obstructive pulmonary disease, esophageal hernia, dyspnea, spinal fracture and cataract. Concomitant products included carvedilol, enalapril, FOSAMAX, omeprazole and Vitamin D. On 8th September 2014, the patient received Influenza vaccine. In 2006, the patient started ADVAIR Diskus (inhaled) 1 puff(s) twice daily (2 puff(s) daily). In October 2014, the patient started BREO ELLIPTA (inhaled) 1 puff(s) once daily (1 puff(s) daily). On an unknown date, the dose was changed to an unknown dose and frequency. On 10th September 2014, 2 days after receiving Influenza vaccine , 8 years after starting ADVAIR Diskus and not applicable after starting BREO ELLIPTA, the patient experienced influenza, sore throat and pain in arm. In October 2014, the patient experienced runny nose, irritability, headache, cough, difficulty sleeping, dyspnea exacerbated and productive cough. In October 2014, the outcome of the runny nose, irritability, headache, cough, difficulty sleeping, dyspnea exacerbated and productive cough were recovered/resolved. On an unknown date, the outcome of the influenza, sore throat and pain in arm were unknown. It was unknown if the reporter considered the influenza, sore throat and pain in arm to be related to influenza vaccine, ADVAIR Diskus and BREO ELLIPTA. The reporter considered the runny nose, irritability, headache, cough, difficulty sleeping, dyspnea exacerbated and productive cough to be almost certainly related to influenza vaccine, ADVAIR Diskus and BREO ELLIPTA. Additional information: When she was taking ADVAIR, she hospitalized for 12 days in 2012 for pneumonia. In October 2014, at an unspecified time after receiving Influenza vaccine, 8 years after starting ADVAIR Diskus and less than a month after starting BREO ELLIPTA, the patient experienced runny nose, irritability, headache, cough, difficulty sleeping, dyspnea exacerbated and productive cough. The patient only took the BREO ELLIPTA for 16 days and also stopped taking ADVAIR. Please refer to case US2014GSK031987 for previous tolerance to ADVAIR.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 26-year-old female patient who received FLUARIX. Previously administered products included gentamicin (Patient has had a previous minor reaction to a gentamicin containing medication). Concurrent medical conditions included food allergy (Patient has multiple food allergies). In September 2014, the patient received FLUARIX (injection). On an unknown date, an unknown time after receiving FLUARIX, the patient experienced injection site erythema, injection site swelling, injection site pain, feels poorly nausea. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain feels poorly and nausea were recovered/resolved. The reporter considered the injection site erythema, injection site swelling, injection site pain, feels poorly and nausea to be probably related to FLUARIX. Additional information received: Clinic manager reports that a patient received FLUARIX 0.5 mL in September. She immediately experienced a moderate local reaction that consisted of pain, redness, and swelling. She also developed a systemic reaction of nausea and feeling poorly. These symptoms resolved 8 days after receiving the vaccine.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Local reaction, Nausea
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 26-year-old female patient who received FLUARIX. Previously administered products included gentamicin (Patient has had a previous minor reaction to a gentamicin containing medication). Concurrent medical conditions included food allergy (Patient has multiple food allergies). In September 2014, the patient received FLUARIX (injection). On an unknown date, an unknown time after receiving FLUARIX, the patient experienced injection site erythema, injection site swelling, injection site pain, feels poorly nausea. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain feels poorly and nausea were recovered/resolved. The reporter considered the injection site erythema, injection site swelling, injection site pain, feels poorly and nausea to be probably related to FLUARIX. Additional information received: Clinic manager reports that a patient received FLUARIX 0.5 mL in September. She immediately experienced a moderate local reaction that consisted of pain, redness, and swelling. She also developed a systemic reaction of nausea and feeling poorly. These symptoms resolved 8 days after receiving the vaccine.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. On an unknown date an unspecified number of patients were vaccinated with ROTATEQ (route of administration, dose and anatomical location was unknown) that underwent another temperature excursion. Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Local reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of local reaction in a adult female patient who received Flu vaccine. In 2013, the patient received Flu vaccine. In 2013, unknown after receiving Flu vaccine, the patient experienced local reaction, drug administered at inappropriate site and possible inappropriate route of vaccination. On an unknown date, the outcome of the local reaction was recovered/resolved and the outcome of the drug administered at inappropriate site and inappropriate route of vaccination were unknown. It was unknown if the reporter considered the local reaction to be related to Flu vaccine. Additional information: Reporter states that in 2013 she received a flu vaccine in her arm. She expressed concern that it was given inappropriately because it was lower on the arm than it should have been, and she thinks it might have been administered subcutaneously. She experienced a local site reaction, which she photographed and sent to her physician.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test normal, Pain in extremity, Paraesthesia, X-ray normal
Clinical narrative: (L) arm pain x 2 months. C/o numbness tingling in the (L) arm as well. X-ray, USU negative on NSAIDs, PT.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Rash erythematous
Clinical narrative: Complains of redness, swelling right arm deltoid.  Tender to touch, small red bumps; itchy area outside of injection and over deltoid area.  Hard area at site of injection.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Complains of redness, swelling right arm deltoid.  Tender to touch, small red bumps; itchy area outside of injection and over deltoid area.  Hard area at site of injection.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Injection site induration, Injection site swelling, Lethargy, Lymphadenopathy
Clinical narrative: Tennis ball circumference hardened swelling around injection site (upper left arm), significantly swollen left armpit lymph node.  Feeling as if blood is cut off to the left arm.  Significant neck pain and headache.  General lethargy. Reporting this issue 4 days after injection, still a significant issue, symptoms remain.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Neck pain
Clinical narrative: Tennis ball circumference hardened swelling around injection site (upper left arm), significantly swollen left armpit lymph node.  Feeling as if blood is cut off to the left arm.  Significant neck pain and headache.  General lethargy. Reporting this issue 4 days after injection, still a significant issue, symptoms remain.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: Stripe of blisters on the right side of lower back, very itchy. Second stripe of blisters on 12/03/2014 PM. Went to see a doctor who could not confirm shingles but advised that he does not recommend a test as in any outcome treatment would not be effective.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Complaint of redness, swelling on right deltoid at injection site started 10/16/2014.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Cough, Headache, Nausea
Clinical narrative: Shivering; coughing; headache; nausea; G.I. distress.
Age: 1.37
Sex: M
Vaccine: PNC
Symptoms: Injection site nodule
Clinical narrative: Localized knot developed at injection site--palpable, non tender or hot to touch.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Laboratory test normal, Pain in extremity, Paraesthesia, X-ray normal
Clinical narrative: (R) arm pain, tingling, weakness x 10 weeks on NSAIDS. Pt and scheduled be seen by ortho. EMG pending.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Nausea
Clinical narrative: Patient states she started feeling nauseated on the night of 12/01/2014 after getting her first dose of Imovax earlier that day.  States she also had bad cramping in her abdomen on and off throughout the day and nausea that continued on until Sunday 12/07/2014. Patient in clinic on 12/08/2014 to receive second dose of Imovax and stated no nausea or abdomen pain since afternoon of 12/07/2014. States she is feeling much better today, 12/08/2014.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Swelling face
Clinical narrative: Shortness of breath and facial swelling occurred shortly after Zostavax administration. Patient returned to clinic and received 2 doses of epinephrine 0.3 mg IM. Symptoms were improving, but patient was sent to an outside hospital ED via EMS. Patient was treated with prednisone at the outside ED and symptoms resolved.
Age: 1.0
Sex: M
Vaccine: FLUX, MMR
Symptoms: Rash, Rash vesicular
Clinical narrative: Vesiculer rash at various stages of healing on trunk, extremities. No treatments attempted. Brought to urgent care for evaluation.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Urticaria
Clinical narrative: Per ER Physician blistering welts covering pts body.  Pt also started Gabapentin a new medication to her 12/5, the day after the vaccine.  I believe the reaction is more likely due to the Gabapentin but feel it prudent to report event, given the proximity to vaccine administration.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus generalised, Rash
Clinical narrative: Rash, iching on neck, chest, thighs, and behind ear for one week.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Chest X-ray normal, Chills, Confusional state, Feeling abnormal
Clinical narrative: Fever 103, chills, not making sense, HA, not feeling good. Blood work, CXR, Tylenol and ibuprofen, IVF.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pyrexia
Clinical narrative: Fever 103, chills, not making sense, HA, not feeling good. Blood work, CXR, Tylenol and ibuprofen, IVF.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Large red bump at site of shot (one inch in diameter) which burns and itches. A really bad headache and a slight fever. Four days later I still have the itchy large rash.  I've been taking Advil and allergy pills which help a little. Also applying ice gives some relief.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: Large red bump at site of shot (one inch in diameter) which burns and itches. A really bad headache and a slight fever. Four days later I still have the itchy large rash.  I've been taking Advil and allergy pills which help a little. Also applying ice gives some relief.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Place where vaccine was injected turned red, a little swollen and itchy. It disappeared in about a week and a half.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cough, Infantile spitting up, Lethargy, Oral administration complication, Pulse abnormal
Clinical narrative: 0925 The pt was here for vaccination. 0930 Pt alert, active & responsive, then nurse started giving Rotavirus (R.V.) orally. Nurse gave R.V. about 2 drops at a time. 0935 After giving 3/4 dose of R.V., the pt started coughing & spitted out small amount of clear liquid. Pt's mother held upright & patted the pt's back. Pt spitted out small amount of clear liquid. Pt looked lethargic, no response to stimulatiion, weak pulse & slow respiration, lips pinkish & skin warm to touch. 0940am informed clinician. Clinician came & assessed the pt's condition. Nurse continued to stimulate pt. 0942 Pt opened both eyes, awake, active & response to mother. Clinician continued to assess pt. Clinician advised no need to give the remaining of R.V. vaccine & just to give the other vaccines today & carred. 0955 PCV13, Pediarix & HIB IM given & pt tolerated well. Instructed pt's mother to stay in the clinic for 15 minutes to monitor for adverse reaction. 1010 nurse assessed pt without any adverse reaction noted. Pt was bottle feeding. 1018 pt's mother & pt left the clinic without notifed nurse.