chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Insomnia, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: "h1n1/seasonal flu vaccine"   I have pain in my left shoulder at the sight of the vaccine injection. It radiates down my arm - my ring finger and little finger on my left hand are somewhat numb. My left shoulder's range of motion is severely limited. A stabbing pain occurs when this limited range of motion is exceeded. It feels like the needle broke off the syringe and is in my arm... though I know this is not the case.  There has been no fever, redness or discoloration at the site of the injection.  Bathing, dressing and daily activity is very limited with my left arm. Sleeping with this injury is very difficult because my arm aches in almost any position when in bed. Heavy lifting and any other type of physical activity or exercise is greatly impaired.  The pain in the muscle at the site of the injection has increased over time.  I've been taking Advil on a daily basis but it does practically nothing for my discomfort.  To date, no sign of recuperation. Clinic - procedure and diagnosis codes:  Influenza Vaccination-V04.81 Vaccine Injection-90471 Flu Vaccine-With Preservative 90658
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Gradually worsening arm pain and decreased range of motion for 1-2 months, then gradual improvement to baseline.
Age: 80.0
Sex: F
Vaccine: MMR
Symptoms: Malaise, Measles antibody positive, Pyrexia, Rash
Clinical narrative: Rash, malaise, low grade fever
Age: 44.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: 2/12 pain and erythema at and around injection site which spread on 2/13. Associated with mild headache 2/13. 2/14 am erythema measured 94mm x 100mm, area indurated. 2/14 pm intense itching, burning at and around injection site and erythema. 2/15 erythema spread beyond markings of 2/14, area now hot to touch.
Age: 44.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth
Clinical narrative: 2/12 pain and erythema at and around injection site which spread on 2/13. Associated with mild headache 2/13. 2/14 am erythema measured 94mm x 100mm, area indurated. 2/14 pm intense itching, burning at and around injection site and erythema. 2/15 erythema spread beyond markings of 2/14, area now hot to touch.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood electrolytes normal, Blood glucose normal, Carbon dioxide normal, Full blood count normal, Unevaluable event
Clinical narrative: Had possible seizure while in the car.  Taken by EMS to Hospital - normal eval there.  Will be undergoing EEG and MRI in the future.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Had a Pneumococcal vax left arm   Now has 4x7inch ( her measurement) induration w/ redness, swelling and pain at injection site Able to move and function w/ left arm and shoulder  No fever,
Age: 54.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Anxiety, Blood pressure increased, Headache, Malaise, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Blood pressure shot way up 180/110; big pressure and headache, anxiety due to illness; have headaches virtually every day since the vaccination.
Age: 54.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Sensation of pressure
Clinical narrative: Blood pressure shot way up 180/110; big pressure and headache, anxiety due to illness; have headaches virtually every day since the vaccination.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Death
Clinical narrative: apparently found dead in bed by parent
Age: 1.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Blood magnesium, Blood phosphorus, Dyskinesia, Metabolic function test, Pyrexia
Clinical narrative: Jerky upper body movements lasting only 3 seconds with temperature of 38.2 C. These jerky movements have decreased in length (now last only a second) but still having multiple episodes per day since onset. Not coinciding with fever (has not had a fever since above stated fever). No staring episodes. No loss of consciousness. Patient seen in office on 2/15/2011 for this issue. Not witnessed by physician. Neurologically stable and appropriate for age.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Lip swelling, Pallor, Pyrexia, Rash
Clinical narrative: 2/11 5pm rash on forehead, swollen lips, pale  2/13 6:00am same as above plus rash on buttocks 2/14 8:00pm same as above plus fever of 101 and rash covering body except palms and soles of feet
Age: 1.37
Sex: F
Vaccine: DTAPIPVHIB, FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Area around site became swollen, red, warm to touch, patient developed a fever. Redness around site 1.5" X 3". Side effects lasted about 48 hours. Patient did have some swelling after the first time she received this injection but not to this degree.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain in extremity
Clinical narrative: arm that she received vaccine is still sore as of this date 2/15/11
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Abdominal pain upper, Culture negative, Headache, Streptococcus test
Clinical narrative: Headache & stomach ache starting within hours of immunizations.  Not sure exact start time
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient is complaining of pain in the injection site.  Has not seen a physician; has been applying a heat pack to the site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Eye swelling, Pyrexia, Swelling face, Urticaria
Clinical narrative: Hives, Difficulty breathing, Eyes and Face swelling, Fever
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Infection, Pruritus
Clinical narrative: Started with an itch that was scratched, skin remained intact, by the evening of 1/13/11 an oblong area about 1.5 - 2 inches long and 1 inch wide developed with redness and a hard center.Patient went to MD on Mon and was diagnosed as infection with a possible allergic component as antihistamine and antibiotic were prescribed. The area has lessened in redness and hardness but the size has slightly enlarged.
Age: 1.06
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Ear infection, Febrile convulsion, Pyrexia
Clinical narrative: Fever, febrile seizure. Acute otitis infection noted at time of seizure.
Age: 49.0
Sex: F
Vaccine: HEP, RUB
Symptoms: Arthralgia, Dermatitis, Headache, Myalgia, Oedema peripheral
Clinical narrative: Rubella immunization 4/7/10. 8 days later -> onset of severe HA, L eye vision changes, then palate lesions that took 8 weeks to resolved. Then had severe joint pain and painful rash. Biopsy showed only inflammation in skin, an autoimmune or malignant origin. LE swelling & myalgia, & arthralgia - persist and are severe. Little response to medication.
Age: 49.0
Sex: F
Vaccine: HEP, RUB
Symptoms: Pain, Palatal disorder, Rash, Visual impairment
Clinical narrative: Rubella immunization 4/7/10. 8 days later -> onset of severe HA, L eye vision changes, then palate lesions that took 8 weeks to resolved. Then had severe joint pain and painful rash. Biopsy showed only inflammation in skin, an autoimmune or malignant origin. LE swelling & myalgia, & arthralgia - persist and are severe. Little response to medication.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Pallor, Syncope, Urinary incontinence
Clinical narrative: Patient sitting in chair fainted and eased to floor. Appeared pale and had urinated, given juice and cookie after 15 min left with mother.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Fainted approximately 5 minutes after vaccination. Inhaled smelling salts, awoke & coherent at all times. Sat patient in chair, rested about 10 minutes. Drank juice, ate cookie. Stated he felt ok. Ambulated on own with staff observation. Left with grandparents.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) arm redness & swelling after recent DTAP. Advised cool compresses, BENADRYL prn itching & ibuprofen prn pain.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Erythema, Neck pain, Oedema peripheral, Skin warm
Clinical narrative: (L) arm tender, red, warm to touch & swollen with progression of symptoms past 3 days. Pain radiating to back & up the neck.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: (L) arm tender, red, warm to touch & swollen with progression of symptoms past 3 days. Pain radiating to back & up the neck.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, IPV, MMR, VARCEL
Symptoms: Eyelid oedema, Sneezing
Clinical narrative: Puffy, swelling - eyelids, sneezing no wheezing no local reaction at site of injections.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness in (R) arm. Area size 4 1/2 x 5 1/2 cm. where varicella injection was given. No distress noted. Reaction occurred same day. Pt returned to our office on 3rd day after shot BENADRYL TID x 1 wk was advised as well as cold compress TID.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swelling in left arm.
Age: 1.32
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Skin lesion
Clinical narrative: On 2/1/11 received DTAP #4 left thigh IM, HIB #4 L (L) thigh IM, varicella #1, (R) thigh SQ as documented by medical assistant. Seen in office 2/10/11 with right thigh with 2 x 2 cm red lesion that was warm to touch with mild tenderness. Mom states DTAP given (R) thigh and concerned this lesion is a DTAP reaction.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth, Oedema peripheral, Tenderness
Clinical narrative: Received vaccine in (L) arm - (L) arm became swollen "2 times" the size of Rt arm. Injection site was warm and red. Employee applied heat & cold to arm. Elevated arm and took MOTRIN. 3 days after vaccine employee states there is axillary & thoracic tenderness on (L) side.
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of severe diarrhea in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date, the subject received unspecified dose of FLULAVAL (details unknown). On unspecified date, two weeks after vaccination with FLULAVAL, the subject experienced severe diarrhea and vomiting. At the time of reporting the outcome of the events was unspecified. No other information was provided.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Electrocardiogram normal, Eye pain, Flushing, Gastrooesophageal reflux disease
Clinical narrative: This case was reported by a consumer and described the occurrence of facial flushing in a 78-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included Baby aspirin, Vitamins, Calcium, Fish oil, STRESS TAB and Biotin. There were no other medical conditions. On 13 October 2010 at 08:30 the subject received unspecified dose of FLULAVAL (unknown, left arm). The subject also reported that after a previous influenza vaccine (unknown manufacturer) on an unspecified date, she experienced local injection site pain and redness. On 13 October 2010, almost immediately after vaccination with FLULAVAL the subject experienced flushing of her face. On 14 October 2010, one day after vaccination with FLULAVAL, she experienced lightheadedness. On an unspecified date, several days after the FLULAVAL vaccination, she experienced reflux and pain in eyes. The subject visited her internist and he performed a cardiogram, which showed no change. She also visited her gastroenterologist, who scheduled her for a colonoscopy and her cardiologist, who scheduled a stress test. The results of the colonoscopy and stress test were unspecified. The subject felt that all of these symptoms occurred as a result of the flu vaccination. The events resolved on 31 October 2010. No other information was available at the time of reporting.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included seasonal allergies, hypercholesterolemia (chronic), hypertension (chronic), hypothyroidism (chronic), insomnia (occasional), sinusitis (occasional) and vitamin b complex deficiency. Concurrent medications included SYNTHROID, AVAPRO, PREMARIN, SINGULAR, ALLEGRA, NASONEX, ASTELIN spray, IMITREX, TRANXENE, PARAFON FORTE, AMBIEN, Aspirin, B12, and Thyroid supplement. On an unspecified date in 2010 the subject received a dose of FLULAVAL (.5 ml, unknown). On an unspecified date in 2010 the subject received a dose of FLULAVAL (.5 ml, unknown). Less than one month after vaccination with FLULAVAL, the subject experienced overall joint pain. The subject sought medical attention on 28 October 2010 approximately one and a half weeks following vaccination. At the time of reporting the outcome of the joint pain was unspecified. Follow-up information was received via the reporter (office manager) on 23 November 2010. It was reported that the female subject was 59 years old at the time of the event. FLULAVAL was given on 08 October 2010, at the subject's, husband's place of work. The events of joint pain and fatigue began on approximately 15 October 2010. Achyness was also reported. Joint pain resolution occurred on 10 October 2010. The events were not considered to be serious. It was reported that the subject was not ill prior to receiving flu vaccine. There was nothing in the subject's history that would appear to suggest any correlation with signs and symptoms of joint pain and sudden onset of achyness. No history of alcohol or tobacco use. It was noted that all previously mentioned concurrent medications were taken by the subject for over 2 years. It was reported that it was rare for the subject to take IMITREX.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Lymph node pain, Lymphadenopathy, Similar reaction on previous exposure to drug
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lymph node enlargement in a 53-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 29 October 2010, after 13:00, the subject received 1st dose of FLULAVAL at 0.5 ml in the left arm. On 30 October 2010, 1 day (24 hours) after vaccination with FLULAVAL, the subject experienced lymph node enlargement. One day later on 31 October 2010, the "nodule" continued to enlarge and the subject experienced lymph node tenderness. The subject went to his physician, but was not prescribed anything. The outcome of the events was indicated to be better at the time of reporting on 04 November 2010. The reporter stated they were not completely resolved yet, but better. Follow-up details received the same day of the initial report, 04 November 2010, indicated that the subject experienced a similar reaction to the H1N1 vaccine in January 2010. No additional details regarding this event were reported. Follow-up information was received from the reporting healthcare professional on 03 January 2011: It was reported that this case had been reported to the Centers for Disease Control (CDC). The onset of the lymph node enlargement and lymph node tenderness was on 30 October 2010. As of 04 November 2010, the subject had a 1 centimeter palpable nodule above the left collarbone and the events were considered as improved. The subject was advised to call if symptoms worsened and no call had been received as of the time of reporting (22 December 2010). The healthcare professional also mentioned that the subject had a similar incident with a previous Flu vaccine - H1N1 vaccine (details unknown, Pandemic vaccine H1N1, unspecified manufacturer) in January 2010.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of pain in arm on lifting in a 65-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 October 2010 the subject received unspecified dose of FLULAVAL (.5 ml, unknown). On 21 October 2010, 48 hours after vaccination with FLULAVAL, the subject experienced pain in arm on lifting and shoulder pain. The pharmacist reported that the subject received FLULAVAL vaccination on 19 October 2010 and approximately 48 hours later the subject was experiencing pain when lifting the arm and shoulder pain also described as radiating pain into her shoulder. At the time of reporting the pain in arm on lifting and shoulder pain were unresolved.
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Muscle spasms
Clinical narrative: This case was reported by a healthcare professional via Novartis and described the occurrence of diarrhea in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced diarrhea and cramp. The healthcare professional reported the subject received FLULAVAL, no FLUVIRIN and experienced "severe diarrhea and cramping similar to when she has had gluten". At the time of reporting the outcome of the diarrhea and cramp were unspecified. Follow-up information received via the reporter on 07 January 2011 indicated that she did not remember reporting an adverse event and no additional information is expected.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia facial
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of facial area in a 30-year-old male patient who was vaccinated with FLULAVAL (GlaxoSmithKline). On 16 November 2010 at 10:20 the subject received unspecified dose of FLULAVAL (.5 cc, unknown, left arm). On 16 November 2010, 2 minutes after vaccination with FLULAVAL, the subject experienced numbness in facial area. The subject felt a numbness in the left facial area two minutes after receiving FLULAVAL. At the time of reporting the numbness in facial area was unresolved.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Feeling abnormal, Oropharyngeal pain, Paraesthesia, Paraesthesia oral
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of hand tingling in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced tingling in the palm of the left hand, tingling of the arches of both feet, left side facial tingling, left side mouth (oral) tingling, sore throat and run down feeling. At the time of reporting the outcome of the events was unspecified. Follow-up information received on 04 January 2011 indicated that the subject was 45 years old. It was reported that events of oral tingling, sore throat and run down feeling were not experienced, but events of strange sensation in palm of left hand, strange feeling in sole of left foot and weird overall feeling were experienced. Onset of all symptoms was indicated to be 03 November 2010, which was the day of FLULAVAL vaccination. Events resolved by 05 November 2010. The reporter noted that when she received seasonal flu vaccine and H1N1 vaccine separated by several weeks in 2009, she experienced no problems. Follow-up information was received on 25 January 2011 via physician who reported the subject received intramuscular injection of FLULAVAL 0.5ml in the left deltoid. The physician reported that the subject "has never notified our office of any adverse events associated with her immunization". At the time of the report, no other information was provided.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Sensory disturbance
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of hand tingling in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced tingling in the palm of the left hand, tingling of the arches of both feet, left side facial tingling, left side mouth (oral) tingling, sore throat and run down feeling. At the time of reporting the outcome of the events was unspecified. Follow-up information received on 04 January 2011 indicated that the subject was 45 years old. It was reported that events of oral tingling, sore throat and run down feeling were not experienced, but events of strange sensation in palm of left hand, strange feeling in sole of left foot and weird overall feeling were experienced. Onset of all symptoms was indicated to be 03 November 2010, which was the day of FLULAVAL vaccination. Events resolved by 05 November 2010. The reporter noted that when she received seasonal flu vaccine and H1N1 vaccine separated by several weeks in 2009, she experienced no problems. Follow-up information was received on 25 January 2011 via physician who reported the subject received intramuscular injection of FLULAVAL 0.5ml in the left deltoid. The physician reported that the subject "has never notified our office of any adverse events associated with her immunization". At the time of the report, no other information was provided.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Band sensation, Condition aggravated, Dizziness, Dry skin, Dysgeusia
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of hand tingling in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced tingling in the palm of the left hand, tingling of the arches of both feet, left side facial tingling, left side mouth (oral) tingling, sore throat and run down feeling. At the time of reporting the outcome of the events was unspecified. Follow-up information received on 04 January 2011 indicated that the subject was 45 years old. It was reported that events of oral tingling, sore throat and run down feeling were not experienced, but events of strange sensation in palm of left hand, strange feeling in sole of left foot and weird overall feeling were experienced. Onset of all symptoms was indicated to be 03 November 2010, which was the day of FLULAVAL vaccination. Events resolved by 05 November 2010. The reporter noted that when she received seasonal flu vaccine and H1N1 vaccine separated by several weeks in 2009, she experienced no problems. Follow-up information was received on 25 January 2011 via physician who reported the subject received intramuscular injection of FLULAVAL 0.5ml in the left deltoid. The physician reported that the subject "has never notified our office of any adverse events associated with her immunization". At the time of the report, no other information was provided.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysstasia, Ear pain, External ear pain, Fatigue, Feeling abnormal
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of hand tingling in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced tingling in the palm of the left hand, tingling of the arches of both feet, left side facial tingling, left side mouth (oral) tingling, sore throat and run down feeling. At the time of reporting the outcome of the events was unspecified. Follow-up information received on 04 January 2011 indicated that the subject was 45 years old. It was reported that events of oral tingling, sore throat and run down feeling were not experienced, but events of strange sensation in palm of left hand, strange feeling in sole of left foot and weird overall feeling were experienced. Onset of all symptoms was indicated to be 03 November 2010, which was the day of FLULAVAL vaccination. Events resolved by 05 November 2010. The reporter noted that when she received seasonal flu vaccine and H1N1 vaccine separated by several weeks in 2009, she experienced no problems. Follow-up information was received on 25 January 2011 via physician who reported the subject received intramuscular injection of FLULAVAL 0.5ml in the left deltoid. The physician reported that the subject "has never notified our office of any adverse events associated with her immunization". At the time of the report, no other information was provided.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Formication, Gait disturbance, Gastrointestinal sounds abnormal, Hypersensitivity, Hypoaesthesia
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of hand tingling in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced tingling in the palm of the left hand, tingling of the arches of both feet, left side facial tingling, left side mouth (oral) tingling, sore throat and run down feeling. At the time of reporting the outcome of the events was unspecified. Follow-up information received on 04 January 2011 indicated that the subject was 45 years old. It was reported that events of oral tingling, sore throat and run down feeling were not experienced, but events of strange sensation in palm of left hand, strange feeling in sole of left foot and weird overall feeling were experienced. Onset of all symptoms was indicated to be 03 November 2010, which was the day of FLULAVAL vaccination. Events resolved by 05 November 2010. The reporter noted that when she received seasonal flu vaccine and H1N1 vaccine separated by several weeks in 2009, she experienced no problems. Follow-up information was received on 25 January 2011 via physician who reported the subject received intramuscular injection of FLULAVAL 0.5ml in the left deltoid. The physician reported that the subject "has never notified our office of any adverse events associated with her immunization". At the time of the report, no other information was provided.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia oral, Joint stiffness, Malaise, Migraine, Mobility decreased
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of hand tingling in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced tingling in the palm of the left hand, tingling of the arches of both feet, left side facial tingling, left side mouth (oral) tingling, sore throat and run down feeling. At the time of reporting the outcome of the events was unspecified. Follow-up information received on 04 January 2011 indicated that the subject was 45 years old. It was reported that events of oral tingling, sore throat and run down feeling were not experienced, but events of strange sensation in palm of left hand, strange feeling in sole of left foot and weird overall feeling were experienced. Onset of all symptoms was indicated to be 03 November 2010, which was the day of FLULAVAL vaccination. Events resolved by 05 November 2010. The reporter noted that when she received seasonal flu vaccine and H1N1 vaccine separated by several weeks in 2009, she experienced no problems. Follow-up information was received on 25 January 2011 via physician who reported the subject received intramuscular injection of FLULAVAL 0.5ml in the left deltoid. The physician reported that the subject "has never notified our office of any adverse events associated with her immunization". At the time of the report, no other information was provided.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Musculoskeletal stiffness, Nausea, Paraesthesia, Paraesthesia oral
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of hand tingling in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced tingling in the palm of the left hand, tingling of the arches of both feet, left side facial tingling, left side mouth (oral) tingling, sore throat and run down feeling. At the time of reporting the outcome of the events was unspecified. Follow-up information received on 04 January 2011 indicated that the subject was 45 years old. It was reported that events of oral tingling, sore throat and run down feeling were not experienced, but events of strange sensation in palm of left hand, strange feeling in sole of left foot and weird overall feeling were experienced. Onset of all symptoms was indicated to be 03 November 2010, which was the day of FLULAVAL vaccination. Events resolved by 05 November 2010. The reporter noted that when she received seasonal flu vaccine and H1N1 vaccine separated by several weeks in 2009, she experienced no problems. Follow-up information was received on 25 January 2011 via physician who reported the subject received intramuscular injection of FLULAVAL 0.5ml in the left deltoid. The physician reported that the subject "has never notified our office of any adverse events associated with her immunization". At the time of the report, no other information was provided.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash, Sensory disturbance
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of hand tingling in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced tingling in the palm of the left hand, tingling of the arches of both feet, left side facial tingling, left side mouth (oral) tingling, sore throat and run down feeling. At the time of reporting the outcome of the events was unspecified. Follow-up information received on 04 January 2011 indicated that the subject was 45 years old. It was reported that events of oral tingling, sore throat and run down feeling were not experienced, but events of strange sensation in palm of left hand, strange feeling in sole of left foot and weird overall feeling were experienced. Onset of all symptoms was indicated to be 03 November 2010, which was the day of FLULAVAL vaccination. Events resolved by 05 November 2010. The reporter noted that when she received seasonal flu vaccine and H1N1 vaccine separated by several weeks in 2009, she experienced no problems. Follow-up information was received on 25 January 2011 via physician who reported the subject received intramuscular injection of FLULAVAL 0.5ml in the left deltoid. The physician reported that the subject "has never notified our office of any adverse events associated with her immunization". At the time of the report, no other information was provided.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Faeces discoloured, Joint swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of white stools in a 70-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included cancer. Concurrent medications included Pravastatin, TOPROL, Multiple vitamins, NIACIN, Baby aspirin, Fenofibrate, Captopril + hydrochlorothiazide, Fish oil, NORVASC and Coenzyme Q10. On 11 November 2010 at approximately 12:00 the subject received a dose of FLULAVAL in the left arm. On 12 November 2010 (at approximately 03:00), 15 hours after vaccination with FLULAVAL, the subject experienced nearly white stools. She reported that her stools were lighter in color. At this same time, she experienced a swollen right wrist and wrist pain. The nearly white stools resolved within the same day, 12 November 2010. Stools lighter in color, swollen right wrist and right wrist pain resolved by 19 November 2010. The consumer noted that she thought that the wrist condition was arthritis, but then it went away after a week.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site pain, Nodule, Swelling face, Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in a 52-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included high cholesterol and sleep apnea. Concurrent medications included LOTREL, Meclizine, Simvastatin and LEXAPRO. On 28 October 2010 the subject received a dose of FLULAVAL in the left arm. On 28 October 2010, less than one day after vaccination with FLULAVAL, the subject experienced injection site pain and injection site discoloration. On 03 November 2010, the subject developed hives all over her body which were unresolved at the time of reporting. Pain and discoloration resolved on 30 November 2010. Follow-up information was received on 16 December 2010 via consumer. The subject reported "my hives got so bad-welts on my scalp down my neck, all the way down my back and legs to knots in the bottom of my feet. My face also started swelling". The subject stated she sought medical attention on 29 November 2010, was given prescriptions and hives were observed.
Age: 30.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Incorrect dose administered, Myalgia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of extra dose administered in a 30-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline), Influenza vaccine. Previous and/or concurrent vaccination included ENGERIX B; GlaxoSmithKline; injection; unknown given on 15 November 2010; FLULAVAL; GlaxoSmithKline; unknown; unknown given in October 2010. There were no concurrent medications. On an unspecified date the subject previously received a dose of Influenza vaccine (unknown). At an unspecified time after vaccination with Influenza vaccine, the subject experienced a sore muscle. At the time of reporting the outcome of the muscle soreness was unspecified. On 15 November 2010 the subject received 2nd dose of FLULAVAL (.5 ml, injection, right arm) and experienced extra dose administered. The subject inadvertently received a second dose of FLULAVAL one month after receiving the first dose. The FLULAVAL lot number was reported as "AF1A521AA" and ENGERIX B lot number was reported as "AHBB942CB".
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Joint stiffness, Lacrimation increased, Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of stiffness in a 34-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included Blood pressure medication. On 2 November 2010 at 11:00 the subject received a dose of FLULAVAL (unknown route, right arm). On 2 November 2010, 8 hours after vaccination with FLULAVAL, the subject experienced stiffness and pain in right shoulder joint. On 5 November 2010 the subject experienced right shoulder pain and painful to move right arm. The subject called the healthcare professional's office on 5 November 2010 to report that she had pain upon rotation in right shoulder and arm. On 16 November 2010, she came to the healthcare professional's office for another reason and indicated that she still had pain upon movement. The healthcare professional reported that the pain brought tears to the eyes of the subject. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Cyanosis, Fatigue, Increased upper airway secretion, Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of runny nose in a 66-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included high blood pressure. Concurrent medications included BENICAR. On 12 October 2010 at 14:25 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. On 12 October 2010 (at night), less than one day after vaccination with FLULAVAL, the subject experienced runny nose, feeling very tired and low grade fever. The following day on 13 October 2010, the subject developed a sore throat on the left side. Other events reported included injection site tenderness, redness of eyes, lip discoloration (blue in color), voice loss, productive cough, chest congestion due to phlegm (green, yellow in color), nasal congestion and fatigue. Low grade fever resolved by 14 October 2010. Other events with resolution on unspecified dates were sore throat, red eyes and lip discoloration. Events indicated to be improved included runny nose, feeling tired, injection site tenderness, loss of voice, productive cough and chest congestion due to phlegm and nasal congestion. Outcome of fatigue was not specifically stated. The consumer reported that she was "sick" for three weeks and at the time of reporting was just starting week four and feeling better, but not completely resolved. Attribution of the symptoms to treatment with FLULAVAL was not provided.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Nasal congestion, Ocular hyperaemia, Oropharyngeal pain, Productive cough
Clinical narrative: This case was reported by a consumer and described the occurrence of runny nose in a 66-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included high blood pressure. Concurrent medications included BENICAR. On 12 October 2010 at 14:25 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. On 12 October 2010 (at night), less than one day after vaccination with FLULAVAL, the subject experienced runny nose, feeling very tired and low grade fever. The following day on 13 October 2010, the subject developed a sore throat on the left side. Other events reported included injection site tenderness, redness of eyes, lip discoloration (blue in color), voice loss, productive cough, chest congestion due to phlegm (green, yellow in color), nasal congestion and fatigue. Low grade fever resolved by 14 October 2010. Other events with resolution on unspecified dates were sore throat, red eyes and lip discoloration. Events indicated to be improved included runny nose, feeling tired, injection site tenderness, loss of voice, productive cough and chest congestion due to phlegm and nasal congestion. Outcome of fatigue was not specifically stated. The consumer reported that she was "sick" for three weeks and at the time of reporting was just starting week four and feeling better, but not completely resolved. Attribution of the symptoms to treatment with FLULAVAL was not provided.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: This case was reported by a consumer and described the occurrence of runny nose in a 66-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included high blood pressure. Concurrent medications included BENICAR. On 12 October 2010 at 14:25 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. On 12 October 2010 (at night), less than one day after vaccination with FLULAVAL, the subject experienced runny nose, feeling very tired and low grade fever. The following day on 13 October 2010, the subject developed a sore throat on the left side. Other events reported included injection site tenderness, redness of eyes, lip discoloration (blue in color), voice loss, productive cough, chest congestion due to phlegm (green, yellow in color), nasal congestion and fatigue. Low grade fever resolved by 14 October 2010. Other events with resolution on unspecified dates were sore throat, red eyes and lip discoloration. Events indicated to be improved included runny nose, feeling tired, injection site tenderness, loss of voice, productive cough and chest congestion due to phlegm and nasal congestion. Outcome of fatigue was not specifically stated. The consumer reported that she was "sick" for three weeks and at the time of reporting was just starting week four and feeling better, but not completely resolved. Attribution of the symptoms to treatment with FLULAVAL was not provided.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Inappropriate schedule of drug administration, Oropharyngeal pain, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of cough in a 5-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included bronchitis. Concurrent medical conditions included allergies and asthma. On 11 November 2010 at 15:30 the subject received a dose of FLULAVAL (.5 cc, unknown, right arm) and experienced wrong vaccine administered. On 14 November 2010, 3 days after vaccination with FLULAVAL, the subject experienced cough and sore throat. The subject received FLULAVAL that is indicated for adults only. The subject had been doing fine until Sunday when he complained of a sore throat and a cough. The subject had not had any problems following the vaccine even though it was not indicated for children his age. The reporter stated that the subject went to the doctor and received antibiotics. The reported did mention to the doctor that the subject received FLULAVAL. At the time of reporting the cough and sore throat were unresolved. Follow-up information was received from the reporting pharmacist on 03 January 2011: The cough and sore throat resolved on 18 November 2010. The reporter considered the events could have been associated with a medical condition (asthma). The subject's allergies, asthma, and bronchitis were reported as historic medical conditions.
Age: 1.66
Sex: M
Vaccine: HEPA, HIBV, PPV, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning her 19 month old son with no pertinent medical history or drug allergies who on 30-APR-2009 was vaccinated with a dose of PEDVAXHIB(lot# not reported), a dose of varicella virus vaccine live (unspecified) (lot# not reported), a dose of pneumococcal conj vaccine (unspecified) (lot# not reported), and a dose of hepatitis A virus vaccine (unspecified) (lot# not reported). There was no concomitant medication. On 30-APR-2009 the patient broke out and was taken to the emergency room. The consumer stated that she had to give her son steroids for 3-5 days. At the time of this report, the patient had recovered. Additional information is not expected.
Age: 1.52
Sex: F
Vaccine: DTP, HIBV
Symptoms: Crying, Listless, Pyrexia, Tic
Clinical narrative: Information has been received from a psychologist concerning her 18 month old daughter with no pertinent medical history or drug reactions who on 16-OCT-2006 was vaccinated with Hib conj vaccine (OMPC)(manufacturer unknown, reported as "Hib" vaccine). Concomitant therapy included diphtheria toxoid (+) pertussis vaccine (unspecified) (reported as "DTP"). The reporter did not know the manufacturer or the brand name of the vaccines. After the patient received the vaccines, she started to look "vacant" and developed fever and became listless on 16-OCT-2006. The next day she had the fever of 104 and cried non stop along with motor tic. She went to an emergency room but later released. She continued to have the fever for 5 days. The fever was resolved and he started to talk again on the sixth day. All the symptoms had disappeared except some occasional tic. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a health professional who was informed by a physician's office concerning a 13 year old patient who on an unknown date was vaccinated with a dose of PEDVAXHIB instead of a dose of hepatitis A injection (unknown manufacturer). No adverse reactions were reported. This is one of several reports received from the same source. No further information is available.
Sex: U
Vaccine: HIBV
Symptoms: Crying
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with PEDVAXHIB (Lot # not provided). It was reported that the patient made a "high pitched sound" after PEDVAXHIB was given. At the time of this report, the patient's outcome was unspecified. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a health professional who was informed by a physician's office concerning a 5 year old patient who on an unknown date was vaccinated with a dose of PEDVAXHIB instead of a dose of hepatitis A injection (unknown manufacturer). No adverse reactions were reported. This is one of several reports received from the same source. This is an amended report. The number of patients included in this report was changed from three to one. No further information is available.
Age: 14.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a health professional who was informed by a physician's office concerning a 14 year old patient who on unknown dates was vaccinated with a dose of PEDVAXHIB instead of a dose of hepatitis A injection (unknown manufacturer). No adverse reactions were reported. This is one of several reports received from the same source. This is an amended report. The number of the patients included in this report was changed from two to one. No further information is available.
Age: 5.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a health professional who was informed by a physician's office concerning a 5 year old patient who on an unknown date was vaccinated with a dose of PEDVAXHIB instead of hepatitis A injection (unknown manufacturer). No adverse reactions were reported. This is one of several reports received from the same source. No further information is available.