chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: RAB
Symptoms: Hypoaesthesia oral
Clinical narrative: Initial report was received 09 June 2011 from a health care professional. A 55-year-old male patient had received an intramuscular deltoid first dose injection of IMOVAX Rabies, lot number D1111 on 26 May 2011, and 20 minutes later, he developed numbness on the left side of his mouth which lasted 24 hours. This same event occurred after the patient had received their second and third dose. The events did not require a doctor's visit. The patient had no concurrent illness, no past medical history and he had not been taking any concomitant medications. The patient had not experienced any adverse events following prior vaccinations. No laboratory or diagnostic testing had been performed. At the time of the report, the patient was scheduled to receive his fourth dose vaccination. Outcome was recovered. Follow-up information was received from the healthcare professional on 18 July 2011. The IMOVAX Rabies lot number was clarified as 942320 (expiration 04 December 2011). The patient was vaccinated at 11:30, and the event occurred at 13:00 (previously reported as 20 minutes post-vaccination). Per the reporter, the patient was immunized due to possible rabies exposure, after having contact with a horse that tested positive for rabies. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: FLUX, OPV, SMALL, TD, FLUX, OPV, SMALL, TD
Symptoms: Generalised erythema, Pyrexia, Sluggishness, Throat irritation
Clinical narrative: Started with scratchy throat on Monday, felt sluggish all day-by Tuesday morning I was running fever and body was reddish.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Allergy to vaccine, Cough, Headache, Pain, Throat tightness
Clinical narrative: Throat closing, coughing, vomiting, headaches and body aches.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vomiting
Clinical narrative: Throat closing, coughing, vomiting, headaches and body aches.
Age: 4.0
Sex: F
Vaccine: MNQ
Symptoms: Dyskinesia, Face injury, Fall, Syncope, Unresponsive to stimuli
Clinical narrative: Pt was running around for a few minutes and then all of a sudden fainted to the floor, fell on her face.  She was unresponsive for a minute and jerky movements of her feet were noted.
Age: 41.0
Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia, Myalgia
Clinical narrative: Initial case received from a consumer, who is also the patient, on 28 July 2011. A 41-year-old female patient, with a history of allergies to penicillin and sulfa, received injections of IMOVAX Rabies and IMOGAM Rabies-HT (lot numbers unknown) on 26 July 2011. The evening of vaccination, the patient developed muscle aches everywhere and numbness on the right side of her face. The day following vaccination, the facial numbness was "slightly improved" and muscle aches had decreased. She reported that she had seen a neurologist on 28 July 2011 due to her symptoms; outcome of the visit was not reported. At the time of the report, the events were still ongoing. Follow-up information received from a physician on 25 August 2011. The reporter only spoke with the patient on the phone and they had no other information to provide for the case. No other information for other contacts were provided. Follow-up information was received from a health care professional on 06 September 2011 reported that the reported did not administer the vaccine and there was no additional information to provide. Documents held by sender: None.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Arthropod bite, Decreased appetite, Heart rate increased, Muscle twitching
Clinical narrative: Initial report was received from a consumer on 27 September 2011. A female patient had received the first dose of an injection of IMOVAX, sanofi pasteur SA (lot number, site and route of administration unknown) on 20 September 2011 and three days later on 22 September 2011 experienced a rapid heart rate tat lasted for two hours. The patient had received the second dose of an injection of IMOVAX, sanofi pasteur SA (lot number, site and route of administration unknown) on 23 September 2011 and later that day experienced rapid heart rate. The patient took BENADRYL and the rapid heart rate lasted one and a half hours. The patient also experienced muscle twitching after the second dose. The patient had received the third dose of an injection of IMOVAX, sanofi pasteur SA (lot number, site and route of administration unknown) on 27 September 2011 and later that day experienced rapid heart rate that lasted one and a half hours. No other vaccinations were given within four weeks and the patient had no illness at the time of vaccination. It was unknown if the patient had any past medical history or took any concomitant medications. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a consumer on 05 March 2012. On 27 September 2011, the patient was seen in follow-up with concern that she may be having an allergic reaction to the vaccination. The physician stated that the symptoms were relatively mild and recommended continuing the vaccination. On 10 October 2011, the patient as seen again for heart palpitations, loss of appetite and legs tingling. She thought she had Lyme disease due to a tick bite " weeks ago". The physician noted a lot of anxiety and suggested talking to a counselor about the stress. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Palpitations, Paraesthesia, Stress
Clinical narrative: Initial report was received from a consumer on 27 September 2011. A female patient had received the first dose of an injection of IMOVAX, sanofi pasteur SA (lot number, site and route of administration unknown) on 20 September 2011 and three days later on 22 September 2011 experienced a rapid heart rate tat lasted for two hours. The patient had received the second dose of an injection of IMOVAX, sanofi pasteur SA (lot number, site and route of administration unknown) on 23 September 2011 and later that day experienced rapid heart rate. The patient took BENADRYL and the rapid heart rate lasted one and a half hours. The patient also experienced muscle twitching after the second dose. The patient had received the third dose of an injection of IMOVAX, sanofi pasteur SA (lot number, site and route of administration unknown) on 27 September 2011 and later that day experienced rapid heart rate that lasted one and a half hours. No other vaccinations were given within four weeks and the patient had no illness at the time of vaccination. It was unknown if the patient had any past medical history or took any concomitant medications. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a consumer on 05 March 2012. On 27 September 2011, the patient was seen in follow-up with concern that she may be having an allergic reaction to the vaccination. The physician stated that the symptoms were relatively mild and recommended continuing the vaccination. On 10 October 2011, the patient as seen again for heart palpitations, loss of appetite and legs tingling. She thought she had Lyme disease due to a tick bite " weeks ago". The physician noted a lot of anxiety and suggested talking to a counselor about the stress. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
Age: 45.0
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Fatigue, Hyperacusis, Photophobia
Clinical narrative: Initial case received from a health care professional on 19 July 2011. A 45-year-old male patient received dose 3 of IMOVAX Rabies, sanofi pasteur SA lot number not reported, on 08 July 2011. The patient had a history of allergy to artificial strawberries. He had been ill since February with multiple problems including prostatitis and tonsillitis. The patient has been in bed most of June but felt better when started the vaccines. His concomitant medications were not reported. The patient had a dog bite on 28 June 2011. The patient received dose 1 of IMOVAX Rabies on 29 June 2011, dose 2 on 04 July 2011 and dose 3 on 08 July 2011. The patient developed the feeling of a little fatigued after the first three doses. He complained of feeling very weak and feels he had an increased sensitivity to noises and light. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 26 August 2011. The patient had only received one dose of the rabies vaccine at the hospital and the lot number was not recorded. It was discovered that the patient had been the initial reporter which was previously reported as a health care professional. No further information was available. The outcome remained not recovered. Follow-up information was received 01 September 2011 from a health care professional. According to the reporter, the patient had only received a first dose of IMOVAX Rabies vaccine (intramuscular left deltoid injection) on 01 July 2011 (previously reported as 29 June 2011) at their facility and that lot number had not been charted by the nurse. Outcome remained not recovered. Follow-up information received on 17 October 2011 from a health care professional. Per the reporter, only the first dose of IMOVAX Rabies was administered at the facility. The lot number was not documented. No information was provided regarding the patient's recovery status. The event after the first three doses of IMOVAX Rabies was captured in case 2011-05016. Documents held by sender: None.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Disorientation, Dyspnoea, Hyperhidrosis, Pneumonia, Tachycardia
Clinical narrative: 4-30-2012 0930 resident disoriented, tachycardic, diaphoretic, experienced shortness of breath. Transported to hospital at 1000, 4/30/12.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Disorientation, Dyspnoea, Hyperhidrosis, Tachycardia
Clinical narrative: 24 hours after administration of vaccine resident became disoriented, tachycardic, diaphoretic, experienced shortness of breath. Transported to hospital 4/19/12 at 1330.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site mass, Injection site pain, Musculoskeletal pain
Clinical narrative: A couple days after I received my flu vaccine, I noticed the "lump" in my arm where the medicine was had not gone down.  It was not absorbed fully for almost two weeks. The pain in my right shoulder/arm began approximately Feb. 12th or so.  It radiates down from the shoulder, all the way to my wrist at times, at different strengths, from a constant 2 to a strong 8 or so. Aspirin does not dull the pain.  I cannot raise my right arm over my head, sleep on it or lift things well.  At times it goes almost numb, sending tingling sensations all the way to my fingertips.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: A couple days after I received my flu vaccine, I noticed the "lump" in my arm where the medicine was had not gone down.  It was not absorbed fully for almost two weeks. The pain in my right shoulder/arm began approximately Feb. 12th or so.  It radiates down from the shoulder, all the way to my wrist at times, at different strengths, from a constant 2 to a strong 8 or so. Aspirin does not dull the pain.  I cannot raise my right arm over my head, sleep on it or lift things well.  At times it goes almost numb, sending tingling sensations all the way to my fingertips.
Sex: F
Vaccine: RAB
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: Initial report received from a consumer who is the patient on 25 August 2011. A female patient (age not reported) who has a history of cold sores, had received "4 shots" of IMOGAM Rabies-HT (lot number not reported, indication not reported) and 2 doses of IMOVAX Rabies (lot number not reported, indication not reported) on 22 August 2011, and at an unspecified amount of time later, the patient developed cold sores. She had no concurrent illnesses at the time of vaccinations. The patient did not require medical evaluation, and it was not reported whether the patient self treated the cold sores. At the time of this report, the patient had not recovered. Documents held by sender: None.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Itching controlled by BENADRYL.
Age: 1.62
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction, Pyrexia
Clinical narrative: Pt developed erythematous, indurated and painful area (L) thigh 48 hrs after the shots were given (DTaP #4 & HIB #4). Ran fever 24 hrs prior to large local reaction developed and with painful wt. bearing as well.
Age: 1.62
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Weight bearing difficulty
Clinical narrative: Pt developed erythematous, indurated and painful area (L) thigh 48 hrs after the shots were given (DTaP #4 & HIB #4). Ran fever 24 hrs prior to large local reaction developed and with painful wt. bearing as well.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Developed urticarial large rash on (L) shoulder deltoid region - site of injection 8 days after vaccination. Treated w/ oral prednisone.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Feeling of body temperature change, Gait disturbance, Myalgia
Clinical narrative: Lasted 12-16 hours.  Reported all over muscle aches, painful joints, arm soreness (on arm vaccine was administered), difficulty walking, hot and cold chills.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Lasted 12-16 hours.  Reported all over muscle aches, painful joints, arm soreness (on arm vaccine was administered), difficulty walking, hot and cold chills.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Redness at sight, mild itching, hot to the touch TTP 1/10, red area increased in size x4 in 24 hrs.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Developed redness, swelling and pain at site of both DTaP #4 and HIB #4 shots that were administered. Redness went way within 48-72 hours; induration still present today without fever afterwards.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Progressive, red, raised," gritty", confluent rash beginning on the trunk and progressing to total body except for soles of feet in about 24 hours.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Scab
Clinical narrative: Headache, scattered blisters and scabs. No treatment.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Mom called our clinic this am to report that patient had a 4 inch area of redness, swelling, hard lump with heat below injection site to right arm where the varicella injection was given.  We had pt come in to have area looked at.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Symptoms: Redness, swelling, warmth, pain to deltoid. Treatment: Saw APRN, who prescribed Loratadine daily and cold compresses today.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Body temperature increased, Headache, Pyrexia, Vomiting
Clinical narrative: Severe headache, fevers, Tmax of 103, vomiting 15 minutes post ibuprofen administration.
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Acute promyelocytic leukaemia, Biopsy bone marrow abnormal, Injection site rash, Pain in extremity, White blood cell count increased
Clinical narrative: RASH AT INJECTION SITE ARM SORE - HIGH WBC ACUTE PROMYELOCYTIC LEUKEMIA.
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Acute promyelocytic leukaemia, Anaemia, Asthenia, Bone marrow myelogram abnormal, Coagulopathy
Clinical narrative: RASH AT INJECTION SITE ARM SORE - HIGH WBC ACUTE PROMYELOCYTIC LEUKEMIA.
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Contusion, Injection site reaction, Platelet count decreased, Rash erythematous, Uterine haemorrhage
Clinical narrative: RASH AT INJECTION SITE ARM SORE - HIGH WBC ACUTE PROMYELOCYTIC LEUKEMIA.
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: White blood cell count decreased
Clinical narrative: RASH AT INJECTION SITE ARM SORE - HIGH WBC ACUTE PROMYELOCYTIC LEUKEMIA.
Age: 55.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Activities of daily living impaired, Pain in extremity
Clinical narrative: Pt reported that she experienced pain in the affected arm about 2 hours after the injection and was "unable to lift groceries" that evening.  Pain persisted, and she reports having needed f/u with her primary care provider twice.  Pt reports that she was treated with oral steroids and pain medication, and reportedly missed work for a few days.
Age: 55.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Muscular weakness, Musculoskeletal pain, Nerve injury, Pain, Radiculitis brachial
Clinical narrative: Pt reported that she experienced pain in the affected arm about 2 hours after the injection and was "unable to lift groceries" that evening.  Pain persisted, and she reports having needed f/u with her primary care provider twice.  Pt reports that she was treated with oral steroids and pain medication, and reportedly missed work for a few days.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Injection site erythema, Injection site swelling, Pharyngeal oedema
Clinical narrative: 5-1-12 ER an hour after vaccine - BENADRYL. 5-4-12 ER - BENADRYL, steroids, ZANTAC. Throat swelling and tightness in chest. Red at injection site and swollen.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Aphasia, Headache, Hyperacusis, Hyporeflexia, Malaise
Clinical narrative: See attached form. On January 13, 2012 patient received a TDAP vaccine at clinic. Within 3 days she noticed that she was having difficulty finding the right words at a business meeting and was physically feeling ill. By Thursday 1/19/12 she had a very bad headache and her neck was very stiff, had blurred vision at the computer and had sensitivity to light and sound. Currently her vision is still impaired, has poor memory, personality change, tremors, diminished right Achilles tendon reflex, her tongue has tremors and drifts to the right, and has word fluency problems. Previous to the vaccine she was a high functioning individual working as a marketing manager and on air personality.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Memory impairment, Musculoskeletal stiffness, Personality change, Photophobia, Tongue paralysis
Clinical narrative: See attached form. On January 13, 2012 patient received a TDAP vaccine at clinic. Within 3 days she noticed that she was having difficulty finding the right words at a business meeting and was physically feeling ill. By Thursday 1/19/12 she had a very bad headache and her neck was very stiff, had blurred vision at the computer and had sensitivity to light and sound. Currently her vision is still impaired, has poor memory, personality change, tremors, diminished right Achilles tendon reflex, her tongue has tremors and drifts to the right, and has word fluency problems. Previous to the vaccine she was a high functioning individual working as a marketing manager and on air personality.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Tremor, Vision blurred, Visual impairment
Clinical narrative: See attached form. On January 13, 2012 patient received a TDAP vaccine at clinic. Within 3 days she noticed that she was having difficulty finding the right words at a business meeting and was physically feeling ill. By Thursday 1/19/12 she had a very bad headache and her neck was very stiff, had blurred vision at the computer and had sensitivity to light and sound. Currently her vision is still impaired, has poor memory, personality change, tremors, diminished right Achilles tendon reflex, her tongue has tremors and drifts to the right, and has word fluency problems. Previous to the vaccine she was a high functioning individual working as a marketing manager and on air personality.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt has round tender spot about size of half dollar around inj site & painful red swollen area 1/2 inch away from injection site.
Age: 0.64
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Rash
Clinical narrative: Child developed rash on chest that he was scratching at. Mother reported he had a similar rash on face before vaccines were given. No trouble breathing, hives, or any other allergic reaction. No treatment given.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Patient presented with redness at the injection site about 1 1/2 inch in diameter he also complained of itchiness; this way approx. 15 minutes after injection. Patient purchased diphenhydramine and instructed for follow up care.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection sites red & swollen.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Irritability
Clinical narrative: Rec'd routine 4 mo immunizations in office 5/8/12 at clinic. Became increasingly fussy in early P.M. Seen at eve. clinic same day, afebrile; (Rt) leg with redness & edema about 2-3" x 2-3" & induration about 1 1/2" x 1 1/2" at site. Tx: TYLENOL q4 hours/warm compresses.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Cellulitis, Injection site induration, Injection site warmth, Oedema peripheral
Clinical narrative: 2 days after shot, arm was swollen and in pain. Had temperature of 102 degrees. Shot area felt warm and hard. Pt went to the ER Saturday. Was told had MRSA and cellulitis. Put on abx, got better by Tuesday.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Staphylococcal infection
Clinical narrative: 2 days after shot, arm was swollen and in pain. Had temperature of 102 degrees. Shot area felt warm and hard. Pt went to the ER Saturday. Was told had MRSA and cellulitis. Put on abx, got better by Tuesday.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Discomfort, stiffness, swelling in upper at inj. site.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Areflexia, Ataxia, Balance disorder, CSF protein increased, Diplopia
Clinical narrative: This case was reported in a literature article and described the occurrence of Miller Fisher syndrome in a 59-year-old male subject who was vaccinated with Influenza vaccine ((unspecified), manufacturer unspecified). This case corresponds to patient 4 in the literature article. On an unspecified date, the subject received an unspecified dose of Influenza vaccine (unspecified) (administration site and route unknown, batch number not provided). 2 weeks after vaccination with Influenza vaccine (unspecified), the subject experienced Miller Fisher syndrome, bilateral vertical and horizontal ophthalmoplegia, imbalance, ataxic gait, right ptosis, generalized areflexia, severe ataxia on finger-to-nose and heel-to-shin maneuvers, diplopia and absent vestibulo ocular reflex. The subject was hospitalised. Cerebrospinal fluid protein was 48 mg/dl. The electrodiagnostic findings on day 18 showed normal nerve conduction studies of the upper and lower extremities, facial nerve and blink reflexes. The subject was treated with normal immunoglobulin (IVIG). At the time of discharge, there was a slow improvement in eye movements, ataxia of gait and hands and persistent areflexia at the end of one week after IVIG. The outcome of the other events was unspecified. Summary of the literature article: Recent epidemiological studies established extremely rare incidence of Guillain-Barre syndrome after contemporary H1N1-influenza vaccine. The authors reported five subjects with 'atypical? GBS variants that started within four weeks of 2010/2011 H1N1-influenza vaccine. There was no evidence for other etiologies of GBS. The subjects presented with sensory ataxia, areflexia, extremity and oropharyngeal paresthesias, numbness, pain, weakness, sphincteric disturbances, and dysautonomia. One subject had Miller Fisher syndrome. All had elevated cerebrospinal fluid protein, and classic electrodiagnostic finding suggestive of GBS. All received the treatment with intravenous immunoglobulin with variable response. The author's conclusion stated that this series of subjects did not necessarily establish cause-effect relationship between the vaccination and the disease. They also emphasized that they couldn't draw general conclusion concerning the types of GBS after H1N1-influenza vaccine in larger populations. Epidemiological studies with large cohort were necessary to confirm excess cases of atypical GBS after H1N1-influenza vaccination. They also speculated the possibility that more "typical" cases of GBS after H1N1-influenza vaccine did not reach their attention at tertiary-care center but were treated by community neurologists. Nevertheless, the main message that we can draw from this study is that high index of suspicion and screening for atypical variant of GBS was warranted for the H1N1-influenza vaccinees who present with neuropathic manifestations within four weeks of vaccination.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Eyelid ptosis, Immunoglobulin therapy, Miller Fisher syndrome, Nerve conduction studies normal, Neurological examination abnormal
Clinical narrative: This case was reported in a literature article and described the occurrence of Miller Fisher syndrome in a 59-year-old male subject who was vaccinated with Influenza vaccine ((unspecified), manufacturer unspecified). This case corresponds to patient 4 in the literature article. On an unspecified date, the subject received an unspecified dose of Influenza vaccine (unspecified) (administration site and route unknown, batch number not provided). 2 weeks after vaccination with Influenza vaccine (unspecified), the subject experienced Miller Fisher syndrome, bilateral vertical and horizontal ophthalmoplegia, imbalance, ataxic gait, right ptosis, generalized areflexia, severe ataxia on finger-to-nose and heel-to-shin maneuvers, diplopia and absent vestibulo ocular reflex. The subject was hospitalised. Cerebrospinal fluid protein was 48 mg/dl. The electrodiagnostic findings on day 18 showed normal nerve conduction studies of the upper and lower extremities, facial nerve and blink reflexes. The subject was treated with normal immunoglobulin (IVIG). At the time of discharge, there was a slow improvement in eye movements, ataxia of gait and hands and persistent areflexia at the end of one week after IVIG. The outcome of the other events was unspecified. Summary of the literature article: Recent epidemiological studies established extremely rare incidence of Guillain-Barre syndrome after contemporary H1N1-influenza vaccine. The authors reported five subjects with 'atypical? GBS variants that started within four weeks of 2010/2011 H1N1-influenza vaccine. There was no evidence for other etiologies of GBS. The subjects presented with sensory ataxia, areflexia, extremity and oropharyngeal paresthesias, numbness, pain, weakness, sphincteric disturbances, and dysautonomia. One subject had Miller Fisher syndrome. All had elevated cerebrospinal fluid protein, and classic electrodiagnostic finding suggestive of GBS. All received the treatment with intravenous immunoglobulin with variable response. The author's conclusion stated that this series of subjects did not necessarily establish cause-effect relationship between the vaccination and the disease. They also emphasized that they couldn't draw general conclusion concerning the types of GBS after H1N1-influenza vaccine in larger populations. Epidemiological studies with large cohort were necessary to confirm excess cases of atypical GBS after H1N1-influenza vaccination. They also speculated the possibility that more "typical" cases of GBS after H1N1-influenza vaccine did not reach their attention at tertiary-care center but were treated by community neurologists. Nevertheless, the main message that we can draw from this study is that high index of suspicion and screening for atypical variant of GBS was warranted for the H1N1-influenza vaccinees who present with neuropathic manifestations within four weeks of vaccination.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Ophthalmoplegia
Clinical narrative: This case was reported in a literature article and described the occurrence of Miller Fisher syndrome in a 59-year-old male subject who was vaccinated with Influenza vaccine ((unspecified), manufacturer unspecified). This case corresponds to patient 4 in the literature article. On an unspecified date, the subject received an unspecified dose of Influenza vaccine (unspecified) (administration site and route unknown, batch number not provided). 2 weeks after vaccination with Influenza vaccine (unspecified), the subject experienced Miller Fisher syndrome, bilateral vertical and horizontal ophthalmoplegia, imbalance, ataxic gait, right ptosis, generalized areflexia, severe ataxia on finger-to-nose and heel-to-shin maneuvers, diplopia and absent vestibulo ocular reflex. The subject was hospitalised. Cerebrospinal fluid protein was 48 mg/dl. The electrodiagnostic findings on day 18 showed normal nerve conduction studies of the upper and lower extremities, facial nerve and blink reflexes. The subject was treated with normal immunoglobulin (IVIG). At the time of discharge, there was a slow improvement in eye movements, ataxia of gait and hands and persistent areflexia at the end of one week after IVIG. The outcome of the other events was unspecified. Summary of the literature article: Recent epidemiological studies established extremely rare incidence of Guillain-Barre syndrome after contemporary H1N1-influenza vaccine. The authors reported five subjects with 'atypical? GBS variants that started within four weeks of 2010/2011 H1N1-influenza vaccine. There was no evidence for other etiologies of GBS. The subjects presented with sensory ataxia, areflexia, extremity and oropharyngeal paresthesias, numbness, pain, weakness, sphincteric disturbances, and dysautonomia. One subject had Miller Fisher syndrome. All had elevated cerebrospinal fluid protein, and classic electrodiagnostic finding suggestive of GBS. All received the treatment with intravenous immunoglobulin with variable response. The author's conclusion stated that this series of subjects did not necessarily establish cause-effect relationship between the vaccination and the disease. They also emphasized that they couldn't draw general conclusion concerning the types of GBS after H1N1-influenza vaccine in larger populations. Epidemiological studies with large cohort were necessary to confirm excess cases of atypical GBS after H1N1-influenza vaccination. They also speculated the possibility that more "typical" cases of GBS after H1N1-influenza vaccine did not reach their attention at tertiary-care center but were treated by community neurologists. Nevertheless, the main message that we can draw from this study is that high index of suspicion and screening for atypical variant of GBS was warranted for the H1N1-influenza vaccinees who present with neuropathic manifestations within four weeks of vaccination.
Age: 38.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Flank pain, Haematemesis, Headache
Clinical narrative: Pt received vaccines around 11 AM on 5/7/12. Pt stated: "At 3pm I got a bad headache and by 4:30 I was throwing up blood and that lasted 2 hrs. I then began hurting on my right side in the liver area. We went to ER and they were full, so we went to another ER. They gave me a shot of PHENERGAN and NUBAIN and told me to follow up with my Dr."
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Tremor
Clinical narrative: Left arm red & swollen 3" very painful, pt shaking. Sent pt to MD office.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Left arm red & swollen 3" very painful, pt shaking. Sent pt to MD office.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Vomiting
Clinical narrative: Headache, vomiting 4 x approximately 30 min after receiving the vaccines.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site pallor, Skin lesion
Clinical narrative: Seen in office 36-48 hours after start of symptoms. 4 inch x 4 inch red, blanchable warm lesion to upper right arm. No pain. No itching. Antibiotic will be started. Ibuprofen PRN. BENADRYL PRN will monitor closely.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema
Clinical narrative: Thigh redness at injection site.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Diarrhoea, Dizziness, Headache, Pyrexia, Tremor
Clinical narrative: On 5/8/12 started vomiting, headache, dizziness, diarrhea, shaking, fever, seen in office 5/9/12.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: On 5/8/12 started vomiting, headache, dizziness, diarrhea, shaking, fever, seen in office 5/9/12.
Age: 19.0
Sex: F
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Asthenia, Blood thyroid stimulating hormone normal, Dizziness, Full blood count normal, Metabolic function test normal
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of acute inflammatory demyelinating polyradiculoneuropathy in a 19-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included asthma. Concurrent vaccination included typhoid vaccine (non-gsk); Crucell; oral given on 13 February 2012. Concurrent medications included "loestrogen". On 13 February 2012 the subject received unspecified dose of HAVRIX (1 ml, unknown route, right arm). On 26 February 2012, 13 days after vaccination with HAVRIX, the subject experienced acute inflammatory demyelinating polyradiculoneuropathy ("acute inflammatory demyelinating polyneuropathy mild presentation"). The subject received 4 doses of oral typhoid vaccine from 13 February 2012 to 19 February 2012. The healthcare professional did not consider the oral typhoid vaccine as co-suspect. The subject required medical attention at her physician's office. This case was assessed as medically serious by GSK. At the time of reporting the event was unresolved. The healthcare professional considered the event was possibly related to vaccination with HAVRIX. Follow-up information was received on 08 May 2012 via healthcare professional who reported signs and symptoms included progressive numbness feet, hands and legs started on 27 February 2012. The subject experienced absent reflexes and paresthesia to the distal extremities. On 27 February 2012 the subject noted decreases sensation, tingling and subjective weakness to toes. The sensation progress to included both feet within the next 24 hours, then the finger tips on day three and later in hands the fourth day. Decreased reflexes on [illegible]. Ad Hepatitis A and first dose of oral typhoid on 13 February 2012. Typhoid completed on 19 February 2012. On day eight sensation changed progress to lower legs. At follow-up six weeks after tingling remained only in feet. The subject had a magnetic resonance image performed on 03 March 2012 reported included impression of single nonspecific T2 hyperintense focus in the right parietal lobe; probable DVA in the left inferior cerebellum; no definite acute intracranial abnormality. The subject may benefit from follow-up imaging if there is clinical concern for a demyelinating process such as multiple sclerosis, however. A follow-up study may also be of value to assess for anticipated stability in the left inferior cerebellum. The healthcare professional clarified oral typhoid vaccine as co-suspect was considered suspect contributing to the event. Immunization series with HAVRIX was discontinued. At the time of the report the acute inflammatory demyelinating polyradiculoneuropathy had improved.
Age: 19.0
Sex: F
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Nausea, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Treponema test negative, Vitamin A normal
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of acute inflammatory demyelinating polyradiculoneuropathy in a 19-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included asthma. Concurrent vaccination included typhoid vaccine (non-gsk); Crucell; oral given on 13 February 2012. Concurrent medications included "loestrogen". On 13 February 2012 the subject received unspecified dose of HAVRIX (1 ml, unknown route, right arm). On 26 February 2012, 13 days after vaccination with HAVRIX, the subject experienced acute inflammatory demyelinating polyradiculoneuropathy ("acute inflammatory demyelinating polyneuropathy mild presentation"). The subject received 4 doses of oral typhoid vaccine from 13 February 2012 to 19 February 2012. The healthcare professional did not consider the oral typhoid vaccine as co-suspect. The subject required medical attention at her physician's office. This case was assessed as medically serious by GSK. At the time of reporting the event was unresolved. The healthcare professional considered the event was possibly related to vaccination with HAVRIX. Follow-up information was received on 08 May 2012 via healthcare professional who reported signs and symptoms included progressive numbness feet, hands and legs started on 27 February 2012. The subject experienced absent reflexes and paresthesia to the distal extremities. On 27 February 2012 the subject noted decreases sensation, tingling and subjective weakness to toes. The sensation progress to included both feet within the next 24 hours, then the finger tips on day three and later in hands the fourth day. Decreased reflexes on [illegible]. Ad Hepatitis A and first dose of oral typhoid on 13 February 2012. Typhoid completed on 19 February 2012. On day eight sensation changed progress to lower legs. At follow-up six weeks after tingling remained only in feet. The subject had a magnetic resonance image performed on 03 March 2012 reported included impression of single nonspecific T2 hyperintense focus in the right parietal lobe; probable DVA in the left inferior cerebellum; no definite acute intracranial abnormality. The subject may benefit from follow-up imaging if there is clinical concern for a demyelinating process such as multiple sclerosis, however. A follow-up study may also be of value to assess for anticipated stability in the left inferior cerebellum. The healthcare professional clarified oral typhoid vaccine as co-suspect was considered suspect contributing to the event. Immunization series with HAVRIX was discontinued. At the time of the report the acute inflammatory demyelinating polyradiculoneuropathy had improved.
Age: 19.0
Sex: F
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Vitamin B12 normal
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of acute inflammatory demyelinating polyradiculoneuropathy in a 19-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included asthma. Concurrent vaccination included typhoid vaccine (non-gsk); Crucell; oral given on 13 February 2012. Concurrent medications included "loestrogen". On 13 February 2012 the subject received unspecified dose of HAVRIX (1 ml, unknown route, right arm). On 26 February 2012, 13 days after vaccination with HAVRIX, the subject experienced acute inflammatory demyelinating polyradiculoneuropathy ("acute inflammatory demyelinating polyneuropathy mild presentation"). The subject received 4 doses of oral typhoid vaccine from 13 February 2012 to 19 February 2012. The healthcare professional did not consider the oral typhoid vaccine as co-suspect. The subject required medical attention at her physician's office. This case was assessed as medically serious by GSK. At the time of reporting the event was unresolved. The healthcare professional considered the event was possibly related to vaccination with HAVRIX. Follow-up information was received on 08 May 2012 via healthcare professional who reported signs and symptoms included progressive numbness feet, hands and legs started on 27 February 2012. The subject experienced absent reflexes and paresthesia to the distal extremities. On 27 February 2012 the subject noted decreases sensation, tingling and subjective weakness to toes. The sensation progress to included both feet within the next 24 hours, then the finger tips on day three and later in hands the fourth day. Decreased reflexes on [illegible]. Ad Hepatitis A and first dose of oral typhoid on 13 February 2012. Typhoid completed on 19 February 2012. On day eight sensation changed progress to lower legs. At follow-up six weeks after tingling remained only in feet. The subject had a magnetic resonance image performed on 03 March 2012 reported included impression of single nonspecific T2 hyperintense focus in the right parietal lobe; probable DVA in the left inferior cerebellum; no definite acute intracranial abnormality. The subject may benefit from follow-up imaging if there is clinical concern for a demyelinating process such as multiple sclerosis, however. A follow-up study may also be of value to assess for anticipated stability in the left inferior cerebellum. The healthcare professional clarified oral typhoid vaccine as co-suspect was considered suspect contributing to the event. Immunization series with HAVRIX was discontinued. At the time of the report the acute inflammatory demyelinating polyradiculoneuropathy had improved.
Age: 19.0
Sex: F
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Areflexia, Blood alkaline phosphatase decreased, Blood chloride increased, Blood thyroid stimulating hormone normal, Cerebral small vessel ischaemic disease
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of acute inflammatory demyelinating polyradiculoneuropathy in a 19-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included asthma. Concurrent vaccination included typhoid vaccine (non-gsk); Crucell; oral given on 13 February 2012. Concurrent medications included "loestrogen". On 13 February 2012 the subject received unspecified dose of HAVRIX (1 ml, unknown route, right arm). On 26 February 2012, 13 days after vaccination with HAVRIX, the subject experienced acute inflammatory demyelinating polyradiculoneuropathy ("acute inflammatory demyelinating polyneuropathy mild presentation"). The subject received 4 doses of oral typhoid vaccine from 13 February 2012 to 19 February 2012. The healthcare professional did not consider the oral typhoid vaccine as co-suspect. The subject required medical attention at her physician's office. This case was assessed as medically serious by GSK. At the time of reporting the event was unresolved. The healthcare professional considered the event was possibly related to vaccination with HAVRIX. Follow-up information was received on 08 May 2012 via healthcare professional who reported signs and symptoms included progressive numbness feet, hands and legs started on 27 February 2012. The subject experienced absent reflexes and paresthesia to the distal extremities. On 27 February 2012 the subject noted decreases sensation, tingling and subjective weakness to toes. The sensation progress to included both feet within the next 24 hours, then the finger tips on day three and later in hands the fourth day. Decreased reflexes on [illegible]. Ad Hepatitis A and first dose of oral typhoid on 13 February 2012. Typhoid completed on 19 February 2012. On day eight sensation changed progress to lower legs. At follow-up six weeks after tingling remained only in feet. The subject had a magnetic resonance image performed on 03 March 2012 reported included impression of single nonspecific T2 hyperintense focus in the right parietal lobe; probable DVA in the left inferior cerebellum; no definite acute intracranial abnormality. The subject may benefit from follow-up imaging if there is clinical concern for a demyelinating process such as multiple sclerosis, however. A follow-up study may also be of value to assess for anticipated stability in the left inferior cerebellum. The healthcare professional clarified oral typhoid vaccine as co-suspect was considered suspect contributing to the event. Immunization series with HAVRIX was discontinued. At the time of the report the acute inflammatory demyelinating polyradiculoneuropathy had improved.
Age: 19.0
Sex: F
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Full blood count normal, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Nervous system disorder
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of acute inflammatory demyelinating polyradiculoneuropathy in a 19-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included asthma. Concurrent vaccination included typhoid vaccine (non-gsk); Crucell; oral given on 13 February 2012. Concurrent medications included "loestrogen". On 13 February 2012 the subject received unspecified dose of HAVRIX (1 ml, unknown route, right arm). On 26 February 2012, 13 days after vaccination with HAVRIX, the subject experienced acute inflammatory demyelinating polyradiculoneuropathy ("acute inflammatory demyelinating polyneuropathy mild presentation"). The subject received 4 doses of oral typhoid vaccine from 13 February 2012 to 19 February 2012. The healthcare professional did not consider the oral typhoid vaccine as co-suspect. The subject required medical attention at her physician's office. This case was assessed as medically serious by GSK. At the time of reporting the event was unresolved. The healthcare professional considered the event was possibly related to vaccination with HAVRIX. Follow-up information was received on 08 May 2012 via healthcare professional who reported signs and symptoms included progressive numbness feet, hands and legs started on 27 February 2012. The subject experienced absent reflexes and paresthesia to the distal extremities. On 27 February 2012 the subject noted decreases sensation, tingling and subjective weakness to toes. The sensation progress to included both feet within the next 24 hours, then the finger tips on day three and later in hands the fourth day. Decreased reflexes on [illegible]. Ad Hepatitis A and first dose of oral typhoid on 13 February 2012. Typhoid completed on 19 February 2012. On day eight sensation changed progress to lower legs. At follow-up six weeks after tingling remained only in feet. The subject had a magnetic resonance image performed on 03 March 2012 reported included impression of single nonspecific T2 hyperintense focus in the right parietal lobe; probable DVA in the left inferior cerebellum; no definite acute intracranial abnormality. The subject may benefit from follow-up imaging if there is clinical concern for a demyelinating process such as multiple sclerosis, however. A follow-up study may also be of value to assess for anticipated stability in the left inferior cerebellum. The healthcare professional clarified oral typhoid vaccine as co-suspect was considered suspect contributing to the event. Immunization series with HAVRIX was discontinued. At the time of the report the acute inflammatory demyelinating polyradiculoneuropathy had improved.