chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: HEP, IPV, MNQ, TYP, YF
Symptoms: Arthritis, Bradyphrenia, Encephalitis, Headache, Herpes simplex serology
Clinical narrative: 2-3 days after vaccination, complained of low grade fever, arthritis, myalgia. Improved. Then around June 16, had HA on L side, got so severe, when to ER on July 4. Seen in ER and released. On 7/7/10, was sluggish in mentation and was admitted to the hospital. MRI was supportive of mild encephalitis. Labs sent to State Health Dept and will be sent to CDC
Age: 56.0
Sex: M
Vaccine: HEP, IPV, MNQ, TYP, YF
Symptoms: Myalgia, Nuclear magnetic resonance imaging abnormal, Pyrexia, West Nile virus test negative
Clinical narrative: 2-3 days after vaccination, complained of low grade fever, arthritis, myalgia. Improved. Then around June 16, had HA on L side, got so severe, when to ER on July 4. Seen in ER and released. On 7/7/10, was sluggish in mentation and was admitted to the hospital. MRI was supportive of mild encephalitis. Labs sent to State Health Dept and will be sent to CDC
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Asthenia, Oedema peripheral
Clinical narrative: WEAKNESS AND SWOLLEN LEFT ARM. NO TREATMENT.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Injection site was red and swollen with hard lump underneath skin.  Arm was hot and painful to touch at left deltoid area.  Diagnosis of cellulitis.  Patient treated with Bactrim PO.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site warmth
Clinical narrative: Injection site was red and swollen with hard lump underneath skin.  Arm was hot and painful to touch at left deltoid area.  Diagnosis of cellulitis.  Patient treated with Bactrim PO.
Age: 1.26
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site pain, Irritability
Clinical narrative: Redness of right deltoid noted ~6cm by 9cm. Appears tender. No fevers. Pt may be slightly more irritable.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever of 101.5 degree axillary, 100.5 degree oral 12 to 24 hours after immunizations. No vomiting, diarrhea, headache, rash nor site erythema, edema or tenderness.
Age: 46.0
Sex: M
Vaccine: DTAP, TYP, YF
Symptoms: Headache, Hypoaesthesia, Lethargy, Myalgia, Oedema peripheral
Clinical narrative: Pt. had hives and rash that looked like a severe sunburn from the neck down. Had heacaches, swelling and numbness of hands and arms, myalgias, and lethargy. A few days after his rash began his son had a similar rash and was diagnosed with Fifth's disease. As of July 8 2010 symptoms improves but not fully resolved.
Age: 46.0
Sex: M
Vaccine: DTAP, TYP, YF
Symptoms: Rash, Urticaria
Clinical narrative: Pt. had hives and rash that looked like a severe sunburn from the neck down. Had heacaches, swelling and numbness of hands and arms, myalgias, and lethargy. A few days after his rash began his son had a similar rash and was diagnosed with Fifth's disease. As of July 8 2010 symptoms improves but not fully resolved.
Age: 16.0
Sex: M
Vaccine: RAB
Symptoms: Bradycardia, Dizziness, Gaze palsy, Musculoskeletal stiffness, Nausea
Clinical narrative: Patient being given rabies immunoglobulin - wound irrigated without difficulty but during IM injection of balance patient got dizzy, eyes rolled back and he had a stiff/tonic seizure lasting 45 secs - after tingling hands/feet, pale, bradycardic - nauseated but no emesis.
Age: 16.0
Sex: M
Vaccine: RAB
Symptoms: Pallor, Paraesthesia, Tonic convulsion, Wound treatment
Clinical narrative: Patient being given rabies immunoglobulin - wound irrigated without difficulty but during IM injection of balance patient got dizzy, eyes rolled back and he had a stiff/tonic seizure lasting 45 secs - after tingling hands/feet, pale, bradycardic - nauseated but no emesis.
Age: 12.0
Sex: F
Vaccine: HBHEPB, TD, VARCEL
Symptoms: Oedema peripheral, Rash pruritic, Skin discolouration
Clinical narrative: Black looking rash and swelling on left arm. The rash disappears after a short while then appears again. It comes on without warning and disappears before one has time to go to see a doctor or emergency room. It itches and increases in size if she scratches. This has continued through out the years since then.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3
Symptoms: Aphasia, Childhood disintegrative disorder, Facial palsy, Immediate post-injection reaction, Swelling face
Clinical narrative: Initial case was received on 25 June 2010 from a consumer who is also the mother of the patient. A 6.5 month old female patient received an injection of FLUZONE No Preservative 2008-2009 (lot number not reported) and DTAP/IPV/Hep B (manufacturer unknown, lot number AC21B163BC) in November 2008. Immediately, half of her face swelled up and half of her face was droopy. In 2009, the patient stopped talking and "lost progress in development." No pre-existing medical conditions, allergies or concomitant medications were reported. Mom filed a VAERS report. Outcome status of events not reported. Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: 07/08/2010 mild other.  Patient received TDAP, MENACTRA, HEP A, and HPV vaccine today.  Had nausea/vomiting within 5 minutes of injections.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash papular, Skin lesion
Clinical narrative: Scattered papular, sl. vesicular lesions scattered back, chest, abd, and prox extremities.
Age: 66.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Blood test, Computerised tomogram, Groin pain, Herpes zoster, Hyperhidrosis
Clinical narrative: On 7-7-10 at approx 0900 began c/o pain in L buttocks and radiated to groin - and at initially feeling it down in back also got nauseated and sweaty. Went to ER treated with pain med and R/O kidney stone - diagnosed with shingles.
Age: 66.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Musculoskeletal pain, Nausea, Urine analysis
Clinical narrative: On 7-7-10 at approx 0900 began c/o pain in L buttocks and radiated to groin - and at initially feeling it down in back also got nauseated and sweaty. Went to ER treated with pain med and R/O kidney stone - diagnosed with shingles.
Age: 1.23
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash to bilat legs & face. No resp distress. Acting normal. 1 tsp BENADRYL given at clinic. Instructed by MD to continue ZYRTEC prescription at home.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Syncope, Tremor
Clinical narrative: The third IPV given on 06/25/10 at about 12 pm, within about 1 minutes after the shot the patient fainted and fell on the floor, but with a support of the MA who gave the shot; pt. shook body 1 time. The pulse is well palpable and woke up within 1 minute. O2 was given 2 liters/min and patient completely woke up within seconds, then became alert well responsive pink BP is stable.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Posture abnormal
Clinical narrative: The HPV (Third HPV) given at about 12:05 pm 06/25/10, about 10 minutes later, patient felt dizzy, head nodded down, but still responsive, not falling, after resting in bed and O2 2 liters given, patient feels well, alert, VS stable.
Age: 1.01
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Ataxia, Computerised tomogram normal, Impaired work ability, Nuclear magnetic resonance imaging normal
Clinical narrative: Ataxia, inability to walk. Head CT, MRI both normal. Symptoms improved over 1 week.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Pyrexia, Salivary hypersecretion, Speech disorder
Clinical narrative: 11/13/09: Became feverish with burning on tip of tongue. 11/18/09: Sensation had spread; tongue felt numb, had trouble talking and increased salivation.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (R) thigh swollen, warm, hard, painful 1 day after vaccinations.
Age: 74.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Patient came into the pharmacy stating she is still in severe shoulder pain which started approximately 1 week post injection. She has seen her physician and is currently under the care of chiropractor for the pain upon arm retraction.
Age: 76.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Blister, Pruritus, Urticaria
Clinical narrative: Symptoms: 1. hives, blisters, itching - comes & goes Suspect Drug #1 Dosing: not sure from this or sulfa/trimethoprim po.
Age: 69.0
Sex: F
Vaccine: TTOX, TTOX
Symptoms: Arthralgia
Clinical narrative: Initial case was received on 28 June 2010 from a consumer who is also the patient. A 69 year old female patient received a left arm injection of Tetanus Toxoid Adsorbed Preservative-Free (lot number U2972AA) on 12 April 2010. She experienced severe joint pain of shoulders, hips and knees ever since. She saw a healthcare professional and treatment included "2 rounds of Prednisone." She continued to have joint pain and was treated with CELEBREX and ibuprofen. The patient reported no illness at the time of vaccination and she had no vaccinations within 4 weeks. Concomitant medications included FOSAMAX and SYNTHROID. She had an allergy to Sulfa, but no medical conditions were reported. The patient was referred to a Rheumatologist. As of this report she had not recovered from joint pain. Documents held by Sender: None.
Age: 69.0
Sex: F
Vaccine: TTOX, TTOX
Symptoms: Antinuclear antibody, Arthralgia, Body temperature decreased, C-reactive protein, Full blood count
Clinical narrative: Initial case was received on 28 June 2010 from a consumer who is also the patient. A 69 year old female patient received a left arm injection of Tetanus Toxoid Adsorbed Preservative-Free (lot number U2972AA) on 12 April 2010. She experienced severe joint pain of shoulders, hips and knees ever since. She saw a healthcare professional and treatment included "2 rounds of Prednisone." She continued to have joint pain and was treated with CELEBREX and ibuprofen. The patient reported no illness at the time of vaccination and she had no vaccinations within 4 weeks. Concomitant medications included FOSAMAX and SYNTHROID. She had an allergy to Sulfa, but no medical conditions were reported. The patient was referred to a Rheumatologist. As of this report she had not recovered from joint pain. Documents held by Sender: None.
Age: 69.0
Sex: F
Vaccine: TTOX, TTOX
Symptoms: Joint swelling, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Initial case was received on 28 June 2010 from a consumer who is also the patient. A 69 year old female patient received a left arm injection of Tetanus Toxoid Adsorbed Preservative-Free (lot number U2972AA) on 12 April 2010. She experienced severe joint pain of shoulders, hips and knees ever since. She saw a healthcare professional and treatment included "2 rounds of Prednisone." She continued to have joint pain and was treated with CELEBREX and ibuprofen. The patient reported no illness at the time of vaccination and she had no vaccinations within 4 weeks. Concomitant medications included FOSAMAX and SYNTHROID. She had an allergy to Sulfa, but no medical conditions were reported. The patient was referred to a Rheumatologist. As of this report she had not recovered from joint pain. Documents held by Sender: None.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Dizziness, Dysphagia, Dyspnoea, Paraesthesia oral
Clinical narrative: Initial report was received 29 June 2010 from a consumer, who is also the patient. A 27-year-old female patient with a history of "numerous allergies" (not specified), had received an injection of ADACEL, lot number C3032AA (route and site of administration not reported) on 19 January 2009 and within several minutes of vaccination, she experienced difficulty swallowing, difficulty breathing and lip tingling. The patient returned to the doctor's office and was noted to have an elevated blood pressure, she felt faint and almost passed out. The patient received unspecified treatment and was released. It was further noted the patient developed a rash (time and date of onset not reported). The patient's medical history included multiple unspecified allergies. According to the patient, she has been seeing an autoimmune / allergist for the symptoms she experienced after vaccination. It was further noted that the patient experienced symptoms of right arm numbness and a rash following a previous vaccination with FLUZONE, lot number U2452AA on 27 October 2007 (captured in case number 2010-03648). At the time of the report, the patient's outcome was unknown. Documents held by sender: None.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Initial report was received 29 June 2010 from a consumer, who is also the patient. A 27-year-old female patient with a history of "numerous allergies" (not specified), had received an injection of ADACEL, lot number C3032AA (route and site of administration not reported) on 19 January 2009 and within several minutes of vaccination, she experienced difficulty swallowing, difficulty breathing and lip tingling. The patient returned to the doctor's office and was noted to have an elevated blood pressure, she felt faint and almost passed out. The patient received unspecified treatment and was released. It was further noted the patient developed a rash (time and date of onset not reported). The patient's medical history included multiple unspecified allergies. According to the patient, she has been seeing an autoimmune / allergist for the symptoms she experienced after vaccination. It was further noted that the patient experienced symptoms of right arm numbness and a rash following a previous vaccination with FLUZONE, lot number U2452AA on 27 October 2007 (captured in case number 2010-03648). At the time of the report, the patient's outcome was unknown. Documents held by sender: None.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Dependence on respirator, Dyspnoea, Guillain-Barre syndrome, Paralysis
Clinical narrative: Initial case was received on 30 June 2010 from a healthcare professional. A 2 year old female child received an injection of HIB (manufacturer and lot number unknown) on an unspecified date. The patient's parent had reported to the physician that the child had experienced Guillain-Barre syndrome (GBS) 10 days after receiving the vaccine. The patient had paralysis, difficulty breathing and was on a respirator at that time. At the time of this report, the child was 12 years old. the physician was calling for information about giving the 12 year old child a "tetanus diphtheria vaccine", since the child had previously experienced GBS post vaccination. The physician stated the child was not a patient of his when she experienced GBS and did not want to be contacted, because he had no further information. The physician said he would not be providing any vaccinations to the child now. The outcome status of the GBS was not reported. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: FLU(H1N1), HEPA, HPV4, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Client administered Hep A adult vaccine should have received Hep A pediatric dose. (Medication error).
Age: 1.01
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Shingles like rash developed 4 mo post VZV immunization.
Age: 39.0
Sex: F
Vaccine: HIBV, IPV, PPV, TD
Symptoms: Injection site erythema, Malaise, Neutrophil percentage increased, White blood cell count increased
Clinical narrative: Feeling unwell, T 103, marked erythema to (L) arm vaccination site, no ulcer, no drainage, mild erythema to (R) arm vaccination site.
Age: 22.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Convulsion, Dizziness, Fall, Injection site pain, Laboratory test
Clinical narrative: Received HEP A adult c/o large amt. of pain in room at site spent few mins. with her she was OK I walked out of room patient felt dizzy sat on table fell off about 3ft. landed on head wrong and had seizure. Sent to ER via ambulance.
Age: 22.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Received HEP A adult c/o large amt. of pain in room at site spent few mins. with her she was OK I walked out of room patient felt dizzy sat on table fell off about 3ft. landed on head wrong and had seizure. Sent to ER via ambulance.
Age: 0.27
Sex: M
Vaccine: RV5
Symptoms: Decreased appetite, Diarrhoea
Clinical narrative: 4-5 watery stools/day from (7/5/10) to present - (7-8-10). Decreased appetite. Afebrile.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Induration, Oedema, Tenderness
Clinical narrative: The left deltoid, biceps and proximal forearm had edema, tenderness, induration.
Age: 40.0
Sex: F
Vaccine: TYP
Symptoms: Blood pressure increased, Feeling abnormal, Palpitations
Clinical narrative: 3 PM received Typhoid Vi. 1 hr. later c/o palpitations. B/P 150/92, P - 100. Generally not feeling right. Sent to ER.
Age: 0.5
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Acoustic stimulation tests normal, Biopsy muscle abnormal, Blood creatine phosphokinase increased, Blood lactic acid normal, Carnitine normal
Clinical narrative: This case was reported in a literature article and described the occurrence of macrophagic myofasciitis in a 6-month-old female subject who was vaccinated with VARICELLA vaccine (manufacturer unspecified) and HEPATITIS B vaccine. This case corresponds to case 3 in the literature article. On an unspecified date, the subject received an unspecified dose of VARICELLA vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of HEPATITIS B vaccine (administration site and route unknown, batch number not provided). She received all of her vaccinations including the vaccines mentioned above. At an unspecified time after vaccination with HEPATITIS B vaccine and VARICELLA vaccine, at the age of 6 months, the subject was diagnosed with developmental delay and failure to thrive with preserved language development. This case was assessed as medically serious by GSK. An extensive evaluation including a swallow study, endoscopy, esophageal pH monitoring, fecal fat analysis, stool and urine cultures, sodium sweat testing, thyroid function, chromosome karyotype, echocardiogram and hearing test were all normal. At 10-months-old, she required gastrostomy tube placement due to poor weight gain. She presented with motor delay. At 12.5 months-old, physical examination demonstrated hypotonia with height at the 25th percentile, weight, 50th - 75th percentile and head circumference, 5th percentile. Diagnostic testing demonstrated normal serum carnitine, lactate, EMG and brain MRI. Her CK was mildly elevated. She was unable to stand or crawl, but was able to sit unsupported and reach for objects. At 23 months-old, her left vastus lateralis was biopsied. It showed stereotyped demonstration of epi, peri and endomysium macrophagic infiltrates without muscle fiber necrosis. No histopathological evidence of ragged red fibers, fiber type atrophy, grouping or significant impairment of mitochondrial oxidative staining. No other organ system involvement was described. By the age of 5 years, she could carry on a conversation, understand cause and effect and was able to rise from the floor without Gower's maneuver, but was not toilet trained. At the time of reporting, the events were improved. The author considered that macrophagic myofasciitis was possibly related to vaccination with VARICELLA vaccine and HEPATITIS B vaccine. This case corresponds to 1 of the 3 cases reported in the literature article.
Age: 0.5
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Culture stool negative, Culture urine negative, Developmental delay, Dysstasia, Echocardiogram normal
Clinical narrative: This case was reported in a literature article and described the occurrence of macrophagic myofasciitis in a 6-month-old female subject who was vaccinated with VARICELLA vaccine (manufacturer unspecified) and HEPATITIS B vaccine. This case corresponds to case 3 in the literature article. On an unspecified date, the subject received an unspecified dose of VARICELLA vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of HEPATITIS B vaccine (administration site and route unknown, batch number not provided). She received all of her vaccinations including the vaccines mentioned above. At an unspecified time after vaccination with HEPATITIS B vaccine and VARICELLA vaccine, at the age of 6 months, the subject was diagnosed with developmental delay and failure to thrive with preserved language development. This case was assessed as medically serious by GSK. An extensive evaluation including a swallow study, endoscopy, esophageal pH monitoring, fecal fat analysis, stool and urine cultures, sodium sweat testing, thyroid function, chromosome karyotype, echocardiogram and hearing test were all normal. At 10-months-old, she required gastrostomy tube placement due to poor weight gain. She presented with motor delay. At 12.5 months-old, physical examination demonstrated hypotonia with height at the 25th percentile, weight, 50th - 75th percentile and head circumference, 5th percentile. Diagnostic testing demonstrated normal serum carnitine, lactate, EMG and brain MRI. Her CK was mildly elevated. She was unable to stand or crawl, but was able to sit unsupported and reach for objects. At 23 months-old, her left vastus lateralis was biopsied. It showed stereotyped demonstration of epi, peri and endomysium macrophagic infiltrates without muscle fiber necrosis. No histopathological evidence of ragged red fibers, fiber type atrophy, grouping or significant impairment of mitochondrial oxidative staining. No other organ system involvement was described. By the age of 5 years, she could carry on a conversation, understand cause and effect and was able to rise from the floor without Gower's maneuver, but was not toilet trained. At the time of reporting, the events were improved. The author considered that macrophagic myofasciitis was possibly related to vaccination with VARICELLA vaccine and HEPATITIS B vaccine. This case corresponds to 1 of the 3 cases reported in the literature article.
Age: 0.5
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Electromyogram normal, Endoscopy normal, Faecal fat increased, Failure to thrive, Gastrostomy tube insertion
Clinical narrative: This case was reported in a literature article and described the occurrence of macrophagic myofasciitis in a 6-month-old female subject who was vaccinated with VARICELLA vaccine (manufacturer unspecified) and HEPATITIS B vaccine. This case corresponds to case 3 in the literature article. On an unspecified date, the subject received an unspecified dose of VARICELLA vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of HEPATITIS B vaccine (administration site and route unknown, batch number not provided). She received all of her vaccinations including the vaccines mentioned above. At an unspecified time after vaccination with HEPATITIS B vaccine and VARICELLA vaccine, at the age of 6 months, the subject was diagnosed with developmental delay and failure to thrive with preserved language development. This case was assessed as medically serious by GSK. An extensive evaluation including a swallow study, endoscopy, esophageal pH monitoring, fecal fat analysis, stool and urine cultures, sodium sweat testing, thyroid function, chromosome karyotype, echocardiogram and hearing test were all normal. At 10-months-old, she required gastrostomy tube placement due to poor weight gain. She presented with motor delay. At 12.5 months-old, physical examination demonstrated hypotonia with height at the 25th percentile, weight, 50th - 75th percentile and head circumference, 5th percentile. Diagnostic testing demonstrated normal serum carnitine, lactate, EMG and brain MRI. Her CK was mildly elevated. She was unable to stand or crawl, but was able to sit unsupported and reach for objects. At 23 months-old, her left vastus lateralis was biopsied. It showed stereotyped demonstration of epi, peri and endomysium macrophagic infiltrates without muscle fiber necrosis. No histopathological evidence of ragged red fibers, fiber type atrophy, grouping or significant impairment of mitochondrial oxidative staining. No other organ system involvement was described. By the age of 5 years, she could carry on a conversation, understand cause and effect and was able to rise from the floor without Gower's maneuver, but was not toilet trained. At the time of reporting, the events were improved. The author considered that macrophagic myofasciitis was possibly related to vaccination with VARICELLA vaccine and HEPATITIS B vaccine. This case corresponds to 1 of the 3 cases reported in the literature article.
Age: 0.5
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Hypotonia, Inability to crawl, Karyotype analysis normal, Laboratory test normal, Motor developmental delay
Clinical narrative: This case was reported in a literature article and described the occurrence of macrophagic myofasciitis in a 6-month-old female subject who was vaccinated with VARICELLA vaccine (manufacturer unspecified) and HEPATITIS B vaccine. This case corresponds to case 3 in the literature article. On an unspecified date, the subject received an unspecified dose of VARICELLA vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of HEPATITIS B vaccine (administration site and route unknown, batch number not provided). She received all of her vaccinations including the vaccines mentioned above. At an unspecified time after vaccination with HEPATITIS B vaccine and VARICELLA vaccine, at the age of 6 months, the subject was diagnosed with developmental delay and failure to thrive with preserved language development. This case was assessed as medically serious by GSK. An extensive evaluation including a swallow study, endoscopy, esophageal pH monitoring, fecal fat analysis, stool and urine cultures, sodium sweat testing, thyroid function, chromosome karyotype, echocardiogram and hearing test were all normal. At 10-months-old, she required gastrostomy tube placement due to poor weight gain. She presented with motor delay. At 12.5 months-old, physical examination demonstrated hypotonia with height at the 25th percentile, weight, 50th - 75th percentile and head circumference, 5th percentile. Diagnostic testing demonstrated normal serum carnitine, lactate, EMG and brain MRI. Her CK was mildly elevated. She was unable to stand or crawl, but was able to sit unsupported and reach for objects. At 23 months-old, her left vastus lateralis was biopsied. It showed stereotyped demonstration of epi, peri and endomysium macrophagic infiltrates without muscle fiber necrosis. No histopathological evidence of ragged red fibers, fiber type atrophy, grouping or significant impairment of mitochondrial oxidative staining. No other organ system involvement was described. By the age of 5 years, she could carry on a conversation, understand cause and effect and was able to rise from the floor without Gower's maneuver, but was not toilet trained. At the time of reporting, the events were improved. The author considered that macrophagic myofasciitis was possibly related to vaccination with VARICELLA vaccine and HEPATITIS B vaccine. This case corresponds to 1 of the 3 cases reported in the literature article.
Age: 0.5
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Myofascitis, Nuclear magnetic resonance imaging normal, Oesophageal pH, Sweat test normal, Thyroid function test normal
Clinical narrative: This case was reported in a literature article and described the occurrence of macrophagic myofasciitis in a 6-month-old female subject who was vaccinated with VARICELLA vaccine (manufacturer unspecified) and HEPATITIS B vaccine. This case corresponds to case 3 in the literature article. On an unspecified date, the subject received an unspecified dose of VARICELLA vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of HEPATITIS B vaccine (administration site and route unknown, batch number not provided). She received all of her vaccinations including the vaccines mentioned above. At an unspecified time after vaccination with HEPATITIS B vaccine and VARICELLA vaccine, at the age of 6 months, the subject was diagnosed with developmental delay and failure to thrive with preserved language development. This case was assessed as medically serious by GSK. An extensive evaluation including a swallow study, endoscopy, esophageal pH monitoring, fecal fat analysis, stool and urine cultures, sodium sweat testing, thyroid function, chromosome karyotype, echocardiogram and hearing test were all normal. At 10-months-old, she required gastrostomy tube placement due to poor weight gain. She presented with motor delay. At 12.5 months-old, physical examination demonstrated hypotonia with height at the 25th percentile, weight, 50th - 75th percentile and head circumference, 5th percentile. Diagnostic testing demonstrated normal serum carnitine, lactate, EMG and brain MRI. Her CK was mildly elevated. She was unable to stand or crawl, but was able to sit unsupported and reach for objects. At 23 months-old, her left vastus lateralis was biopsied. It showed stereotyped demonstration of epi, peri and endomysium macrophagic infiltrates without muscle fiber necrosis. No histopathological evidence of ragged red fibers, fiber type atrophy, grouping or significant impairment of mitochondrial oxidative staining. No other organ system involvement was described. By the age of 5 years, she could carry on a conversation, understand cause and effect and was able to rise from the floor without Gower's maneuver, but was not toilet trained. At the time of reporting, the events were improved. The author considered that macrophagic myofasciitis was possibly related to vaccination with VARICELLA vaccine and HEPATITIS B vaccine. This case corresponds to 1 of the 3 cases reported in the literature article.
Age: 0.5
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Weight gain poor
Clinical narrative: This case was reported in a literature article and described the occurrence of macrophagic myofasciitis in a 6-month-old female subject who was vaccinated with VARICELLA vaccine (manufacturer unspecified) and HEPATITIS B vaccine. This case corresponds to case 3 in the literature article. On an unspecified date, the subject received an unspecified dose of VARICELLA vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of HEPATITIS B vaccine (administration site and route unknown, batch number not provided). She received all of her vaccinations including the vaccines mentioned above. At an unspecified time after vaccination with HEPATITIS B vaccine and VARICELLA vaccine, at the age of 6 months, the subject was diagnosed with developmental delay and failure to thrive with preserved language development. This case was assessed as medically serious by GSK. An extensive evaluation including a swallow study, endoscopy, esophageal pH monitoring, fecal fat analysis, stool and urine cultures, sodium sweat testing, thyroid function, chromosome karyotype, echocardiogram and hearing test were all normal. At 10-months-old, she required gastrostomy tube placement due to poor weight gain. She presented with motor delay. At 12.5 months-old, physical examination demonstrated hypotonia with height at the 25th percentile, weight, 50th - 75th percentile and head circumference, 5th percentile. Diagnostic testing demonstrated normal serum carnitine, lactate, EMG and brain MRI. Her CK was mildly elevated. She was unable to stand or crawl, but was able to sit unsupported and reach for objects. At 23 months-old, her left vastus lateralis was biopsied. It showed stereotyped demonstration of epi, peri and endomysium macrophagic infiltrates without muscle fiber necrosis. No histopathological evidence of ragged red fibers, fiber type atrophy, grouping or significant impairment of mitochondrial oxidative staining. No other organ system involvement was described. By the age of 5 years, she could carry on a conversation, understand cause and effect and was able to rise from the floor without Gower's maneuver, but was not toilet trained. At the time of reporting, the events were improved. The author considered that macrophagic myofasciitis was possibly related to vaccination with VARICELLA vaccine and HEPATITIS B vaccine. This case corresponds to 1 of the 3 cases reported in the literature article.
Age: 0.5
Sex: M
Vaccine: FLUX, HEP
Symptoms: Amino acid level normal, Asthenia, Barium swallow normal, Biopsy muscle abnormal, Blood creatine phosphokinase normal
Clinical narrative: This case was reported in a literature article and described the occurrence of macrophagic myofasciitis in a 6-month-old male subject who was vaccinated with HEPATITIS B (manufacturer unspecified), Influenza virus vaccine. This case corresponds to case 4 in the literature article. The subject's medical history included feeding related apneic episode diagnosed as gastroesophageal reflux, atrial flutter treated with cardioversion, an episode of several febrile seizure, oxygen therapy, pneumonia which required oxygen therapy (10 days in the neonatal intensive care), prematurity (born at 35 weeks) and ventricular septal defect that resolved without treatment. His mother was diagnosed with Munchausen by proxy related to misinformation regarding his feeding, atypical spells and inability to wean from nasal oxygen. On an unspecified date, the subject received an unspecified dose of Hepatitis B vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of Influenza vaccine (administration site and route unknown, batch number not provided). He had received all of his vaccinations. At an unspecified time after vaccination with Hepatitis B vaccine and Influenza vaccine, at 6 months-old, the subject demonstrated gross motor delay and poor oral feeding requiring supplements via a nasal gastric tube. He had poor head control, inability to sit, axial hypotonia, failure to thrive, weakness in neck and deep tendon reflexes decreased. This case was assessed as medically serious by GSK. EEG and MRI evaluations were unremarkable for premature birth. Serum CK, plasma acylcarnitines, amino acids, urine organic acids, karyotype, sweat chloride test, swallow study, small bowel follow-through, polysomnogram and abdominal ultrasound were normal. At 8-months-old, his right vastus lateralis was biopsied. Muscle biopsy was with stereotyped demonstration of epi, peri and endomysium macrophagic infiltrates without muscle fiber necrosis. No histopathological evidence of ragged red fibers, fiber type atrophy, grouping or significant impairment of mitochondrial oxidative staining. Electron transport chain function of the muscle was tested and was normal. At the age of 13-months-old, he was starting to walk and say a few words with normal progression of milestones. No radiological evidence of central nervous system dysfunction or parental consanguinity. At the time of reporting, the events were improved. The author considered that macrophagic myofasciitis was possibly related to vaccination with Hepatitis B vaccine and Influenza vaccine. This case corresponds to 1 of the 3 cases reported in the literature article.
Age: 0.5
Sex: M
Vaccine: FLUX, HEP
Symptoms: Electroencephalogram normal, Electromyogram normal, Enteral nutrition, Failure to thrive, Feeding disorder of infancy or early childhood
Clinical narrative: This case was reported in a literature article and described the occurrence of macrophagic myofasciitis in a 6-month-old male subject who was vaccinated with HEPATITIS B (manufacturer unspecified), Influenza virus vaccine. This case corresponds to case 4 in the literature article. The subject's medical history included feeding related apneic episode diagnosed as gastroesophageal reflux, atrial flutter treated with cardioversion, an episode of several febrile seizure, oxygen therapy, pneumonia which required oxygen therapy (10 days in the neonatal intensive care), prematurity (born at 35 weeks) and ventricular septal defect that resolved without treatment. His mother was diagnosed with Munchausen by proxy related to misinformation regarding his feeding, atypical spells and inability to wean from nasal oxygen. On an unspecified date, the subject received an unspecified dose of Hepatitis B vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of Influenza vaccine (administration site and route unknown, batch number not provided). He had received all of his vaccinations. At an unspecified time after vaccination with Hepatitis B vaccine and Influenza vaccine, at 6 months-old, the subject demonstrated gross motor delay and poor oral feeding requiring supplements via a nasal gastric tube. He had poor head control, inability to sit, axial hypotonia, failure to thrive, weakness in neck and deep tendon reflexes decreased. This case was assessed as medically serious by GSK. EEG and MRI evaluations were unremarkable for premature birth. Serum CK, plasma acylcarnitines, amino acids, urine organic acids, karyotype, sweat chloride test, swallow study, small bowel follow-through, polysomnogram and abdominal ultrasound were normal. At 8-months-old, his right vastus lateralis was biopsied. Muscle biopsy was with stereotyped demonstration of epi, peri and endomysium macrophagic infiltrates without muscle fiber necrosis. No histopathological evidence of ragged red fibers, fiber type atrophy, grouping or significant impairment of mitochondrial oxidative staining. Electron transport chain function of the muscle was tested and was normal. At the age of 13-months-old, he was starting to walk and say a few words with normal progression of milestones. No radiological evidence of central nervous system dysfunction or parental consanguinity. At the time of reporting, the events were improved. The author considered that macrophagic myofasciitis was possibly related to vaccination with Hepatitis B vaccine and Influenza vaccine. This case corresponds to 1 of the 3 cases reported in the literature article.
Age: 0.5
Sex: M
Vaccine: FLUX, HEP
Symptoms: Gastrointestinal tube insertion, Gross motor delay, Hyporeflexia, Hypotonia, Karyotype analysis normal
Clinical narrative: This case was reported in a literature article and described the occurrence of macrophagic myofasciitis in a 6-month-old male subject who was vaccinated with HEPATITIS B (manufacturer unspecified), Influenza virus vaccine. This case corresponds to case 4 in the literature article. The subject's medical history included feeding related apneic episode diagnosed as gastroesophageal reflux, atrial flutter treated with cardioversion, an episode of several febrile seizure, oxygen therapy, pneumonia which required oxygen therapy (10 days in the neonatal intensive care), prematurity (born at 35 weeks) and ventricular septal defect that resolved without treatment. His mother was diagnosed with Munchausen by proxy related to misinformation regarding his feeding, atypical spells and inability to wean from nasal oxygen. On an unspecified date, the subject received an unspecified dose of Hepatitis B vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of Influenza vaccine (administration site and route unknown, batch number not provided). He had received all of his vaccinations. At an unspecified time after vaccination with Hepatitis B vaccine and Influenza vaccine, at 6 months-old, the subject demonstrated gross motor delay and poor oral feeding requiring supplements via a nasal gastric tube. He had poor head control, inability to sit, axial hypotonia, failure to thrive, weakness in neck and deep tendon reflexes decreased. This case was assessed as medically serious by GSK. EEG and MRI evaluations were unremarkable for premature birth. Serum CK, plasma acylcarnitines, amino acids, urine organic acids, karyotype, sweat chloride test, swallow study, small bowel follow-through, polysomnogram and abdominal ultrasound were normal. At 8-months-old, his right vastus lateralis was biopsied. Muscle biopsy was with stereotyped demonstration of epi, peri and endomysium macrophagic infiltrates without muscle fiber necrosis. No histopathological evidence of ragged red fibers, fiber type atrophy, grouping or significant impairment of mitochondrial oxidative staining. Electron transport chain function of the muscle was tested and was normal. At the age of 13-months-old, he was starting to walk and say a few words with normal progression of milestones. No radiological evidence of central nervous system dysfunction or parental consanguinity. At the time of reporting, the events were improved. The author considered that macrophagic myofasciitis was possibly related to vaccination with Hepatitis B vaccine and Influenza vaccine. This case corresponds to 1 of the 3 cases reported in the literature article.
Age: 0.5
Sex: M
Vaccine: FLUX, HEP
Symptoms: Laboratory test normal, Metabolic function test normal, Muscle disorder, Myofascitis, Nuclear magnetic resonance imaging normal
Clinical narrative: This case was reported in a literature article and described the occurrence of macrophagic myofasciitis in a 6-month-old male subject who was vaccinated with HEPATITIS B (manufacturer unspecified), Influenza virus vaccine. This case corresponds to case 4 in the literature article. The subject's medical history included feeding related apneic episode diagnosed as gastroesophageal reflux, atrial flutter treated with cardioversion, an episode of several febrile seizure, oxygen therapy, pneumonia which required oxygen therapy (10 days in the neonatal intensive care), prematurity (born at 35 weeks) and ventricular septal defect that resolved without treatment. His mother was diagnosed with Munchausen by proxy related to misinformation regarding his feeding, atypical spells and inability to wean from nasal oxygen. On an unspecified date, the subject received an unspecified dose of Hepatitis B vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of Influenza vaccine (administration site and route unknown, batch number not provided). He had received all of his vaccinations. At an unspecified time after vaccination with Hepatitis B vaccine and Influenza vaccine, at 6 months-old, the subject demonstrated gross motor delay and poor oral feeding requiring supplements via a nasal gastric tube. He had poor head control, inability to sit, axial hypotonia, failure to thrive, weakness in neck and deep tendon reflexes decreased. This case was assessed as medically serious by GSK. EEG and MRI evaluations were unremarkable for premature birth. Serum CK, plasma acylcarnitines, amino acids, urine organic acids, karyotype, sweat chloride test, swallow study, small bowel follow-through, polysomnogram and abdominal ultrasound were normal. At 8-months-old, his right vastus lateralis was biopsied. Muscle biopsy was with stereotyped demonstration of epi, peri and endomysium macrophagic infiltrates without muscle fiber necrosis. No histopathological evidence of ragged red fibers, fiber type atrophy, grouping or significant impairment of mitochondrial oxidative staining. Electron transport chain function of the muscle was tested and was normal. At the age of 13-months-old, he was starting to walk and say a few words with normal progression of milestones. No radiological evidence of central nervous system dysfunction or parental consanguinity. At the time of reporting, the events were improved. The author considered that macrophagic myofasciitis was possibly related to vaccination with Hepatitis B vaccine and Influenza vaccine. This case corresponds to 1 of the 3 cases reported in the literature article.
Age: 0.5
Sex: M
Vaccine: FLUX, HEP
Symptoms: Posture abnormal, Sleep study, Sleep study normal, Sweat test normal, Ultrasound abdomen normal
Clinical narrative: This case was reported in a literature article and described the occurrence of macrophagic myofasciitis in a 6-month-old male subject who was vaccinated with HEPATITIS B (manufacturer unspecified), Influenza virus vaccine. This case corresponds to case 4 in the literature article. The subject's medical history included feeding related apneic episode diagnosed as gastroesophageal reflux, atrial flutter treated with cardioversion, an episode of several febrile seizure, oxygen therapy, pneumonia which required oxygen therapy (10 days in the neonatal intensive care), prematurity (born at 35 weeks) and ventricular septal defect that resolved without treatment. His mother was diagnosed with Munchausen by proxy related to misinformation regarding his feeding, atypical spells and inability to wean from nasal oxygen. On an unspecified date, the subject received an unspecified dose of Hepatitis B vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of Influenza vaccine (administration site and route unknown, batch number not provided). He had received all of his vaccinations. At an unspecified time after vaccination with Hepatitis B vaccine and Influenza vaccine, at 6 months-old, the subject demonstrated gross motor delay and poor oral feeding requiring supplements via a nasal gastric tube. He had poor head control, inability to sit, axial hypotonia, failure to thrive, weakness in neck and deep tendon reflexes decreased. This case was assessed as medically serious by GSK. EEG and MRI evaluations were unremarkable for premature birth. Serum CK, plasma acylcarnitines, amino acids, urine organic acids, karyotype, sweat chloride test, swallow study, small bowel follow-through, polysomnogram and abdominal ultrasound were normal. At 8-months-old, his right vastus lateralis was biopsied. Muscle biopsy was with stereotyped demonstration of epi, peri and endomysium macrophagic infiltrates without muscle fiber necrosis. No histopathological evidence of ragged red fibers, fiber type atrophy, grouping or significant impairment of mitochondrial oxidative staining. Electron transport chain function of the muscle was tested and was normal. At the age of 13-months-old, he was starting to walk and say a few words with normal progression of milestones. No radiological evidence of central nervous system dysfunction or parental consanguinity. At the time of reporting, the events were improved. The author considered that macrophagic myofasciitis was possibly related to vaccination with Hepatitis B vaccine and Influenza vaccine. This case corresponds to 1 of the 3 cases reported in the literature article.