chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Dry skin, Postpartum state, Rash generalised
Clinical narrative: 25 y/o female received TDAP -> postpartum 7 days. Developed rash on (R) arm -> spread to entire body over next 24-48 hours. No resp distress or other systemic rxn - rash appears dry - like rxn.
Age: 11.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt's mom came in on 1/20/11. She stated that child's (R) arm at injection site began to become red & itchy on 1/18/11. Examined site on 1/20/11. Red area - 4 cm x 3 cm, no raised, no warmth, no hard. NP also examined area. Advised to take BENADRYL, apply alternating warm & cold packs. Called mom 1/21/11 - area now less red, no itchy. Advised mom to call if area becomes larger, hot, hard.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Computerised tomogram normal, Convulsion
Clinical narrative: Seizure, treated at ER. F/u with Dr., no treatment needed, self resolved, no fever.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Injection site erythema, Malaise, Palpitations
Clinical narrative: Redness at injection site on Friday night, Sat it became firing red. Used over the counter BENADRYL lotion. Then started to feel sick, couldn't eat or drink. Finally went to ER after she felt heart palpitation. Dr at ER said it could be an adverse effect to the vaccine.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Given client expired rotavirus; had client to wait 15 min after meds. given; no problem noted. Inform Dr. & supervisor. Will call or send letter to revaccinate.
Age: 1.03
Sex: F
Vaccine: MMR, PNC13
Symptoms: Urticaria
Clinical narrative: Hives that comes & goes, treatment 1/2 tsp ZYRTEC daily until no longer symptomatic.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 2" diameter reddened area at injection site, warm, somewhat tender to touch.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Swelling
Clinical narrative: 1" x 1" rash, red/swollen in area.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Injection site erythema, Injection site swelling, Vaccination complication
Clinical narrative: Reaction to 13b PROQUAD - MMR/V redness/swelling L 5in x W 4.5in no fever/pain.
Age: 1.54
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea, Hypotonia, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Fever 103, pronounced redness, heat, hard at injection site lethargic x 3 days followed by 7 day high-pitch screaming withdrawal, loss eye contact, persistent diarrhea, sleep disturbances, restlessness, flopping.
Age: 1.54
Sex: M
Vaccine: HEPA
Symptoms: Lethargy, Pyrexia, Restlessness, Screaming, Sleep disorder
Clinical narrative: Fever 103, pronounced redness, heat, hard at injection site lethargic x 3 days followed by 7 day high-pitch screaming withdrawal, loss eye contact, persistent diarrhea, sleep disturbances, restlessness, flopping.
Age: 1.54
Sex: M
Vaccine: HEPA
Symptoms: Social avoidant behaviour
Clinical narrative: Fever 103, pronounced redness, heat, hard at injection site lethargic x 3 days followed by 7 day high-pitch screaming withdrawal, loss eye contact, persistent diarrhea, sleep disturbances, restlessness, flopping.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: On 1-14-11 pt. stopped here at the clinic to report she developed a very red, warm, sore area at injection site. There is a firm, warm, red area measuring 13cm x 14cm below the deltoid muscle more toward the inner aspect of the upper arm.
Age: 3.0
Sex: F
Vaccine: UNK
Symptoms: Convulsion, Cyanosis, Learning disability, Personality change, Pyrexia
Clinical narrative: Got a high temperature - Patient was having seizure - turned blue- unable to breathe - had learning disabilities. Personality changed, weight size increased - hospital.
Age: 3.0
Sex: F
Vaccine: UNK
Symptoms: Respiratory arrest, Weight increased
Clinical narrative: Got a high temperature - Patient was having seizure - turned blue- unable to breathe - had learning disabilities. Personality changed, weight size increased - hospital.
Age: 29.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Local reaction, Mobility decreased, Pain in extremity, Pain of skin
Clinical narrative: Large local reaction x 2 days - fever 101.3 same day after receiving injection - could not lift arm above head. Arm was sore, red & tender to touch. Advised by physician to use ALLEGRA & ALAVERT. Use topical steroid & NSAIDS.
Age: 29.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: Large local reaction x 2 days - fever 101.3 same day after receiving injection - could not lift arm above head. Arm was sore, red & tender to touch. Advised by physician to use ALLEGRA & ALAVERT. Use topical steroid & NSAIDS.
Age: 29.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pyrexia, Tenderness
Clinical narrative: Large local reaction x 2 days - fever 101.3 same day after receiving injection - could not lift arm above head. Arm was sore, red & tender to touch. Advised by physician to use ALLEGRA & ALAVERT. Use topical steroid & NSAIDS.
Age: 1.02
Sex: M
Vaccine: FLUX, HEPA, PPV
Symptoms: Allergy to vaccine, Blood test, Decreased appetite, Dizziness, Heart rate increased
Clinical narrative: My son had a high fever (over 104 degree fever) for 6 straight days, hives on his legs, rash on his upper body, fast heart beat, dizziness, lethargic, no appetite.  He was admitted into the ER on the evening of Friday Jan. 14th, 2011 for all the conditions listed above.
Age: 1.02
Sex: M
Vaccine: FLUX, HEPA, PPV
Symptoms: Injection site urticaria, Lethargy, Pyrexia, Rash, Urine analysis
Clinical narrative: My son had a high fever (over 104 degree fever) for 6 straight days, hives on his legs, rash on his upper body, fast heart beat, dizziness, lethargic, no appetite.  He was admitted into the ER on the evening of Friday Jan. 14th, 2011 for all the conditions listed above.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Lethargy, Vomiting
Clinical narrative: Stomach pain, vomiting, lethargy
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Drug administered at inappropriate site, Pain in extremity, Skin discolouration
Clinical narrative: Heavy bruising & soreness - I've been getting flu shots yearly for most of my life and NEVER had it do that. It held the bruising discoloration for over a month and even a health care provider saw it and wondered where I got such an awful bruise. I told her it was from my flu shot. She was appalled that it was given so high on my arm.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Nausea
Clinical narrative: significant headache, nausea, diarrhea
Age: 0.55
Sex: M
Vaccine: FLU3, DTAPIPVHIB, FLU3, PNC, RV5
Symptoms: Convulsion, Laboratory test, Pyrexia, Tongue disorder, Unresponsive to stimuli
Clinical narrative: Seizure, not responding and tongue popping and high fever. Called 911 and rushed to Emergency.
Age: 0.55
Sex: M
Vaccine: FLU3, DTAPIPVHIB, FLU3, PNC, RV5
Symptoms: Body temperature increased, Cyanosis, Febrile convulsion, Gaze palsy, Tongue paralysis
Clinical narrative: Seizure, not responding and tongue popping and high fever. Called 911 and rushed to Emergency.
Age: 0.55
Sex: M
Vaccine: FLU3, DTAPIPVHIB, FLU3, PNC, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Seizure, not responding and tongue popping and high fever. Called 911 and rushed to Emergency.
Age: 2.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Computerised tomogram, Febrile convulsion
Clinical narrative: Febrile Seizure.  First ever seizure.
Age: 47.0
Sex: M
Vaccine: UNK
Symptoms: Cellulitis, Vaccination site cellulitis
Clinical narrative: CELLULITIS AT VACCINATION SITE.
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: NO ADVERSE REACTIONS REPORTED AT THIS TIME
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Computerised tomogram head, Computerised tomogram normal, Convulsion, Full blood count
Clinical narrative: seizure; jaw-locked, tonic-clonic activity x 3-4 minutes, witnessed by EMS
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Haemoglobin normal, Metabolic function test, Platelet count normal, Tonic clonic movements, Trismus
Clinical narrative: seizure; jaw-locked, tonic-clonic activity x 3-4 minutes, witnessed by EMS
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Urine analysis abnormal, White blood cell count increased
Clinical narrative: seizure; jaw-locked, tonic-clonic activity x 3-4 minutes, witnessed by EMS
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Large area of Hives on and under breast and across waist
Age: 5.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Aldolase increased, Arthralgia, Biopsy muscle abnormal, Blood lactate dehydrogenase increased, Dermatomyositis
Clinical narrative: Fatigue, low-grade fever, nausea, rash on knees and elbows (like psoriasis), joint pains, muscle weakness progressing to inability to climb stairs or get out of bed one month later. Diagnosis: dermatomyositis. Hospitalized, received steroids, methotrexate and plaquenil, is still on medications.
Age: 5.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Fatigue, Liver function test abnormal, Muscular weakness, Nausea, Pyrexia
Clinical narrative: Fatigue, low-grade fever, nausea, rash on knees and elbows (like psoriasis), joint pains, muscle weakness progressing to inability to climb stairs or get out of bed one month later. Diagnosis: dermatomyositis. Hospitalized, received steroids, methotrexate and plaquenil, is still on medications.
Age: 5.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash
Clinical narrative: Fatigue, low-grade fever, nausea, rash on knees and elbows (like psoriasis), joint pains, muscle weakness progressing to inability to climb stairs or get out of bed one month later. Diagnosis: dermatomyositis. Hospitalized, received steroids, methotrexate and plaquenil, is still on medications.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: patient reports pain, pain with abduction of the arm, pain w/sleeping on the arm, no redness, no swelling, no fever, using NSAIDs/icing/heating
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt received TDAP on (R) upper arm on 1/17/11 by evening (5 hours later) had 2cm area of erythema, swelling 7cm and 8cm of erythema, warmth and mild redness.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Rash, Syncope
Clinical narrative: Fainting passed out for 5 minutes. Following day rash on legs after receiving Gardasil Vaccine dose number 1.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Neuralgia
Clinical narrative: SEVERE PAIN IN INJECTION SITE, JOINT PAIN IN SHOULDER, NERVE PAIN, ALL IN LEFT ARM. LIMITED USE OF ARM, DOES NOT SEEM TO BE GETTING ANY BETTER. 1/24/2011
Age: 44.0
Sex: M
Vaccine: DTAP
Symptoms: Musculoskeletal chest pain, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pain in shoulder and neck muscles, stiff neck can not move neck right/left/up/down. Rib cage hurts very much can not breathe completely in/out, short breath.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Abnormal behaviour, Agitation, Dysphemia, Irritability, Tension
Clinical narrative: In the evening of the day after the vaccinations, I noticed patient having a slight stutter. She would repeat the first syllable in a word, usually the first word in her sentence, multiple times. She seemed very strained. She also started acting more agitated, irritable, unpredictable with some of her social behaviors. The stutter got progressively worse. Sometimes the stutter of just one letter would last five of six seconds, and by the new year (1/2011) I was seeing more than one stutter in a sentence sometimes. But it was not consistant. Since then, the stutter and the behavioral problems have been slightly improving.
Age: 49.0
Sex: F
Vaccine: DTAP
Symptoms: Chest discomfort, Chills, Cough, Injection site erythema, Injection site rash
Clinical narrative: Chills, Nausea, Migraine, Heaviness in Chest, Cough, Fever, Redness and Rash on vaccinated area of arm, Tight Muscles in Shoulder and Upper Back.
Age: 49.0
Sex: F
Vaccine: DTAP
Symptoms: Migraine, Muscle tightness, Nausea, Pyrexia
Clinical narrative: Chills, Nausea, Migraine, Heaviness in Chest, Cough, Fever, Redness and Rash on vaccinated area of arm, Tight Muscles in Shoulder and Upper Back.
Age: 1.32
Sex: M
Vaccine: DTAP, MEN
Symptoms: Diarrhoea
Clinical narrative: Diarrhea every 15 minutes for 4 hours straight.  Starting on 1/21/11, diarrhea every 2 hours for 24 hours.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Severe hives
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Arrhythmia, Dehydration, Drug exposure during pregnancy, Dyspnoea, Heart rate increased
Clinical narrative: Case previously recorded as MA2009-3639. Initial case report received from Vaccine Adverse Event Reporting System (VAERS), on 06 NOV 2009. A 24-year-old female patient was vaccinated with FLUVIRIN (batch no. unknown) on 03 NOV 2008. The patient experienced arrhythmia, rapid heart rate, shortness of breath, excessive sweating and dehydration on 07 NOV 2008. She was hospitalized for one day. Furthermore she was pregnant. The outcome was unknown at time of the report. VARES reference no.: 353794. Follow-up received on 20 Jan 2011: Multiple attempts were made to collect additional information and outcome of event without success. This case is considered lost to follow up.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis
Clinical narrative: Case previously recorded as MA2009-3639. Initial case report received from Vaccine Adverse Event Reporting System (VAERS), on 06 NOV 2009. A 24-year-old female patient was vaccinated with FLUVIRIN (batch no. unknown) on 03 NOV 2008. The patient experienced arrhythmia, rapid heart rate, shortness of breath, excessive sweating and dehydration on 07 NOV 2008. She was hospitalized for one day. Furthermore she was pregnant. The outcome was unknown at time of the report. VARES reference no.: 353794. Follow-up received on 20 Jan 2011: Multiple attempts were made to collect additional information and outcome of event without success. This case is considered lost to follow up.
Age: 20.0
Sex: M
Vaccine: ANTH, HEPAB, SMALL, TYP
Symptoms: Chills, Decreased appetite, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: This case was received on 10 December 2009 via a QScan search on the VAERS database, under reference number 356135. A 20 year old male patient received the following vaccines on 11 August 2009: ACAM2000 (lot number VV04003A); TYPHIM VI (lot number B07062); BIOTHRAX (Emergent Biosolutions, FAV198) and TWINRIX (GlaxoSmithKline, AHABB140AA). Sites of administration were not reported. Twelve days after vaccination, the patient developed fevers, chills, sweats, fatigue and decreased appetite. The patient also developed 2 lesions on the right cheek which appeared to be at the same stage as the primary vaccination lesion. No treatment was reported. The patient recovered. Note: There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. List of documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: ANTH, HEPAB, SMALL, TYP
Symptoms: Skin lesion, Vaccination site reaction
Clinical narrative: This case was received on 10 December 2009 via a QScan search on the VAERS database, under reference number 356135. A 20 year old male patient received the following vaccines on 11 August 2009: ACAM2000 (lot number VV04003A); TYPHIM VI (lot number B07062); BIOTHRAX (Emergent Biosolutions, FAV198) and TWINRIX (GlaxoSmithKline, AHABB140AA). Sites of administration were not reported. Twelve days after vaccination, the patient developed fevers, chills, sweats, fatigue and decreased appetite. The patient also developed 2 lesions on the right cheek which appeared to be at the same stage as the primary vaccination lesion. No treatment was reported. The patient recovered. Note: There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. List of documents held by sender: none.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Hypoaesthesia, Nodule, Pruritus, Viral test
Clinical narrative: This case was received on 10 December 2009 via a QScan search on the VAERS database, under reference number 357581. A 29 year-old male patient received the following vaccinations on 28 August 2009: ACAM2000 (Lot number VV04-003A), TYPHIM VI (lot number BI0262) and anthrax (manufacturer unknown, lot number FAV206). Eight days after vaccination the patient noted numbness of the left tricep area. Smallpox vaccination was to the patient's right arm. Over the next few days he experienced pruritis of the left shoulder blade. One week after his symptoms began, bumps began forming near his left axilla and spread over his back. They were initially painless. A viral culture was performed and results were pending at the time of this report. No outcome was reported. No additional information was provided. NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. List of documents held by sender: None.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Alanine aminotransferase increased, Aortic valve incompetence, Aspartate aminotransferase increased, Blood calcium decreased, Electrocardiogram abnormal
Clinical narrative: This case was received on 10 December 2009 via a QScan search on the VAERS database, under reference number 358102. A 27 year old male patient received the following vaccines on 03 September 2009: a percutaneous injection of ACAM2000 (lot number VV04003A), an intramuscular injection of TYPHIM VI (lot number B1147) and an intramuscular injection of BIOTHRAX (lot number FAU197). On 12 September 2009, nine days after vaccination, the patient developed a headache for two days and chest pain with breathing for two days. The patient was referred to cardiology. Assessment revealed: aortic regurgitation. An electrocardiogram was reported as abnormal, with trace mitral regurgitation, trace tricuspid regurgitation, and mild aortic regurgitation. Laboratory results also included the following: alanine aminotransferase increased, monocyte percentage increased (12.6%), aspartate aminotransferase increased, haematocrit decreased (38.6%), red blood cell count decreased (4.28 x 10 (6)/UL, lymphocyte percentage decreased (17.40%), and blood calcium decreased. Corrective treatment was not reported. The outcome was not reported. On 23 December 2009: A corrective version was generated using the receipt date from the previous version for the sole purpose of amending the lot number for anthrax vaccine reported in the narrative. The correct lot number is FAU217. No new information was provided. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Haematocrit decreased, Headache, Lymphocyte percentage decreased, Mitral valve incompetence, Monocyte percentage increased
Clinical narrative: This case was received on 10 December 2009 via a QScan search on the VAERS database, under reference number 358102. A 27 year old male patient received the following vaccines on 03 September 2009: a percutaneous injection of ACAM2000 (lot number VV04003A), an intramuscular injection of TYPHIM VI (lot number B1147) and an intramuscular injection of BIOTHRAX (lot number FAU197). On 12 September 2009, nine days after vaccination, the patient developed a headache for two days and chest pain with breathing for two days. The patient was referred to cardiology. Assessment revealed: aortic regurgitation. An electrocardiogram was reported as abnormal, with trace mitral regurgitation, trace tricuspid regurgitation, and mild aortic regurgitation. Laboratory results also included the following: alanine aminotransferase increased, monocyte percentage increased (12.6%), aspartate aminotransferase increased, haematocrit decreased (38.6%), red blood cell count decreased (4.28 x 10 (6)/UL, lymphocyte percentage decreased (17.40%), and blood calcium decreased. Corrective treatment was not reported. The outcome was not reported. On 23 December 2009: A corrective version was generated using the receipt date from the previous version for the sole purpose of amending the lot number for anthrax vaccine reported in the narrative. The correct lot number is FAU217. No new information was provided. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Painful respiration, Red blood cell count decreased, Tricuspid valve incompetence
Clinical narrative: This case was received on 10 December 2009 via a QScan search on the VAERS database, under reference number 358102. A 27 year old male patient received the following vaccines on 03 September 2009: a percutaneous injection of ACAM2000 (lot number VV04003A), an intramuscular injection of TYPHIM VI (lot number B1147) and an intramuscular injection of BIOTHRAX (lot number FAU197). On 12 September 2009, nine days after vaccination, the patient developed a headache for two days and chest pain with breathing for two days. The patient was referred to cardiology. Assessment revealed: aortic regurgitation. An electrocardiogram was reported as abnormal, with trace mitral regurgitation, trace tricuspid regurgitation, and mild aortic regurgitation. Laboratory results also included the following: alanine aminotransferase increased, monocyte percentage increased (12.6%), aspartate aminotransferase increased, haematocrit decreased (38.6%), red blood cell count decreased (4.28 x 10 (6)/UL, lymphocyte percentage decreased (17.40%), and blood calcium decreased. Corrective treatment was not reported. The outcome was not reported. On 23 December 2009: A corrective version was generated using the receipt date from the previous version for the sole purpose of amending the lot number for anthrax vaccine reported in the narrative. The correct lot number is FAU217. No new information was provided. List of documents held by sender: none.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Arthralgia, Headache, Lymphadenopathy, Oedema peripheral, Pharyngeal oedema
Clinical narrative: This case was received on 10 December 2009 via a QScan search on the VAERS database, under reference number 358725. A 25 year old male patient received the following vaccines on 02 September 2009: a percutaneous injection of ACAM2000 (lot number reported as ACAM2000); an intramuscular injection of TYPHIM VI (lot number B0706); and BIOTHRAX (Emergent Biosolutions, lot number FAV217). The sites of administration were not reported. On the same day as vaccination the patient reported swollen lymph nodes in the neck, swelling in the throat and right arm, and joint pain in the right arm. The patient also reported experiencing headaches and blurred vision. No additional information was reported. List of documents held by sender: none.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Vision blurred
Clinical narrative: This case was received on 10 December 2009 via a QScan search on the VAERS database, under reference number 358725. A 25 year old male patient received the following vaccines on 02 September 2009: a percutaneous injection of ACAM2000 (lot number reported as ACAM2000); an intramuscular injection of TYPHIM VI (lot number B0706); and BIOTHRAX (Emergent Biosolutions, lot number FAV217). The sites of administration were not reported. On the same day as vaccination the patient reported swollen lymph nodes in the neck, swelling in the throat and right arm, and joint pain in the right arm. The patient also reported experiencing headaches and blurred vision. No additional information was reported. List of documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: SMALL, TYP
Symptoms: Abdominal pain, Behcet's syndrome, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was received on 10 December 2009 via a QScan search on the VAERS database, under reference number 360365. A 23 year old female patient received the following vaccines on 06 April 2009: a percutaneous injection of ACAM2000 (lot number not reported); an intramuscular injection of TYPHIM VI (lot number B07062); and anthrax vaccine (Emergent Biosolutions, Biothrax, lot number FAV141). The site of administration were not reported. Approximately 10 days after vaccination the patient experienced abdominal pain. The patient has a history of Behcet disease and reported an episode in July 2009. The patient's abdominal pain became severe at this time. Additional symptoms noted were blurred vision, and burning in her mouth and esophagus. The patient was also concerned with the appearance of the smallpox vaccination site. The skin over the site was described as raised, smooth, pink and shiny and the area appeared to be increasing in size. There was also pain and itching at the injection site. The patient reported the occurrence of a small keloid scar at the vaccination site with previous immunizations. No additional information was provided. NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. List of documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: SMALL, TYP
Symptoms: Oesophageal pain, Oral discomfort, Vision blurred
Clinical narrative: This case was received on 10 December 2009 via a QScan search on the VAERS database, under reference number 360365. A 23 year old female patient received the following vaccines on 06 April 2009: a percutaneous injection of ACAM2000 (lot number not reported); an intramuscular injection of TYPHIM VI (lot number B07062); and anthrax vaccine (Emergent Biosolutions, Biothrax, lot number FAV141). The site of administration were not reported. Approximately 10 days after vaccination the patient experienced abdominal pain. The patient has a history of Behcet disease and reported an episode in July 2009. The patient's abdominal pain became severe at this time. Additional symptoms noted were blurred vision, and burning in her mouth and esophagus. The patient was also concerned with the appearance of the smallpox vaccination site. The skin over the site was described as raised, smooth, pink and shiny and the area appeared to be increasing in size. There was also pain and itching at the injection site. The patient reported the occurrence of a small keloid scar at the vaccination site with previous immunizations. No additional information was provided. NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. List of documents held by sender: none.
Age: 58.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was received on 01 March 2010 via a QScan search on the VAERS database, under reference number 368202. A 58 year old male patient received the following vaccines on 12 November 2009: a percutaneous injection of ACAM2000 (lot number VV04003A); an intramuscular injection of TYPHIM VI (lot number B1147); an intramusuclar injection of BIOTHRAX (Emergent Biosolutions, lot number FAV217); and an intramuscular injection of ENGERIX-B (GlaxoSmithKline, lot number AHBVB736BA). The sites of administration were not reported. Two days post-vaccination, the patient experienced swelling, redness, itching and warmth of the right arm. The events were coded by the Health Authority as occurring at the injection site. No additional information was provided. List of documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Erythema, Induration
Clinical narrative: This case was received on 30 July 2010 via a QScan search on the VAERS database, under reference number (VAERS ID 381816). A 25-year-old female patient received the following vaccinations on 22 February 2010: ACAM2000 (lot number VV04-003A), TYPHIM VI (lot number d0191), anthrax (Other manufacturer, lot number fav223). Ten days post vaccination on 04 March 2010, the patient experienced an area of induration 6cm in diameter with red streaking down to the axillary lymph nodes under the left arm. Streaking was anterior and progressing medially and then inferiorly. The patient received "just symptomatic treatment". Recovery status was not reported. Documents held by sender: None.
Age: 33.0
Sex: F
Vaccine: ANTH, SMALL, TYP, YF
Symptoms: Erythema, Fatigue, Pain in extremity
Clinical narrative: This case was received on 30 July 2010 via a QScan search on the VAERS database, under reference number 382715. A 33-year-old female patient received the following vaccines on 06 March 2010: ACAM2000 (lot number W04-003A); TYPHIM VI (lot number B1026); YF-VAX (lot number UF583AA); and anthrax vaccine (manufacturer and lot number not reported). On 16 March 2010, 10 days post-vaccination, she complained that her arm hurt and was red, and that she felt tired. No additional information was provided, and outcome was not reported.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Blister, Dermatitis, Erythema, Papule, Paraesthesia
Clinical narrative: This case was received on 30 July 2010 via a QScan search on the VAERS database, under reference number (VAERS ID 383253). A 21-year-old male patient received the following vaccinations on 09 March 2010: ACAM2000 (lot number VV04-003A), TYPHIM VI (lot number D0191), anthrax (other manufacturer, lot number FAV214). On 17 March 2010, eight days post vaccination (also reported as seven days), the patient developed mildly pruritic pustular eruptions over his upper extremity and torso with no other systemic symptoms. On 19 March 2010, he was medically evaluated. Vital signs were normal and examination revealed erythematous papules over bilateral upper arms, chest and most on the back with few vesicles and few pustules. The vaccine site (the specific vaccine was not reported) on the right shoulder was normal; no ecchymosis. The patient was diagnosed with dermatitis and received ALLEGRA, BENADRYL and VOLTAREN as corrective treatment. The patient's clinical presentation and photos were consistent with non-IgE mediated reaction associated with smallpox vaccine. By 22 March 2010, "SM" (abbreviation not specified) improved and the patient recovered (date not reported). The patient was recommended for medical reactive exemption for future smallpox vaccine in the pre-exposure setting. It was further reported that, "Symptoms: Rash oth nonspecific skin eruption, Disturbance of skin sensation". Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Pruritus, Rash pustular
Clinical narrative: This case was received on 30 July 2010 via a QScan search on the VAERS database, under reference number (VAERS ID 383253). A 21-year-old male patient received the following vaccinations on 09 March 2010: ACAM2000 (lot number VV04-003A), TYPHIM VI (lot number D0191), anthrax (other manufacturer, lot number FAV214). On 17 March 2010, eight days post vaccination (also reported as seven days), the patient developed mildly pruritic pustular eruptions over his upper extremity and torso with no other systemic symptoms. On 19 March 2010, he was medically evaluated. Vital signs were normal and examination revealed erythematous papules over bilateral upper arms, chest and most on the back with few vesicles and few pustules. The vaccine site (the specific vaccine was not reported) on the right shoulder was normal; no ecchymosis. The patient was diagnosed with dermatitis and received ALLEGRA, BENADRYL and VOLTAREN as corrective treatment. The patient's clinical presentation and photos were consistent with non-IgE mediated reaction associated with smallpox vaccine. By 22 March 2010, "SM" (abbreviation not specified) improved and the patient recovered (date not reported). The patient was recommended for medical reactive exemption for future smallpox vaccine in the pre-exposure setting. It was further reported that, "Symptoms: Rash oth nonspecific skin eruption, Disturbance of skin sensation". Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: CSF culture negative, CSF glucose normal, CSF protein normal, CSF test normal, Encephalitis
Clinical narrative: Initial report was received on 28 September 2010 via a Q-Scan search of the VAERS database, under reference number 398858. A 24-year-old male patient with no pre-existing medical condition, no congenital defect and without chronic medical conditions, had received the following vaccinations on 28 April 2010: ACAM2000 (lot number VV040003A), TYPHIM VI (lot number D0191), and anthrax (other manufacturer, lot number not reported). he had not received any other vaccines in the 30 day window. The patient was admitted to ICU (intensive care unit) via the ED (emergency department) with "?" diagnosis of smallpox vaccinia/encephalitis (date of onset reported as 20 May 2010). Symptoms consisted of headache, generalized pain, rash and an other nonspecific skin eruption. Laboratory results included normal CSF glucose and protein; negative CSF culture; negative CSF PCR studies FR vaccinia and varicella. Recovery status was unknown. No additional information was provided. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Headache, Intensive care, Pain, Polymerase chain reaction, Rash
Clinical narrative: Initial report was received on 28 September 2010 via a Q-Scan search of the VAERS database, under reference number 398858. A 24-year-old male patient with no pre-existing medical condition, no congenital defect and without chronic medical conditions, had received the following vaccinations on 28 April 2010: ACAM2000 (lot number VV040003A), TYPHIM VI (lot number D0191), and anthrax (other manufacturer, lot number not reported). he had not received any other vaccines in the 30 day window. The patient was admitted to ICU (intensive care unit) via the ED (emergency department) with "?" diagnosis of smallpox vaccinia/encephalitis (date of onset reported as 20 May 2010). Symptoms consisted of headache, generalized pain, rash and an other nonspecific skin eruption. Laboratory results included normal CSF glucose and protein; negative CSF culture; negative CSF PCR studies FR vaccinia and varicella. Recovery status was unknown. No additional information was provided. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Vaccinia virus infection, Varicella virus test negative, Viral test negative
Clinical narrative: Initial report was received on 28 September 2010 via a Q-Scan search of the VAERS database, under reference number 398858. A 24-year-old male patient with no pre-existing medical condition, no congenital defect and without chronic medical conditions, had received the following vaccinations on 28 April 2010: ACAM2000 (lot number VV040003A), TYPHIM VI (lot number D0191), and anthrax (other manufacturer, lot number not reported). he had not received any other vaccines in the 30 day window. The patient was admitted to ICU (intensive care unit) via the ED (emergency department) with "?" diagnosis of smallpox vaccinia/encephalitis (date of onset reported as 20 May 2010). Symptoms consisted of headache, generalized pain, rash and an other nonspecific skin eruption. Laboratory results included normal CSF glucose and protein; negative CSF culture; negative CSF PCR studies FR vaccinia and varicella. Recovery status was unknown. No additional information was provided. Documents held by sender: None.
Age: 49.0
Sex: F
Vaccine: TYP
Symptoms: Hypoaesthesia, Lymphadenopathy, Muscular weakness
Clinical narrative: Initial spontaneous report received from a health care professional on 27 May 2010. A 49-year-old female patient with a history of Hashimoto's Disease received a left deltoid injection of TYPHIM VI (lot number D0191-2) on 28 April 2010. The patient had previously received oral Typhoid vaccine, and was taking SYNTHROID concomitantly. She had no known allergies, and was not ill at the time of vaccination. On 01 May 2010, 3 days post-vaccination, the patient complained of weakness in the left leg and left shoulder. Symptoms became progressively worse, and at the time of the report the patient was experiencing numbness in her left leg. She also complained of swollen lymph nodes, and noted that she had seen 4 doctors. Symptoms remained ongoing at the time of the report. Follow-up information was received from a health care professional on 02 August 2010 reported that it was unknown if the patient had undergone testing, required treatment or if the event was due to a vascular origin. No etiological workup was available. The outcome for the event was reported as unknown. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Initial report received on 28 September 2010 via a QScan search on the VAERS database, under reference number 390469. A 23-year-old male patient received the following vaccinations on 26 May 2010: ACAM2000 (lot number "VV04003A"), TYPHIM Vi (lot number D0412), BIOTHRAX (lot number FAV241) and ENGERIX-B (lot number AHBVB909AB) and 4 days post-vaccination on 30 May 2010, the patient had a lymph node in the under arm that was swollen and sore that required an emergency visit. No laboratory data was ordered. Treatment received was not reported. The patient had no prior medical history, no concurrent illnesses, and no use of other medications. Recovery status was reported as unknown. NOTE: Although the manufacturer for the smallpox vaccine was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccinations. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Adenovirus test, Biopsy skin abnormal, Cytomegalovirus test negative, Differential white blood cell count normal, Eosinophil count decreased
Clinical narrative: Initial report received on 28 September 2010 via a QScan search on the VAERS datebase, under reference number 391105. A 20-year-old male patient received the following vaccinations on 03 May 2010: ACAM2000 (lot number "VV04003A"), TYPHIM VI (lot number D0191), and anthrax (Manufacturer not reported, lot number FAV217) and 18 days post-vaccination, the patient had a possible vaccine related etiology of pruritic, papulo-vesicular rash on the upper arms and back of neck-predominantly on sun exposed areas. The patient also had several isolated lesions on the abdomen and legs bilaterally. There were no rashes on the trunk or back. The patient's tan line from his t-shirt marked the rash distribution on the upper body. Per the report, the rash began as a small patch located on the lateral aspect of the right upper arm that was extremely pruritic. The patient scratched the area excessively and about a day later the patient noticed that the rash had spread and required emergency visit. Other than the pruritic rash the patient was asymptomatic. At the time of vaccinations the patient had not experienced any recent colds or illnesses. He also had no known drug allergies. It was noted the patient was on detail pulling weeds and trimming grass the week prior to the adverse events. Laboratory tests included: Abnormal biopsy of skin, decreased eosinophil count, decreased lymphocyte percentage, and increased monocyte count. Normal laboratory tests included: negative cytomegalovirus test, herpes simplex serology, varicella virus test and viral test. The following were also normal: differential white blood cell count, haematocrit, haemoglobin, mean cell volume, mean cell haemoglobin, mean platelet volume, neutrophil count, and red blood cell count. Adenovirus test and mean cell haemoglobin concentration test results were not reported. Treatments received for the adverse events included ALLEGRA and ATARAX. The patient had no prior medical history with no known drug allergies, no recent colds, no concurrent illnesses. The patient recovered (date not reported). Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Haematocrit normal, Haemoglobin normal, Herpes simplex serology negative, Lymphocyte percentage decreased, Mean cell haemoglobin concentration
Clinical narrative: Initial report received on 28 September 2010 via a QScan search on the VAERS datebase, under reference number 391105. A 20-year-old male patient received the following vaccinations on 03 May 2010: ACAM2000 (lot number "VV04003A"), TYPHIM VI (lot number D0191), and anthrax (Manufacturer not reported, lot number FAV217) and 18 days post-vaccination, the patient had a possible vaccine related etiology of pruritic, papulo-vesicular rash on the upper arms and back of neck-predominantly on sun exposed areas. The patient also had several isolated lesions on the abdomen and legs bilaterally. There were no rashes on the trunk or back. The patient's tan line from his t-shirt marked the rash distribution on the upper body. Per the report, the rash began as a small patch located on the lateral aspect of the right upper arm that was extremely pruritic. The patient scratched the area excessively and about a day later the patient noticed that the rash had spread and required emergency visit. Other than the pruritic rash the patient was asymptomatic. At the time of vaccinations the patient had not experienced any recent colds or illnesses. He also had no known drug allergies. It was noted the patient was on detail pulling weeds and trimming grass the week prior to the adverse events. Laboratory tests included: Abnormal biopsy of skin, decreased eosinophil count, decreased lymphocyte percentage, and increased monocyte count. Normal laboratory tests included: negative cytomegalovirus test, herpes simplex serology, varicella virus test and viral test. The following were also normal: differential white blood cell count, haematocrit, haemoglobin, mean cell volume, mean cell haemoglobin, mean platelet volume, neutrophil count, and red blood cell count. Adenovirus test and mean cell haemoglobin concentration test results were not reported. Treatments received for the adverse events included ALLEGRA and ATARAX. The patient had no prior medical history with no known drug allergies, no recent colds, no concurrent illnesses. The patient recovered (date not reported). Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte count increased, Neutrophil count normal
Clinical narrative: Initial report received on 28 September 2010 via a QScan search on the VAERS datebase, under reference number 391105. A 20-year-old male patient received the following vaccinations on 03 May 2010: ACAM2000 (lot number "VV04003A"), TYPHIM VI (lot number D0191), and anthrax (Manufacturer not reported, lot number FAV217) and 18 days post-vaccination, the patient had a possible vaccine related etiology of pruritic, papulo-vesicular rash on the upper arms and back of neck-predominantly on sun exposed areas. The patient also had several isolated lesions on the abdomen and legs bilaterally. There were no rashes on the trunk or back. The patient's tan line from his t-shirt marked the rash distribution on the upper body. Per the report, the rash began as a small patch located on the lateral aspect of the right upper arm that was extremely pruritic. The patient scratched the area excessively and about a day later the patient noticed that the rash had spread and required emergency visit. Other than the pruritic rash the patient was asymptomatic. At the time of vaccinations the patient had not experienced any recent colds or illnesses. He also had no known drug allergies. It was noted the patient was on detail pulling weeds and trimming grass the week prior to the adverse events. Laboratory tests included: Abnormal biopsy of skin, decreased eosinophil count, decreased lymphocyte percentage, and increased monocyte count. Normal laboratory tests included: negative cytomegalovirus test, herpes simplex serology, varicella virus test and viral test. The following were also normal: differential white blood cell count, haematocrit, haemoglobin, mean cell volume, mean cell haemoglobin, mean platelet volume, neutrophil count, and red blood cell count. Adenovirus test and mean cell haemoglobin concentration test results were not reported. Treatments received for the adverse events included ALLEGRA and ATARAX. The patient had no prior medical history with no known drug allergies, no recent colds, no concurrent illnesses. The patient recovered (date not reported). Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Rash, Rash papular, Rash pruritic, Red blood cell count normal, Skin lesion
Clinical narrative: Initial report received on 28 September 2010 via a QScan search on the VAERS datebase, under reference number 391105. A 20-year-old male patient received the following vaccinations on 03 May 2010: ACAM2000 (lot number "VV04003A"), TYPHIM VI (lot number D0191), and anthrax (Manufacturer not reported, lot number FAV217) and 18 days post-vaccination, the patient had a possible vaccine related etiology of pruritic, papulo-vesicular rash on the upper arms and back of neck-predominantly on sun exposed areas. The patient also had several isolated lesions on the abdomen and legs bilaterally. There were no rashes on the trunk or back. The patient's tan line from his t-shirt marked the rash distribution on the upper body. Per the report, the rash began as a small patch located on the lateral aspect of the right upper arm that was extremely pruritic. The patient scratched the area excessively and about a day later the patient noticed that the rash had spread and required emergency visit. Other than the pruritic rash the patient was asymptomatic. At the time of vaccinations the patient had not experienced any recent colds or illnesses. He also had no known drug allergies. It was noted the patient was on detail pulling weeds and trimming grass the week prior to the adverse events. Laboratory tests included: Abnormal biopsy of skin, decreased eosinophil count, decreased lymphocyte percentage, and increased monocyte count. Normal laboratory tests included: negative cytomegalovirus test, herpes simplex serology, varicella virus test and viral test. The following were also normal: differential white blood cell count, haematocrit, haemoglobin, mean cell volume, mean cell haemoglobin, mean platelet volume, neutrophil count, and red blood cell count. Adenovirus test and mean cell haemoglobin concentration test results were not reported. Treatments received for the adverse events included ALLEGRA and ATARAX. The patient had no prior medical history with no known drug allergies, no recent colds, no concurrent illnesses. The patient recovered (date not reported). Documents held by sender: None.