chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Fatigue, Laboratory test, Myalgia
Clinical narrative: Information has been received from a 60 year old female consumer reporting on herself who on 07-MAR-2011 was subcutaneously vaccinated with a 0.65 ml of a dose of ZOSTAVAX (Merck) (Lot# 669588/1452Z, expiration: 28-JAN-2012). The consumer reported that the next morning after received a dose of ZOSTAVAX (Merck), on 08-MAR-2011, she started experiencing upper body muscle aches. The consumer sought medical attention by an office visit. A blood work was performed, results were not provided. The consumer received pain medication as treatment for the adverse event. At the time of reporting the consumer had not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Information has been received from a 60 year old female consumer reporting on herself who on 07-MAR-2011 was subcutaneously vaccinated with a 0.65 ml of a dose of ZOSTAVAX (Merck) (Lot# 669588/1452Z, expiration: 28-JAN-2012). The consumer reported that the next morning after received a dose of ZOSTAVAX (Merck), on 08-MAR-2011, she started experiencing upper body muscle aches. The consumer sought medical attention by an office visit. A blood work was performed, results were not provided. The consumer received pain medication as treatment for the adverse event. At the time of reporting the consumer had not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Balance disorder, Cardiac stress test, Chest pain, Echocardiogram
Clinical narrative: Information has been received from a 60 year old female consumer reporting on herself who on 07-MAR-2011 was subcutaneously vaccinated with a 0.65 ml of a dose of ZOSTAVAX (Merck) (Lot# 669588/1452Z, expiration: 28-JAN-2012). The consumer reported that the next morning after received a dose of ZOSTAVAX (Merck), on 08-MAR-2011, she started experiencing upper body muscle aches. The consumer sought medical attention by an office visit. A blood work was performed, results were not provided. The consumer received pain medication as treatment for the adverse event. At the time of reporting the consumer had not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Electrocardiogram, Fatigue, Grip strength decreased, Laboratory test, Memory impairment
Clinical narrative: Information has been received from a 60 year old female consumer reporting on herself who on 07-MAR-2011 was subcutaneously vaccinated with a 0.65 ml of a dose of ZOSTAVAX (Merck) (Lot# 669588/1452Z, expiration: 28-JAN-2012). The consumer reported that the next morning after received a dose of ZOSTAVAX (Merck), on 08-MAR-2011, she started experiencing upper body muscle aches. The consumer sought medical attention by an office visit. A blood work was performed, results were not provided. The consumer received pain medication as treatment for the adverse event. At the time of reporting the consumer had not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Muscle spasms, Myalgia, Nasal disorder, Pain, Rash
Clinical narrative: Information has been received from a 60 year old female consumer reporting on herself who on 07-MAR-2011 was subcutaneously vaccinated with a 0.65 ml of a dose of ZOSTAVAX (Merck) (Lot# 669588/1452Z, expiration: 28-JAN-2012). The consumer reported that the next morning after received a dose of ZOSTAVAX (Merck), on 08-MAR-2011, she started experiencing upper body muscle aches. The consumer sought medical attention by an office visit. A blood work was performed, results were not provided. The consumer received pain medication as treatment for the adverse event. At the time of reporting the consumer had not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Splint application
Clinical narrative: Information has been received from a 60 year old female consumer reporting on herself who on 07-MAR-2011 was subcutaneously vaccinated with a 0.65 ml of a dose of ZOSTAVAX (Merck) (Lot# 669588/1452Z, expiration: 28-JAN-2012). The consumer reported that the next morning after received a dose of ZOSTAVAX (Merck), on 08-MAR-2011, she started experiencing upper body muscle aches. The consumer sought medical attention by an office visit. A blood work was performed, results were not provided. The consumer received pain medication as treatment for the adverse event. At the time of reporting the consumer had not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test, Myalgia
Clinical narrative: Information has been received from a 60 year old female consumer reporting on herself who on 07-MAR-2011 was subcutaneously vaccinated with a 0.65 ml of a dose of ZOSTAVAX (Merck) (Lot# 669588/1452Z, expiration: 28-JAN-2012). The consumer reported that the next morning after received a dose of ZOSTAVAX (Merck), on 08-MAR-2011, she started experiencing upper body muscle aches. The consumer sought medical attention by an office visit. A blood work was performed, results were not provided. The consumer received pain medication as treatment for the adverse event. At the time of reporting the consumer had not recovered. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Breast induration, Breast pain, Breast swelling, Erythema, Injection site induration
Clinical narrative: Received vaccination in L upper arm; L breast swollen, painful, hard, and red. L arm lymph nodes swollen and hard radiating down my arm to just above elbow.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Lymphadenopathy
Clinical narrative: Received vaccination in L upper arm; L breast swollen, painful, hard, and red. L arm lymph nodes swollen and hard radiating down my arm to just above elbow.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: At 1529 patient was administered MCV4 & TDAP. Patient tolerated vaccines well and was advised to wait 15 minutes in our waiting area. Within a few seconds I heard a loud noise, and saw our patient had fainted. Patient looked pale and did not respond for a few seconds before being responsive. First responders were called & patient was transferred to pediatric clinic.
Age: 39.0
Sex: F
Vaccine: MMR, TYP
Symptoms: Anti-GAD antibody, Anti-insulin antibody, Anti-islet cell antibody, Blood glucose increased, Fatigue
Clinical narrative: Pt was in her usual state of good health prior to Dec 2008. Looking back, pt recalls developing symptoms of hyperglycemia sometime around December 2008/Jan 2009 while deployed. She experienced 3-4 month hx of polyuria, polydipsia, fatigue, and blurred vision prior to being diagnosed with T2DM. At diagnosis, her blood glucose level was greater than 440, without evidence of ketoacidosis. Documented exam at diagnosis reported BMI about 25 and absence of acanthosis. Pt was med-evac'd to another clinic after being started on oral agents. She continued on various oral agents with diet modification and varying degrees of glycemic control over the next 18 months. Following fibroid arterial embolization and suboptimal glycemic control in Jan 2010, she was hospitalized for DKA in Feb 2010. In June 2010, she was referred to a Diabetes Center where in Oct 2010, she was reclassified as having Latent Autoimmune Diabetes in Adults (LADA). At that time, she was taken off all oral agents and intensive insulin therapy was initiated. She currently is following a regimen of premeal NOVOLOG with supplementation for hyperglycemia and once daily LEVEMIR. Since diagnosis, pt has been followed through the Diabetes Center, as well as with a local primary care provider. Pt received AVA (4) vaccine in Dec 2008 and INFLUENZA vaccine in Aug 2008 prior to onset of DM-related symptoms. She denies any unusual or prolonged reactions within the first week following vaccine receipt, except for 1-2 weeks of fatigue following receipt of vaccines. Pt does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Pt does not recall a history of infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to her diagnosis of DM. Pt reports a history of gestational diabetes (GDM) in 2003; of note, she inadvertently received her first anthrax vaccine in 2003 before she knew she was pregnant. She denies previous history of elevated blood pressure levels or history of hypertension. She has a strong family hx of T2DM.
Age: 39.0
Sex: F
Vaccine: MMR, TYP
Symptoms: Glycosylated haemoglobin increased, Hyperglycaemia, Laboratory test normal, Latent autoimmune diabetes in adults, Medical diet
Clinical narrative: Pt was in her usual state of good health prior to Dec 2008. Looking back, pt recalls developing symptoms of hyperglycemia sometime around December 2008/Jan 2009 while deployed. She experienced 3-4 month hx of polyuria, polydipsia, fatigue, and blurred vision prior to being diagnosed with T2DM. At diagnosis, her blood glucose level was greater than 440, without evidence of ketoacidosis. Documented exam at diagnosis reported BMI about 25 and absence of acanthosis. Pt was med-evac'd to another clinic after being started on oral agents. She continued on various oral agents with diet modification and varying degrees of glycemic control over the next 18 months. Following fibroid arterial embolization and suboptimal glycemic control in Jan 2010, she was hospitalized for DKA in Feb 2010. In June 2010, she was referred to a Diabetes Center where in Oct 2010, she was reclassified as having Latent Autoimmune Diabetes in Adults (LADA). At that time, she was taken off all oral agents and intensive insulin therapy was initiated. She currently is following a regimen of premeal NOVOLOG with supplementation for hyperglycemia and once daily LEVEMIR. Since diagnosis, pt has been followed through the Diabetes Center, as well as with a local primary care provider. Pt received AVA (4) vaccine in Dec 2008 and INFLUENZA vaccine in Aug 2008 prior to onset of DM-related symptoms. She denies any unusual or prolonged reactions within the first week following vaccine receipt, except for 1-2 weeks of fatigue following receipt of vaccines. Pt does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Pt does not recall a history of infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to her diagnosis of DM. Pt reports a history of gestational diabetes (GDM) in 2003; of note, she inadvertently received her first anthrax vaccine in 2003 before she knew she was pregnant. She denies previous history of elevated blood pressure levels or history of hypertension. She has a strong family hx of T2DM.
Age: 39.0
Sex: F
Vaccine: MMR, TYP
Symptoms: Polydipsia, Polyuria, Therapeutic embolisation, Type 2 diabetes mellitus, Urine ketone body absent
Clinical narrative: Pt was in her usual state of good health prior to Dec 2008. Looking back, pt recalls developing symptoms of hyperglycemia sometime around December 2008/Jan 2009 while deployed. She experienced 3-4 month hx of polyuria, polydipsia, fatigue, and blurred vision prior to being diagnosed with T2DM. At diagnosis, her blood glucose level was greater than 440, without evidence of ketoacidosis. Documented exam at diagnosis reported BMI about 25 and absence of acanthosis. Pt was med-evac'd to another clinic after being started on oral agents. She continued on various oral agents with diet modification and varying degrees of glycemic control over the next 18 months. Following fibroid arterial embolization and suboptimal glycemic control in Jan 2010, she was hospitalized for DKA in Feb 2010. In June 2010, she was referred to a Diabetes Center where in Oct 2010, she was reclassified as having Latent Autoimmune Diabetes in Adults (LADA). At that time, she was taken off all oral agents and intensive insulin therapy was initiated. She currently is following a regimen of premeal NOVOLOG with supplementation for hyperglycemia and once daily LEVEMIR. Since diagnosis, pt has been followed through the Diabetes Center, as well as with a local primary care provider. Pt received AVA (4) vaccine in Dec 2008 and INFLUENZA vaccine in Aug 2008 prior to onset of DM-related symptoms. She denies any unusual or prolonged reactions within the first week following vaccine receipt, except for 1-2 weeks of fatigue following receipt of vaccines. Pt does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Pt does not recall a history of infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to her diagnosis of DM. Pt reports a history of gestational diabetes (GDM) in 2003; of note, she inadvertently received her first anthrax vaccine in 2003 before she knew she was pregnant. She denies previous history of elevated blood pressure levels or history of hypertension. She has a strong family hx of T2DM.
Age: 39.0
Sex: F
Vaccine: MMR, TYP
Symptoms: Uterine leiomyoma, Vision blurred
Clinical narrative: Pt was in her usual state of good health prior to Dec 2008. Looking back, pt recalls developing symptoms of hyperglycemia sometime around December 2008/Jan 2009 while deployed. She experienced 3-4 month hx of polyuria, polydipsia, fatigue, and blurred vision prior to being diagnosed with T2DM. At diagnosis, her blood glucose level was greater than 440, without evidence of ketoacidosis. Documented exam at diagnosis reported BMI about 25 and absence of acanthosis. Pt was med-evac'd to another clinic after being started on oral agents. She continued on various oral agents with diet modification and varying degrees of glycemic control over the next 18 months. Following fibroid arterial embolization and suboptimal glycemic control in Jan 2010, she was hospitalized for DKA in Feb 2010. In June 2010, she was referred to a Diabetes Center where in Oct 2010, she was reclassified as having Latent Autoimmune Diabetes in Adults (LADA). At that time, she was taken off all oral agents and intensive insulin therapy was initiated. She currently is following a regimen of premeal NOVOLOG with supplementation for hyperglycemia and once daily LEVEMIR. Since diagnosis, pt has been followed through the Diabetes Center, as well as with a local primary care provider. Pt received AVA (4) vaccine in Dec 2008 and INFLUENZA vaccine in Aug 2008 prior to onset of DM-related symptoms. She denies any unusual or prolonged reactions within the first week following vaccine receipt, except for 1-2 weeks of fatigue following receipt of vaccines. Pt does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Pt does not recall a history of infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to her diagnosis of DM. Pt reports a history of gestational diabetes (GDM) in 2003; of note, she inadvertently received her first anthrax vaccine in 2003 before she knew she was pregnant. She denies previous history of elevated blood pressure levels or history of hypertension. She has a strong family hx of T2DM.
Sex: U
Vaccine: PNC13
Symptoms: Injection site haematoma
Clinical narrative: This is an initial spontaneous report by a contactable physician. This physician reported on behalf of a patient who received a dose (reported as 1x/2months) of PREVENAR 13 administered intramuscularly in anterolateral femoral skin flap to prevent pneumococcal infection on an unspecified date in Apr2011. Relevant medical history included hemophilia factor-5 deficiency. Relevant concomitant medications were none. In Jun2011 the patient developed hematoma at the sight of injection of PREVNAR-13. Relevant lab data was none. At the time of report the patient had recovered from hematoma in Jun2011. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVENAR 13.
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Antinuclear antibody increased, Arthralgia, Blood test, Chest pain
Clinical narrative: Migraine, joint pain, tiredness, generally feeling unwell, chest pain, stomach ache, aching muscles, period abnormal
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Electrocardiogram abnormal, Endoscopy, Fatigue, Inflammatory marker increased, Malaise
Clinical narrative: Migraine, joint pain, tiredness, generally feeling unwell, chest pain, stomach ache, aching muscles, period abnormal
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Menstrual disorder, Migraine, Myalgia, Nerve block, Nuclear magnetic resonance imaging
Clinical narrative: Migraine, joint pain, tiredness, generally feeling unwell, chest pain, stomach ache, aching muscles, period abnormal
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Nuclear magnetic resonance imaging brain, Palpitations
Clinical narrative: Migraine, joint pain, tiredness, generally feeling unwell, chest pain, stomach ache, aching muscles, period abnormal
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Woke up the day following vaccination with bad headache, nausea (but no vomiting), fatigue, aches/pain all over.  Symptoms slowly faded over Sat/Sun (30/31 July) and were pretty much over by end of 8/1.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Hot, red circular rash around injection site, not sensitive to the touch, roughly 3cm in diameter, appeared 7 days after injection (no reaction was present prior).  Doctor  said maybe it was an infection at the injection site and quickly prescribed an antibiotic. No antibiotic was given at parent's discretion.  Redness began to fade 2 days later, not longer warm to touch 2 days later.  Faded circle still visible 15 days post-injection, but does not seem to be affecting patient's health.
Age: 1.29
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: CSF test normal, Cerebellar ataxia, Computerised tomogram head, Computerised tomogram normal, Lumbar puncture
Clinical narrative: Acute cerebellar ataxia. Diagnosed and managed by pediatric neurologist.
Age: 1.29
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Nuclear magnetic resonance imaging brain normal
Clinical narrative: Acute cerebellar ataxia. Diagnosed and managed by pediatric neurologist.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Blood test, CSF test, Heart rate increased, Skin discolouration
Clinical narrative: Vomiting & color change. Elevated heart rate. Not as responsive as normal.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Slow response to stimuli, Urine analysis, Vomiting
Clinical narrative: Vomiting & color change. Elevated heart rate. Not as responsive as normal.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (R) arm - swelling/red, red spot - 3in long 2in wide, 1/4 in swelling - arm circ.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Decreased appetite, Fatigue
Clinical narrative: Extreme weakness & tired, no appetite, no fever.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: Clnt experienced episode of syncope with mild seizure activity 1-2 minutes after vaccination. Fully recovered.
Age: 0.61
Sex: M
Vaccine: RAB
Symptoms: Pyrexia, Streptococcus test negative, Urine analysis normal
Clinical narrative: High fever 104 for 24 hours.
Age: 1.14
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised, Rash macular
Clinical narrative: Pt developed rash after 7-10 days after MMR vaccine. Rash macular, started on neck, head spread to trunk to extremities, including palm & sole. No pustular/vesicle.
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Chills, Pyrexia, Rash erythematous
Clinical narrative: Rash - erythematous & clear vesicles on face, abdomen, arms & legs. Pt stated fever, chills, temp during office visit normal but had taken fever reducer.
Age: 11.0
Sex: M
Vaccine: UNK
Symptoms: Oedema peripheral
Clinical narrative: His left upper arm area was swollen from deltoid to almost his elbow. Mom call nurse triage the night of the shot and then went to the ER. They treated him for a possible cellulitis by antibiotic. Swelling started going down by the 2nd day. (day after the shot). Much better after 2-3 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Injection site discolouration, Injection site erythema, Injection site haematoma, Injection site induration, Injection site swelling
Clinical narrative: Mom states that on Tues., July 26 around 5pm the parents noticed pt's leg swollen, red, and hot where child received (2) shots on Monday in the (Lf) leg. States will bring child to doctor. Had appointment w/doctor 7/27/11. Doctor feels that it may be a mild allergic reaction to the shot, not an infection. 7/28/11 mom states that today lf. thigh is still hard and turning dark like a bruise.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Injection site warmth
Clinical narrative: Mom states that on Tues., July 26 around 5pm the parents noticed pt's leg swollen, red, and hot where child received (2) shots on Monday in the (Lf) leg. States will bring child to doctor. Had appointment w/doctor 7/27/11. Doctor feels that it may be a mild allergic reaction to the shot, not an infection. 7/28/11 mom states that today lf. thigh is still hard and turning dark like a bruise.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Pain at injection site x 4 weeks following vaccine; resolved spontaneously.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyelonephritis, Pyrexia
Clinical narrative: Fever 101-102 degrees 24 hours after - body aches, saw MD, gave IM inj ceftriaxone & started MACROBID for presumed pyelonephritis - condition resolv. 5-8 days later.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose decreased, Fall, Gaze palsy, Hypotension, Pallor
Clinical narrative: Per mom, pt was shaking, eyes rolled backward face became pale and fell over while still sitting in her chair. We called paramedics & pt was taken to the hospital. Seizure like symptoms happened within a few minutes after vaccine was given & lasted a few seconds.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Seizure like phenomena, Tremor
Clinical narrative: Per mom, pt was shaking, eyes rolled backward face became pale and fell over while still sitting in her chair. We called paramedics & pt was taken to the hospital. Seizure like symptoms happened within a few minutes after vaccine was given & lasted a few seconds.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Red arm, welt, warm to touch.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: Left arm at site was red, irritated & sore, patient called pharmacy - told  to take TYLENOL & watch it, redness resolved.
Age: 21.0
Sex: M
Vaccine: YF
Symptoms: Eye pruritus, Eye swelling, Lip swelling, Oral pruritus, Respiratory tract congestion
Clinical narrative: Itching & swelling around eyes, lips & congestion of chest & sinuses. Given SOLU MEDROL in ER and recovered. Given epi s.q. & BENADRYL. Symptoms began approximately 10 min after vaccination. In ER 1500.
Age: 21.0
Sex: M
Vaccine: YF
Symptoms: Sinus congestion
Clinical narrative: Itching & swelling around eyes, lips & congestion of chest & sinuses. Given SOLU MEDROL in ER and recovered. Given epi s.q. & BENADRYL. Symptoms began approximately 10 min after vaccination. In ER 1500.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Rash, Skin discolouration
Clinical narrative: Patient got an unspecified rash, pretty big in size and shape, dark red/brown colored, was painful if touched. Got the rash after 10-12 hrs. of injection of ZOSTAVAX. No treatment necessary. Rash is going away after 2 days.
Age: 40.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Body temperature increased, Oedema peripheral, Pain
Clinical narrative: VS. BP 124/80 Pulse 56 T=98.2 RR 18 Bilateral arm swelling worst on left but improving, (L) axillary area. No increased warm & nontender. Hx of headaches but hx of migraine. Breast pain but none now. Tx with TYLENOL without ADVAIR for pain or return to clinic or ER.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: (L) shoulder swelling with KINRIX.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus, Skin warm
Clinical narrative: Started 7/26/11 burning & itching & warm to touch using anti-itch spray w/aloe for symptom relief & also reported to primary doctor; took BENADRYL no Rx was given .
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Dizziness, Eye pain, Headache, Middle ear effusion
Clinical narrative: C/o severe dizziness and n/v started 7/23/11. Went to ER 7/25/11 and refused to stay overnight for observation. Headache, dizziness and sharp pain to Lt eye. Dr at ER referred pt back to pt family internal medicine Dr. at 1:30 on 7/26/11, and to return to ER if symptoms persist or worsen. Says Dr. told her "she had fluid in Lt ear" takes meclizine. (Referred pt back to ER).
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Vomiting
Clinical narrative: C/o severe dizziness and n/v started 7/23/11. Went to ER 7/25/11 and refused to stay overnight for observation. Headache, dizziness and sharp pain to Lt eye. Dr at ER referred pt back to pt family internal medicine Dr. at 1:30 on 7/26/11, and to return to ER if symptoms persist or worsen. Says Dr. told her "she had fluid in Lt ear" takes meclizine. (Referred pt back to ER).
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling, Mobility decreased
Clinical narrative: On 7/20/11, pt received 1st MENACTRA. On 2nd day, deltoid started to swell & turn red - "the size of a softball" per mother. It limited use of shoulder. By 7/23/11 it started to improve.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Dyskinesia, Emotional disorder, Hypoaesthesia facial, Nervousness, Tinnitus
Clinical narrative: Numbness in face, nervousness, ringing in ears. Very emotional later had tremors jerking movements called ambulance.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Tremor
Clinical narrative: Numbness in face, nervousness, ringing in ears. Very emotional later had tremors jerking movements called ambulance.
Age: 75.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: On pt's (L) arm there is a 6" x 3.5" red, warm area that starts at the lower inj. site and extends to the elbow. Pt. denies any pain. Pt. states that this started "3 days" after receiving inj. which was yesterday.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Abnormal behaviour, Arthralgia, Asthenia, Pyrexia, Weight decreased
Clinical narrative: Weakness, arthralgia, not herself, fever after vaccination, wt loss 6 (P).
Age: 0.99
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Erythema, Exposure to communicable disease, Swelling
Clinical narrative: On 7/23 developed red raised spots and continued to break out. Was exposed to cousin with chicken pox.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dyspnoea
Clinical narrative: S.O.B - decreased B.P. for about 10 minutes then normalized.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt diagnosed with shingles on 7-25. Received vaccine on 7-6-11.
Age: 37.0
Sex: F
Vaccine: DT
Symptoms: Abscess drainage, Injection site erythema, Injection site mass, Rash, Vomiting
Clinical narrative: Initial report was received on 22 July 2011 from a consumer who is also the patient. A 37 year-old female patient with no medical history and an allergy to seafood and gluten had received an intramuscular left arm injection of DECAVAC, lot number U3399AB (not a valid sanofi pasteur lot number) on 05 July 2011 after she had stepped on a nail. On 07 July 2011, the patient experienced vomiting, a rash on her left arm, very red area of the arm from above the injection site to the elbow and a "golf-ball" sized lump at the injection site. The patient reported that symptoms continued until 11 July 2011 when she stated she started to feel better. On 12 July 2011, she "started vomiting again". On 13 July 2011, the patient had outpatient surgery to "lance" the "5cm x 5cm and 3cm deep" area. According to the patient, she continues to have a wound with packing and "treatment" (type of treatment not reported). The patient had no illness at the time of vaccination and concomitant medications were reported as none. The patient reported she had several doses of DECAVAC in the past however her last dose was received 10 or more years ago. The patient's outcome reported as not recovered. Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: DT
Symptoms: Wound treatment
Clinical narrative: Initial report was received on 22 July 2011 from a consumer who is also the patient. A 37 year-old female patient with no medical history and an allergy to seafood and gluten had received an intramuscular left arm injection of DECAVAC, lot number U3399AB (not a valid sanofi pasteur lot number) on 05 July 2011 after she had stepped on a nail. On 07 July 2011, the patient experienced vomiting, a rash on her left arm, very red area of the arm from above the injection site to the elbow and a "golf-ball" sized lump at the injection site. The patient reported that symptoms continued until 11 July 2011 when she stated she started to feel better. On 12 July 2011, she "started vomiting again". On 13 July 2011, the patient had outpatient surgery to "lance" the "5cm x 5cm and 3cm deep" area. According to the patient, she continues to have a wound with packing and "treatment" (type of treatment not reported). The patient had no illness at the time of vaccination and concomitant medications were reported as none. The patient reported she had several doses of DECAVAC in the past however her last dose was received 10 or more years ago. The patient's outcome reported as not recovered. Documents held by sender: none.
Sex: M
Vaccine: DTP
Symptoms: Dyspnoea, Erythema
Clinical narrative: Initial report was received on 21 July 2011 from a consumer, who is also the patient's parent. A 14 year-old male who was "two or three years-old" at the time of vaccination had received an injection of DTP (manufacturer, lot number, route, site and date of administration not reported) and with in a few minutes turned red and had difficulty breathing. The patient was treated in the physician's office. Treatments were not reported. According to the reporter, "it was so many years ago she had no other information to provide. She refused contact information for the patient's past or present health care professional  and wishes no further contact regarding this report. No further information was available at the time of the report. The patient's outcome was not reported. Document held by sender: none.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Breech presentation, Caesarean section, Cervical dysplasia, Drug exposure during pregnancy
Clinical narrative: Information has been received from a Certified Nurse Midwife for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female patient with abnormal pap smear (low grade squamous intraepithelial lesions) (06-JAN-2011) and no known drug reactions/allergies, who on an unspecified date was inadvertently administered IM a 0.5 ml dose of GARDASIL (lot number not provided), at about 16 weeks of gestation. Concomitant therapy included ibuprofen. The patient had an initial prenatal ultrasound on 06-JAN-2011 and no problems were reported. The patient was scheduled to have an anatomical ultrasound on 03-FEB-2011 but at the time of the report the results were pending. Patient's last menstrual period was approximately on 15-OCT-2010. Expected date of delivery was 22-JUL-2011. Follow up information has been received from a pregnancy questionnaire concerning the patient who on 05-JAN-2011 was inadvertently vaccinated IM with the first dose of GARDASIL (lot # 666163/0664Z). Other concomitant medication included prenatal vitamins. On 06-JAN-2011 an initial prenatal ultrasound (result 16 1/7 weeks). It was reported that on 06-JAN-2011 a Maternal Serum Alpha-Fetoprotein Screening (MSAFP) was performed (result: negative) and on 03-FEB-2011 a second ultrasound was performed (result: 20.3 weeks and no gross anomalies). The certified nurse midwife indicated that the estimated delivery date was on 22-JUN-2011. Follow up information has been received from the Certified Nurse Midwife concerning the student patient who on 06-JAN-2011 (previous reported as 05-JAN-2011) was vaccinated IM into the left deltoid with the first dose of GARDASIL (lot # 666163/0664Z) in undiagnosed pregnant term. Follow up information has been received from the Certified Nurse Midwife who indicated that on 03-JUN-2011 the patient delivered a normal male baby, with no congenital anomalies, at 37 1/7 weeks from LMP. The baby's weight was 6 lb 4 oz, apgar score was 8 / 9. Baby's length and head circumference were not reported. The certified nurse midwife reported that other complications included breech presentation with cesarean section for delivery. The certified nurse midwife also stated that there were no infections or illnesses during pregnancy and no other patient's concurrent medical conditions. Upon internal review, breech presentation with Cesarean delivery was considered an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test, Smear cervix abnormal, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a Certified Nurse Midwife for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female patient with abnormal pap smear (low grade squamous intraepithelial lesions) (06-JAN-2011) and no known drug reactions/allergies, who on an unspecified date was inadvertently administered IM a 0.5 ml dose of GARDASIL (lot number not provided), at about 16 weeks of gestation. Concomitant therapy included ibuprofen. The patient had an initial prenatal ultrasound on 06-JAN-2011 and no problems were reported. The patient was scheduled to have an anatomical ultrasound on 03-FEB-2011 but at the time of the report the results were pending. Patient's last menstrual period was approximately on 15-OCT-2010. Expected date of delivery was 22-JUL-2011. Follow up information has been received from a pregnancy questionnaire concerning the patient who on 05-JAN-2011 was inadvertently vaccinated IM with the first dose of GARDASIL (lot # 666163/0664Z). Other concomitant medication included prenatal vitamins. On 06-JAN-2011 an initial prenatal ultrasound (result 16 1/7 weeks). It was reported that on 06-JAN-2011 a Maternal Serum Alpha-Fetoprotein Screening (MSAFP) was performed (result: negative) and on 03-FEB-2011 a second ultrasound was performed (result: 20.3 weeks and no gross anomalies). The certified nurse midwife indicated that the estimated delivery date was on 22-JUN-2011. Follow up information has been received from the Certified Nurse Midwife concerning the student patient who on 06-JAN-2011 (previous reported as 05-JAN-2011) was vaccinated IM into the left deltoid with the first dose of GARDASIL (lot # 666163/0664Z) in undiagnosed pregnant term. Follow up information has been received from the Certified Nurse Midwife who indicated that on 03-JUN-2011 the patient delivered a normal male baby, with no congenital anomalies, at 37 1/7 weeks from LMP. The baby's weight was 6 lb 4 oz, apgar score was 8 / 9. Baby's length and head circumference were not reported. The certified nurse midwife reported that other complications included breech presentation with cesarean section for delivery. The certified nurse midwife also stated that there were no infections or illnesses during pregnancy and no other patient's concurrent medical conditions. Upon internal review, breech presentation with Cesarean delivery was considered an other important medical event. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: Convulsion, Feeling hot, Injection site macule, Otitis media, Pyrexia
Clinical narrative: Mom noted pt felt warm at 345 am (7/19/11). Gave her TYLENOL & seemed ok. Took her to daycare. Between 5-5pm, pt had high fever (104.8 Rectal) & seizure. Transported by EMS to ER. Given 150 mg TYLENOL, fever decreased. Otitis media diagnosed, antibiotics prescribed (AMOXIL). Some macules over arms/legs, & fine rash on facial cheeks bilat.
Age: 1.03
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: Rash
Clinical narrative: Mom noted pt felt warm at 345 am (7/19/11). Gave her TYLENOL & seemed ok. Took her to daycare. Between 5-5pm, pt had high fever (104.8 Rectal) & seizure. Transported by EMS to ER. Given 150 mg TYLENOL, fever decreased. Otitis media diagnosed, antibiotics prescribed (AMOXIL). Some macules over arms/legs, & fine rash on facial cheeks bilat.
Age: 54.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness, Xanthopsia
Clinical narrative: Pt. stated - extreme dizziness and items in his vision appeared to be bright yellow.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Dyskinesia, Erythema, Immediate post-injection reaction
Clinical narrative: States, "I feel faint", immediately following injection. Head fell forward while sitting in chair. Skin pale, moist. Pt began to jerk in spasmodic motions. Face became red. Right arm rigidly extended above head. Episode lasted 20-30 seconds. After incident pt states, "what happened". No nausea/vomit.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle rigidity, Pallor, Posture abnormal
Clinical narrative: States, "I feel faint", immediately following injection. Head fell forward while sitting in chair. Skin pale, moist. Pt began to jerk in spasmodic motions. Face became red. Right arm rigidly extended above head. Episode lasted 20-30 seconds. After incident pt states, "what happened". No nausea/vomit.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Feeling cold, Headache, Lethargy, Loss of consciousness, Nausea
Clinical narrative: Pt reports she "passed out" after vaccines admin. Skin cool and pale. Lethargic, c/o nausea, c/o HA. Per Dr. - no injury. Monitored in office and dc'd to father at 1035.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Pallor
Clinical narrative: Pt reports she "passed out" after vaccines admin. Skin cool and pale. Lethargic, c/o nausea, c/o HA. Per Dr. - no injury. Monitored in office and dc'd to father at 1035.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Patient received 4 immunizations today and then on the way out of the building per the patient's mom, she passed out in the elevator and then again when she got back out of the elevator. Found patient on the floor. She was breathing, alert and oriented; color pale. Pt said she hadn't eaten anything prior to the appointment. Patient's mom not sure if she hit her head, reported no pain. Patient then wheeled back to exam room. VS - B/P 96/72, P64, given crackers and juice and examined by physician.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Pruritus, Swelling, Tenderness
Clinical narrative: Approx 2 days after vaccination, patient developed 6-8 small blisters around the injection site. Patient reports itching, swelling and tenderness as well.
Age: 13.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: (L) outer aspect of arm swollen & painful. Apply ice 5 min every 2 hours IBU or TYLENOL PRN pain & swelling.
Age: 1.16
Sex: F
Vaccine: DTAPIPVHIB, MMRV, PNC13
Symptoms: Diarrhoea, Injection site rash, Pyrexia, Rash generalised
Clinical narrative: Fever first 4 days not exceeding 100.4 then diarrhea for next 3 days. Began to develop rash, that is all over body per mom, on 8/1/11. No respiratory problems noted. Referred to PCP. S/S cleared up by 8/3/11.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose increased, Myoclonus, Pallor, Unresponsive to stimuli
Clinical narrative: Pt noted pale/ leaned over to mother's shoulders. Not responsive to verbal command and with myoclonic jerk of hands and arms.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat irritation
Clinical narrative: throat became itchy
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Rash
Clinical narrative: Rash to face
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Paraesthesia oral, Rash pruritic
Clinical narrative: Itchy rash, local swelling, lip tingling. Used Benadryl to curb effects. Symptoms have pretty much resolved at time of this report. She did note have a possible hypersensitivity reaction 6 years prior to Neosporin (neomycin).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Rash
Clinical narrative: Rash and swelling in arm vaccine administered too. Benadryl recommended.
Age: 54.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Pyrexia
Clinical narrative: cold chills, fever
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: 2 CM IN DIAMETER OF RED AREA AND SLIGHTLY SWELLING
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: The patient was getting ready to exit the office, when he fainted. We stabilized patient, then took him to a room to lay down for 15 minutes for observation.  Patient was then released.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Patient ran a fever after vaccine of 100.  On 08/02/2011, patient began breaking out in a varicella rash on legs and arms.  Fever continued - 101.3. Rash continued to spread to torso, buttocks, feet, hands, face, and scalp on 08/03/2011.  Fever continued at 100.2. Patient presented with 100+ lesions.  Patient returned to doctor and was diagnosed with varicella.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS AT INJECTION SITE NOW 6-7 INCHES WIDE, WARM TO TOUCH. AREA RAISED AND SWOLLEN.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The patient experienced erythema, pain, tenderness, swelling and warmth at the site of injection.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Pt had a 3 inch in diameter red, raised area at site of vaccine. Negative itching. No other signs, symptoms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Pruritus generalised
Clinical narrative: 7/29/11 Reports lump on site with pain & redness & "feeling itchy all over", she took BENADRYL. Advised to seek medical evaluation.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Gaze palsy, Immediate post-injection reaction, Posture abnormal
Clinical narrative: 8/3/11 9:05 am - Gave pt 2 shots in (R) deltoid with no problems, gave GARDASIL in (L) deltoid. Pt immediately eyes rolled in head and head sagged down. Laid pt down. Took vitals called RN to assist, cool wash rag to head.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: PAIN, SWELLING, AND KNOT ON LEFT ARM WHERE SHOT WAS GIVEN
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bone pain, Headache, Movement disorder, Neck pain, Neurological examination
Clinical narrative: Very bad pain in neck and at base of skull.  Could barely move my head from side to side, incredible pain in cervical area of my neck when lifting my head off the pillow or turning over in bed.  Also some pain in middle and lower part of my spine.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Very bad pain in neck and at base of skull.  Could barely move my head from side to side, incredible pain in cervical area of my neck when lifting my head off the pillow or turning over in bed.  Also some pain in middle and lower part of my spine.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Neck pain, Paraesthesia, Tenderness
Clinical narrative: Very bad pain in neck and at base of skull.  Could barely move my head from side to side, incredible pain in cervical area of my neck when lifting my head off the pillow or turning over in bed.  Also some pain in middle and lower part of my spine.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bone pain, Headache, Movement disorder, Neck pain, Neurological examination
Clinical narrative: Information has been received from a 65 year old male patient with no drug allergy and no medical history who on 15-MAR-2011 was vaccinated with a dose of 0.65 ml ZOSTAVAX (Merck) (lot # not reported). There was no concomitant medication. On approximately 22-MAR-2011 (about a week later) the patient began to experience bad neck pains and a headache shooting up from the base of the neck. He also had tender spots on the top of his scalp and a tingling feeling on the scalp. The patient had called his family doctor but would also like to follow up with a neurologist. No treatment was given to the patient. Lab test was not performed. The symptoms had improved over time but he was still concerned about his recovery. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Information has been received from a 65 year old male patient with no drug allergy and no medical history who on 15-MAR-2011 was vaccinated with a dose of 0.65 ml ZOSTAVAX (Merck) (lot # not reported). There was no concomitant medication. On approximately 22-MAR-2011 (about a week later) the patient began to experience bad neck pains and a headache shooting up from the base of the neck. He also had tender spots on the top of his scalp and a tingling feeling on the scalp. The patient had called his family doctor but would also like to follow up with a neurologist. No treatment was given to the patient. Lab test was not performed. The symptoms had improved over time but he was still concerned about his recovery. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Neck pain, Paraesthesia, Tenderness
Clinical narrative: Information has been received from a 65 year old male patient with no drug allergy and no medical history who on 15-MAR-2011 was vaccinated with a dose of 0.65 ml ZOSTAVAX (Merck) (lot # not reported). There was no concomitant medication. On approximately 22-MAR-2011 (about a week later) the patient began to experience bad neck pains and a headache shooting up from the base of the neck. He also had tender spots on the top of his scalp and a tingling feeling on the scalp. The patient had called his family doctor but would also like to follow up with a neurologist. No treatment was given to the patient. Lab test was not performed. The symptoms had improved over time but he was still concerned about his recovery. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram head, Computerised tomogram normal, Differential white blood cell count normal, Dizziness, Fatigue
Clinical narrative: Received #2 dose of HPV4 (Gardasil) and approximately 10 minutes after receiving the vaccine she started feeling dizzy.  She was seen in the office 8-2-11 with persistant dizziness and complaints of fatigue.  No vomiting, but is nauseated.  She feels like her "world is spinning."  No changes with position, the dizziness is constant.  Has been afebrile. These symptoms have persisted since vaccination.  LMP:  7-18-2011.  Orthostatic BP at 8-2-11 office visit:  Supine  134/80; sitting  124/77; standing  119/79.  Was prescribed Meclizine 25mg, 1-2 tabs BID-TID prn dizziness.  CBC W/ diff, CMP, Thyroid screen, CAT scan of brain all WNL. BMI:  39.68.  Birth control: Depo Provera.