chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Sensory disturbance, Treponema test negative, Vitamin B12 normal
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of acute inflammatory demyelinating polyradiculoneuropathy in a 19-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included asthma. Concurrent vaccination included typhoid vaccine (non-gsk); Crucell; oral given on 13 February 2012. Concurrent medications included "loestrogen". On 13 February 2012 the subject received unspecified dose of HAVRIX (1 ml, unknown route, right arm). On 26 February 2012, 13 days after vaccination with HAVRIX, the subject experienced acute inflammatory demyelinating polyradiculoneuropathy ("acute inflammatory demyelinating polyneuropathy mild presentation"). The subject received 4 doses of oral typhoid vaccine from 13 February 2012 to 19 February 2012. The healthcare professional did not consider the oral typhoid vaccine as co-suspect. The subject required medical attention at her physician's office. This case was assessed as medically serious by GSK. At the time of reporting the event was unresolved. The healthcare professional considered the event was possibly related to vaccination with HAVRIX. Follow-up information was received on 08 May 2012 via healthcare professional who reported signs and symptoms included progressive numbness feet, hands and legs started on 27 February 2012. The subject experienced absent reflexes and paresthesia to the distal extremities. On 27 February 2012 the subject noted decreases sensation, tingling and subjective weakness to toes. The sensation progress to included both feet within the next 24 hours, then the finger tips on day three and later in hands the fourth day. Decreased reflexes on [illegible]. Ad Hepatitis A and first dose of oral typhoid on 13 February 2012. Typhoid completed on 19 February 2012. On day eight sensation changed progress to lower legs. At follow-up six weeks after tingling remained only in feet. The subject had a magnetic resonance image performed on 03 March 2012 reported included impression of single nonspecific T2 hyperintense focus in the right parietal lobe; probable DVA in the left inferior cerebellum; no definite acute intracranial abnormality. The subject may benefit from follow-up imaging if there is clinical concern for a demyelinating process such as multiple sclerosis, however. A follow-up study may also be of value to assess for anticipated stability in the left inferior cerebellum. The healthcare professional clarified oral typhoid vaccine as co-suspect was considered suspect contributing to the event. Immunization series with HAVRIX was discontinued. At the time of the report the acute inflammatory demyelinating polyradiculoneuropathy had improved.
Age: 19.0
Sex: F
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Vitamin D
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of acute inflammatory demyelinating polyradiculoneuropathy in a 19-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included asthma. Concurrent vaccination included typhoid vaccine (non-gsk); Crucell; oral given on 13 February 2012. Concurrent medications included "loestrogen". On 13 February 2012 the subject received unspecified dose of HAVRIX (1 ml, unknown route, right arm). On 26 February 2012, 13 days after vaccination with HAVRIX, the subject experienced acute inflammatory demyelinating polyradiculoneuropathy ("acute inflammatory demyelinating polyneuropathy mild presentation"). The subject received 4 doses of oral typhoid vaccine from 13 February 2012 to 19 February 2012. The healthcare professional did not consider the oral typhoid vaccine as co-suspect. The subject required medical attention at her physician's office. This case was assessed as medically serious by GSK. At the time of reporting the event was unresolved. The healthcare professional considered the event was possibly related to vaccination with HAVRIX. Follow-up information was received on 08 May 2012 via healthcare professional who reported signs and symptoms included progressive numbness feet, hands and legs started on 27 February 2012. The subject experienced absent reflexes and paresthesia to the distal extremities. On 27 February 2012 the subject noted decreases sensation, tingling and subjective weakness to toes. The sensation progress to included both feet within the next 24 hours, then the finger tips on day three and later in hands the fourth day. Decreased reflexes on [illegible]. Ad Hepatitis A and first dose of oral typhoid on 13 February 2012. Typhoid completed on 19 February 2012. On day eight sensation changed progress to lower legs. At follow-up six weeks after tingling remained only in feet. The subject had a magnetic resonance image performed on 03 March 2012 reported included impression of single nonspecific T2 hyperintense focus in the right parietal lobe; probable DVA in the left inferior cerebellum; no definite acute intracranial abnormality. The subject may benefit from follow-up imaging if there is clinical concern for a demyelinating process such as multiple sclerosis, however. A follow-up study may also be of value to assess for anticipated stability in the left inferior cerebellum. The healthcare professional clarified oral typhoid vaccine as co-suspect was considered suspect contributing to the event. Immunization series with HAVRIX was discontinued. At the time of the report the acute inflammatory demyelinating polyradiculoneuropathy had improved.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Headache, Malaise, Pyrexia, Urticaria
Clinical narrative: 5 yr. immunizations given 05/08/12 at WCE. C/O H/A. 5/9/12 AM & 'not feeling well'; fever began that afternoon at school & hive patch (Lt) cheek - (resolved before exam). No rashes. Tx with Ibuprofen q6-8 hours. Call for F.U. appt. if s/s increase.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a nurse practitioner concerning an 82 year old female patient with allergy to ZITHROMAX who in 2008 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot# not provided) "by an unspecified pharmacist". Concomitant therapy included SYNTHROID, metoprolol and unspecified supplements. It was reported that on approximately 23-APR-2012 "earlier last week", the patient developed shingles. The nurse stated that it was a horrible case of the shingles, it was in the genital areas and wide spread over entire dermatome area. The patient was treated with SILVADENE on lesion, acyclovir and hydrocodone. No laboratory tests were performed. At the time of the report, the patient had not recovered from the event. The patient contacted the nurse practitioner. Shingles was considered to be disabling by the reporting nurse practitioner, "the patient was in pain". This is one of several reports received from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Axillary pain, Erythema, Haemoglobin decreased, Injection site mass, Injection site swelling
Clinical narrative: 5/1/12 Pt states she started to have pain (Lt) axilla & (Lt) arm in 4 days swelling/lump on deltoid. Redness on whole (Lt) arm up to elbow 4/28/12, 4/29/12. Started getting better 4/30/12. On 4/20/12 pt was sent from our office with a hgb of 83 for blood transfusion at medical center 2 units packed cells on 4-26-12.
Age: 50.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Pain in extremity
Clinical narrative: 5/1/12 Pt states she started to have pain (Lt) axilla & (Lt) arm in 4 days swelling/lump on deltoid. Redness on whole (Lt) arm up to elbow 4/28/12, 4/29/12. Started getting better 4/30/12. On 4/20/12 pt was sent from our office with a hgb of 83 for blood transfusion at medical center 2 units packed cells on 4-26-12.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Within minutes after administration the patient's forearm (left) became red and raised rash. I kept patient in pharmacy for 30 minutes, rash lightened, instructed to take antihistamine and call 911 if it progressed or trouble breathing.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes
Clinical narrative: Pt woke up with cold sore and took 2 tablets of acyclovir 200mg. Called pharmacy, told pt not recommended to take antivirus & to follow up with MD office. Called Merck to verify they recommended filling out report.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: Pt woke up with cold sore and took 2 tablets of acyclovir 200mg. Called pharmacy, told pt not recommended to take antivirus & to follow up with MD office. Called Merck to verify they recommended filling out report.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Death
Clinical narrative: Information has been received from a consumer, concerning a 16 month old brother, who approximately in May 1982 ("30 years ago"), was vaccinated with a dose of MMR II (Lot #, dose and route not reported). It was reported that approximately in May 1982 ("30 years ago") the patient died after getting a MMR II shot. The cause of death was unknown. It was reported to the Center for Disease Control. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: MMR
Symptoms: Brain operation, Vaccination complication
Clinical narrative: Information has been received from a patient's mother reporting about her 15 year old daughter, who on unknown date was vaccinated with the first dose of MMR II (lot#, dose and route not reported). Patient's mother reported that her daughter on unknown date had a reaction to the first MMR II shot but she was fine after the second one. The patient had a brain surgery 1 and a half years ago. Upon internal review, brain surgery was consider to be an other important medical event. At the time of reporting the patient status was unknown. It was unknown if the patient sought medical attention. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Blindness
Clinical narrative: Father report that child woke up blind the next morning. He brought her to the clinic & he was instructed to take the child to the emergency room.
Age: 56.0
Sex: M
Vaccine: TYP
Symptoms: Dehydration, Dizziness
Clinical narrative: Rolling over in bed made it feel like the room was spinning. This continued until 8:00 AM. Slightly dehydrated after getting up. No fever.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Site of injection red, swollen entire top of arm, hard knot where injection was administered, warm to the touch. He is complaining that it itches and hurts.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Site of injection red, swollen entire top of arm, hard knot where injection was administered, warm to the touch. He is complaining that it itches and hurts.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph Nodes under collar bone and under arm.
Age: 0.53
Sex: F
Vaccine: DPP
Symptoms: Abnormal behaviour, Crying, Decreased appetite, Irritability, Lethargy
Clinical narrative: Lethargy initially, Irritability, clinginess, loss of appetite, constant whining/crying, regression of skills (was sitting but prefers to lie down now).
Age: 0.53
Sex: F
Vaccine: DPP
Symptoms: Regressive behaviour
Clinical narrative: Lethargy initially, Irritability, clinginess, loss of appetite, constant whining/crying, regression of skills (was sitting but prefers to lie down now).
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autism spectrum disorder, Body temperature increased, Crying
Clinical narrative: Temperature of 101.0 for about a day.  My child was inconsolable for 6 hours after the vaccination. He cried the entire 6 hours nonstop. At birth he was given the same vaccine without my knowledge and as a result had a high fever and was given IV antibiotics. My son now has an Autism spectrum disorder.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Nerve block
Clinical narrative: CHRONIC AND SEVERE DAILY HEADACHES.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Blood culture negative, Cerebral cyst, Computerised tomogram head normal, Decreased activity
Clinical narrative: CHRONIC AND SEVERE DAILY HEADACHES.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Enterovirus test negative, Fatigue, Headache, Herpes simplex serology negative, Hyperacusis
Clinical narrative: CHRONIC AND SEVERE DAILY HEADACHES.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Insomnia, Intracranial pressure increased, Neck pain, Nerve block, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: CHRONIC AND SEVERE DAILY HEADACHES.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Obesity, Oedema peripheral, Pain, Photophobia, Pregnancy test urine negative
Clinical narrative: CHRONIC AND SEVERE DAILY HEADACHES.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Psychiatric evaluation normal, Red blood cell count decreased, Tinnitus, Varicella virus test negative
Clinical narrative: CHRONIC AND SEVERE DAILY HEADACHES.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site cyst, Ultrasound scan normal, Vaccination site pain
Clinical narrative: Large soft tender cystic-like structure at vaccine site on left thigh area.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Severe swelling and erythema 10cm x 8cm around injection site.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia, Rash erythematous, Rash morbilliform
Clinical narrative: 5-4-12 Mother report 5 mo. old with red dots to scalp & neck. Slight fever 5-3-12, infant alert, oriented report no distress. Advised PCP visit to evaluate rash. ER Dr at hospital advised was "a measle like rash due to live vaccine - ROTATEQ. Mother reports a few more spots on legs & arms. 5-8-12 Check on infant-mother reports infant fine & rash fading.
Age: 28.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site is swollen and red. No fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. has redness, soreness, swelling and itching at site of injection. Symptoms began w/i 24 hrs of receiving vaccine. Pt stated she will take BENADRYL.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Arthralgia, Herpes zoster, Myalgia, Neck pain
Clinical narrative: I developed a case of shingles 12 days after receiving the Shingles (Zoster) vaccine. Rash on left side of neck, extreme pain along left side of neck, left arm and all muscles of left shoulder and joint. Was given anti-viral drug 7 days after symptoms appeared. It's been three months and there is no let-up in terrible nerve pain along the area described. I am left handed and cannot write, nor use my hand or arm in any other way without triggering more nerve pain. I am a daily swimmer, more than 30 years, and because of the vaccine cannot swim either. Although I was given a fact sheet of benefits & risks, it was missing so much risk information as to be useless in helping me to decide if I should take my doctor's advice. I can also say that MERCK is heavily advertising their Shingles vaccine on TV. I am very angry at what has happened to my life.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain, Pain in extremity, Rash
Clinical narrative: I developed a case of shingles 12 days after receiving the Shingles (Zoster) vaccine. Rash on left side of neck, extreme pain along left side of neck, left arm and all muscles of left shoulder and joint. Was given anti-viral drug 7 days after symptoms appeared. It's been three months and there is no let-up in terrible nerve pain along the area described. I am left handed and cannot write, nor use my hand or arm in any other way without triggering more nerve pain. I am a daily swimmer, more than 30 years, and because of the vaccine cannot swim either. Although I was given a fact sheet of benefits & risks, it was missing so much risk information as to be useless in helping me to decide if I should take my doctor's advice. I can also say that MERCK is heavily advertising their Shingles vaccine on TV. I am very angry at what has happened to my life.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: On 5/3/12 10-11cm circular dull redness in (L) upper arm midline redness 5-6cm posteriorly within - bright red the site of ZOSTAVAX vaccine. That was given 2 days ago. Treatment. Heat to site 15min x3d continue ibuprofen 200mg f/u if increased pain or swelling.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Pharyngeal oedema
Clinical narrative: Flush, swollen throat.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Culture, Erythema, Papule
Clinical narrative: 4 1/2 x 5 inch x 4 inch area of erythema 1 x 1 1/2 inch area with 1 blister & small papules.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Extreme injection site - pain, stiffness, hematoma.
Age: 32.0
Sex: F
Vaccine: FLUN3
Symptoms: Conjunctivitis, Influenza, Keratitis, Lymph gland infection, Sinusitis
Clinical narrative: 1. Flu. 2. Sinus infection. 3. Conjunctivitis. 4. Sinus infection. 5. Keratitis (ongoing). 6. Lymph node infection (ongoing) 7 rounds of antibiotics since Oct 2012 when vacc was rec.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Skin red, hot warm, swollen, 8 cm & hard.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm to touch injection site.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood iron, Blood thyroid stimulating hormone, Full blood count, Metabolic function test, Paraesthesia
Clinical narrative: Pt has been having a tingling sensation on her arms, heels and toes since she received the HPV4 vaccine. This was her 2nd dose of the vaccine. This has been happening intermittently and will last for 10-15 minutes each time.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Paraesthesia
Clinical narrative: Pt has been having a tingling sensation on her arms, heels and toes since she received the HPV4 vaccine. This was her 2nd dose of the vaccine. This has been happening intermittently and will last for 10-15 minutes each time.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Dizziness, Fall, Feeling cold, Muscle rigidity
Clinical narrative: After injection, He became pale, started to slump forward and was nonresponsive. While being assisted to geri chair became rigid from shoulders to feet. Episode lasted 5-10 seconds. 911 called at 2:40 PM. Feet elevated, cool compress applied to forehead, B/P 108/54 P-63. At 2:44 remains pale, but more alert. At 2:45 B/P 94/57 P71 Remains in chair. At 2:46 PM Paramedics arrived. Report given. Patient complaint of being cold and shivering. Not diaphoretic, remains pale and subdued in mannerisms. Paramedics had patient ambulate to stretcher. Patient gestered with finger making circles indicating he was dizzy. At 2:51 PM transported to Hospital by ambulance.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: After injection, He became pale, started to slump forward and was nonresponsive. While being assisted to geri chair became rigid from shoulders to feet. Episode lasted 5-10 seconds. 911 called at 2:40 PM. Feet elevated, cool compress applied to forehead, B/P 108/54 P-63. At 2:44 remains pale, but more alert. At 2:45 B/P 94/57 P71 Remains in chair. At 2:46 PM Paramedics arrived. Report given. Patient complaint of being cold and shivering. Not diaphoretic, remains pale and subdued in mannerisms. Paramedics had patient ambulate to stretcher. Patient gestered with finger making circles indicating he was dizzy. At 2:51 PM transported to Hospital by ambulance.
Age: 19.0
Sex: F
Vaccine: HEPAB
Symptoms: Head injury, Loss of consciousness
Clinical narrative: About one minute after receiving vaccine passed out and struck head against wall at the front desk. Patient regained consciousness and was A/0 x 3.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: She has noted redness and swelling to there left arm, surrounding the injection site. Denies pain, but does note itching.  There is mild erythema to the posterior deltoid region, no pain or tenderness to palpation.  No vesicles noted.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Malaise, Pyrexia
Clinical narrative: Fever - chills. Joint pain. General malaise.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic shock, Pulmonary oedema, Pyrexia, Vaccination error
Clinical narrative: Fever - chills. Joint pain. General malaise.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Cellulitis of the arm at injection site. Red, hot, swollen, tender over most of the left upper arm.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Cellulitis of the arm at injection site. Red, hot, swollen, tender over most of the left upper arm.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Electrocardiogram, Haematocrit, Haemoglobin, Headache
Clinical narrative: Dizziness & HA. Started 10 min. after vaccine. Went away & then returned. Went to ER & had a normal EKG & bloodwork & was released.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Metabolic function test
Clinical narrative: Dizziness & HA. Started 10 min. after vaccine. Went away & then returned. Went to ER & had a normal EKG & bloodwork & was released.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test normal, Dizziness, Electrocardiogram normal, Headache
Clinical narrative: Dizziness & HA. Started 10 min. after vaccine. Went away & then returned. Went to ER & had a normal EKG & bloodwork & was released.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pruritus
Clinical narrative: Patient noticed lump and itching night of 5-9-12 when trying to sleep. MD observed a red, egg-sized lump that was itchy at the injection site morning of 5-10-12. Lump is not hot or painful & patient has no temperature.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Pain in extremity, Rash, Rash macular, Skin discolouration
Clinical narrative: One to two days following vaccination patient developed a fine, pin point rash on both lower legs.  The rash progressively worsened, becoming large blotches.  Went to Urgent Care and received anti-inflammatory, with no improvement.  Developed cellulitis in right foot.  Went to ER X2 and received Rocephin 1 Gram IV x 3, Ceptra double strength.  Rash appeared to follow veins on lower legs.  No pain other than right foot when walking.  Diagnosed with vascular cellulitis in ER.  Rash remains, some swelling but has gone down, right and foot ankle slightly bluish in color.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: One to two days following vaccination patient developed a fine, pin point rash on both lower legs.  The rash progressively worsened, becoming large blotches.  Went to Urgent Care and received anti-inflammatory, with no improvement.  Developed cellulitis in right foot.  Went to ER X2 and received Rocephin 1 Gram IV x 3, Ceptra double strength.  Rash appeared to follow veins on lower legs.  No pain other than right foot when walking.  Diagnosed with vascular cellulitis in ER.  Rash remains, some swelling but has gone down, right and foot ankle slightly bluish in color.
Age: 92.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient administered Herpes Zoster Vaccine.  After administration it was discovered that a previous dose had been administered 3 years prior. No adverse events currently noted.
Age: 31.0
Sex: M
Vaccine: YF
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient did not have an Adverse recaction. Patient was accidentally given two injections of Yellow Fever.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event noted. Patient inadvertently received a second dose of Zostavax.  Received first dose in 2006.
Age: 1.28
Sex: F
Vaccine: MMR
Symptoms: Convulsion, Full blood count abnormal, Platelet count increased, Pyrexia, White blood cell count increased
Clinical narrative: 2 minute seizure associated with a fever of 101.2 degrees.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC13, RV1
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Child given both Pentacel and Pediarix at this visit.  No adverse avent noted at this time.  The family was informed of the immunization error.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling underneath site of injection.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Dyspnoea, Fatigue, Injection site erythema
Clinical narrative: Pt reports on evening of 05/08/2012 (same day as shot) she had some minor tenderness and a very small red bump at injection site. She reports when she woke up on 05/09/2012 the bump had increased slightly to a little smaller than a dime. She reports she did take 1 Tylenol at that time which helped tenderness for awhile. Pt states by that afternoon she felt chills, very fatigued, mildly feverish and a clear nasal drainage. She said she also was experiencing "sharp pains in throat". Her arm is rather very tender and whole shoulder is tender with movement and touch - rates as a 6 on a 0-10 pain scale. She thinks her bicep area appears swollen slightly, but no redness or warmth outside of dime size bump. Pt did notice yesterday evening/late afternoon she became very itchy all over and she started to develop hives on her chest and lower neck. Today hives have spread to her legs and she "feels as if she has something in her throat". Lips are not swollen, still very fatigued and chills with nasal drainage. Has not taken temperature. She states she does feel a bit short of breath with exertion, more than normal. I discussed normal side effects such as pain, redness, mild swelling and red bump even, but that hives, throat sensation, itching and some dyspnea is abnormal. Pt reports she has called her OB who told her to call HD and to continue Tylenol as needed. I recommended she be seen in urgent care to address breathing concerns. Pt agrees to this and I will follow up with her tomorrow.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Maternal exposure during pregnancy, Oropharyngeal pain, Pain
Clinical narrative: Pt reports on evening of 05/08/2012 (same day as shot) she had some minor tenderness and a very small red bump at injection site. She reports when she woke up on 05/09/2012 the bump had increased slightly to a little smaller than a dime. She reports she did take 1 Tylenol at that time which helped tenderness for awhile. Pt states by that afternoon she felt chills, very fatigued, mildly feverish and a clear nasal drainage. She said she also was experiencing "sharp pains in throat". Her arm is rather very tender and whole shoulder is tender with movement and touch - rates as a 6 on a 0-10 pain scale. She thinks her bicep area appears swollen slightly, but no redness or warmth outside of dime size bump. Pt did notice yesterday evening/late afternoon she became very itchy all over and she started to develop hives on her chest and lower neck. Today hives have spread to her legs and she "feels as if she has something in her throat". Lips are not swollen, still very fatigued and chills with nasal drainage. Has not taken temperature. She states she does feel a bit short of breath with exertion, more than normal. I discussed normal side effects such as pain, redness, mild swelling and red bump even, but that hives, throat sensation, itching and some dyspnea is abnormal. Pt reports she has called her OB who told her to call HD and to continue Tylenol as needed. I recommended she be seen in urgent care to address breathing concerns. Pt agrees to this and I will follow up with her tomorrow.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus generalised, Pyrexia, Rhinorrhoea, Sensation of foreign body, Swelling
Clinical narrative: Pt reports on evening of 05/08/2012 (same day as shot) she had some minor tenderness and a very small red bump at injection site. She reports when she woke up on 05/09/2012 the bump had increased slightly to a little smaller than a dime. She reports she did take 1 Tylenol at that time which helped tenderness for awhile. Pt states by that afternoon she felt chills, very fatigued, mildly feverish and a clear nasal drainage. She said she also was experiencing "sharp pains in throat". Her arm is rather very tender and whole shoulder is tender with movement and touch - rates as a 6 on a 0-10 pain scale. She thinks her bicep area appears swollen slightly, but no redness or warmth outside of dime size bump. Pt did notice yesterday evening/late afternoon she became very itchy all over and she started to develop hives on her chest and lower neck. Today hives have spread to her legs and she "feels as if she has something in her throat". Lips are not swollen, still very fatigued and chills with nasal drainage. Has not taken temperature. She states she does feel a bit short of breath with exertion, more than normal. I discussed normal side effects such as pain, redness, mild swelling and red bump even, but that hives, throat sensation, itching and some dyspnea is abnormal. Pt reports she has called her OB who told her to call HD and to continue Tylenol as needed. I recommended she be seen in urgent care to address breathing concerns. Pt agrees to this and I will follow up with her tomorrow.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness, Urticaria
Clinical narrative: Pt reports on evening of 05/08/2012 (same day as shot) she had some minor tenderness and a very small red bump at injection site. She reports when she woke up on 05/09/2012 the bump had increased slightly to a little smaller than a dime. She reports she did take 1 Tylenol at that time which helped tenderness for awhile. Pt states by that afternoon she felt chills, very fatigued, mildly feverish and a clear nasal drainage. She said she also was experiencing "sharp pains in throat". Her arm is rather very tender and whole shoulder is tender with movement and touch - rates as a 6 on a 0-10 pain scale. She thinks her bicep area appears swollen slightly, but no redness or warmth outside of dime size bump. Pt did notice yesterday evening/late afternoon she became very itchy all over and she started to develop hives on her chest and lower neck. Today hives have spread to her legs and she "feels as if she has something in her throat". Lips are not swollen, still very fatigued and chills with nasal drainage. Has not taken temperature. She states she does feel a bit short of breath with exertion, more than normal. I discussed normal side effects such as pain, redness, mild swelling and red bump even, but that hives, throat sensation, itching and some dyspnea is abnormal. Pt reports she has called her OB who told her to call HD and to continue Tylenol as needed. I recommended she be seen in urgent care to address breathing concerns. Pt agrees to this and I will follow up with her tomorrow.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Swelling, redness, heat at site of the injection, severe headache - all worsening over the next 36h, then also started having rash with swelling, itching on the L side of her body and down the L arm.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Swelling
Clinical narrative: Swelling, redness, heat at site of the injection, severe headache - all worsening over the next 36h, then also started having rash with swelling, itching on the L side of her body and down the L arm.
Age: 1.06
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: High fever started 04/07/2012 and lasted until 04/09/2012. Rash states to develop on 04/10/2012.
Sex: M
Vaccine: FLU3
Symptoms: Jaundice neonatal, Maternal exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of jaundice in a male neonate subject who was exposed to FLULAVAL (GlaxoSmithKline) received by the mother while pregnant. On 5 October 2011 at 16:10 the mother received a dose of FLULAVAL at 0.5 ml in the right arm. The baby experienced maternal vaccine exposure. The mother's date of last menstrual period was not reported and her estimated date of delivery was 24 December 2011. 07 May 2012: It was reported that conception was normal and there was no in-vitro fertilization. The mother had received FLULAVAL at 29 weeks gestation on 05 October 2011. The live, male neonate was delivered on 22 December 2011 (40 weeks gestation) via forceps assisted, vaginal delivery. The neonate weighed 7 pounds and 4 ounces at birth and was 20 inches in length. No birth defects were noted; however, the neonate experienced jaundice at birth requiring no phototherapy. Jaundice was considered to be medically serious via GlaxoSmithKline. The subject was discharged in usual time. In the reporter's opinion, the event was not considered to be related to vaccination with FLULAVAL.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site streaking
Clinical narrative: Extensive redness and streaking at injection site. DR said it was cellulitis. Gave prednisone and cephalexin.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Chest pain, Dizziness, Electrocardiogram abnormal, Erythema, Headache
Clinical narrative: Received pneumonia vaccine (poly 23) on 2-21-12 in (L) delt. States chest pain began 2 hrs later. Went to E.R. EKG - tachy. (L) arm redness also c/o headache, dizziness. Ice applied to arm TID x 3 days - labs OK - chest pain resolved 2-22-12 will defer anymore PNEUMOVAX.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Laboratory test normal, Tachycardia
Clinical narrative: Received pneumonia vaccine (poly 23) on 2-21-12 in (L) delt. States chest pain began 2 hrs later. Went to E.R. EKG - tachy. (L) arm redness also c/o headache, dizziness. Ice applied to arm TID x 3 days - labs OK - chest pain resolved 2-22-12 will defer anymore PNEUMOVAX.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Body temperature decreased, Cardiac arrest, Convulsion, Renal failure, Respiratory arrest
Clinical narrative: Received shots on 4/24/12 (3pm appointment time). 5/4/12 went down for nap -> checked in 90 min & not breathing. ER chart received. CPR started at scene 1543. At ER 1553 in triage. Asystole on strip. 1608 temp 96.7. By 1608 pulse without compression, epinephrine drip. Renal failure by next day. No spont respiration. Seizures (+) after event.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Resuscitation
Clinical narrative: Received shots on 4/24/12 (3pm appointment time). 5/4/12 went down for nap -> checked in 90 min & not breathing. ER chart received. CPR started at scene 1543. At ER 1553 in triage. Asystole on strip. 1608 temp 96.7. By 1608 pulse without compression, epinephrine drip. Renal failure by next day. No spont respiration. Seizures (+) after event.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Patients mother called 5/4/12, day after Dtap-IPV injection saying she had a red circular reaction to left thigh. No fever, was taken to ER that night & was put on BACTRIM. Patient returned to office 5/5/12 with 3 3/4 in x 2 1/2 circular reaction. Advised to give BENADRYL. Spoke with patients mother on 5/9/12 and was doing well.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Skin warm, Tenderness
Clinical narrative: Red area (approximately 2 inches x 3 inches) around injection site, warmth, tender to touch. Told pt to use BENADRYL & ice.
Age: 1.07
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Full blood count, Petechiae, Pyrexia, Rash
Clinical narrative: Fever, rash, petechiae.
Age: 48.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Abdominal pain lower, Documented hypersensitivity to administered drug, Nausea, Neuralgia
Clinical narrative: 10 hours s/p vaccines c/o nausea; lower abdominal cramping, back "nerve pain". C/O sulfa in Hep B vaccine that she is allergic to.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site rash, Injection site warmth, Rash erythematous
Clinical narrative: Rash developed at injection site. Patient noticed adverse effect within 24 hours of injection. Rash is red, warm, and feels hard at injection site. No fever is reported. Immunizer advised patient to report to MD if rash worsens or does not subside.
Age: 50.0
Sex: F
Vaccine: JEV1
Symptoms: Injection site swelling, Pruritus
Clinical narrative: After receiving the Encephalitis vaccine she was fine. Within 10 minutes she had swelling at injection site and itching of feet. We followed protocol by administrating BENADRYL 50 mg, Epinephrine 0.3 ml, SOLUMEDROL 125 mg, PEPCID.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV1, DTAPIPVHIB, RV1
Symptoms: Convulsion, Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: Initial report was received from a health care professional, who was also the patient's aunt, on 30 April 2012. A two-month-old female patient had received dose one of an intramuscular injection of PENTACEL, sanofi pasteur Ltd., lot number C4115AA (administration site not reported) on 06 April 2012. She also received dose one of oral ROTARIX Vaccine, GSK, lot number A41SBZ47A on same day, 06 April 2012. Approximately 48 hours later, on 08 April 2012, the patient experienced a seizure. The reporter stated she witnessed the event as the patient was also her niece, and she observed the patient's body tightened up, she turned red and her lips turned blue. The patient was taken to the emergency room "ER", and she was hospitalized for seven days, then released to home on anti-seizure medications. The patient's outcome was reported as recovered (date not reported). Documents held by sender: None.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV1, DTAPIPVHIB, RV1
Symptoms: Convulsion, Cyanosis, Erythema, Muscle tightness
Clinical narrative: Initial report was received from a health care professional, who was also the patient's aunt, on 30 April 2012. A two-month-old female patient had received dose one of an intramuscular injection of PENTACEL, sanofi pasteur Ltd., lot number C4115AA (administration site not reported) on 06 April 2012. She also received dose one of oral ROTARIX Vaccine, GSK, lot number A41SBZ47A on same day, 06 April 2012. Approximately 48 hours later, on 08 April 2012, the patient experienced a seizure. The reporter stated she witnessed the event as the patient was also her niece, and she observed the patient's body tightened up, she turned red and her lips turned blue. The patient was taken to the emergency room "ER", and she was hospitalized for seven days, then released to home on anti-seizure medications. The patient's outcome was reported as recovered (date not reported). Documents held by sender: None.
Age: 16.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Angina pectoris, Asthenia, Chest pain, Discomfort, Headache
Clinical narrative: Case number PHEH2012US009655 is an initial spontaneous report received from a consumer on 04 May 2012. This report refers to a 16-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not specified. He was vaccinated with FLUVIRIN (batch number: 1101601) intramuscularly on to unspecified site on 05 Apr 2012. Immediately after the dose, he developed chest pain, heart pain, weakness, paleness, a fast heart beat, muscle twitching and generalized pain. He went to emergency room four times since administration and visited a primary doctor five times. The outcome of the event was reported as condition unchanged.
Age: 16.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Heart rate increased, Immediate post-injection reaction, Muscle spasms, Muscle twitching, Myalgia
Clinical narrative: Case number PHEH2012US009655 is an initial spontaneous report received from a consumer on 04 May 2012. This report refers to a 16-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not specified. He was vaccinated with FLUVIRIN (batch number: 1101601) intramuscularly on to unspecified site on 05 Apr 2012. Immediately after the dose, he developed chest pain, heart pain, weakness, paleness, a fast heart beat, muscle twitching and generalized pain. He went to emergency room four times since administration and visited a primary doctor five times. The outcome of the event was reported as condition unchanged.
Age: 16.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Pallor
Clinical narrative: Case number PHEH2012US009655 is an initial spontaneous report received from a consumer on 04 May 2012. This report refers to a 16-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not specified. He was vaccinated with FLUVIRIN (batch number: 1101601) intramuscularly on to unspecified site on 05 Apr 2012. Immediately after the dose, he developed chest pain, heart pain, weakness, paleness, a fast heart beat, muscle twitching and generalized pain. He went to emergency room four times since administration and visited a primary doctor five times. The outcome of the event was reported as condition unchanged.
Age: 16.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Angina pectoris, Asthenia, Chest pain, Heart rate increased, Immediate post-injection reaction
Clinical narrative: Case number PHEH2012US009655 is an initial spontaneous report received from a consumer on 04 May 2012. This report refers to a 16-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not specified. He was vaccinated with FLUVIRIN (batch number: 1101601) intramuscularly on to unspecified site on 05 Apr 2012. Immediately after the dose, he developed chest pain, heart pain, weakness, paleness, a fast heart beat, muscle twitching and generalized pain. He went to emergency room four times since administration and visited a primary doctor five times. The outcome of the event was reported as condition unchanged.
Age: 16.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Muscle twitching, Pain, Pallor
Clinical narrative: Case number PHEH2012US009655 is an initial spontaneous report received from a consumer on 04 May 2012. This report refers to a 16-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not specified. He was vaccinated with FLUVIRIN (batch number: 1101601) intramuscularly on to unspecified site on 05 Apr 2012. Immediately after the dose, he developed chest pain, heart pain, weakness, paleness, a fast heart beat, muscle twitching and generalized pain. He went to emergency room four times since administration and visited a primary doctor five times. The outcome of the event was reported as condition unchanged.
Age: 16.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Angina pectoris, Asthenia, Heart rate increased, Immediate post-injection reaction, Malaise
Clinical narrative: Case number PHEH2012US009655 is an initial spontaneous report received from a consumer on 04 May 2012. This report refers to a 16-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not specified. He was vaccinated with FLUVIRIN (batch number: 1101601) intramuscularly on to unspecified site on 05 Apr 2012. Immediately after the dose, he developed chest pain, heart pain, weakness, paleness, a fast heart beat, muscle twitching and generalized pain. He went to emergency room four times since administration and visited a primary doctor five times. The outcome of the event was reported as condition unchanged.
Age: 16.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Muscle twitching, Muscular weakness, Pallor, Product quality issue
Clinical narrative: Case number PHEH2012US009655 is an initial spontaneous report received from a consumer on 04 May 2012. This report refers to a 16-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not specified. He was vaccinated with FLUVIRIN (batch number: 1101601) intramuscularly on to unspecified site on 05 Apr 2012. Immediately after the dose, he developed chest pain, heart pain, weakness, paleness, a fast heart beat, muscle twitching and generalized pain. He went to emergency room four times since administration and visited a primary doctor five times. The outcome of the event was reported as condition unchanged.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Dermatitis diaper, Irritability, Rash, Rash erythematous, Rash vesicular
Clinical narrative: She was fussy for at least 72 hours after her vaccines. She then woke up with a slight rash covering her entire torso, face, and slight in diaper area. I called the doctor and they said it was from her chicken pox vaccine. That is would pass in a week or so. It continued to worsen, and she continued to be fussy, not running a fever though. This later for a full 14 days an was what appeared to be a chicken pox rash without the pus. Raised red bumps covering body.
Age: 38.0
Sex: M
Vaccine: DTAP
Symptoms: Hypoaesthesia, Initial insomnia, Injection site erythema, Pain in extremity, Paralysis
Clinical narrative: When I woke up in the morning I felt pain in the upper part of my left hand and something like numbness (paralysis) of that part. I still see little bit of redness at the injection spot. Also I was not able to fall asleep last night untill about 11:30 pm which is very unusual for me since I always wake up at 5:30 am and fall asleep at 10:00 pm.
Age: 1.03
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Autopsy, Death, Toxicologic test
Clinical narrative: Pt. died of unknown causes. Autopsy. Toxicology testing in process.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood blister, Contusion, Epistaxis, Immunoglobulin therapy, Oral mucosal blistering
Clinical narrative: Cl. states 7-8 days after receiving Tdap she started noticing blood blisters in her mouth, blood on tissue when she blew her nose and bruising "all over [her] body." Cl. went to Dr. who performed lab tests, sent client to ER for admission to hospital last night 5/3/12 secondary low platelet count of 3000. Cl. receiving IVIG presently and also to receive corticosteroids.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Platelet count decreased
Clinical narrative: Cl. states 7-8 days after receiving Tdap she started noticing blood blisters in her mouth, blood on tissue when she blew her nose and bruising "all over [her] body." Cl. went to Dr. who performed lab tests, sent client to ER for admission to hospital last night 5/3/12 secondary low platelet count of 3000. Cl. receiving IVIG presently and also to receive corticosteroids.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Biopsy bone marrow, Blood blister, Blood test, Cerebral haemorrhage, Chemotherapy
Clinical narrative: Cl. states 7-8 days after receiving Tdap she started noticing blood blisters in her mouth, blood on tissue when she blew her nose and bruising "all over [her] body." Cl. went to Dr. who performed lab tests, sent client to ER for admission to hospital last night 5/3/12 secondary low platelet count of 3000. Cl. receiving IVIG presently and also to receive corticosteroids.