chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Employee had Tdap on 6/25/11 at 9 AM, by Sunday night her arm at injection site was red, swollen & hard. Monday 6/28/11 she work in ER one of the PA look at her & diagnosis cellulitis & place her on KEFLEX. Her arm at that time was red, not swollen on hand & redness was below injection site by 2 inch. Today talk with her much improved, almost gone.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Employee had Tdap on 6/25/11 at 9 AM, by Sunday night her arm at injection site was red, swollen & hard. Monday 6/28/11 she work in ER one of the PA look at her & diagnosis cellulitis & place her on KEFLEX. Her arm at that time was red, not swollen on hand & redness was below injection site by 2 inch. Today talk with her much improved, almost gone.
Age: 63.0
Sex: M
Vaccine: BCG
Symptoms: Rash
Clinical narrative: Per MD note: called and discussed rash and possible reaction to BCG treatment with patient. He states his rash is better. Informed pt that Dr. thinks this could be a reaction to the BCG and for him to take the rest of the treatments. The patient also received ciprofloxacin at the time of the instillation of the BCG so it could not be determined which medication caused the reaction.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chest X-ray, Feeling abnormal, Pyrexia, Upper respiratory tract infection
Clinical narrative: Pt stated she received a Tdap and then forgot and recieved a 2nd Tdap 06/15/2011 and developed fever of 103.5.  She went to the walk-in clinic and was treated with Z-pac because she had other signs of URI.  She also told me that she felt run down from previous bowel surgery.  Temp was 99.7 at clinic.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Arthralgia, Cold sweat, Diarrhoea, Fatigue
Clinical narrative: Severe abdominal cramping, nausea, vomiting, diarrhea, fatigue, and cold sweats. After being sent home and napping, I woke up to severe muscle and join pain all over my body. This continues today, 06/29/2010.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: Severe abdominal cramping, nausea, vomiting, diarrhea, fatigue, and cold sweats. After being sent home and napping, I woke up to severe muscle and join pain all over my body. This continues today, 06/29/2010.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count, Joint stiffness, Muscle tightness, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: Parasthesia in both hands and fingers; muscle tightness and heaviness in both legs and knees, graduating to arm muscles next day.  Feelings of shakiness.  No pain at all. Developed pins and needles in hands and feet as the week progressed. 4 weeks later, still having same symptoms.  No paralysis, reflexes good.  Stiffness in muscles and joints and parasthesia continue.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Sensation of heaviness, Tremor
Clinical narrative: Parasthesia in both hands and fingers; muscle tightness and heaviness in both legs and knees, graduating to arm muscles next day.  Feelings of shakiness.  No pain at all. Developed pins and needles in hands and feet as the week progressed. 4 weeks later, still having same symptoms.  No paralysis, reflexes good.  Stiffness in muscles and joints and parasthesia continue.
Age: 18.0
Sex: F
Vaccine: MEN, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness; swelling at Varicella Vaccine site.
Age: 0.15
Sex: M
Vaccine: 6VAX-F, PPV, RVX
Symptoms: Choking, Crying, Screaming
Clinical narrative: Just 3 hours after vaccination administration my son starting hysterically screaming non stop for 3.5 hours. His cry I would describe as high pitched so hard that he'd be out of breath choking. I could not calm my son down with anything I did. I was never so scared in my life. The doctor would not even recommend an alternative to help if this happens. Had I not asked, she would not even recommend to get infant Tylenol. Because she did not even described a needed dosage for an infant I had to call her home that night while baby screaming on my arms to tell me allowed dosage according to his weight. When baby finally calm down after 4 -5 hours I held him in my arms all night just to make sure he was breathing.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Reddened area (1 1/2 to 2 inches long), sore, and warm to touch at injection site.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Presyncope, Syncope
Clinical narrative: vasovagal symptoms, syncope
Age: 0.59
Sex: M
Vaccine: PPV, RVX
Symptoms: Crying, Decreased appetite, Insomnia, Irritability
Clinical narrative: About 4 hours after vaccination the baby had become very fussy, irritated, excessively crying, did not sleep or ate well. I was advised by a nurse not to give infant's Tylenol as it would decrease vaccine respond. When questioned Dr. of safety of vaccines she ignorantly laughed.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Pain at injection site, spread to the arm, pain when abducting arm, chills, low grade fever, Aleve 2 tabs
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash generalised, Rash pruritic
Clinical narrative: Rash started on Tuesday on trunk and by Thursday it covered his entire body and was extremely itchy.  He developed a fever on Friday and continues to have a mild fever today.  The fever at its highest was 102. Rash is getting better but it still quite itchy.  Patient took Benadryl and Tylenol Friday evening and Saturday morning.
Age: 1.0
Sex: F
Vaccine: PPV, VARCEL
Symptoms: Anxiety, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: Fever 103.3 F Treated symptoms with acetaminophen Patient uncharacteristically fatigued next day. Loss of appetite, uncharacteristic separation anxiety
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Abscess drainage, Blood pressure increased, Breast abscess, Immune system disorder, Paralysis
Clinical narrative: Received Tdap vaccine in the hospital afteer delivering baby on 12/10/10. Blood pressure began to elevate 2 days later before my release and stayed high for over a month. I also experienced partial paralysis of the right side of face and lips and tongue on 12/18/11. Suspected Bells Palsy and was confirmed at the ER the following day 12/19/11. Was prescribed steroids and antiviral medicine. Slowly I regained feeling and motion. Shortly after that I developed a breast abscess from the steroids and lowered immune system. This resulted in having to have it drained surgically.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Tongue paralysis, VIIth nerve paralysis
Clinical narrative: Received Tdap vaccine in the hospital afteer delivering baby on 12/10/10. Blood pressure began to elevate 2 days later before my release and stayed high for over a month. I also experienced partial paralysis of the right side of face and lips and tongue on 12/18/11. Suspected Bells Palsy and was confirmed at the ER the following day 12/19/11. Was prescribed steroids and antiviral medicine. Slowly I regained feeling and motion. Shortly after that I developed a breast abscess from the steroids and lowered immune system. This resulted in having to have it drained surgically.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema
Clinical narrative: 5 x 6 area of erythema to (R) leg no warmth or tenderness.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Body temperature increased, Headache, Influenza like illness, Pain
Clinical narrative: Flu like sxs - severe body aches, back pain, headaches, Temp increased 101.6 x 48 hours.
Age: 1.04
Sex: M
Vaccine: MMR, MMR
Symptoms: Abscess, Abscess drainage, Culture, Erythema, Full blood count
Clinical narrative: Had swollen neck glands & fevers 101-104 beginning 1 wk after MMR vaccine. Treated with AMOXIL; changed to AUGMENTIN. Received ROCEPHIN IM in office. (L) neck gland tender, red, swollen. Admitted on 6/21/11. Tx with IV abx, positive abscess; drained; Dc'd home 6/23/11. Dx Lymphandenitis/Abscess.
Age: 1.04
Sex: M
Vaccine: MMR, MMR
Symptoms: Incisional drainage, Lymph node pain, Lymphadenitis, Lymphadenopathy, Pyrexia
Clinical narrative: Had swollen neck glands & fevers 101-104 beginning 1 wk after MMR vaccine. Treated with AMOXIL; changed to AUGMENTIN. Received ROCEPHIN IM in office. (L) neck gland tender, red, swollen. Admitted on 6/21/11. Tx with IV abx, positive abscess; drained; Dc'd home 6/23/11. Dx Lymphandenitis/Abscess.
Age: 1.04
Sex: M
Vaccine: MMR, MMR
Symptoms: Abscess drainage, Culture, Erythema, Local swelling, Lymph node abscess
Clinical narrative: Had swollen neck glands & fevers 101-104 beginning 1 wk after MMR vaccine. Treated with AMOXIL; changed to AUGMENTIN. Received ROCEPHIN IM in office. (L) neck gland tender, red, swollen. Admitted on 6/21/11. Tx with IV abx, positive abscess; drained; Dc'd home 6/23/11. Dx Lymphandenitis/Abscess.
Age: 1.04
Sex: M
Vaccine: MMR, MMR
Symptoms: Lymphadenopathy, Pyrexia, Streptococcus test, Tenderness, White blood cell count increased
Clinical narrative: Had swollen neck glands & fevers 101-104 beginning 1 wk after MMR vaccine. Treated with AMOXIL; changed to AUGMENTIN. Received ROCEPHIN IM in office. (L) neck gland tender, red, swollen. Admitted on 6/21/11. Tx with IV abx, positive abscess; drained; Dc'd home 6/23/11. Dx Lymphandenitis/Abscess.
Age: 1.05
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Discomfort, Pyrexia, Rash generalised
Clinical narrative: Child received Hep A, PREVNAR, Hib, MMR, varicella on 6-22-11. Awoke at 6:00 am 6-23-11 with rash on body. "Low grade" fever per mom. Rash appears widespread on legs, arms, abdomen & per mom, child seemed uncomfortable, & scratched at it continuously. No meds given. Seen 6-23-11 by FNP, no problems with breathing reported. No anaphylaxis.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blister, Bronchiolitis, Diarrhoea, Nasal congestion, Oedema peripheral
Clinical narrative: 29 Jun 2011 Pt. develop swelling of both legs and testicle. Was seen in ER yesterday. Treated with BENADRYL and TYLENOL. Today swelling is gone. Baby develop diarrhea since yesterday afternoon x 5. Also having nasal congestion (has URI since 23 Jun 11), and expiratory wheeze -> bronchiolitis.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Wheezing
Clinical narrative: 29 Jun 2011 Pt. develop swelling of both legs and testicle. Was seen in ER yesterday. Treated with BENADRYL and TYLENOL. Today swelling is gone. Baby develop diarrhea since yesterday afternoon x 5. Also having nasal congestion (has URI since 23 Jun 11), and expiratory wheeze -> bronchiolitis.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Grand mal convulsion, Syncope
Clinical narrative: Pt received 3rd dose of HPV vaccine. Pt fainted and had tonic/clonic seizures for about 5-10 seconds, and then she recovered.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria, Vaccination complication
Clinical narrative: Localized allergic reaction to IPV with hives and erythema around injection site. Patient placed on BENADRYL.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma
Clinical narrative: 2"x3" Bruise at injection site on arm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient states that she developed shingles post-vaccination and it was also diagnosed by her primary care physician.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood sodium, Ecchymosis, Injection site erythema, Injection site induration
Clinical narrative: 6-20-11 2-3cm induration Rt upper arm at inj site, erythema, warmth. 6-22-11 6.5 x 2.5cm induration - Rt upper arm at inj. site, erythema, warmth, pain, joint pain. Sed rate 82, Sodium 128. 6-24-11 Sed rate 98, Sodium 128 - using walking/wheelchair x 2 days. 6-28-11 ecchymosis 2" diameter - central firmness with erythema, Sed rate 78, Sodium 129.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Red blood cell sedimentation rate, Walking aid user
Clinical narrative: 6-20-11 2-3cm induration Rt upper arm at inj site, erythema, warmth. 6-22-11 6.5 x 2.5cm induration - Rt upper arm at inj. site, erythema, warmth, pain, joint pain. Sed rate 82, Sodium 128. 6-24-11 Sed rate 98, Sodium 128 - using walking/wheelchair x 2 days. 6-28-11 ecchymosis 2" diameter - central firmness with erythema, Sed rate 78, Sodium 129.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Wheelchair user
Clinical narrative: 6-20-11 2-3cm induration Rt upper arm at inj site, erythema, warmth. 6-22-11 6.5 x 2.5cm induration - Rt upper arm at inj. site, erythema, warmth, pain, joint pain. Sed rate 82, Sodium 128. 6-24-11 Sed rate 98, Sodium 128 - using walking/wheelchair x 2 days. 6-28-11 ecchymosis 2" diameter - central firmness with erythema, Sed rate 78, Sodium 129.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain, redness & erythema at injection site.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Pt received shot on 6-22-11 - has a history of leukemia. We called oncology & family doctor - they okayed her to get the shot. Two days later she appeared with a reaction on her arm. It was blistered area around inj. Went to doctor & got antibiotics and told to keep it bandaged. Reported to Merck.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Swelling, X-ray
Clinical narrative: Patient received shot, had no problems. Came in with his wife a week later - experienced a rash around injection site & also an elevated pulsating raise a few inches away from injection site. Made appt with MD for x-ray on 6-30- awaiting results.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling & warmth at injection site.
Age: 0.71
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Described by mother on (telephone call) 1) redness 2) swelling 3) tenderness at RT injection site.
Age: 59.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Rash generalised, Rash papular
Clinical narrative: Per progress note of 5/13/2010: I have been itching and have rash all over body, the only thing I think it might be was the H1N1 vaccine, I had on Tuesday, I started breaking out in rash really bad yesterday and the itching is really getting to me. Patient had light red raised rash thru-out trunk, bilateral legs and arms. No drainage noted from site. Patient told nurse that he had H1N1 vaccine when he was in clinic on 5/11/10 and that would be the only new product he had used, denied any new meds., food, detergent or clothes. Prednisone 20 mg every day, oatmeal PRN.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Arrhythmia, Ventricular extrasystoles
Clinical narrative: Case number PHHY2011US54746, is an initial report from a physician received on 17 Jun 2011. This report refers to a 50-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number unknown) on an unspecified date. The patient developed Premature Ventricular Contraction (PVC) arrhythmia after receiving FLUVIRIN. The patient had been seen by a cardiologist.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchospasm, Hypersensitivity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergy attack possibly due to latex (allergic reaction) in a 28-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 17 September 2010 the subject received unspecified dose of FLUARIX (.5 ml, unknown). On 17 September 2010, less than one day after vaccination with FLUARIX, the subject experienced allergy attack possibly due to latex (allergic reaction). A possibe latex allergic reaction developed following a FLUARIX vaccination; the reporting nurse stated that the subject was admitted overnight in the hospital due to the reaction. The subject was hospitalized and the healthcare professional considered the event was disabling, life threatening and clinically significant (or requiring intervention). On 17 September 2010, the allergic reaction was resolved. Follow-up information received from reporting healthcare professional on 20 October 2010: It was reported that the subject had not previously had any allergic reactions to other drugs. It was unknown if she had received FLUARIX previously. The subject received one dose of FLUARIX prior to the hypersensitivity reaction. At the time of the allergy attack possibly due to latex (allergic reaction), the subject experienced bronchospasm. She was taken to the emergency room and stayed in the hospital for two nights (17 September and 18 September 2010). The duration of the event was reported as two days, however, the reporter indicated that the subject had not made a full recovery at the time of reporting as the subject was still being seen for complications due to this incident. At the time of reporting, the outcome of the allergy attack possibly due to latex (allergic reaction) was reported as unresolved. The reporter considered it was probable that the event was caused by the FLUARIX vaccine.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of facial rash in a 53-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified). On 30 September 2010 the subject received a dose of Flu vaccine (details unknown) at the school where she works. The brand name and manufacturer of the vaccine was unknown. On 1 October 2010, 1 day after vaccination with Flu vaccine, the subject experienced facial rash. The subject woke up on the morning of 1 October 2010 with rash on her face. She called her physician's office to report the event. At the time of reporting the outcome of the event was unspecified.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Decreased appetite
Clinical narrative: This case was reported by a consumer, via Mylan Pharmaceuticals Inc, and described the occurrence of abdominal cramp in a 60-year-old female subject who was vaccinated with Influenza vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. Co-suspect medication included Buspirone hydrochloride tablet for an unknown drug indication. On an unspecified date the subject received unspecified dose of Influenza vaccine (unknown). On an unknown date, the subject started Buspirone hydrochloride (unknown) at 15 mg, unknown dosing. At an unspecified time after vaccination with Influenza vaccine and taking Buspirone hydrochloride, the subject experienced abdominal cramp and decreased appetite. At the time of reporting the outcome of the abdominal cramp and decreased appetite were unspecified.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of hives in a 51-year-old male subject who was vaccinated with Flu vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included diabetes, high blood pressure and hypothyroidism. Concurrent medications included Insulin, CARDIZEM and Levothyroxin. On 21 September 2010 the subject received unspecified dose of Flu vaccine at 0.5 ml in the left arm. On 21 September 2010, less than one day after vaccination with Flu vaccine, the subject experienced hive. The subject was treated with prednisolone and BENADRYL. At the time of reporting the event was unresolved.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Oropharyngeal pain, Upper respiratory tract infection, Urticaria
Clinical narrative: This case reported by a consumer (the subject) and described the occurrence of upper respiratory infection in a 52-year-old male subject who was vaccinated with Flu vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included food allergy and seasonal allergy. On an unspecified date in 2010 the subject received a dose of Flu vaccine (details unknown). The subject reported that the flu vaccine was a GSK brand, but did not know whether it was FLUARIX or FLULAVAL. Within days of vaccination with Flu vaccine, the subject experienced upper respiratory infection, sore throat, hives all over and fatigue. The subject was treated with ZYRTEC, BENADRYL and prednisone. The subject reported that he had visited his physician soon after his reaction began, but the ZYRTEC prescribed did nothing. Upon his second visit, the subject was prescribed BENADRYL and prednisone. The course of prednisone was completed 9 days later, but the subject continued to develop new batches of hives everywhere. At the time of reporting the upper respiratory infection, sore throat and fatigue had resolved after more than a week duration. The hives all over were improved after being ongoing for more than 3 weeks.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza in a female subject of unspecified age who was vaccinated with Flu vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergies, asthma, chronic obstructive pulmonary disease, high blood pressure, rheumatoid arthritis and cholesterol "problems". Previous and/or concurrent vaccination included Influenza vaccine trivalent; GlaxoSmithKline; unknown; unknown given in 2010. Concurrent medications included Vitamin; Prednisone; ADVAIR diskus; Ibuprofen; YASMIN; Calcium; Spironolactone; Hydroxychloroquine; Folic acid; HYZAAR; LYRICA; DETROL LA; ENBREL; Morphin; Oxycodone; Unknown; REQUIP and CRESTOR. On unspecified dates every year since 1997 and on an unspecified date in 2007 the subject received a dose of Flu vaccine (unknown). Every year since 1997, one day after vaccination with Flu vaccine, the subject experiences erythema, swelling and pain. It was reported that "since 1997 the subject has had flu vaccines every year in the fall after which she develops a reaction of redness, swelling, and pain in the arm around the next day after the injection. After a week, these symptoms usually go away". Approximately three years ago in 2007, one week after vaccination with Flu vaccine, the subject experienced influenza, vomiting, fever, and nausea. "Three years ago after her regular flu shot, a week after this particularly injection, patient got really sick with the flu. The physician then said that she must have had the flu infection inside her when she got the flu vaccine and that is why her flu infection surfaced so shortly after the injection. This flu infection three years ago resulted in vomiting, fever, and nausea. Most recently she had a FLULAVAL vaccine and she didn't not have any of these usual localized reactions that she gets normally". At the time of reporting the outcome of the influenza, vomiting, fever, and nausea that occurred in 2007 were unspecified. The outcome of redness, swelling, and pain every year since 1997 usually resolved after approximately one week.
Sex: M
Vaccine: FLUX
Symptoms: Accidental exposure, Pain in extremity, Underdose
Clinical narrative: This case was reported by a consumer and described the occurrence of sore arm in an adult male subject who was vaccinated with Flu vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On 29 September 2010 the subject received unspecified dose of Flu vaccine. During administration of the flu vaccine, some vaccine squirted out onto the subject's skin (vaccine underdose and inadvertent exposure to vaccine). The subject believed that the needle was not put on tightly enough-that there wasn't a good "seal" between the needle and syringe. The subject's right arm was sore for two days following vaccination. The subject did not consult a healthcare professional regarding these events. At the time of reporting the outcome of the sore arm was unspecified. The reporter was the subject.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in an unspecified number of subjects of unspecified age and gender who were vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subjects received a dose of FLUARIX (.5 ml, unknown route and site) which had possibly previously been frozen (incorrect storage of drug). The lot number was reported as AFLUA52NAA from the reporter; however based on a safety lot number review, the lot number was updated to AFLUA524AA. At an unspecified time after vaccination with FLUARIX, some of the subjects experienced injection site pain and injection site redness. The injection site pain and injection site redness lasted 2 to 3 days in some subjects. At the time of reporting the outcome of the events was unspecified. The pharmacist reported that some dose of FLUARIX were frozen, and an unknown number of employees were vaccinated with possibly previously frozen FLUARIX. The pharmacist stated that possibly over 100 employees received the vaccine, and some did experience pain and redness at the injection site that last 2 to 3 days in some instances.
Sex: F
Vaccine: FLUX
Symptoms: Latex allergy
Clinical narrative: This case was reported by a consumer (the subject) and described the occurrence of latex allergic reaction in a female subject of unspecified age who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of Influenza vaccine (details unknown). At an unspecified time after vaccination with Influenza vaccine, the subject experienced latex allergic reaction. The consumer reported that she once got a flu shot and had a reaction to the latex content. At the time of reporting the outcome of the event was unspecified. No further information was provided.
Age: 87.0
Sex: F
Vaccine: FLUX
Symptoms: Cough
Clinical narrative: This case was reported by a consumer and described the occurrence of cough in a 87-year-old female patient who received ADVAIR multi dose powder inhaler for an unknown drug indication. A physician or other health care professional has not verified this report. Co-suspect medication included Flu shot. Concurrent medications included VENTOLIN. On an unknown date, the patient started Fluticasone propionate+salmeterol xinafoate. On 25 October 2010, the patient experienced cough. At the time of reporting, the outcome of the event was unknown.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Oropharyngeal pain
Clinical narrative: This case was reported by a consumer via another manufacturer and described the occurrence of sore throat in a 74-year-old female subject who was vaccinated with Influenza vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 8 October 2010, the subject received unspecified dose of Influenza vaccine (details unknown). On 12 October 2010, 4 days after vaccination with an unknown GlaxoSmithKline Flu vaccine, the subject experienced sore throat and flu-like symptoms. At the time of reporting, the subject had not yet seen a physician. At the time of reporting the outcome of the events was unspecified.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer and described the occurrence of flu-like symptoms in a 44-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified) and TYKERB tablet for breast cancer. A physician or other health care professional has not verified this report. The subject's medical history included brain cancer. Concurrent medical conditions included breast cancer. Concurrent medications included KEPPRA, PROTONIX and Vitamin b12. In 2005 the patient started Lapatinib (oral) at 250 mg five times per day. On an unspecified date in October 2010 the subject received unspecified dose of Influenza vaccine (unknown). On an unspecified date in October 2010, since the vaccination with Influenza vaccine and while taking Lapatinib, the subject experienced flu-like symptoms. At the time of reporting the flu-like symptoms improved. Patient started taking TYKERB in 2005 after she had her right breast removed due to cancer. She has been taking TYKERB 1250 mg per day since 2005. She received the flu vaccine in October 2010 (date unknown) and has been experiencing flu-like symptoms since the vaccine.
Sex: M
Vaccine: FLUX
Symptoms: Flushing, Nausea, Urticaria, Vomiting
Clinical narrative: This case was reported by a healthcare professional, via Takeda Pharmaceuticals N.A., and described the occurrence of hive in male subject aged between 70 and 79 years old who was vaccinated with Influenza vaccine, (manufacturer unspecified) and DEXILANT over a period of 1 days for an unknown drug indication. Concurrent medical conditions included alcoholism. On an unspecified date, the subject received a dose of Influenza vaccine (unknown) and started Dexlansoprazole (oral) at 60 mg daily. Therapy dates and indication were not reported. Less than one day after receiving Influenza vaccine and starting Dexlansoprazole, the subject experienced hives, nausea, vomiting and being flushed. Treatment with Dexlansoprazole was discontinued after the first dose. Treatment included BENADRYL. At the time of reporting the hive, nausea, vomiting and flushing resolved. The healthcare professional considered the events were possibly related to DEXILANT therapy and provided an alternative etiology of alcohol consumption.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via a sales representative and described the occurrence of injection site pruritus in a subject of unspecified age and gender who was vaccinated with FLUARIX. On an unspecified date the subject received unspecified dose of FLUARIX (unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced injection site pruritus. At the time of reporting the outcome of the event was unspecified.
Age: 1.45
Sex: M
Vaccine: IPV, PNC13, IPV, PNC13, IPV, PNC
Symptoms: Convulsion, Malaise, Pyrexia
Clinical narrative: Initial report received from a health care professional on 20 June 2011. A 17-month-old male patient had received a first intramuscular left thigh injection of IPOL (lot number E0204-1), and a first intramuscular right thigh injection of PREVNAR (manufacturer Wyeth, lot number 915192) on 31 May 2011 and 3 days later was in the ER (emergency room) with seizure, fever and "illness." It was not reported whether the patient had been admitted to the hospital from the emergency room. Pre-existing medical history included no known allergies, no use of other medications, and no reported adverse events following prior vaccinations. Outcome for the event was unknown. No further information was available to the reporter. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: HEPAB, SMALL, YF, HEPAB, SMALL, YF, SMALL
Symptoms: Epistaxis, Petechiae, Platelet count decreased
Clinical narrative: Week 7 recruit seen on Monday 20JUN2011 for a diffuse, lower extremity, petechial rash and ecchymosis following vaccination with Yellow Fever, TWINRIX (dose # 2), and Smallpox about 1 week prior. He reported being otherwise well and only taking MOTRIN. After referral to the ER, his platelets were found to be at 7, splenomegaly was noted, was diagnosed with ITP, was admitted to ward, provided 1 unit of platelets, started on IVIG (with initial rise to 22, with drop back to 10), and transferred to Intensive Care Unit (with additional 2 units of Platelets given, and Hematology and Infectious Disease consults provided). Initially, there was concern that his condition may have been casually related to his vaccination with yellow fever. Contact with the CDC's Dr. (YF vaccine) and another Dr.
Age: 21.0
Sex: M
Vaccine: HEPAB, SMALL, YF, HEPAB, SMALL, YF, SMALL
Symptoms: Activated partial thromboplastin time, Antinuclear antibody, Blood folate, Blood immunoglobulin G, Blood immunoglobulin M
Clinical narrative: Week 7 recruit seen on Monday 20JUN2011 for a diffuse, lower extremity, petechial rash and ecchymosis following vaccination with Yellow Fever, TWINRIX (dose # 2), and Smallpox about 1 week prior. He reported being otherwise well and only taking MOTRIN. After referral to the ER, his platelets were found to be at 7, splenomegaly was noted, was diagnosed with ITP, was admitted to ward, provided 1 unit of platelets, started on IVIG (with initial rise to 22, with drop back to 10), and transferred to Intensive Care Unit (with additional 2 units of Platelets given, and Hematology and Infectious Disease consults provided). Initially, there was concern that his condition may have been casually related to his vaccination with yellow fever. Contact with the CDC's Dr. (YF vaccine) and another Dr.
Age: 21.0
Sex: M
Vaccine: HEPAB, SMALL, YF, HEPAB, SMALL, YF, SMALL
Symptoms: Blood iron normal, Chest X-ray normal, Computerised tomogram abnormal, Cytomegalovirus test positive, Ecchymosis
Clinical narrative: Week 7 recruit seen on Monday 20JUN2011 for a diffuse, lower extremity, petechial rash and ecchymosis following vaccination with Yellow Fever, TWINRIX (dose # 2), and Smallpox about 1 week prior. He reported being otherwise well and only taking MOTRIN. After referral to the ER, his platelets were found to be at 7, splenomegaly was noted, was diagnosed with ITP, was admitted to ward, provided 1 unit of platelets, started on IVIG (with initial rise to 22, with drop back to 10), and transferred to Intensive Care Unit (with additional 2 units of Platelets given, and Hematology and Infectious Disease consults provided). Initially, there was concern that his condition may have been casually related to his vaccination with yellow fever. Contact with the CDC's Dr. (YF vaccine) and another Dr.
Age: 21.0
Sex: M
Vaccine: HEPAB, SMALL, YF, HEPAB, SMALL, YF, SMALL
Symptoms: Epstein-Barr virus antigen positive, HIV test negative, HLA marker study, Haptoglobin normal, Idiopathic thrombocytopenic purpura
Clinical narrative: Week 7 recruit seen on Monday 20JUN2011 for a diffuse, lower extremity, petechial rash and ecchymosis following vaccination with Yellow Fever, TWINRIX (dose # 2), and Smallpox about 1 week prior. He reported being otherwise well and only taking MOTRIN. After referral to the ER, his platelets were found to be at 7, splenomegaly was noted, was diagnosed with ITP, was admitted to ward, provided 1 unit of platelets, started on IVIG (with initial rise to 22, with drop back to 10), and transferred to Intensive Care Unit (with additional 2 units of Platelets given, and Hematology and Infectious Disease consults provided). Initially, there was concern that his condition may have been casually related to his vaccination with yellow fever. Contact with the CDC's Dr. (YF vaccine) and another Dr.
Age: 21.0
Sex: M
Vaccine: HEPAB, SMALL, YF, HEPAB, SMALL, YF, SMALL
Symptoms: Immunoglobulin therapy, Intensive care, International normalised ratio, Iron binding capacity total, Lymphocyte count
Clinical narrative: Week 7 recruit seen on Monday 20JUN2011 for a diffuse, lower extremity, petechial rash and ecchymosis following vaccination with Yellow Fever, TWINRIX (dose # 2), and Smallpox about 1 week prior. He reported being otherwise well and only taking MOTRIN. After referral to the ER, his platelets were found to be at 7, splenomegaly was noted, was diagnosed with ITP, was admitted to ward, provided 1 unit of platelets, started on IVIG (with initial rise to 22, with drop back to 10), and transferred to Intensive Care Unit (with additional 2 units of Platelets given, and Hematology and Infectious Disease consults provided). Initially, there was concern that his condition may have been casually related to his vaccination with yellow fever. Contact with the CDC's Dr. (YF vaccine) and another Dr.
Age: 21.0
Sex: M
Vaccine: HEPAB, SMALL, YF, HEPAB, SMALL, YF, SMALL
Symptoms: Metabolic function test normal, Parasite blood test, Petechiae, Platelet count decreased, Platelet function test normal
Clinical narrative: Week 7 recruit seen on Monday 20JUN2011 for a diffuse, lower extremity, petechial rash and ecchymosis following vaccination with Yellow Fever, TWINRIX (dose # 2), and Smallpox about 1 week prior. He reported being otherwise well and only taking MOTRIN. After referral to the ER, his platelets were found to be at 7, splenomegaly was noted, was diagnosed with ITP, was admitted to ward, provided 1 unit of platelets, started on IVIG (with initial rise to 22, with drop back to 10), and transferred to Intensive Care Unit (with additional 2 units of Platelets given, and Hematology and Infectious Disease consults provided). Initially, there was concern that his condition may have been casually related to his vaccination with yellow fever. Contact with the CDC's Dr. (YF vaccine) and another Dr.
Age: 21.0
Sex: M
Vaccine: HEPAB, SMALL, YF, HEPAB, SMALL, YF, SMALL
Symptoms: Prothrombin time normal, Serum ferritin, Serum ferritin normal, Splenomegaly, Toxoplasma serology negative
Clinical narrative: Week 7 recruit seen on Monday 20JUN2011 for a diffuse, lower extremity, petechial rash and ecchymosis following vaccination with Yellow Fever, TWINRIX (dose # 2), and Smallpox about 1 week prior. He reported being otherwise well and only taking MOTRIN. After referral to the ER, his platelets were found to be at 7, splenomegaly was noted, was diagnosed with ITP, was admitted to ward, provided 1 unit of platelets, started on IVIG (with initial rise to 22, with drop back to 10), and transferred to Intensive Care Unit (with additional 2 units of Platelets given, and Hematology and Infectious Disease consults provided). Initially, there was concern that his condition may have been casually related to his vaccination with yellow fever. Contact with the CDC's Dr. (YF vaccine) and another Dr.
Age: 21.0
Sex: M
Vaccine: HEPAB, SMALL, YF, HEPAB, SMALL, YF, SMALL
Symptoms: Vitamin B12
Clinical narrative: Week 7 recruit seen on Monday 20JUN2011 for a diffuse, lower extremity, petechial rash and ecchymosis following vaccination with Yellow Fever, TWINRIX (dose # 2), and Smallpox about 1 week prior. He reported being otherwise well and only taking MOTRIN. After referral to the ER, his platelets were found to be at 7, splenomegaly was noted, was diagnosed with ITP, was admitted to ward, provided 1 unit of platelets, started on IVIG (with initial rise to 22, with drop back to 10), and transferred to Intensive Care Unit (with additional 2 units of Platelets given, and Hematology and Infectious Disease consults provided). Initially, there was concern that his condition may have been casually related to his vaccination with yellow fever. Contact with the CDC's Dr. (YF vaccine) and another Dr.
Age: 17.0
Sex: U
Vaccine: MNQ, MNQ
Symptoms: Abdominal pain lower, Back pain, C-reactive protein increased, Colitis, Computerised tomogram abdomen abnormal
Clinical narrative: Initial report was received 23 June 2011 from a health care professional. A 17-year-old patient (gender not reported) had received a booster dose injection of MENACTRA, lot number U3677AA, on 13 June 2011 (route and site of administration not reported), and an unspecified amount of time later, they were admitted to the hospital (date not reported) with symptoms of fever and abdominal pain. A CAT scan revealed right side colon inflammation and the patient was diagnosed with right sided colitis. The patient remained hospitalized on 24 June 2011. Outcome was not recovered. The patient's physician was unsure if there was a correlation, and stated they would file a VAERS report. No additional information was provided at the time of the report. Documents held by sender.
Age: 17.0
Sex: U
Vaccine: MNQ, MNQ
Symptoms: Condition aggravated, Hypophagia, Nausea, Pyrexia
Clinical narrative: Initial report was received 23 June 2011 from a health care professional. A 17-year-old patient (gender not reported) had received a booster dose injection of MENACTRA, lot number U3677AA, on 13 June 2011 (route and site of administration not reported), and an unspecified amount of time later, they were admitted to the hospital (date not reported) with symptoms of fever and abdominal pain. A CAT scan revealed right side colon inflammation and the patient was diagnosed with right sided colitis. The patient remained hospitalized on 24 June 2011. Outcome was not recovered. The patient's physician was unsure if there was a correlation, and stated they would file a VAERS report. No additional information was provided at the time of the report. Documents held by sender.
Age: 17.0
Sex: U
Vaccine: MNQ, MNQ
Symptoms: Abdominal pain, Colitis, Computerised tomogram abnormal, Pyrexia
Clinical narrative: Initial report was received 23 June 2011 from a health care professional. A 17-year-old patient (gender not reported) had received a booster dose injection of MENACTRA, lot number U3677AA, on 13 June 2011 (route and site of administration not reported), and an unspecified amount of time later, they were admitted to the hospital (date not reported) with symptoms of fever and abdominal pain. A CAT scan revealed right side colon inflammation and the patient was diagnosed with right sided colitis. The patient remained hospitalized on 24 June 2011. Outcome was not recovered. The patient's physician was unsure if there was a correlation, and stated they would file a VAERS report. No additional information was provided at the time of the report. Documents held by sender.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Throat tightness
Clinical narrative: Information has been received from a licensed practical nurse concerning a 27 year old female patient with no medical history and no drug reactions/allergies who on 10-JUN-2011 was vaccinated with a dose of MMR II (lot number 666510/1624Y, expiry on 19-NOV-2011). There was no concomitant medication. On 11-JUN-2011, after administration of MMR II the patient developed "constriction of the throat". The patient went to the emergency room and was treated with SOLU-MEDROL IV and BENADRYL IV, she was released with a prescription for MEDROL DOSEPAK. There was no diagnostic laboratory test performed. On 17-JUN-2011, the patient recovered from constriction of the throat. Constriction of the throat was considered to be immediately life-threatening and an other important medical event by the licensed practical nurse. A lot check has been initiated. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood aluminium, Lymphadenitis, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female patient who was vaccinated with the first dose of GARDASIL (lot number not reported) on 22-AUG-2007, the second dose (lot number not reported) on 29-NOV-2010, and the third dose (lot number 666987/1016Z, expiry on 22-NOV-2012) on 12-APR-2011. On an unspecified date, after getting her third GARDASIL dose, the patient developed "lymphadenitis and was vomiting every day". She was admitted to hospital for 10 days. Tests for aluminum were performed, no results provided. "There was some kind of intervention done, but I'm not sure what". At the time of this report, the patient's outcome was unknown. Lymphadenitis and vomiting every day were considered to be other important medical events by the registered nurse. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Anaphylaxis.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: 3 DAYS AFTER MMR ONSET OF FEVER OF 104 AND DIARRHEA. LASTED 5-6 DAYS
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Patient suffered a seizure at pre-school during nap time.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Hypoaesthesia, Localised oedema, Lymphadenopathy, Pain
Clinical narrative: 6-1/Received vaccine. 6-2/tenderness at site. 6-3/Bilateral underarm edema & pain. 6-4 & 6-5/increased edema, increased pain. 6-6/Employee Health MD visit  - prescribed prednisone & hot soaks for 5 days for lymphadenopathy. 6-21/call to MD prescribed Ibuprofen for 1 week. Mild edema/pain still remains numbness upper arm area at times, better but not well yet.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Child given injection 6/27/11 - seen 6/29/11 c/o redness (4 cm area) & edema to site. (Lt) arm MMR given.
Age: 1.09
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on leg.
Age: 9.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: No adverse event
Clinical narrative: Patient is a 9 yr old male who received KINRIX on 6/13/11, had no adverse events or symptoms.
Age: 59.0
Sex: M
Vaccine: HEPAB, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: (R) upper arm about 24 hrs. after injection, site was red, tender and warm. Improved in 3 days, resolved 2 days later. Treated with ice and ibuprofen.
Age: 50.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: C-reactive protein increased, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Lightheaded, nausea, fever, headache, sore throat, terrible body aches, fatigue.
Age: 50.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Lightheaded, nausea, fever, headache, sore throat, terrible body aches, fatigue.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Tinnitus
Clinical narrative: Pt. given GARDASIL in LA, also received first DEPO injection immediately broke out in sweat with complaint of dizziness and ears roaring, pt. placed in reclining position with knees bent, cool compress to head. B/P 113/71, P 67, O2 sats 100%, Dr. informed and B/S ordered, B/S 89, pt. in sitting position after about 10 min slowly stood with no additional sx present.
Age: 0.35
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Enema administration, Grunting, Intussusception, Laboratory test normal
Clinical narrative: Approx. 4h after vaccine pt awoke from nap with " grunting/abnormal breathing" -> parents called 911, transported to hospital ER. CXR/KUB normal. U/S obtained secondary to concern for intussusception -> U/S could not r/o intussusception therefore air enema ordered but was normal. MD felt pt had intussusception that cleared prior to therapeutic air enema.
Age: 0.35
Sex: M
Vaccine: DTAP
Symptoms: Respiration abnormal, Ultrasound abdomen abnormal, Urinary system X-ray
Clinical narrative: Approx. 4h after vaccine pt awoke from nap with " grunting/abnormal breathing" -> parents called 911, transported to hospital ER. CXR/KUB normal. U/S obtained secondary to concern for intussusception -> U/S could not r/o intussusception therefore air enema ordered but was normal. MD felt pt had intussusception that cleared prior to therapeutic air enema.
Age: 1.09
Sex: M
Vaccine: HEPA, MMR
Symptoms: Varicella
Clinical narrative: Varicella spots - 20-25 on trunk/back, 20 groin - 6/30/11.