chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Small, itchy, red rash spots. 4-5 on chest area. Next day 6 spots also appeared on upper left thigh. Next few days spots appeared in a randomly spaced line along outer thigh to knee of right leg. Itchy. Not blistery. After 2 days of appearing each went flat and stayed on skin for 4 more days. On 3/25/2011 developed hives around upper back and down left arm. May be stress related but lasted several days. Very itchy. No blisters.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Pyrexia, Screaming, Urine analysis normal, Vaccination complication
Clinical narrative: Patient has been extremely irritable and feverish since having the last staggered set of her 2 month shots. She has ran a fever of around 102 on and off since the 23rd. On 03/28/2011 I had to leave work early because she had been screaming for about 3 hours and the babysitter could not calm her down. We took her to Hospital on 03/28/2011 because we could tell something was exceptionally wrong with her. They tested her for a urinary tract infection which came back negative and sent us home because they couldn't see anything wrong. 2 days later (03/30/2011) I took her to her pediatrician because she was still not herself. During the visit her pediatrician said the most likely cause was from the vaccinations. She was only supposed to receive Hib#1, Prev#1, and Rota#2 but the Health Dept took it upon themselves to give her DTap, HepB, and Polio as well.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: Woke up in AM of March 29 with injections sites with minimal Redness, Warm, induration, Swelling and pain.  Mother was given Home comfort measures and to return March 30 for follow up.  Child returned and injection sites symptoms have gotton worse throughout the night.  Dr. examined child and treated her for infected injection sites and child is to return to Clinic in one week for follow up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Woke up in AM of March 29 with injections sites with minimal Redness, Warm, induration, Swelling and pain.  Mother was given Home comfort measures and to return March 30 for follow up.  Child returned and injection sites symptoms have gotton worse throughout the night.  Dr. examined child and treated her for infected injection sites and child is to return to Clinic in one week for follow up.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warm to the touch at injection site.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Diagnostic procedure, Drug exposure during pregnancy, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numbness in tongue followed by complete bilateral facial paralysis.  Numbness moved down body. Lower body paralysis/numbness within 3 weeks. Continuing for months. Treating for GBS
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Nerve conduction studies, Nuclear magnetic resonance imaging, Paralysis, VIIth nerve paralysis
Clinical narrative: Numbness in tongue followed by complete bilateral facial paralysis.  Numbness moved down body. Lower body paralysis/numbness within 3 weeks. Continuing for months. Treating for GBS
Age: 30.0
Sex: F
Vaccine: FLU3, HEPAB, IPV, MMR
Symptoms: Contraindication to vaccination, Urine human chorionic gonadotropin positive
Clinical narrative: contraindications POSITIVE HCG within 2 weeks of last Live Vaccines. MMR,  Varicella
Age: 34.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Dry mouth, Halo vision, Hemicephalalgia, Hot flush
Clinical narrative: This started within 10 minutes of receiving my vaccination. First my mouth became completely dry, I had hot flashes, I felt lightheaded, and very nauseated.  I was released from work for the day.  I went home and after a couple hours I began to vomit.  The vomiting was technically 1 episode, however, I stayed in the bathroom for about 45 minutes vomiting intermittently.  About 3  4 hours after the vaccination I began seeing a halo around the lights in the room, shortly after that I began having a really bad headache on the left side of my head.  The next day, I still felt very nauseated so instead of going to work I went to Medical Center. I had a provisional diagnosis of migraine headaches secondary to the H1N1 Vaccine.  I was then told that I needed to follow up with my primary care provider.  I did just that.  My PCP also diagnosed me with migraines.
Age: 34.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Migraine, Nasal congestion, Nausea, Neurological examination, Otitis media
Clinical narrative: This started within 10 minutes of receiving my vaccination. First my mouth became completely dry, I had hot flashes, I felt lightheaded, and very nauseated.  I was released from work for the day.  I went home and after a couple hours I began to vomit.  The vomiting was technically 1 episode, however, I stayed in the bathroom for about 45 minutes vomiting intermittently.  About 3  4 hours after the vaccination I began seeing a halo around the lights in the room, shortly after that I began having a really bad headache on the left side of my head.  The next day, I still felt very nauseated so instead of going to work I went to Medical Center. I had a provisional diagnosis of migraine headaches secondary to the H1N1 Vaccine.  I was then told that I needed to follow up with my primary care provider.  I did just that.  My PCP also diagnosed me with migraines.
Age: 34.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Rhinorrhoea, Sinus headache, Vomiting
Clinical narrative: This started within 10 minutes of receiving my vaccination. First my mouth became completely dry, I had hot flashes, I felt lightheaded, and very nauseated.  I was released from work for the day.  I went home and after a couple hours I began to vomit.  The vomiting was technically 1 episode, however, I stayed in the bathroom for about 45 minutes vomiting intermittently.  About 3  4 hours after the vaccination I began seeing a halo around the lights in the room, shortly after that I began having a really bad headache on the left side of my head.  The next day, I still felt very nauseated so instead of going to work I went to Medical Center. I had a provisional diagnosis of migraine headaches secondary to the H1N1 Vaccine.  I was then told that I needed to follow up with my primary care provider.  I did just that.  My PCP also diagnosed me with migraines.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: c/o pain/swelling right arm are where he had Pneumovax injection on 3/15/11
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Drug administration error, No adverse event
Clinical narrative: MISADMINISTRATION - 4yo series given at age 3 - no adverse events noticed
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Crying, Decreased appetite, Erythema, Pyrexia, Swelling
Clinical narrative: RED SWOLLEN AREA 2 INCHES BY THREE INCHES. CRYING, FEVER, LOSS OF APPETITE, FEVER ONGOING 103.5 ADMIN. TYLENOL AND ADVIL ALTERNATING EVERY 3 TO 5 HOURS
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Dizziness, Headache, Heart rate increased, Pain in extremity
Clinical narrative: Vaginal itching and irritation, abdominal pains, headaches, dizziness, chronic low grade fever, leg pains, rapid heart beat.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Vulvovaginal discomfort, Vulvovaginal pruritus
Clinical narrative: Vaginal itching and irritation, abdominal pains, headaches, dizziness, chronic low grade fever, leg pains, rapid heart beat.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dry eye, Eye pruritus, Feeling abnormal, Headache
Clinical narrative: Started with the worst sore throat ever. Then headaches, dry itchy eyes. 3/29 moved to chest, bad dry cough, cloudy head
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pulmonary function test, Vaccination complication
Clinical narrative: Started with the worst sore throat ever. Then headaches, dry itchy eyes. 3/29 moved to chest, bad dry cough, cloudy head
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of injection site redness in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). On 22 February 2011 the subject received 1st dose of KINRIX (.5 ml, unknown, unknown arm). On 22 February 2011, immediately after vaccination with KINRIX, the subject experienced injection site redness. That same day on 22 February 2011, after vaccination with KINRIX, the subject experienced fever, injection site muscle pain, muscle pain and arthralgia. On 24 February 2011, the injection site redness, fever, injection site muscle pain, muscle pain and arthralgia were resolved.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of injection site redness in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). On 22 February 2011 the subject received 1st dose of KINRIX (.5 ml, unknown, unknown arm). On 22 February 2011, immediately after vaccination with KINRIX, the subject experienced injection site redness. That same day on 22 February 2011, after vaccination with KINRIX, the subject experienced fever, injection site muscle pain, muscle pain and arthralgia. On 24 February 2011, the injection site redness, fever, injection site muscle pain, muscle pain and arthralgia were resolved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HIBV
Symptoms: Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: This case was reported by a sales representative and described the occurrence of skin infection arm in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Previous and/or concurrent vaccination included HIBERIX; GlaxoSmithKline; unknown; unknown given on 24 February 2011. On 24 February 2011 at 11:15 the subject received 1st dose of KINRIX (.5 cc, unknown, left arm). On 24 February 2011, that same day after vaccination with KINRIX, the subject experienced skin infection arm, arms redness and swelling arm. At the time of reporting the skin infection arm, arms redness and swelling arm were improved.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, PNC
Symptoms: Pyrexia, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 4-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included HIB (non-gsk); Sanofi; unknown given on 28 February 2011; PREVNAR (non-gsk); Wyeth Labs; unknown given on 28 February 2011. On 28 February 2011 the subject received 2nd dose of KINRIX (unknown, left thigh) and experienced wrong vaccine administered. On 1 March 2011, 1 day after vaccination with KINRIX, the subject experienced fever that lasted three or four days. The subject received KINRIX by mistake for the second dose of the DTaP series. At the time of reporting the fever was resolved.
Age: 1.0
Sex: U
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Body temperature increased, Decreased activity, Flushing, Heart rate abnormal, Influenza virus test negative
Clinical narrative: Fussiness & soreness after injections. Rectal temp 104.7, flushed, trembling, heart rate 170. Decreased activity x 48hr. Severe swelling/tenderness at site. Went to ER.
Age: 1.0
Sex: U
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Injection site pain, Injection site swelling, Irritability, Pain, Respiratory syncytial virus test negative
Clinical narrative: Fussiness & soreness after injections. Rectal temp 104.7, flushed, trembling, heart rate 170. Decreased activity x 48hr. Severe swelling/tenderness at site. Went to ER.
Age: 22.0
Sex: M
Vaccine: RAB
Symptoms: Autoimmune disorder, Inflammation, Lichen planus, Rash, Rash erythematous
Clinical narrative: Reports rash on inner lower arms, inner lower legs that appeared 6/10. Rash became inflamed & red then, scars darker now, healing. Dermatologist - "Lichen Planus" - Autoimmune Disease Response. Seen 11/10 reported to us 3/29/11.
Age: 22.0
Sex: M
Vaccine: RAB
Symptoms: Scar
Clinical narrative: Reports rash on inner lower arms, inner lower legs that appeared 6/10. Rash became inflamed & red then, scars darker now, healing. Dermatologist - "Lichen Planus" - Autoimmune Disease Response. Seen 11/10 reported to us 3/29/11.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling - pain & redness. Prednisone.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13
Symptoms: Full blood count normal, Metabolic function test, Pyrexia, Serum sickness-like reaction, Urine analysis normal
Clinical narrative: 7 days after vaccines -> urticarial rash. 8 days after vaccines -> rash worsened to resemble serum sickness-like reaction and fever (antihistamines & steroid given).
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13
Symptoms: Urticaria
Clinical narrative: 7 days after vaccines -> urticarial rash. 8 days after vaccines -> rash worsened to resemble serum sickness-like reaction and fever (antihistamines & steroid given).
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site haematoma
Clinical narrative: Patient developed bruising at injection site.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema multiforme, Serum sickness
Clinical narrative: Erythema, multiforme, serum sickness.
Age: 1.88
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever stated on 3/26/11 T 102-104. Reevaluated 3/29/11. Had fever that morning but afebrile in office. Pimple like rash on chest, back, a few on his neck and groin area. Incidentally, older sister got Varicella vaccine that day.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Body temperature, Condition aggravated, Convulsion
Clinical narrative: Brief seizure & Temp 1/29, local reaction.
Age: 15.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Adverse reaction, Lip oedema
Clinical narrative: Left upper lip edema on evening following vaccination. Suspect related to food almost completely resolved by office visit on the following day 3/29/11. BENADRYL 25 mg po x 1.
Age: 1.0
Sex: U
Vaccine: HEPA, HIBV, PNC, VARCEL
Symptoms: Blister, Erythema
Clinical narrative: Pt. received chicken pox vaccine in Rt. thigh 2 weeks ago. Pt. seen today with red 2-3cm area & blisters in center - also 1 blister on ear lobe.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Cyanosis, Nail discolouration, Rash macular
Clinical narrative: Patient received vaccine in arm at clinic. Later in day had red "blotches" on trunk, toe nails became bluish in color. No shortness of breath or lethargy. Mom advised to seek medical thru PCP or local ER.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: (L) arm red/swollen/indurated mild "itchiness" per pt mild pain no fever blisters - superficial - where band aids were applied (? latex allergy) went to ER last pm (3/29/11). Got KEFLEX & BENADRYL.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: (L) arm red/swollen/indurated mild "itchiness" per pt mild pain no fever blisters - superficial - where band aids were applied (? latex allergy) went to ER last pm (3/29/11). Got KEFLEX & BENADRYL.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Mass, Pain, Skin warm
Clinical narrative: Hard bump started 03/29/11. Redness & warm started 03/29/11 and has increased in size, sore all time 5 on (0 to 10 scale).
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Erythema, Injection site urticaria, Skin warm
Clinical narrative: Initial report received on 09 April 2010 from a healthcare professional. This case includes information on 1 patient in a cluster of 3 patients that received the same vaccine from the same lot and experienced the same adverse event. Information on the other 2 patients is captured in case 2010-02103. A patient (identified as a child) received either the fourth or fifth intramuscular injection of DAPTACEL (lot number C3191AA) in April 2010. A few hours after vaccination, the patient developed a 3 to 4 inch wheal at the injection site. No other symptoms were reported. The patient was treated with antibiotics and the event improved. The patient's outcome is unknown. Follow-up information received from a health care professional on 10 June 2010. This case contains the information of 1 patient from a cluster of 4 patients (previously reported as a cluster of 3 patients). Information on the first patient is captured in case 2010-02103. Information on the second patient is captured in case 2010-03338. Information on the fourth patient is captured in case 2010-03339. This case has been identified as a 2-year-old female patient, with medical history of knee deformity and no illness at time of vaccination, received the following injections on 07 April 2010 at 11:00 AM: Right thigh intramuscular (IM) injection (dose 4) of DAPTACEL, lot number C3191AA, a left thigh IM injection (dose 4) of ACTHIB, lot number AHIBC262BA, and a left thigh IM injection (dose 3) of VAQTA, Merck lot number 1538Y. On 07 April 2010 at 8:00 PM the patient developed a red and warm area (location not specified). The patient was advised to use MOTRIN or TYLENOL. A follow-up call on 09 April 2010 reported that the redness had gone away. The patient's concomitant medication was reported as "FLOR-A-DAY". The outcome for the events was reported as recovered. List of documents held by sender: none.
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Febrile convulsion
Clinical narrative: This case was received on 27 January 2011 via a third party query tool search on the VAERS database, under reference number 398056. A female child, age reported as 1.3 (date of birth not reported) had received on 10 September 2010 an intramuscular left leg injection of ACTHIB (Dose 3, lot number UH163AA, sanofi pasteur SA lot number E0893-1), and an intramuscular right leg injection of FLUZONE (Dose 0, lot number UT3570DA), and an intramuscular left leg injection of INFANRIX (Dose 3, GlaxoSmithKline, lot number AC14B118BA) and the same day (also reported as 1 day post-vaccination) suffered from a febrile seizure. The patient was transported by EMS to the hospital emergency room where the patient was admitted and evaluated. Lab data was reported as "none." The patient had a history of dysphagia and slow stomach emptying. Other medications and current illnesses were reported as "none." The patient recovered (date not reported). Documents held by sender: None.
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Convulsion, Irritability, Pyrexia
Clinical narrative: Initial report received from an extraction from VAERS database (VAERS identification number 399001) using a third party query tool on 27 January 2011. A female child, age reported as 1.2 (no birth date provided), received on 17 September 2010 a left leg intramuscular injection (dose 1) of FLUZONE 2010-2011, lot number UH181AB, a left leg intramuscular injection (dose 3) of ACTHIB, sanofi pasteur Inc. lot number UH080AA and sanofi pasteur SA lot number E0711-1, and a left leg intramuscular injection (dose 1) of DTP, lot number V3282CA (invalid lot number). The patient had no illnesses, no medical history and took no concomitant medications. On 17 September 2010, the patient developed a mild fever of 100.1 (units not provided) and became cranky. The patient's fever was controlled with minimal Tylenol. In the morning, she had a seizure which required an Emergency visit. The patient still was running fevers 4 days later, but seemed she would recover. The outcome was reported as recovered. Documents held by sender: None.
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Asthenia, Body temperature increased, Condition aggravated, Febrile convulsion
Clinical narrative: This case was received on 27 January 2011 via a third party query tool search on the VAERS database, under reference number 401627. A female patient (age reported as 1.5) who had a past history of a febrile seizure March 2010 (reported as 3/10), had received a third dose intramuscular right arm injection of DAPTACEL, lot number C3473AA, and an intramuscular left arm injection of FLUZONE 2010-2011, lot number UT3567AA (dose 0), and a third dose intramuscular right arm injection of ACTHIB, lot number UH093AA (corresponding sanofi pasteur SA lot number E0747-2), and an intramuscular left arm injection of PREVNAR 13 (manufacturer Pfizer/Wyeth, lot number 914265, dose number not reported) on 30 September 2010 and an unspecified amount of time later that day, the patient experienced a febrile seizure. The patient had a temperature of 101.2 lasting two minutes. There was no convulsing, just lifeless, and the patient was taken to the hospital for an emergency visit. At the time of vaccination, the patient had been healthy. Outcome was recovered (date not reported). Documents held by sender: None.
Sex: M
Vaccine: FLU3, HIBV
Symptoms: Blood test, Febrile convulsion, Pyrexia
Clinical narrative: Initial report received from an extraction from VAERS database (VAERS identification number 406287) using a third party query tool on 27 January 2011. A male child, age reported as 1.0 (no birth date provided), received on 12 October 2010 a leg injection (route unknown) of FLUZONE 2010-2011, sanofi pasteur lot number UT3566BA and a leg injection (route unknown) of ACTHIB, sanofi pasteur invalid lot number UA116AB. The patient had no illnesses, no medical history and concomitant medications were not reported. On 12 October 2010, the patient developed a fever and a febrile seizure. He was seen in the Emergency Room (ER) where blood test was performed but no details were provided. The outcome was reported as recovered. Documents held by sender: None.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Chest X-ray normal, Febrile convulsion, Neutrophil count, Urine analysis normal, White blood cell count increased
Clinical narrative: This case was received on 27 January 2011 via a third party query tool search on the VAERS database, under reference number 407907. A 1-year-old male patient received the following vaccines on 10 November 2010: an intramuscular first right leg injection of FLUZONE (lot number UT3641CA), a fourth intramuscular left leg injection of ACTHIB (sanofi pasteur Inc lot number UH092AA and sanofi pasteur SA lot number E0746), a first intramuscular right leg injection of HAVRIX (GlaxoSmithKline, lot number AHAVB441AA), a fourth intramuscular right leg injection of PREVNAR 13 (Pfizer/Wyeth, lot number E80083), and a first subcutaneous left leg injection of PROQUAD (Merck, lot number 0649Z). Approximately 8 hours post-vaccination, the patient experienced a febrile seizure and was seen in the emergency department. Laboratory testing revealed a white blood count of 20,000 and absolute neutrophil count of 13.86; urinalysis and chest x-ray were negative. The patient had a history of mild asthma and mild infant hydronephrosis, and was not ill at the time of vaccination. He subsequently recovered. Documents held by sender: None.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Lymphadenopathy, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Employee came to Employee Health due to redness, swelling and aching of the left arm. Verbalizes swollen glands under left arm and fever of 100.7. Instructed to take Motrin and apply heat for not more than 20 minutes at a time.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed zoster 1 day after receiving ZOSTAVAX.
Age: 0.64
Sex: M
Vaccine: RV5
Symptoms: Asthma, Bronchiolitis, Chest X-ray normal, Condition aggravated, Culture stool positive
Clinical narrative: Initial and follow up information has been received from a registered nurse and a licensed practical nurse concerning a 7 month old male with asthma and no known drug allergies who was respectively vaccinated with the first, second and third dose of ROTATEQ, 2ml, oral on 08-FEB-2010, 05-APR-2010 and 23-JUL-2010 (Lot no. 664782/1441Y, expiration date: 23-APR-2011 (1st), lot no. 664884/1524Y, expiration date: 23-APR-2011 (2nd), lot no. 667461/0500Z, expiration date: unknown (3rd).  The third dose was given 15 weeks after the second dose when the patient was 33 week old.  On 14-MAR-2011, the patient presented to the emergency room for bronchiolitis, diarrhea and flu like symptoms.  He was hospitalized and was found bilateral ear infections, asthma exacerbation, flu (determined by a nasopharyngeal wash), and Rotavirus (determined by stool culture); chest x-ray was negative.  The patient was treated with fluids and albuterol.  On 24-MAR-2011, the patient discharged home on ORAPRED and amoxicillin.  At the time of report, the patient's outcome was recovering.  Rotavirus was considered to be an other important medical event by the registered nurse.  Additional information has been requested.
Age: 0.64
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Ear infection, Influenza, Influenza like illness, Influenza virus test positive
Clinical narrative: Initial and follow up information has been received from a registered nurse and a licensed practical nurse concerning a 7 month old male with asthma and no known drug allergies who was respectively vaccinated with the first, second and third dose of ROTATEQ, 2ml, oral on 08-FEB-2010, 05-APR-2010 and 23-JUL-2010 (Lot no. 664782/1441Y, expiration date: 23-APR-2011 (1st), lot no. 664884/1524Y, expiration date: 23-APR-2011 (2nd), lot no. 667461/0500Z, expiration date: unknown (3rd).  The third dose was given 15 weeks after the second dose when the patient was 33 week old.  On 14-MAR-2011, the patient presented to the emergency room for bronchiolitis, diarrhea and flu like symptoms.  He was hospitalized and was found bilateral ear infections, asthma exacerbation, flu (determined by a nasopharyngeal wash), and Rotavirus (determined by stool culture); chest x-ray was negative.  The patient was treated with fluids and albuterol.  On 24-MAR-2011, the patient discharged home on ORAPRED and amoxicillin.  At the time of report, the patient's outcome was recovering.  Rotavirus was considered to be an other important medical event by the registered nurse.  Additional information has been requested.
Age: 0.64
Sex: M
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Initial and follow up information has been received from a registered nurse and a licensed practical nurse concerning a 7 month old male with asthma and no known drug allergies who was respectively vaccinated with the first, second and third dose of ROTATEQ, 2ml, oral on 08-FEB-2010, 05-APR-2010 and 23-JUL-2010 (Lot no. 664782/1441Y, expiration date: 23-APR-2011 (1st), lot no. 664884/1524Y, expiration date: 23-APR-2011 (2nd), lot no. 667461/0500Z, expiration date: unknown (3rd).  The third dose was given 15 weeks after the second dose when the patient was 33 week old.  On 14-MAR-2011, the patient presented to the emergency room for bronchiolitis, diarrhea and flu like symptoms.  He was hospitalized and was found bilateral ear infections, asthma exacerbation, flu (determined by a nasopharyngeal wash), and Rotavirus (determined by stool culture); chest x-ray was negative.  The patient was treated with fluids and albuterol.  On 24-MAR-2011, the patient discharged home on ORAPRED and amoxicillin.  At the time of report, the patient's outcome was recovering.  Rotavirus was considered to be an other important medical event by the registered nurse.  Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Pneumonia, Pyrexia, X-ray
Clinical narrative: Information has been received from a 66 year old male pharmacist with no allergies and no pertinent medical history, who in February 2000, was vaccinated with a first dose of PNEUMOVAX 23 ( Lot# not reported), in approximately February 2005 was vaccinated with a second dose of PNEUMOVAX 23 (Lot# not reported), and in approximately 2010 "Over one year ago" was vaccinated with a third dose of PNEUMOVAX 23 (Lot# not reported), IM.  Concomitant therapy included aspirin.  It was reported that the patient had received three doses of PNEUMOVAX 23 in the past "spaced about 5 years apart".  Pharmacist stated that "About 4-5 weeks ago" on approximately 14-FEB-2011 had developed pneumonia in the right lung; some cough and fever of 101 F for 4-5 days.  Pharmacist also stated that missed work about 4-5 days of work".  X-rays were performed (No results reported).  It was reported the patient received the following treatment for the adverse events: montelukast sodium (MSD), LEVAQUIN, TUSSIONEX, DELSYM, VENTOLIN HFA and FLUNASE.  The patient sought unspecified medical attention.  At the time of the report the patient was recovering and had some cough.  Pneumonia in the right lung, fever 101F and cough, were considered to be disabling by the reporter.  Additional information has been requested.
Sex: U
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Local reaction
Clinical narrative: Both had red local reaction non systemic or anaphylaxis noticed.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Induration, Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 55 year old female patient who on 10-FEB-2011 was vaccinated with PNEUMOVAX 23 (lot no. 669374/1623Z, exp: 12-AUG-2012) 0.5 mL intramuscularly.  On 11-FEB-2011 the patient experienced left arm injection site redness, swelling all the way down to elbow, diagnosed with cellulites of the left arm and was given KEFLEX.  The patient sought unspecified medical attention.  At the time of this report, the patient's outcome was not recovered.  Follow up information has been received from the nurse practitioner who reported that the female patient with no illness at time of vaccination was vaccinated with a dose of PNEUMOVAX 23 (lot no. 667712/1211Z, previously reported as 669374/1623Z) 0.5 mL intramuscularly into the left deltoid at private doctor's office/hospital.  On 11-FEB-2011, the patient experienced erythema and warmth induration from deltoid injection site to left wrist.  The patient experienced fever, lymphangitis and pain, at the time of the report the patient's outcome was not reported.  Fever, lymphagitis and pain were considered to be other important medical events by the nurse.  Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Lymphangitis, Pain, Pyrexia
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 55 year old female patient who on 10-FEB-2011 was vaccinated with PNEUMOVAX 23 (lot no. 669374/1623Z, exp: 12-AUG-2012) 0.5 mL intramuscularly.  On 11-FEB-2011 the patient experienced left arm injection site redness, swelling all the way down to elbow, diagnosed with cellulites of the left arm and was given KEFLEX.  The patient sought unspecified medical attention.  At the time of this report, the patient's outcome was not recovered.  Follow up information has been received from the nurse practitioner who reported that the female patient with no illness at time of vaccination was vaccinated with a dose of PNEUMOVAX 23 (lot no. 667712/1211Z, previously reported as 669374/1623Z) 0.5 mL intramuscularly into the left deltoid at private doctor's office/hospital.  On 11-FEB-2011, the patient experienced erythema and warmth induration from deltoid injection site to left wrist.  The patient experienced fever, lymphangitis and pain, at the time of the report the patient's outcome was not reported.  Fever, lymphagitis and pain were considered to be other important medical events by the nurse.  Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 55 year old female patient who on 10-FEB-2011 was vaccinated with PNEUMOVAX 23 (lot no. 669374/1623Z, exp: 12-AUG-2012) 0.5 mL intramuscularly.  On 11-FEB-2011 the patient experienced left arm injection site redness, swelling all the way down to elbow, diagnosed with cellulites of the left arm and was given KEFLEX.  The patient sought unspecified medical attention.  At the time of this report, the patient's outcome was not recovered.  Follow up information has been received from the nurse practitioner who reported that the female patient with no illness at time of vaccination was vaccinated with a dose of PNEUMOVAX 23 (lot no. 667712/1211Z, previously reported as 669374/1623Z) 0.5 mL intramuscularly into the left deltoid at private doctor's office/hospital.  On 11-FEB-2011, the patient experienced erythema and warmth induration from deltoid injection site to left wrist.  The patient experienced fever, lymphangitis and pain, at the time of the report the patient's outcome was not reported.  Fever, lymphagitis and pain were considered to be other important medical events by the nurse.  Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Headache, Injection site pain, Pain
Clinical narrative: Woke with severe headache, aching all over, soreness at site, temperature that rose over the day to 103.9
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: This is one case out of a cumulative total of 16 cases received during the surveillance period from 01 January 2010 to 22 March 2011. Initial report received on 22 March 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 11 month old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms (date not reported), and on 08 February 2011 approximately five months after the last dose, developed a cough. On 26 February 2011, the subject developed a paroxysmal cough without whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray finding were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 01 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, although PCR was negative on 28 February 2011, this case was epidemiologically linked to a laboratory confirmed case (twin sibling captured in case number 2011-01491). Investigator causality assessment is not required as per protoccol. Documents held by sender: None.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 16 cases received during the surveillance period from 01 January 2010 to 22 March 2011. Initial report received on 22 March 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 11 month old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms (date not reported), and on 08 February 2011 approximately five months after the last dose, developed a cough. On 26 February 2011, the subject developed a paroxysmal cough without whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray finding were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 01 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, although PCR was negative on 28 February 2011, this case was epidemiologically linked to a laboratory confirmed case (twin sibling captured in case number 2011-01491). Investigator causality assessment is not required as per protoccol. Documents held by sender: None.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test normal, Nasopharyngitis, Pertussis
Clinical narrative: This is one case out of a cumulative total of 16 cases received during the surveillance period from 01 January 2010 to 22 March 2011. Initial report received on 22 March 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 11 month old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms (date not reported), and on 08 February 2011 approximately five months after the last dose, developed a cough. On 26 February 2011, the subject developed a paroxysmal cough without whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray finding were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 01 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, although PCR was negative on 28 February 2011, this case was epidemiologically linked to a laboratory confirmed case (twin sibling captured in case number 2011-01491). Investigator causality assessment is not required as per protoccol. Documents held by sender: None.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 16 cases received during the surveillance period from 01 January 2010 to 22 March 2011. Initial report received on 22 March 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 11 month old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms (date not reported), and on 08 February 2011 approximately five months after the last dose, developed a cough. On 26 February 2011, the subject developed a paroxysmal cough without whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray finding were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 01 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, although PCR was negative on 28 February 2011, this case was epidemiologically linked to a laboratory confirmed case (twin sibling captured in case number 2011-01491). Investigator causality assessment is not required as per protoccol. Documents held by sender: None.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sick relative, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 16 cases received during the surveillance period from 01 January 2010 to 22 March 2011. Initial report received on 22 March 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 11 month old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms (date not reported), and on 08 February 2011 approximately five months after the last dose, developed a cough. On 26 February 2011, the subject developed a paroxysmal cough without whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray finding were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 01 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, although PCR was negative on 28 February 2011, this case was epidemiologically linked to a laboratory confirmed case (twin sibling captured in case number 2011-01491). Investigator causality assessment is not required as per protoccol. Documents held by sender: None.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: Surveillance for Rates of Pertussis Disease Among Persons Birth through 59 months of Age Receiving PENTACEL or Other Pertussis Vaccines.  This is one case out of a cumulative total of 16 cases received during the surveillance period from 01 January 2010 to 22 March 2011.  Incident ID# 489264.  Initial report received on 22 March 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16.  A case of pertussis disease in an 11 month old female subject (initials not collected) was identified by the investigator based on review of data from agency.  The subject's vaccine history included 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA/C3623AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported).  The subject developed cold-like symptoms (date not reported), and approximately five months after the last dose, developed a cough on 08 February 2011.  On 26 February 2011, the subject developed a paroxysmal cough without whoop.  The subject also experienced posttussive vomiting and sleep disturbance.  Laboratory testing included positive PCR on 28 February 2011.  Chest x-ray findings were negative for pneumonia.  Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unspecified number of days.  The subject was not hospitalized.  At the time of final contact on 01 March 2011, the subject's cough was still persisting.  The duration of the cough was reported at that time as 21 days.  Investigator causality assessment is not required as per protocol.  The subject had a twin sibling who also developed pertussis (captured in case number 2011-01492).  Sponsor Comment: No vaccine protects 100% of individuals against infection.  It is therefore, not unexpected to find cases of pertussis after vaccination.  In this particular case, no medical history has been provided so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination.  Documents held by sender: None.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Surveillance for Rates of Pertussis Disease Among Persons Birth through 59 months of Age Receiving PENTACEL or Other Pertussis Vaccines.  This is one case out of a cumulative total of 16 cases received during the surveillance period from 01 January 2010 to 22 March 2011.  Incident ID# 489264.  Initial report received on 22 March 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16.  A case of pertussis disease in an 11 month old female subject (initials not collected) was identified by the investigator based on review of data from agency.  The subject's vaccine history included 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA/C3623AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported).  The subject developed cold-like symptoms (date not reported), and approximately five months after the last dose, developed a cough on 08 February 2011.  On 26 February 2011, the subject developed a paroxysmal cough without whoop.  The subject also experienced posttussive vomiting and sleep disturbance.  Laboratory testing included positive PCR on 28 February 2011.  Chest x-ray findings were negative for pneumonia.  Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unspecified number of days.  The subject was not hospitalized.  At the time of final contact on 01 March 2011, the subject's cough was still persisting.  The duration of the cough was reported at that time as 21 days.  Investigator causality assessment is not required as per protocol.  The subject had a twin sibling who also developed pertussis (captured in case number 2011-01492).  Sponsor Comment: No vaccine protects 100% of individuals against infection.  It is therefore, not unexpected to find cases of pertussis after vaccination.  In this particular case, no medical history has been provided so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination.  Documents held by sender: None.