chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Swollen, hot, hard and itchy at site. Swollen upper arm. Sore and stiff neck and arm muscles same side of the body as injection site. Slight swelling right side of the jaw. Overall itchiness.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Myalgia, Neck pain, Pruritus generalised, Swelling
Clinical narrative: Swollen, hot, hard and itchy at site. Swollen upper arm. Sore and stiff neck and arm muscles same side of the body as injection site. Slight swelling right side of the jaw. Overall itchiness.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Sore arm, red approx 3" around site, warm to touch, slightly swollen, general malaise.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Induration, Pain
Clinical narrative: Temp 100.5, no vomiting. Pain worse when moves ( L ) arm. Indurated area 5 cm. Normal grip sensory exam.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: The patient came back two days after her vaccination and had a very large bruise & swelling around the injection site and had swelling and redness down her right arm almost to her elbow. she said her arm was painful and was warm to the touch. I recommended that she see her doctor right away. Doctor saw her and said it was cellulitis and he prescribed her some BACTRIM DS which she filled on 5-12-2010. She said it felt better than yesterday.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: The patient came back two days after her vaccination and had a very large bruise & swelling around the injection site and had swelling and redness down her right arm almost to her elbow. she said her arm was painful and was warm to the touch. I recommended that she see her doctor right away. Doctor saw her and said it was cellulitis and he prescribed her some BACTRIM DS which she filled on 5-12-2010. She said it felt better than yesterday.
Age: 49.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Exfoliative rash, Rash erythematous, Urticaria
Clinical narrative: Noted no reaction at time of vaccination.  8-10 days later, developed red, flat, itchy, dry, scaly rash beginning on thorax - upper chest.  2-3 nickel-sized spots on each arm.  Not responding to OTC hydrocortisone or Benadryl cream.
Age: 15.0
Sex: M
Vaccine: RAB
Symptoms: Abdominal pain, Full blood count, Headache, Malaise, Myalgia
Clinical narrative: Approx 8 hrs. after vaccination, patient complained of generalized muscle pains, headache, malaise, abdominal pain and was noted to have a fever of 101. Given Tyelenol, & one hr later fever was 102. Given Motrin.  Still is not feeling well.
Age: 15.0
Sex: M
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: Approx 8 hrs. after vaccination, patient complained of generalized muscle pains, headache, malaise, abdominal pain and was noted to have a fever of 101. Given Tyelenol, & one hr later fever was 102. Given Motrin.  Still is not feeling well.
Sex: M
Vaccine: TDAP
Symptoms: Bordetella test positive, Cough, Malaise
Clinical narrative: The initial case was received on 10 May 2010 from a local healthcare professional. A male patient (age not reported) received a left deltoid intramuscular injection of ADACEL (sanofi pasteur Inc. lot number UF484CA, sanofi pasteur Inc. lot number C3086) on 19 August 2009. The patient had no illness at the time of the vaccination. He had no pre-existing medical conditions or allergies. Concomitant medications included CELEXA 20 mg and an unspecified vitamin supplement. On 03 May 2010 the patient tested positive for pertussis. The symptoms of a severe cough and an "overall feeling of being unwell" began 5-7 days prior to pertussis testing. The patient required a doctor's visit and was treated with Z-PACK. The outcome was recovered. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Left thigh swelling (same site of injection) 1 day after administration of DTaP. Symptoms lasting 2 days, resolving. No treatment intervention. Counseling provided.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Dysphagia, Dyspnoea, Lymphadenopathy
Clinical narrative: Received MMR midday.  Later in evening, developed swollen lymph nodes and difficulty swallowing and breathing.  Used rescue inhaler and KEFLEX.  Father is MD.  He was consulted.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: 2 areas of inflammation at vaccine sites upper left leg #1 Halo only.  #2 quarter size red flat non tender area extending from 2nd site.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Cough, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Back of left arm where VARICELLA given became hot & hard at injection site (about 2 1/2 X 3 1/2) with redness spreading toward under arm.  Site is tender.  No fever.  No body aches.  (5/5/10).  A little less red 5/6/10 but cont's hot & hard.  No fever.  5/11/10 phone call to mother.  Reaction got worse before getting better.  Site became very swollen & itchy.  Given BENADRYL 5/6/10 & 5/7/10 with good results.  5/10/10 began coughing & sore throat but no fever and went to school.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Oropharyngeal pain
Clinical narrative: Back of left arm where VARICELLA given became hot & hard at injection site (about 2 1/2 X 3 1/2) with redness spreading toward under arm.  Site is tender.  No fever.  No body aches.  (5/5/10).  A little less red 5/6/10 but cont's hot & hard.  No fever.  5/11/10 phone call to mother.  Reaction got worse before getting better.  Site became very swollen & itchy.  Given BENADRYL 5/6/10 & 5/7/10 with good results.  5/10/10 began coughing & sore throat but no fever and went to school.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, tenderness, swelling, warmth, and pain where the shot was given.
Age: 1.1
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Varicella
Clinical narrative: Patient received his MMR, VARIVAX, HEP A #1 on 04/27/10.  He got a rash a week later which appears to be varicella, as a result of his VARIVAX shot.  He also have fever.
Age: 4.0
Sex: F
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: 24 hrs after injection - 3 cm.  36 hrs after injection - 4 cm.  Redness - DTP.
Age: 0.22
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying
Clinical narrative: 6 hours of inconsolable crying w/in 24 hours of vax admin.
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: This case was considered medically important for the injection of injection site cellulitis. Information regarding PREVNAR 13 was received from a healthcare professional regarding an 18-month-old female patient who experienced localized redness and cellulitis at the site of administration of the PREVNAR 13. The patient received the first dose on 04-May-2010. The patient also received a dose of Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine (manufacturer unknown) on 04-May-2010. The patient was administered the PREVNAR 13 and DTaP in the same leg on 04-May-2010. After being administered the vaccine, the patient experienced localized redness in her leg. The next day, on 05-May-2010, the patient returned to the doctor's office due to an event and was diagnosed with cellulitis. Treatment included a course of unspecified antibiotic. It was reported that the events were due to PREVNAR 13 and not the DTaP because they knew where the patient was administered each vaccine and determined the causal relationship with PREVANR 13 based on the location of the redness and cellulitis. The events persisted. No additional information was available at the time of this report.
Age: 10.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dizziness, Nausea
Clinical narrative: Pt experienced dizziness & nausea after receiving, MMR & varicella.  Vital signs taken - WNL.  Pt rested for 10 mins & was improved.
Age: 18.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Hypersensitivity, Rash macular, Rash pruritic
Clinical narrative: Diffuse erythematous, macular rash on trunk/extremities -itchy.  Confirmed allergic reaction by Dermatologist - treated with BENADRYL and PREDNISONE.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Palpable lymph node left armpit approx 46 hours after receiving TDAP vaccination in left deltoid.  Lymph node approx size of marble with swelling of surrounding tissue anteriorally to it.  Rates pain as 5 (1-10 scale) when palpated only.  Afebrile, full ROM Rue.  No erythema.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Wrong drug administered
Clinical narrative: 0.4 % normal saline vial stated as "dilutent for Haemophilus influenzae type B conjugate" was drawn up at administered IM to patient.  No adverse SX.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: CSF cell count abnormal, CSF protein increased, Electromyogram abnormal, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Tingling in feet, weakness in legs worsening over course of about 2 weeks. Treated with IVIG.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Lumbar puncture abnormal, Nerve conduction studies abnormal, Paraesthesia
Clinical narrative: Tingling in feet, weakness in legs worsening over course of about 2 weeks. Treated with IVIG.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash on abdomen.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Erythma, swelling, approximatley 4 1/2 - 5 inches in diameter, some warmth.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: R deltoid swollen to 11cm, red and warm.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Amnesia, Arthralgia, Blindness transient, Blood test normal
Clinical narrative: Last dose of Gardasil was administered in January, 2009.  Adverse symptoms include:  Migraine headaches, dizziness, lightheadedness, chronic fatigue, seizures, intermittent paralysis, numbness in lower extremities, leg pain, temporary loss of vision, muscle weakness, fainting spells, memory loss, joint pain, muscle pain, hair loss, chest pain, appetite loss, loss of weight, insomnia, itching and rashes.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Computerised tomogram normal, Convulsion, Decreased appetite, Dizziness
Clinical narrative: Last dose of Gardasil was administered in January, 2009.  Adverse symptoms include:  Migraine headaches, dizziness, lightheadedness, chronic fatigue, seizures, intermittent paralysis, numbness in lower extremities, leg pain, temporary loss of vision, muscle weakness, fainting spells, memory loss, joint pain, muscle pain, hair loss, chest pain, appetite loss, loss of weight, insomnia, itching and rashes.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Electroencephalogram normal, Electromyogram normal, Fatigue, Hypoaesthesia, Insomnia
Clinical narrative: Last dose of Gardasil was administered in January, 2009.  Adverse symptoms include:  Migraine headaches, dizziness, lightheadedness, chronic fatigue, seizures, intermittent paralysis, numbness in lower extremities, leg pain, temporary loss of vision, muscle weakness, fainting spells, memory loss, joint pain, muscle pain, hair loss, chest pain, appetite loss, loss of weight, insomnia, itching and rashes.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Muscular weakness, Myalgia, Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: Last dose of Gardasil was administered in January, 2009.  Adverse symptoms include:  Migraine headaches, dizziness, lightheadedness, chronic fatigue, seizures, intermittent paralysis, numbness in lower extremities, leg pain, temporary loss of vision, muscle weakness, fainting spells, memory loss, joint pain, muscle pain, hair loss, chest pain, appetite loss, loss of weight, insomnia, itching and rashes.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Paralysis, Pruritus, Rash, Syncope, Weight decreased
Clinical narrative: Last dose of Gardasil was administered in January, 2009.  Adverse symptoms include:  Migraine headaches, dizziness, lightheadedness, chronic fatigue, seizures, intermittent paralysis, numbness in lower extremities, leg pain, temporary loss of vision, muscle weakness, fainting spells, memory loss, joint pain, muscle pain, hair loss, chest pain, appetite loss, loss of weight, insomnia, itching and rashes.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: X-ray normal
Clinical narrative: Last dose of Gardasil was administered in January, 2009.  Adverse symptoms include:  Migraine headaches, dizziness, lightheadedness, chronic fatigue, seizures, intermittent paralysis, numbness in lower extremities, leg pain, temporary loss of vision, muscle weakness, fainting spells, memory loss, joint pain, muscle pain, hair loss, chest pain, appetite loss, loss of weight, insomnia, itching and rashes.
Age: 58.0
Sex: F
Vaccine: DTAP
Symptoms: Activities of daily living impaired, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: Pain, swelling, heat and redness at injection site, body aches, fever(100.5), headache, extremely tired, nausea, chills, and sore joints. It is interfering with normal activities. I am attempting to get medical attention. The physician that administered the injection said there is nothing they can do. They just give the injection. I was advised to call urgent care but I have a call into my family physician.
Age: 58.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Pain, swelling, heat and redness at injection site, body aches, fever(100.5), headache, extremely tired, nausea, chills, and sore joints. It is interfering with normal activities. I am attempting to get medical attention. The physician that administered the injection said there is nothing they can do. They just give the injection. I was advised to call urgent care but I have a call into my family physician.
Age: 58.0
Sex: F
Vaccine: DTAP
Symptoms: Pain, Pyrexia
Clinical narrative: Pain, swelling, heat and redness at injection site, body aches, fever(100.5), headache, extremely tired, nausea, chills, and sore joints. It is interfering with normal activities. I am attempting to get medical attention. The physician that administered the injection said there is nothing they can do. They just give the injection. I was advised to call urgent care but I have a call into my family physician.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Noted above red, itching rash over site of injectiion.  Warmth noted, some headache associated.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Pyrexia, Rash
Clinical narrative: FEVER; RASH
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Pain, redness in site of immunization. On exam, local cellulitis. Started on Bactrim, 20 ml twice a day x 10 days.
Age: 28.0
Sex: F
Vaccine: MNQ
Symptoms: Discomfort, Extensive swelling of vaccinated limb, Injection site swelling
Clinical narrative: Marked swelling of arm at site and upper arm, and under armpit and on inside of chest. No redness or warmth. Marked discomfort of outer arm and armpit. Still swollen 5/14/2010.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Awoke with a fever, body aches, and swelling at the site of the vaccination.
Age: 23.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and swollen area approximately 10CM by 10 CM at injection site.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Blood electrolytes normal, Culture stool negative, Diarrhoea, Full blood count, Haematochezia
Clinical narrative: Bloody breast fed stools began 5/8.  Diarrhea developed 5/9 with mucousy bloody stools 12 times a day.  Developed fever 101.5 5/10.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Mucous stools, Parasite blood test, Parasite stool test, Pyrexia
Clinical narrative: Bloody breast fed stools began 5/8.  Diarrhea developed 5/9 with mucousy bloody stools 12 times a day.  Developed fever 101.5 5/10.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Crying, Serum sickness
Clinical narrative: Severe joint pain in knees at night. Woke up crying that she was in pain. This is the second time she has reported joint pain since this vaccine was given. I gave her children's Tylenol, 1 1/2 ts. and put heating pad on knees and legs. She was better within an hour or two.  She had the same pain when she had amoxicillin. THey called it serum sickness.
Age: 30.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Impaired work ability, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Full body ache, low fever, headache, arm soreness. Could not attend work the following day because of flu-like symptoms.
Age: 30.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Full body ache, low fever, headache, arm soreness. Could not attend work the following day because of flu-like symptoms.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Picked up child from daycare, one out of three shots is swollen red and is hot in a large area on her shoulder.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1), HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood glucose normal, Dizziness, Feeling hot, Haemoglobin increased, Heart rate normal
Clinical narrative: Approx 8 min after receiving seven vaccines pt began complaining of feeling dizzy.  She then slumped to her knees saying she was going to pass out.  A code blue was called and Dr. immediately responded.  Pt had already been assisted to a chair.  She was perspiring and c/o feeling hot.  Dr. gave her Gatorade to drink and ordered Glu which was 97 and Hgb (15.2) BP initially 66/40, 5 min later 70/42.  She was asked to put her head between her knees.  She began to feel better after 15 min later.  She walked to exam room to finish her visit.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1), HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Hyperhidrosis, Hypotension
Clinical narrative: Approx 8 min after receiving seven vaccines pt began complaining of feeling dizzy.  She then slumped to her knees saying she was going to pass out.  A code blue was called and Dr. immediately responded.  Pt had already been assisted to a chair.  She was perspiring and c/o feeling hot.  Dr. gave her Gatorade to drink and ordered Glu which was 97 and Hgb (15.2) BP initially 66/40, 5 min later 70/42.  She was asked to put her head between her knees.  She began to feel better after 15 min later.  She walked to exam room to finish her visit.
Age: 1.02
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Varicella
Clinical narrative: 2 wks after injection-child developed chicken pox, approx 50-249 lesions.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Left SQ of arm with erythema and swelling about 1.5cm in diameter.
Age: 0.27
Sex: M
Vaccine: HEP, HPVX, IPV
Symptoms: Vaccination error, Wrong drug administered
Clinical narrative: Mother took her son to get 3 months shot & checkup which consisted of HEP B and POLIO shot which was given at the time.  After leaving mother recv'd a call about 6 hrs later that her son had been given an HPV vax.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Nodule, Paraesthesia, Skin warm
Clinical narrative: Pt recv'd shingles vax on 5/12/10 around 4:30PM.  Shortly after pt. experienced burning in her throat.  She sat in front of pharmacy for about 10-15 min and tingling and burning went away.  She also noticed 4 or 5 nodules in her arm, very warm, red, and inflamed.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat irritation
Clinical narrative: Pt recv'd shingles vax on 5/12/10 around 4:30PM.  Shortly after pt. experienced burning in her throat.  She sat in front of pharmacy for about 10-15 min and tingling and burning went away.  She also noticed 4 or 5 nodules in her arm, very warm, red, and inflamed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site reaction
Clinical narrative: Excessive local reaction to the injection site.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Dyskinesia, Syncope
Clinical narrative: 11 y/o female patient, was being given MENACTRA, Varicella Tdap, GARDASIL. While administering HPV vaccine, patient fainted with some jerky movement x 7 secs., regain consciousness. No drooling No incontinence noted.
Age: 1.39
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Medication error, Unevaluable event
Clinical narrative: None-Tdap given error.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Erythema induratum, Swelling
Clinical narrative: 4x4 left leg erythemic reaction, swollen, induration.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: After ZOSTAVAX vaccination pt developed a red spot about 1" by 1 1/2" red, hot slight rash. Benadryl 25 1 q4-6h and Hc 1% cream QID.
Age: 9.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: RUE lat biceps sl large than silver dollar sized erythema and sl increased heat to touch but non tender. Not intense erythema seems improved resolving or more diffuse.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Rash generalised
Clinical narrative: Rash all over body 1 day after vaccine administration.
Age: 4.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Multiple blisters at vaccine site, swollen.
Age: 0.3
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Erythema, Flushing
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of flush all over in a 4-month-old subject of unspecified gender who was vaccinated with PEDIARIX, (GlaxoSmithKline), HIB, (non-gsk) ROTATEQ and PREVNAR.  On an unspecified date, the subject received 2nd dose of PEDIARIX (.5 ml, unknown), unspecified dose of HIB (unknown), unspecified dose of ROTATEQ (unknown), unspecified dose of PREVNAR (unknown).  At an unspecified time after vaccination with HIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced flush all over and skin turned red.  The physician reported a 4-month old subject experienced flushing all over and turned bright red after receiving his 2nd PEDIARIX.  At the time of reporting the outcome of the events were unspecified.  The physician considered the events were possibly related to vaccination with PEDIARIX, HIB, ROTATEQ and PREVNAR.
Age: 0.3
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Lethargy, Pyrexia
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of flush all over in a 4-month-old subject of unspecified gender who was vaccinated with PEDIARIX, (GlaxoSmithKline), HIB, ROTATEQ (non-gsk), and PREVNAR.  On an unspecified date, the subject received 2nd dose of PEDIARIX (.5 ml, unknown), unspecified dose of HIB (unknown), unspecified dose of ROTATEQ (unknown), unspecified dose of PREVNAR (unknown).  At an unspecified time after vaccination with HIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced high fever and lethargy.  The physician reported a 4-month old subject experienced high fever and lethargy after receiving his 2nd PEDIARIX.  At the time of reporting the outcome of the events were unspecified.  The physician considered the events were possibly related to vaccination with PEDIARIX, HIB, ROTATEQ and PREVNAR.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of fever in a 6-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline), PREVNAR, HIB and ROTATEQ.  On an unspecified date the subject received 3rd dose of PEDIARIX (.5 ml, unknown), unspecified dose of PREVNAR (unknown), unspecified dose of HIB vaccine (unknown), unspecified dose of ROTATEQ (unknown).  At an unspecified time after vaccination with HIB vaccine, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced fever.  The subject's fever was up to 102 degrees that resolved 48 hours after vaccination.  The subject was treated with TYLENOL and MOTRIN alternating doses every three hours.  At the time of reporting the event was resolved.  Follow-up information received on 27 January 2009 indicated that the subject developed injection site swelling and tenderness in the leg following administration of PEDIARIX in addition to fever.  PEDIARIX was given on 06 January 2009.  The events resolved and were considered by the reporter to be related to treatment with PEDIARIX.  It was noted that the subject did not experience anaphylaxis.
Age: 1.11
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased, Febrile convulsion, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of febrile seizure in a 1-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline).  Previous and/or concurrent vaccination included ACTHIB; Sanofi given on 22 January 2009; (non-gsk) PREVNAR; Wyeth Labs given on 22 January 2009.  On 22 January 2009 the subject received 3rd dose of PEDIARIX.  On 22 January 2009, within 24 hours after vaccination with PEDIARIX, the subject experienced fever of 103 and febrile seizure.  The subject was taken to the emergency room but was discharged.  This case was assessed as medically serious by GSK.  At the time of reporting the events were resolved.  The physician considered the events were possibly related to vaccination with PEDIARIX.
Age: 1.11
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased, Febrile convulsion, Otitis media, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of febrile seizure in a 1-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline).  Previous and/or concurrent vaccination included ACTHIB; Sanofi given on 22 January 2009; (non-gsk) PREVNAR; Wyeth Labs given on 22 January 2009.  On 22 January 2009 the subject received 3rd dose of PEDIARIX.  On 22 January 2009, within 24 hours after vaccination with PEDIARIX, the subject experienced fever of 103 and febrile seizure.  The subject was taken to the emergency room but was discharged.  This case was assessed as medically serious by GSK.  At the time of reporting the events were resolved.  The physician considered the events were possibly related to vaccination with PEDIARIX.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Oedema peripheral
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of swollen leg in a subject of unspecified age and gender who was vaccinated with PEDIARIX (GlaxoSmithKline). In 2008 the subject received 3rd dose of PEDIARIX in the right thigh. The report indicated that the subject had been experiencing swelling in the right leg after receiving three PEDIARIX injections in that leg between 6 to 12 months prior to reporting. At the time of reporting the outcome of the event was unspecified. The physician considered event was possibly related to vaccination with PEDIARIX.
Age: 0.59
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Chills, No reaction on previous exposure to drug, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 6-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), TETRACOQ and pneumococcal vaccines (non-GSK). There were no concurrent medications. The subject had no relevant medical history or any adverse events following previous vaccinations. On 8 June 2007 at 15:00 the subject received 3rd dose of PEDIARIX (.5 ml, unknown), the 3rd dose of TETRACOQ and the 3rd dose of Pneumococcal vaccine. On 8 June 2007, less than one day after vaccination with PEDIARIX, TETRACOQ and Pneumococcal vaccine, the subject experienced fever and chills. The physician reported that per the subject's father, the infant experienced fever and chills on the same day he was vaccinated with PEDIARIX back in 2007. The infant had to be treated in the emergency room for these events. The treatment required was not known by the reporting physician. The reporting physician did not know which vaccine may have caused the events as the child was concurrently vaccinated with TETRACOQ and pneumococcal vaccine on the same day as PEDIARIX. The reporting physician was considering whether to continue the child's vaccination series DTAP. The child is currently two years old. The events resolved on an unspecified date.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Fatigue, Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a consumer and described the occurrence of tiredness in a 6-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Previous vaccination included PEDIARIX (GlaxoSmithKline) given on 27 March 2009. Concurrent vaccination included Haemophilus influenza type b vaccine (manufacturer unspecified) given on 13 April 2009 and (non-gsk) PREVNAR (manufacturer unspecified) given on 13 April 2009. Concurrent medications included Multivitamins. On 13 April 2009 at 15:00 the subject mistakenly received 3rd dose of PEDIARIX (route unknown, right thigh) after only receiving his 2nd dose 17 days ago (drug dose administration interval too short). On 13 April 2009, 5 hours after vacciantion with PEDIARIX, the subject experienced tiredness. At the time of reporting the event was unresolved.
Age: 0.2
Sex: U
Vaccine: DTAP, DTAPHEPBIP
Symptoms: Crying
Clinical narrative: This case was reported by a sales representative and described the occurrence of crying in a 2-month-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline), INFANRIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of PEDIARIX (unknown) or unspecified dose of INFANRIX (unknown). The reporter was not exactly sure that the vaccine administered to the subject was PEDIARIX.  It reportedly could have been INFANRIX.  At an unspecified time after vaccination with PEDIARIX or INFANRIX, the subject experienced crying.  It was indicated that the subject cried for 9 hours after vaccination, however, resolution was not specifically stated.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injury
Clinical narrative: This case was reported by a lawyer and described the occurrence of vaccine-related injuries in a 4-year-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On 26 August 2005, the subject received unspecified dose of PEDIARIX (unknown).  At an unspecified time after vaccination with PEDIARIX, the subject experienced vaccine-related injuries.  At the time of reporting the outcome of the events was unspecified.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC, RV5
Symptoms: Accidental overdose, Irritability, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of unintentional overdose in a 2-month-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) PENTACEL. Previous and/or concurrent vaccination included (non-gsk) PREVNAR; non-GSK manufacturer given on 20 July 2009; (non-gsk) ROTATEQ. On 20 July 2009 at 14:15 the subject received 1st dose of PEDIARIX (unknown left thigh) and unspecified dose of PENTACEL (unknown) and experienced unintentional overdose. The pediatrician was concerned that the subject received PEDIARIX and PENTACEL in the same day. Follow up received from healthcare professional 11 August 2009: The subject was male. The subject had not experienced adverse events following previous vaccination. The healthcare professional indicated that the subject experienced business following vaccination with PEDIARIX and PENTACEL, no more than usual, which resolved the next day and the subject was fine. The time to onset since vaccination was not specified. The healthcare professional did not consider the events serious and identified the suspect products as PEDIARIX and PENTACEL. The healthcare professional considered the events could have been associated with erroneous administration; subject received PENTACEL and PEDIARIX in error, no adverse effects.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of high fever in a 1-year-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). No information was available regarding concomitant medications, medical history or any adverse events following previous vaccinations. Previous and/or concurrent vaccinations included 10 valent pneumococcal conjugate vaccine; manufacturer unspecified given on an unspecified date; combined diphtheria, tetanus, acellular pertussis and Haemophilus influenzae type b vaccine; manufacturer unspecified given on an unspecified date. On an unspecified date the subject received unspecified dose of PEDIARIX (details unknown). On 12 March 2004, at an unspecified time after vaccination with PEDIARIX, the subject experienced high fever. At the time of reporting the outcome of the event was unspecified. No further information was available.
Age: 57.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Fever over 101 for two days.
Age: 0.18
Sex: M
Vaccine: RV1
Symptoms: Diarrhoea
Clinical narrative: Diarrhea.
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Abnormal behaviour, Activities of daily living impaired, Catatonia, Confusional state, Feeling cold
Clinical narrative: On Friday, September 25, 2009 at approximately 2:30pm, our family had influenza vaccines administered at the Health Center.  Other person had his vaccine a week or so earlier. That night, around 8pm, 9 year-old patient complained of a headache.  I checked his temperature and he had a fever of about 99.8°.  I gave him children's Motrin and put him to bed.  During the night he got up and vomited 3 times.  In the morning he still had a fever so I gave him another dose of Motrin. Saturday afternoon he was feeling better and his temperature was normal.  He ate a little and had a shower.  After his shower he was cold so he lied down in bed.  At about 5:30pm (after he'd been in bed about an hour), I heard him shout from his bed.  I went to him and he was very pale.  I checked him for fever and it had returned and was about 100°.  I gave him another dose of Motrin.  As I talked to him, he wasn't answering normally and seemed to be acting funny.  I called someone in to look at him.  We tried to talk to patient but he just stared at us like he couldn't hear us.  He was nearly catatonic.  Other person kept saying his name forcefully and tried to get patient to look at him.  Other person held up a couple of fingers and asked patient how many fingers he saw.  Patient didn't answer, he just stared at us.  Other person pressed him to answer how many fingers he was holding up and finally patient said, "What do you mean?"  Patient asked a couple of strange questions:  "Why are you moving so fast?" and "Are we going to do it like we did before? (When we questioned, "Do what?" he answered, "Make smiley faces like you have in your room?"  This had no meaning to us.).  I was terrified because this was so out of character for patient, who is an A+ student while barely trying.  I wanted to take him in to the hospital right away.  Other person persuaded me to watch patient for 30 minutes, however.  He thought he might be disoriented and have low blood sugar from taking an afternoon nap and not eating much that day (other person has experienced something similar).  I got patient some dinner and sat with him on his bed to eat.  He still was not functioning well and when he couldn't pick up his spaghetti with the fork, he asked me to do it for him.  He ate a couple of bites and then said he wasn't hungry and didn't want anymore.  Patient stayed up that night until about 11:45pm.  He slowly seemed to become more cognizant of what was going on, although he remained confused for some time.  Other person kept asking him math questions, which patient was able to answer correctly. We kept patient home all day on Sunday and he remained normal and without fever.  We think he does not have any lasting effects.  We do, however, believe that he had an adverse reaction to the influenza vaccine and are doubtful that we will immunize for influenza in the future.
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Pallor, Pyrexia, Staring, Vomiting
Clinical narrative: On Friday, September 25, 2009 at approximately 2:30pm, our family had influenza vaccines administered at the Health Center.  Other person had his vaccine a week or so earlier. That night, around 8pm, 9 year-old patient complained of a headache.  I checked his temperature and he had a fever of about 99.8°.  I gave him children's Motrin and put him to bed.  During the night he got up and vomited 3 times.  In the morning he still had a fever so I gave him another dose of Motrin. Saturday afternoon he was feeling better and his temperature was normal.  He ate a little and had a shower.  After his shower he was cold so he lied down in bed.  At about 5:30pm (after he'd been in bed about an hour), I heard him shout from his bed.  I went to him and he was very pale.  I checked him for fever and it had returned and was about 100°.  I gave him another dose of Motrin.  As I talked to him, he wasn't answering normally and seemed to be acting funny.  I called someone in to look at him.  We tried to talk to patient but he just stared at us like he couldn't hear us.  He was nearly catatonic.  Other person kept saying his name forcefully and tried to get patient to look at him.  Other person held up a couple of fingers and asked patient how many fingers he saw.  Patient didn't answer, he just stared at us.  Other person pressed him to answer how many fingers he was holding up and finally patient said, "What do you mean?"  Patient asked a couple of strange questions:  "Why are you moving so fast?" and "Are we going to do it like we did before? (When we questioned, "Do what?" he answered, "Make smiley faces like you have in your room?"  This had no meaning to us.).  I was terrified because this was so out of character for patient, who is an A+ student while barely trying.  I wanted to take him in to the hospital right away.  Other person persuaded me to watch patient for 30 minutes, however.  He thought he might be disoriented and have low blood sugar from taking an afternoon nap and not eating much that day (other person has experienced something similar).  I got patient some dinner and sat with him on his bed to eat.  He still was not functioning well and when he couldn't pick up his spaghetti with the fork, he asked me to do it for him.  He ate a couple of bites and then said he wasn't hungry and didn't want anymore.  Patient stayed up that night until about 11:45pm.  He slowly seemed to become more cognizant of what was going on, although he remained confused for some time.  Other person kept asking him math questions, which patient was able to answer correctly. We kept patient home all day on Sunday and he remained normal and without fever.  We think he does not have any lasting effects.  We do, however, believe that he had an adverse reaction to the influenza vaccine and are doubtful that we will immunize for influenza in the future.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Lip swelling, Pruritus, Urticaria
Clinical narrative: Swollen lips, hives, swollen eyes. Received Prednisone and took for 10 days. Hives worsened over the 10 days. Have since diminished but have still have 6 weeks later. Took Benadryl and no relief.  Taking hydroxysine for itch.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Hyperhidrosis, Hypoaesthesia, Hypoaesthesia oral, Pain
Clinical narrative: TACHYCARDIA, TACHYPNEA, PALPITATIONS, THROBBING PAIN IN BILATERAL FEMORAL ARTERIES AND CAROTID ARTERIES, DIAPHORESIS, NUMBNESS AND TINGLING IN THE LIPS, HANDS AND FEET, DIZZINESS. ACUTE PHASE LASTED 12 HOURS, CHRONIC PHASE LASTED 5 DAYS.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Palpitations, Paraesthesia, Paraesthesia oral, Tachycardia, Tachypnoea
Clinical narrative: TACHYCARDIA, TACHYPNEA, PALPITATIONS, THROBBING PAIN IN BILATERAL FEMORAL ARTERIES AND CAROTID ARTERIES, DIAPHORESIS, NUMBNESS AND TINGLING IN THE LIPS, HANDS AND FEET, DIZZINESS. ACUTE PHASE LASTED 12 HOURS, CHRONIC PHASE LASTED 5 DAYS.
Age: 34.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: Petechiae. Very low platelet count (2,000). Diagnosed with idiopathic thrombocytopenic purpura (ITP). Hospitalized for a week.
Age: 1.39
Sex: M
Vaccine: MMR
Symptoms: Breath sounds abnormal, Cough, Hyperventilation, Measles, Ocular hyperaemia
Clinical narrative: Child received MMR. Few days later started having runny nose, then cough, fever, vomiting, red spots on face, body, buttocks, red eyes, breathing hard/noisy. Doctor diagnosed measles.
Age: 1.39
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash erythematous, Rhinorrhoea, Vomiting
Clinical narrative: Child received MMR. Few days later started having runny nose, then cough, fever, vomiting, red spots on face, body, buttocks, red eyes, breathing hard/noisy. Doctor diagnosed measles.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Biopsy, Immune system disorder, Malaise, Pain, Paraesthesia
Clinical narrative: Severe paresthesia in lower extremities bilateral. Pain scale 8/10 continued for 72 hours then over the course of weeks development of painful subcutaneous nodules erupting every 2-6 weeks with malaise weight loss and continued pain during last five months, lately arms are affected as well. Meds Tylenol and ibuprofen every 4-6  hours ever since plus pregabalin and lidoderm. Biopsies pending diagnosis in progress. Missdirected immune system most likely. Vasculitis, panniculitis, lympthoma, connective tissue etc all possibilities in development. One thing for sure 100% healthy before the vaccination.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Subcutaneous nodule, Weight decreased
Clinical narrative: Severe paresthesia in lower extremities bilateral. Pain scale 8/10 continued for 72 hours then over the course of weeks development of painful subcutaneous nodules erupting every 2-6 weeks with malaise weight loss and continued pain during last five months, lately arms are affected as well. Meds Tylenol and ibuprofen every 4-6  hours ever since plus pregabalin and lidoderm. Biopsies pending diagnosis in progress. Missdirected immune system most likely. Vasculitis, panniculitis, lympthoma, connective tissue etc all possibilities in development. One thing for sure 100% healthy before the vaccination.
Age: 49.0
Sex: F
Vaccine: FLU(H1N1), HEPA
Symptoms: Pain, Skin tightness
Clinical narrative: Tightness in upper arm where injection was administered.  Also sharp shooting pain with movement of arm which continues till todate.  Cold and hot compress.
Age: 1.26
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: He experienced a fever 4 days and had 6 spots on him from the MMR shot.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Urticaria, Wheezing
Clinical narrative: Information has been received from a nurse practitioner concerning a 5 year old male who was vaccinated with a first dose of VARIVAX (Merck) (lot # 658376/1119U) and a second dose of MMR II (lot # 660581/1209X).  Other concomitant therapy included DTAP (unspecified) and IPV (unspecified).  On 06-APR-2009, after vaccine was given the patient experienced wheezing, difficulty breathing.  It was also reported the patient had hives on the left arm, but the nurse was not sure which vaccine was given on the left arm.  The patient was taken to the emergency room and spoke to the nurse.  On the same day, the patient recovered and was not admitted to the hospital.  Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a nurse concerning a 10 year old female who on 14-JUL-2009 at 09:40, was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (lot # 664694/0695Y) in her right leg.  There was no concomitant therapy.  There was no illness at the time of vaccination.  On 15-JUL-2009 at 10:00, the patient had a local reaction at the site approximately 11.5 cm wide by 12.5 cm high.  The patient was seen by primary care physician (PCP), no treatment except for TYLENOL for pain if needed.  At the time of the report, the patient had recovered.  No further information is available.  This is one of several reports received from the same source.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 17 year old male who on 24-JUL-2009 was vaccinated subcutaneously with the second 0.5mL dose of VARIVAX (Merck) (LOT# 664620/0797Y). On 31-JUL-2009, the patient was seen in the office with severe swelling from the elbow to the shoulder of the arm in which he was vaccinated. The date of onset of swelling was unknown. There was no lab diagnostics performed. The patient was not recovered at the time of this report. Follow-up information has been received from the nurse. The patient was 16 year old (previous reported as 17). He experienced swelling from right elbow to shoulder. The patient was given BENADRYL for 24 to 48 hours and prescribed AUGMENTIN. The patient was in office on 31-JUL-2009 and it was determined that he was recovered. Follow-up information has been received from the nurse concerning the 16 year old male patient (birth weight was 6 pound 8 ounce) who on 29-JUL-2009 (previous reported as 24-JUL-2009) was vaccinated subcutaneously with the second 0.5mL dose of VARIVAX (Merck) (LOT# 664620/0797Y). On 30-JUL-2009 (also reported as two day post vaccination), the patient experienced a local reaction described as swelling from deltoid to elbow on right arm and was warm to touch. The patient was given BENADRYL, 50mg, once, then every 6 hours for 24 to 48 hours and prescribed AUGMENTIN, 400mg, BID for 10 day. On an unknown date, the patient recovered. A lot check has been initiated. This is one of several reports from the same source. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from a Registered Nurse concerning a 9 year old female patient with penicillin allergy and no illness at the time of vaccination who on 15-AUG-2009 was vaccinated with a second dose of VARIVAX (Merck) (lot # 664624/0857Y) subcutaneously into left arm at 11:00 AM.  On 16-AUG-2009 the patient experienced one large 2 1/2" X 4" hive on left arm, itchy, hot to touch and slight pain at the injection site.  BENADRYL oral was given as well as cortisone applied per mother.  On an unspecified date the events were remarkably reduced.  Large 2 1/2" X 4" hive on left arm, itchy, hot to touch and slight pain at the injection site outcome was recovering/resolving.  There were no laboratories diagnostic studies performed.  No further information is available.