chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Autoimmune thrombocytopenia, Contusion, Idiopathic thrombocytopenic purpura
Clinical narrative: Severe bruising over entire body.  Requires multiple weekly blood tests for several months to monitor platlet count. 12/11/08-records received for DOS 8/19/08-seen for 11 day history of easy bruising and rash classic for petechiae.   Impression:classic childhood auto-immune thrombocytopenic purpura (AITP or ITP) likely trigger 4 weeks prior is VZV vaccine.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Red, swollen area approx 3cm X 6cm to left deltoid
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Irritability, Physical examination, Pyrexia
Clinical narrative: Fever over 101 beginning 9 hours after vaccination; irritability
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Induration, Oedema peripheral, Skin warm
Clinical narrative: On 08/16/08 parent reported by phone 3-1/4" X 4" area on R arm that was red, swollen, warm to touch. Pt was afebrile. Tx'd with cold compresses and ibuprofen.  Pt was seen in our office on 08/18/08, had 12cm X 12cm area of mild induration over R upper arm, no warmth or erythema, afebrile. No add'l tx recommended.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother reported by phone:  Reaction began 12-16 hours after immunization, entire left thigh with swelling and redness, lasted <24 hours, tx'd with ibuprofen.  Mom read in VIS that she should report adverse events, so she did.  Pt was not seen in the office.
Age: 26.0
Sex: F
Vaccine: DTAP
Symptoms: Chest discomfort, Dizziness, Flushing, Immediate post-injection reaction, Inappropriate schedule of drug administration
Clinical narrative: light headed, tightness in chest, pale, flushed about 5 minutes after TdaP administration
Age: 26.0
Sex: F
Vaccine: DTAP
Symptoms: Pallor
Clinical narrative: light headed, tightness in chest, pale, flushed about 5 minutes after TdaP administration
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Autopsy, Blood test, Decreased appetite, Fatigue, Laboratory test
Clinical narrative: Patient had Minengitis vaccine on 5/30/2008 to meet the requirement of joining a tour this summer. He had fever for two days. On 6/1 his fever was above 100. The next few days temperature had been reduced, but he looked very tired all the time. His appetite also reduced tremendously. On the morning of 6/22/08 he suddenly and unexpectedly passed away during his sleep. Medical Examiner could not find any cause of the death so far. 9/2/08-cardiac arrhythmia of undetermined etiology.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia, Sudden death
Clinical narrative: Patient had Minengitis vaccine on 5/30/2008 to meet the requirement of joining a tour this summer. He had fever for two days. On 6/1 his fever was above 100. The next few days temperature had been reduced, but he looked very tired all the time. His appetite also reduced tremendously. On the morning of 6/22/08 he suddenly and unexpectedly passed away during his sleep. Medical Examiner could not find any cause of the death so far. 9/2/08-cardiac arrhythmia of undetermined etiology.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Borrelia burgdorferi serology, Borrelia burgdorferi serology positive, Facial palsy
Clinical narrative: Isolated Bell's Palsy occurred 10 days after patient received Menactra.  Patient also had positive Lyme titers, drawn with this episode.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Full blood count, Hyperhidrosis, Laboratory test, Pain, Pyrexia
Clinical narrative: On 8-04-08 patient was administered a Pneumovax and a Zoster vaccine, 24 hours after she started experiencing high fevers of 102 and higher. On 8-08-08 she was seen in the ER, still with a high temp. Labs, x-ray and urine were analyzed, everything came back normal. On 8-12-08 she was seen in urgent care still experiencing a fever of 101.4, feeling sweaty and achy. She was put on antiobiotics for ten 10 days.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Urine analysis normal, X-ray normal
Clinical narrative: On 8-04-08 patient was administered a Pneumovax and a Zoster vaccine, 24 hours after she started experiencing high fevers of 102 and higher. On 8-08-08 she was seen in the ER, still with a high temp. Labs, x-ray and urine were analyzed, everything came back normal. On 8-12-08 she was seen in urgent care still experiencing a fever of 101.4, feeling sweaty and achy. She was put on antiobiotics for ten 10 days.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm, Swelling
Clinical narrative: 13X10cm swollen area. Mildly warm to the touch. No axillary or supra trochlea adenopathy, no elevated temperature. No other skin lesions. No swollen joints
Age: 25.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Palpitations, Speech disorder
Clinical narrative: 1 1/2 hours after receiving vaccine, pt. stated she was dizzy, speech inappropriate, heart palpations lasting ove a period of approx. 2 hours,  Pt. did not report reaction to medical dept until 8/20/08 (7 days later)
Age: 1.0
Sex: F
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Bronchitis, Chest X-ray abnormal, Convulsion, Febrile convulsion, Pharyngitis
Clinical narrative: On 08/22/2008 Child was taken to ER Via ambulance from her Day care where she had spiked a fever of  103, and experienced seziure like activity.  ER Physician gave Discharge Diagnosis of Febrile Seziure, Acute Pharyngitis.  Was treated with Rocephin 500mg IM, and was sent home with Amoxil 125 mg TID, Tylenol and Motrin Prn.   Went for follow up visit with regular Physician, who suggested the child may have had a reaction to the MMR given on 8/14/2008. Her notes indicate she spoke with Dr.with the Department of Health.
Age: 1.0
Sex: F
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Pyrexia, Viral infection
Clinical narrative: On 08/22/2008 Child was taken to ER Via ambulance from her Day care where she had spiked a fever of  103, and experienced seziure like activity.  ER Physician gave Discharge Diagnosis of Febrile Seziure, Acute Pharyngitis.  Was treated with Rocephin 500mg IM, and was sent home with Amoxil 125 mg TID, Tylenol and Motrin Prn.   Went for follow up visit with regular Physician, who suggested the child may have had a reaction to the MMR given on 8/14/2008. Her notes indicate she spoke with Dr.with the Department of Health.
Age: 59.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: 101 degree fever.
Age: 11.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Headache, Inappropriate schedule of drug administration, Influenza like illness, Influenza serology negative, Laboratory test normal
Clinical narrative: flu-like illness with fever 101-102, myalgias, headache, malaise, nausea and vomitinh
Age: 11.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Malaise, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: flu-like illness with fever 101-102, myalgias, headache, malaise, nausea and vomitinh
Age: 11.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: White blood cell count normal
Clinical narrative: flu-like illness with fever 101-102, myalgias, headache, malaise, nausea and vomitinh
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Contusion, Dizziness, Dyspepsia, Dyspnoea
Clinical narrative: extremely weak, heart racing several times a day, shortness of breath, light-headed occasionally, on the first evening (5 hours later) extreme indigestion/nausea, local redness and bruising
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Nausea, Palpitations
Clinical narrative: extremely weak, heart racing several times a day, shortness of breath, light-headed occasionally, on the first evening (5 hours later) extreme indigestion/nausea, local redness and bruising
Age: 11.0
Sex: M
Vaccine: HEPA, MEN, TD
Symptoms: Chills, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Patient had 3 vaccines: hep A, Meningococcal, and Tdap. symptoms:pain in arms, fever, chill, headache, tiredness, and nausea.
Age: 11.0
Sex: M
Vaccine: HEPA, MEN, TD
Symptoms: Pyrexia
Clinical narrative: Patient had 3 vaccines: hep A, Meningococcal, and Tdap. symptoms:pain in arms, fever, chill, headache, tiredness, and nausea.
Age: 20.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Symptoms: Numbness, Pain. Service Member received AVA, typhoid and Smallpox vaccines on 3/23/06. She believes she received 1 or 2 vaccines in her right deltoid, but is not sure if it was smallpox, typhoid or both vaccines. She knows she received her first anthrax vaccine in her left deltoid area. She denies any unusual burning during or immediately following receipt of the anthrax vaccine. She denies any unusual redness, swelling or induration at or surrounding the anthrax vaccine site. (She recalls redness and swelling about the size of a nickel surrounding the anthrax vaccine site. She also recalls a subcutaneous nodule < the size of a pea.) She does not recall experiencing any systemic symptoms like fever, chills, headaches, fatigue or arthralgias within the first week of vaccine receipt. Almost immediately after vaccine receipt, SM noted aching pain ("like after receipt of thyroid vaccine", just in area of vaccine receipt), but by mid-afternoon she experienced an intensified pain that affected her whole arm. This pain was accompanied by numbness. The pain is described as muscle pain - "like after working out for too long" and the numbness is described like the sensation after receipt of lidocaine by the dentist. Her arm movement and functioning were limited both by pain and the inability to really feel what her hand was doing. SM was out-processing for deployment so she did not seek evaluation or a profile. The pain was rated as 6/10 using a pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). She took ibuprofen which slightly diminished the pain (deceased to level 4-5/10) but did not resolve. The pain and numb sensation lasted approximately 3-4 days before completely resolving. On 12 April 2006, SM received her 2nd anthrax vaccine in her left deltoid region and experienced a very similar reaction. She experienced muscle pain and numbness within hours of vaccine receipt that lasted about 3-4 days before completely resolving. Otherwise, she denies any unusual or prolonged local or systemic symptoms following receipt of her second anthrax vaccine. She has had no recurrence of symptoms since April 2006. She has received a typhoid vaccine in her left deltoid without experiencing unusual pain and/or numbness of that extremity.
Age: 20.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Injection site swelling, Myalgia, Pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Symptoms: Numbness, Pain. Service Member received AVA, typhoid and Smallpox vaccines on 3/23/06. She believes she received 1 or 2 vaccines in her right deltoid, but is not sure if it was smallpox, typhoid or both vaccines. She knows she received her first anthrax vaccine in her left deltoid area. She denies any unusual burning during or immediately following receipt of the anthrax vaccine. She denies any unusual redness, swelling or induration at or surrounding the anthrax vaccine site. (She recalls redness and swelling about the size of a nickel surrounding the anthrax vaccine site. She also recalls a subcutaneous nodule < the size of a pea.) She does not recall experiencing any systemic symptoms like fever, chills, headaches, fatigue or arthralgias within the first week of vaccine receipt. Almost immediately after vaccine receipt, SM noted aching pain ("like after receipt of thyroid vaccine", just in area of vaccine receipt), but by mid-afternoon she experienced an intensified pain that affected her whole arm. This pain was accompanied by numbness. The pain is described as muscle pain - "like after working out for too long" and the numbness is described like the sensation after receipt of lidocaine by the dentist. Her arm movement and functioning were limited both by pain and the inability to really feel what her hand was doing. SM was out-processing for deployment so she did not seek evaluation or a profile. The pain was rated as 6/10 using a pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). She took ibuprofen which slightly diminished the pain (deceased to level 4-5/10) but did not resolve. The pain and numb sensation lasted approximately 3-4 days before completely resolving. On 12 April 2006, SM received her 2nd anthrax vaccine in her left deltoid region and experienced a very similar reaction. She experienced muscle pain and numbness within hours of vaccine receipt that lasted about 3-4 days before completely resolving. Otherwise, she denies any unusual or prolonged local or systemic symptoms following receipt of her second anthrax vaccine. She has had no recurrence of symptoms since April 2006. She has received a typhoid vaccine in her left deltoid without experiencing unusual pain and/or numbness of that extremity.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Cellulitis left arm round 2cm x 2cm, hot, swollen, tender area at site of vaccine - IM Rocephin + PO Bactrim.
Age: 0.9
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse event
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Fainting
Age: 18.0
Sex: F
Vaccine: HPV4, MMR
Symptoms: Loss of consciousness
Clinical narrative: Within 5 minutes of receiving HPV vaccine, patient passed out.  Was receiving MMR vaccine at the time of fainting.  But was within the time frame of HPV precautions.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: After vaccinated patient to waiting room for 20 min to see if any side effects. Patient was dizzy and light headed. RN at side. Cool cloth and water given; Patient had not eaten all morning. Patient sent home with family when stable AM
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: After vaccinated patient to waiting room to see if has any side effects. Patient became dizzy. After 5 min. Patient was well enough to drink water and home with mom.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Complaint of hair loss (patch) following administration of 2nd dose of GARDASIL.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Pharyngeal oedema, Pharyngolaryngeal pain
Clinical narrative: Patient was fine initially after shots.  Patients usually get the burning, tingling and numbness after shot.  Patient did tell me that after shot (Gardasil) mom looked very concerned on the side effects.  So I checked patient after 10 minutes.  No reaction at the time.  After 15 minutes, I checked patient to see if any reaction - none at time.  Advised patient and mother to make next appointment at front desk.  Patient then told mother her throat was hurting.  Mother told receptionist to see if that was ok.  Receptionist got me - then I proceeded to put patient back in room to get the doctor to examine her.  Mother told me she started to have a sore throat after vaccines were given.  I asked patient how she was feeling regarding her breathing.  She said (patient) she was fine.  Again I asked to see if maybe her throat felt like it was closing.  They all giggled and patient said I think I would know.  I interrupted the doctor with her next patient to inform her and mother came out and said her daughter felt like her throat was swollen.  The doctor then saw patient while I got the float nurse to do vitals and pulse ox.  Float nurse requested to report to room that patient was in.  Patient was jovial when arrived, asked how patient felt, stated she felt fine.  Took Pulse Ox (99), Pulse (92), Resp (24) and BP (90/60).  Asked if she had difficulty breathing.  Patient stated "no".  Lungs sound clear.
Age: 10.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: none
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm red, swollen and warm to touch at injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site discolouration, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Left leg was noted to be painful and hard after immunization. Enlarged with itching Left thigh with 13x6cm area of mild discoloration and warmth spreading from her injection site medially.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site warmth
Clinical narrative: Left leg was noted to be painful and hard after immunization. Enlarged with itching Left thigh with 13x6cm area of mild discoloration and warmth spreading from her injection site medially.
Age: 1.31
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, heat, swelling to injection site.  Treated with Benadryl as needed and given prescription for Keflex, one tsp tid x 10 days.
Age: 64.0
Sex: F
Vaccine: TYP
Symptoms: Oedema peripheral, Pruritus, Urticaria
Clinical narrative: 8/21/08 started Celebrex; 8/23/08 started oral typhoid; 8/25/08 7AM started oral typhoid 12:30 P took Celebrex; 130 P noted swelling in hands and itching took Benadryl 50mg itchiness improved; 530 P Noted welts around wrist and persisted hand swelling took Benadryl - went to hospital - stopped oral typhoid. Cut rings off. No other treatment.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash generalised, Respiratory tract congestion, Urticaria
Clinical narrative: Patient received Varivax at approximately 11:45.  Per mother's report, patient developed diffuse rash, itching and congestion.  Patient medicated with Benadryl 25mg PO by mother at 12:30.  Patient arrived to office at 13:30 with diffuse urticarial rash, clear lung sounds, normal appearing throat.  Patient and mother instructed to monitor for respiratory involved, give Benadryl every 6 hrs prn and to call for change in symptoms or with any questions.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Approx 24 hours after receiving varicella and hep A, child developed redness in her face and was itchy. The itching continued the  next day and the redness on the face became more rash like. Child has long history of environmental and food allergies. Symptoms: Rash, pruritic, Erythema, Pruritus.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Dermatitis bullous, Injection site abscess, Injection site erythema, Injection site pruritus
Clinical narrative: Vaccine administered 8/21/08 right triceps SQ; Patient mother telephoned 8/22/08 and advised injection site red, swollen and itchy - No pain, Afebrile; Patient returned to clinic on 8/23/08 - On exam 14mm bullous lesion - Cut - impressive erythema right tricep; 8/25/08 considerably improved
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: Vaccine administered 8/21/08 right triceps SQ; Patient mother telephoned 8/22/08 and advised injection site red, swollen and itchy - No pain, Afebrile; Patient returned to clinic on 8/23/08 - On exam 14mm bullous lesion - Cut - impressive erythema right tricep; 8/25/08 considerably improved
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Initial report was received from a consumer on 24 January 2008.  A five-year-old male child with a history of peanut allergies, had received an intramuscular right deltoid injection of TRIPEDIA (lot number not reported) and an intramuscular left deltoid injection of IPOL (lot number not reported) on 22 January 2008 and 24 hours later, he developed right arm swelling, redness and itching from the shoulder to the elbow.  Corrective treatments included TYLENOL.  At the time of the report, the patient had been scheduled to follow-up with their pediatrician and had not yet recovered from the event.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Crying, Irritability
Clinical narrative: Initial non-serious report received from the vaccine provider in the United States on 18 July 2007. A ten-week-old male with no known pre-existing medical conditions or allergies was vaccinated with ActHIB, Daptacel, IPOL, Hepatitis B (trade name and manufacturer not reported) and Prevnar (manufactured by Wyeth) on 10 July 2007. Lot numbers and routes/sites of administration were not provided for any of these vaccines. The reporter indicated that the patient's parent called stating that the baby cried inconsolably for two hours. The baby had gone home and slept for three hours, then woke up with inconsolable crying for two hours. The baby fed well and was irritable afterwards. There was no known illness at the time of vaccination. Tylenol was given and the patient recovered. No additional information was provided at the time of this report. Follow-up information received on 01 October 2007 from a health care professional. In response to a query requesting lot numbers and routes and sites of administration of the previously reported vaccinations, the reporter provided the following information. The subject had received a right thigh, intramuscular injection of IPOL, lot number Y1032 (not a valid sanofi pasteur lot number); a left thigh, intramuscular injection of Daptacel, lot number C2552AA; a left thigh, intramuscular injection of ActHIB, lot number UFOU98AB (not a valid sanofi pasteur lot number); and a right thigh, intramuscular injection of Prevnar, manufacturer Wyeth, lot number B53981E. The patient had experienced an episode of inconsolable crying followed by three hours of sleep. He was able to eat but was irritable and cried when the vaccination site was touched.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: This case was reported by a health professional in the United States on 27 August 2007. A four-year-old male patient with no medical history received the following vaccinations on 17 August 2007: DAPTACEL (lot number C2651AA) in the left deltoid, IPOL (lot number Z08722) in the left deltoid, and MMR (Merck, lot number 0424U) in the right outer aspect of arm. On 18 August 2007, the entire outer portion of the patient's left upper arm became swollen, hot, red and tender. He presented to the emergency room and was diagnosed with cellulitis. Treatment was unknown, the event subsequently recovered. A corrective version has been created using the latest receipt date in order to update the seriousness criteria. The previous version had "Other - medically significant" as seriousness criteria, however the event is non-serious and criteria was entered in error. Follow-up information received on 13 November 2007 from a health care professional. Relevant diagnostic testing was none. The patient was not seen in the office for follow-up. The patient was treated with BACTRIM. The patient recovered from the event.
Age: 0.33
Sex: M
Vaccine: HIBV, IPV, PNC, RV5
Symptoms: Injection site bruising, Injection site mass, Injection site scar
Clinical narrative: Initial report received on 06 February 2008 from a health care professional. A 4 months male patient received on 21 January 2008 a dose of IPOL (sanofi pasteur, lot# Z0547), into the right thigh. The patient also received into the left thigh on the same day: PREVNAR (Wyeth, lot# 870143A) and HIB vaccine (manufacturer unknown, lot# 0076U). The patient also received on the same day oral dose of Rotavirus (lot# 1242U). On 22 January 2008, a day post vaccination, the patient developed a 2 inch bump at injection site of the right thigh. Bruising occurred, followed by a scar. The bump had not gone yet. The patient had not recovered. The patient had no illness at vaccination time, was not taking other medications, and had no medical conditions. His birth weight (at 1 week old) was 8 lb and 8 oz. The patient required a doctor visit. The lot# provided for IPOL is not a sanofi pasteur valid lot#.
Age: 0.2
Sex: M
Vaccine: HIBV, IPV
Symptoms: Crying, Vomiting
Clinical narrative: This case was received from a health professional in the United States on 04 March 2008, and is one of a cluster of two cases. A three-month-old male patient received an intramuscular left leg injection of ACTHIB (lot number UF345AC, A0512) and an intramuscular right leg injection of IPOL (lot number A0474-2) on 03 March 2008. His parents called the physician's office five hours after vaccination to report constant crying, which they described as "screaming", and vomiting. Outcome was unknown. Follow-up information was received from the health professional on 25 June 2008. The patient's date of birth was reported as 16 November 2007. Date of administration was 15 February 2008, and the events occurred later the same day. On 14 January 2008, the patient had received first intramuscular thigh injections of TRIPEDIA (lot number U2291BA) and PREVNAR (Wyeth, lot number B54007H). No additional information was provided. The health professional who reported this case also reported a similar event for another three-month-old patient, this event is captured in case number 2008-00645.
Age: 0.2
Sex: F
Vaccine: HIBV, IPV
Symptoms: Crying, Vomiting
Clinical narrative: This case was received from a health professional in the United States on 04 March 2008, and is one of a cluster of two cases. A three-month-old female patient received an intramuscular left leg injection of ACTHIB (lot number UF345AC, A0512) and an intramuscular right leg injection of IPOL (lot number A0474-2) on 15 February 2008. Her parents reported constant crying for 24 hours following vaccination, which they described as "screaming". The patient also experienced vomiting during the same 24 hour period. The events resolved. Follow-up information was received from the health professional on 25 June 2008. The patient's date of birth was provided as 05 December 2007. The date of vaccine administration was 03 March 2008. She had also received first intramuscular thigh injections of TRIPEDIA (lot number U2291BA) and PREVNAR (Wyeth, lot number B54007H) on 04 February 2008. The events recovered. The health professional who reported this case also reported a similar event for another three-month-old patient, the patient is captured in case number 2008-00644.
Sex: U
Vaccine: IPV
Symptoms: Injection site discolouration
Clinical narrative: Initial report received on 04 April 2008 from a nurse in the USA. An unreported number of patients (no individual identification provided) developed a black dot at the injection site after having received, on an unspecified date, an intramuscular dose of IPOL (lot number, dosage and site not reported). The reporter claimed that a large practice of 20 offices has found black dots occurring in patients who have received IPOL from a multi dose vial. The black dot did not seem to be subsiding. No other symptoms occurred in the patients. The practice was monitoring the situation. At the time of the report (04 April 2008), the patients had not recovered.
Age: 51.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Initial report received on 24 April 2008 from a health care professional in the USA. A 51 year old male patient received on 21 April 2008 a left deltoid intramuscular injection of ADACEL (lot# C2937AA) and a left arm subcutaneous injection of IPOL (lot # A0490). On the evening of vaccination, the patient developed muscle pain, described as "feeling bruised", to the right lower extremity behind the thigh and also weakness in the leg. The patient self-medicated with an unspecified muscle relaxant, which seemed to help somewhat. The patient had no illness at the time of vaccination and had a history of coronary artery disease (CAD), rosacea, and allergies. Concomitant medications were unknown. At the time of the report, 24 April 2008, the patient had not recovered.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, IPV, VARCEL
Symptoms: Injection site discolouration
Clinical narrative: Initial report received 29 April 2008 from a health care professional. A one-year-old male patient developed a black dot at the injection site after receiving a left thigh injection of IPOL and DTaP on 06 March 2007 or after receiving a left thigh ActHIB and Varicella Vaccine on 10 September 2007. On 06 March 2007, the patient received a left thigh injection of IPOL, lot number Z0547-2 (route not reported) and a concomitant left thigh injection of DTaP (manufacturer and lot number not reported). On 10 September 2007, the patient subsequently received a left thigh injection of ActHIB, sanofi pasteur Inc lot number UF207AA, (corresponding sanofi pasteur SA lot number A0175-2) and a concomitant left thigh injection of Varicella Vaccine (manufacturer and lot number not reported). According to the reporter, the physician noticed the black dot on the patient's left thigh on 20 September 2007. At the time of the report, the patient's recovery status was unknown. The reporter received a cluster of reports of black dots at the injection site from multiple satellite locations who were all affiliated with the reporter. The facilities used McKesson alcohol wipes and syringes which included safety glide and vanish point with 25 gauge needles. Some of the black dots were reported to have appeared immediately with some present four months post immunization. This event had been noticed by all health care workers at the facilities and had not been noticed in the past. The reporter indicated follow-up information would be provided as obtained upon future request. The reporter for this case is the same as for case numbers 2008-01334 (IPOL), 2008-01335 (IPOL), 2008-01336 (IPOL and DTaP), 2008-01338 (IPOL) and 2008-01339(Fluzone). These events occurred at multiple satellite locations which are all affiliated with the reporter.
Age: 1.0
Sex: U
Vaccine: IPV
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site haemorrhage
Clinical narrative: Initial report received 29 April 2008 from a health care professional. A 15-month-old patient (gender not provided) developed a black dot with 1 cm slight ecchymosis at the injection site after receiving a left thigh injection of IPOL, lot number A0298-2 on 15 February 2008. According to the reporter, the physician observed the black dot on the patient's left thigh on 25 February 2008. At the time of the report, it was unknown if the patient recovered from the event. The reporter received a cluster of reports of black dots at the injection site from multiple satellite locations who were all affiliated with the reporter. The facilities used McKesson alcohol wipes and syringes which included safety glide and vanish point with 25 gauge needles. Some of the black dots were reported to have appeared immediately with some present two months post immunization. This event had been noticed by all health care workers at the facilities and had not been noticed in the past. The reporter indicated follow-up information would be provided as it is obtained. The reporter for this case is the same as for case numbers 2008-01333 (IPOL and ActHIB), 2008-01335 (IPOL), 2008-01336 (IPOL and DTaP), 2008-01338 (IPOL) and 2008-1339 (Fluzone). These events occurred at multiple satellite locations which are all affiliated with the reporter.
Age: 0.5
Sex: M
Vaccine: IPV
Symptoms: Immediate post-injection reaction, Injection site discolouration
Clinical narrative: Initial report received 29 April 2008 from a health care professional. A 6-month-old male patient developed a black dot at the injection site after receiving a right thigh injection of IPOL, lot number A0169 on 08 January 2008. According to the reporter, the physician observed a black dot on the patient's right thigh on 10 March 2008 when the patient had returned for their six month well visit. At the time of the report, it was unknown if the patient recovered from the event. The reporter received a cluster of reports of black dots at the injection site from multiple satellite locations who were all affiliated with the reporter. The facilities used McKesson alcohol wipes and syringes which included safety glide and vanish point with 25 gauge needles. Some of the black dots were reported to have appeared immediately with some present two months post immunization. This event had been noticed by all health care workers at the facilities and had not been noticed in the past. The reporter indicated follow-up information would be provided as it is obtained. The reporter for this case is the same as for case numbers 2008-01333 (IPOL and ActHIB), 2008-01334 (IPOL), 2008-01336 (IPOL and DTaP), 2008-01338 (IPOL) and 2008-01339 (Fluzone). These events occurred at multiple satellite locations which are all affiliated with the reporter.
Age: 1.0
Sex: U
Vaccine: DTAP, IPV
Symptoms: Immediate post-injection reaction, Injection site discolouration
Clinical narrative: Initial report received 29 April 2008 from a health care professional. This report (2008-01336) and case numbers 2008-01334 and 2008-01335 case from the same satellite location. A 12-month-old patient (gender not reported) developed a black dot at the injection site after receiving a left thigh injection of IPOL, lot number Z0547 and a left thigh injection of DAPTACEL, lot number C2650AA on 13 June 2007 during their two month well visit. The patient returned to their physician's office for their four month well visit on 16 August 2007, at which time the physician noticed a black dot on the patient's left thigh. The patient subsequently received a left thigh injection of IPOL, lot number Z0812 on 16 August 2007. When the patient returned two months later for their six month well visit (date not provided), the physician noticed the appearance of a second black dot on the child's left thigh. Both black dots had been present at that time. The recovery status of the patient was unknown at the time of the report. The reporter received a cluster of reports of black dots at the injection site from multiple satellite locations who were all affiliated with the reporter. The facilities used McKesson alcohol wipes and syringes which included safety glide and vanish point with 25 gauge needles. Some of the black dots were reported to have appeared immediately with some present two months post immunization. This event had been noticed by all health care workers at the facilities and had not been noticed in the past. The reporter indicated follow-up information would be provided as it is obtained. 19/May/2008: Corrective version created for the purpose of amending the lot number on the DAPTACEL product screen to C2650A (previously entered as C2605A). The reporter for this case is the same as for case numbers 2008-01333 (IPOL and ActHIB), 2008-01334 (IPOL), 2008-01335 (IPOL), 2008-01338 (IPOL) and 2008-01339 (Fluzone).
Age: 0.2
Sex: F
Vaccine: IPV
Symptoms: Immediate post-injection reaction, Injection site discolouration
Clinical narrative: Initial report received 29 April 2008 from a health care professional. A cluster of four unidentified patients developed a black dot at the injection site after receiving an injection of IPOL, lot number A0298-2 (route/site not reported). At the time of the report, the patients had not recovered from the event. The reporter received a cluster of reports of black dots at the injection site from multiple satellite locations who were all affiliated with the reporter. The facilities used alcohol wipes and syringes which included safety glide and vanish point with 25 gauge needles. Some of the black dots were reported to have appeared immediately with some present two months post immunization. This event had been noticed by all health care workers at the facilities and had not been noticed in the past. The reporter indicated follow-up information would be provided as it is obtained. Additional information was received from the initial reporter on 02 May 2008. The reporter provided individual patient identifiers for the four previously unidentified patients. The information contained in this case (2008-01338) is now for a two-month-old female, whose black dot appeared on 24 March 2008. This patient's case was one of four cases which were reported from the same satellite site. The information for the other three patients is contained in cases 2008-01427, 2008-01428, and 2008-01429. The reporter for this case is the same as for case numbers 2008-01333 (IPOL and ActHIB), 2008-01334 (IPOL), 2008-01335 (IPOL), 2008-01336 (IPOL and DTaP), 2008-01339 (Fluzone), 2008-01427 (IPOL), 2008-01428 (IPOL), and 2008-01429 (IPOL). These events occurred at multiple satellite locations which are all affiliated with the reporter.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Immediate post-injection reaction, Injection site discolouration
Clinical narrative: Information was received 02 May 2008 from a health care professional. A 4-year-old male patient had received an injection of IPOL, lot number A0298-2 (date, route and site of administration not provided) and on 24 March 2008, he subsequently developed a black dot at the injection site. The reporter received a cluster of reports of black dots at the injection site from multiple satellite locations who were all affiliated with the reporter. This patient's case was one of four cases reported from the same satellite site. This report (2008-01427) and case numbers 2008-01338, 2008-01428 and 2008-01429 case from the same satellite location. All facilities used McKesson alcohol wipes and syringes which included safety glide and vanish point with 25 gauge needles. Some of the black dots were reported to have appeared immediately with some present two months post immunization. This event had been noticed by all health care workers at the facilities and had not been noticed in the past. The reporter indicated follow-up information would provided as it is obtained. The reporter for this case is the same as for case numbers 2008-01333(IPOL and ActHIB), 2008-01334 (IPOL), 2008-01335 (IPOL), 2008-01336 (IPOL and DTaP), 2008-01338, 2008-01339 (Fluzone), 2008-01428 (IPOL), and 2008-01429 (IPOL).
Age: 0.2
Sex: M
Vaccine: IPV
Symptoms: Injection site discolouration
Clinical narrative: Information was received 02 May 2008 from a health care professional. A 2-month-old male patient had received an injection of IPOL, lot number A0298-2 (date, route and site of administration not reported) and on 25 March 2008, he subsequently developed a black dot at the injection site. The reporter received a cluster of reports of black dots at the injection site from multiple satellite locations who were all affiliated with the reporter. This patient's case was one of four cases which were reported from the same satellite site. The information for the other three patients is contained in case numbers 2008-1338, 2008-01427, and 2008-1429. All facilities used McKesson alcohol wipes and syringes which included safety glide and vanish point with 25 gauge needles. Some of the black dots were reported to have appeared immediately with some present two months post immunization. This event had been noticed by all health care workers at the facilities and had not been noticed in the past. The reporter indicated follow-up information would be provided as it is obtained. The reporter for this case is the same as for case numbers 2008-01333 (IPOL and ActHIB), 2008-01334 (IPOL), 2008-01335 (IPOL), 2008-01336 (IPOL and DTaP), 2008-01338 (IPOL), 2008-01339 (Fluzone), 2008-01427 (IPOL), and 2008-01429 (IPOL).
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Injection site discolouration
Clinical narrative: Information was received 02 May 2008 from a health care professional. A 4-year-old male patient had received an injection of IPOL, lot number A0298-2 (date, route and site of administration not reported) and on 25 March 2008, he subsequently developed a black dot at the injection site. The reporter received a cluster of reports of black dots at the injection site from multiple satellite locations who were all affiliated with the reporter. This patient's case was one of four cases which were reported from the same satellite site. The information for the other three patients is contained in case numbers 2008-01338, 2008-1427, and 2008-01428. All facilities used McKesson alcohol wipes and syringes which included safety glide and vanish point with 25 gauge needles. Some of the black dots were reported to have appeared immediately with some present two months post immunization. This event had been noticed by all health care workers at the facilities and had not been noticed in the past. The reporter indicated follow-up information would be provided as it is obtained. The reporter for this case is the same as for case numbers 2008-01333 (IPOL and ActHIB), 2008-01334 (IPOL), 2008-01335 (IPOL), 2008-01336 (IPOL and DTaP), 2008-01338 (IPOL), 2008-01339 (Fluzone), 2008-01427 (IPOL), and 2008-01428 (IPOL).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth, Local swelling
Clinical narrative: This case was received from a health professional in the United States on 08 May 2008, and is one of three patients reported in a cluster. A four-year-old female patient received an intramuscular left deltoid fifth injection of DAPTACEL (lot number C2950AA) and an intramuscular right deltoid fourth injection of IPOL (lot not reported) on 05 May 2008. The following day, on 06 May 2008, she returned to her doctor's office with complaints of large local left arm swelling, described as the size of a lemon. In addition, the injection site was red and warm to the touch. Treatment included BENADRYL and MOTRIN, outcome was unknown. The reporter in this case also reported two other patients with large local limb swelling following administration of DAPTACEL; those events are captured in case numbers 2008-1482 and 2008-01481.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: This case was received from a health professional in the United States on 08 May 2008, and is one of three patients reported in a cluster. A five-year-old female patient received an intramuscular left deltoid fifth injection of DAPTACEL (lot number C2933AB) and an intramuscular left deltoid fourth injection of IPOL (lot reported as A047U) on 01 May 2008. Five days later, on 06 May 2008, she complained of a nickel-sized red bump on the left arm at the injection site, which was hard to the touch and itchy. Treatment included BENADRYL and MOTRIN, the patient recovered. The reporter in this case also reported two other patients with large local limb swelling following administration of DAPTACEL; those events are captured in case numbers 2008-01480 and 2008-01482.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Body temperature increased, Erythema, Local swelling, Oedema peripheral, Pain in extremity
Clinical narrative: This case was received from a health professional in the United States on 08 May 2008, and is one of three patients reported in a cluster. A two-month-old male patient received an intramuscular right leg first injection of DAPTACEL (lot number C2950AA), an intramuscular right leg first injection of IPOL (lot not known), an intramuscular left leg first injection of ActHIB (lot number not known), an intramuscular left leg first injection of Prevnar (Wyeth, lot unknown), and an intramuscular right leg first injection of Hepatitis B (Merck, lot number unknown) on 07 May 2008. Four hours later, the patient was noted to have right leg swelling the size of an orange, as well as limb redness, warmth, and pain. Temperature was 100.9 degrees Fahrenheit, and the patient was sent to the emergency room for sepsis work-up. Per the reporter, the name of the emergency room and treating physician were not known. Treatment, diagnosis, and outcome were unknown. The reporter of this case also reported two other patients with large local limb swelling following administration of DAPTACEL; those events are captured in case numbers 2008-01480 and 2008-01481.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Skin warm
Clinical narrative: This case was received from a health professional in the United States on 08 May 2008, and is one of three patients reported in a cluster. A two-month-old male patient received an intramuscular right leg first injection of DAPTACEL (lot number C2950AA), an intramuscular right leg first injection of IPOL (lot not known), an intramuscular left leg first injection of ActHIB (lot number not known), an intramuscular left leg first injection of Prevnar (Wyeth, lot unknown), and an intramuscular right leg first injection of Hepatitis B (Merck, lot number unknown) on 07 May 2008. Four hours later, the patient was noted to have right leg swelling the size of an orange, as well as limb redness, warmth, and pain. Temperature was 100.9 degrees Fahrenheit, and the patient was sent to the emergency room for sepsis work-up. Per the reporter, the name of the emergency room and treating physician were not known. Treatment, diagnosis, and outcome were unknown. The reporter of this case also reported two other patients with large local limb swelling following administration of DAPTACEL; those events are captured in case numbers 2008-01480 and 2008-01481.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site swelling
Clinical narrative: Initial report received on 19 May 2008 from another manufacturer, report number A0723483A. The original reporter to the other manufacturer was a sales representative who received the report from a physician. A four-year-old male patient had received a fourth dose injection of IPOL, lot number A0342 (route/site not reported) and a fifth dose injection of Infanrix (Manufacturer GlaxoSmithKline), lot number AC14B069AA (route/site not reported) on 18 March 2008, and approximately two days later, experienced severe swelling in his left upper arm through his elbow. The physician indicated that the subject had received an unspecified treatment and the event resolved. According to the physician, the extensive swelling of the patient's left arm was not considered to be possibly related to the use of IPOL. The reporter for this case is the same as for case number 2008-01358.
Age: 22.0
Sex: F
Vaccine: FLU3, HEPA, IPV
Symptoms: Headache, Nausea, Oral contraception, Vomiting
Clinical narrative: Headache, vomiting, nausea.  Initial report received on 11 April 2008 from a nurse practitioner. A 22 year old female patient received on 26 March 2008 a subcutaneous left arm injection of IPOL (Lot#20474-2), an intramuscular left deltoid injection of FLUSONE (lot#U2479BA) and a first intramuscular right deltoid injection of HAVRIX (GSK, lot#AHAVB144AD). On 28 March 2008, two days post vaccination, the patient developed nausea, vomiting, and a headache for 24 hours. corrective treatment was not reported. The patient had no previous medical history and her only medication was ORTHO TRI-CYCLIN. At the time of the report, 11 April 2008, the patient had recovered.
Age: 20.0
Sex: F
Vaccine: HEPA, IPV, TDAP
Symptoms: Pain in extremity
Clinical narrative: Initial report received on 18 April 2008 from a nurse in the USA. A 20 year old female patient received on 09 April 2008 a left deltoid intramuscular injection of ADACEL (lot # C2936BA), a left deltoid intramuscular injection of IPOL (A0342-2) and a right deltoid intramuscular injection of a HEPATITIS A vaccine (GSK, lot # AHAVB224CA). The patient's medical history included no known allergies and hypothyroidism and concomitant medication was LEVOTHYROXINE. The patient had no illness at the time of vaccination. On 18 April 2008, nine days post-vaccination, the patient developed a sore left arm. There were no signs and symptoms of infection and no decreased range of motion. The recommended treatment was "OTC" pain medication and warm packs. At the time of reporting, 18 April 2008, the patient had not recovered.