chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal behaviour, Social avoidant behaviour
Clinical narrative: See attached notes from mother. *Pt was not seen @ time of advent. Mom reported SE on return visit on 9/8/10. I took my son to his 6 month check-up on 6-9-2010. About 30 min before his appt I gave him a .8 ml dose of infant TYLENOL. After his appt. he fell asleep in the car. When we got home about 2 hours later he just didn't seem like himself. I gave him a 1.25ml dose of infant ADVIL. Over the next few days he just didn't act like himself. He wouldn't smile, laugh or really acknowledge anyone. He was very zombie like. During this time his eating & sleeping habits stayed the same. This lasted about 3 days after his appt. then he just seemed to "wake-up".
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Patient had vaccine administered on 9/16/10 (TDAP). (L) shoulder/arm swollen & unable to move. Extremely painful.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Pt seen in Family Planning Clinic - given TDAP and Depo - Pt states she had nausea & vomiting, tenderness at injection site, headache, and fever 101 degrees began 9/21/pm.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Pt seen in Family Planning Clinic - given TDAP and Depo - Pt states she had nausea & vomiting, tenderness at injection site, headache, and fever 101 degrees began 9/21/pm.
Age: 9.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling/redness in left upper arm at injection site. Sent to Urgent Care for evaluation.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Rash papular
Clinical narrative: Papular rash after PCV 13 on arms legs in clusters. No other etiology - lasted 2 days - pruritis.
Age: 48.0
Sex: M
Vaccine: DT
Symptoms: Pain in extremity
Clinical narrative: Shot administered 9-6-10 but both arms got sore and are slowly getting better (9-22-10).
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 09/20/10- inj. -  Pneu. immunization redness, pain swelling at injection site treatment antihistamines, ice.
Age: 21.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Erythema, Immediate post-injection reaction, Injection site nodule, Pruritus generalised, Rash
Clinical narrative: SM complaining of immediate nodule sensation to AVA site 10/20/2006 and then itching which progressed to entire body within 30 minutes with "goose bump" like rash. Rash described as skin toned colored individually maculars w/o hive like formations. Within 1-2 days c/o two quarter size flat red patches, one to anterior left thigh and second to lateral right ankle (?from scratching). No other symptoms...denied SOB, swelling, sore throat, CP or any anaphylactic symptoms. (DEERs and AHLTA vac dates conflicting. No medical records available, new record begun with transfer).
Age: 21.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Rash macular
Clinical narrative: SM complaining of immediate nodule sensation to AVA site 10/20/2006 and then itching which progressed to entire body within 30 minutes with "goose bump" like rash. Rash described as skin toned colored individually maculars w/o hive like formations. Within 1-2 days c/o two quarter size flat red patches, one to anterior left thigh and second to lateral right ankle (?from scratching). No other symptoms...denied SOB, swelling, sore throat, CP or any anaphylactic symptoms. (DEERs and AHLTA vac dates conflicting. No medical records available, new record begun with transfer).
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: Arm hot to touch - rash - itching.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Blister
Clinical narrative: Several small "water blisters" on foot starting 1 day after the vaccine. MD treated with Mupirocin 2% oint., AUGMENTIN XR 1000 mg, BACTRIM DS & PERCOCET 5/325.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Back pain, Chills, Headache, Induration
Clinical narrative: Pt reported: swelling from shoulder to elbow, hardness/lump in arm, feverish arm to touch, chills, back pain, N/V, weakness, headache. Started midnight after shot. Pt went to Dr. treatment unknown.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mass, Nausea, Oedema peripheral, Skin warm, Vomiting
Clinical narrative: Pt reported: swelling from shoulder to elbow, hardness/lump in arm, feverish arm to touch, chills, back pain, N/V, weakness, headache. Started midnight after shot. Pt went to Dr. treatment unknown.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Bradycardia, Cold sweat, Dizziness, Feeling cold, Hypotension
Clinical narrative: Within minutes of vaccination patient felt lightheaded/dizzy. Felt cool/clammy hypotensive bradycardia. NP from Clinic assisted patient prior to 911 call.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient got both flu and pneumonia shots on 9/12/10. She came to pharmacy and showed her left arm, where she got the flu shot. Her arm was swollen, red, painful, and warm. She had to take some BENADRYL and she was followed-up 2 days later. Her arm is okay now.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid muscle erythema, warmth, swelling-approximately 3" in circumference.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: No reaction on previous exposure to drug, Oedema peripheral, Pain in extremity
Clinical narrative: Pt woke up day after vaccine administered with left arm area swollen. Pt had received pneumonia & flu vaccines in past with no problems. Advised pt to use heat/cold to area, pain reliever & diphenhydramine & to call MD/ER if tongue/lips swell or difficulty breathing.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Death
Clinical narrative: Was informed that patient died 2 days after flu shot, no symptoms were reported by police office department.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Agitation, Chest pain, Oxygen saturation normal, Pharyngeal oedema
Clinical narrative: 10 minutes after vaccine administration, pt. reported chest pain, abdominal pain, and throat swelling. On exam, she was mildly agitated but in no respiratory distress. Exam revealed slight wheezes (B) & urticaria on her abdomen. O2 sats NL. She received EPI-PEN JR. EMS brought her to medical center where pt. had clinically improved, so no further tx was necessary. Pt. recovered well.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Urticaria, Wheezing
Clinical narrative: 10 minutes after vaccine administration, pt. reported chest pain, abdominal pain, and throat swelling. On exam, she was mildly agitated but in no respiratory distress. Exam revealed slight wheezes (B) & urticaria on her abdomen. O2 sats NL. She received EPI-PEN JR. EMS brought her to medical center where pt. had clinically improved, so no further tx was necessary. Pt. recovered well.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness, Nausea
Clinical narrative: Dizzy/passed out/nauseated called 911 - patient went to ER for observation.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Pain, Papule
Clinical narrative: At the time of injection, there was slight redness and a slightly raised bump. Approximately one hour from injection, she started to have soreness to the bone. This shot also possibly resulted in shooting pain down her left arm with numbness in her fingertips. Her initial reaction was normal. Adverse reaction started one hour later. She also had red striations on the inner part of her left arm. This area was not painful. She said it appeared the morning after getting flu shot.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Spoke to patient, she broke out in a rash a day after receiving the flu shot has rash on breasts, arms and feet. She spoke to her wound care physician they told her it was still good she rec'd vaccine. I recommend BENADRYL if no relief to go to MD for follow-up.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient developed hives on face after administration of flu vaccine
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: Injections were given around 10:40 am and within 20 minutes after leaving office, patient became violently ill. He began throwing up every 10 min, until he came back to office around 5pm.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Got varicella despite 2 full doses of vaccine.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Headache
Clinical narrative: About 10 minutes after vaccine patient complained of headache & chest pain, advised patient to seek immediate medical attention.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Rash erythematous, Rash pruritic
Clinical narrative: Pt. received flu vac on 9/16/10. She developed difficulty swallowing on 9/19 the awoke with red, raised rash on torso. It was pruritic. She is unable to think of another cause & has no constitutional symptoms. She took 2 BENADRYL on 9/21 & has significant improvement today.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Eye disorder, Hypoaesthesia, Paraesthesia
Clinical narrative: 9/22/10 tingling sensation on left arm; left leg went numb twice; right eye lost control for less than a minute and felt lightheaded. Pt sent/referred to hospital per MD.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Feeling hot, Headache, Vomiting
Clinical narrative: Had headache, diarrhea and fatigue starting about 8pm 9/17/10. Felt feverish during night. Had vomiting 9/18 and 9/19. Went to ER 9/19 and had IV fluids. Continues to have fatigue 9/21/10.
Age: 1.32
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 15-month-old male patient who experienced erythema at injection site and mild swelling at the injection site.  The patient received a dose on 19-Apr-2010.  The patient experienced erythema at injection site and mild swelling at the injection site within 24 hours of PREVENAR 13 administration in Apr-2010.  The outcome was unknown at the time of this report.  No additional information was available at the time of this report.
Age: 1.32
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 15-month-old male patient who experienced erythema at injection site and mild swelling at the injection site.  The patient received a dose on 19-Apr-2010.  The patient experienced erythema at injection site and mild swelling at the injection site within 24 hours of PREVENAR 13 administration in Apr-2010.  The outcome was unknown at the time of this report.  No additional information was available at the time of this report.
Age: 4.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 4-year-old female patient who experienced swelling at injection site and multiple blisters at injection site. At 4 years of age, the patient received a dose on 11-May-2010. The patient experienced swelling at injection site and multiple blisters at injection site on 11-May-2010. The outcome of both events was unknown. No additional information was available at the time of this report.
Age: 1.29
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 15-month-old female patient who experienced 7 cm x 3.5 cm area of redness at the immunization site of the PREVNAR 13. At 15 months of age, the patient received the first dose on 18-May-2010. The patient experienced a 7 cm x 3.5 cm area of redness at the immunization site of the PREVNAR 13 in May-2010. Outcome was unknown. No additional information was available at the time of this report.
Age: 1.29
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 15-month-old female patient who experienced 7 cm x 3.5 cm area of redness at the immunization site of the PREVNAR 13. At 15 months of age, the patient received the first dose on 18-May-2010. The patient experienced a 7 cm x 3.5 cm area of redness at the immunization site of the PREVNAR 13 in May-2010. Outcome was unknown. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: HIBV, PNC13, HIBV, PNC13
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: New information was received in source details, patient details, medical history, product details, event details and outcome. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old male patient who experienced erythema multiforme. The patient received the first dose on 21-May-2010. The patient also received the fourth dose of HIBERIX on 21-May-2010. The patient experienced erythema multiforme on 22-May-2010. The outcome of the event is resolved. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: HIBV, PNC13, HIBV, PNC13
Symptoms: Erythema multiforme
Clinical narrative: New information was received in source details, patient details, medical history, product details, event details and outcome. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old male patient who experienced erythema multiforme. The patient received the first dose on 21-May-2010. The patient also received the fourth dose of HIBERIX on 21-May-2010. The patient experienced erythema multiforme on 22-May-2010. The outcome of the event is resolved. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Erythema multiforme
Clinical narrative: Additional information was received in source details, patient details, medical history, test results, and event details. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 24-month-old male patient who experienced erythema multiforme. At 24 months of age, the patient received the first dose on 18-May-2010. The patient experienced erythema multiforme on 19-May-2010. The event resolved. No additional information was available at the time of this report.
Age: 1.02
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 12-month-old female patient who experienced blisters at the injection site of PREVNAR 13. The patient received a dose on 13-May-2010. The patient also received a dose of Hepatitis A Vaccine (manufacturer unknown), a dose of MMR (Sanofi Pasteur), a dose of Varicella Virus Vaccine, Live (manufacturer unknown) and a dose of PENTACEL (Aventis-Pasteur) on 13-May-2010. The patient experienced blisters at the injection site of PREVNAR 13 in May or on 01-Jun-2010. The patient was brought to her physician and the outcome of the event was unknown at the time of this report. No additional information was available at the time of this report.
Age: 1.02
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 12-month-old female patient who experienced blisters at the injection site of PREVNAR 13. The patient received a dose on 13-May-2010. The patient also received a dose of Hepatitis A Vaccine (manufacturer unknown), a dose of MMR (Sanofi Pasteur), a dose of Varicella Virus Vaccine, Live (manufacturer unknown) and a dose of PENTACEL (Aventis-Pasteur) on 13-May-2010. The patient experienced blisters at the injection site of PREVNAR 13 in May or on 01-Jun-2010. The patient was brought to her physician and the outcome of the event was unknown at the time of this report. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old male patient who experienced swelling at the injection site and redness at injection site. At 3 years of age, the patient received the first dose on 01-Jun-2010. The patient experienced swelling at the injection site and redness at injection site in Jun-2010. Outcome was unknown. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old male patient who experienced swelling at the injection site and redness at injection site. At 3 years of age, the patient received the first dose on 01-Jun-2010. The patient experienced swelling at the injection site and redness at injection site in Jun-2010. Outcome was unknown. No additional information was available at the time of this report.
Age: 3.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old female patient who experienced injection site swelling, injection site warmth and injection site redness. The patient received a dose on 01-Jun-2010. The patient experienced injection site swelling, injection site warmth and injection site redness on 03-Jun-2010. The patient was seen by her physician and the outcome was unknown at the time of this report. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Follow-up was received that provided updated medical history and updated physical assessment test. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old male patient who experienced vomited and seizure. At 3 years of age, the patient received the first dose on 14-Jul-2010. On 14-Jul-2010, approximately 2 hours post-vaccination with a booster dose of PREVNAR 13, the patient vomited and experienced a seizure, becoming unresponsive. The patient was hospitalized. A CAT scan was performed which was normal. The patient was diagnosed as having had a seizure. Treatment was not reported. On 15-Jul-2010 the patient was considered recovered. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Computerised tomogram normal, Convulsion, Unresponsive to stimuli, Vomiting
Clinical narrative: Follow-up was received that provided updated medical history and updated physical assessment test. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old male patient who experienced vomited and seizure. At 3 years of age, the patient received the first dose on 14-Jul-2010. On 14-Jul-2010, approximately 2 hours post-vaccination with a booster dose of PREVNAR 13, the patient vomited and experienced a seizure, becoming unresponsive. The patient was hospitalized. A CAT scan was performed which was normal. The patient was diagnosed as having had a seizure. Treatment was not reported. On 15-Jul-2010 the patient was considered recovered. No additional information was available at the time of this report.
Age: 33.0
Sex: F
Vaccine: JEV, JEVX
Symptoms: Acute disseminated encephalomyelitis, Ataxia, Dysphemia, Hemiparesis, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: This authority case has been downloaded during weekly research from VAERS homepage on 06 Sep 2010. A 33 year old female received her third dose of Japanese Encephalitis vaccine (unknown manufacturer, batch number not reported) s.c. on 05 May 2010 in the right arm. She had received two doses previously. On 10 Jun 2010 patient was diagnosed with acute disseminated encephalomyelitis, which was manifested as stuttering, neurological symptoms, and culminated in right-sided ataxic-hemiparesis. Symptoms peaked about 23 24 days after onset (i.e. 03/04 Jul 2010). Brain MRI showed multifocal white-matter lesions of appearance and location consistent with synchronous central nervous system demyelination. She has been hospitalized for 11 days and had been treated with SOLUMEDROL i.v. By the time of report symptoms had gradually improved, but continue with mild residuals.
Age: 33.0
Sex: F
Vaccine: JEV, JEVX
Symptoms: Acute disseminated encephalomyelitis, Ataxia, Central nervous system lesion, Demyelination, Dysphemia
Clinical narrative: This authority case has been downloaded during weekly research from VAERS homepage on 06 Sep 2010. A 33 year old female received her third dose of Japanese Encephalitis vaccine (unknown manufacturer, batch number not reported) s.c. on 05 May 2010 in the right arm. She had received two doses previously. On 10 Jun 2010 patient was diagnosed with acute disseminated encephalomyelitis, which was manifested as stuttering, neurological symptoms, and culminated in right-sided ataxic-hemiparesis. Symptoms peaked about 23 24 days after onset (i.e. 03/04 Jul 2010). Brain MRI showed multifocal white-matter lesions of appearance and location consistent with synchronous central nervous system demyelination. She has been hospitalized for 11 days and had been treated with SOLUMEDROL i.v. By the time of report symptoms had gradually improved, but continue with mild residuals.
Age: 33.0
Sex: F
Vaccine: JEV, JEVX
Symptoms: Hemiparesis, Neurological symptom, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: This authority case has been downloaded during weekly research from VAERS homepage on 06 Sep 2010. A 33 year old female received her third dose of Japanese Encephalitis vaccine (unknown manufacturer, batch number not reported) s.c. on 05 May 2010 in the right arm. She had received two doses previously. On 10 Jun 2010 patient was diagnosed with acute disseminated encephalomyelitis, which was manifested as stuttering, neurological symptoms, and culminated in right-sided ataxic-hemiparesis. Symptoms peaked about 23 24 days after onset (i.e. 03/04 Jul 2010). Brain MRI showed multifocal white-matter lesions of appearance and location consistent with synchronous central nervous system demyelination. She has been hospitalized for 11 days and had been treated with SOLUMEDROL i.v. By the time of report symptoms had gradually improved, but continue with mild residuals.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV, PNC13, HEPA, HIBV, PNC13
Symptoms: Cellulitis, Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 33-month-old male patient who experienced cellulitis, swelling, tenderness on palpation at the injection site, warmth and redness. The patient received a dose on 27-Jul-2010. Additional suspect medication included HepA Vaccine and HIBERIX. The patient experienced cellulitis, swelling, tenderness on palpation at the injection site, warmth and redness on 29-Jul-2010. Treatment included ceftriaxone and cephalexin. At the time of this report, all events were recovering. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV, PNC13, HEPA, HIBV, PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 33-month-old male patient who experienced cellulitis, swelling, tenderness on palpation at the injection site, warmth and redness. The patient received a dose on 27-Jul-2010. Additional suspect medication included HepA Vaccine and HIBERIX. The patient experienced cellulitis, swelling, tenderness on palpation at the injection site, warmth and redness on 29-Jul-2010. Treatment included ceftriaxone and cephalexin. At the time of this report, all events were recovering. No additional information was available at the time of this report.
Age: 0.99
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 12-month-old male patient who experienced cellulitis, swelling, tenderness on palpation at the injection site, warmth and redness. The patient received a dose on 27-Jun-2010. Additional suspect medication included MMR, VARILRIX and HepA. The patient experienced cellulitis, swelling, tenderness on palpation at the injection site, warmth and redness in Jul-2010. Treatment included ceftriaxone and cephalexin. At the time of this report, the outcome of these events were unknown. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Body temperature increased, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site macule
Clinical narrative: Information regarding PREVNAR 13 was received from a consumer regarding her son, a 3-year-old male, who experienced possible incorrect vaccine given, change of behaviour, fever, arm and shoulder became pink, red and very warm to touch, slight rash around mouth and what looked like a chemical reaction and shoulder looked like it was bruised. The patient received a dose on 12-Aug-2010. The patient experienced possible incorrect vaccine given. The consumer read the product description, which describes the vaccine as looking light blue, but it looked to her "more like a clear pink or orange" color. The mother observed a change in behaviour of the child and fever on 12-Aug-2010, arm and shoulder became pink, red and very warm to touch and slight rash around mouth on 13-Aug-2010. The patient was taken to the doctor's office, and the patient was started on amoxicillin/clavulanic acid. Because symptoms continued, the patient was taken to the Emergency Room on 14-Aug-2010, where the physician ruled out cellulitis and said that it looked like a chemical reaction on 14-Aug-2010. No treatment was given. The patient was feeling better by 15-Aug-2010. The shoulder looked like it was bruised on 17-Aug-2010. The patient's behavioral change has not resolved. The outcome of the other events is unknown. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Information regarding PREVNAR 13 was received from a consumer regarding her son, a 3-year-old male, who experienced possible incorrect vaccine given, change of behaviour, fever, arm and shoulder became pink, red and very warm to touch, slight rash around mouth and what looked like a chemical reaction and shoulder looked like it was bruised. The patient received a dose on 12-Aug-2010. The patient experienced possible incorrect vaccine given. The consumer read the product description, which describes the vaccine as looking light blue, but it looked to her "more like a clear pink or orange" color. The mother observed a change in behaviour of the child and fever on 12-Aug-2010, arm and shoulder became pink, red and very warm to touch and slight rash around mouth on 13-Aug-2010. The patient was taken to the doctor's office, and the patient was started on amoxicillin/clavulanic acid. Because symptoms continued, the patient was taken to the Emergency Room on 14-Aug-2010, where the physician ruled out cellulitis and said that it looked like a chemical reaction on 14-Aug-2010. No treatment was given. The patient was feeling better by 15-Aug-2010. The shoulder looked like it was bruised on 17-Aug-2010. The patient's behavioral change has not resolved. The outcome of the other events is unknown. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Abnormal behaviour, Contusion, Erythema, Pyrexia, Rash
Clinical narrative: Information regarding PREVNAR 13 was received from a consumer regarding her son, a 3-year-old male, who experienced possible incorrect vaccine given, change of behaviour, fever, arm and shoulder became pink, red and very warm to touch, slight rash around mouth and what looked like a chemical reaction and shoulder looked like it was bruised. The patient received a dose on 12-Aug-2010. The patient experienced possible incorrect vaccine given. The consumer read the product description, which describes the vaccine as looking light blue, but it looked to her "more like a clear pink or orange" color. The mother observed a change in behaviour of the child and fever on 12-Aug-2010, arm and shoulder became pink, red and very warm to touch and slight rash around mouth on 13-Aug-2010. The patient was taken to the doctor's office, and the patient was started on amoxicillin/clavulanic acid. Because symptoms continued, the patient was taken to the Emergency Room on 14-Aug-2010, where the physician ruled out cellulitis and said that it looked like a chemical reaction on 14-Aug-2010. No treatment was given. The patient was feeling better by 15-Aug-2010. The shoulder looked like it was bruised on 17-Aug-2010. The patient's behavioral change has not resolved. The outcome of the other events is unknown. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Skin discolouration, Skin irritation, Skin warm
Clinical narrative: Information regarding PREVNAR 13 was received from a consumer regarding her son, a 3-year-old male, who experienced possible incorrect vaccine given, change of behaviour, fever, arm and shoulder became pink, red and very warm to touch, slight rash around mouth and what looked like a chemical reaction and shoulder looked like it was bruised. The patient received a dose on 12-Aug-2010. The patient experienced possible incorrect vaccine given. The consumer read the product description, which describes the vaccine as looking light blue, but it looked to her "more like a clear pink or orange" color. The mother observed a change in behaviour of the child and fever on 12-Aug-2010, arm and shoulder became pink, red and very warm to touch and slight rash around mouth on 13-Aug-2010. The patient was taken to the doctor's office, and the patient was started on amoxicillin/clavulanic acid. Because symptoms continued, the patient was taken to the Emergency Room on 14-Aug-2010, where the physician ruled out cellulitis and said that it looked like a chemical reaction on 14-Aug-2010. No treatment was given. The patient was feeling better by 15-Aug-2010. The shoulder looked like it was bruised on 17-Aug-2010. The patient's behavioral change has not resolved. The outcome of the other events is unknown. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: HEPA, PNC13, HEPA, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding a 3-year-old male patient who experienced redness, tenderness and swelling at the injection site; and hot, warm, red, large (9.25 cm) possible local reaction - possibly due to a bug bite. The patient received the first dose on 18-Aug-2010. The nurse reported that the patient experienced tenderness, swelling, and redness at the injection site on 19-Aug-2010. The patient was taken to the doctor's office and was seen by the physician on 19-Aug-2010. The patient was noted to have a hot, warm, red, large (9.25 cm) possible local reaction. The physician stated that it could be a possible reaction to a bug bite. Outcome for all events was unknown. The nurse stated that she thought "the area might be slightly lower on the arm than the injection site". No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: HEPA, PNC13, HEPA, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding a 3-year-old male patient who experienced redness, tenderness and swelling at the injection site; and hot, warm, red, large (9.25 cm) possible local reaction - possibly due to a bug bite. The patient received the first dose on 18-Aug-2010. The nurse reported that the patient experienced tenderness, swelling, and redness at the injection site on 19-Aug-2010. The patient was taken to the doctor's office and was seen by the physician on 19-Aug-2010. The patient was noted to have a hot, warm, red, large (9.25 cm) possible local reaction. The physician stated that it could be a possible reaction to a bug bite. Outcome for all events was unknown. The nurse stated that she thought "the area might be slightly lower on the arm than the injection site". No additional information was available at the time of this report.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Dyskinesia, Injection site pain
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 4-month-old patient (sex not reported) who experienced being extremely irritable and wouldn't move right leg. At 4 months of age, the patient received a dose on 28-Jun-2010. The patient also received a dose of ROTATEQ (Merck & Co Inc) (oral) and a dose of PENTACEL (Aventis-Pasteur) on 28-Jun-2010. The patient experienced being extremely irritable and wouldn't move right leg on 28-Jun-2010. Gait disturbance and irritability were not resolved. No additional information was available at the time of this report.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Gait disturbance, Injected limb mobility decreased, Irritability
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 4-month-old patient (sex not reported) who experienced being extremely irritable and wouldn't move right leg. At 4 months of age, the patient received a dose on 28-Jun-2010. The patient also received a dose of ROTATEQ (Merck & Co Inc) (oral) and a dose of PENTACEL (Aventis-Pasteur) on 28-Jun-2010. The patient experienced being extremely irritable and wouldn't move right leg on 28-Jun-2010. Gait disturbance and irritability were not resolved. No additional information was available at the time of this report.
Age: 77.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Adverse event, Myalgia, Pain in extremity
Clinical narrative: Constant pain, left arm muscle vaccine was injected, on Sept. 3, 2010 at 9:47AM ALEVE & heat.
Age: 77.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Constant pain, left arm muscle vaccine was injected, on Sept. 3, 2010 at 9:47AM ALEVE & heat.
Age: 84.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Heart rate increased, Pyrexia
Clinical narrative: 9 hours after injection - chills, fever, 101 degrees F, pulse rate 93, sore muscles, headache, lethargy that continued for two days.
Age: 84.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Headache, Lethargy, Myalgia, Pyrexia
Clinical narrative: 9 hours after injection - chills, fever, 101 degrees F, pulse rate 93, sore muscles, headache, lethargy that continued for two days.
Age: 5.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chest pain, Cough, Dyspnoea, Intensive care, Mechanical ventilation
Clinical narrative: Temp of 103.3, rapid heartbeat, lethargic, grunting, and breathing fast. Pt was brought to the ER and had pulmonary edema by chest X-ray. He was intubated and spent the night in the pediatric intensive care getting dialysis.
Age: 5.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pulmonary oedema, Pyrexia, Vomiting
Clinical narrative: Temp of 103.3, rapid heartbeat, lethargic, grunting, and breathing fast. Pt was brought to the ER and had pulmonary edema by chest X-ray. He was intubated and spent the night in the pediatric intensive care getting dialysis.
Age: 5.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Body temperature increased, Chest X-ray abnormal, Dialysis, Endotracheal intubation, Grunting
Clinical narrative: Temp of 103.3, rapid heartbeat, lethargic, grunting, and breathing fast. Pt was brought to the ER and had pulmonary edema by chest X-ray. He was intubated and spent the night in the pediatric intensive care getting dialysis.
Age: 5.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Heart rate increased, Intensive care, Lethargy, Pulmonary oedema
Clinical narrative: Temp of 103.3, rapid heartbeat, lethargic, grunting, and breathing fast. Pt was brought to the ER and had pulmonary edema by chest X-ray. He was intubated and spent the night in the pediatric intensive care getting dialysis.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Nervousness, Pruritus, Rash macular
Clinical narrative: Pt report back to clinic site almost an hour later with red blotches on both arms, itching to face and neck, and feeling hot and shaky.  Pt monitored by staff, reported no hives or trouble breathing.  Pt took 1 Benadryl from personal stock, and reported relief of itching and red blotches.  After 15mins She felt well enough to go back to work.
Age: 32.0
Sex: M
Vaccine: FLUX, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Arthralgia, Axillary pain, Chills, Headache, Injected limb mobility decreased
Clinical narrative: Started with headache, nausea and chills. 24 hours after administration, shot site turned bright red and swollen. Hot to touch, the redness spread to about an 8 inch diameter circle. At this point had a fever of 100.1+. Unable to move arm, severe pain into arm pit and down to wrist. Saw doctor around 3:30pm on 9/21/10 prescribed Keflex thinking it was an infection. Fever, pain and redness continued for 10 more hours.
Age: 32.0
Sex: M
Vaccine: FLUX, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea, Pyrexia
Clinical narrative: Started with headache, nausea and chills. 24 hours after administration, shot site turned bright red and swollen. Hot to touch, the redness spread to about an 8 inch diameter circle. At this point had a fever of 100.1+. Unable to move arm, severe pain into arm pit and down to wrist. Saw doctor around 3:30pm on 9/21/10 prescribed Keflex thinking it was an infection. Fever, pain and redness continued for 10 more hours.
Age: 32.0
Sex: M
Vaccine: FLUX, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Started with headache, nausea and chills. 24 hours after administration, shot site turned bright red and swollen. Hot to touch, the redness spread to about an 8 inch diameter circle. At this point had a fever of 100.1+. Unable to move arm, severe pain into arm pit and down to wrist. Saw doctor around 3:30pm on 9/21/10 prescribed Keflex thinking it was an infection. Fever, pain and redness continued for 10 more hours.
Age: 32.0
Sex: M
Vaccine: FLUX, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Injection site swelling, Lymph node pain, Oedema peripheral, Tenderness
Clinical narrative: Started with headache, nausea and chills. 24 hours after administration, shot site turned bright red and swollen. Hot to touch, the redness spread to about an 8 inch diameter circle. At this point had a fever of 100.1+. Unable to move arm, severe pain into arm pit and down to wrist. Saw doctor around 3:30pm on 9/21/10 prescribed Keflex thinking it was an infection. Fever, pain and redness continued for 10 more hours.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Heart rate increased, Malaise, Tachycardia, Tremor
Clinical narrative: Pt had high dose flu vaccine at health department and subsequently experienced shaking, chills, malaise, tachycardia with HR increased to 130s - taken to local ER where he was evaluated and released as symptoms began to resolve
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Urine analysis normal
Clinical narrative: Pt had high dose flu vaccine at health department and subsequently experienced shaking, chills, malaise, tachycardia with HR increased to 130s - taken to local ER where he was evaluated and released as symptoms began to resolve
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Localized erythema and induration at injection site.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Radiating pain in left shoulder. Going to MD on 09-24-10.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Erythema, Headache, Nausea, Oedema peripheral
Clinical narrative: TDAP (L) deltoid 9/20/2010 Received vaccine - TDAP. 9/21/2010 woke up at 3:30AM c/o pain in arm. Arm not swollen or red. Mother gave TYLENOL & applied ice. In the morning client then c/o headache, stomach ache, had a fever - temp was unknown, arm slightly swollen red. 9/22 (L) arm deltoid area redness & swelling increased c/o stomach ache. Red area was reported to be from the front to the back of his deltoid area. 9/23 still c/o nausea - increased in redness & size. 9/24 - no nausea- mother states deltoid area is red swollen & increased size to about 4" x 6".
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: TDAP (L) deltoid 9/20/2010 Received vaccine - TDAP. 9/21/2010 woke up at 3:30AM c/o pain in arm. Arm not swollen or red. Mother gave TYLENOL & applied ice. In the morning client then c/o headache, stomach ache, had a fever - temp was unknown, arm slightly swollen red. 9/22 (L) arm deltoid area redness & swelling increased c/o stomach ache. Red area was reported to be from the front to the back of his deltoid area. 9/23 still c/o nausea - increased in redness & size. 9/24 - no nausea- mother states deltoid area is red swollen & increased size to about 4" x 6".
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female patient who received three doses of GARDASIL and now has a positive Papanicolau (PAP) test.  It was reported that the patient was HPV positive and it was high risk.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Erythema, Lip swelling, Rash
Clinical narrative: FACE RED, RASH ON ARMS, LIP SWOLLEN, WENT TO DOCTORS CARE AT FOUR, I WAS AT WORK AND COULDN'T LEAVE UNTIL FOUR. HAD MILD EFFECT BECAUSE I WAS ON METHYLPREDNISONLONE FOR SHINGLES.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Injection site pruritus, Pruritus generalised, Urticaria
Clinical narrative: Allergic reation, hives, alot of itching all over my body and the site of the injection.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: PATIENT BEGAN EXPERIENCING ITCH, RASH, REDNESS IN THE RIGHT ARM A FEW HOURS AFTER VACCINATION.
Age: 57.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Upon waking the next day after the administration of H1N1 vaccine, he described a numbness on the left side on his body. Upon further questioning this is more like paresthesias and has not diminished.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Lip swelling, Oral pruritus, Swollen tongue, Urticaria
Clinical narrative: Very swollen bottom right side of lip and tongue, itching on tongue and lip, pain in left arm muscle (where vaccine was given), hives on left arm morning of 09/23/2010. Called the doctor, they recommended taking Benadryl and calling if symptoms persist or get worse.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dysphagia, Dyspnoea, Electrocardiogram normal, Gastrointestinal pain
Clinical narrative: Patient went home after vaccination, started with a headache first around 8 pm on 9/23/10 and symptoms started progressing with sore throat ("lump in her throat that it was hard to swallow) then body ache and diarrhea and kind of having instestinal spasm ("like charlie horses"). Because of the spasm patient was having hard time breathing. Patient didn't have any allergic symptoms. It was more like Flu like symptoms. Patient is getting better as per converstation (9/23/10 9:30 AM).
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Oropharyngeal pain, Pain, Sensation of foreign body
Clinical narrative: Patient went home after vaccination, started with a headache first around 8 pm on 9/23/10 and symptoms started progressing with sore throat ("lump in her throat that it was hard to swallow) then body ache and diarrhea and kind of having instestinal spasm ("like charlie horses"). Because of the spasm patient was having hard time breathing. Patient didn't have any allergic symptoms. It was more like Flu like symptoms. Patient is getting better as per converstation (9/23/10 9:30 AM).
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: TINGLING/PAIN IN ARM VACCINE WAS ADMINISTERED IN
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: redness at injection site; rash and itching
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Gingival disorder, Injection site erythema, Injection site swelling
Clinical narrative: Mom called at 9:30PM to report swelling and redness at injection site, right arm as well as "4 or 6 bumps on her gums, some like pus". Gargling with salt water.  Recommended cool application as well as Motrin as appropriate for age to reduce pain and swelling. Call to mom 10:15 AM this morning, swelling improving "not as hard" after tx and Motrin, switching to warm applications later today. Child slept well during night.  Will see dentist today.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Pain, Pyrexia
Clinical narrative: Fever, body aches.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling jittery, Pain, Palpitations
Clinical narrative: Body aches, jittery feeling, felt like my heart was racing.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Fatigue, Flushing, Laboratory test, Musculoskeletal pain
Clinical narrative: Extreme fatigue, pain in neck & left shoulder, red eyes, burning eyes, fever (low grade), flushing.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Ocular hyperaemia, Pyrexia
Clinical narrative: Extreme fatigue, pain in neck & left shoulder, red eyes, burning eyes, fever (low grade), flushing.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Aches, chills, fever, headache - onset 7 hrs. after injection - lasted about 10 hours.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever - 12-16 hours symptoms lasted severe body aches severe headache. TYLENOL & Ibuprofen.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nervousness, Pain in extremity, Palpitations
Clinical narrative: 10:AM nervous racing heart rate (Approx 2 hrs) on same day. 2 days later -aching left arm & neck muscles.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Body temperature increased, Chills, Headache, Nausea
Clinical narrative: Temp of 101.7 with chills, joint pain, headache, nausea.