chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Oedema, Pain, Tenderness
Clinical narrative: 1pm pain slight swelling, tender to touch. Began cold compresses 1 Aleve for symptoms progressed to increased swelling, more tender, some redness continued cold compresses alternated with warm moist heat. Continued Aleve Q 6 hrs as needed.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site induration, Injection site vesicles
Clinical narrative: Localized vesicles and induration.
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Movement disorder
Clinical narrative: Seizure Activity after receiving 4mo immunizations at PHD in DTaP, HIB, IPV, Prevnar. Abnormal head movements.
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site oedema, Pyrexia
Clinical narrative: Indurated area, swelling at site of injection, fever 101-102.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Convulsion, Electroencephalogram abnormal, Fall, Hyperkinesia, Injury
Clinical narrative: Seizure disorder, being treated by neurologist at children's medical center. 2/15/06  Medical records reviewed. Diagnosis stated as myoclonic seizures. Additional symptoms at onset of AE include fever to 102 degrees, emesis, falling and hurting herself, quick startle movements, and twitching.  Per 60 day follow up report- Continues to have seizures and is on medication. Siezure disorder requiring medication. 12/31/09 Seizure disorder requiring medication.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Muscle twitching, Myoclonic epilepsy, Pyrexia, Vomiting
Clinical narrative: Seizure disorder, being treated by neurologist at children's medical center. 2/15/06  Medical records reviewed. Diagnosis stated as myoclonic seizures. Additional symptoms at onset of AE include fever to 102 degrees, emesis, falling and hurting herself, quick startle movements, and twitching.  Per 60 day follow up report- Continues to have seizures and is on medication. Siezure disorder requiring medication. 12/31/09 Seizure disorder requiring medication.
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema
Clinical narrative: Swollen upper arm around vaccine to elbow and shoulder.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash, Urticaria
Clinical narrative: Hive, rash on forehead Benadryl given.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Left thigh w induration and surrounding redness, no abscess noted
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Tenderness
Clinical narrative: Arm swelling, redness, hot to touch, temp tender to touch 4" oval.
Age: 3.0
Sex: F
Vaccine: DTAPH, IPV, MMR
Symptoms: Blister, Oedema, Tenderness
Clinical narrative: Bullea, swollen, tender to touch.
Age: 47.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Pruritus, Skin burning sensation
Clinical narrative: Shots given in same Left arm. Arm became very sore then intense itching and burning continuing for 1 week (7-10 days). Pt self-treated w/Benadryl. Also itching torso for 3 days.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Face oedema, Injection site erythema, Injection site mass, Tenderness
Clinical narrative: 10/1/05 onset swelling R face with tenderness. Exam showed mild swelling from pre auricular area to undermath mandibular rim right face, associated and mild tenderness, induration. No redness neck nl. Lab: WBC 10.2, Hgb 11.3, ESR 24, strip neg. No treatment. Had received MMR 9/2/05.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Coma, Gaze palsy, Pyrexia
Clinical narrative: 1 1/2 minutes starving, would not respond to any stimulation. Fever of 103.2F.
Age: 44.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Feeling hot, Injection site induration, Injection site oedema, Injection site vesicles, Skin disorder
Clinical narrative: Entire upper arm indurated, area where Varivax given blistering, skin taut, warm to touch, swollen. Pt states less swelling today than yesterday. More swelling near Varivax site than TD area.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Hypersensitivity, Oedema
Clinical narrative: Right thigh 7 cm swelling and fading redness, no pain, no calor gait from at hip and knee.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Conjunctivitis, Lymphadenopathy, Rash
Clinical narrative: Conjunctivitis bilateral, rash chest and back, swollen glands back of neck, started 10 days after injection.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Fluid retention, Injection site hypersensitivity, Injection site oedema, Skin disorder, Skin ulcer
Clinical narrative: Weeks after small pox vaccine pt had redden, swelling, pus and deep wound at site. Was put on Keflex improving and filling in with time. Today is approx 1 cm across x 1 cm deep lesion in skin with granulation tissue at base.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR, DTAPHEPBIP, IPV, MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: Accidental overdose, Wrong drug administered. This case was reported by a healthcare professional and described a 4-year-old male subject who inadvertently received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combine (Pediarix) plus a separate injection of poliomyelitis virus vaccine (IPOL). The subject had no pre-existing medical conditions. On 06 June 2005, the subject received a dose of Pediarix (lot AC21A013AA) rather than the intended diphtheria and tetanus toxoids and acellular pertussis vaccine (DTPA) for an unspecified dose in the diphtheria, tetanus, and pertussis immunization series. On 06 June 2005, the patient also received a separate injection of poliomyelitis virus vaccine (IPOL). Follow-up was received on 08 September 2005 from the reporting healthcare professional. On 07 June 2005, one day following receipt of the immunizations, the subject experienced a fever of 100 degrees Fahrenheit and vomited one time. The fever and vomiting resolved on 09 June 2005. The healthcare professional considered the fever and vomiting to possibly be related to vaccination with Pediarix.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR, DTAPHEPBIP, IPV, MMR
Symptoms: Incorrect dose administered, Pyrexia, Vomiting
Clinical narrative: Accidental overdose, Wrong drug administered. This case was reported by a healthcare professional and described a 4-year-old male subject who inadvertently received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combine (Pediarix) plus a separate injection of poliomyelitis virus vaccine (IPOL). The subject had no pre-existing medical conditions. On 06 June 2005, the subject received a dose of Pediarix (lot AC21A013AA) rather than the intended diphtheria and tetanus toxoids and acellular pertussis vaccine (DTPA) for an unspecified dose in the diphtheria, tetanus, and pertussis immunization series. On 06 June 2005, the patient also received a separate injection of poliomyelitis virus vaccine (IPOL). Follow-up was received on 08 September 2005 from the reporting healthcare professional. On 07 June 2005, one day following receipt of the immunizations, the subject experienced a fever of 100 degrees Fahrenheit and vomited one time. The fever and vomiting resolved on 09 June 2005. The healthcare professional considered the fever and vomiting to possibly be related to vaccination with Pediarix.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Asthenia, Facial palsy, Hypoaesthesia, Lacrimation increased, Tongue disorder
Clinical narrative: 16 year old male with history of essential hypertension developed facial weakness left eye tearing and tongue numbness and asymmetric smile.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain, Hypoaesthesia, Nerve compression, Oedema, Paraesthesia
Clinical narrative: Numbness, tingling, pain swelling in both legs 10 or so days after vaccine. Went back to the clinic and being treated for pinched nerve in her back. She is a jogger and she has not been able to run because her feet are numb and swollen.
Age: 59.0
Sex: U
Vaccine: FLU3, HEPA
Symptoms: Medication error
Clinical narrative: Given Hep A vaccine instead of Flu Vaccine in right deltoid. Last Hep A app 3 weeks ago. Explained to Pt, given the vaccine right deltoid.
Age: 1.66
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Malaise, Viral infection
Clinical narrative: Patient exposed to Varicella, patient experienced 35-40 blisters, felt sick but no fever.
Age: 8.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site reaction, Injection site urticaria
Clinical narrative: Red, urticaria around injection site for DTaP
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Hypersensitivity, Oedema, Tension
Clinical narrative: Swollen redness and tense right upper arm extending to elbow.
Age: 1.2
Sex: M
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site oedema, Irritability
Clinical narrative: Client had DTaP, Varicella, and Prevnar vaccines in left leg 10/06/2005. C/O on 10/07/2005 very fussy red, swollen left leg. On 10/13/2005 still had knots at left leg. Referred to pediatrician.
Age: 0.35
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Coma, Pallor, Skin discolouration, Syncope vasovagal
Clinical narrative: Per mom after shots on 10/11/2005 child turned pale legs, legs turned blue, child unresponsive. Mom called 911 took child through medical center. According to mom ER physician diagnosed with vasovagal reaction.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Medication error
Clinical narrative: This case was reported by a nurse and described a 4-year-old female subject who experienced an injection site reaction after inadvertently receiving a dose of diphtheria and tetanus toxoids and acellular pertussis adsorbed hepatitis B recombinant and inactivate poliovirus vaccine combine (Pediarix). On 20 June 2005, the subject inadvertently received a dose of Pediarix (lot number and site of injection not specified) rather than the intended fourth dose of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). Approximately tow days after vaccination with Pediarix, on 22 June 2005, the subject developed a red lump and swelling at the injection site of Pediarix and was seen at a physician's office. The injection site reaction resolved on an unspecified date on or after 22 June 2005 and on or before 03 August 2005.
Age: 0.6
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of fever in a 6-month-old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On an unspecified date on or before 21 June 2005 the subject received a dose of Pediarix (dose number and lot number not provided). At an unspecified time after vaccination with Pediarix on or before 21 June 2005, the subject experienced a fever of 103 degrees Fahrenheit. The outcome of the fever was not reported.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of fever in a 4 month old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. On an unspecified date on or before 06/21/2005 the subject received a dose of Pediarix. At an unspecified time after vaccination with Pediarix, on or before 06/21/2005, the subject experienced a fever of 104 degrees Fahrenheit. The outcome of the fever was not reported.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of fever in a 6 month old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. On an unspecified date on or before 06/21/2005 the subject received a dose of Pediarix. At an unspecified time after vaccination with Pediarix, on or before 06/21/2005, the subject experienced a fever of 103 degrees Fahrenheit. The outcome of the fever was not reported.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: Pyrexia This case was reported by a physician to a sales repesentative and described the occurrence of fever in a 4 month old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. On an unspecified date on or before 06/21/2005 the subject received a dose of Pediarix. At an unspecified time after vaccination with Pediarix, on or before 06/21/2005, the subject experienced a fever of 104 degrees Fahrenheit. Yhe outcome of the fever was not reported.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pyrexia, vomiting  This case was reported by a physician and described the occurrence of fever in a 2 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and  inactivated poliovirus vaccine combined for prophylaxis. On 02/09/2005 the subject received the 1st dose of Pediarix. On 02/10/2005, 1 day after vaccination with Pediarix, the subject experienced fever and vomiting. The subject was seen in an emergency room. The outcome of the events was not reported.
Age: 1.29
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a consumer and described the occurrence of diarrhea in a 1 year old male subject who was vaccinated with Pediarix for prophylaxis. The reporter is the mother of the pt. A physician or other health care professional has not verified this report. Medical history included developmental delay and speech problem ("...[he] has almost no frenulum which interferes with his speech"). Family history included one brother with autism. There were no concurrent medications. On 17 June 2005 the subject received 1st dose of Pediarix (lot number not specified). "In the evening" on 17 June 2005, less than one day after vaccination with Pediarix, the subject experienced "severe diarrhea". At the time of reporting, on 28 June 2005, the diarrhea was unresolved.
Age: 13.0
Sex: M
Vaccine: DTAPHEPBIP, TD
Symptoms: Abnormal behaviour, Medication error
Clinical narrative: This case was reported by a consumer and described the occurrence of quiet behavior in a 13-year-old male subject who inadvertently received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combine (Pediarix) for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. On 28 June 2005 the subject inadvertently received a dose of Pediarix (dose number not provided). Pediarix is not recommended for immunizing individual 7 years of age or older. On 28 June 2005, the subject also received vaccination with tetanus and diphtheria toxoids adsorbed (adult formulation). The reporter state that at an unspecified time following the receipt of the immunizations, on 28 June 2005, the subject "was quieter than usual." The outcome of the event was not reported.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia, Rash, Wheezing
Clinical narrative: This case was reported by a nurse practitioner to a sales representative and described the occurrence of fever in a 4-moth-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On 05 July 2005 the subject received the 2nd dose of Pediarix. On 05 July 2005, less than one day after vaccination with Pediarix, the subject experienced a "high fever." "At midnight" on 06 July 2005, the subject developed a rash "all over her body." On 11 July 2005. the subject experienced wheezing. The subject was treated with diphenhydramine hydrochloride (Benadryl). At the time of initial reporting , 13 July 2005, the fever and rash had resolved on or before 13 July 2005 and the wheezing was ongoing. The vaccination course with Pediarix was discontinued. The nurse practitioner considered the events were possibly related to vaccination with Pediarix.
Age: 0.63
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Face oedema, Rash
Clinical narrative: This case was reported by a physician and described the occurrence of facial edema in a 7-month-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On 27 July 2005 the subject received the 3rd dose of Pediarix (lot AC21A019AA)/ On 27 July 2005, the subject was also vaccinated with th 2nd dose of 7-valent pneumococcal conjugate vaccine (Prevnar) and Haemophilus influenzae type B conjugate vaccine (PedvaxHib dose number not provided).On 29 July 2005, 2 days after vaccination with Pediarix, the subject experienced facial edema and a rash described a "a diffuse rash which covered the body and was red and circular." The subject was seen by the reporting physician on 02 August 2005. The rash was diagnosed as a "hypersensitivity rash." The subject was prescribed oral diphenhydramine hydrochloride (Benadryl). The facial edema and hypersensitivity rash resolved on 05 August 2005. The physician considered the events to possibly be related to vaccination with Pediarix. This case was initially received from the physician on 04 August 2005. On 06 September 2005 this report was received from research.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hive in a 3-year-old male subject who vas vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combine (Pediarix) for prophylaxis. On 01 August 2005 the subject received 1st dose of Pediarix (lot AC21B005AA) to the left thigh. On 01 August 2005, approximately 2 hours after vaccination with Pediarix, the subject developed hives around the injections site, on his stomach, and back. He was treated with diphenhydramine hydrochloride (Benadryl). At the time of reporting, on 23 August 2005, the event had improved. The healthcare professional considered the event was possibly related to vaccination with Pediarix.
Age: 37.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Chills, Dyspnoea, Headache, Medication error, Myalgia
Clinical narrative: This case was reported by a nurse and described the occurrence of shortness of breath in a 36-year-old male subject who was inadvertently vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combine (Pediarix) for prophylaxis. On 21 July 2005 the subject inadvertently received a dose of Pediarix in the left arm (lot AC21A012AA) rather then the intended third dose of hepatitis B vaccine recombination (Engerix-B). On 21 July 2005, less than one day after vaccination with Pediarix, the subject experienced shortness of breath, headache, fever , nausea, chills, sore arm and drowsiness. The subject was seen at a physician's office. The events resolved on 22 July 2005. The nurse considered the events to be related to the vaccination with Pediarix.
Age: 37.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Nausea, Pyrexia, Somnolence
Clinical narrative: This case was reported by a nurse and described the occurrence of shortness of breath in a 36-year-old male subject who was inadvertently vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combine (Pediarix) for prophylaxis. On 21 July 2005 the subject inadvertently received a dose of Pediarix in the left arm (lot AC21A012AA) rather then the intended third dose of hepatitis B vaccine recombination (Engerix-B). On 21 July 2005, less than one day after vaccination with Pediarix, the subject experienced shortness of breath, headache, fever , nausea, chills, sore arm and drowsiness. The subject was seen at a physician's office. The events resolved on 22 July 2005. The nurse considered the events to be related to the vaccination with Pediarix.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Dyskinesia, Ear disorder, Neurodevelopmental disorder, Rash, Rosacea
Clinical narrative: This case was reported by a consumer and described the occurrence of jerky movements in a 2-month-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combine (Pediarix) for prophylaxis. The reporter is the father of the subject. A physician or other health care professional has not verified this report. The subject's medical history included birth "six weeks premature." The subject weight 2.5 pounds at birth. Concurrent medications included unspecified "medications typical for a premature baby." On 25 June 2003 the subject received the 1st dose of Pediarix. On 25 June 2003 the subject was also vaccinated with Haemophilus influenzae type B conjugate vaccine (ActHib). Approximately one month following the administration of the vaccinations on an unspecified date in August 2003, the subject experienced "jerking movements in her limbs and head."  The subject was examined by a neurologist and "no problems were found". The jerking movements resolved on an unspecified date on or before 08 August 2005. On an unspecified date after August 2003 and on or before 08 August 2005, the consumer reported that the subject, "exhibited a flapping motion in her arms when she is excited and experienced delayed speech development - a few months behind what it should be, ear infection, rash and rosacea." The ear infection, rash and rosacea resolved on an unspecified date on or before 08 August 2005. The flapping motion and delayed speech development were ongoing at the time of initial reporting, 08 August 2005. No further information will be available.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Speech disorder
Clinical narrative: This case was reported by a consumer and described the occurrence of jerky movements in a 2-month-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combine (Pediarix) for prophylaxis. The reporter is the father of the subject. A physician or other health care professional has not verified this report. The subject's medical history included birth "six weeks premature." The subject weight 2.5 pounds at birth. Concurrent medications included unspecified "medications typical for a premature baby." On 25 June 2003 the subject received the 1st dose of Pediarix. On 25 June 2003 the subject was also vaccinated with Haemophilus influenzae type B conjugate vaccine (ActHib). Approximately one month following the administration of the vaccinations on an unspecified date in August 2003, the subject experienced "jerking movements in her limbs and head."  The subject was examined by a neurologist and "no problems were found". The jerking movements resolved on an unspecified date on or before 08 August 2005. On an unspecified date after August 2003 and on or before 08 August 2005, the consumer reported that the subject, "exhibited a flapping motion in her arms when she is excited and experienced delayed speech development - a few months behind what it should be, ear infection, rash and rosacea." The ear infection, rash and rosacea resolved on an unspecified date on or before 08 August 2005. The flapping motion and delayed speech development were ongoing at the time of initial reporting, 08 August 2005. No further information will be available.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a physician via a sales representative and described a child "under the age of 2" and of unspecified gender who did not respond to the diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combine (Pediarix) immunization series. The subject's family medical history included hepatitis (not specified). On an unspecified date in February 2005, the subject received the third injections of Pediarix. Approximately six months later, in August 2005,  unspecified titers were negative.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC
Symptoms: Oral intake reduced, Pyrexia, Somnolence
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 2-month-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix). The reporter is the mother of the subject. A physician or other health care professional has not verified this report. Medical history included breast feeding. On an unspecified date in June 2005, the subject received the 1st dose of Pediarix (lot number not provided). On the same day, the subject was also vaccinated with Haemophilus influenzae type B conjugate vaccine, measles, mumps and rubella virus vaccine (MMRII) and 7-valent pneumococcal conjugate vaccine (Prevnar). The consumer reported that the subject received these vaccinations, "in both hips." The mother also reported that, "in the middle of the night after having the immunizations," on an unspecified date in June 2005, the subject "spiked a high fever of 103 degrees Fahrenheit. He was also very sleepy and would nut nurse. He slept most of the following day." The subject was treated with paracetamol (Tylenol). The events resolved on an unspecified date in June 2005.
Age: 1.26
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Convulsion
Clinical narrative: 3 Seizures, 1 at home 2 at hospital lasted about 1 min. DC DX: Seizures without any apparent cause, two episodes, seizure free for the last 24 hours. In ER observed generalized tonic, clonic seizure lasting less than one minutes and resolved on its own without any medication. At the time of the immunizations 2 days prior, had diarrhea 3-5 bowel movements everyday, mostly watery and runny. No blood in the bowel movements. No vomiting. No fever. Temp 99.3.  PE: unremarkable. Neurolgoic: at time of exam patient was in post-ictal state and his tone was normal all over the body.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site hypersensitivity
Clinical narrative: Redness around arm near injection site, with feeling of warmth. Dr treated pt with antibiotics and redness has subsided as of 10/06/2005.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Pruritus, Tenderness
Clinical narrative: Arm swelling, itching, redness with axillary tenderness with flu vaccine.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Large local swelling, redness and warmth around site from left shoulder point to just above elbow. DX large local reaction to vaccine DTap prob. Tx Benadryl 2 tsp TID x 2D.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site induration, Injection site swelling, Pruritus
Clinical narrative: Pt received Varicella vaccine 10/05/2005 SC on Left arm. Pts mother noticed area was red on 10/06/2005, area increased redness on 10/07/2005. On exam area was red, raised and warm to touch, Child complained of itching in the localized area. Area measured 5.4 x 3 cm induration. Child was examined by Dr.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site induration
Clinical narrative: Patients mother said he had a red bump to right upper leg where shots were given. She said leg felt hot. He had no fever, no SOB, no hives, no rash. Mother said she doesn't know if it was a reaction because he was kicking, made legs hard and moved a lot. Mother said she did not see bump until 2 days later on Monday.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever x 2 1/2 day rash appeared on 3rd day supportive care.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Cyanosis, Dyskinesia, Loss of consciousness, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: 14 yr old passed out after Td administered. Fell to floor face forward, landed on abd and face, turned slightly cyanotic, had slight jerking once, rigid, responded after 1-2 mins. O2 at 6 later, feet slanted, pt taken to ER for evaluation accompanied by mom and brother and 2 ambulance personnel. Pt stated after rec'd TD felt tingle sensation to left arm.
Age: 15.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Headache, Malaise, Pyrexia
Clinical narrative: Onset of headache, malaise, weakness in legs and fever (103.3) x 12 hrs, no local reaction noted now at injection site, told to take ibuprofen and Tylenol for fever, go to ER if condition worsens, call Dr if questions.
Age: 79.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain
Clinical narrative: Pt c/o pain at injection site. Pt called on 9/17 received injection on 9/6/05. Was going to MD.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Hypokinesia, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Site swollen, red, warm to touch, swollen area approx 5cm. No fever c/o pain with motion.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever of 101.3 started at 4AM.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Increased left deltoid area swelling/edema x pain touch, size 9cmx9cm.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Feeling hot, Hyperhidrosis, Injection site erythema, Injection site oedema
Clinical narrative: Immz 10/6/05 Thurs, Fri small red spot, chills, vomited all night, sweats began Sat T 102.3, achy all over. Sun arm turned, hot, swollen pain entire arm except small area in upper arm. Mon gave keflex 500 TID and Benadryl.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Myalgia, Vomiting
Clinical narrative: Immz 10/6/05 Thurs, Fri small red spot, chills, vomited all night, sweats began Sat T 102.3, achy all over. Sun arm turned, hot, swollen pain entire arm except small area in upper arm. Mon gave keflex 500 TID and Benadryl.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Skin ulcer
Clinical narrative: Pt had vaccine induced varicella with 21 lesions on face and trunk at different stages of development.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: Fever, inconsolable crying, irritable.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Agitation, Crying, Irritability, Pyrexia, Screaming
Clinical narrative: Fever, inconsolable crying, irritable
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Throat tightness
Clinical narrative: C/O heavy chest, unable to take deep breath. Feels like cold air with deep breathing.  Throat feels tight.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Pharyngeal oedema
Clinical narrative: Swelling of throat within 12 hours of the vaccine.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Arm became sore right after shot. As evening progressed, arm started hurting down to finger tips, then up to shoulder, into back of neck. Started running fever 101, started chilling, severe headache, laid down at this time, throat started feeling like it was closing up.  Called my son in medical. He said if this continued to go to EM. I took 2 Tylenol, covered up, because of chilling. Went to sleep.  Woke up sweating. Fever gone. Next morning upon arising my ears were ringing, sound was like in a cave. I figured it was all from the shot. I got o.k. by that evening, everything o.k. Not. Took the shot last year, no problem at all.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness, Tinnitus
Clinical narrative: Arm became sore right after shot. As evening progressed, arm started hurting down to finger tips, then up to shoulder, into back of neck. Started running fever 101, started chilling, severe headache, laid down at this time, throat started feeling like it was closing up.  Called my son in medical. He said if this continued to go to EM. I took 2 Tylenol, covered up, because of chilling. Went to sleep.  Woke up sweating. Fever gone. Next morning upon arising my ears were ringing, sound was like in a cave. I figured it was all from the shot. I got o.k. by that evening, everything o.k. Not. Took the shot last year, no problem at all.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: Pt. presented 22 days after receiving the Varivax vaccine with a mild case of Varicella.  Supportive treatment prescribed.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: Pt states had 1" X 1" local, reddened and warm to touch area a few hours post revaccination of the Pneumovax. Today, arm is not sore, but continues with the red local reaction. Pt advised to call back if area.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pain, Paraesthesia, Swelling
Clinical narrative: A few days after the vaccination in her left arm, her right forearm started swelling and it was tingling & sore.  There was apparently no reason for the swelling - the NP said she didn't know the cause but to take an anti-inflammatory.  In a few days the strange swelling went away.
Age: 0.82
Sex: M
Vaccine: PNC
Symptoms: Dysphonia, Face oedema
Clinical narrative: Patient developed hoarseness and swelling of face several hours after receiving the Prevnar vaccine.  He had similar episodes after receiving the vaccine at 2 and 4 months of age.  He was evaluated by an allergist for this reaction and underwent skin prick testing for Prevnar vaccine as well as to the Pediarix and Hib vaccines and gelatin.  The allergy testing showed no reactions.  The mother elected continuing with vaccinations but only giving one at a time on a weekly basis.  He recieved DTaP, IPV and Hep B as individual vaccines with out any problems.  When given the Prevnar, he had a reaction.  It was not immediate and occurred after several hours,  similar to the first two episodes in description and timing of the event.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient presented with 8-8.5 cm swollen area around injection site. Tender, moderate erythema, warm to touch, there is no adenopathy, no evidence of abcess. Temp. 99 .2 at home 10-12-2005. No Temp. noted 10-13-2005 Placed on oral Keflex 1 gram  twice daily for 10 days. Pt. will follow up Monday the 17th or sooner if needed.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Throat tightness
Clinical narrative: Approximately 45 minutes after receiving the Sanofi Pasture Fluzone Lot # u1839AA.  Prior to arrival back at the clinic, She felt a tightness in the chest and throat that reminded her of asthma like symptoms.  Client had a history of Asthma, and used her Inhailer (Albuterol) 2 puffs, with some relief.  Client reported the above, was seated in the clinic BP 150/80 p 100, Respirations 22 regular but slightly labored. Client was observed for 20 minutes and s/sx did not worsen she was allowed to leave with instructions to return if s/sx worsened, or to go to DR or Hospital.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Acne
Clinical narrative: The patient had her flu shot on 10/12/05. Patient called reporting fixed drug eruptions on face, back and chest.  She says they look like pimples.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pain
Clinical narrative: 9 cm. area of redness, induration, painful and warm to touch.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Chest discomfort, Dyspnoea, Feeling abnormal, Injection site erythema
Clinical narrative: Client came back to flu clinic at approx. 12:30pm complaining of "not feeling right".  Received her flu vaccination at approx.10:30am.  Stated she began with asthma symptoms within 1 hour of receiving her flu vaccination.  Describes symptoms of tightness in chest, with some difficulty breathing.  She administered 2 puffs of her Albuterol Inhaler with minimal relief at approx. 11:30am.  She also complained of tingling in her L arm at the site of flu injection.  Minimal reddness/swelling noted.  BP at 12:30pm was 130/82  HR-76 reg and Respir.20 easy and non-labored.  Dr was notified at this time.  Information re: clients medical history/medications and visit assessment given to Dr.  Dr. felt this not to be an acute event and no further tx was warrented at this time. He did ask that client be informed to see her Primary Care Physician if symptoms became more severe and writer did inform client of Dr's recommendations.  Writer did call client back at 3:00pm for  follow-up and client stated her symptoms had improved.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Paraesthesia
Clinical narrative: Client came back to flu clinic at approx. 12:30pm complaining of "not feeling right".  Received her flu vaccination at approx.10:30am.  Stated she began with asthma symptoms within 1 hour of receiving her flu vaccination.  Describes symptoms of tightness in chest, with some difficulty breathing.  She administered 2 puffs of her Albuterol Inhaler with minimal relief at approx. 11:30am.  She also complained of tingling in her L arm at the site of flu injection.  Minimal reddness/swelling noted.  BP at 12:30pm was 130/82  HR-76 reg and Respir.20 easy and non-labored.  Dr was notified at this time.  Information re: clients medical history/medications and visit assessment given to Dr.  Dr. felt this not to be an acute event and no further tx was warrented at this time. He did ask that client be informed to see her Primary Care Physician if symptoms became more severe and writer did inform client of Dr's recommendations.  Writer did call client back at 3:00pm for  follow-up and client stated her symptoms had improved.
Age: 1.19
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: A few red spots on back and belly a few days after vaccine. October 1 and 2, had a fever of 100.9. October 4 red spots on legs, back and abdomen.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Face oedema, Gingivitis
Clinical narrative: Lips swelled.  Difficulty swallowing.  Inside of mouth burned.  Gums were red.  Took Benadryl and symptoms subsided.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Cough, Dysphonia, Wheezing
Clinical narrative: Information described was reported to writer by RN.  She reports that client came to see her on October 11, 2005 at approx. 4:20pm. Client reported that she had received that influenza vaccine earlier in the day at approx. 10am.  Client reported that she experienced onset of symptoms at approx. 1pm consisting of tightness and heaviness in her chest, hoarness of voice with wheezing and coughing.  Client did reportedly stated she took 50 mg of Benedryl by mouth at 2pm with some relief of symptoms.  Client's medical hx is significant for Asthmatic Bronchitis and Cold Induced Asthma.  Client was assessed and a referral to the ED was made.
Age: 75.0
Sex: F
Vaccine: MMR, TD
Symptoms: Abdominal pain, Coma, Diarrhoea, Feeling abnormal, Feeling hot
Clinical narrative: At approximately 09:30 A.M., client was questioned by nurse regarding allergy to medication.  Pt. states allergic only to Penicillin, and she is diabetic but does not have to take meds/insulin.  No breakfast this A.M. Pt. here for Td, and MMR.  09:40 A.M. --Pt's daughter came into immunization dept. states her mother the Pt. is complaining that her throat is closing-up, itchy, tongue feels fat, abdominal pain like "diarrhea", feel that her body is getting very hot, and feels like she is dying.  Immediately immunizaitons nurses headed out to the health dept. parking lot where the pt. was in the car.  Pt. was slumped over, and was sweating profusely.  Pt. was nonresponsive to the ammonia inhalants/shaking of shoulders.  Pulse non-palpable.  Pts. head repositioned as not to compromise airway.  Shallow up and down chest movement.  Does not appear to have trouble breathing. Lung auscultation---clear.  Immunization sites examined---no arthus reaction.  As a precaution and standard, a tourniquet was placed above injection sites.  Initiated Code Blue and 911.  B/P-non-readable.  Epinephrine 1:1000.30cc sub-q. (rt.arm).  After five minutes, pt. vaguely responding via moaning and answering questions per yes and no head movement.  Pt. placed in recumbent position and elevated lover extremities.  (B/P--86/42, Pulse--40) Paramedics and ambulance arrived on site. Benadryl 100mg IM administered (rt.arm). Informatin and Pt. status given to paramedics--placed Pt. on gurney.  Pt. transported to hospital via ambulance.
Age: 75.0
Sex: F
Vaccine: MMR, TD
Symptoms: Hyperhidrosis, Pruritus, Throat tightness, Tongue disorder, Tremor
Clinical narrative: At approximately 09:30 A.M., client was questioned by nurse regarding allergy to medication.  Pt. states allergic only to Penicillin, and she is diabetic but does not have to take meds/insulin.  No breakfast this A.M. Pt. here for Td, and MMR.  09:40 A.M. --Pt's daughter came into immunization dept. states her mother the Pt. is complaining that her throat is closing-up, itchy, tongue feels fat, abdominal pain like "diarrhea", feel that her body is getting very hot, and feels like she is dying.  Immediately immunizaitons nurses headed out to the health dept. parking lot where the pt. was in the car.  Pt. was slumped over, and was sweating profusely.  Pt. was nonresponsive to the ammonia inhalants/shaking of shoulders.  Pulse non-palpable.  Pts. head repositioned as not to compromise airway.  Shallow up and down chest movement.  Does not appear to have trouble breathing. Lung auscultation---clear.  Immunization sites examined---no arthus reaction.  As a precaution and standard, a tourniquet was placed above injection sites.  Initiated Code Blue and 911.  B/P-non-readable.  Epinephrine 1:1000.30cc sub-q. (rt.arm).  After five minutes, pt. vaguely responding via moaning and answering questions per yes and no head movement.  Pt. placed in recumbent position and elevated lover extremities.  (B/P--86/42, Pulse--40) Paramedics and ambulance arrived on site. Benadryl 100mg IM administered (rt.arm). Informatin and Pt. status given to paramedics--placed Pt. on gurney.  Pt. transported to hospital via ambulance.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Redness, swelling, heat, pain, hardness of large area between left elbow and shoulder around site of pneumonia injection. (No adverse reaction from flu shot in right arm.)  First night- bands of black and red around swollen area.  Second night - black and red bands were gone, but all other symptoms remained.  Third night - swelling somewhat diminished, redness & hardness significantly diminished, radiating heat is gone, tenderness has replaced pain in arm.
Sex: M
Vaccine: FLU3
Symptoms: Bacterial infection, Pyrexia, Rash, Shoulder pain
Clinical narrative: Fever day of vaccine; no fever in office at time of vaccination. Child appeared to be fine for next 3 days. About 3 days after 10/8, awoke with T 105, facial rash and left arm/shoulder pain. Seen in office 10/9 AM; lab evaluation. Transported to hospital. Care at ER and PICU.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Influenza like illness, Injection site erythema, Injection site oedema
Clinical narrative: Pt received both Pneumovax 23 and Fluzone per pt request on 10/11/05 in the right deltoid. On 10/12/05 her arm began swelling and started turning red. She had no fever except locally in the arm and felt mild flu-like symptoms.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Pharyngitis, Rhinitis
Clinical narrative: Pt received both Pneumovax 23 and Fluzone 2005 in left deltoid on her request  on 10/7/05. Over the weekend she experienced cold-like symptoms and redness that spread throughout the backside of her left arm. Pt saw family physician.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema, Injection site erythema, Rash
Clinical narrative: Redness at injection site. Rash about the face with swelling when Pt returned the following day. Gave pt some Benadryl and advised her to contact her physician.
Age: 1.27
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: Child received vaccine (Prevnar) at 9:00am on 10/12/2005. Spiked a fever of 102.6 1-2 hours afterwards. No other reactions.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: Warmth and erythema of left shoulder, itching 24 hours later. Keflex 250/5 T Tsp PO Bid, Benadryl 12.5/5 1 1/2 Tsp 26 PRN itching.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Knot feeling in throat. Patient describe feeling short of breath onset 30 minutes after TD given Monitored Pt and 2 Tsp Benadryl liquid given. Discharged home in improved stable condition.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Tenderness
Clinical narrative: Patchy localized erythema and tenderness at injection site. Total size 12x15cm.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Tenderness
Clinical narrative: Erythema, swelling and tenderness at injection site extending distally to forearm (left) extent 25cmx12cm.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site oedema
Clinical narrative: Inflamed, Edematous upper arm
Age: 73.0
Sex: F
Vaccine: FLU3, TD, YF
Symptoms: Arthralgia, Feeling hot, Hypersensitivity, Oedema, Toothache
Clinical narrative: Swelling, noted, redness, edema, warmth to touch, joints aching, Teeth aching.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a 78 yr old hospitalized female who was vaccinated SC with a 575mcg dose of PNEUMOVAX 23 (lot 651539/1100P). Subsequently, the pt developed a whole body rash. Unspecified medical attention was sought. Subsequently, the pt was discharged from the hospital and noted to be improved. No product quality complaint was involved. The pt's hospitalization was possibly prolonged due to the adverse events. No further information is available.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Skin irritation
Clinical narrative: Information has been received from a pharmacist concerning a 74 year old hospitalization female who was vaccinated SC with a 575mcg dose of pneumococcal 23v polysaccharide vaccine (lot 651525/1078P). Subsequently, the pt developed irritation and a rash at the injection site. Unspecified medical attention and sought. Subsequently, the pt was discharged from the hospital and noted to be improved. No product quality complaint was involved. The pt's hospitalization was possibly prolonged due to the adverse events. No further information is available.