chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.86
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, PNC
Symptoms: Nasal congestion, Pyrexia, Upper respiratory tract infection
Clinical narrative: R THIGH CELLULITIS, URI. COUGH, CONGESTED, FUSSY. R THIGH WARM, RED. TEMP 101(R). TREATED WITH MOTRIN.
Age: 55.0
Sex: M
Vaccine: HEPA, TD, TYP, YF
Symptoms: Pruritus, Urticaria
Clinical narrative: Stated the on 12/25/2006 started with some itching of feet that has contiued with the development of hives progressing to the torso. Has been usunf benadry for the itching and increasing dose.
Age: 94.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Hypotension, Respiratory distress, Urinary tract infection
Clinical narrative: Admitting diagnosis: respiratory distress, hypotension, UTI.
Age: 0.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Medication error, Pyrexia, Syncope
Clinical narrative: Patient contacted after vaccination and told he received a 2.5 mL dose, not 0.5 mL dose of Tdap vaccine on 12/14/2006. Syncopal episode, fever, cough caused him to be seen at the emergency department.  Manufacturer contacted- no documented cases of infection from receiving higher doses than 0.5 mL. Vaccine is inactive, so unlikely to have caused the current infection, but wanted to submit this, as patient received 5 times the regular dose, then presented with symptoms 2 weeks later.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUX, IPV, MMR, VARCEL
Symptoms: Blister, Erythema, Feeling hot, Injection site infection, Pyrexia
Clinical narrative: my son went in for shots. on 12/26/2006. when he woke up on 12/27/2006. his arm and leg were swollen and bright red, and hot to the touch. i called the office on 12/27/2006 and was told thats normal because hes a large boy and to put hot compress on the sight. by that evening he was running a tep of 103.8 i gave him tylenol and his temp wouldnt go down. the redness on his arm and leg were bigger and he had blisters on his arm. i took him back to the dr on 12/28/2006 he was still running a temp. the dr informed me had an infection on the shot sights. i asked what shots were given where and he said it wasnt written down.i have no ideal what shots did this to him. the dr put him on antibiotics.and on hydroxyzine.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUX, IPV, MMR, VARCEL
Symptoms: Swelling
Clinical narrative: my son went in for shots. on 12/26/2006. when he woke up on 12/27/2006. his arm and leg were swollen and bright red, and hot to the touch. i called the office on 12/27/2006 and was told thats normal because hes a large boy and to put hot compress on the sight. by that evening he was running a tep of 103.8 i gave him tylenol and his temp wouldnt go down. the redness on his arm and leg were bigger and he had blisters on his arm. i took him back to the dr on 12/28/2006 he was still running a temp. the dr informed me had an infection on the shot sights. i asked what shots were given where and he said it wasnt written down.i have no ideal what shots did this to him. the dr put him on antibiotics.and on hydroxyzine.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site warmth, Pain
Clinical narrative: Large painful warm indurated right deltoid.
Age: 22.0
Sex: M
Vaccine: ANTH, FLU3, SMALL, TYP
Symptoms: Pericarditis
Clinical narrative: Pt. is suspected to have a reaction to small pox vaccine. (pericarditis).  Records received from reporter documenting an overnight hospital stay for c/o sudden onset of chest pain of 12 hours duration, 1 week following smallpox and anthrax vax.   PE: Unremarkable except for erythematous, raised bumps on anterior and sup. shoulders. Impression: 1) Atypical chest pain.  Pericarditis d/t viral(?) vs. smallpox  vaccine.  2) hyperlipidemia. Records received from VA hospital. Report as above.  Principal DX: Pericarditis.
Age: 0.0
Sex: M
Vaccine: FLU3
Symptoms: Skin nodule
Clinical narrative: THIS PATIENT REPORTED TODAY THAT THE FLU VACCINE HE RECEIEVED 12/4/06 PRODUCED SWOLLEN NODULES AT BOTH NIPPLES, 2 DAYS POST VACCINATION. PATIENT SEEN BY HIS OWN PHYSICIAN AND TOLD THIS WAS MOST LIKELY AN IMMUNE RESPONSE TO THE VACCINE. HIS PHYSICIAN WILL FOLLOW-UP IN ONE MONTH.
Age: 2.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: MMR administered in Right leg.  Mtr noted swelling and redness begining around 7 pm.  Area  around injection swollen >5 inches, redness and itching present.  Swelling spread into groin area and was warm to touch.  Child unable to ambulate.  Child seen in the emergency room and by MD (the following day). Oral Benadryl was given and a topical cream was applied prn.  Reaction resolved after approximately 1 wk.
Age: 50.0
Sex: F
Vaccine: DTAPH, MNQ, PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Patient received injection 26 Dec 2006 in left arm. Within 30 mins pt. reported pruritis, site was erythemic, swollen, and warm to touch. Pt took 50mg diphenhydramine PO. Arm continued to swell after pt went home and called office the following day. Pt advised to report to PCP. PCP placed pt on antibiotic and told to continue diphenhydramine and follow-up next day. Pt reported to our office 29 Dec 2006, per pt arm less swollen and felling better.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 77 year old female who on 06 Dec 2006 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 655152/0889F). On 06 Dec 2006 the patient experienced pain in her arm and could not use it for almost a day. Unspecified medical attention was sought. At the time of the report, the patient was recovering. The reporting physician considered the events to be disabling. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 67 year old female who on 16 Dec 2006 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #0655152/0889F). Subsequently, on 15 Dec 2006, the patient had pain in her arm and could not use it for almost a day. Unspecified medical attention was sought. At the time of the report, the patient was considered to be not recovered. It was noted regarding the therapy that she never got it again. There were no relevant diagnostic or laboratory tests. The reporter considered the patient's experience to be disabling. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site oedema, Oedema, Pain
Clinical narrative: Information has been received from a certified medical assistant concerning a 58 year old female with DILANTIN allergy who on 05 Dec 2006 was vaccainted with a first dose of pneumococcal 23v polysaccharide vaccine (lot 651437/0899F) (0.5ml), in the left deltoid. Concomitant therapy that day included a dose of influenza virus vaccine, in the right deltoid. On 07 Dec 2006 the patient called the office to report she developed swollen, red injection site reaction from deltoid around to the armpit of the same arm. The patient hurt so badly and thought she was swelling in other areas of the body. The patient went to the emergency room and was treated with Benadryl injection. The patient was not hospitalized. The patient recovered. The reporter considered the patient's experience to be an other medical event (OMIC). Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Pain, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: 2-3 lymph nodes swelled to size of grapes. They were very tender to touch 8-9/10 pain scale. Fever 101 degrees, aches from head to toe, even teeth hurt, sore throat. Patient had exacerbation same symptoms which patient had Tdap vaccination.
Age: 0.54
Sex: M
Vaccine: DTAP, FLU3, HEP, HIBV, PNC
Symptoms: Muscle spasms, Torticollis
Clinical narrative: Mom noticed head tilting to left after shots. Recheck arm torticollos with spasm of left sternoderomastoid muscle. Local warm compresses and Tylenol recommended.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Headache, Joint stiffness, Myalgia
Clinical narrative: Within 6 hours of vaccine developed headache, 8 hours of vaccine had myalgia. And by 12 hours severe pain throughout body, chills, stiffness, dizziness, nausea, headache for 48 hours.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain
Clinical narrative: Within 6 hours of vaccine developed headache, 8 hours of vaccine had myalgia. And by 12 hours severe pain throughout body, chills, stiffness, dizziness, nausea, headache for 48 hours.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Sensation of heaviness
Clinical narrative: Flu vaccine given 12/11/06 0.5 cc IM Right deltoid. Patient stated that by 8pm he experienced breathing problem and had to use his inhaler-he could not cough anything up.-episode lasted approximately one hour. The next day he felt "washed out". Has no allergy to eggs.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Angioneurotic oedema, Urticaria
Clinical narrative: Generalized urticaria and angioedema 8 hours after injection. No respiratory symptoms or decreased lack of consciousness. Resolved with Benadryl. Has no history of egg or other food allergies. Had 1st injection of two about
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Laboratory test abnormal, Malaise
Clinical narrative: Onset of polyarthralgia malaise within 24 hours of vaccine administration. Duration of symptoms about 10 days, resolved with oral corticosteroid administration.
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Eye oedema, Infection transmission via personal contact
Clinical narrative: Patient was showering with her husband 6 days after he received his smallpox vaccination when water from his injection site splashed in patients right eye. Within 10 minutes of water hitting my eye it began to swell. At that time called the CDC and their on call provider. Resolved with hot/cold compresses follow up with provider. Swelling is now gone.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Musculoskeletal stiffness, Oedema peripheral, Pain
Clinical narrative: Vaccine 10/25 am, woke 10/26 diffuse joint pain, swelling fingers/feet. Used Advil. 10/17-persistent pain shoulders/elbows/knees,spine, wrists painful, decreased flexion. Symptoms gradually resolved over 48 hours.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever 101F 6 days after vaccine given lasting 4 days. Rash 6 days after vaccine given. Has not resolved after 4 days.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chest pain, Chills, Hyperaesthesia, Hyperhidrosis
Clinical narrative: 1430-1630 severe upper arm pain, limited ROM, not able to abduct arm, 400 mg Motrin with minimal relief. 1730-2200 cont'd right arm pain (moderate to severe). Systemic overall aches, felt like being hit by a truck, severe chills, T 101.6. At 2200 took 800 Motrin, went to bed slept 4.5 hr woke up soaking wet. 0230 11/10/06 awoke, soaking wet, but felt better with chills were gone. I was finally able to move my arm around with moderate but not complete ROM. 11/10/06 slept most of day no energy, right arm from elbow to shoulder, complete circumference, including right side chest wall extremely sore and untouchable. Able to move arm though. 11/11/06 pain, soreness right upper arm slowly dissipating, 11/12/06 pain, soreness right upper arm almost gone. 11/13/06 pain completely gone in right arm.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Joint range of motion decreased, Pain, Pyrexia, Somnolence
Clinical narrative: 1430-1630 severe upper arm pain, limited ROM, not able to abduct arm, 400 mg Motrin with minimal relief. 1730-2200 cont'd right arm pain (moderate to severe). Systemic overall aches, felt like being hit by a truck, severe chills, T 101.6. At 2200 took 800 Motrin, went to bed slept 4.5 hr woke up soaking wet. 0230 11/10/06 awoke, soaking wet, but felt better with chills were gone. I was finally able to move my arm around with moderate but not complete ROM. 11/10/06 slept most of day no energy, right arm from elbow to shoulder, complete circumference, including right side chest wall extremely sore and untouchable. Able to move arm though. 11/11/06 pain, soreness right upper arm slowly dissipating, 11/12/06 pain, soreness right upper arm almost gone. 11/13/06 pain completely gone in right arm.
Age: 1.32
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Skin ulcer, Viral infection
Clinical narrative: Rash noted that day varicella about 15 lesions.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Site of injection red, warm to touch, Pt was put on course of antibiotics Keflex x 1 week.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Rash
Clinical narrative: Patient experience redness, rash, warm to touch at site of inject in approximately 30 mins after injection. Pt then began to develop a rash.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Hot flush, Nausea, Rash
Clinical narrative: Patient (employee) received 2nd dose of Hep B series. Pt received injection then preceded back to work area. Once at work are experienced rash, nausea, hot flash approximately 10/15 mins after shot. Pt checked into our emergency room.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of hive in a pediatric subject of unspecified age and gender who was vaccinated with Pediarix. for prophylaxis. The subjects medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date the subject received a dose of Pediarix (dose and lot numbers not specified). At an unspecified time after vaccination with Pediarix, the subject experienced hive. At the time of reporting the outcome of the events was unspecified. The reporting physician stated the pediatric subject had been referred to him, however, at the time of reporting the physician had not seen the subject. The physician considered the event was possibly related to vaccination with Pediarix.
Age: 0.39
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site reaction, Injury, Medication error
Clinical narrative: This case was reported by a consumer and described the occurrence of scratch at injection site in a 4 month old female subject who was vaccinated with Pediarix for prophylaxis. The reporter is the subject's grandmother. A physician or other health care professional has not verified this report. The subjects medical history included eczema. Concurrent medications included Eczema medication. 01/19/06 the subject received 2nd dose of Pediarix in the thigh. The consumer reported that, at the time of the vaccination (with Pediarix), the baby kicked, the liquid from the vaccine squirted out and there is a scratch on the baby's leg. The reporter is concerned that the baby may have received an incomplete dose of Pediarix. On 01/19/06, the subject also received an unspecified vaccine (vaccine name not provided) and HIB (manufacturer unknown). At the time of initial reporting, 01/19/06, the scratch at the injection site was ongoing.
Age: 0.14
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Crying, Screaming
Clinical narrative: This case was reported by a physician and described the occurrence of crying in a 7 week old male subject who was vaccainted with Pediarix for prophylaxis. On 01 February 2006 the subject received 1st dose of Pediarix (lot AC21D037CA). Approximately eight hours after receipt of the 1st dose of Pediarix, on 01 February 2006, the subject experienced non stop crying. No fever was reported. At the time of initial reporting, 2/08/2006 the crying was ongoing.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Vision blurred
Clinical narrative: This case was reported by a physician and described the occurrence of blurred vision in an adult female subject who was accidentally exposed to diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis, The subject is a nurse. Medical history included that the subject wore "glasses". The physician reported that on 08 February 2006, "between 1:00 p.m. and 2:00 p.m., "some of the vaccine (Pediarix) squirted in the nurse's eye behind her glasses. A few hours later, at approximately 5:30 p.m.," the nurse experienced blurred vision in that eye". At the time of initial reporting, 08 February 2006, the blurred vision was ongoing.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Hyperhidrosis, Hypersensitivity, Rash, Urticaria
Clinical narrative: This case was reported by a medical assistant to a sales representative and described the occurrence of allergic reaction in a 4-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.  The medical assistant reported that, "recently (on an unspecified date on or before 07 February 2006), the child had been started on rice and vitamins (Unknown, non manufacturer)". On 07 February 2006 the subject received 1st dose of Pediarix. On 07 February 2006, the subject was also vaccinated with 7-valent pneumococcal conjugate vaccine (Prevnar) and Haemophilus influenza type b conjugate vaccine (ActHib). On 09 February 2006, 2 days after vaccination with Pediarix, the subject experienced sweating and redness of the ears, urticaria, " a rash from the shoulders down", swollen ears and hands. The subject was seen at a physician's office on 10 February 2006 and was diagnosed with an allergic reaction and noted to have "no fever".The subject was treated with diphenhydramine hydrochloride (Benadryl). The events resolved on an unspecified date on or before 15 February 2006. The medical assistant considered the events to not be related to vaccination with Pediarix and "could have possibly been related to the vitamins and the rice".
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, FLU3
Symptoms: Body temperature decreased, Irritability, Medication error, Pyrexia
Clinical narrative: This case was reported by a pharmacist and described a 4-month-old male subject who was inadvertently vaccinated with a dose of diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) sooner than recommended. On 14 February 2006 the subject received 1st dose of Pediarix. On 14 February 2006, the subject then inadvertently received the 2nd dose of Pediarix. This resulted in the subject receiving more than the recommended daily dose of poliovirus vaccine. The recommended interval between the 1st and 2nd doses of Pediarix is 6 to 8 weeks. On the evening of 14 February 2006, the subject experienced a " low grade" fever and fussiness. The fever and fussiness resolved on 15 February 2006. The pharmacist considered the events to possibly be related to vaccination with Pediarix.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Medication error, Skin burning sensation
Clinical narrative: This case was reported by a nurse and described the occurrence of burning sensation skin in an adult female subject who was inadvertently exposed to Pediarix. On 2/24/06 at 11:30am an infant was receiving a dose of Pediarix, some of the vaccine was exposed to the mothers skin. The exposure caused burning. The skin was subsequently flushed with water. The outcome of the event to the mother was not reported.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: This case was reported by a nurse and described the occurrence of allergic hives in a 4-year-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. There were no concurrent medications. On 23 February 2006 at 3:24 p.m., the subject received a dose Pediarix in the left thigh (lot AC21B05AA). The nurse reported that this was the "1st dose of Pediarix, but this was the 5th dose in the diphtheria and tetanus toxoids and acellular pertussis vaccination series", Pediarix is only recommended for the first three doses in the diphtheria and tetanus toxoids and acellular pertussis vaccination series. On 24 February 2006, "in the morning", approximately 1 day after vaccination with Pediarix, the subject was seen at a physician's office and was treated with diphenhydramine hydrochloride (Benadryl) and compresses. On 27 February 2006, the redness and swelling at the injection site resolved. The allergic wheal resolved on an unspecified date on or after 27 February 2006 and on or before 11 March 2006. The nurse considered the events to possibly be related to vaccination with Pediarix.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 4-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. The reporter is the mother of the subject. A physician or other health care professional has not verified this report.  Concurrent medical conditions included gastroesophageal reflux. Concurrent medications included Famotidine (Pepcid). On 28-October 2004, the subject received 1st dose of Pediarix (lot AC21A007AA). On 28 October 2004, the subject also received Haemophilus influenzae type b conjugate vaccine (non, unknown manufacturer). On 28 October 2004, at 10:00 p.m., less than one day after vaccination with Pediarix, the subject experienced fever. The fever resolved on 29 October 2004. On  03 January 2005, the subject again experienced a fever. The subject was seen at a physician's office. The fever resolved on an unspecified date before 08 March 2006. On an unspecified date on or before 08 March 2006, the subject received the 3rd dose of Pediarix. The mother of the subject reported that the subject "did not experience fever with the 3rd dose" of Pediarix. Follow-up information received via the mother in an authorization to contact physician indicated that the subject's fever went to 105 degrees. The physician and her nurse instructed the mother to treat her son's fevers with Tylenol. No additional details were received at the time of reporting.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of lump injection site in a 4-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) plus a separate injection of Haemophilus influenzae type b conjugate vaccine (Hib vaccine, unknown noon manufacturer). On 17 March 2006 the subject received 2nd dose of Pediarix in an unspecified thigh (lot number not provided) and an unspecified dose of Hib vaccine "in the same thigh". On 17 March 2006, the subject also received 7-valent pneumococcal conjugate vaccine (Prevnar) "in the other thigh". On 17 March 2006, less than one day after vaccination with Pediarix and Hib vaccine at an unspecified time after vaccination with Pediarix and Hib vaccine, the subject experienced redness and swelling at the injection site and a small lump under the skin at the injection site of Pediarix and Hib vaccine. At the time of initial reporting, 27 March 2006, the swelling injection site had resolved, the redness injection site had improved and the lump under the skin at the injection site was ongoing. The nurse considered the events to possibly be related to vaccination with Pediarix and Hib vaccine. Follow-up will not be available.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse and described the occurrence of hives in an infant 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 an unknown date the subject was vaccinated with Pediarix. The subject was also vaccinated with 7-valent pneumococcal conjugate vaccine (Prevnar) and Haemophilus influenzae type b conjugate vaccine (HibTITER). Two days after vaccination with Pediarix, the subject experienced hives. The outcome and causality of the events was unknown.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Rash
Clinical narrative: This case was reported by another manufacturer and described the occurrence of rash in child of unknown gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. It was reported that the child was started on rice and vitamins (Unknown, non manufacturer) the day of the vaccination. At an unknown date, the subject received a dose of Pediarix. The subject was also vaccinated with 7-valent pneumococcal conjugate vaccine (Prevnar) and Haemophilus influenzae type b conjugate vaccine (unknown manufacturer). Two days after vaccination with Pediarix, the subject experienced a rash. The events resolved on an unspecified date. The reporter stated that the rash could have possibly been related to the vitamins and the rice and not the vaccines.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described the occurrence of a positive pertussis identification test in an infant subject gender (unknown) who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. At an unspecified time, the subject received a dose of Pediarix (lot number unknown). At an unspecified time after vaccination with Pediarix, the subject had a pertussis identification test that was positive. The nurse stated that she called to "find out if Pediarix could cause a false positive on the polymerase chain reaction (PCR) for pertussis". The outcome of the events was not reported.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described the occurrence of a positive pertussis identification test in an infant subject gender (unknown) who was vaccinated with diphtheria and tetanus toxoids poliovirus vaccine combined (Pediarix) for prophylaxis. At an unspecified time, the subject received a dose of Pediarix (lot number unknown). At an unspecified time after vaccination with Pediarix, the subject had a pertussis identification test that was positive. The nurse stated that the physician did not think the case was related to Pediarix. She stated that she called to "find out if Pediarix could cause a false positive on the polymerase chain reaction (PCR) for pertussis". The outcome of the events was not reported.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described the occurrence of a positive pertussis identification test in an infant subject gender unknown who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. At an unspecified time, the subject received a dose of Pediarix (lot number unknown). At an unspecified time after vaccination with Pediarix, the subject had a pertussis identification test that was positive. The nurse stated that the physician did not think the case was related to Pediarix. She stated that she called to "find out if Pediarix could cause a false positive on the polymerase chain reaction (PCR) for pertussis". The outcome of the events was not reported.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Injection site mass, Pyrexia
Clinical narrative: This case was reported by a physician and medical assistant to a sales representative and described the occurrence of fever in a subject of unspecified age and 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 unknown date on or before 19 April 2006, the subject received an unspecified dose of Pediarix (unknown). On an unknown date on or before 19 April 2006, after vaccination with Pediarix, the subject experienced fever and knot in leg at site of administration. The physician and medical assistant reported that "these events possibility happened with several patient's, but did not indicate a specific number of patients at the time of reporting. They also reported that "the fever happened with vaccine purchased with public, as well as, private funds because it could have happened on both sides of the clinic (one part is 'VFC'- public). The fever resolved by the second day after the Pediarix was administered. The outcome of the knot at the site of administration was unknown. The physician considered the events were probably related to vaccination with Pediarix.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Pain, Rash, Restlessness
Clinical narrative: This case was reported by a consumer and described the occurrence of rash in a 4-month-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix), plus separate injections of 23-valent pneumococcal polysaccharide vaccine (Pneumovax) and Haemophilus influenzae type b conjugate vaccine. (Hib vaccine, non, unspecified manufacturer) for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. On 18 April 2006 the subject received 2nd dose of Pediarix plus separate injections of Pneumovax (dose number not reported) and Hib vaccine (dose number not reported).On 18 April 2006, less than one day after vaccination with Hib vaccine, Pediarix and Pneumovax, the subject experienced rash, restlessness and pain. The subject was seen at a physician's office. At the time of initial reporting, 26 April 2006, the rash and pain had improved and the restlessness was ongoing.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Skin discolouration
Clinical narrative: This case was reported by a physician and described the occurrence of discoloration of skin at injection site in a female subject of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On 29 April 2006 the subject received 2nd dose of Pediarix in the left thigh (lot AC21AC15AA). On 29 April 2006, the subject also received injections of Haemophilus influenzae type b conjugate vaccine (Prevnar) at unspecified site of administration. On an unspecified date on or after 29 April 2006 and on or before 01 May 2006, less than one week after vaccination with Pediarix, the subject experienced, "grey discoloration of pigment that is proximally up the thigh and a little bit laterally from where the injection (of Infanrix) was given". The physician stated that this is, "not ecchymosis and is very faint". The outcome of the event was not reported.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Injection site haemorrhage
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of injection site hemorrhage in a subject of unspecified age and 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 24 April 2006, the subject received a dose of Pediarix (dose number and lot number not reported). Less than one day after vaccination with Pediarix, on an unspecified date on or before 24 April 2006, the subject experienced injection site bleeding. The healthcare professional reported that, "the TIP-LOK syringes made the patient bleed more because they had to push harder to give the injection". The outcome of the event was not reported. Follow-up will not be available.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of fever in a child 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. No medical history, conditions or concurrent medications were reported. On an unspecified dates subjects received unspecified dose of Pediarix. The physician reportedly stated that he seen a higher incidence of fever with the use of Pediarix in his patients. Actual number of patients and demographics were not reported. At an unspecified time after vaccination with Pediarix, the subject experienced fever. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of injection site erythema in over 20 subjects of unspecified age and gender who were 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, the subjects received an unspecified dose of Pediarix (unknown). The physician estimated that there were over 20 subjects who experienced local injection site erythema and induration on unspecified dates, after an unspecified time after vaccination with Pediarix. At the time of reporting, the outcome of the events was unspecified . Follow-up received on 22 June 2006 indicated that the office would not follow-up and did not provided the outcome.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Cyanosis, Pallor
Clinical narrative: This case was reported by the vaccinating physician and described the occurrence of pallor in a 2 month old male subject who was vaccinated with Pediarix for prophylaxis. There was no relevant medical history. His concurrent medical conditions were not reported. He had not experienced any adverse events following previous vaccinations. On 13 June 2006 at 1:30 pm, the subject received the 1st dose of Pediarix (lot number AC21B067BA, right leg). On the same day, he was also vaccinated with a 1st dose of Prevnar (lot number B17697K) and a 1st dose of ActHib (lot number APUE802AA). On 13 June 2006, approximately four hours after vaccination with Pediarix and following a dose of Tylenol for an unspecified indication, the subject's parents noticed he turned pale and gray and also blue around the eyes. The episode lasted for less than two minutes and then happened again a few minutes later. The second episode also lasted less than two minutes. The subject was taken to the emergency room. An electrocardiogram was performed and was normal. The subject was admitted overnight for observation. He was seen by both a neurologist and a pulmonologist. The subject did not experience anymore episodes and the events resolved on 13 June 2006. He was discharged the next day. The physician considered the events were possibly related to vaccination with Pediarix. Follow up was received on 17 July 2006. According to the reporting physician, the final diagnosis was apneic episode and pallor. The reporting physician considered the events to be life threatening. On 14 June 2006 results from the electroencephalogram were normal. It was reported that the immunization series with Pediarix was discontinued at the parents request.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site redness 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) for prophylaxis. Previous and/or concurrent vaccination included Haemophilus influenzae type b vaccine given on 19 July 2006; pneumococcal vaccine, unspecified (Prevnar) given on 19 July 2006. The subject's mother thought that the subject had a milk allergy since he was born due to reactions in the past such as cramping, vomiting, fussy, and gassy which occurred with milk, therefore, the subject's mother had completely eliminated milk from her diet because she was breastfeeding. There were no concurrent medications. On 19 July 2006 at 15:15, the subject received the 1st dose of Pediarix (unknown, right thigh). On 19 July 2006, at an unspecified time after vaccination with Pediarix, the subject experienced injection site redness and swelling. On 20 July 2006, the subject experienced cramping, vomiting, fussy, and gassy. The nurse called to report that the subject had symptoms similar to symptoms he has after ingesting milk. The subject's mother thought that the stomach symptoms were due to Pediarix since she read that Pediarix has bovine casein. The events of injection site redness and swelling resolved on an unspecified date in July 2006. The nurse considered the events were probably related to vaccination with Pediarix. At the time of reporting, cramping, vomiting, fussy, and gassy were unresolved. The physician did not think that the stomach symptoms were related to Pediarix. Follow-up received on 10 August 2006 from the nurse indicated that the symptoms resolved on 20 July 2006.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site cyst, Injection site induration, Injection site infection
Clinical narrative: This case was initily reported by a consumer and described the occurrence of injection site induration in a 4 month old male subject who was vaccinated with Pediarix for prophylaxis. Follow up for this case was received from a physician. The consumer had initially reported that the subject received Infanrix. Follow up received from the physician indicated that the subject had actually received Pediarix. The subject had no relevant medical history. Concurrent medications included Zantac for an unspecified drug indication. At eight weeks of age, on 24 May 2006 at 1:00pm the subject received the 1st dose of Pediarix in the right thigh (lot number not provided). The subject also received other immunizations on 24 May 2006; however, the specific vaccinations received were not reported. One day following receipt of the 1st dose of Pediarix, on 25 May 2006, the subject experienced injection site infection. The subject was seen by a surgeon for incision and drainage of the injection site infection and was treated with an unspecified oral medication. The event resolved on an unspecified date on or before 26 July 206. On 26 July 2006, the subject received the 2nd dose of Pediarix in the left thigh (lot number not provided). On the same day as receipt of the 2nd dose of Pediarix, 26 July 2006, the subject experienced injection site induration and injection site cyst. The subject was again seen by a surgeon for incision and drainage of the injection site cyst and was treated with an unspecified oral medication. The events resolved on an unspecified date after 26 Jul 2006 and on or before 08 September 2006. The physician considered the events to be related to vaccination with Pediarix.
Age: 0.9
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Irritability, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of fever in a 10 month old male subject who was vaccinated with Pediarix for prophylaxis. No medical history, concurrent conditions or concurrent medications were reported. The subject was also vaccinated with Haemophilus influenzae type b and Infanrix. On 17 August 2006, the subject received the third dose of Pediarix. On 18 August 2006, the subject experienced fever and irritability. He was treated with Ibuprofen. At an unspecified time after vaccination with Pediarix, the subject experienced fever. At the time of reporting the outcome of the event was unspecified.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site reaction, Injection site vesicles, Laboratory test abnormal, Swelling, Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of urticaria in a 4 month old female subject who was vaccinated with Pediarix, HIB, and Prevnar for prophylaxis. On 13 June 2006 at 12:00 pm, the subject received 2nd dose of Pediarix (0.f ml, intramuscular, left thigh, lot number AC21B055AA), the 2nd dose of HIB (unknown, lot number 0739R), and 2nd dose of Prevnar (unknown, lot number B8651H). On the same day as vaccination, "the subject experienced urticaria, hives and swelling coincident with the use of Pediarix." The swelling and hives occurred on both lower extremities and to a lesser degree on the trunk. On 13 June 2006, the events resolved spontaneously within 30 to 40 minutes. On an unspecified date after 13 June 2006, but on or before 30 August 2006, the reporting physician saw the subject for allergy testing. He performed a 10% skin test for all the vaccinations (Pediarix, Hib, and Prevnar) that were administered on 13 June 2006. The percutaneous tests were all negative, but the 10% intradermal tests were positive to Pediarix and Prevnar and negative to HIB. After the intradermal tests, the subject developed further infiltrates and blistering at the site of the Pediarix, which again resolved spontaneously. On the day of reporting, 30 August 2006, the subject received Pediarix, HIB, Prevnar as three separate injections. The subject did not experience any reactions following these separate vaccinations.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Hepatitis, Laboratory test abnormal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of antigenemia in an infant subject of unspecified gender who was vaccinated with Pediarix for prophylaxis. On an unspecified date the subject received unspecified dose of Pediarix (unknown). At an unspecified time after vaccination with Pediarix, the subject experienced antigenemia. Relevant test results included a positive hepatitis b surface antigen two days after Pediarix was given. At the time of reporting the outcome of the event was worse.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Hepatitis, Immune system disorder
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of antigenemia in an infant subject of unspecified gender who was vaccinated with Pediarix for prophylaxis. On an unspecified date the subject received unspecified dose of Pediarix (unknown). At an unspecified time after vaccination with Pediarix, the subject experienced antigenemia. Relevant test results included a positive hepatitis b surface antigen two days after Pediarix was given. At the time of reporting the outcome of the event was worse.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Hepatitis, Laboratory test abnormal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of antigenemia in an infant subject of unspecified gender who was vaccinated with Pediarix for prophylaxis. On an unspecified date the subject received unspecified dose of Pediarix (unknown). At an unspecified time after vaccination with Pediarix, the subject experienced antienemia. Relevant test results included a positive hepatitis b surface antigen two days after Pediarix was given. At the time of reporting the outcome of the event was worse.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, PNC, UNK
Symptoms: Injection site induration, Medication error
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a hard lump at the injection site in a 4 month old male subject who was vaccinated with Pediarix for prophylaxis. The subject had no significant medical history or concurrent conditions. Concurrent vaccination included pneumococcal vaccine and an unspecified vaccine given in the left leg on the same date, 06 September 2006, as Pediarix. On 06 September 2006 the subject received 2nd dose of Pediarix at 0.5 ml, intramuscularly, in the right thigh. An unknown amount of time later, on the same day of vaccine administration, the subject developed "a knot at the sight of administration of the Pediarix." This was considered to be a medication error. It was thought that the vaccine went into the fat instead of the muscle. At the time of reporting the outcome of the events was unspecified.
Age: 0.88
Sex: M
Vaccine: DTAPHEPBIP, PNC, UNK
Symptoms: Injection site induration, Medication error
Clinical narrative: On 22 September had no significant medical history or concurrent conditions. Concurrent vaccination include pneumococcal vaccine and an unspecified vaccine each given in the left leg on the same date, 22 September 2006, as Pediarix. On 22 September 2006 the subject received 2nd dose of Pediarix at 0.5 ml intramuscularly, in the right thigh. An unknown amount of time later, on the same day of vaccine administration, the subject developed "a knot at the sight of administration of the Pediarix." This was considered to be a medication error. It was thought that the vaccine went into fat instead of the muscle. At the time of reporting  the outcome of the events was unspecified.
Age: 32.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest pain
Clinical narrative: On the fifth day following immunization in the afternoon patient began to experience pain in the central chest area which increased with occasional sharp increases in pain intensity.  Patient was seen at hospital @ 2200 , no prior problems, no family history of heart attack, heart disease or other related problems. Pain continued for approximately one week following ER visit then subsided.  Normal progression of vaccination site.
Age: 39.0
Sex: M
Vaccine: FLUN3
Symptoms: Dyspepsia, Early satiety, Ejection fraction normal, Endoscopy small intestine normal, Gastric emptying study
Clinical narrative: Approximately 2 months after the vaccination the patient began to experience vomiting, nausea and early satiety.  The symptoms never resolved and that patient has chronic nausea and early satiety.  Studies done revealed damage to the Vagal Nerve (presumed post viral) with resulting Gastric Antral Hypomotility and imparied Gastric Accomodation.  After 2 years of Chronic Nausea the patient required a gastric electrical stimulator placed. This improved symptoms about 50% although the patient still suffers from chronic nausea and early satiety. 03/29/07-records received from patient/reporter. Dates of service for multiple ED visits, PCP visits and GI procedures. 01/20/04-9/10/06 DX: Nausea, vomiting and anorexia of unclear etiology. weight loss, liver hemangiomas. Chronic nausea with dyspeptic symptoms with impaired gastric accommodation. HX: chronic mild episodic nausea for years without significant vomiting. Idiopathic gastroparesis with pacemaker placement. Per information received from annual follow up: My husband continues to suffer from gastroparesis; unfortunately, he recently developed POT syndrome immediately after surgery. This could also be due to a damaged vagus nurve, which in theory, could have occurred during a temporary autoimmune response after the vaccination.