chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash papular, Rash vesicular, Varicella
Clinical narrative: Started with multiple red papules on 12/01/07.  Examined 12/04/07.  Physician noted multiple red papules with vesicles all over.  Dx: chicken pox.  Plan: Benadryl, Motrin/Tylenol prn.
Age: 0.7
Sex: M
Vaccine: FLU3, PNC
Symptoms: Decreased appetite, Irritability, Pyrexia, Rhinorrhoea
Clinical narrative: 1/3/08 - Fever within one day of vaccine to 102 degrees.  Mom gave Tylenol, temp decreased to 100.8.  Started runny nose, clear.  Fussy morning after shots.  1/4/08 - Afebrile, not fussy, with decreased appetite.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure normal, Feeling abnormal, Heart rate normal, Immediate post-injection reaction, Muscle twitching
Clinical narrative: Within 5 minutes of injection administered, pt became faint, lied down, twitched, sat up stating "something's really wrong", lied down again.  BP & P WNL.  Waited, OK within 15 minutes.  DC 30 minutes home.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Within 5 minutes of injection administered, pt became faint, lied down, twitched, sat up stating "something's really wrong", lied down again.  BP & P WNL.  Waited, OK within 15 minutes.  DC 30 minutes home.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: Rash at injection sites within 24 hours, then facial rash at 12 days.
Age: 23.0
Sex: M
Vaccine: RAB
Symptoms: Chills, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Headachy, chills, fever, dizziness, nausea.  Onset 3 hours after immunization, sudden onset, subsided over next day.  No treatment necessary-full recovery spontaneously.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pruritus
Clinical narrative: Patient became lightheaded and remained in chair for 20-30 minutes.  She requested water.  She kept her head lowered to help with lightheadedness.  She reported itching especially on her head.  We gave 50mg PO Benadryl and symptoms improved in 30-40 minutes.  Her husband took her home.  We made a follow up call to patient early afternoon next day and she said she was fine.
Age: 28.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Arm red, hot, swollen, painful.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site papule, Pallor, Rash erythematous
Clinical narrative: Erythematous blanching 45 x 4cm, slight induration left thigh with 2 puncture spots; non-tender, not warm.  Right anterior thigh slightly blanching erythema papule at injection site.  Benadryl every 6 hours.  ? allergy to eggs in future.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash papular, Varicella
Clinical narrative: Varicella vaccine breakthrough.  Had varicella vaccine on 8-27-97 and 10-4-07.  Diagnosed with varicella in office on 1-2-08.  Had 20 vesicles & papules.  No fever.
Age: 0.7
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Moaning, Pyrexia
Clinical narrative: Moaning while sleeping woke her up very high fever over 103.5. Taken to ER, given 2mg Motrin. Fever decreased to 102.9. Gave alternating doses Tylenol/ Motrin every 4 hours. Fever went completely away 24 hrs later.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Mother phoned 12/11/07 stating when patient woke up at 9AM had a fine generalized rash over entire body.  No fever.  Has been on Amoxicillin & Albuterol for URI since 12/3/07.  Hx of asthma & eczema.  Referred him to another facility.  He was seen there on 12/11/07, dx with macro-papular type eruption.  Unsure if secondary to varicella vaccine.  Benadryl ordered TID & to return if no better.  Pt never returned.  Phoned 1/4/08, spoke with grandmother & he is doing fine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Injection site pruritus, Injection site rash, Injection site swelling, Vision blurred
Clinical narrative: Rash, swelling, itching (site) (expected), left eye had blurred vision and some pain for about 24 hrs (not expected).
Age: 1.3
Sex: F
Vaccine: DTAP, FLU3, MMR
Symptoms: Injection site erythema, Injection site swelling, Restlessness
Clinical narrative: MMR injection given with well child visit, SQ left upper thigh.  Child unable to settle after injection.  Approximately 10 minutes later reddened raised area approx 8 cm x 6 cm.  Benadryl & Tylenol given as per Dr. - cont to assess x30 minutes.  Reaction site reduced greatly in size prior to leaving the office.
Age: 23.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Faint feeling, dizzy, diaphoric, pale 9:45AM.  Tx: Laid donor down, elev. feet - H2O given, cool compress.  Laid for 15 min - was able to leave on own.
Age: 66.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Asthenia, Gait disturbance, Injected limb mobility decreased, Joint stiffness
Clinical narrative: Jaw muscles hard to open mouth first thing in morning Nov. 14, 07 - wasn't told about mercury.  Severe aches and pain in all joints, swelling of ankles, can hardly walk in morning, couldn't use arm.  Symptoms ongoing, no strength in hands & arms.  Pain med.
Age: 66.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Joint swelling
Clinical narrative: Jaw muscles hard to open mouth first thing in morning Nov. 14, 07 - wasn't told about mercury.  Severe aches and pain in all joints, swelling of ankles, can hardly walk in morning, couldn't use arm.  Symptoms ongoing, no strength in hands & arms.  Pain med.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling at site of injection 13x14 cm - seen at urgent care 12/30/07.  Rx-written PO Atavax.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Hive at injection site.  Benadryl given.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Culture throat, Erythema
Clinical narrative: R Btx erythema appx. 5 cm in diameter without induration.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient had severe swelling and some pain in the arm of the injection site.  It resolved with no treatment after two days.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Pharyngolaryngeal pain, Pyrexia, Rash, Rash generalised
Clinical narrative: 1. Feverish on 12/23.  2. Fine rash 12/25 with mild sore throat, put on Medrol Dosepak.  3. Seen again at urgent care clinic 12/26, stable vs dizzy, worse rash, spread from neck & face 12/24 to torso & limbs 12/26.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Streptococcal identification test, Streptococcal identification test negative
Clinical narrative: 1. Feverish on 12/23.  2. Fine rash 12/25 with mild sore throat, put on Medrol Dosepak.  3. Seen again at urgent care clinic 12/26, stable vs dizzy, worse rash, spread from neck & face 12/24 to torso & limbs 12/26.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Mobility decreased, Myalgia, Oedema peripheral
Clinical narrative: On 12/12/07 about 5pm pt reports swelling, pain and unable to raise right arm.  On 12/14 PHN notes swelling in Rd deltoid area 5 1/2" x 5 1/2", warmth and redness.  Able to raise arm.  Also reported chills & myalgia on 12/12.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Skin warm
Clinical narrative: On 12/12/07 about 5pm pt reports swelling, pain and unable to raise right arm.  On 12/14 PHN notes swelling in Rd deltoid area 5 1/2" x 5 1/2", warmth and redness.  Able to raise arm.  Also reported chills & myalgia on 12/12.
Age: 1.0
Sex: M
Vaccine: HEP, HIBV, MMR, PNC, VARCEL
Symptoms: Convulsion, Drooling, Musculoskeletal stiffness, Pyrexia, Unresponsive to stimuli
Clinical narrative: Story told by mom 12-3-07.  In health department 10-18-07 8:30 for well check & shots.  Mom states had seizure in car at 5:30pm.  Mom driving, mom present-stiff, drooling, unresponsive x15 mins per mom.  Ambulance called & patient woke up with them present.  Taken to ER.  Mom states no fever at ER/no tx.  To Dr. 10-19-07, child had 2 previous seizures, both on same day 7-17-07 per mom, had 103 degree fever per mom.  No tx. by Dr. 10-19-07 per mom.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Neuralgia, Paraesthesia, Rash vesicular
Clinical narrative: L facial & ear patchy rash with vesicular eruption, neuropathic (tingling, burning, sharp) pain.  12 d after Zostavax.  Tx-Valtrex 1000 mg Po q 8h x 7d; Prednisone taper (60-50-40-30-20-10).
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Blood pressure, Blood pressure increased
Clinical narrative: Blood pressure elevated next am, none-18.  Increase Micardis 40 mg q day to 1 tab BID.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Redness, itching on arm started 1 day after vaccine given; seen 4 days after vaccine with 2 inch area redness, induration, tenderness around vaccine site.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, IPV, MMR, VARCEL
Symptoms: Cough, Urticaria, Wheezing
Clinical narrative: Child was coughing/wheezing, had hives on chest, arms, legs and bottom of neck. Tx was started with 1 3/4 tsp of Benadryl given at 10:05 A followed by Albuterol 0.083% at 10:05. Vitals were HR 129, O2 98%, BP 82/42, R 20. Decadron 8mg given, epinephrine 1/1000, 0.16 mg given SQ. 11:25 rechecked vitals BP 100/54, HR 120, O2 98, temp 98.8, R 22, epinephrine 1/1000 0.16 mg given SQ. 12:25 Vitals rechecked BP 102/52, HR 130, O2 98, temp 98.7, R 26. Pt remained under close observation and was clear to leave office.
Age: 24.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Received Influenza and Pneumoccocal Polysaccharide vaccines 01-07-08.  Client reports at 9 pm.  01-07-08 noted redness, swelling, warmth, tenderness of right arm where both shots were given.  Noted 2 areas of erythema, some swelling, warmth upper right arm at injection sites.  Also, reports fever 102.1.  Aches of body.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Emotional distress, Screaming
Clinical narrative: High pitched scream x several hours beginning at 1:30PM.  Pt inconsolable for several hours.  No fever.  No irritation at injection sites.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient came to pharmacy on 12/22/2007 to receive flu shot.  Patient contacted pharmacy on 12/27/2007 with report of hives from flu shot.  Patient wasn't initially going to let us know about the reaction, so patient was not upset in any way whatsoever about the reaction.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: The brand Fluzone injection is supposed to be given to individuals under 18 years of age.  A dose of Fluarix prefilled vaccine was given by mistake.  The fluarix is used for the same purpose, it just hasn't been tested for safety yet under 18 years of age.  The patient's mother was not upset, she said her daughter was feeling fine.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: The brand Fluzone injection is supposed to be given to individuals under 18 years of age.  A dose of Fluarix prefilled vaccine was given by mistake.  The fluarix is used for the same purpose, it just hasn't been tested for safety yet under 18 years of age.  The patient's mother was not upset, she said her daughter was feeling fine.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: I was told Monday (10/22/07) morning that a pharmacist may have given a flu shot in a patient's hip rather than in the deltoid.  I looked through the consent forms and found one for patient stating that the shot was administered in the hip.  It is my understanding that the patient insisted she be given the shot in the hip as she could not take in the arm.  No symptoms reported at this time.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Heart rate, Hypotension
Clinical narrative: Got shot at 11:30AM.  Patient called at 3pm, had low blood pressure and was lightheaded.  118/70, pulse 102, at 3:09, 112/65, pulse 71, 3:33, 128/66, pulse 69, 3:40 118/63, pulse 63.  She's feeling better.  She just asked if this could be a reaction to the flu shot.  I said I'd call MD.  Dr. didn't think low BP could be because of flu shot.  He never heard of that.  I called her at 6PM BP 14/82, pulse 56.  She was feeling better and said I must love my job to "put up with customers like her".  She was feeling much better.
Age: 0.8
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Abscess, Injection site abscess, Injection site erythema, Injection site swelling
Clinical narrative: This case reported by a physician and described the occurrence of sterile abscess at injection site in a 9-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline) for prophylaxis. The subject's medical history included sterile abscess and swelling, both at the injection site, following administration of Prevnar vaccination when the subject was 4-months-old. On 5 January 2007 the subject received 3rd dose of Pediarix (0.5 ml, unknown). At an unspecified time after vaccination with Pediarix, on or after 5 January 2007, but before 15 February 2007, the subject experienced sterile abscess at injection site, swelling injection site and injection site redness. As a results of these events, the subject required medical attention at his doctor's office. It was reported that the subject had never had this response to previous Pediarix injections. At the time of reporting, the outcome of the events was unspecified. Follow-up was received on 12 March 2007 via the physician. The reporter stated that the subject received previous administrations of this immunization at the health department and he did not know if Pediarix was given or if separated components were given. The events occurred on 12 January 2007 and resolved on 19 February 2007. The Pediarix series was discontinued. The physician considered that the events were possibly related to the use of Pediarix.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Stevens-Johnson syndrome, Swelling
Clinical narrative: During the first few days at this hospital while waiting to find out my real diagnosis of Stevens-Johnson Syndrome, they gave me a pneumonia shot. My reaction was raised, red, itching and swelling on my upper left arm in a patch about 3-4 inches in diameter. It left a scar the same size. This may have been due to having the Stevens-Johnson starting or the fact that I already have an autoimmune disease called Lupus. I don't remember them treating it specifically, but just a day later I was transferred to a burn center as my whole body had to be treated.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Abnormal behaviour, Acoustic stimulation tests abnormal, Audiogram abnormal, Body temperature increased, Brain stem auditory evoked response abnormal
Clinical narrative: Child passed newborn hearing screen (OAE)--have record documentation. Previously well by report until 6 month well child visit. At that visit child received 4 immunizations, listed below. Of note, Hep B component of the Pediarix vaccine was 4th Heb B shot since child received one at birth as well. No prior adverse reaction. Parent reports temperature elevation to 103-104 range beginning 3 hours after shots and persisting for one week. Also reports "stiff neck" and what sounds like torticollis with head in position with right ear touching right shoulder. Parent reports placing repeated calls to doctor but receiving only reassurance. Child not admitted to hospital and no labs or tests performed. After one week, fever subsided and child began holding hands to ears and crying. This persisted for next 3-4 months after which child underwent ENT evaluation and hearing test. After tubes were placed for fluid in ears, child was found by audiology and brainstem audiometry to have severe to profound deafness. This has been repeated on a number of tests and patient is now being considered for a cochlear implant. Only a few cases of deafness after immunization have been reported in the literature. Possibility of encephalitis or meningitis exists but cannot be proven since child did not undergo lumbar puncture at the time.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Crying, Deafness, Encephalitis, Meningitis, Musculoskeletal stiffness
Clinical narrative: Child passed newborn hearing screen (OAE)--have record documentation. Previously well by report until 6 month well child visit. At that visit child received 4 immunizations, listed below. Of note, Hep B component of the Pediarix vaccine was 4th Heb B shot since child received one at birth as well. No prior adverse reaction. Parent reports temperature elevation to 103-104 range beginning 3 hours after shots and persisting for one week. Also reports "stiff neck" and what sounds like torticollis with head in position with right ear touching right shoulder. Parent reports placing repeated calls to doctor but receiving only reassurance. Child not admitted to hospital and no labs or tests performed. After one week, fever subsided and child began holding hands to ears and crying. This persisted for next 3-4 months after which child underwent ENT evaluation and hearing test. After tubes were placed for fluid in ears, child was found by audiology and brainstem audiometry to have severe to profound deafness. This has been repeated on a number of tests and patient is now being considered for a cochlear implant. Only a few cases of deafness after immunization have been reported in the literature. Possibility of encephalitis or meningitis exists but cannot be proven since child did not undergo lumbar puncture at the time.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Posture abnormal, Pyrexia, Torticollis
Clinical narrative: Child passed newborn hearing screen (OAE)--have record documentation. Previously well by report until 6 month well child visit. At that visit child received 4 immunizations, listed below. Of note, Hep B component of the Pediarix vaccine was 4th Heb B shot since child received one at birth as well. No prior adverse reaction. Parent reports temperature elevation to 103-104 range beginning 3 hours after shots and persisting for one week. Also reports "stiff neck" and what sounds like torticollis with head in position with right ear touching right shoulder. Parent reports placing repeated calls to doctor but receiving only reassurance. Child not admitted to hospital and no labs or tests performed. After one week, fever subsided and child began holding hands to ears and crying. This persisted for next 3-4 months after which child underwent ENT evaluation and hearing test. After tubes were placed for fluid in ears, child was found by audiology and brainstem audiometry to have severe to profound deafness. This has been repeated on a number of tests and patient is now being considered for a cochlear implant. Only a few cases of deafness after immunization have been reported in the literature. Possibility of encephalitis or meningitis exists but cannot be proven since child did not undergo lumbar puncture at the time.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Allergy to vaccine, Body temperature increased, Fatigue, Full blood count, Injection site discolouration
Clinical narrative: Information has been received from a physician concerning a 5 year old healthy male with a history of pyloric stenosis surgery, burn to chest from hot liquid as a toddler and no allergies who on 17-JUL-2007 at 16:30 PM was vaccinated SC with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 657535/0541U).  Concomitant therapy on the same day included a IM fourth dose of IPOL (Vero) (Lot # Y1068) and an IM fifth dose of INFANRIX (Lot # AC145B047AA).  There was no illness at the time of vaccination.  On 18-JUL-2007 at 6:00 AM the patient developed fever of 102 and significant redness and swelling at the injection site of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  The patient was very tired and lethargic.  The redness of the site became increasingly larger, more red and tender.  On 19-JUL-2007 it became yellow scabbing centrally.  The patient was seen in the clinic on 20-JUL-2007 as the rash had got worse.  The patient's fever had resolved.  Central area of redness was 5x3 cm, larger surrounding area was 16x12.5 cm.  A complete blood count test was undertaken.  The patient was treated with BENADRYL.  The physician had diagnosed the rash as allergy to the varicella part of the vaccine.  On 21-JUL-2007 the patient had recovered.  No further information is expected.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site scab, Injection site swelling, Lethargy
Clinical narrative: Information has been received from a physician concerning a 5 year old healthy male with a history of pyloric stenosis surgery, burn to chest from hot liquid as a toddler and no allergies who on 17-JUL-2007 at 16:30 PM was vaccinated SC with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 657535/0541U).  Concomitant therapy on the same day included a IM fourth dose of IPOL (Vero) (Lot # Y1068) and an IM fifth dose of INFANRIX (Lot # AC145B047AA).  There was no illness at the time of vaccination.  On 18-JUL-2007 at 6:00 AM the patient developed fever of 102 and significant redness and swelling at the injection site of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  The patient was very tired and lethargic.  The redness of the site became increasingly larger, more red and tender.  On 19-JUL-2007 it became yellow scabbing centrally.  The patient was seen in the clinic on 20-JUL-2007 as the rash had got worse.  The patient's fever had resolved.  Central area of redness was 5x3 cm, larger surrounding area was 16x12.5 cm.  A complete blood count test was undertaken.  The patient was treated with BENADRYL.  The physician had diagnosed the rash as allergy to the varicella part of the vaccine.  On 21-JUL-2007 the patient had recovered.  No further information is expected.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Pyrexia, White blood cell count normal
Clinical narrative: Information has been received from a physician concerning a 5 year old healthy male with a history of pyloric stenosis surgery, burn to chest from hot liquid as a toddler and no allergies who on 17-JUL-2007 at 16:30 PM was vaccinated SC with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 657535/0541U).  Concomitant therapy on the same day included a IM fourth dose of IPOL (Vero) (Lot # Y1068) and an IM fifth dose of INFANRIX (Lot # AC145B047AA).  There was no illness at the time of vaccination.  On 18-JUL-2007 at 6:00 AM the patient developed fever of 102 and significant redness and swelling at the injection site of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  The patient was very tired and lethargic.  The redness of the site became increasingly larger, more red and tender.  On 19-JUL-2007 it became yellow scabbing centrally.  The patient was seen in the clinic on 20-JUL-2007 as the rash had got worse.  The patient's fever had resolved.  Central area of redness was 5x3 cm, larger surrounding area was 16x12.5 cm.  A complete blood count test was undertaken.  The patient was treated with BENADRYL.  The physician had diagnosed the rash as allergy to the varicella part of the vaccine.  On 21-JUL-2007 the patient had recovered.  No further information is expected.
Age: 27.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: Wrong drug administered, Wrong technique in drug usage process
Clinical narrative: Information has been received from a registered nurse, for the pregnancy registry for PROQUAD concerning a 27 year old female who on 17-Aug-2007 was vaccinated with a dose of PROQUAD and MMRII instead of venipuncture for rubella varicella blood titers.  Pregnancy information for PROQUAD was not reported.  No adverse symptoms were reported.  Unspecified medical attention was sought.  There was no product quality complaint.  Follow up information has been received from a registered nurse concerning a 27 year old female who on 17-Aug-2007 was inadvertently vaccinated with a dose of MMRII and a dose of MMRII (not the previously reported dose of PROQUAD) instead of venipuncture for titers.  No adverse symptoms were reported.  This is one of several reports from the same source.  Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAPH, FLU3, MMRV, PNC, DTAP, FLU3, HIBV, MMRV, PNC
Symptoms: Familial risk factor, Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning six patients who were vaccinated with Varivax (Oka/Merck). Subsequently, the patients experienced breakthrough chickenpox. A product quality complaint was not involved. Follow-up received 20-SEP-2007: Follow-up information has been received from a registered nurse concerning a 21-month-old female with no pertinent medical history or allergies who on 20-JAN-2007 was vaccinated in her left thigh with her first dose of ProQuad (lot # 656165/1387F). It was unknown if there were any illnesses at the time of vaccination. On 20-JAN-2007 concomitant vaccines included fourth dose of TriHIBit (Sanofi Pasteur) (Lot # V1455AA & VE959AA), a fourth dose of Prevnar (Wyeth) (Lot # B08684A) and first 0.25 mg dose of influenza virus vaccine (unspecified) (Sanofi Pasteur) (Lot # UT2176JA). On 18AUG-2007 the patient developed numerous lesions on her face. The patient was prescribed with ZOVIRAX 200 mg-5 mL three times a day for 5 days. The patient recovered from the adverse event at an unspecified date. The event was considered to be an other important medical event by the reporter. It was noted that the patient's sibling (WAES # 0709USA03345) experienced an adverse event. This is one of several reports from the same source. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAPH, FLU3, MMRV, PNC, DTAP, FLU3, HIBV, MMRV, PNC
Symptoms: Skin lesion, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning six patients who were vaccinated with Varivax (Oka/Merck). Subsequently, the patients experienced breakthrough chickenpox. A product quality complaint was not involved. Follow-up received 20-SEP-2007: Follow-up information has been received from a registered nurse concerning a 21-month-old female with no pertinent medical history or allergies who on 20-JAN-2007 was vaccinated in her left thigh with her first dose of ProQuad (lot # 656165/1387F). It was unknown if there were any illnesses at the time of vaccination. On 20-JAN-2007 concomitant vaccines included fourth dose of TriHIBit (Sanofi Pasteur) (Lot # V1455AA & VE959AA), a fourth dose of Prevnar (Wyeth) (Lot # B08684A) and first 0.25 mg dose of influenza virus vaccine (unspecified) (Sanofi Pasteur) (Lot # UT2176JA). On 18AUG-2007 the patient developed numerous lesions on her face. The patient was prescribed with ZOVIRAX 200 mg-5 mL three times a day for 5 days. The patient recovered from the adverse event at an unspecified date. The event was considered to be an other important medical event by the reporter. It was noted that the patient's sibling (WAES # 0709USA03345) experienced an adverse event. This is one of several reports from the same source. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC, RV5, DTAP, FLU3, HIBV, PNC
Symptoms: Bacterial infection, Barium enema, Dehydration, Haematochezia, Hypoventilation
Clinical narrative: My 7 month old son began vomiting in the evening on Nov. 25th. He threw up a dark brownish substance all night. The morning of Nov. 26, I took him to his pediatrician, he was severely dehydrated and listless. He was hospitalized that afternoon. We were suspecting a viral stomach bug, but after 2 days in the hospital (being given fluids intravenously), he showed no signs of improvement, in fact his condition worsened. He continued to vomit, only holding a few teaspoons of water down over the course of the two days. The doctor and I began to suspect something more serious than a virus. At about 4 am Wednesday, the 28th, he passed a bloody-streaked mucus stool. This signaled to the doctor intussusception (Finally - a proper diagnosis). He was then transported to another hospital and the diagnosis was confirmed with an ultrasound. A previous x-ray had not shown anything. He was then given a barium enema (seven times) and it relieved the intussusception. When he came out of the procedure, he had a lot of bad bacteria released into his body, which sent him into a kind of shock, he turned grayish - mottled and was taking rapid shallow breaths. He was sent to the PICU until the next day. After he had stabilized was sent to a regular room and released on Thurs. the 29th. This all started 11 days after receiving his 3rd dose of the Rotavirus vaccine Rotateq. He received a dose at 2 months, 4 months and 6 months (it was after this he suffered from intussusception). If you have any questions - call me.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC, RV5, DTAP, FLU3, HIBV, PNC
Symptoms: Intensive care, Intussusception, Listless, Livedo reticularis, Mucous stools
Clinical narrative: My 7 month old son began vomiting in the evening on Nov. 25th. He threw up a dark brownish substance all night. The morning of Nov. 26, I took him to his pediatrician, he was severely dehydrated and listless. He was hospitalized that afternoon. We were suspecting a viral stomach bug, but after 2 days in the hospital (being given fluids intravenously), he showed no signs of improvement, in fact his condition worsened. He continued to vomit, only holding a few teaspoons of water down over the course of the two days. The doctor and I began to suspect something more serious than a virus. At about 4 am Wednesday, the 28th, he passed a bloody-streaked mucus stool. This signaled to the doctor intussusception (Finally - a proper diagnosis). He was then transported to another hospital and the diagnosis was confirmed with an ultrasound. A previous x-ray had not shown anything. He was then given a barium enema (seven times) and it relieved the intussusception. When he came out of the procedure, he had a lot of bad bacteria released into his body, which sent him into a kind of shock, he turned grayish - mottled and was taking rapid shallow breaths. He was sent to the PICU until the next day. After he had stabilized was sent to a regular room and released on Thurs. the 29th. This all started 11 days after receiving his 3rd dose of the Rotavirus vaccine Rotateq. He received a dose at 2 months, 4 months and 6 months (it was after this he suffered from intussusception). If you have any questions - call me.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC, RV5, DTAP, FLU3, HIBV, PNC
Symptoms: Pallor, Shock, Skin discolouration, Ultrasound scan abnormal, Vomiting
Clinical narrative: My 7 month old son began vomiting in the evening on Nov. 25th. He threw up a dark brownish substance all night. The morning of Nov. 26, I took him to his pediatrician, he was severely dehydrated and listless. He was hospitalized that afternoon. We were suspecting a viral stomach bug, but after 2 days in the hospital (being given fluids intravenously), he showed no signs of improvement, in fact his condition worsened. He continued to vomit, only holding a few teaspoons of water down over the course of the two days. The doctor and I began to suspect something more serious than a virus. At about 4 am Wednesday, the 28th, he passed a bloody-streaked mucus stool. This signaled to the doctor intussusception (Finally - a proper diagnosis). He was then transported to another hospital and the diagnosis was confirmed with an ultrasound. A previous x-ray had not shown anything. He was then given a barium enema (seven times) and it relieved the intussusception. When he came out of the procedure, he had a lot of bad bacteria released into his body, which sent him into a kind of shock, he turned grayish - mottled and was taking rapid shallow breaths. He was sent to the PICU until the next day. After he had stabilized was sent to a regular room and released on Thurs. the 29th. This all started 11 days after receiving his 3rd dose of the Rotavirus vaccine Rotateq. He received a dose at 2 months, 4 months and 6 months (it was after this he suffered from intussusception). If you have any questions - call me.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC, RV5, DTAP, FLU3, HIBV, PNC
Symptoms: X-ray
Clinical narrative: My 7 month old son began vomiting in the evening on Nov. 25th. He threw up a dark brownish substance all night. The morning of Nov. 26, I took him to his pediatrician, he was severely dehydrated and listless. He was hospitalized that afternoon. We were suspecting a viral stomach bug, but after 2 days in the hospital (being given fluids intravenously), he showed no signs of improvement, in fact his condition worsened. He continued to vomit, only holding a few teaspoons of water down over the course of the two days. The doctor and I began to suspect something more serious than a virus. At about 4 am Wednesday, the 28th, he passed a bloody-streaked mucus stool. This signaled to the doctor intussusception (Finally - a proper diagnosis). He was then transported to another hospital and the diagnosis was confirmed with an ultrasound. A previous x-ray had not shown anything. He was then given a barium enema (seven times) and it relieved the intussusception. When he came out of the procedure, he had a lot of bad bacteria released into his body, which sent him into a kind of shock, he turned grayish - mottled and was taking rapid shallow breaths. He was sent to the PICU until the next day. After he had stabilized was sent to a regular room and released on Thurs. the 29th. This all started 11 days after receiving his 3rd dose of the Rotavirus vaccine Rotateq. He received a dose at 2 months, 4 months and 6 months (it was after this he suffered from intussusception). If you have any questions - call me.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC, RV5, DTAP, FLU3, HIBV, PNC
Symptoms: Barium enema, Blood culture, Blood test, Crying, Culture stool
Clinical narrative: My 7 month old son began vomiting in the evening on Nov. 25th. He threw up a dark brownish substance all night. The morning of Nov. 26, I took him to his pediatrician, he was severely dehydrated and listless. He was hospitalized that afternoon. We were suspecting a viral stomach bug, but after 2 days in the hospital (being given fluids intravenously), he showed no signs of improvement, in fact his condition worsened. He continued to vomit, only holding a few teaspoons of water down over the course of the two days. The doctor and I began to suspect something more serious than a virus. At about 4 am Wednesday, the 28th, he passed a bloody-streaked mucus stool. This signaled to the doctor intussusception (Finally - a proper diagnosis). He was then transported to another hospital and the diagnosis was confirmed with an ultrasound. A previous x-ray had not shown anything. He was then given a barium enema (seven times) and it relieved the intussusception. When he came out of the procedure, he had a lot of bad bacteria released into his body, which sent him into a kind of shock, he turned grayish - mottled and was taking rapid shallow breaths. He was sent to the PICU until the next day. After he had stabilized was sent to a regular room and released on Thurs. the 29th. This all started 11 days after receiving his 3rd dose of the Rotavirus vaccine Rotateq. He received a dose at 2 months, 4 months and 6 months (it was after this he suffered from intussusception). If you have any questions - call me.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC, RV5, DTAP, FLU3, HIBV, PNC
Symptoms: Culture urine, Dehydration, Diet refusal, Haematemesis, Haematochezia
Clinical narrative: My 7 month old son began vomiting in the evening on Nov. 25th. He threw up a dark brownish substance all night. The morning of Nov. 26, I took him to his pediatrician, he was severely dehydrated and listless. He was hospitalized that afternoon. We were suspecting a viral stomach bug, but after 2 days in the hospital (being given fluids intravenously), he showed no signs of improvement, in fact his condition worsened. He continued to vomit, only holding a few teaspoons of water down over the course of the two days. The doctor and I began to suspect something more serious than a virus. At about 4 am Wednesday, the 28th, he passed a bloody-streaked mucus stool. This signaled to the doctor intussusception (Finally - a proper diagnosis). He was then transported to another hospital and the diagnosis was confirmed with an ultrasound. A previous x-ray had not shown anything. He was then given a barium enema (seven times) and it relieved the intussusception. When he came out of the procedure, he had a lot of bad bacteria released into his body, which sent him into a kind of shock, he turned grayish - mottled and was taking rapid shallow breaths. He was sent to the PICU until the next day. After he had stabilized was sent to a regular room and released on Thurs. the 29th. This all started 11 days after receiving his 3rd dose of the Rotavirus vaccine Rotateq. He received a dose at 2 months, 4 months and 6 months (it was after this he suffered from intussusception). If you have any questions - call me.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC, RV5, DTAP, FLU3, HIBV, PNC
Symptoms: Intensive care, Intussusception, Irritability, Livedo reticularis, Mucous stools
Clinical narrative: My 7 month old son began vomiting in the evening on Nov. 25th. He threw up a dark brownish substance all night. The morning of Nov. 26, I took him to his pediatrician, he was severely dehydrated and listless. He was hospitalized that afternoon. We were suspecting a viral stomach bug, but after 2 days in the hospital (being given fluids intravenously), he showed no signs of improvement, in fact his condition worsened. He continued to vomit, only holding a few teaspoons of water down over the course of the two days. The doctor and I began to suspect something more serious than a virus. At about 4 am Wednesday, the 28th, he passed a bloody-streaked mucus stool. This signaled to the doctor intussusception (Finally - a proper diagnosis). He was then transported to another hospital and the diagnosis was confirmed with an ultrasound. A previous x-ray had not shown anything. He was then given a barium enema (seven times) and it relieved the intussusception. When he came out of the procedure, he had a lot of bad bacteria released into his body, which sent him into a kind of shock, he turned grayish - mottled and was taking rapid shallow breaths. He was sent to the PICU until the next day. After he had stabilized was sent to a regular room and released on Thurs. the 29th. This all started 11 days after receiving his 3rd dose of the Rotavirus vaccine Rotateq. He received a dose at 2 months, 4 months and 6 months (it was after this he suffered from intussusception). If you have any questions - call me.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC, RV5, DTAP, FLU3, HIBV, PNC
Symptoms: Pyrexia, Respiratory rate increased, Ultrasound scan, Vomiting, X-ray
Clinical narrative: My 7 month old son began vomiting in the evening on Nov. 25th. He threw up a dark brownish substance all night. The morning of Nov. 26, I took him to his pediatrician, he was severely dehydrated and listless. He was hospitalized that afternoon. We were suspecting a viral stomach bug, but after 2 days in the hospital (being given fluids intravenously), he showed no signs of improvement, in fact his condition worsened. He continued to vomit, only holding a few teaspoons of water down over the course of the two days. The doctor and I began to suspect something more serious than a virus. At about 4 am Wednesday, the 28th, he passed a bloody-streaked mucus stool. This signaled to the doctor intussusception (Finally - a proper diagnosis). He was then transported to another hospital and the diagnosis was confirmed with an ultrasound. A previous x-ray had not shown anything. He was then given a barium enema (seven times) and it relieved the intussusception. When he came out of the procedure, he had a lot of bad bacteria released into his body, which sent him into a kind of shock, he turned grayish - mottled and was taking rapid shallow breaths. He was sent to the PICU until the next day. After he had stabilized was sent to a regular room and released on Thurs. the 29th. This all started 11 days after receiving his 3rd dose of the Rotavirus vaccine Rotateq. He received a dose at 2 months, 4 months and 6 months (it was after this he suffered from intussusception). If you have any questions - call me.
Age: 1.5
Sex: F
Vaccine: HIBV
Symptoms: Cardiac arrest, Death, Multi-organ failure
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 month old female with mental retardation, pulmonary hypertension, ventricular septal defect, congestive heart failure, patent ductus arteriosus and no known allergies who on 02-OCT-2007 was vaccinated intramuscularly in the right arm with the 1st 0.5ml dose of PEDVAXHIB (lot#656521/0436U). The nurse practitioner was calling from a long term care facility for mental retardation. The reporter stated that the patient was on numerous medications but did not specify them. On 08-OCT-2007, the patient went into cardiac arrest and was rushed to a local hospital 10 miles away. On the same day the child was transported via helicopter to another hospital. on 13-OCT-2007 at 7:30 pm, the patient died at the hospital. The cause of death was cardiac arrest and multiple symptom organ failure. Cardiac arrest and multiple symptom organ failure were considered to be immediately life-threatening, disabling, other important medical events and congenital anomalies by the nurse practitioner. Additional information has been requested.  1/11/08 Reviewed hospital medical records from initial hospital which reveals patient arrived in cardiac arrest w/cpr in progress on 10/8/2007.  Reportedly playing in state school home when suddenly became unresponsive & apneic/pulseless.  Resuscitated & transferred to higher level of care. FINAL ER Dx: cardio-pulmonary arrest. 1/11/08 Reviewed hospital medical records from transfer hospital which reveal patient admitted to PICU on pressors, antibiotics & ventilator.  Developed multi-system organ failure includeing renal failure, liver failure, cardiac failure, respiratory failure & refractory shock.  Admitted 10/9-10/13/2007 when expired.  5/15/09 Death certificate states COD as brain death; hypoxic ischemic injury; multiple congenital anomalies.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: Zostavax vaccine was given IM instead of SQ.  Pt did not report any adverse effects.
Age: 56.0
Sex: M
Vaccine: FLU3, HEP, TDAP
Symptoms: Arthralgia, Injection site pain, Lymph node pain
Clinical narrative: Constant consistent noticeable pain in upper left arm where all three shots were given.  Some joint pain/finger joint pain in left arm and hand, lymph node pain below ears; under arms.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Fall, Head injury, Lethargy, Pallor
Clinical narrative: About 3-5 mins. after DTaP, IVP, MMR & Varivax given, child became pale & fell & hit head on floor.  No LOC but was acting lethargic.  Given Epipen Jr & Decadron 4 mg within 1-2 mins after meds given.  Child more alert, active, color returned.  Monitored about 30 mins in office.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Convulsion, Electrocardiogram, Incontinence, Loss of consciousness
Clinical narrative: On Friday, November 16, 2007 our 25 year old daughter received a Gardasil vaccine from our family medical practice. At 3:00 a.m. on Saturday, November 17, 2007 she awoke came to our bedroom saying she wasn't feeling well. She fainted in the doorway, and became rigid. When she came to, my husband and I carried her to her bed where she lost consciousness, became rigid again and lost continence. We called 911. The EMT's arrived, checked her vital signs and recommended that we contact our physician the next day. We took her to the doctor's office and they told us to take her to the emergency room for further tests which we did that day. The physicians suggested that due to the incontinence and rigidity/lost of consciousness she had suffered a seizure.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Muscle rigidity, Nuclear magnetic resonance imaging, Syncope, Urine analysis
Clinical narrative: On Friday, November 16, 2007 our 25 year old daughter received a Gardasil vaccine from our family medical practice. At 3:00 a.m. on Saturday, November 17, 2007 she awoke came to our bedroom saying she wasn't feeling well. She fainted in the doorway, and became rigid. When she came to, my husband and I carried her to her bed where she lost consciousness, became rigid again and lost continence. We called 911. The EMT's arrived, checked her vital signs and recommended that we contact our physician the next day. We took her to the doctor's office and they told us to take her to the emergency room for further tests which we did that day. The physicians suggested that due to the incontinence and rigidity/lost of consciousness she had suffered a seizure.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: 12-28-07 complained of pain in deltoid since receiving flu vaccine 11-20-07.  No edema, erythema, tenderness with palpation.  Pain with movement.  Referred to private physician.
Age: 7.0
Sex: M
Vaccine: MMR, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Swelling
Clinical narrative: Benadryl q 4 hr x 48 hr. Swelling, redness, painful to Rt bicep measurements 5" long 3" wide 7" circ. Reaction to PPV23.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Patient c/o: "pain & redness & edema to elbow from shoulder, ? cellulitis".
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthma, Condition aggravated, Liver function test abnormal, Pyrexia, Thrombocytopenia
Clinical narrative: Thrombocytopenia, Abn LFT's, fever. Varicella rash, increased asthma symptoms.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Thrombocytopenia, Abn LFT's, fever. Varicella rash, increased asthma symptoms.
Age: 20.0
Sex: M
Vaccine: ANTH, HEPA
Symptoms: Arthralgia, Headache, Pruritus, Rash
Clinical narrative: Rash, itching, pain at joints, headaches.  The symptoms last about 3 days and occurs weekly.
Age: 27.0
Sex: M
Vaccine: ANTH, PPV, SMALL
Symptoms: Acne, Bipolar disorder, Depression, Gastric disorder, Headache
Clinical narrative: Headaches, nervous condition, high blood pressure, sleep apnea, running nose, stomach condition, bipolar condition, depression, skin acne.
Age: 27.0
Sex: M
Vaccine: ANTH, PPV, SMALL
Symptoms: Hypertension, Nervousness, Rhinorrhoea, Sleep apnoea syndrome
Clinical narrative: Headaches, nervous condition, high blood pressure, sleep apnea, running nose, stomach condition, bipolar condition, depression, skin acne.
Sex: U
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: We stock the pediatric hepatitis B vaccine (Engerix B) 10 mcg dose/syringe from GlaxoSmithKline.  We used to receive the individual syringes labeled as "For Pediatric and Adolescents Only".  Now, the manufacturer has changed the labeling such that this comment is no longer printed on each syringe.  It is, however, still printed on the outer box.  More often than not, the box (with "For Pediatric and Adolescents") may be discarded and we have no way of knowing what it is except for the color and the dose on the syringe.  Adult dose syringes are also with the same problem of no comment as "adult only" printed on the label of the syringe.  This is clearly an area of labeling to be improved on, as the adult syringe can be very easily mistaken with the adult syringe (same size syringe, just different dose and strength) and vice versa.