chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Aneurysm, Echocardiogram abnormal, Immunoglobulins, Kawasaki's disease, Pyrexia
Clinical narrative: Fever with rash, conjunctivitis x 10 days. ECHO - multiple aneurysms. Kawasaki disease - Rx with IVIG. 9/27/07-vac records received-lot numbers not included for DOS 7/20/07-only data available from provider is for date of service 9/25/2007. Will contact provider to obtain information related to vaccines administered on 7/20/07. 10/30/07-records received for DOS 8/31-9/4/07-DC DX: Kawasaki disease. Presented with fever on 8/21/07-subsequent visit to ER presented with fever rash, continued to spike fever. Blood and urine culture negative. Transferred on 8/31/07-listless, lethargic, crying. Sclerae red. Lips red and cracked macuopapular rash. Per 60 follow up: Child is being followed up for coronary artery dilatation with cardiologist.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Rash
Clinical narrative: Fever with rash, conjunctivitis x 10 days. ECHO - multiple aneurysms. Kawasaki disease - Rx with IVIG. 9/27/07-vac records received-lot numbers not included for DOS 7/20/07-only data available from provider is for date of service 9/25/2007. Will contact provider to obtain information related to vaccines administered on 7/20/07. 10/30/07-records received for DOS 8/31-9/4/07-DC DX: Kawasaki disease. Presented with fever on 8/21/07-subsequent visit to ER presented with fever rash, continued to spike fever. Blood and urine culture negative. Transferred on 8/31/07-listless, lethargic, crying. Sclerae red. Lips red and cracked macuopapular rash. Per 60 follow up: Child is being followed up for coronary artery dilatation with cardiologist.
Age: 24.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Bruxism, Crying, Petit mal epilepsy
Clinical narrative: Post HPV (1st dose), Menactra (2nd dose), HEP A (2nd dose) Petite mal seizure occurred-clenched teeth no fists x 30 seconds-post sobbing, no vomiting or defraction following impact.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: macular papular erythematous rash on trunk and back
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: In school day after vaccine and developed a fever 105.2 at 1430 pm. Temp x 2 at 1445 pm 104.9 (?how taken) mom picked up -to ER at 3:00 pm. T 102.2 (po). Discharged w/instructions.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Headache
Clinical narrative: Reportedly woke up in the night with headache. Went to school in the morning-school nurse took temp of >101 "almost 102" per mother. No other allergic type symptoms, no nausea or vomiting. Taking Tylenol for headache and fever
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever 103.2 (R) the night after vaccines given.
Age: 68.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Wrong drug administered
Clinical narrative: Patient had redness and swelling at injection site. Area was about 4 inches by about 2 1/2 inches. Right arm
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: C-reactive protein increased, Injection site cellulitis, Injection site swelling, Malaise, Presyncope
Clinical narrative: (L) arm at injection site (+) swelling and cellulitis Pt had near syncope, feverish and generalised malaise
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: (L) arm at injection site (+) swelling and cellulitis Pt had near syncope, feverish and generalised malaise
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Drug hypersensitivity, Dyspnoea, Lymphadenopathy
Clinical narrative: Patient returned to ER for possible allergic reaction and "trouble breathing" swollen glands. Per ER pt given epinephrine x one, Solumedrol and Pepcid. Discharged on Decadron/clindamycin and Benadryl Also dx w/possible throat infection
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: see ER note of 8/25/07 and office note of 9/18/07.  9/27/07 Case closed as complete w/medical records which accompanied report.  ER note of 8/25/07 reveals patient experienced headache, fever, vomiting & generally feeling unwell since received 2nd HPV vax on 8/21.  Developed left side ear ache & facial weakness 8/24 w/difficulty smiling & closing left eye.  Tx w/prednisone & antiviral meds.  D/C to home.  PCP office visit 9/19/07 reveals patient had continued mild left facial droop otherwise improved.  Warts had improved on antiviral & that med was continued. FINAL DX: Bell's palsy; viral syndrome.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Culture, Erythema, Polymerase chain reaction, Rash vesicular
Clinical narrative: Pt had red bumps on torso, groin area and arms-discreet vesicular lesions with erythemic base
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Bradycardia, Dizziness, Mental status changes
Clinical narrative: dizziness, bradycardia, change of mental status no loss of consciousness, no anaphylactic vasovagal O2 given and IVF referred to ER recovered successfully.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: Approximately the end of August pt had severe Herpes Simplex outbreak on mouth/face/nose was given Zostavax on 6/27/2007. Pt given Valtrex reported to pharmacy on 9/10/2007 pt had been in sun on a long walk
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Urticaria, Varicella
Clinical narrative: Tdap-local urticarial lesion 3 cm Varicella-local urticarial-9 1/2 cm lesion
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Malaise
Clinical narrative: Pt complains of malaise and light-headedness, also stated children are ill.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Blood glucose, Hyperhidrosis, Hypoaesthesia, Pain in extremity, Pallor
Clinical narrative: Pt was sitting up on exam table. Was given immun. x 2. Started c/o arm pain with numbness in (R) arm. Pale with diaphoresis. Pt was layed down with cool compress forehead. Pt was monitored and sent home with mom
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Rash erythematous, Tenderness
Clinical narrative: Varivax vaccine given to (L) arm SQ rash (L) arm confluent, red, tender to touch 8 cm diameter. No drainage noted
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Diarrhoea
Clinical narrative: Immunizations on 9/18/07 Diarrhea started 9/22/07. Continued next day. Went to on call-9/23/07 doctor over weekend. Lost 2oz-14.4 started. Pedialyte. Follow up 9/24/07-no vomit diarrhea continues
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Urticaria
Clinical narrative: Hives all over body-Recommended Benadryl.
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Received Hep B (2 shot) around 2 pm. At 5 pm began experiencing pains in shoulder and neck worsened over next 20 hrs.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash macular
Clinical narrative: noted to have red dots on 9/23/ or 9/24/07 per mom. (-) h/o fever (+) h/o new sun burn. Exam 9/25/07 revealed macules on arms/legs. Now on trunk
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Pruritus, Skin warm, Vaccination complication
Clinical narrative: Reaction to Varicella redness (cellulitis) warm to touch itchy
Age: 43.0
Sex: F
Vaccine: ANTH, HEP, SMALL
Symptoms: Arthralgia, Computerised tomogram, Lymphadenopathy, Myalgia, Tenderness
Clinical narrative: Muscle aches and joint aches (elbows, wrist, knees, fingers and jaw). Swelling and tenderness of lymph nodes especally underarm and neck.
Age: 43.0
Sex: F
Vaccine: ANTH, HEP, SMALL
Symptoms: X-ray
Clinical narrative: Muscle aches and joint aches (elbows, wrist, knees, fingers and jaw). Swelling and tenderness of lymph nodes especally underarm and neck.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Injection site induration, Local swelling
Clinical narrative: Localized swelling, redness, induration at site of DTAP shot on LL
Sex: U
Vaccine: HEPA, HIBV, MMR, PPV
Symptoms: Pyrexia, Rash
Clinical narrative: Had high fever 102.8 for 3 days (7 days after the vaccination) Began body rash 9 days after vaccination and still has the rash.  Took to ER and they gave him a steriod to help with rash but did not.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Approx. 2 weeks after administration of Zostavax client broke out with shingles which was diagnosed by her primary care provider. Shingles breakout was on L side under arm area. No visible vessicles but is very painful. Made visits to ER x 2 for pain. Pain continues to this date but is starting to lessen in severity.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot and cold, Injection site pruritus, Injection site rash
Clinical narrative: Presented with c/o rash, itch, at sight of vaccination L triceps area.  States feeling hot/cold, yesterday.  Onset noticed about 11pm, 9/25, reaction larger when seen at clinic 2:30pm, 9/26. raised erythematous area L triceps, 50X60 mm. No pox noted, no body rash. T-98.5, no respiratory symptoms. Top hydrocortisone 1% applied.  Suggest oral benadryl 25mg, or try tylenol or advil to help decrease symptoms. Call if increase in symptoms, return to clinic 9/28 to recheck
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site infection, Injection site scab, Injection site swelling
Clinical narrative: Patient was given Dtap,Ipv and MMR in his right arm. The Dtap was given first IM in his upper deltoid and the Ipv was given 1 inch below that and the MMR was given sub q in the back fatty part of his right arm. The shots were given on Monday September 17, 2007 and his arm started getting red and swollen on Wednesday and his right arm where the Dtap was given was crusted over with what looked like two open chicken pox bumps that had pus in them and looked like they were infected.
Age: 14.0
Sex: M
Vaccine: HEP, HEPA, IPV, TDAP
Symptoms: Dizziness, Somnolence
Clinical narrative: Complained of dizziness and drowsiness after shots.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient received Hep B vaccine for employee health and developed severe itching and hives on torso region and upper extremities.
Age: 31.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Asthenia, Blood count, Chills, Dyspnoea, Headache
Clinical narrative: Severe Chills and Body aches. Fever. Headache. Nausea. Overall weakness. Difficulty breathing.
Age: 31.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Inappropriate schedule of drug administration, Nausea, Pain, Pyrexia
Clinical narrative: Severe Chills and Body aches. Fever. Headache. Nausea. Overall weakness. Difficulty breathing.
Age: 36.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Asthenia, Chills, Dyspnoea, Headache, Nausea
Clinical narrative: Severe Chills and Body aches. Fever. Headache. Nausea. Overall weakness. Difficulty breathing.
Age: 36.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Pain, Pyrexia
Clinical narrative: Severe Chills and Body aches. Fever. Headache. Nausea. Overall weakness. Difficulty breathing.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Both ear lobes developed varicella-like rash approximately five days after second varicella vaccination administered.  Varicella symptoms lasted for five days. Photographs available for attachment.
Age: 6.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Inflammation, Pain
Clinical narrative: Day after vaccines patient's mom complained that child had right arm pain, inflamation, and redness.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Condition aggravated, Eczema, Injection site vesicles, Pyrexia
Clinical narrative: Baby presented to health department 9/19/07 with multiple blisters on uper half of r thigh. Taken to pediatrician and told that local reactio to shot due to severe eczema.  Fever 100.1. No sob. Baby is active and playful. Mom was given 1% hydrolcortison to apply to eczema-not blistered area BID.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Skin warm
Clinical narrative: erythema to upper arm from shoulder to elbow, warm to touch, nontender, afebrile.
Age: 1.05
Sex: F
Vaccine: HIBV, MMRV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Pt arrived at provider office 7 dy after receiving MMRV vaccine.  Pt. arrives with fever 104.8 (rectal) and procedes to have seizure event in provider office.  911 was activated. Pt taken to hospital and will be observed over night.  10/11/2007 MR received for ER visit 9/26/2007 for DX:  Febrile Seizure.  Febrile Illness.  pt had had decreased oral intake x 2 days with several vomiting episodes.  PE (+) for abdominal distention.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Anorexia, Dizziness, Nausea, Pain, Pyrexia
Clinical narrative: after 18 hours: experiencing high fever, pain, dizzy, nausea, vomitting, lose appetite.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: after 18 hours: experiencing high fever, pain, dizzy, nausea, vomitting, lose appetite.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Malaise
Clinical narrative: Subjective fevers, chills, arthralgias, malaise, headaches and flu like sx's for 3 weeks.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: Subjective fevers, chills, arthralgias, malaise, headaches and flu like sx's for 3 weeks.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Faeces discoloured, Full blood count normal, Haematochezia, Occult blood positive, Physical examination normal
Clinical narrative: 7 days after vaccinations,4 month old passed 3 dark, bloody stools in diaper. No other symptoms presented. Doc examined and decided to admit patient into Hospital for tests and observation. Stool Hemoccult poss. CBC normal, examined by Ped G.I. Meckels scan negative and unnecessary! No conclussion/diagnosis. Possible milk protein allergy per Dr., infectious disease Doc., but rare in breastfeed infant. 3 day hospital stay and expense, invaisive and unnecessary tests. 10/27/07-records received for DOS 8/28-8/30/07-DC DX: Allergic Colitis. Cow's milk progein allergy in breastfed infant. Presented to hospital after passing dark maroon colored stool, no bright red blood noted. Stool heme positive. Two subsequent maroon colored stools while hospitalized otherwise completely asymptomatic. Had been strictly breastfed until day before admission when he had his first meal of rice cereal mixed with breast milk. Mom's diet had larger serving of dairly the day prior to admission.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: L arm redness and swelling 2x1.5.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Asthenia, Dizziness, Erythema, Hypoaesthesia, Pain
Clinical narrative: Right away: Swelling, redness, numbness of side the vaccine was administered on. Within a few hours: severe pain, weakness, extremely high fever. Next day: high fever, dizziness, patient fainted and had to be taken to the emergency room. Fever persisted several days, patient made full recovery.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Pyrexia, Swelling, Syncope
Clinical narrative: Right away: Swelling, redness, numbness of side the vaccine was administered on. Within a few hours: severe pain, weakness, extremely high fever. Next day: high fever, dizziness, patient fainted and had to be taken to the emergency room. Fever persisted several days, patient made full recovery.
Age: 68.0
Sex: F
Vaccine: PPV, TD
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: (L) arm swelling 1st & with increasing redness over 3 days Treated with antibiotics for possible cellulitis 9/21/07
Age: 29.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Pyrexia, Rash vesicular, Swelling
Clinical narrative: Patient called me reporting that on 9/10/07 he developed "boils"-fluid filled on his abdomen, elbow, buttocks (6 total), a fever, and achey joints. (L) knee became swollen on 9/12/07. He plans to be seen in the ER today.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pruritic
Clinical narrative: itchy rash legs and arms, torso, scalp, cheeks, groin x 1 wk
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria
Clinical narrative: Received Pneumovax 9/17/07 Developed urticaria on arm near and surrounding injection on 9/19.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash pruritic
Clinical narrative: Information has been received from an 84 year old male with no known allergies, type II diabetes mellitus and skin cancer of the nose who on 18-MAY-2007 at 10:02 AM was vaccinated SC in the left arm with a 0.65 mL first dose of Zostavax (Oka/Merck) (lot # 657559/0462U).  Concomitant therapy included baby aspirin daily, ACCUPRIL and PRANDIN. On 25-MAY-2007, the patient developed a shingles rash.  The rash spread across the lower back is was very itchy and uncomfortable.  Unspecified medical attention was sought and no diagnostic laboratory tests were performed.  At the time of the report, the patient was recovering.  A product quality complaint was not involved.  Additional information was received from a registered nurse who reported that on 28-MAY-2007 (previously reported as 25-MAY-2007), the patient noticed that he had an outbreak on the lower right side of his back.  The patient presented to his primary care physician on 01-JUN-2007 and was diagnosed with shingles and treated with VALTREX.  Additionally, the patient has skin cancer of the nose and was told to cancel his surgery date that was scheduled for the week of 04-JUN-2007.  At the time of the report, the patient had not recovered (previously reported as recovering).  Additional information was received from the registered nurse who reported that the patient called the office on 01-JUN-2007 to report that he developed a rash on the right lower back on 28-MAY-2007.  He reported that the rash was itchy but was not painful.  He saw a physician and was given VALTREX on 01-JUN-2007.  It was unknown if the patient recovered.  Additional information is not expected.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: Information has been received from an 84 year old male with no known allergies, type II diabetes mellitus and skin cancer of the nose who on 18-MAY-2007 at 10:02 AM was vaccinated SC in the left arm with a 0.65 mL first dose of Zostavax (Oka/Merck) (lot # 657559/0462U).  Concomitant therapy included baby aspirin daily, ACCUPRIL and PRANDIN. On 25-MAY-2007, the patient developed a shingles rash.  The rash spread across the lower back is was very itchy and uncomfortable.  Unspecified medical attention was sought and no diagnostic laboratory tests were performed.  At the time of the report, the patient was recovering.  A product quality complaint was not involved.  Additional information was received from a registered nurse who reported that on 28-MAY-2007 (previously reported as 25-MAY-2007), the patient noticed that he had an outbreak on the lower right side of his back.  The patient presented to his primary care physician on 01-JUN-2007 and was diagnosed with shingles and treated with VALTREX.  Additionally, the patient has skin cancer of the nose and was told to cancel his surgery date that was scheduled for the week of 04-JUN-2007.  At the time of the report, the patient had not recovered (previously reported as recovering).  Additional information was received from the registered nurse who reported that the patient called the office on 01-JUN-2007 to report that he developed a rash on the right lower back on 28-MAY-2007.  He reported that the rash was itchy but was not painful.  He saw a physician and was given VALTREX on 01-JUN-2007.  It was unknown if the patient recovered.  Additional information is not expected.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Pruritus, Rash
Clinical narrative: Information has been received from an 84 year old male with no known allergies, type II diabetes mellitus and skin cancer of the nose who on 18-MAY-2007 at 10:02 AM was vaccinated SC in the left arm with a 0.65 mL first dose of Zostavax (Oka/Merck) (lot # 657559/0462U).  Concomitant therapy included baby aspirin daily, ACCUPRIL and PRANDIN. On 25-MAY-2007, the patient developed a shingles rash.  The rash spread across the lower back is was very itchy and uncomfortable.  Unspecified medical attention was sought and no diagnostic laboratory tests were performed.  At the time of the report, the patient was recovering.  A product quality complaint was not involved.  Additional information was received from a registered nurse who reported that on 28-MAY-2007 (previously reported as 25-MAY-2007), the patient noticed that he had an outbreak on the lower right side of his back.  The patient presented to his primary care physician on 01-JUN-2007 and was diagnosed with shingles and treated with VALTREX.  Additionally, the patient has skin cancer of the nose and was told to cancel his surgery date that was scheduled for the week of 04-JUN-2007.  At the time of the report, the patient had not recovered (previously reported as recovering).  Additional information was received from the registered nurse who reported that the patient called the office on 01-JUN-2007 to report that he developed a rash on the right lower back on 28-MAY-2007.  He reported that the rash was itchy but was not painful.  He saw a physician and was given VALTREX on 01-JUN-2007.  It was unknown if the patient recovered.  Additional information is not expected.
Age: 76.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Aphthous stomatitis, Blister, Herpes zoster, Laboratory test, Lip pain
Clinical narrative: Information has been received from a registered nurse concerning a 76 year old female who on 30-MAY-2007 was vaccinated with Zostavax (Oka/Merck). On 31-MAY-2007 the patient developed sores on her mouth and chin and two days later a C-shaped rash from her cheek to her chin that was diagnosed as shingles at an urgent care center. On 04-JUN-2007 the patient also went to her primary care physician who also diagnosed her with shingles. The primary care physician drew blood to test her immune system and everything came back normal. The patient's shingles persisted as of 08-JUN-2007. Additional information has been requested.
Age: 76.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Immunology test normal, Laboratory test, Rash, Stomatitis
Clinical narrative: Information has been received from a registered nurse concerning a 76 year old female who on 30-MAY-2007 was vaccinated with Zostavax (Oka/Merck). On 31-MAY-2007 the patient developed sores on her mouth and chin and two days later a C-shaped rash from her cheek to her chin that was diagnosed as shingles at an urgent care center. On 04-JUN-2007 the patient also went to her primary care physician who also diagnosed her with shingles. The primary care physician drew blood to test her immune system and everything came back normal. The patient's shingles persisted as of 08-JUN-2007. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of drug administration, Off label use, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a 15 month old male patient who on 01-MAY-2007 was vaccinated with 0.65 ml dose of Zostavax (Oka/Merck) (Lot # 656861/0329U) instead of a dose of Varivax (MSD).  A product quality complaint was not involved.  Additional information has been received from the certified medical assistant who stated that she was to give Varivax (MSD) but instead took Zostavax (MSD).  No further information is expected.  This is one of several reports received from the same source.  It was also reported that the patient's sibling had a similar experience. (WAES # 0705USA00605)
Age: 1.3
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a 15 month old male patient who on 01-MAY-2007 was vaccinated with 0.65 ml dose of Zostavax (Oka/Merck) (Lot # 656861/0329U) instead of a dose of Varivax (MSD).  A product quality complaint was not involved.  Additional information has been received from the certified medical assistant who stated that she was to give Varivax (MSD) but instead took Zostavax (MSD).  No further information is expected.  This is one of several reports received from the same source.  It was also reported that the patient's sibling had a similar experience. (WAES # 0705USA00605)
Age: 3.0
Sex: U
Vaccine: DTAP, HEPA, HIBV, IPV, PNC, VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning two patient who on 03-JUL-2007 were vaccinated with Zostavax (Oka/Merck) instead of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (MSD).  The incident was a mistake and was not due to product confusion.  The patients did not experienced any kind of symptoms.  Additional information has been requested. Follow-up information has been received from a registered nurse concerning a 35 month old patient with no illness at the time of vaccination and no pre-existing physician diagnosed allergies, birth defects, or medical conditions, who on 03-JUL-2007 at 9:00 AM was vaccinated with a first dose of ZOSTAVAX (656859/0357U), SC in the right arm. Other vaccinations received the same day included a thrid dose of INFANRIX (AC14B046A), IM in the left leg, a third dose of PEDVAX HIB (653596/0281F), IM in the left arm, a third dose of PREVNAR (B08670H) and a first dose of HAVRIX (AHAVB148AA), IM in the left leg. It was reported that the patient was inadvertently given ZOSTAVAX (656859/0357U) instead of MMRV. On 10-JUL-2007, it was reported that a phone call was made to the patient's mother and she stated that "the kids were doing fine now". It was reported that the patient's mother was to make arrangements for varicella IgG antobody titer testing. The patient's sibling also had an experience on ZOSTAVAX.  No further information is available.
Age: 3.0
Sex: U
Vaccine: DTAP, HEPA, HIBV, IPV, PNC, VARZOS, VARZOS
Symptoms: Accidental exposure, No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning two patient who on 03-JUL-2007 were vaccinated with Zostavax (Oka/Merck) instead of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (MSD).  The incident was a mistake and was not due to product confusion.  The patients did not experienced any kind of symptoms.  Additional information has been requested. Follow-up information has been received from a registered nurse concerning a 35 month old patient with no illness at the time of vaccination and no pre-existing physician diagnosed allergies, birth defects, or medical conditions, who on 03-JUL-2007 at 9:00 AM was vaccinated with a first dose of ZOSTAVAX (656859/0357U), SC in the right arm. Other vaccinations received the same day included a thrid dose of INFANRIX (AC14B046A), IM in the left leg, a third dose of PEDVAX HIB (653596/0281F), IM in the left arm, a third dose of PREVNAR (B08670H) and a first dose of HAVRIX (AHAVB148AA), IM in the left leg. It was reported that the patient was inadvertently given ZOSTAVAX (656859/0357U) instead of MMRV. On 10-JUL-2007, it was reported that a phone call was made to the patient's mother and she stated that "the kids were doing fine now". It was reported that the patient's mother was to make arrangements for varicella IgG antobody titer testing. The patient's sibling also had an experience on ZOSTAVAX.  No further information is available.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a physician concerning a 60 year old female who on 14-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (657764/0584U) (exp. 30-Sep-2008).  On 14-JUN-2007 the patient experienced itching and redness at injection site and developed bruise further down the arm.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 9/24/2007.  Follow-up information received from the physician on 05-SEP-2007 indicating that the patient received the vaccination in the left deltoid.  Concomitant therapy included aspirin and vitamins (unspecified).  The patient has allergies to penicillin, sulfa, KEFLEX, "emycin" and codeine.  The patient also experienced pain at the injection site.  The onset date for the AE's was 21-Jun-2007 (formerly reported as 14-Jun-2007).  All AE's resolved on 27-Jun-2007.  These events were considered non-serious.  No further information is expected.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Contusion, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a physician concerning a 60 year old female who on 14-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (657764/0584U) (exp. 30-Sep-2008).  On 14-JUN-2007 the patient experienced itching and redness at injection site and developed bruise further down the arm.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 9/24/2007.  Follow-up information received from the physician on 05-SEP-2007 indicating that the patient received the vaccination in the left deltoid.  Concomitant therapy included aspirin and vitamins (unspecified).  The patient has allergies to penicillin, sulfa, KEFLEX, "emycin" and codeine.  The patient also experienced pain at the injection site.  The onset date for the AE's was 21-Jun-2007 (formerly reported as 14-Jun-2007).  All AE's resolved on 27-Jun-2007.  These events were considered non-serious.  No further information is expected.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of Zostavax (Oka/Merck).  It was reported that the patient developed a rash one day after vaccination.  Unspecified medical attention was sought.  At the time of report the patient was recovering.  A product quality complaint was not involved.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a physician concerning an 85 year old female with cough, hypertension, coronary artery disease and hyperlipidaemia who on 13-JUL-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). It was reported that the patient developed a rash one day after vaccination. Unspecified medical attention was sought. At the time of report the patient was recovering. A product quality complaint was not involved. Additional information has been received from the physician who stated that one day after vaccination the patient developed an itchy rash on abdomen and thighs. At the time of report the patient had recovered. It was reported that the patient was vaccinated at a health department. No further information is expected.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of Zostavax (Oka/Merck).  It was reported that the patient developed a rash one day after vaccination.  Unspecified medical attention was sought.  At the time of report the patient was recovering.  A product quality complaint was not involved.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a physician concerning an 85 year old female with cough, hypertension, coronary artery disease and hyperlipidaemia who on 13-JUL-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). It was reported that the patient developed a rash one day after vaccination. Unspecified medical attention was sought. At the time of report the patient was recovering. A product quality complaint was not involved. Additional information has been received from the physician who stated that one day after vaccination the patient developed an itchy rash on abdomen and thighs. At the time of report the patient had recovered. It was reported that the patient was vaccinated at a health department. No further information is expected.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Back pain, Blister, Herpes zoster, Musculoskeletal pain
Clinical narrative: Information has been received from a physician and a licensed practical nurse (L.P.N.) concerning a 65-year-old female who on 05-JUN-2007 was vaccinated with a first dose of 0.65 milliliters of Zostavax (Oka/Merck) (lot# 656395/0290U).  On 07-Jun-2007 the patient had left hip area pain.  On 17-Jun-2007, the patient went to the emergency room and was diagnosed with left buttocks area shingles and was given FAMVIR and LORTAB.  It is reported that a rash did not occur at the injection site or elsewhere within 42 days of the vaccination.  A specimen was not collected for PCR.  On 21-Jun-2007, the patient went to the clinic for an emergency room follow-up and it was reported that the shingles were resolving.  The outcome is reported as recovered.  No product quality complaint is involved.  No more information is expected.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash
Clinical narrative: Information has been received from a physician and a licensed practical nurse (L.P.N.) concerning a 65-year-old female who on 05-JUN-2007 was vaccinated with a first dose of 0.65 milliliters of Zostavax (Oka/Merck) (lot# 656395/0290U).  On 07-Jun-2007 the patient had left hip area pain.  On 17-Jun-2007, the patient went to the emergency room and was diagnosed with left buttocks area shingles and was given FAMVIR and LORTAB.  It is reported that a rash did not occur at the injection site or elsewhere within 42 days of the vaccination.  A specimen was not collected for PCR.  On 21-Jun-2007, the patient went to the clinic for an emergency room follow-up and it was reported that the shingles were resolving.  The outcome is reported as recovered.  No product quality complaint is involved.  No more information is expected.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Herpes zoster
Clinical narrative: Information has been received from a physician and a licensed practical nurse (L.P.N.) concerning a 65-year-old female who on 05-JUN-2007 was vaccinated with a first dose of 0.65 milliliters of Zostavax (Oka/Merck) (lot# 656395/0290U).  On 07-Jun-2007 the patient had left hip area pain.  On 17-Jun-2007, the patient went to the emergency room and was diagnosed with left buttocks area shingles and was given FAMVIR and LORTAB.  It is reported that a rash did not occur at the injection site or elsewhere within 42 days of the vaccination.  A specimen was not collected for PCR.  On 21-Jun-2007, the patient went to the clinic for an emergency room follow-up and it was reported that the shingles were resolving.  The outcome is reported as recovered.  No product quality complaint is involved.  No more information is expected.
Age: 75.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Pain
Clinical narrative: Information has been received from a 75 year old male with a history of allergic reaction to amoxicillin (+) clavulanate potassium who on 15-JUN-2007 was vaccination in the left upper arm with a single dose of Zostavax (Oka/Merck). On 16-JUN-2007 the patient experienced left lower extremity bone pain. The patient reported developing herpes zoster on 28-JUN-2007, as well as red lesions on his left leg that same day. The patient was examined by a physician on 28 JUN 2007, and "blood work" was ordered. No treatment was prescribed. At the time of reporting the patient had not recovered. Unspecified medical attention was sought. There was no product quality complaint.
Age: 75.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Bone pain, Erythema, Herpes zoster, Laboratory test, Skin lesion
Clinical narrative: Information has been received from a 75 year old male with a history of allergic reaction to amoxicillin (+) clavulanate potassium who on 15-JUN-2007 was vaccination in the left upper arm with a single dose of Zostavax (Oka/Merck). On 16-JUN-2007 the patient experienced left lower extremity bone pain. The patient reported developing herpes zoster on 28-JUN-2007, as well as red lesions on his left leg that same day. The patient was examined by a physician on 28 JUN 2007, and "blood work" was ordered. No treatment was prescribed. At the time of reporting the patient had not recovered. Unspecified medical attention was sought. There was no product quality complaint.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a nurse concerning a 74 year old female with a history of Hodgkin's disease and chemotherapy, six years ago, who on 04-JAN-2007 was vaccinated SC on the left arm with a first dose of Zostavax (Oka/Merck) (lot # 652947/1411F). Concomitant therapy included lovastatin (manufacturer unknown), FLONASE, ALLEGRA, GLUCOPHAGE. On 17-JUL-2007 the patient developed shingles on the right flank area. At the time of the report the shingles rash was spreading. Medical attention was sought and treatment included DEMEROL for pain, DARVOCET-N and VALTREX. At the time of the report the patient had not recovered. No additional information  was provided. There was no product quality complaint involved. Additional information from another nurse indicated that the patient was enrolled in the VZVIP program: the varicella zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the Oka/Merck vaccine VZV strain. The specimen was collected by the physician and was being sent for evaluation. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning a 74 year old female with a history of Hodgkin's disease and chemotherapy, six years ago, who on 04-JAN-2007 was vaccinated SC on the left arm with a first dose of Zostavax (Oka/Merck) (lot # 652947/1411F). Concomitant therapy included lovastatin (manufacturer unknown), FLONASE, ALLEGRA, GLUCOPHAGE. On 17-JUL-2007 the patient developed shingles on the right flank area. At the time of the report the shingles rash was spreading. Medical attention was sought and treatment included DEMEROL for pain, DARVOCET-N and VALTREX. At the time of the report the patient had not recovered. No additional information  was provided. There was no product quality complaint involved. Additional information from another nurse indicated that the patient was enrolled in the VZVIP program: the varicella zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the Oka/Merck vaccine VZV strain. The specimen was collected by the physician and was being sent for evaluation. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, VARZOS, DTAP, IPV, VARZOS
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a healthy, 5-year-old female child with no medical history and no known allergies, who on 18-JUL-2007 was vaccinated subcutaneously with one vial of ZOSTAVAX (Oka/Merck) (lot# 658082/0744U) instead of PROQUAD (Oka/Merck upgrade process). Concomitant vaccinations included TRIPEDIA (lot# U1985AB) and IPOL (lot# Z0001-2). It is reported that this product confusion was total human error. The patient was notified and was taken to the emergency room a few days after the vaccination and was not admitted. There were no adverse reactions. No product quality complaint was involved. No more information is expected. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a registered nurse (R.N.) concerning a healthy, 5-year-old female child with no known allergies, birth defects or medical conditions, who on 18-JUL-2007 was vaccinated subcutaneously in the right arm with a first dose of ZOSTAVAX (Oka/Merck) (lot# 658082/0744U) instead of PROQUAD (Oka/Merck upgrade process). Concomitant vaccinations included an intramuscular fifth dose in the left deltoid of TRIPEDIA (lot# U1985AB) and a subcutaneous fourth dose in the left arm of IPOL (lot# Z0001-2). There was no illness at the time of vaccination. It is reported that this product confusion was total human error. The patient was notified and was taken to the emergency room a few days after the vaccination and was not admitted. There were no adverse reactions. No product quality complaint was involved. Follow up information received indicated that the error was discovered at the end of the day on 18-JUL-2007 after the patient left the health center. Phone calls and home visits were made to the family on 18-JUL-2007 and 19-JUL-2007. Letters were left with phone numbers to reach the health department and R.N., however no response from the family was received. Certified letters were sent to the family on 20-JUL-2007. A phone call from the mother was received on 24-JUL-2007. She reported that the child had no illness following vaccination. She took the child to the emergency room on 22-JUL-2007 where the doctor found no problems with unspecified lab work or examination. The child had no fever, rash or medical problems. She was instructed to call the health center if the child develops any illness. It is unknown if the child or siblings have ever had an adverse reaction with previous vaccinations. No further information had been received. No more information is expected.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, VARZOS, DTAP, IPV, VARZOS
Symptoms: Laboratory test normal, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a healthy, 5-year-old female child with no medical history and no known allergies, who on 18-JUL-2007 was vaccinated subcutaneously with one vial of ZOSTAVAX (Oka/Merck) (lot# 658082/0744U) instead of PROQUAD (Oka/Merck upgrade process). Concomitant vaccinations included TRIPEDIA (lot# U1985AB) and IPOL (lot# Z0001-2). It is reported that this product confusion was total human error. The patient was notified and was taken to the emergency room a few days after the vaccination and was not admitted. There were no adverse reactions. No product quality complaint was involved. No more information is expected. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a registered nurse (R.N.) concerning a healthy, 5-year-old female child with no known allergies, birth defects or medical conditions, who on 18-JUL-2007 was vaccinated subcutaneously in the right arm with a first dose of ZOSTAVAX (Oka/Merck) (lot# 658082/0744U) instead of PROQUAD (Oka/Merck upgrade process). Concomitant vaccinations included an intramuscular fifth dose in the left deltoid of TRIPEDIA (lot# U1985AB) and a subcutaneous fourth dose in the left arm of IPOL (lot# Z0001-2). There was no illness at the time of vaccination. It is reported that this product confusion was total human error. The patient was notified and was taken to the emergency room a few days after the vaccination and was not admitted. There were no adverse reactions. No product quality complaint was involved. Follow up information received indicated that the error was discovered at the end of the day on 18-JUL-2007 after the patient left the health center. Phone calls and home visits were made to the family on 18-JUL-2007 and 19-JUL-2007. Letters were left with phone numbers to reach the health department and R.N., however no response from the family was received. Certified letters were sent to the family on 20-JUL-2007. A phone call from the mother was received on 24-JUL-2007. She reported that the child had no illness following vaccination. She took the child to the emergency room on 22-JUL-2007 where the doctor found no problems with unspecified lab work or examination. The child had no fever, rash or medical problems. She was instructed to call the health center if the child develops any illness. It is unknown if the child or siblings have ever had an adverse reaction with previous vaccinations. No further information had been received. No more information is expected.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Polymerase chain reaction, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 73 year old female with hyperthyroidism, atrial fibrillation, hyperlipidaemia, Spinal stenosis, hypertension and a history of chicken pox who on 19-JUL-2007 was vaccinated with a dose of ZOSTER (658081/0743U) intramuscularly (instead of subcutaneously) in the left arm (deltoid). Concomitant therapy included CELEXA, ezetimibe (+) simvastatin (MSD), PERCOCET, LOPRESSOR, warfarin, TAPAZOLE, digoxin, ACIPHEX and diltiazem hydrochloride. On 20-JUL-2007 the patient developed a zoster-like rash on the right side of neck. Unspecified medical attention was sought. No product quality complaint. Follow-up information received from physician indication that the patient was enrolled in the Varicella Zoster Virus identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV stain or with the OKA/Merck vaccine VZV strain. The date that the herpes zoster was diagnosed and sample of the lesion was collected on 20-Jul-2007. The sample was taken from vesicular lesion on the right side of the neck. The lesions were described as "3 cm of erythematous base and 4 lesions within a confluent patch". Other systemic symptoms were pruritis, but no pruritis at the injection site. The patient did not know if she was recently exposed to chicken pox. A direct fluorescent antibody test was not done. Specimen was not collected for PCR. A photo of the lesion was not taken. The patient did not recover at the time of the report. Follow-up information received regarding the PCR results for the specimen - result was WILD type VZV. No further information is available.