chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Amniocentesis, Drug exposure during pregnancy, Pregnancy, Pregnancy test positive
Clinical narrative: Initial and follow-up information has been received from the Pregnancy Registry via a health professional concerning an 18 year old female with asthma who on 18-JUL-2007 was vaccinated with a first dose of Gardasil (Lot #657868/0523U). Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA). Subsequently, it was discovered that the patient was pregnant. The patient's last menstrual period was on 26-JUN-2007 and the estimated date of delivery was 04-APR-2007. A pregnancy test was performed, results positive. On 12-SEP-2007 an ultrasound was performed revealing an 11 week and 7 day intrauterine pregnancy. On 27-SEP-2007 an amniocentesis was scheduled, results not reported. On 23-OCT-2007, an elective termination of Pregnancy was performed. At the time of the report the patient's outcome was unknown. Upon internal review, elective termination was considered an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: Initial and follow-up information has been received from the Pregnancy Registry via a health professional concerning an 18 year old female with asthma who on 18-JUL-2007 was vaccinated with a first dose of Gardasil (Lot #657868/0523U). Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA). Subsequently, it was discovered that the patient was pregnant. The patient's last menstrual period was on 26-JUN-2007 and the estimated date of delivery was 04-APR-2007. A pregnancy test was performed, results positive. On 12-SEP-2007 an ultrasound was performed revealing an 11 week and 7 day intrauterine pregnancy. On 27-SEP-2007 an amniocentesis was scheduled, results not reported. On 23-OCT-2007, an elective termination of Pregnancy was performed. At the time of the report the patient's outcome was unknown. Upon internal review, elective termination was considered an other important medical event. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site rash, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 67 year old male patient with a history of cigarette smoking, chronic obstructive pulmonary disease, gastrooesophageal reflux disease and hyperlipidaemia who on 05-Dec-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot #1383U) intramuscularly in the right arm.  Concomitant therapy included esomeprazole magnesium (Nexium), lovastatin (Lipivas (lovastatin)), tiotropium bromide (spiriva), albuterol inhaler and bupropion.  On 07-Dec-2007 the patient developed a fever and an injection site rash that was reddened, large, painful and radiated from the injection site to the elbow.  The patient went to the emergency room for treatment of a fever and was admitted until discharged on 08-Dec-2007.  The patient's white blood cell count was 23,000.  Treatment during hospitalization was unspecified and the patient's current status was unspecified.  Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a nurse concerning a 67 year old male patient with a history of cigarette smoking, chronic obstructive pulmonary disease, gastrooesophageal reflux disease and hyperlipidaemia who on 05-Dec-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot #1383U) intramuscularly in the right arm.  Concomitant therapy included esomeprazole magnesium (Nexium), lovastatin (Lipivas (lovastatin)), tiotropium bromide (spiriva), albuterol inhaler and bupropion.  On 07-Dec-2007 the patient developed a fever and an injection site rash that was reddened, large, painful and radiated from the injection site to the elbow.  The patient went to the emergency room for treatment of a fever and was admitted until discharged on 08-Dec-2007.  The patient's white blood cell count was 23,000.  Treatment during hospitalization was unspecified and the patient's current status was unspecified.  Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Physical examination normal
Clinical narrative: Patient is a 4 month 12 day old male. Source of information on MD office visit of 9/26/07 was mother. Past medical history reviewed and found to be negative. Physical exam on 9/26/07 office visit was WNL.  12/28/07 Reviewed autopsy report which states COD SIDS.  Sleeping in adult bed, supine position & found unresponsive w/vomitus on face.  Findings at autopsy included: bilateral otitis media (culture neg), slight hepatomegaly & resolved SDH (probable birth trauma).
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Sudden infant death syndrome, Unresponsive to stimuli, Vomiting
Clinical narrative: Patient is a 4 month 12 day old male. Source of information on MD office visit of 9/26/07 was mother. Past medical history reviewed and found to be negative. Physical exam on 9/26/07 office visit was WNL.  12/28/07 Reviewed autopsy report which states COD SIDS.  Sleeping in adult bed, supine position & found unresponsive w/vomitus on face.  Findings at autopsy included: bilateral otitis media (culture neg), slight hepatomegaly & resolved SDH (probable birth trauma).
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Physical examination normal
Clinical narrative: Infant found unresponsive in bed with vomitus on his face on 10/10/07. Died. Autopsy states SIDS as cause of death.  12/28/07 Reviewed autopsy report which states COD SIDS.  Sleeping in adult bed, supine position & found unresponsive w/vomitus on face.  Findings at autopsy include: bilateral otitis media (culture neg), slight hepatomegaly & resolved SDH (probable birth trauma).
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Sudden infant death syndrome, Unresponsive to stimuli, Vomiting
Clinical narrative: Infant found unresponsive in bed with vomitus on his face on 10/10/07. Died. Autopsy states SIDS as cause of death.  12/28/07 Reviewed autopsy report which states COD SIDS.  Sleeping in adult bed, supine position & found unresponsive w/vomitus on face.  Findings at autopsy include: bilateral otitis media (culture neg), slight hepatomegaly & resolved SDH (probable birth trauma).
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Blood product transfusion, Dysgeusia, Gastrointestinal tube insertion, Mechanical ventilation, Muscular weakness
Clinical narrative: Pt developed "tin" taste in mouth 2 hours after Adacel shot.  Rapid progression over 48h of weakness leg, foot.  Guillain Barre, hospital, respirator dependent.12/28/07-records received with report for DOS 11/23-12/19/07-DC DX: Guillain-Barre syndrome treated with plasmapheresis and IVIG. Required a tracheotomy and feeding tube placement. Three days prior to admission received tetanus shot. Two hours after shot developed tinny taste in mouth and paresthesias on tongue that reolved that day. Two days prior to admission noticed numbness and tingling on soles of both feet and his hands felt hot underneath cold water. Day prior to admission awoke and noticed bilateral leg weakness with mild left foot drop and weakness in proximal arms. Developed progressive weakness with hypophonic speech, decreased cough and neck flexion weakness. Required mechanical ventilation. 1/15/2010 Weakness arms, legs, and hands.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Plasmapheresis, Red blood cells CSF positive, Tracheostomy
Clinical narrative: Pt developed "tin" taste in mouth 2 hours after Adacel shot.  Rapid progression over 48h of weakness leg, foot.  Guillain Barre, hospital, respirator dependent.12/28/07-records received with report for DOS 11/23-12/19/07-DC DX: Guillain-Barre syndrome treated with plasmapheresis and IVIG. Required a tracheotomy and feeding tube placement. Three days prior to admission received tetanus shot. Two hours after shot developed tinny taste in mouth and paresthesias on tongue that reolved that day. Two days prior to admission noticed numbness and tingling on soles of both feet and his hands felt hot underneath cold water. Day prior to admission awoke and noticed bilateral leg weakness with mild left foot drop and weakness in proximal arms. Developed progressive weakness with hypophonic speech, decreased cough and neck flexion weakness. Required mechanical ventilation. 1/15/2010 Weakness arms, legs, and hands.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Generalised erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Mom noticed left arm swelling, redness from shoulder down to elbow. Some soreness in arm as well.Swelling is more on upper arm.
Age: 1.1
Sex: M
Vaccine: FLU3, HEP, HIBV, IPV, MMRV, PNC
Symptoms: Convulsion, Intubation, Pyrexia
Clinical narrative: Child has Dravet's Syndrome. Physician provided script requesting child receive his immunizations, except Dtap. He is to receive Dt instead. He has history of seizures, almost monthly. Had been seizure free since 9-25-07. Mom reported on 11/21/07 that child had a total of 7 seizures the evening after his immunizations. Mom states he didn't have a fever until the following evening, but started seizing.. was taken by squad to hospital and intubated. He spent 2 days in the hospital and was released. 4/7/08-records received for DOS 11/15/07 and 12/22/07-Short stay for increased seizure activity most likely due to AFI.  Presented to ED with 24 hour history of acute febrile illness.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: The day of the vaccine, which was administered in the right deltoid, she developed localized soreness, which has persisted for the past 2 months.  The vaccine was given on 10/28/07.  She still has pain and some weakness of the proximal musculature of the right upper extremity.  Worse at night and in the morning.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL, TDAP
Symptoms: Cardiac stress test, Cardiomyopathy, Dizziness, Echocardiogram abnormal, Syncope
Clinical narrative: Syncopal episode x 2 DEC 16th 2007 occured @ 1030 PM lasting over a minute with lightheadedness in the shower. 01/02/08-records received for DOS 12/26/07-DX: Syncope. HX: Full syncope episode while in shower. Head eaten very little all day, during hot shower felt lightheaded and passed out.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Induration, Swelling
Clinical narrative: 12/27/2007  Telephone call from parent.  Slight redness and swelling.  Will monitor. 12/28/2007  Was seen in office.  Redness 6 inches of induration and erythema.  no discharge.  Has had similar reactions to other vaccines ie.  DTaP and Td
Age: 4.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Medication error, Wrong drug administered
Clinical narrative: pt was given boostrix in stead of infanrix. pt had no adverse effects of this injections. The CDC and poison control center was notified and they stated that pt will have no adverse effects of this and since it was her fifth dose she dose not need any more of the DTAP injections. It was given in the vastus laterus left. on 12-28-07 at 2:oopm.
Age: 0.7
Sex: F
Vaccine: IPV, PNC
Symptoms: Pyrexia, Urinary tract infection
Clinical narrative: Mother reported events on 12/28/2007  Fever began 2 days after vaccinations. Fever lasted for 5 days. Went to ER on 9/18/07 was discharged that same evening. Mother returned to ER on 9/25/07 and was admitted and released on 9/27/07. Was treated for a bacterial UTI. 2/1/08-records received for DOS 9/25-9/27/07- DC DX: Urinary tract infection. Seen in ED with fever 100 and nasal confestion. Upper respiratory infection and fever spike of 104.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Nausea
Clinical narrative: dizziness,nausea, elevated blood pressure in the 24 hours after the vaccine was given
Age: 86.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Oedema peripheral, Pain in extremity
Clinical narrative: pt reports he had swelling and pain in the left arm from the shoulder to the elbow within hours of the vaccines.  he came in within a half hour of talking him on the phone after his daughter called me.  on examination he has cellulitis which is treated with oral keflex as recommended by my medical supervisor.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Insomnia, Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a consumer, who is also a pharmacist and described the occurrence of pain in a 46-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject thought the vaccine was manufactured by GlaxoSmithKline. On 5 October 2007 at 14:00, the subject received unspecified dose of Influenza vaccine (.5 ml, unknown, left arm). On 6 October 2007, 1 day after vaccination with Influenza vaccine, the subject experienced pain, which radiated from her shoulder down to her hand. The pain in her hand was intermediate, but the frequency had increased. In November 2007, the subject experienced numbness and tingling in her arm, leg, and lip on left side. The subject reported she had not slept in three days. The subject considered the events jeopardizing and required intervention at the doctor's office. The subject was treated with ibuprofen and aspirin. At the time of reporting, the events were worse.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: This case was reported by a consumer, who is also a pharmacist and described the occurrence of pain in a 46-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject thought the vaccine was manufactured by GlaxoSmithKline. On 5 October 2007 at 14:00, the subject received unspecified dose of Influenza vaccine (.5 ml, unknown, left arm). On 6 October 2007, 1 day after vaccination with Influenza vaccine, the subject experienced pain, which radiated from her shoulder down to her hand. The pain in her hand was intermediate, but the frequency had increased. In November 2007, the subject experienced numbness and tingling in her arm, leg, and lip on left side. The subject reported she had not slept in three days. The subject considered the events jeopardizing and required intervention at the doctor's office. The subject was treated with ibuprofen and aspirin. At the time of reporting, the events were worse.
Age: 1.9
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Swelling, Urticaria
Clinical narrative: Hives at bilateral axilla, sides of trunk inguinal area, bilateral thigh and swelling at (R) >> (L) knee
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: First time I gave her the HPV shot she fainted and had a small seizure for approx 5 sec. Today, I gave her the 2nd HPV shot, she was sitting this time, had a seizure for approx 5-8 sec, w/ no fainting and was aware this time of her surroundings.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Blood pressure, Chills, Heart rate normal, Oxygen saturation normal
Clinical narrative: Patient received vaccine at 17:00 and felt fine.  She went to radiology for an x-ray and then pharmacy.  45-50 minutes after injection patient had uncontrollable shaking and chills.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Patient received vaccine at 17:00 and felt fine.  She went to radiology for an x-ray and then pharmacy.  45-50 minutes after injection patient had uncontrollable shaking and chills.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site swelling
Clinical narrative: Swelling noted on right thigh injection site.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Heart rate increased, Pneumonia, Pyrexia
Clinical narrative: rapid heart rate (5 days later) 11-3-07, hoarseness (2 days later) 10-31-07, fever (6 days later) 11-4-07, pneumonia (reported to Rx) 12-28-07
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, RV5
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Diarrhea, blood in stool.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 4 cm by 4 cm swollen red area on left thigh
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error, Wrong technique in drug usage process
Clinical narrative: Patient required 2 injections; 1st injection given with no flu vaccine in syringe; 2nd injection had flu vaccine drawn up - was given.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Flu shot given (L) arm shortly afterwards, Pt c/o pain radiating down her (L) arm into hand. After she made a fist pain was better. Instructed to use ice pack and use ibuprofen.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Nausea, Rash, Urticaria, Vaccination complication, Vomiting
Clinical narrative: Had hives all over, nausea and vomiting day after receiving vaccine.  He woke up with rash.  Did not have rash when he went to bed.  11/29/07 - went to St. Joseph's emergency room and doctor called it reaction to vaccine.  Treated with Benadryl and oral steroids.
Age: 0.8
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased, Crying, Dyspnoea, Heart rate increased, Incorrect dose administered
Clinical narrative: Temp 102, fussy, crying, drowsy, difficult breathing, heart rate fast. Nurse used a large amount of vaccine, did not recommend child return for second dose of flu vaccine.
Age: 0.8
Sex: M
Vaccine: FLUX
Symptoms: Irritability, Somnolence
Clinical narrative: Temp 102, fussy, crying, drowsy, difficult breathing, heart rate fast. Nurse used a large amount of vaccine, did not recommend child return for second dose of flu vaccine.
Age: 26.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Injection site discolouration
Clinical narrative: Patient has hypopigmentation in the area of bandaid which covered injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Total swelling, redness, heat  circumferentially around (right arm and part of forearm.  Symptoms of local itching.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site swelling
Clinical narrative: Redness and swelling on injection site on right thigh.
Age: 0.6
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever 104 x 3 days.
Age: 0.2
Sex: F
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Expired drug administered
Clinical narrative: None. 11/21/07 Patient was given Rotavirus oral vaccine with 10/18/07 expiration date.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Local erythema and pruritus at site of injection in (R) subcutaneous arm 1 day following.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: patient received Adacel 12/22/06 the was given an additional Adacel on 12/21/07
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus generalised
Clinical narrative: Within 1 hour, felt itchy all over.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Tenderness
Clinical narrative: Received flu vaccine on 12/04/2007.  Has never had a flu vaccine in the past.  Awoke this morning with erythema to bilateral elbows and knees.  Affected areas also tender to touch, and itchy.  No limits to ROM.  Vital signs: temp 96, bp 125/80, hr 62 regular.  Other employees received flu shots from the same multi-dose vial without similar symptoms.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: swelling, erythema, cellulitis 4 days post
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh cellulitis. Area where injection given - red, warm, swollen, slightly indurated.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: area of redness at injection site 2x3 cm worsening redness going up to shoulder appears to be cellulitis
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Osteomyelitis
Clinical narrative: Admitted to hospital for osteomyelitis of toe. Discovered to have cellulitis of arm, at site of Pneumovax (from previous admission).  2/12/08 Reviewed hospital med records which reveal patient was hospitalized for pain & osteomyelitis of left 5th toe w/subsequent amputation 8/1-8/6/06.  While hospitalized, received pneumovax.  No vax record available.  Readmitted 8/8-8/9/06 for cellulitis of left foot near amputation site & also cellulitis of pneumo site left arm.  The vax site had erythema, warmth & pain.  Left foot cellulitis was actually contact dermatitis.  D/C to home on continued oral antibiotics. FINAL DX: left arm cellulitis at Pneumovax site.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pruritus
Clinical narrative: Left arm where immunizations given - area itching and red. Dr felt it to be normal reaction.
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Lethargy, Pyrexia
Clinical narrative: Fever of 103 face and ears were red acting lethargic and droopy
Age: 0.4
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Mother reports a fever of 104.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a 66 year old female who on 12-JUL-2007 was vaccinated SC in the left arm with a dose of Zostavax (Oka/Merck) (lot# 652965/0622F) which expired on 11-JUN-2007. The patient developed localized pruritus (also reported as no adverse experience). It was unspecified if medical attention was sought. The patient's outcome was not reported. There was no product quality complaint involved. No further information was provided. Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 7-year-old patient (gender unknown), who on 19-JUL-2007 was vaccinated with Zostavax. The patient was vaccinated due to human error. It was reported that the patient had no symptoms. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Follow-up information received from the registered nurse (R.N.) indicates that the patient is a healthy male with no pre-existing allergies, birth defects or medical conditions who was vaccinated in the right arm with a first subcutaneous dose of Zostavax (lot# 656607/0163U) instead of a dose of Varivax at 11:47 AM. (It was previously reported that he was to receive a dose of Gardasil, which was reported in error). There was no illness at the time of vaccination. There were no concomitant medications given. On 20-Jul-2007, the doctor notified the mother of the error in immunization. The mother reported that the child had no fever or rash. On 26-Jul-2007, the patient came in for a follow-up clinic visit and it was noted that there was no reaction to the Zostavax. There were no laboratory or diagnostic tests performed. It is reported that the patient has never had an adverse event following prior vaccinations. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse and a licensed practical nurse concerning a 5 year old male patient who on 15-AUG-2007 was vaccinated with Zostavax (Oka/Merck) (Lot #658086/0761U) instead of Varivax (Oka/Merck) (MSD).  The nurse confirms that this was staff error only.  Unspecified medical attention was sought.  No symptoms were noted.  No other information was provided.  There was no product quality complaint involved.  Follow up information from the nurse indicated that the nurse who administered the vaccination had a lot of experience, but did not realized what she had done until the next morning when she was about to administer another vaccine.  The nurse reported that the vaccines are kept in trays with posted notes to identify the two vaccines.  She stated she did not feel that this event had anything to do with the packaging but more to do with the storage of both vaccines.  The patient was seen in the office and was doing fine.  Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 5 year old female who on  17-AUG-2007 was vaccinated with zoster vaccine live (Oka/Merck). There was no adverse event reported. In follow-up, the physician noted that the patient was in for a routine varicella virus vaccine live (Oka/Merck) booster. The employee who gave the vaccine was not permanent staff but medical assistant from OB/GYN who was helping out. The administering health professional stated that the vaccines were both in the freezer in their own boxes. She stated that they both stated zoster and the boxes did not state adult or pediatric use. The box in front was zoster vaccine live (Oka/Merck) and she pulled that one out and administered it. The physician noted that the patient did not experience any untoward effect. No further information is expected.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Pain in extremity, Scab, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old retired white male with no known allergies or pertinent medical history who on 17-AUG-2007 was vaccinated in the left deltoid with a first dose of Zostavax (Lot# 656413/01477F). There was no illness at the time of vaccination. Subsequently on 24-AUG-07, the patient developed a couple lesions at the injection site after the vaccination. The pharmacist received a call from the patient's physician who had diagnosed the lesions as shingles. The patient's shingles persisted as of 27-AUG-2007. 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 vaccine VZV strain. The sample of the lesion was collected on 28-AUG-2007. The sample was taken from a vesicle on the patient's left arm. PCR results were provided: the isolated virus was wild type VZV strain. An office visit on 29-AUG-07 indicated that the left arm shingles had more crusting and some pain. The physician prescribed 7 days of LYRICA. Follow up information from the physician indicated on 04-SEP-07 the patient had finished treatment with VALTREX and LYRICA. There was some pain and numbness. Additional information from the physician indicated that the lesions were pretty well healed. Some still crusted on the left arm, and pain if he hit his elbow on a hard surface, and some numbness. The patient declined more LYRICA. According to the reporter the patient recovered on 18-SEP-07. No further information was provided. On the initial office visit on 27-AUG-2007 there was on the left arm a rash consistent with shingles. Manufacturer and I.D. recommended treatment with VALTREX 1 gm three times a day by mouth for 7 days. On 29-AUG-2007 in the office it was noted the left arm shingles more crusting some pain. The treatment of 7 days of LYRICA was added. On 04-SEP-2007 after finishing treatment with VALTREX and LYRICA the patient complained of some pain and numbness. At the office visit of 18-SEP-2007 the lesions were pretty well healed, some still crusted on the left arm. There was pain if he hit his elbow on a hard surface and some numbness. More pregabalin was declined. Additional information is not expected. This is a consolidation of 2 reports concerning the same patient. It has been determined that WAES # 0708USA04950 is a duplicate of WAES # 0708USA04938. Therefore, WAES # 0708USA04938 is being deleted from our files and the reports consolidated into WAES # 0708USA04950.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Pruritus, Rash
Clinical narrative: Initial and follow up information has been received from a physician concerning a 77 year old white male with no pertinent medical history, drug reactions or allergies who on 31-JUL-2007, at 13:30, was vaccinated intramuscularly into the right arm with a first dose, 0.65 ml, of Zostavax (Oka/Merck) (Lot #656858/0356U).  Concomitant therapy included oxaprozin (Daypro), metoprolol succinate (Toprol XL tablets), simvastatin (MSD), famotidine (MSD) and amitriptyline hydrochloride (MSD).  Approximately two days after receiving "the shot", 01 AUG 2007, at 9:30, the patient developed a rash, four or five itchy pimples and three pea size pimples on his back, leg and armpit.  Medical attention was not sought.  There was no product quality complaint.  There were no lab diagnostic studies performed.  There was no illness at the time of vaccination.  At the time of reporting it was unknown if the patient had recovered from the reported events.  Additional information is not expected.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Rash
Clinical narrative: Information has been received from a 78 year old male with an arthritic knee and no reported drug reactions/allergies who on 23-JUL-2007 was vaccinated with zoster vaccine live (Oka/Merck) (lot # 656606/0033U). Concomitant therapy included diclofenac. On 26-AUG-2007 the patient experienced rashes and clusters of blisters on his feet, hands, forearms, thighs, and buttocks. The patient reported that these areas itched a great deal. On 27-AUG-2007, within twenty four hours all of the rashes and blisters went away and there are no residual marks or remnants of them on his body. Because they went away so fast there was no opportunity for a physician to observe them or to take specimens for testing. Follow up information has been received from the physisican who reported there was no information to report and that "he believed this was not vaccine". No further information available.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Intraocular pressure increased, Pruritus, Rash, Vision blurred
Clinical narrative: Information has been received from a 75 year old male with a history of glaucoma who on 09-AUG-2007 (previously reported as 07-AUG-2007) was vaccinated with Zostavax. Concomitant therapy included FLOMAX and an unspecified blood pressure medication. On 10-AUG-2007 the patient experienced blurred vision. He visited an ophthalmologist and was advised his eye pressure was up. The patient's blurred vision and eye pressure is up persisted. Additional information has been received from the 75 year old male who stated that after vaccination he had developed red itching patches on his legs and ankles that "comes and goes daily". No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a female who in August 2007 was vaccinated with a dose of Zostavax (Oka/Merck).  The physician reported that on 27-AUG-2007, the patient developed a varicella rash on both feet.  It was unknown if medical attention was sought.  At the time of this report, the outcome was unknown.  No further information is available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Pruritus, Secondary transmission
Clinical narrative: Information has been received from a physician concerning a 66 year old female whose husband vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included alendronate sodium (MSD). On approximately 10-AUG-2007 the patient experienced four or five itchy pimples. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with Zostavax (Oka/Merck).  The physician reported the patient experienced an adverse experience.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Laboratory test, Neuropathy, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 67 year old female who on 15-AUG-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included gemfibrozil, aspirin and metoprolol succinate (Toprol XL tablets).  The patient experienced arm pain in the arm that received the injection.  The pain lasted four days.  On approximately 23-AUG-2007 the patient presented to the physician's office complaining of pain in both calves that she called neuropathy.  She had no leg weakness and she was able to ambulate.  Exam on that day was "totally normal".  The physician ordered labs and a Doppler test and told the patient he felt gemfibrozil was most likely causing the calf pain, not the Zostavax.  The patient was upset to hear this and was insistent that the Zostavax was causing her calf pain.  The physician, upon not receiving the test results, called the patient and she informed him that she went to another physician who did testing that showed the Zostavax caused her calf pain.  Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Influenza, Upper respiratory tract infection
Clinical narrative: Information has been received from an 81 year old female with a sulfonamide allergy and no pertinent medical history who on 30-Jul-2007 was vaccinated with a dose of Zostavax.  Concomitant therapy included "HBP" and ascorbic acid (+) beta carotene (+) cupric oxide (+) vitamin E acetate (+) zinc oxide (Ocuvite Preservision).  About one week after vaccination, in "early August 2007" the patient developed coughing and flu symptoms.  Unspecified medical attention was sought.  No lab studies were performed.  Follow-up information received from the patient indicated that she experienced an upper respiratory infection after vaccination.  At the time of this report the patient was recovering.  No further information was provided.  There was no product quality complaint involved.  Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: Information has been received from a 74 year old female with allergies to unspecified antibiotics and no pertinent medical history who on 07-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included pioglitazone hydrochloride (Actos).  "A few weeks after vaccination", the patient developed fatigue and severe muscle pain.  Unspecified medical attention was sought.  No lab studies were performed.  At the time of this report the patient had not recovered.  No further information was provided.  There was no product quality complaint involved.  No further information is available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Epicondylitis, Immediate post-injection reaction, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a 66 year old white female consumer with no known allergies or pertinent medical history who on 21-May-2007 was vaccinated SC with a single first 0.65 ml dose of Zostavax.  There was no concomitant medication.  The patient immediately developed a swollen and painful arm.  She also was experiencing bronchitis which "goes away and comes back".  Unspecified medical attention was sought.  No lab studies were performed.  At the time of this report the patient was recovering.  No further information was provided.  There was no product quality complaint involved.  Follow up information received from the physician indicated that the patient was vaccinated IM (previously reported as SC) in the left arm with a first dose of Zostavax.  On 06-Jun-2007 the patient developed an upper respiratory infection which the physician did not believe was related to the vaccination.  The patient was also diagnosed with lateral epicondylitis which the physician did not think was at all related to vaccine, but the patient believed it might be.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Upper respiratory tract infection
Clinical narrative: Information has been received from a 66 year old white female consumer with no known allergies or pertinent medical history who on 21-May-2007 was vaccinated SC with a single first 0.65 ml dose of Zostavax.  There was no concomitant medication.  The patient immediately developed a swollen and painful arm.  She also was experiencing bronchitis which "goes away and comes back".  Unspecified medical attention was sought.  No lab studies were performed.  At the time of this report the patient was recovering.  No further information was provided.  There was no product quality complaint involved.  Follow up information received from the physician indicated that the patient was vaccinated IM (previously reported as SC) in the left arm with a first dose of Zostavax.  On 06-Jun-2007 the patient developed an upper respiratory infection which the physician did not believe was related to the vaccination.  The patient was also diagnosed with lateral epicondylitis which the physician did not think was at all related to vaccine, but the patient believed it might be.  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 70 year old female gastroesophageal reflux, hypertension and osteoporosis and no known allergies who on 21-AUG-2007 was vaccinated SC in the left upper arm with a single dose of Zostavax (Oka/Merck) (Lot#658086/0761U). Concomitant therapy included alendronate sodium (MSD), lansoprazole (PREVACID) and aspirin (ECOTRIN). On 21-AUG-2007 the patient developed a red, raised, itchy area at the injection site of the left upper arm several hours after vaccination. The patient self treated with diphenhydramine topical cream (BENADRYL). The patient was examined in the office on 28-AUG-2007 and found to have a 9x7 cm erythematous, warm wheal at the injection site. The patient was prescribed diphenhydramine HCl (BENADRYL) and a methylprednisolone (MEDROL) dose pack and was advised to apply ice packs to the affected area. No lab studies were performed. A follow up appointment was scheduled for 31-AUG-2007. At the time of this report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Eye swelling, Herpes simplex, Ocular hyperaemia, Oral herpes
Clinical narrative: Initial and follow up information has been received from a physician concerning a 63 year old white female with environmental allergies, a history of shingles in February 2007 and no known drug allergies who on 27-MAR-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck) (Lot #652947/1411F).  Concomitant therapy included aluminum hydroxide (+) magnesium hydroxide (+) simethicone (Mylanta).  On 17-APR-2007 the patient developed a herpes simplex eruption under her nose and on her lips.  The patient was treated with valacyclovir hydrochloride (Valtrex).  On 17-JUN-2007 the patient developed swollen eyes.  Medical attention was sought.  The patient was seen in the office on 28-AUG-2007 with red, swollen, and itchy eyes.  The patient was treated with prednisone.  No lab studies were performed.  At the time of this report the patient had not recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Beta globulin, Body temperature, Laboratory test, Pruritus, Scab
Clinical narrative: Information has been received from physician and a 74 year old male with Parkinsonism, hypertension and allergies to penicillin, iodine and erythromycin who on 25-JUL-2007 was vaccinated with Zostavax (Oka/Merck) in the left upper arm subcutaneously.  Concomitant therapy included lisinopril (manufacturer unknown), alprazolam (Xanax), carbidopa, entacapone (Comtan) tolterodine tartrate (Detrol LA) and zolpidem tartrate (Ambien) and Parkinson's medication (unspecified).  On 27-AUG-2007 the patient developed seven to eight isolated lesions on his bilateral upper and lower extremities (temp. 97.5).  The patient did not have a history of chicken pox and did not have recent exposure to chicken pox or herpes zoster.  He had three lesions on his arms, one on his leg, one on his forehead and the others scattered on his body.  The patient described the lesions to be a quarter of an inch in diameter and were very itchy.  The patient tried to use diphenhydramine hydrochloride (Benadryl).  On 04-SEP-2007, a specimen of a dry scab was sent to the laboratory.  They were all small scabs.  They soaked for approximately one week.  Sample #1 was taken from the right forearm; adequate specimen, no VZV identified, negative, (+) B-Globin.  Sample #2 taken from the right bicep scab; inadequate specimen, negative for B-Globin, no strand ID.  Sample #3 taken from the left posterior thigh scab; inadequate specimen, negative for B-Globin, no strand ID.  Photos were not taken of the patient's lesions.  As of 04-SEP-2007, the patient had not recovered.  Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Information has been received from physician and a 74 year old male with Parkinsonism, hypertension and allergies to penicillin, iodine and erythromycin who on 25-JUL-2007 was vaccinated with Zostavax (Oka/Merck) in the left upper arm subcutaneously.  Concomitant therapy included lisinopril (manufacturer unknown), alprazolam (Xanax), carbidopa, entacapone (Comtan) tolterodine tartrate (Detrol LA) and zolpidem tartrate (Ambien) and Parkinson's medication (unspecified).  On 27-AUG-2007 the patient developed seven to eight isolated lesions on his bilateral upper and lower extremities (temp. 97.5).  The patient did not have a history of chicken pox and did not have recent exposure to chicken pox or herpes zoster.  He had three lesions on his arms, one on his leg, one on his forehead and the others scattered on his body.  The patient described the lesions to be a quarter of an inch in diameter and were very itchy.  The patient tried to use diphenhydramine hydrochloride (Benadryl).  On 04-SEP-2007, a specimen of a dry scab was sent to the laboratory.  They were all small scabs.  They soaked for approximately one week.  Sample #1 was taken from the right forearm; adequate specimen, no VZV identified, negative, (+) B-Globin.  Sample #2 taken from the right bicep scab; inadequate specimen, negative for B-Globin, no strand ID.  Sample #3 taken from the left posterior thigh scab; inadequate specimen, negative for B-Globin, no strand ID.  Photos were not taken of the patient's lesions.  As of 04-SEP-2007, the patient had not recovered.  Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received concerning a patient who was vaccinated with Zostavax.  Subsequently the patient experienced a red rash at the injection site.  This is one of several reports from the same source.  No further information is available.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 71 year old male who on 08-AUG-2007 was vaccinated with Zostavax (658085/0882U). On 17-AUG2007 the patient experienced a generalized pruritic rash. The patient's generalized pruritic rash persisted. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Varicose vein
Clinical narrative: Information has been received from a registered nurse concerning a 72 year old female with a history of peripheral swelling of the legs and feet, and no known allergies who on 23-Aug-2007 was vaccinated with a single dose of Zostavax.  Concomitant therapy  included celecoxib (Celebrex), montelukast sodium (MSD), levothyroxine Na (Levoxyl), fexofenadine hydrochloride (Allegra), omeprazole (Prilosec), lisinopril (Zestril), lorazepam, hyoscyamine and acetaminophen (+) propoxphene napsylate (Darvocet-N).  On 23-Aug-2007 the patient developed intense redness, swelling, and broken blood vessels on her left foot and right calf.  Unspecified medical attention was sought.  At the time of this report the patient was recovering.  No further information was provided.  There was no product quality complaint involved.  Follow up information from the nurse indicated that the patient had "bad varicose veins".  Additional concomitant therapies included vitamins (unspecified), calcium (unspecified) (+) vitamin D (unspecified), calcium (unspecified) (+) vitamin D (unspecified), dimethyl sulfone (+) glucosamine, omega-3 marine triglycerides, vitamin E, ascorbic acid, magnesium (unspecified) and flaxseed oil, a sleep aid, tylenol (8-hour twice daily) (sometimes), and cephalexin 2 gm 1 hour prior to dental appointments.  The patient noticed left instep of foot looked like it had hemorrhaged and swelled when she was standing.  She stated that also the right leg behind the knee was very sore.  The patient did see the physician for this and was told it was not related to Zostavax.  There were no lab studies performed, no illness at the time of vaccination, and no adverse events following prior vaccinations.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. Additional follow-up has been received concerning a retired female with a positive TB skin test but does not have tuberculosis-negative chest x-ray and a "pear sized" mass in right back for 1 1/2 years for which she will be having an MRI. On 23-Aug-2007 she was vaccinated subcutaneously in the left arm with ZOSTAVAX vaccine (Merck) at a pharmacy. On 23-Aug-2007 between 7-8pm (previously reported as between 6-8 pm) the patient started experiencing the adverse events. It was reported that the patient had stopped taking aspirin lately because she felt like she was bruising easily. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a female who was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient experienced small rash at the injection site on the arm.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abasia, Blood test, Herpes zoster, Injection site pain
Clinical narrative: Information has been received from a 67 year old female with no allergies or pertinent medical history who on 20-AUG-2007 was vaccinated with a single dose of Zostavax (Oka/Merck). On 20-AUG-2007 the patient developed injection site pain which expanded throughout her body. The patient "can't walk." The patient described herself as "symptomatic of having shingles". Unspecified medical attention was sought. Unspecified "blood work" was performed. No results were reported. At the time of this report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Additional information is not expected.