chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Culture throat negative, Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: 5/13 developed edema at sight of DTAP vaccine, fever with max of 102. Edema increased 5/14. (5/18 went to ED due to fever and swelling, sent home, no admission. 5/14 seen in office. Per doctor's note from 5/14, "left  arm with generalized swelling, increased warmth, non tenderness, very red with area of 16x22cm. Able to move arm." 5/15 Dad reported over telephone that swelling, redness were much better, overall "completely fine on 5/15," no fever.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Pyrexia, Streptococcus test negative, Swelling
Clinical narrative: 5/13 developed edema at sight of DTAP vaccine, fever with max of 102. Edema increased 5/14. (5/18 went to ED due to fever and swelling, sent home, no admission. 5/14 seen in office. Per doctor's note from 5/14, "left  arm with generalized swelling, increased warmth, non tenderness, very red with area of 16x22cm. Able to move arm." 5/15 Dad reported over telephone that swelling, redness were much better, overall "completely fine on 5/15," no fever.
Age: 1.29
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient seen in office on 5/14/2010 for vaccines; came to office on 5/15/10 with redness & swelling to left leg (thigh).  Area measured 1 3/4 in X 1 in.  Patient woke the AM of 5/15/10 with reddened area.  Patient treated with KEFLEX 250/5 3/4 tsp TID X 10 days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: Red, itchy, swollen arm at injection site and arm.  Took BENADRYL and put ice on it.  Swelling has gone down.  Arm still a little sore and red.
Age: 42.0
Sex: F
Vaccine: DTP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash, Neck mass
Clinical narrative: May 11, 2010 received immunization for college in right arm. I noticed lump on right side of my neck above my collar bone. Redness, itching, hard skin, tiny bumps on the injection site. I noticed these symptoms on 05/16/2010. The itching and redness is unusual. I don't scratch that spot though I want to. I don't want to infect it. I called doctor and reported symptoms approximately 9:00am on Monday, May 17, 2010. The nurse scheduled an appointment for me to come in. I scheduled for Tuesday, May 18, 2010 at 5:30pm so that this would not affect my work.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea, Ocular hyperaemia
Clinical narrative: I had a difficult time swallowing, and breathing, I awakened one morning after about 2 weeks and my left eye was red. The symptoms lasted for about 6 months.
Age: 1.6
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Death
Clinical narrative: Child found dead one morning.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Flushing, Glucose tolerance test, Nausea
Clinical narrative: Patient stated flushing, redness to face and arms with nausea. Pt came to lobby of clinic at 3:00pm Dr. to room shortly after, vital signs taken, Benadryl given and pt. monitored, finger stick glucose taken read at 89. Dr and I monitored pt until driver arrived and pt.'s symptoms resloved.  Inst. to go to ER if she has breathing problems.
Age: 1.1
Sex: M
Vaccine: HIBV, MM, VARCEL
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Rash from back to face. Fever and irritability.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Dyspnoea, Erythema, Injection site erythema, Laboratory test
Clinical narrative: Pt called our office on 5/14/10 complaining of arm pain, swelling, redness, tenderness, shortness of breath and wheezing. She used her albuterol inhaler to alleviate respiratory sxs. Dr. recommended she take 600-800mg ibuprofen and ice the area and continue to monitor. Pt went to walk in clinic on Friday night d/t development of swollen/painful lymph nodes and worsening redness at injection site. Saturday pt went to the hospital as she developed 102 fever and worsening sxs. She was admitted.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Lymph node pain, Lymphadenopathy, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Pt called our office on 5/14/10 complaining of arm pain, swelling, redness, tenderness, shortness of breath and wheezing. She used her albuterol inhaler to alleviate respiratory sxs. Dr. recommended she take 600-800mg ibuprofen and ice the area and continue to monitor. Pt went to walk in clinic on Friday night d/t development of swollen/painful lymph nodes and worsening redness at injection site. Saturday pt went to the hospital as she developed 102 fever and worsening sxs. She was admitted.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness, Wheezing
Clinical narrative: Pt called our office on 5/14/10 complaining of arm pain, swelling, redness, tenderness, shortness of breath and wheezing. She used her albuterol inhaler to alleviate respiratory sxs. Dr. recommended she take 600-800mg ibuprofen and ice the area and continue to monitor. Pt went to walk in clinic on Friday night d/t development of swollen/painful lymph nodes and worsening redness at injection site. Saturday pt went to the hospital as she developed 102 fever and worsening sxs. She was admitted.
Age: 0.6
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Lethargy, Pyrexia
Clinical narrative: Patient ran fever of 104 degrees off & on x 3 days, lethargic - treated with TYLENOL & MOTRIN to reduce fever.
Age: 44.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right deltoid - painful, red, swollen, warm to touch.  Warm compress bid.  MEDROL dose pak.
Age: 12.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: C/o right arm edema, erythema, and tenderness beginning next day after vaccine administration.
Age: 1.02
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Body temperature increased, Irritability, Rash generalised, Rhinorrhoea
Clinical narrative: Grandmother of Pt called to say child is "covered in spots" 2 wks after MMR & VZV vaccines on 4/30/10.  Had temp of 103 X 2 days after shots ; cranky, fussy, runny nose since then.  Spots appeared around 5/14, non-vesicular, on torso, diaper area & arms and legs.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Angioedema, Dyspnoea, Erythema, Swelling, Throat tightness
Clinical narrative: Within 5-10 minutes of given GARDASIL vaccine patient developed urticaria and angioedema of face, cheeks, ears. Patient also complained of throat tightness and sense of difficulty breathing. Erythema also developed of face and progressively spread with swelling to neck and chest. Epi 0.2cc given subcut. with notable improvement.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Within 5-10 minutes of given GARDASIL vaccine patient developed urticaria and angioedema of face, cheeks, ears. Patient also complained of throat tightness and sense of difficulty breathing. Erythema also developed of face and progressively spread with swelling to neck and chest. Epi 0.2cc given subcut. with notable improvement.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Condition aggravated, Rash generalised, Syncope, Tremor
Clinical narrative: Within 5-10 minutes of given GARDASIL vaccine patient developed urticaria and angioedema of face, cheeks, ears. Patient also complained of throat tightness and sense of difficulty breathing. Erythema also developed of face and progressively spread with swelling to neck and chest. Epi 0.2cc given subcut. with notable improvement.
Age: 16.0
Sex: F
Vaccine: HEPAB, HPV4, IPV, MNQ
Symptoms: Concussion, Contusion, Dizziness, Excoriation, Fall
Clinical narrative: Following vaccination patient got up from table and started to feel lightheaded w/ tunnel vision and blackening. Patient then fell to floor, w/o loss of consciousness. Resulted in child abrasion, contusion on left side of face and mild concussion. Patient released from clinic w/ f/u appointment in 2 days.
Age: 16.0
Sex: F
Vaccine: HEPAB, HPV4, IPV, MNQ
Symptoms: Loss of consciousness, Tunnel vision
Clinical narrative: Following vaccination patient got up from table and started to feel lightheaded w/ tunnel vision and blackening. Patient then fell to floor, w/o loss of consciousness. Resulted in child abrasion, contusion on left side of face and mild concussion. Patient released from clinic w/ f/u appointment in 2 days.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Joint swelling
Clinical narrative: Mother reported swelling in right thigh and knee after having vaccination.  Child seen in our office for evaluation upon assessment right thigh 1/4" > in diameter than left.  No redness no tenderness, full weight bearing on extremity.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: Left leg at anterior thigh red, warm, mild induration 15 cm X 18 cm.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Zoster-like rash ( R ) side of face & neck.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Rash, Rash pruritic, Skin warm
Clinical narrative: Zoster-like rash ( R ) side of face & neck.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: 2 inch diameter erythematous raised wheal to upper right arm, no s/s of infection.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: SWOLLEN THIGHS (SITES OF ADMINISTRATION) LASTED < 24 HOURS; TREATED WITH WARM COMPRESSES.  EXAM THE FOLLOWING DAY WAS NORMAL.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: 2 inch diameter erythematous raised wheal on upper right arm, no s/s of infection.
Age: 11.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness, induration on right deltoid area at injection site (5x3cm).
Age: 60.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Respiratory tract infection
Clinical narrative: Initial report received from health authority (116453) on 11 May 2010: This polymedicated patient with underlying condition of bronchopneumonia was vaccinated with S-OIV FOCETRIA (batch number 0902201) on 09 Nov 2009. The patient also received seasonal influenza vaccine (manufacturer and batch number unknown) on an unspecified date. The patient presented with an increase of respiratory infection on 03 Jan 2010. As corrective measures, the patient was given treatment with CIPROXIN, 500 mg oral from 03 Jan 2010 for 12 days and GLAZIDIM from 06 Apr 2010 for 6 days. Final outcome of the events was reported as not yet recovered.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Rash
Clinical narrative: STUDENT WITH FINE RASH NOTED TO FOREARMS, NECK AND CHEEK. NO DIFFICULTY BREATHING OR SHORTNESS OF BREATH.  STUDENT GIVEN ORAL BENADRYL 12.5 MG.  RASH IMPROVED.  STUDENT WAS WELL THE NEXT DAY PER SCHOOL NURSE.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left thigh, induration with warmth and erythema @ injection site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Awakened Friday am and noticed heat in right arm and round reddened area at injection site;  pt took Tylenol and applied ice to site.  On Monday, 5/17/10, pt reports redness is "almost gone".
Age: 2.0
Sex: M
Vaccine: HEPA, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: FOR 3/2/2010 I GAVE THE PNEUMOCOCCAL VACCINE TO LEFT THIGH.  ON 3/3/2010 CHILD RETURNED FOR READING TB TEST AND FAMILY INFORMED ME ABOUT REDNESS ON LEFT THIGH.  NOTICED 3 BY 4 INCHES INDURATION, REDNESS, SWELLING.  PRESCRIBE KEFLEX AND INFORM MOTHER BY PHONE AT 12:30 AM ON SAME DAY MAY BE A REACTION TO PNEUMOCOCCAL VACCINE OR INFECTION.  ADVISE TO RETURN THE NEXT DAY BUT PATIENT NEVER RETURNED.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: PATIENT'S MOTHER CALLED THE DAY AFTER VACCINE ADMINISTERED ON 3/2/2010 STATING CHILD'S ARM INDURATED THE DIZE OF MOTHER'S PALM.  WARM TO TOUCH, SORE AND ITCHING CHILD ON LEFT ARM BETWEEN THE SIDE AND BACK OF ARM.
Age: 13.0
Sex: F
Vaccine: IPV, MEN, TDAP
Symptoms: Injection site swelling
Clinical narrative: 1 DAY POST VACCINATION CHILD HAD A LARGE SWOLLEN AREA ON RIGHT ARM WHERE TDAP AND IPV WERE GIVEN.  MOM CALLED POISON CONTROL CENTER TO SEE IF SHE SHOULD APPLY HEAT OR COLD.  GIVEN ADVIL, TYLENOL, BENADRYL AND HEAT.  MOM WILL TAKE TO MD IF DOES NOT GO AWAY OR STARTS TO LOOK INFECTED.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood cholinesterase, Muscular weakness, Myasthenia gravis, Tensilon test abnormal
Clinical narrative: Muscle weakness which was ultimately diagnosed at myasthenia gravis.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscular weakness, Myasthenia gravis
Clinical narrative: Muscle weakness which was ultimately diagnosed at myasthenia gravis.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Right arm -severe pain at injection site with redness started by 4pm on 5/17 at Pneumovax site. Left arm developed redness at Zostavax injection site next am with "heat in it".
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Dizziness, Erythema, Nausea
Clinical narrative: Pt c/o nausea, loose stools, chills, feverish, body aches, dizziness, vertigo s/s, uncontrolled shaking and was unable to sleep related to s/s. Pt took Motrin on 12th. No redness noted. On 5/13/2010 seen by Dr. at 11:00 s/s remained with nausea & shaking increased on the 5-13-10.  Noted reddened mark however the redness was gone prior to leaving office. Pt took Benadryl & Motrin on the 13th in the afternoon. S/s resolved on 5-14-10.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Sleep disorder, Tremor, Vertigo
Clinical narrative: Pt c/o nausea, loose stools, chills, feverish, body aches, dizziness, vertigo s/s, uncontrolled shaking and was unable to sleep related to s/s. Pt took Motrin on 12th. No redness noted. On 5/13/2010 seen by Dr. at 11:00 s/s remained with nausea & shaking increased on the 5-13-10.  Noted reddened mark however the redness was gone prior to leaving office. Pt took Benadryl & Motrin on the 13th in the afternoon. S/s resolved on 5-14-10.
Age: 1.14
Sex: M
Vaccine: MMR
Symptoms: Computerised tomogram, Convulsion, Cyanosis, Electroencephalogram, Myoclonus
Clinical narrative: Seizure, myoclonic jerking, turned blue face turned white, ran a fever, developed a rash.
Age: 1.14
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash, Skin discolouration
Clinical narrative: Seizure, myoclonic jerking, turned blue face turned white, ran a fever, developed a rash.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Computerised tomogram, Hyperaesthesia, Muscular weakness, Nerve conduction studies
Clinical narrative: SKIN SENSITIVITY. SECOND DAY-LEG WEAKNESS. THIRD DAY-COULDN'T MOVE NECK. FOURTH DAY COULDN'T WALK AND WAS ADMITTED TO THE HOSPITAL.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Nuchal rigidity, Nuclear magnetic resonance imaging
Clinical narrative: SKIN SENSITIVITY. SECOND DAY-LEG WEAKNESS. THIRD DAY-COULDN'T MOVE NECK. FOURTH DAY COULDN'T WALK AND WAS ADMITTED TO THE HOSPITAL.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Syncope, Tremor
Clinical narrative: Fainted/LOC & trembling of extremities briefly <- not seizurelike tonic-clonic activity. Quickly regained consciousness and awakened - became alert/oriented. Felt dizzy -> resolved after resting minutes in clinic.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site rash
Clinical narrative: 5-15-10 patient seen in office for rash around injection site with itching located on the right upper arm. Description is 10 cm area of erythema mild edema over right deltoid.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Received 4 vaccines - asked to sit in chair x 15 min after HPV- stay next to pt admin (R) arm - after 2 min walk to chair to continue vaccine. Saw pt lean to (R) can get it lower to floor - after several seconds open eyes -talking no sign of injury with nurse x 10 min - given Panar Barrett wash - Denies having anything - no sign of injury. Ambulated to school nurse office. Dad called and made aware to call  PM and to  doctor. Pt denied any problems. 3 friends gave lunch stayed with in office -"Im fine". 5/17/10 called and spoke with pt Dad. 15:40 - Pt's fine "120" didn't feel well @ 1st and pt snapped out of it She is fine".
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Headache
Clinical narrative: C/o headaches off and on since TDAP vaccine given on 5/6/10 per patient statement.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right swollen area on site of injection red in color.
Age: 1.35
Sex: M
Vaccine: DTAP, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site urticaria
Clinical narrative: Urticaria within 5 minutes of immunization. Bilateral thighs with associated edema, redness, swelling. BENADRYL 12.5 mg IM given with resolution. *At MMR and Varicella sites*
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Hyperaesthesia, Rash erythematous, Rash vesicular
Clinical narrative: Classic case of shingles in the right T2-T3 distribution (burning pain with skin sensitivity starting 1 week after receiving the vaccine and on erythematous vesicular rash in the same distribution five days after the pain started).
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None Reported.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a patient who on unspecified dates was vaccinated with two doses of VARIVAX (Merck). On 29-JUL-2009 the patient developed a case of breakthrough chicken pox after getting two doses of VARIVAX (Merck). The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site infection, Varicella post vaccine
Clinical narrative: Information has been received from a consumer concerning her 24 month old granddaughter, who on "about a week and a half ago" was vaccinated with a dose of VARIVAX (Merck). Then a few days later she go an infection at the injection site and then broke out with chickenpox all over the body. The consumer reported that the patient saw her physician who stated that she had developed a mutation of the chickenpox. The consumer reported that at the time of reporting on 30-JUL-2009 the patient was recovering. No further information is expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received from a nurse concerning a 7 year old male who on 29-JUL-2009 was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (Lot# 0508Y). The patient's mother called the office on 30-JUL-2009 and stated that on 27-Jul-2009 her son developed a headache and nausea. On 28-JUL-2009, when the patient awoke, the injection site was red, swollen, and itchy and there was a blister (one pox) at the site. The patient's mother had called about a year ago and mentioned that she thought her son had had a breakthrough case of the chicken pox. The patient was never seen in the office to have a diagnosis made. The patient was recovering. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Nausea
Clinical narrative: Information has been received from a nurse concerning a 7 year old male who on 29-JUL-2009 was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (Lot# 0508Y). The patient's mother called the office on 30-JUL-2009 and stated that on 27-Jul-2009 her son developed a headache and nausea. On 28-JUL-2009, when the patient awoke, the injection site was red, swollen, and itchy and there was a blister (one pox) at the site. The patient's mother had called about a year ago and mentioned that she thought her son had had a breakthrough case of the chicken pox. The patient was never seen in the office to have a diagnosis made. The patient was recovering. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Medication error
Clinical narrative: Information has been received from a physician concerning an adult male patient who on an unspecified date was vaccinated with VARIVAX (Merck) (lot # not reported). The patient received VARIVAX (Merck) series while on chronic acyclovir. Follow up information has been received via telephone call from a radiologist who indicated that the patient was on acyclovir for herpes simplex virus. He indicated that the patient did not have any titer and any adverse experiences after received VARIVAX (Merck) doses. He did not have any information on the date of vaccination and the VARIVAX (Merck) lot #. Follow up information has been received from a physician who reported that the patient was taking acyclovir and was not told to stop, so he did not have immunity after he received the two doses of VARIVAX (Merck) (lot number not reported). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female with no pertinent medical history nor drug reaction who on 03-AUG-2009 was vaccinated subcutaneously with the second 0.5ml dose of VARIVAX (Merck) (lot # 664468/0684Y).  There was no concomitant medication.  On 03-AUG-2009 the patient developed an immediate reaction at the injection site of redness, warmth, itching and burning.  Dose 1 was administered at a different facility and no information known about that dose.  The patient was in the office.  No lab diagnostics studies was performed.  She was told to take BENADRYL and to apply ice.  At the time of reporting the patient was not recovered.  Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of VARIVAX (Merck) (lot#, route and site of administration not reported). Subsequently, the patient experienced "some type of injection site reaction". Unspecified medical attention was sought. At the time of reporting the patient's outcome was unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old male who on 20-JUN-2003 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot#, site of administration unknown) and a dose of PREVNAR. On 31-JUL-2007 the patient was vaccinated subcutaneously with the second dose of VARIVAX (Merck)  (lot# 657449/0597U) into the left arm. On 29-JUL-2009 the patient developed rash on body for a day. The physician examined and found approximately 25 lesions, afebrile. And the patient was diagnosed "probable varicella". No relevant diagnostic tests were performed. At the time of reporting the patient's rash on body persisted. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site irritation, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 14 year old female who on 28-JUL-2009 was vaccinated subcutaneously with the second 0.5mL dose of VARIVAX (Merck) (LOT # 664620/0797Y). On an unspecified date, the patient experienced local reaction at the injection site. There was no lab diagnostics performed. The patient was not recovered at the time of this report. Follow-up information has been received from the nurse. The patient was 22 years old (previous reported as 14). She has recovered on an unspecified date. Follow-up information has been received from the registered nurse concerning the 22 year old female patient who on 28-JUL-2009 was vaccinated subcutaneously with the third (previous reported as second) 0.5mL dose of VARIVAX (Merck) (LOT # 664620/0797Y). On 29-JUL-2009, the patient experienced local injection site irritation described as itchy and swollen. On 30-JUL-2009, 24 hours later, the patient experienced a temperature of 100 and a larger area of swelling. The patient was treated with ice and symptomatic treatment. On an unknown date the patient recovered. A lot check has been initiated. This is one of several reports from the same source. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning four patients who on unspecified dates was vaccinated with a dose of VARIVAX (Merck) (LOT# not reported). On unreported dates, after vaccination, the patients experienced local injection site reactions. No further information was available at the time of this report. Follow-up information has been received from a nurse concerning a 10 year old female who in the week or so of 24-JUL-2009 was vaccinated with a dose of VARIVAX (Merck) (LOT# 66420/0797Y). "During the week or so of 24-JUL-2009", the patient experienced injection site reactions. She had recovered at the time of this report. Follow-up information has been received from a registered nurse concerning the 10 year old female who on 31-JUL-2009 was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (LOT# 664620/0797Y). Concomitant vaccination included a dose of VAQTA (663683/1715X), IM, on the same day. On 01-AUG-2009, the patient experienced local injection site reaction to varicella described as with warm, itchy, red and swollen. The patient was treated with cool compresses and observation. The patient had recovered on an unspecified date. A lot check has been initiated. This is one of several reports from the same source. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a male patient who at the age of one in approximately 1999 was vaccinated subcutaneously with the first dose of VARIVAX (Merck). There was no concomitant medication. In 2005 when the patient was approximately 7 years old, the patient developed shingles as confirmed by physician. The patient had sought medical attention via office visit and had recovered (date unknown). There was no laboratory studies performed. Additional information has been requested.
Age: 1.46
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning an approximately 17 month of female patient who developed rash that appeared to be similar to "mosquito bites" on the patient's arms and legs after receiving a dose of 0.5 VARIVAX (Merck) (lot # 660341/0371X) subcutaneously on 06-JUL-2009 and MMR (lot # 661732/1290X) on 01-JUN-2009. There are less than 50 lesions on her. Unspecified medical attention has been sought. The patient was recovering at the time of reporting. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Malaise, Pruritus, Pyrexia, Varicella
Clinical narrative: Information has been received from a physician concerning a 36 month old female who was vaccinated with the first 0.5ml dose of VARIVAX (Merck) when she was one year old in 2007 and experienced itchiness, fever and malaise. No lot # was provided. Follow-up information has been received from the physician indicated that the patient developed chicken pox after the first dose of VARIVAX (Merck), at the time as the fever, itchiness and malaise. The patient had sought unknown medical attention. The patient recovered on an unspecified date. No further information is available.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with allergies to CECLOR, cephalexin (manufacturer unknown), gentamicin eye drops (manufacturer unknown), penicillin (manufacturer unknown), ZITHROMAX and with ADVIL caused asthma who on 22-AUG-1995 was vaccinated SC with the first 0.5ml dose of VARIVAX (Merck) and on 03-AUG-2009 was vaccinated SC with the second 0.5ml dose of VARIVAX (Merck) (Lot# 664712/0799Y). Concomitant therapies included OCELLA and ALLEGRA. The patient also was vaccinated with DTP vaccine (manufacturer unknown) on the same visit but different site. On 04-AUG-2009 the patient developed a red raised area the size of softball at the site of injection. The patient had sought unknown medical attention. At the time of report the patient's status was not recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 1.52
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: Information has been received from a nurse concerning an approximately 14 year old male with a history of reactive airways disease who on 23-FEB-1996 was vaccinated with the first dose of VARIVAX (Merck). At an unknown time later the patient experienced shingles. The nurse did not know when the shingles occurred and the lesions were completely healed. VZVID program was discussed and the nurse is not interested in it because the lesions have healed. The patient had not sought medical attention. At the time of report the patient's status was recovered. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: VARCEL
Symptoms: Seroconversion test negative, Vaccination failure
Clinical narrative: Information has been received from a medical assistant concerning a 27 year old male with no pertinent medical history and no drug allergies, who on 08-MAY-2009 was vaccinated with the first 0.5ml dose of VARIVAX (Merck) (lot # 659604/1743X) SC, and the second 0.5ml dose (lot # 659604/1743X) SC on 18-JUN-2009. There was no concomitant medication. After 2 doses of vaccination, the patient had failed to seroconvert. Titers were taken. The patient sought unspecified medical attention. At the time of the report, the patient did not seroconvert. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: FLU3, PNC, VARCEL
Symptoms: Pyrexia, Rash papular, Skin lesion
Clinical narrative: Information has been received from a health professional concerning a 20 month old male patient who on 24-FEB-2009 was vaccinated in the right leg with the first dose of VARIVAX (Merck) (lot number 660663/1534X). The same day was vaccinated in the left leg with the fourth dose of PREVNAR (lot number C27703) and in the left leg with the second dose of FLUZONE (lot number UT2788HA). On 15-NOV-2009 the patient experienced fever (100-103) that resolved for 2 days and papule vesicle lesion trunk, head and lower leg. On 24-Nov-2009 the patient recovered. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of VARIVAX (Merck), SC. Two weeks later the patient developed "a varicella-like rash". The patient had contacted the office for medical attention. The patient's varicella-like rash persisted at the time of the report. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with VARIVAX (Merck). The physician reported that on an unspecified date, after receiving the VARIVAX (Merck), the patient experienced shingles. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who on 17-DEC-2009 was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck) due to a human error. There were no adverse effects reported. It was unknown if the patient had sought medical attention. At the time of report the patient's status was unknown. On 20-JAN-2010 all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with VARIVAX (Merck). The physician reported that on an unspecified date, after received the VARIVAX (Merck), the patient experienced shingles. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: No therapeutic response, Varicella virus test negative
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old male patient who on 16-FEB-1999 and 21-JAN-2000 was vaccinated with two doses of VARIVAX (Merck) (lot #, dose and route unknown). In 1999, he had a negative varicella titer prior to receiving the vaccine. The patient's relevant past drug history and concomitant medications were unknown. On 24-DEC-2009 the patient's varicella titer was still negative. As of 28-DEC-2009, it was unknown if the patient would receive VARIVAX (Merck) again. Labs or diagnostic tests included varicella titer which was negative. At the time of the report, the outcome was not reported. Information has been received from a registered nurse concerning the 24 year old male patient who failed to seroconvert after 2 known doses of VARIVAX (Merck). It was noted he may have received one dose as a child but there was no record of that dose. It was reported that the patient had a negative titer in January 1999 so he received VARIVAX (Merck) (16-FEB-1999 & 21-JAN-2000). A titer done on 24-DEC-2009 was negative. This is a consolidation of two reports concerning the same patient. No further information is available.
Age: 38.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Joint stiffness, Swelling
Clinical narrative: Information has been received from a 38 year old male patient who on 20-FEB-2009 was vaccinated with a 0.5 mL first dose of VARIVAX(Merck) and on 22-MAY-2009 received a second dose of VARIVAX (Merck). The patient stated that he received the second dose of VARIVAX (Merck) 50 minutes after reconstitution rather than within the recommended 30 minutes. In approximately August 2009, about 3 months after getting the VARIVAX (Merck), the patient experienced stiffness and swelling in hands and fingers. The patient sought unspecified medical attention. At the time of reporting the patient had not recovered from stiffness and swelling in hands and fingers. No further information is available.
Age: 0.3
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 month old male, with no relevant medical history, who on 02-JAN-2009 was accidentally vaccinated with VARIVAX (Merck). Concomitant medications and past drug history were unknown. It was reported that on 02-JAN-2009, the infant was given the wrong vaccine while in the pediatrician's office. The licensed practical nurse reported that the patient was doing fine. It was unknown if there was any relevant laboratory data. As of 02-JAN-2009, it was unknown if he would continue to get VARIVAX (Merck) and he was doing fine. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: FLU(H1N1), FLU3, PNC, VARCEL
Symptoms: Rash papular, Scab, Upper respiratory tract infection
Clinical narrative: Information has been received from a health professional concerning a 13 month old female patient who on 30-OCT-2009 was vaccinated with the first dose of VARIVAX (Merck) (Lot # 665395/1079Y) subcutaneously into the right thigh. Concomitant vaccination included the fourth dose into the left leg of PREVNAR (Lot # 066586), the first dose intramuscularly into the left leg of H1N1 (Lot # UP012AA) and the first dose intramuscularly into the left leg of Influenza virus vaccine (unspecified) (Lot # U3262EA). On 18-DEC-2009 the patient experienced 20-25 papules like vesicles, some vesicular some scabby and 2-10 scabby in trunk and upper respiratory tract infection symptoms. On 28-DEC-2009, the patient recovered. The patient did not seek medical attention. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: Information has been received from a consumer who reported that his 5 years old niece's daughter with a history of unspecified surgeries was vaccinated with VARIVAX (Merck) (lot # not reported) on an unspecified date.  Concomitant therapy included antibiotics (unspecified).  It was reported that the patient was 4 years old when she received VARIVAX (Merck) and developed weird outbreaks whenever she got colds.  The outbreaks started on approximately 04-JAN-2009 "about a year ago".  The outbreaks were always on one side of her body and they were blister rashes.  One physician who checked the patient said that it was shingles.  The patient had another outbreak recently but she was over it at the time of this report.  The reporter indicated that the patient had received H1N1 in the last few months.  On an unknown date, the patient recovered.  Follow-up information from her physician revealed that the patient did not currently have a rash but was checking in the event the patient developed another episode.  Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received form a certified medical assistant concerning a patient who on 22-DEC-2009 was inadvertently vaccinated subcutaneously with a 0.5ml dose of VARIVAX (Merck) (lot # not reported) instead of ZOSTAVAX (Merck). No adverse effect was reported. The reporter stated that this was related to staff error and not product confusion. Follow-up information has been received from a medical assistant who reported that the patient was 66 year old. On 22-DEC-2009, the patient was vaccinated with a dose of VARIVAX (Merck) instead of receiving ZOSTAVAX (Merck). The medical assistant stated that a medication error had occurred and not product confusion. The patient did not receive any concomitant vaccination at that time. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Information has been received from a consumer concerning her 12 months old daughter who "2 weeks ago", on approximately 29-DEC-2009 was vaccinated with a dose of VARIVAX (Merck) (lot number not reported). About 1 and 1/2 weeks after the vaccination, on approximately 09-JAN-2010 the patient developed a mark at the  injection site. It was a "wide red ring with a bump". The child was seen by doctor who said not related to VARIVAX (Merck). The mother believed it was because it was the exact spot where the vaccine was administered. At the time of the report, the patient had not recovered. No further information is available.
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was inadvertently vaccinated with a dose of VARIVAX (Merck) (lot# not reported) instead of ZOSTAVAX (Merck). No adverse effect was reported. Follow-up information has been received from a registered nurse who reported the patient's gender as male and said the event occurred on 14-NOV-2009. She explained that theirs is a small office and the person who administered the vaccine picked up wrong vial. There was no adverse event. The patient was given the ZOSTAVAX (Merck) at a later date. Additional information is not expected.
Age: 66.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Skin warm, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 18-AUG-2009 was mistakenly vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck). No adverse effect was reported. It was unknown if the patient sought medical attention. Follow-up information was received from the registered nurse. She mentioned the patient was 66 year old. The wrong vaccine was administered due to human error and computer error. She noted that the computer system was new within the last coupe of months. The nurse indicated that the provider "heard shingles" but it "came through" as VARIVAX (Merck). She said that the provider selected VARIVAX in error. The nurse added that the label intact and that it was not due to a label error. She also reported that the patient returned 2 days after receiving the vaccination with an adverse experience of injection site redness and warm to touch. She indicated the red area measured 2.5in x 3in. The patient had recovered from the events. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Drug exposure during pregnancy, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a consumer (mother's patient) for the Pregnancy Registry for VARIVAX (Merck), concerning her daughter an 18 year old female with "urinary tract infection" who on 30-JUN-2009 was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not reported). Suspect therapy included DTaP on the same day (on 30-JUN-2009, manufacturer unspecified) (dose, route and lot number not reported). The mother reported that her daughter was already pregnant with "21 weeks" of gestation (LMP: approximately 26-MAR-2009, EDD: approximately on 8-JAN-2010), when she was vaccinated with the two vaccines on the same day (on 30-JUN-2009). The patient had recently an ultrasound performed, which revealed fluid in the baby's kidneys. At the time of the report the outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Varicella
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 year old female with convulsion and no allergies who on 30-APR-2002 was vaccinated subcutaneously with a 0.5ml dose of VARIVAX (Merck) (lot # and site of administration not reported).  Concomitant therapy included TRILEPTAL for seizures.  On 22-AUG-2009, the patient was seen in the office with a few raised red spots.  On 24-AUG-2009, in the morning, the patient's mother called the office and stated that more spots had erupted, afebrile.  On 24-AUG-2009 the nurse reported that the patient had chickenpox now.  The patient was treated with calamine lotion and oatmeal baths.  No laboratory diagnostics studies were performed.  At the time of this report, the patient had not recovered.  This is one of several reports from the same source.  Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash maculo-papular, Varicella post vaccine
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 year old female with no health history or allergies who on 02-JUL-1997 was vaccinated subcutaneously with a 0.5ml dose of VARIVAX (Merck) (lot# and site of administration not reported). On 21-AUG-2009, the patient developed a few raised red spots and on 22-AUG-2009 she was seen in the office with more than 100 raised red spots, afebrile. On 24-AUG-2009 the  nurse reported that the patient had chickenpox now. The patient was treated with calamine lotion and oatmeal baths. No laboratory diagnostics studies were performed. At the time of this report, the patient had not recovered. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a patient who on 25-AUG-2009 was vaccinated with VARIVAX (Merck) (lot# not reported), instead of with ZOSTAVAX (Merck) due to human error. No adverse effect reported. Additional information has been requested.
Age: 1.8
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash generalised, Varicella
Clinical narrative: Information has been received from a nurse concerning a 22 month old male who on 24-MAR-2009 was vaccinated with the first 0.5ml dose of VARIVAX (Merck) (lot#, route and site of administration not reported). On approximately 24-JUN-2009 ("3 months after the first vaccination") the patient developed a case of viral out break of chickenpox. The patient also had fever and random type like rash all over his body. On 11-AUG-2009 the patient was seen at the physician's office. On an unspecified date, the patient was completely recovered. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from a Registered Nurse concerning a 14 year old male patient with pertinent medical history reported as none and seasonal allergies who on 16-AUG-1996 was vaccinated with first dose of VARIVAX (Merck) (lot # 616867/0243D) subcutaneously. On 17-OCT-2006 he received second dose of VARIVAX (Merck) (lot # 654530/1046F) subcutaneously. Concomitant therapy included ZYRTEC. On approximately 13-AUG-2009 he was in contact with a friend who had chicken pox. On 25-AUG-2009 the patient broke out with a chicken pox rash to his back, stomach, body and shoulders. The lesions were patchy through these areas. The patient sought medical attention by phone. At the time of the report on 27-AUG-2009 the patient was recovering. There were no laboratories diagnostics studies performed. No further information is available.
Age: 65.0
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old patient who on 27-AUG-2009 was vaccinated with a dose of VARIVAX (Merck) (Lot number 662125/0379Y) instead of ZOSTAVAX (Merck) due to a nursing error. No adverse reactions reported. The registered nurse stated that the label on the vial was intact and legible. It was unspecified if the patient sought medical attention. At the time of the report, the outcome of the event was unknown. No further information is available.