chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.53
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Convulsion, Pyrexia
Clinical narrative: Suffered from convulsions accompanied with low grade fever. Convulsions began on 09/08/07 lasting 1-2 min, no reported pattern, happened roughly 4 times in the following weeks. 4/28/08-records received-evaluation 3/31/08 13 months of age-Assessment: not eligible for early intervention services.  Per family patient screamed after 2, 4 and 6 month immunizations and experienced convulsions.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, X-ray abnormal
Clinical narrative: Patient had intussusception on 3/31/08.  6/3/08 Reviewed hospital medical records for 3/31-4/1/2008. FINAL DX: Intussusception, enema reduced. Records reveal patient experienced vomiting, bloody stools x 1 day.  Admitted for observation s/p enema reduction of IS.  Overnight had apparent abdominal pain upon feeding.  Repeat US was neg for IS, revealed mild bowel edema.  Improved & was d/c to home.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Barium enema abnormal, Enema administration, Gastrointestinal oedema
Clinical narrative: Patient had intussusception on 3/31/08.  6/3/08 Reviewed hospital medical records for 3/31-4/1/2008. FINAL DX: Intussusception, enema reduced. Records reveal patient experienced vomiting, bloody stools x 1 day.  Admitted for observation s/p enema reduction of IS.  Overnight had apparent abdominal pain upon feeding.  Repeat US was neg for IS, revealed mild bowel edema.  Improved & was d/c to home.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Haematochezia, Intussusception, Ultrasound scan abnormal, Vomiting, X-ray abnormal
Clinical narrative: Patient had intussusception on 3/31/08.  6/3/08 Reviewed hospital medical records for 3/31-4/1/2008. FINAL DX: Intussusception, enema reduced. Records reveal patient experienced vomiting, bloody stools x 1 day.  Admitted for observation s/p enema reduction of IS.  Overnight had apparent abdominal pain upon feeding.  Repeat US was neg for IS, revealed mild bowel edema.  Improved & was d/c to home.
Age: 1.2
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: CSF test normal, Convulsion, Electroencephalogram normal, Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Seizures requiring one week hospitalization with multiple medications to control. Seizures lasted 2 months despite Dilantin and Keppra. In control at present, weaning anti-seizure medications. MRI/MRV - negative; Video EEG - negative.  4/29/08 Reviewed hospital medical records for 1/10-1/12/2008. FINAL DX: likely pertussis encephalopathy; recurrent seizures. Records reveal patient experienced nasal congestion x 2-3 days, received vaccines, developed fever, irritability, generalized tonic-clonic seizure lasting 3-4 min.  Seen in outlying ER & continued to have seizures w/eyes rolling back, frothing at mouth, desaturations & tachycardia despite medications.  Total of approx 15-17 seizures.  Temp in ER 101.2.  Transferred to higher level of care.  Peds ICU.  Tx w/antiseizure meds & precautionary antivirals initially then d/c'd.    Neuro consult done.  Continued to have brief seizures w/perioral cyanosis.  Progressed w/fewer & shorter seizures.  D/C to home on antiseizure med.  F/U phone call by MD on 1/13/2008 parent stated continued to seize approx every hour for approx 90 secs w/brief cyanosis.  Parents refused readmission, meds were changed & were to f/u w/neuro on 1/14.
Age: 1.2
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Viral test negative
Clinical narrative: Seizures requiring one week hospitalization with multiple medications to control. Seizures lasted 2 months despite Dilantin and Keppra. In control at present, weaning anti-seizure medications. MRI/MRV - negative; Video EEG - negative.  4/29/08 Reviewed hospital medical records for 1/10-1/12/2008. FINAL DX: likely pertussis encephalopathy; recurrent seizures. Records reveal patient experienced nasal congestion x 2-3 days, received vaccines, developed fever, irritability, generalized tonic-clonic seizure lasting 3-4 min.  Seen in outlying ER & continued to have seizures w/eyes rolling back, frothing at mouth, desaturations & tachycardia despite medications.  Total of approx 15-17 seizures.  Temp in ER 101.2.  Transferred to higher level of care.  Peds ICU.  Tx w/antiseizure meds & precautionary antivirals initially then d/c'd.    Neuro consult done.  Continued to have brief seizures w/perioral cyanosis.  Progressed w/fewer & shorter seizures.  D/C to home on antiseizure med.  F/U phone call by MD on 1/13/2008 parent stated continued to seize approx every hour for approx 90 secs w/brief cyanosis.  Parents refused readmission, meds were changed & were to f/u w/neuro on 1/14.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash macular, Rash papular, Rash vesicular
Clinical narrative: 4-12-08 48 hours after injection developed macular/papular/vesicular rash inner right thigh and right buttocks.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Small bowel angioedema, X-ray abnormal
Clinical narrative: Bloody diarrhea.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Developed urticaria approximately 12-16 hours after last HPV vaccination. Was back at college at the time. Went to urgent care - prescribed steroids to treat and advised not to get HPV#3.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site urticaria, Urticaria
Clinical narrative: Developed hives immediately after receiving vaccine at site and on trunk.  Benadryl given.  Mother requested to have child monitored - Vital signs and O2 stable for 45 minutes.  Parent requested patient to be monitored longer - transported to ED via ambulance.  Referred to allergist also.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed zoster rash 9 days after receiving vaccine
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: No adverse events.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Rash generalised, Vomiting
Clinical narrative: Had rash-all over body started on stomach-had her soak in oatmeal.  Vomited-just gave her water.  Shot on Saturday-symptoms on Wednesday.
Age: 28.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Chills, Diarrhoea, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pain near injection site.  Local 4cm surrounding warmth erythema to injection site R arm Hep A.  Infraclavicular lymphadenopathy.  Nausea, diarrhea.  Fevers/chills.  Headache.  All symptom onset within 24 hours.
Age: 28.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Injection site warmth, Local reaction, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: Pain near injection site.  Local 4cm surrounding warmth erythema to injection site R arm Hep A.  Infraclavicular lymphadenopathy.  Nausea, diarrhea.  Fevers/chills.  Headache.  All symptom onset within 24 hours.
Age: 1.0
Sex: F
Vaccine: FLU3, HBHEPB, IPV, MMR, PNC
Symptoms: Pyrexia, Rash pustular, Varicella
Clinical narrative: Fever - Pustules; Varicella outbreak after vaccination; Motrin - Tylenol
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Arm was red/swollen/warm to the touch.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Back pain, Condition aggravated, Herpes zoster, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 5 year old female with no medical history or allergies who on 23-FEB-2007 was vaccinated with a second dose of VARIVAX (Oka/Merck). There was no concomitant therapy. There was no illness at the time of vaccination. The patient was vaccinated with first dose of vaccine on an unspecified date. On 21-SEP-2007 (previously reported as 23-SEP-2007) the patient developed shingles rash. Unspecified medical attention was sought. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been received which stated that the patient on 21-SEP-2007 developed shingles. The patient also had fever, vomiting, rash from left middle back to side. The patient had "lots and lots" of pain which felt like "someone kicking her in the back". On 30-SEP-2007 the patient recovered. Additional information has been received from the nurse, the patient's mother, indicating that the patient weighs 43 pounds (previously reported as 30 pounds). On 23-Feb-2007 the patient was vaccinated with a dose of MMR II (Enders-Edmonston) plus VARIVAX (Oka/Merck upgrade process), previously reported as a second dose of VARIVAX (Oka/Merck). It was reported that the patient had shingles at the time of vaccination. A rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. On 22-Sep-2007 (also reported as 21-Sep-2007 and October 2007) at 11 AM the patient developed shingles. The patient rated the pain a 10 on a scale of 1 to 10 (10 being the most painful). There were no laboratory or diagnostic tests performed. There was no history of chickenpox, recent exposure to chickenpox or herpes zoster. On 06-Oct-2007, (also reported as 30-Sep-2007, and lasting a week) the patient recovered. It was reported that the patient is "doing okay", with nothing since the initial outbreak. She is healthy and happy. The reporter considered shingles to be an other important medical event. No further information is expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dysphonia, Headache, Injection site erythema, Injection site pain
Clinical narrative: Completely feeling fine prior to receiving shingles virus shot.  Took 2 Tylenol.  At 2 AM bad headache, took 2 more Tylenol.  Site of shot became red, pain & swelled.  Became hoarse & started cough, then nose congestion & achy body muscles.  Still ongoing now.  Temp. was not taken.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Nasal congestion
Clinical narrative: Completely feeling fine prior to receiving shingles virus shot.  Took 2 Tylenol.  At 2 AM bad headache, took 2 more Tylenol.  Site of shot became red, pain & swelled.  Became hoarse & started cough, then nose congestion & achy body muscles.  Still ongoing now.  Temp. was not taken.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4-year-old Caucasian female with no pertinent medical history or allergies who on 07-JAN-2008 was vaccinated with the first dose 0.5 ml dose of PROQUAD (lot # 657300/0545U) SQ in the right thigh.  There was no illness at the time of vaccination.  There were no concomitant medications.  On 13-JAN-2008 the patient developed a red, itchy induration at the injection site of the right thigh.  The nurse described the red area as 14 x 22 mm red area on right thigh where the PROQUAD was given.  The patient was examined in the office on 14-JAN-2008 and was prescribed diphenhydramine hydrochloride (BENADRYL).  No diagnostic labs were performed.  The patient had previously been administered PROQUAD on 29-SEP-2004.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Additional information has been requested. This is a follow-up to report (s) previously submitted on 4/4/2008.  Information has been received from a licensed practical nurse concerning a 4-year-old female with no pertinent medical history or allergies who on 07-JAN-2008 was vaccinated with the first dose 0.5 ml dose of PROQUAD (lot # 657300/0545U) SQ in the right thigh.  There was no illness at the time of vaccination.  There were no concomitant medications.  On 13-JAN-2008 the patient developed a red, itchy induration at the injection site of the right thigh.  The nurse described the red are as 14 x 22 mm red area on right thigh where the PROQUAD was given.  The patient was examined in the office on 14-JAN-2008 and was prescribed BENADRYL.  No diagnostic labs were performed.  The patient had previously been  administered PROQUAD on 29-SEP-2004.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  No additional information is expected.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chest discomfort, Chills, Nausea, Palpitations
Clinical narrative: Fever to 101.3, chest tightness, chills, nausea, heart racing, aching in multiple joints, no rashes.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever to 101.3, chest tightness, chills, nausea, heart racing, aching in multiple joints, no rashes.
Sex: F
Vaccine: MMRV
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated SC with a 0.5 ml dose of PROQUAD. It was reported that the patient developed rash after vaccination. The patient's rash looked like chickenpox and appeared on her abdomen. Unspecified medical attention was sought. At the time of report the patient had recovered. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Pruritus, Skin warm, Swelling
Clinical narrative: Had Menactra IM RD & Varivax area with knot SQ R arm on 3-24-08 in am.  Called at 3:02 on 3-25-08 by mo.  c/o knot on arm size of tennis ball with heat, redness & itching.  Take Benadryl as directed, ER prn.  On 3-26-08 in clinic with swelling 95 x 99 mm with redness.  MD saw increased Benadryl & Epsom salt compress.  Better by 3-28-08.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Rash generalised, Rash morbilliform
Clinical narrative: Information has been received from a pharmacist concerning her 1-year-old son with no pertinent medical history of allergies, who on 16-JAN-2008 was vaccinated with a dose of PROQUAD.  There was no concomitant medication.  On 25-JAN-2008 the patient developed a measles like rash all over his body.  After the initial outbreak, the rash seemed to be going away, but several days later the rash appeared again all over his body.  The patient was seen by a physician.  There were no laboratory or diagnostic studies performed.  The outcome was reported as not recovered.  No product quality complaint was involved.  Additional information has been requested. This is in follo-up to report(s) previously submitted on 4/4/2008.  Follow-up information has been received from the physician who indicated that he has no further information regarding the adverse experience.  Additional information is not expected.
Sex: F
Vaccine: MMRV
Symptoms: Injection site rash
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated SC with a 0.5 ml dose of PROQUAD. It was reported that the patient developed rash after vaccination. The patient's rash appeared on her injection site. Unspecified medical attention was sought. At the time of report the patient had recovered. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested. This is one several reports received from the same source.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Urticaria 24hr after vaccines
Age: 0.2
Sex: F
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a licensed visiting nurse (L.V.N.) concerning a 2-month-old female (also reported as 4-months) who on 11-DEC-2007 was vaccinated with a dose of PROQUAD (lot# 657535/0541U) instead of HIB conj-hepatitis B vaccine.  No adverse reaction noted.  Medical attention was sought in the office.  The L.V.N. reported that "they did not administer the vaccine to the patient".  This error was discovered after reviewing the patient's chart.  The L.V.N. could not confirm if this was product confusion.  No product quality complaint was involved.  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 4 year old female who on 29-JAN-2008 was vaccinated with a dose of PROQUAD (03480 invalid lot#). On 29-JAN-2008 the patient experienced pain, redness, swelling and hot to the touch at the injection site. Subsequently, the patient recovered on an unknown date. Unknown if medical attention was sought. No product quality complaint. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: HEPAB, YF
Symptoms: Burning sensation, Chest discomfort, Dyspnoea, Palpitations, Pruritus
Clinical narrative: "Heart racing, thighs burning/itching, chest felt constricted, hives over entire body, difficulty breathing."  ER at 1:00 PM.  Benadryl, steroid (did not know name of steroid).  Pepcid given IV.  Sent home at 4:30 PM with Epi Pen.  Rx for Benadryl, dose pack of steroid, Pepcid x7 days.
Age: 33.0
Sex: M
Vaccine: HEPAB, YF
Symptoms: Urticaria
Clinical narrative: "Heart racing, thighs burning/itching, chest felt constricted, hives over entire body, difficulty breathing."  ER at 1:00 PM.  Benadryl, steroid (did not know name of steroid).  Pepcid given IV.  Sent home at 4:30 PM with Epi Pen.  Rx for Benadryl, dose pack of steroid, Pepcid x7 days.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Swelling face
Clinical narrative: 1 1/2 days after Gardasil shot given in left deltoid: - reaction started Thursday morning - face swelled and rash all over body.  Took Benadryl Thursday pm and better by Friday A.M.  (History of allergy to pertussis as child).
Sex: U
Vaccine: HEPA, MMRV
Symptoms: Convulsion
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with PROQUAD.  Suspect therapy included hepatitis A virus vaccine (mfr. unknown).  Subsequently the patient experienced seizures.  Upon internal review seizures were determined to be an other important medical event.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Dyspnoea, Eye swelling, Flushing, Rash macular, Throat irritation
Clinical narrative: Face flushed, throat scratchy, had some SOB, no itching, blotched-light, swelling around eyes.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, IPV, MMRV
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a physician concerning a 4 year old female who on approximately 19-FEB-2008 was vaccinated with "one dose" of PROQUAD. Concomitant therapy included poliovirus vaccine inactivated unspecified and PEDIARIX given in the other leg. On approximately 19-FEB-2008 the patient developed "one localized big hive in the injection area' after receiving the vaccine. No further information was provided. Unspecified medical attention was sought, the patient called the physician. The outcome was reported as recovered approximately 21-FEB-2008, "within a couple of days after receiving the vaccine. There were no lab diagnostic studies performed. there was no product quality complaint. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: HIBV, PNC, RV5
Symptoms: Body temperature increased, Electroencephalogram, Skin discolouration
Clinical narrative: Child received immunization and was ok when left Health Department.  Child went to daycare.  After a short time at daycare, child turned "blue" and was rushed to ER.  Case manager stated child's temperature was 101.
Sex: U
Vaccine: MMRV
Symptoms: Febrile convulsion
Clinical narrative: It was reported in a newspaper article that children, ages 12 months through 23 months, who were vaccinated with a dose of PROQUAD suffered higher rates of fever related convulsions than children vaccinated with two separate shots, one for chickenpox and one for the three other diseases. The study reported that the rate of seizures was twice as high, which translates to about one extra case of convulsion for every 2,000 doses administered. The study focused on children who develop fevers and then go into convulsions, an occurrence that frightens parents but usually has no lingering consequences. There were no deaths in the study. Upon internal review, febrile convulsions was considered to be an other important medical event. Additional information is not expected.
Age: 1.02
Sex: M
Vaccine: HBHEPB, IPV, MMRV
Symptoms: Febrile convulsion
Clinical narrative: Information has been received from a certified medical assistant concerning a 12 month old male with no pertinent medical history or drug allergies who on 12-SEP-2007 was vaccinated SC with a 0.5 ml dose of PROQUAD, VARIVAX (lot# 658185/0788U).  Suspect vaccination administered on that same day included a dose of COMVAX.  Concomitant vaccination also administered that day included a dose of poliovirus vaccine inactivated (unspecified).  On 21-SEP-2007 the patient experienced a febrile seizure and was evaluated in the emergency room.  The seizure lasted about 30 seconds.  The patient was not admitted to the hospital, but was seen later that same day in the physician's office.  Subsequently, the patient recovered.  There was no product quality complaint.  Febrile seizure was considered to be disabling by the reporter.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC
Symptoms: Convulsion
Clinical narrative: Seizure after Proquad, no fever associated.
Age: 1.1
Sex: M
Vaccine: DTAP, HBHEPB, HEPA, IPV, MMRV
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 20 month old male who on 03-AUG-2007 was vaccinated SC with a 0.5 ml dose of PROQUAD (lot# 656164/1353F). Concomitant vaccinations administered on that same day included a dose hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (MSD), a dose poliovirus inactivated (unspecified), a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of hepatitis A vaccine (unspecified) (manufacturer unknown). On 17-FEB-2008 the patient experienced diagnosed with chickenpox characterized by a rash on the neck and trunk of less than 50 lesions. The patient sought medical attention through a physician office visit. No labs or diagnostic studies were performed. Subsequently, the patient recovered. There was no product quality complaint. No further information is available.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site bruising, Injection site induration, Injection site nodule, Injection site urticaria
Clinical narrative: Patient came to office on 4/8/08 - vaccines given 4/4/08. Patient with 1cm x 2cm hardened nodule with 3in x 3in bruising around sq injection site on right arm - left arm with 0.7cm x 0.7cm bruising with 1cm x 1cm urticaria. Mom reported much worse 1-2 days after injection. No fever, no other symptoms or complaints at this time.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Scratch, Skin lesion, Tenderness
Clinical narrative: Lesions from scratching 12 cm in width.  Tender to touch.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: Copious loose stools 4/4 to 4/7 present likely Rotavirus GE, not dehydrated.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Lymphadenopathy
Clinical narrative: "Patient" was given a meningococcal vaccine and a Tdap - 2 days later both lymph nodes under chin swelled. No fever, ok energy.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Local reaction, Pain, Swelling
Clinical narrative: Local pain/swelling after MCV4.
Age: 14.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction, Pyrexia
Clinical narrative: Local mild redness/tenderness, warmth, on the R site of arm.  Fever.
Age: 63.0
Sex: F
Vaccine: HEPAB, TDAP, VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: Client reports, "I got the shingles from my shingles shot".  Client reports getting Zoster shot on 2/11/08 and having blisters appear (2) by her (L) eye then (1) in her (L) eye.  Client reports pain being so severe that she can't wear her glasses.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Anxiety, Fatigue, Lethargy
Clinical narrative: ~ 2 hours after inj of GARDASIL, pt reports abd cramping, "no control of my body", increased anxiety, "felt like I was having a nervous brkdown".  Increased lethargy & fatigue x ~ 12 hours.
Age: 12.0
Sex: F
Vaccine: TDAP, TYP, VARCEL
Symptoms: Body temperature increased, Dizziness, Erythema, Oedema peripheral, Rash
Clinical narrative: Morning after shots, clients R arm started with small redness & rash.  Spread with soft swelling.  Placed cold at site & gave ibuprofen.  Temperature up to 102 degrees F.  48 hours after symptoms started, they resolved.  Fever lasted only 24 hours.  Dizziness 24 hours.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Autism, Convulsion, Developmental delay, Pyrexia, Screaming
Clinical narrative: High pitched screaming for 3 days (more than 3 hrs over the course of 3 days), chest congestion, and low grade fever - developmentally delayed. 4/28/08-records received-evaluation 3/31/08 13 months of age- Assessment: not eligible for early intervention services.  Per family patient screamed after 2, 4 and 6 month immunizations and experienced convulsions.  Follow-up: Diagnosed w/ Autism. Suffering from seizures. Thank you for your hand in poisoning my child.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Upper respiratory tract congestion
Clinical narrative: High pitched screaming for 3 days (more than 3 hrs over the course of 3 days), chest congestion, and low grade fever - developmentally delayed. 4/28/08-records received-evaluation 3/31/08 13 months of age- Assessment: not eligible for early intervention services.  Per family patient screamed after 2, 4 and 6 month immunizations and experienced convulsions.  Follow-up: Diagnosed w/ Autism. Suffering from seizures. Thank you for your hand in poisoning my child.
Age: 1.4
Sex: M
Vaccine: DTAP
Symptoms: Paralysis, Urticaria
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of paralysis in a 16-month-old male subject who was vaccinated with INFANRIX, GlaxoSmithKline.  The subject is currently almost seven years old.  On an unspecified date the subject received unspecified dose of INFANRIX (unknown).  Fifteen minutes after vaccination with INFANRIX, the subject experienced paralysis and within thirty minutes the subject experienced hives.  This case was assessed as medically serious by GSK.  At the time of reporting the paralysis and hives were resolved.  The physician considered the events were possibly related to vaccination with INFANRIX.
Age: 0.76
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Crying, Erythema, Familial risk factor, Flushing
Clinical narrative: 5-10 minutes after receiving third series of shots while parents were putting child in car seat in waiting room, child's legs both upper and lower experienced red flushing which spread to her face.  Removed from car seat and returned to clinic area for observation and possible treatment.  Heart rate 172 Lungs clear and no respiratory difficulty.  Child was crying but able to be comforted by parents.  911 called and transported to hospital.  Parents disclosed to paramedics that child had received eggs for the first time 4/14/08 45 minutes prior to immunization appointment.  Later determined that child's grandfather has an egg allergy as well.  In follow up telephone conversation with father today, no treatment was rendered at hospital ER.  Parents were instructed not to give an eggs until after 12 months of age and follow up with primary physician.  Redness eventually disappeared. Parents plan to follow up with primary care physician.  Concerned about further vaccinations.  Advised that none of vaccines administered were derived from egg.  Advised no flu vaccine at this time.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Skin warm, Swelling, Urticaria
Clinical narrative: Patchy reddened swollen warm area about 3"X2.5" located on Left arm about 5 inches below injection site.  No fever or arthralgia.  Used Benadryl without effect initially.  Used ice and Ibuprofen which were helpful. Saw HCP. On 4/15 pm she described the beginning of hives starting in the scalp and moving downward on the body. She took Benadryl and it stopped the hives at the waist.  On 4/16, the arm area has moved upward toward the injection site and has enlarged to approx. 6" in diameter but is less swollen, hot and painful.  She continues with Benadryl or Zyrtec and Ibuprofen. She also called her HCP after the hives started.
Age: 0.52
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Grandmother called in and reported that patient had 2 seizures after receiving Imm. Also had fever 103.8 to 104.1 Taken to Hosp where parents were instructed to alternate Tylenol and ibuprofen for next 48 hours.
Age: 1.29
Sex: M
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: Abnormal behaviour, Aggression, Antisocial behaviour, Blood test, Head banging
Clinical narrative: Patient Developed a high fever the day of the vacines. After I noticed a diference in his whole self he shut down started banging his head with violent mood swings. He became withdrawn antisocial and started in on other behaviors such as biting, pulling hair, so I switched daycare. At the next one he was overtaken with the doors (open and closing) so they said he was a safety risk and that I should have him tested. So I did.  5/20/08 Reviewed PCP medical records & vax records of 8/2003-3/22/2007.   FINAL DX: autism spectrum disorder, PDD, developmental delays, hyperactivity. Records reveal patient experienced recent strep on day of vaccination.  Next visit note is for 4/04 & pt doing well but being treated for strep.  In 11/04, pt seen for strep recheck & parent requested testing for PDD.  Exam revealed loss of eye contact & unable to follow simple commands.  Parents reported tantrums, picky eater, aggressive behavior, social withdrawal, hyperactivity, insensitivity to pain, inappropriate attachment to plastic toy, sleep disturbance w/screaming, head banging, hand flapping & sustained odd repetitive play.  Dx w/developmental delays & referred to peds neuro.  Neuro consult of 12/2004 dx w/autism spectrum disorder.  Patient to receive early intervention services.
Age: 1.29
Sex: M
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: Mood swings, Nuclear magnetic resonance imaging, Pyrexia, Social avoidant behaviour
Clinical narrative: Patient Developed a high fever the day of the vacines. After I noticed a diference in his whole self he shut down started banging his head with violent mood swings. He became withdrawn antisocial and started in on other behaviors such as biting, pulling hair, so I switched daycare. At the next one he was overtaken with the doors (open and closing) so they said he was a safety risk and that I should have him tested. So I did.  5/20/08 Reviewed PCP medical records & vax records of 8/2003-3/22/2007.   FINAL DX: autism spectrum disorder, PDD, developmental delays, hyperactivity. Records reveal patient experienced recent strep on day of vaccination.  Next visit note is for 4/04 & pt doing well but being treated for strep.  In 11/04, pt seen for strep recheck & parent requested testing for PDD.  Exam revealed loss of eye contact & unable to follow simple commands.  Parents reported tantrums, picky eater, aggressive behavior, social withdrawal, hyperactivity, insensitivity to pain, inappropriate attachment to plastic toy, sleep disturbance w/screaming, head banging, hand flapping & sustained odd repetitive play.  Dx w/developmental delays & referred to peds neuro.  Neuro consult of 12/2004 dx w/autism spectrum disorder.  Patient to receive early intervention services.
Age: 0.39
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: No adverse event
Clinical narrative: Mother ill with GE symp for approx 1 week following first vaccination.  Mother and father ill with GE symp for approx 1 week after second vaccination.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Mass
Clinical narrative: Diffuse redness, swelling, itching and pain at injection site (left deltoid). Eventual residual was hyperpigmetation, nodular mass (2" diameter).
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Nodule, Skin hyperpigmentation
Clinical narrative: Diffuse redness, swelling, itching and pain at injection site (left deltoid). Eventual residual was hyperpigmetation, nodular mass (2" diameter).
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blood sodium decreased, Blood test normal, Chest X-ray normal, Computerised tomogram normal, Convulsion
Clinical narrative: Patient started with vomiting on 4/10/08, 5pm, lasting sporadically throughout the night.  No symptoms on Friday, 4/11/08.  Vomiting and diarrhea began again on 4/12/08 at 8am, first seizure at 10am. Went to emergency room at 12pm.  Released and sent home.  Second seizure at 3pm.  More vomiting at 6pm and third seizure shortly thereafter at 6:15.  Admitted to hopsital for observation overnight.  On-call pediatrician suggested it may be side effects of the rotavirus. Coincidentally, our older son started having seizures 5 days after his 6 month old shots in 2006.  I will fill out a report for him as well.  Older son, now 2 1/2, was diagnosed with Benign, Familial, Infantile Seizure disorder and treated with Phenobarbitol for 6 months.  After his initial cluster of seizures, he never had another, due to the medication and possibly outgrowing the disorder, which is thought to last 3-6 months.  4/29/08 Reviewed ER medical records of 4/12/2008. FINAL DX: seizures & viral illness Records reveal patient w/vomiting, diarrhea x 2 days & seizure x 1.  No seizure activity in ER.  Tx w/antinausea meds & sent home.  Returned to ER later on same day & admitted overnight for observation.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Electroencephalogram, Familial risk factor, Vomiting
Clinical narrative: Patient started with vomiting on 4/10/08, 5pm, lasting sporadically throughout the night.  No symptoms on Friday, 4/11/08.  Vomiting and diarrhea began again on 4/12/08 at 8am, first seizure at 10am. Went to emergency room at 12pm.  Released and sent home.  Second seizure at 3pm.  More vomiting at 6pm and third seizure shortly thereafter at 6:15.  Admitted to hopsital for observation overnight.  On-call pediatrician suggested it may be side effects of the rotavirus. Coincidentally, our older son started having seizures 5 days after his 6 month old shots in 2006.  I will fill out a report for him as well.  Older son, now 2 1/2, was diagnosed with Benign, Familial, Infantile Seizure disorder and treated with Phenobarbitol for 6 months.  After his initial cluster of seizures, he never had another, due to the medication and possibly outgrowing the disorder, which is thought to last 3-6 months.  4/29/08 Reviewed ER medical records of 4/12/2008. FINAL DX: seizures & viral illness Records reveal patient w/vomiting, diarrhea x 2 days & seizure x 1.  No seizure activity in ER.  Tx w/antinausea meds & sent home.  Returned to ER later on same day & admitted overnight for observation.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Blood test, Chest X-ray, Convulsion
Clinical narrative: Starting having cluster of seizures starting on 3/18 around 8am, continuing throughtout the weekend, admitted to hospital on Sunday, total seizures equalling 5 or 6, last seizure on Monday morning around 6 am.  Phenobarbitol was administered and no futher seizures were experienced.  5/6/08 Reviewed hospital medical records of 3/20-3/22/2006. FINAL DX: Seizures & URI. Records reveal patient experienced seizure activities & irritability over past few weeks w/increased frequency.  Seen in ER 3/19 where head CT neg.  Temp 99.8.  Tx w/antiseizure meds, improved & d/c to home w/PCP & neuro f/u.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Didn't feel well that night, headache, fever (101) next morning, stomach muscles hurt.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Onset of acute myalgia in shoulders, back, pelvic girdle and thighs 3 days post injection.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: LEFT THIGH BECAME RED AND SWOLLEN ABOUT FIVE MINUTES AFTER INJECTION WAS GIVEN. PATIENT WAS GIVEN 1/2 TSP ZYRTEC A COLD PACK WAS APPLIED TO THE SWOLLEN SIGHT. PATIENT WAS OBSERVED FOR ABOUT 30 MINUTES PATIENT WAS THEN CHECKED BY THE DR. PATIENTS MOTHER WAS GIVEN A SAMPLE OF ZYRTEC INSTRUCTED TO GIVE FOR THREE DAYS, ALSO IF SIGN & SYMPTOMS INCREASED AT ANY TIME TO GO TO ER.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site infection, Injection site pruritus, Injection site warmth
Clinical narrative: Patient received vaccine 5 days prior to reporting redness at injection site with warmth and itching.  Redness spreads from tricep area to wrist.  Nurse Practioner recommended starting antibiotic for infection at injection site.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Gardasil/Menactra given IM yesterday at 10am. and promptly developed redness at shot site. Within hours developed hives. No fever, cough, runny nose, nor dizziness.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Patient received Rotateq at 2 m visit, 2/13/08.  Admitted to hospital ~2 days later, found to have intussusception -> treated with colonoscopy. 5/9/08-clinic follow up visit notes received for DOS 2/20/08-DX: Intussusception. Second attempt at reduction successful.  5/14/08-records received for DOS 2/17-2/19/08-DC DX: Intussusception status post reduction barium enema. History of nonbloody nonbilious emesis times 2 and decreased energy level and poor feeding for approximately 1 day prior to admission. Presented to transferring facility ED where 3 attempts to reduce by barium enema failed. Replogle placed to suction.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abscess drainage, Myositis, Staphylococcal skin infection
Clinical narrative: Myositis (L) leg - (L) Lower thigh - + staph aureus. S to all but PCN. 5/6/08-reecords received for DOS 4/7-4/11/08-DC DX: Left thigh myositis abscess. Six days prior to admission unable to straighten left leg, swelling noted in left thigh. Decreased oral intake and decreased urinary output. 4/2/08 diagnosed with Caffey's disease. Treated as outpatient. Admitted to another facility for ultrasound showed fluid collection. Surgical intervention debridement.
Age: 12.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Induration, Local reaction, Pruritus
Clinical narrative: Patient came in for routine care. 4/3/08 - was given two vaccines MCV4 and Varicella. Woke in AM w/severe localized reaction. Checked by Dr in office. No fever, slight induration, slight itching. Benadryl 1 q4hrs. Call if increase in size or fever.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Chills, Dizziness, Nausea, Pallor
Clinical narrative: Nausea, dizziness, pale, chills ~ 1 hr. then resolved spontaneously.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Oedema peripheral, Rash papular, Skin lesion
Clinical narrative: Patient received smallpox vaccination 9 FEB 08.  26 FEB patient was seen in ER for swelling of both hands, elbow and ears with lesions and papules.  Hibiclens ordered.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Auricular swelling, Joint swelling, Oedema peripheral, Rash papular, Skin lesion
Clinical narrative: Patient received smallpox vaccination 9 FEB 08.  26 FEB patient was seen in ER for swelling of both hands, elbow and ears with lesions and papules.  Hibiclens ordered.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Break-through varicella.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Chest discomfort, Increased upper airway secretion, Injection site induration, Injection site swelling, Palpitations
Clinical narrative: Pt left the office after receiving the vaccines.  She & her mom returned approx 30 min later, because she c/o her heart racing - chest discomfort & felt like she also was clearing her throat frequently.  She was assessed .  Per physician was given Benadryl 25 mg-watched for 30 min.  D/C feeling better.  Injection site swollen & firm to touch.  (Ice pack applied).
Age: 95.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Dyspnoea, Full blood count
Clinical narrative: After around 3 minutes getting Pneumovax #23, patient complained of shortness of breath.  "I can't breath".  Patient looks distressed.  Administer 8 hrs O2/NC.  911 was called.  After 15 minutes patient not in distress anymore, no shortness of breath.  Later she told us that she had chest pains during the episode.  Patient then was taken to ER for further evaluation.  Patient was attended by MD during episode.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blister, Erythema, Local swelling, Pain, Pyrexia
Clinical narrative: Severe local swelling with skin vesicle formation, pain, fever with erythema developing 24 hours after injection.  Treated with Bactrim and Benadryl with significant improvement at 48 hours.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: + Left arm w/ 10-15 cm area of redness.  + inflammation.  Only mild tenderness to palpation.
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Pruritic rash on neck/trunk starting within 30 minutes of Hep A and Varivax.  No shortness of breath/wheezing.
Age: 1.0
Sex: M
Vaccine: MMR, PNC
Symptoms: Erythema
Clinical narrative: Redness to area 24 hours after injection - slight spread at 48 hours.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Received vaccinations right upper arm.  Began to have swelling about six hours later.  Swelling, pain & redness continued to progress.  No fever, or other symptoms.
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Area of injection (given 4/7/08) just started to redden and itch yesterday 4/1508. Area of redness is 2" x 2 1/2". Site marked by Dr.. Antibiotic Dicloxicillin and Atarax x 1 week. Pt will phone if no improvement.
Age: 21.0
Sex: F
Vaccine: HEPAB
Symptoms: Urticaria
Clinical narrative: Developed "hive" like rash on trunk of body.  1 week after 2nd dose of Twinrix.  Rash continues of this report 4/3/08.  No SOB, no difficulty swallowing, no fever.  Referred her to her primary care physician.
Age: 0.68
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Child came into clinic on 12/13/05 and received Pediarix, Hib & PCV.  Child returned on 12/29/05 for well child visit.  Received Pediarix, Hib & Prevnar again.  Child received extra set of vaccines.
Age: 0.71
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Incorrect dose administered
Clinical narrative: Extra set of vaccines given.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Erythema, Feeling hot
Clinical narrative: Warm, non-tender area of erythema over right deltoid measuring 10cm longitudinal by 7.5cm width.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain at injection site.  Started 24 hours post injection.  Afebrile.  Hot compresses and Motrin.  Monitoring.
Age: 3.0
Sex: M
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Rash on ears and neck and shoulders. Pin prick like. Showed 2 hours after shot and went away after approx. 24 hrs.
Age: 31.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site pain, Injection site scab, Injection site swelling
Clinical narrative: Patient reported Anthrax was given by Bioject.  Injection site found to be tender to touch, raised and scabbed over.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Anxiety, Dizziness, Loss of consciousness
Clinical narrative: Pt does not handle getting shots very well.  Pt "worked herself up", and caused her to feel dizzy and light-headed, which lead to her "passing out".
Age: 1.68
Sex: F
Vaccine: DTAP
Symptoms: Discomfort, Haematoma, Injection site erythema, Injection site rash, Pruritus
Clinical narrative: Right thigh hematoma in a couple of days.  Erythematous rash 6cm x 6.5cm surrounding injection site onset - morning of 4-8-08.  Pruritis and discomfort noted at that time and swelling.  Treated with Claritin syrup 1/4 tsp PO qd x 2d.  Good results.
Age: 1.68
Sex: F
Vaccine: DTAP
Symptoms: Swelling
Clinical narrative: Right thigh hematoma in a couple of days.  Erythematous rash 6cm x 6.5cm surrounding injection site onset - morning of 4-8-08.  Pruritis and discomfort noted at that time and swelling.  Treated with Claritin syrup 1/4 tsp PO qd x 2d.  Good results.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Papular, confluent non discolored pruritis rash developed ~ 4 days after MMR vaccination on L arm.  Rash spread down L axilla - trunk - leg.  No systemic reaction, fever, neurologic Sx.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pt developed redness, swelling, pain to left thigh.  Dx: cellulitis to area - 9 cm erythematous indurated wheal on L medial inner upper thigh.  Prescribed Keflex.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Pt developed redness, swelling, pain to left thigh.  Dx: cellulitis to area - 9 cm erythematous indurated wheal on L medial inner upper thigh.  Prescribed Keflex.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Induration, Local reaction
Clinical narrative: Left leg 8cm x 5cm knot, large local reaction - cool compresses with Benadryl for symptom control.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Right deltoid swelling at site of injection.
Age: 33.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Eczema, Rash papular
Clinical narrative: Developed dot-like rash to the R side of belly button after 3rd dose of oral typhoid.  "I have eczema".  Began typhoid 3/28, finished the doses on 4/4.  Saw the rash on 4/3/08.  Rash now size of 2 quarters blended together.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Information has been received from a consumer who contacted a representative to report that after vaccination with ZOSTAVAX the patient had experienced adverse event (unspecified). The consumer was advised to initiate further communication to provide additional information. Additional information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX and developed shingles. A product quality complaint was not reported. Additional information was not available.