chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Application site erosion, Application site vesicles, Injection site vesicles
Clinical narrative: Bullae at injection site within 24 h (as reported by mother) at the time of visit -vesicle 3mm at injection site with excoriated area. Monitor for infection.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Pyrexia, Wrong drug administered
Clinical narrative: 2 - PREVNAR administered on 4/13/09 instead of 1. Mother called at 11:30 PM on 4/13/09 and stated had fever 102. Instructed to give TYLENOL  and if persisted to call back. Attempted to contact family several times but no answer.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Pain, Urticaria
Clinical narrative: 10 minutes after shot: body aches- hives, no respiration distress.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Chills, Dizziness, Pain
Clinical narrative: Pt had the TDAP vaccine 10-29-08. Later that day after vaccine administration, patient complained of weakness, dizziness, chills and body aches. Lasted 2 days. Reported these events today 4-14-09.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Anorexia, Asthenia, Back pain, Blood electrolytes, Blood pressure increased
Clinical narrative: 4/4/09 Sat. noon sudden onset with severe back pain & body ache like the flu. Diarrhea    started - went to bed - 200 went to ER. Received a bag of fluids of IV ZOFRAN & 1 MG DILAUDID & felt better. 4/5/06 woke up felt weak, but better - as day progressed weakness, 5x for med stool then loose again. Poor appetite. Ate cherries, kept them down! 4-6-09 ER visit again. Diagnosed 4/7/09 as Virus.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Chest X-ray normal, Diarrhoea, Electrocardiogram normal, Fibrin D dimer normal, Full blood count
Clinical narrative: 4/4/09 Sat. noon sudden onset with severe back pain & body ache like the flu. Diarrhea    started - went to bed - 200 went to ER. Received a bag of fluids of IV ZOFRAN & 1 MG DILAUDID & felt better. 4/5/06 woke up felt weak, but better - as day progressed weakness, 5x for med stool then loose again. Poor appetite. Ate cherries, kept them down! 4-6-09 ER visit again. Diagnosed 4/7/09 as Virus.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Pain
Clinical narrative: 4/4/09 Sat. noon sudden onset with severe back pain & body ache like the flu. Diarrhea    started - went to bed - 200 went to ER. Received a bag of fluids of IV ZOFRAN & 1 MG DILAUDID & felt better. 4/5/06 woke up felt weak, but better - as day progressed weakness, 5x for med stool then loose again. Poor appetite. Ate cherries, kept them down! 4-6-09 ER visit again. Diagnosed 4/7/09 as Virus.
Age: 31.0
Sex: M
Vaccine: TTOX, TTOX
Symptoms: Blood lactic acid decreased, Blood pressure decreased, Computerised tomogram abnormal, Diarrhoea, Injection site erythema
Clinical narrative: Swelling of arm at injection site, diarrhea, vomiting, fever. Symptoms began 24 hr after vaccine. Erythema, edema of Rt deltoid. BP decreased.   6/24/09 Hospital ER record DOS 4/6/09 and Inpatient Hospital records and DC summary received DOS 4/8/09 to 4/24/09. FINAL DIAGNOSIS: Cellulitis and abcess of unspecified sites. Patient presented with laceration of L hand and abrasion to abdomen. Laceration  was cleaned and sutured and pt given tetanus prohylaxis, and discharged. 2 days later patient presented with shoulder swollen, erythematous, tender, and warm to touch - area of vaccine injection site. Vomiting, diarrhea, fever, anxious. IV antibiotics administered. Incision and drainage of R shoulder. ICD-9 Codes: 882.0
Age: 31.0
Sex: M
Vaccine: TTOX, TTOX
Symptoms: Injection site oedema, Injection site swelling, Pyrexia, Vomiting, X-ray abnormal
Clinical narrative: Swelling of arm at injection site, diarrhea, vomiting, fever. Symptoms began 24 hr after vaccine. Erythema, edema of Rt deltoid. BP decreased.   6/24/09 Hospital ER record DOS 4/6/09 and Inpatient Hospital records and DC summary received DOS 4/8/09 to 4/24/09. FINAL DIAGNOSIS: Cellulitis and abcess of unspecified sites. Patient presented with laceration of L hand and abrasion to abdomen. Laceration  was cleaned and sutured and pt given tetanus prohylaxis, and discharged. 2 days later patient presented with shoulder swollen, erythematous, tender, and warm to touch - area of vaccine injection site. Vomiting, diarrhea, fever, anxious. IV antibiotics administered. Incision and drainage of R shoulder. ICD-9 Codes: 882.0
Age: 31.0
Sex: M
Vaccine: TTOX, TTOX
Symptoms: Blood lactic acid, Blood pressure decreased, Diarrhoea, Injection site erythema, Injection site oedema
Clinical narrative: Swelling of arm at injection site, diarrhea, vomiting, fever. Symptoms began 24 hr after vaccine. Erythema, edema of Rt deltoid. BP decreased.   6/24/09 Hospital ER record DOS 4/6/09 and Inpatient Hospital records and DC summary received DOS 4/8/09 to 4/24/09. FINAL DIAGNOSIS: Cellulitis and abcess of unspecified sites. Patient presented with laceration of L hand and abrasion to abdomen. Laceration  was cleaned and sutured and pt given tetanus prohylaxis, and discharged. 2 days later patient presented with shoulder swollen, erythematous, tender, and warm to touch - area of vaccine injection site. Vomiting, diarrhea, fever, anxious. IV antibiotics administered. Incision and drainage of R shoulder. ICD-9 Codes: 882.0
Age: 31.0
Sex: M
Vaccine: TTOX, TTOX
Symptoms: Injection site swelling, Pyrexia, Vomiting, X-ray abnormal
Clinical narrative: Swelling of arm at injection site, diarrhea, vomiting, fever. Symptoms began 24 hr after vaccine. Erythema, edema of Rt deltoid. BP decreased.   6/24/09 Hospital ER record DOS 4/6/09 and Inpatient Hospital records and DC summary received DOS 4/8/09 to 4/24/09. FINAL DIAGNOSIS: Cellulitis and abcess of unspecified sites. Patient presented with laceration of L hand and abrasion to abdomen. Laceration  was cleaned and sutured and pt given tetanus prohylaxis, and discharged. 2 days later patient presented with shoulder swollen, erythematous, tender, and warm to touch - area of vaccine injection site. Vomiting, diarrhea, fever, anxious. IV antibiotics administered. Incision and drainage of R shoulder. ICD-9 Codes: 882.0
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: None stated.
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Extremely swelling to the site. Mother states approx. 5X5". Red, hot to the touch. C/o itchy. Painful.
Age: 0.6
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Electroencephalogram, Full blood count normal, Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Staring
Clinical narrative: 6 mos had 3 seizures following 6 mos vaccines lasting 1 1/2-2 min. 1st was tonic clonic. 2nd was clonic with staring. 3rd was a staring spell witnessed by ER personnel. Admitted MRI (-) LP (-) EEG pending.  4/29/09 Received hospital medical records of 4/16-4/17/2009. FINAL DX: febrile & afebrile seizures Records reveal patient experienced irritability, fever, staring, LOC, generalized tonic-clonic seizure w/postictal period.  Exam in ER WNL.   D/C to home w/PCP f/u next day; however, had 2 more seizures while afebrile, returned to ER 4/17 & admitted overnight.  Neuro consult & LP done.  Tx w/antibiotics.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Urticaria
Clinical narrative: 2 days after vaccination, patient had about 10 spots of urticaria (red, raised) scattered on wrists, arms trunk & behind ear.  Relieved after bath in the morning - still red but flat & diffused.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rhinorrhoea
Clinical narrative: Rash, itch, rhinorrhea started the following day after vaccination, today 4/20/09 saw MD for treatment.
Age: 0.7
Sex: F
Vaccine: FLU3
Symptoms: Cough, Crying, Dyskinesia, Irritability, Nasopharyngitis
Clinical narrative: 03/21/2009 started with cold & cough, gave TYLENOL for fever.  On 3/26/09 Baby was very irritable R side of body- hand & leg would jerk simultaneously every 1/2 hour.  Irritability & crying increased went to ER 3 27 09 gave given IV fluids and hosp. was told due to "shots"
Age: 0.7
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: 03/21/2009 started with cold & cough, gave TYLENOL for fever.  On 3/26/09 Baby was very irritable R side of body- hand & leg would jerk simultaneously every 1/2 hour.  Irritability & crying increased went to ER 3 27 09 gave given IV fluids and hosp. was told due to "shots"
Age: 1.4
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Ulcer
Clinical narrative: Vesicles and ulcers over scrotum, trunk and scalp, >100 lesions.
Age: 0.1
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Hives, swollen feet + hands
Age: 1.4
Sex: M
Vaccine: DTAP, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Within 48 hours, he had an 11 cm sized area of redness at the injection site that was firm & warm & his thigh was swollen.  The area was non tender.  This reaction was at the site of the DTaP vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis (R) upper arm. Started on KEFLEX - 25x 10 1/2 cm Follow-up in 2 days
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Chicken pox. Patient had vaccine on 11/14/00
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Local reaction 4x5cm, induration and erythema within 24hrs at MMR site. Advised to apply warm or cold compresses, TYLENOL po, or BENADRY and to follow up if worse.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Convulsion
Clinical narrative: Patient experienced a seizure approximately minutes after vaccine administration. Was taken to emergency room.
Age: 12.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Dizziness
Clinical narrative: As per patient on off dizziness since receiving vaccine on 4/17/09. But complaining on weekend fever negative, vomiting negative shingle negative follow up for questions.
Age: 12.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Dizziness, Laboratory test normal
Clinical narrative: As per patient on off dizziness since receiving vaccine on 4/17/09. But complaining on weekend fever negative, vomiting negative shingle negative follow up for questions.
Age: 12.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Dizziness, Headache
Clinical narrative: As per patient on off dizziness since receiving vaccine on 4/17/09. But complaining on weekend fever negative, vomiting negative shingle negative follow up for questions.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Face and mouth X-ray, Facial bones fracture, Fall, Syncope
Clinical narrative: Syncope post GARDASIL and MENACTRA administration. Patient fractured nose during syncope event (hit office counter during fall).
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Facial bones fracture, Fall, Loss of consciousness, Syncope, X-ray
Clinical narrative: Syncope post GARDASIL and MENACTRA administration. Patient fractured nose during syncope event (hit office counter during fall).
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: Developed fever approximately 8 hours after vaccine.  (105 degrees F).  Next AM, joint and muscle tenderness;  "whole body" 5x responded to Ibuprofen.
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Pyrexia
Clinical narrative: Student had fever 100.1 and chills. Student took Advil and an hour later felt fine. T.100.1 BP 130/80 P100 029690 CNRA
Age: 51.0
Sex: F
Vaccine: HEPAB
Symptoms: Biopsy, Headache, Lichen planus, Nausea, Rash
Clinical narrative: Headache, nausea after 1st shot, recovered in 2 days. Developed rash in a week after 2nd shot. Saw dr, dermatologist and allergist finally diagnosed by Dr after having rash for 1 year. Rash continued for 15 months and has not reoccurred.
Age: 15.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Patient given VARICELLA & MENACTRA vaccinations and after he walked into lobby he passed out.  Patient set in wheelchair & assisted by Dr. .  BP 60/33 - Pt wheeled to room and left to rest on table.  Patient walked out w/o problems w/dad and BP was 99/66.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Asthenia, Conjunctival hyperaemia, Dysphagia, Nausea, Sneezing
Clinical narrative: Sneezing, congestion, swallowing freq. weak nausea - approx. a minute and half - called mom (parents) this AM - but was unable to get update.
Age: 1.4
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dyspnoea, Rash
Clinical narrative: 04/16/2009 Mother called and spoke to call center who then called our office. Child received MMR and VARIVAX today, rash developed on face, and arm according to call center. I then asked the call center to find out if there was difficulty breathing, upon hearing that there was, I advised them to tell mom to immediately cal 911. Dr. informed.   See attached.
Age: 28.0
Sex: U
Vaccine: SMALL, SMALL
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase normal, Cardiac stress test, Chest X-ray normal, Chest discomfort
Clinical narrative: Pt received SPV left arm on 4/4/09.  On 4/9/09 the pt experienced about 60 min of central chest pressure (2/10).  He states that he felt like his heart rate was increased.  He did not have SOB, N,V, diaphoresis, radiation of the pain.  The pain was not affected by activity, position or deep breathing.  Over the next 3 days the pt had 1-2 episodes of central chest pressure per day which lasted about 20 minutes.  Again, it was non positional, did not radiate, and the pt had no associated symptoms.  He went to the VA ER on 4/13/09 where he had a negative work up and was discharged.  The pt saw the unit flight surgeon on 4/14/09--at which time the pt was grounded (pt is a Navigator) and determined to be non-deployable.  Pt instructed to start taking MOTRIN 600mg qid with food.  The pt had one episode of chest pressure (1/10) on 4/15/09 which lasted 10 minutes and no chest discomfort on 4/16/09 Symptoms:  Chest Pain.
Age: 28.0
Sex: U
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Electrocardiogram, Fibrin D dimer normal, Heart rate increased, Metabolic function test
Clinical narrative: Pt received SPV left arm on 4/4/09.  On 4/9/09 the pt experienced about 60 min of central chest pressure (2/10).  He states that he felt like his heart rate was increased.  He did not have SOB, N,V, diaphoresis, radiation of the pain.  The pain was not affected by activity, position or deep breathing.  Over the next 3 days the pt had 1-2 episodes of central chest pressure per day which lasted about 20 minutes.  Again, it was non positional, did not radiate, and the pt had no associated symptoms.  He went to the VA ER on 4/13/09 where he had a negative work up and was discharged.  The pt saw the unit flight surgeon on 4/14/09--at which time the pt was grounded (pt is a Navigator) and determined to be non-deployable.  Pt instructed to start taking MOTRIN 600mg qid with food.  The pt had one episode of chest pressure (1/10) on 4/15/09 which lasted 10 minutes and no chest discomfort on 4/16/09 Symptoms:  Chest Pain.
Age: 28.0
Sex: U
Vaccine: SMALL, SMALL
Symptoms: Pain, Troponin I
Clinical narrative: Pt received SPV left arm on 4/4/09.  On 4/9/09 the pt experienced about 60 min of central chest pressure (2/10).  He states that he felt like his heart rate was increased.  He did not have SOB, N,V, diaphoresis, radiation of the pain.  The pain was not affected by activity, position or deep breathing.  Over the next 3 days the pt had 1-2 episodes of central chest pressure per day which lasted about 20 minutes.  Again, it was non positional, did not radiate, and the pt had no associated symptoms.  He went to the VA ER on 4/13/09 where he had a negative work up and was discharged.  The pt saw the unit flight surgeon on 4/14/09--at which time the pt was grounded (pt is a Navigator) and determined to be non-deployable.  Pt instructed to start taking MOTRIN 600mg qid with food.  The pt had one episode of chest pressure (1/10) on 4/15/09 which lasted 10 minutes and no chest discomfort on 4/16/09 Symptoms:  Chest Pain.
Age: 28.0
Sex: U
Vaccine: SMALL, SMALL
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Cardiac stress test, Chest X-ray, Chest discomfort
Clinical narrative: Pt received SPV left arm on 4/4/09.  On 4/9/09 the pt experienced about 60 min of central chest pressure (2/10).  He states that he felt like his heart rate was increased.  He did not have SOB, N,V, diaphoresis, radiation of the pain.  The pain was not affected by activity, position or deep breathing.  Over the next 3 days the pt had 1-2 episodes of central chest pressure per day which lasted about 20 minutes.  Again, it was non positional, did not radiate, and the pt had no associated symptoms.  He went to the VA ER on 4/13/09 where he had a negative work up and was discharged.  The pt saw the unit flight surgeon on 4/14/09--at which time the pt was grounded (pt is a Navigator) and determined to be non-deployable.  Pt instructed to start taking MOTRIN 600mg qid with food.  The pt had one episode of chest pressure (1/10) on 4/15/09 which lasted 10 minutes and no chest discomfort on 4/16/09 Symptoms:  Chest Pain.
Age: 28.0
Sex: U
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Electrocardiogram, Fibrin D dimer, Heart rate increased, Metastasis
Clinical narrative: Pt received SPV left arm on 4/4/09.  On 4/9/09 the pt experienced about 60 min of central chest pressure (2/10).  He states that he felt like his heart rate was increased.  He did not have SOB, N,V, diaphoresis, radiation of the pain.  The pain was not affected by activity, position or deep breathing.  Over the next 3 days the pt had 1-2 episodes of central chest pressure per day which lasted about 20 minutes.  Again, it was non positional, did not radiate, and the pt had no associated symptoms.  He went to the VA ER on 4/13/09 where he had a negative work up and was discharged.  The pt saw the unit flight surgeon on 4/14/09--at which time the pt was grounded (pt is a Navigator) and determined to be non-deployable.  Pt instructed to start taking MOTRIN 600mg qid with food.  The pt had one episode of chest pressure (1/10) on 4/15/09 which lasted 10 minutes and no chest discomfort on 4/16/09 Symptoms:  Chest Pain.
Age: 28.0
Sex: U
Vaccine: SMALL, SMALL
Symptoms: Pain, Troponin, Ventricular extrasystoles
Clinical narrative: Pt received SPV left arm on 4/4/09.  On 4/9/09 the pt experienced about 60 min of central chest pressure (2/10).  He states that he felt like his heart rate was increased.  He did not have SOB, N,V, diaphoresis, radiation of the pain.  The pain was not affected by activity, position or deep breathing.  Over the next 3 days the pt had 1-2 episodes of central chest pressure per day which lasted about 20 minutes.  Again, it was non positional, did not radiate, and the pt had no associated symptoms.  He went to the VA ER on 4/13/09 where he had a negative work up and was discharged.  The pt saw the unit flight surgeon on 4/14/09--at which time the pt was grounded (pt is a Navigator) and determined to be non-deployable.  Pt instructed to start taking MOTRIN 600mg qid with food.  The pt had one episode of chest pressure (1/10) on 4/15/09 which lasted 10 minutes and no chest discomfort on 4/16/09 Symptoms:  Chest Pain.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Urticaria started 48-72 hours after Hep A # 2 and no obvious trigger. CLARITIN 5mg/5ml qd prn.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Oval upper thigh induration 10x9cm, mild tenderness to left upper thigh.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Dyspnoea, Oxygen saturation decreased, Pallor, Throat irritation, Wheezing
Clinical narrative: Within minutes of the DTAP, pt had reaction, wheezing, sob, tickling in the throat, appeared grayish in mouth, 2 tsp BENADRYL, alb nebs X 2, SOLUMEDROL 36 mg X 1. O2 92% & after O2 99% Pt. given epi-pen Jr X 1 in office for anaphylactic.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles 4/15/09.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA, IPV, MMR, MNQ, VARCEL
Symptoms: Injection site pain, Joint swelling, Oedema peripheral, Pruritus, Rash
Clinical narrative: Per mother of Pt; Pt arms became tender + painful (@ injection site) approx 6-7 hrs after injections, the hands became swollen itching next day Pt reported to mother. A rash between her fingers - mother noticed swelling on her wrists Pt mother reported s/s resolved @ the time.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, Product quality issue
Clinical narrative: A non-serious, spontaneous report of administered expired product was received from a nurse concerning a four-year-old female, subsequent to FLUMIST. The patient received FLUMIST on 20-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up received 31-Mar-2009: added product complaint investigation results.
Age: 1.3
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, Product quality issue
Clinical narrative: A non-serious, spontaneous report of administered expired product was received from a nurse concerning a 15-month-old female subsequent to FLUMIST. The patient received FLUMIST on 23-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up received 31-Mar-2009: added product complaint investigation results.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, Product quality issue
Clinical narrative: A non-serious, spontaneous report of administered expired product was received from a nurse concerning a four-year-old female, subsequent to FLUMIST. The patient received FLUMIST on 17-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 31-Mar-2009 and incorporated into the narrative: added product complaint investigation results.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, Medication error, Product quality issue
Clinical narrative: A non-serious, spontaneous report of administered expired product was received from a nurse concerning a four-year-old female, subsequent to FLUMIST. The patient received FLUMIST on 17-Feb-2009, which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 31-Mar-2009 and incorporated into the narrative: added product complaint investigation results. Reporter does not have lut number. Information cannot be obtained. 29 JUL 2009.
Age: 3.9
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of expired FLUMIST given was received from a company sales representative concerning a 47-month-old male. On 23-Feb-2009, a Medical Assistant on a Student Health campus inadvertently administered expired FLUMIST to a child. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. This is in follow-up to report(s) previously submitted on 03/02/2009. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up received on 06-Apr-2009 includes: this was patient's first dose of FLUMIST; country where the office is located and no adverse events were reported. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Cough, Dyspnoea, Face oedema, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a male who last week was vaccinated with VARIVAX (Merck). Concomitant therapy included FLUZONE. The patient experienced difficulty breathing, hives, cough and facial edema. Additional information has been requested.
Age: 48.0
Sex: U
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Similar reaction on previous exposure to drug
Clinical narrative: Approximately 2 days after AVA #5 experienced increased site redness, swelling from deltoid to half way down arm, itching, tenderness. Site reactions getting worse since AVA #4.
Age: 29.0
Sex: F
Vaccine: YF
Symptoms: Chest pain
Clinical narrative: Ask VHC contacted on 6/04/08 Pulm/Critical Care re: 29 y/o AD female who developed severe 10/10 anterior chest pain one week after receipt of YF vaccine on 2-11-08. Per SM also received Flu vaccine, Split IM on 1/25/08.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local reaction, Oedema peripheral
Clinical narrative: Received MENACTRA 4/8/09 at 4:15PM, close to that time. Checked the vial for how to administer, it didn't state, checked refrigerator (see attached) immunization list, it read Meningococcal Sq. but was listed under 18 yrs-next to that list was MENACTRA IM. See by Dr. on 4/9/09 - arm swelling, red. Dr. asked if I gave and I said yes, Said she had local reaction, circled site. 4/9/09 Pt saw Dr. - redness had increased - went outside circle mark - Prescribe BENADRYL - local reaction
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: 5 minutes post vaccine -> felt dizzy, diaphoretic helped to sit down no syncope no loss of consciousness supine x 10 min then sat up received orange juice + felt better total 30 min (observation.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Conjunctival hyperaemia, Eye swelling, Hypersensitivity, Lip swelling, No reaction on previous exposure to drug
Clinical narrative: Pt presented with Sx of allergic Rxn after shots.  No food, drink or other exposure noted.  Sx started about 1 hr after shots.  No probs w/ previous shots.  Patient had swollen eyes & lips.  Injected conjunctiva.  Resolved with BENADRYL.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Rash
Clinical narrative: Rash Tightness of chest next day.  Benadryl + steroids.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Joint stiffness, Laboratory test, Musculoskeletal pain
Clinical narrative: After Gardasil #3 woke up with shoulder pain L  now hands fingers hard to work.  Tests for lupus & arthritis - neg.  Now very stiff joints hands & knees.  Vague history when sym started.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Condition aggravated, Joint swelling, Knee operation, Rheumatoid arthritis
Clinical narrative: After Gardasil #3 woke up with shoulder pain L  now hands fingers hard to work.  Tests for lupus & arthritis - neg.  Now very stiff joints hands & knees.  Vague history when sym started.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on face and trunk extremities. Intense itching.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Pt seen with vesicular rash on trunk 4/16/09 - rash appeared 4/14/09 on trunk.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cough, Irritability, Pyrexia, Rash, Rash papular
Clinical narrative: 3/30/09 physical with immunization 4/3/09 fever to 101 X 24 hrs, then 4/6/09 developed no fever.  Developed cough, cranky, not sleeping seen by Dr. with diagnosis fever.  Then 4/10/09 seen again with fever increase 102 cough congestion dx fever next day rash small papular rash over torso
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Sleep disorder, Upper respiratory tract congestion
Clinical narrative: 3/30/09 physical with immunization 4/3/09 fever to 101 X 24 hrs, then 4/6/09 developed no fever.  Developed cough, cranky, not sleeping seen by Dr. with diagnosis fever.  Then 4/10/09 seen again with fever increase 102 cough congestion dx fever next day rash small papular rash over torso
Sex: U
Vaccine: HEP, PPV
Symptoms: Erythema, Skin induration
Clinical narrative: Information has been received from an investigator via agency concerning a patient who on an unspecified date was enrolled in a study. This report was part of a post-marketing surveillance program. On an unspecified date the patient was vaccinated with a dose of RECOMBIVAX HB. Secondary suspect vaccine included a dose of PNEUMOVAX 23 (manufacturer unknown). It was reported that 1 week post vaccination the patient experienced erythema and skin induration. The reporting investigator felt that erythema was possibly related to RECOMBIVAX HB and to PNEUMOVAX 23 (manufacturer unknown). Skin induration was definitely related to RECOMBIVAX and to PNEUMOVAX 23 (manufacturer unknown). Erythema and skin induration were considered to be other important medical events. No further information is available.
Sex: U
Vaccine: MMR, PPV
Symptoms: Erythema
Clinical narrative: Via agency concerning a patient who was enrolled in a study. This report was part of a post-marketing surveillance program. On an unknown date the patient who was vaccinated with PNEUMOVAX 23 (manufacturer unknown). Other suspect therapy included MMR II. On an unknown date, the patient experienced erythema. The reporting investigator felt that erythema was related to PNEUMOVAX 23 and there was no relationship to MMR II. Erythema was considered to be an other important medical event. Additional information is not expected.
Sex: U
Vaccine: MMR, PPV
Symptoms: Erythema
Clinical narrative: Information has been received from an investigator via agency concerning a patient who was enrolled in a study. This report was part of a post-marketing surveillance program. On an unspecified date, the patient was vaccinated a dose of PNEUMOVAX 23 (manufacturer unknown). The patient was also vaccinated with a dose of MMR II. On an unknown date (at week 16), the patient developed erythema, grade 3. The reporting investigator felt that erythema was definitely related to PNEUMOVAX 23 (manufacturer unknown) and that there was no relationship to the MMR II. Erythema, grade 3 was considered to be an other important medical event. Additional information is not expected.
Sex: U
Vaccine: HEP, MMR, PNC, PPV
Symptoms: Immunisation reaction
Clinical narrative: Information has been received from an investigator via agency concerning a patient who was enrolled in a study. On an unspecified date the patient was vaccinated with PNEUMOVAX 23 (lot # not reported). Concomitant therapy included MMR II, PREVNAR and RECOMBIVAX HB. It was reported that the patient experienced immunization/vaccine reaction. The investigator felt that immunization/vaccine reaction was related to PNEUMOVAX 23. Immunization/vaccine reaction was considered to be an other important medical event. No further information is available.
Sex: U
Vaccine: HEP, PPV
Symptoms: Induration, Oedema, Swelling
Clinical narrative: Information has been received from an investigator via DAIDS concerning a patient who was enrolled in a study. On an unspecified date the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot not reported) and a dose of hepatitis B virus vaccine rHBsAg (manufacturer unknown). This report was part of a post-marketing surveillance program. At week 1, the patient experienced edema (grade 3), swelling (grade 3) and induration (grade 3). The reporting investigator felt that edema (grade 3), swelling (grade 3) and induration (grade 3) were possibly related to PNEUMOVAX 23 and were not related to hepatitis B virus vaccine rHBsAg (manufacturer unknown. Edema (grade 3), swelling (grade 3) and induration (grade 3) were considered to be an other important medical event. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Incorrect route of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female with no past drug history, who on 06-DEC-2008 was vaccinated with a 0.5 mL second dose of GARDASIL (lot # 661703/0651X), subcutaneously. There was no concomitant medication. It was reported that in January 2009 the patient had a pregnancy. On 23-MAR-2009 the patient had a spontaneous abortion. There were no laboratory studies performed. On 11-APR-2009 the patient received her third dose of GARDASIL. Follow up information received on 16-APR-2009 from a registered nurse stated that the patient received the first dose of GARDASIL on 03-AUG-2008; second dose on 06-DEC-2008 (lot # 661703/0651X) and third dose on 11-APR-2009 (lot # 661846/1312X). There was no mention of pregnancy at the time of the 06-DEC-2008 dose (second dose). The LMP date was not indicated in the chart, nor was the # of weeks from LMP to the time of the spontaneous abortion (not an elective termination). Also not indicated in the notes was whether or not the products of conception were examined. This was the patient's first pregnancy. Upon internal review spontaneous abortion was determined to be an other important medical event. No further information is available.
Sex: M
Vaccine: RAB
Symptoms: Computerised tomogram normal, Dysarthria, Electroencephalogram normal, Oedema peripheral, Thinking abnormal
Clinical narrative: Initial report received 07 April 2009 from a consumer who was the patient's mother-in-law.  A male patient (age not reported) with a history of sleep disorder, had been exposed to a bat and received their first dose of IMOVAX rabies vaccine (lot number not reported) at a local health department on an unspecified date during November 2008. The patient had no concurrent illness at the time of vaccination. The patient received the remaining doses of the post exposure IMOVAX rabies vaccine series at a physician's office, and an unspecified amount of time after receiving the fourth or fifth dose, he developed slurred speech, his hands and feet became swollen and his thought process became affected and were not clear and concise. The patient was evaluated at the emergency room on 04 April 2009. Diagnostic testing included an EEG within normal limits and a CT Scan of the head with normal results. The patient was advised to follow-up with a neurologist. At the time of the report, the patient had not recovered from the event. No additional information was provided at the time of the report. Documents held by sender: None
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Cyanosis, Dyspnoea, Urticaria
Clinical narrative: Initial report received 09 April 2009 from a health care professional. A four-month-old male patient with a history of eczema and an egg allergy, had received a second dose intramuscular left thigh injection of ACTHIB, lot number UF620AB (Sanofi Pasteur SA lot number B0406-1), a second dose intramuscular left thigh injection of DAPTACEL, lot number C3084AA, a second dose intramuscular right thigh injection of IPOL, lot number B04575 (lot number invalid), and a second dose intramuscular right thigh injection of PREVNAR, lot number D26083 (manufacturer Wyeth) on 02 April 2009 and within 10 minutes of receiving the vaccines, the patient developed labored breathing, cyanosis of the lips and general hives. The patient received corrective treatment with an EPIPEN Junior, oxygen and BENADRYL and had been hospitalized for 24 hours (also reported as one day; dates of not reported). It was unknown at the time of the report if any laboratory or diagnostic testing had been performed. The patient had not been receiving any concomitant medications at the time of vaccination and he had not experienced any reactions following receipt of the same vaccines two months earlier. According to the reporter, the patient recovered from the event (date of recovery not reported). Documents held by sender: None.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC
Symptoms: Anoxia, Chest X-ray, Full blood count, Influenza serology, Laboratory test
Clinical narrative: Syncopal episode, fever - 102.7, partial absence spell or seizure which resulted in some anoxia post ictal phase, sign tachycardia. 4/29/09 Received clinic medical records of 4/7/09-4/13/09. FINAL DX: Records reveal patient had not been seen except for 6 mo visit & no vaccines had been given at that time.  When seen on 4/7, parent concerned re lack of speech.  RTC 4/13 s/p ER visit on 4/7.  Parent had flu the past week.  Patient was in daycare when had apparent syncopal episode w/cyanosis, decreased responsiveness.  Temp 102.7 in ER, labs WNL.  No problem since ER visit./ss  5/6/09 Received ED/Hospital records of 4/7/09-4/22/09. 780.2  780.31  034.0 DOS 4/7/09-4/8/09  DX: Strep pharyngitis, high fever, occult febrile seizures Syncopal episode associated with turning blue, tachycardia, poor responsiveness. Febrile and warm to palpation. Pulse initially 156 then 100. ED DOS 4/19/09 DX: Left otitis media and bronchitis Left TM acutely red, infected. Right TM red. Nasal congestion. ED DOS 4/22/09 FINAL DX: Rash of unclear etiology, suspect viral exanthum Diffuse 3mm punctate papular lesions, trunk, perineum, face and neck.  Mild expectory rhochi. Scleral hemorrhage right eye.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC
Symptoms: Petit mal epilepsy, Postictal state, Pyrexia, Respiratory syncytial virus test, Syncope
Clinical narrative: Syncopal episode, fever - 102.7, partial absence spell or seizure which resulted in some anoxia post ictal phase, sign tachycardia. 4/29/09 Received clinic medical records of 4/7/09-4/13/09. FINAL DX: Records reveal patient had not been seen except for 6 mo visit & no vaccines had been given at that time.  When seen on 4/7, parent concerned re lack of speech.  RTC 4/13 s/p ER visit on 4/7.  Parent had flu the past week.  Patient was in daycare when had apparent syncopal episode w/cyanosis, decreased responsiveness.  Temp 102.7 in ER, labs WNL.  No problem since ER visit./ss  5/6/09 Received ED/Hospital records of 4/7/09-4/22/09. 780.2  780.31  034.0 DOS 4/7/09-4/8/09  DX: Strep pharyngitis, high fever, occult febrile seizures Syncopal episode associated with turning blue, tachycardia, poor responsiveness. Febrile and warm to palpation. Pulse initially 156 then 100. ED DOS 4/19/09 DX: Left otitis media and bronchitis Left TM acutely red, infected. Right TM red. Nasal congestion. ED DOS 4/22/09 FINAL DX: Rash of unclear etiology, suspect viral exanthum Diffuse 3mm punctate papular lesions, trunk, perineum, face and neck.  Mild expectory rhochi. Scleral hemorrhage right eye.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC
Symptoms: Tachycardia
Clinical narrative: Syncopal episode, fever - 102.7, partial absence spell or seizure which resulted in some anoxia post ictal phase, sign tachycardia. 4/29/09 Received clinic medical records of 4/7/09-4/13/09. FINAL DX: Records reveal patient had not been seen except for 6 mo visit & no vaccines had been given at that time.  When seen on 4/7, parent concerned re lack of speech.  RTC 4/13 s/p ER visit on 4/7.  Parent had flu the past week.  Patient was in daycare when had apparent syncopal episode w/cyanosis, decreased responsiveness.  Temp 102.7 in ER, labs WNL.  No problem since ER visit./ss  5/6/09 Received ED/Hospital records of 4/7/09-4/22/09. 780.2  780.31  034.0 DOS 4/7/09-4/8/09  DX: Strep pharyngitis, high fever, occult febrile seizures Syncopal episode associated with turning blue, tachycardia, poor responsiveness. Febrile and warm to palpation. Pulse initially 156 then 100. ED DOS 4/19/09 DX: Left otitis media and bronchitis Left TM acutely red, infected. Right TM red. Nasal congestion. ED DOS 4/22/09 FINAL DX: Rash of unclear etiology, suspect viral exanthum Diffuse 3mm punctate papular lesions, trunk, perineum, face and neck.  Mild expectory rhochi. Scleral hemorrhage right eye.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mom stated child c/o pain, redness and swelling noted to (left) vastus lateralis approximately 3cm x 5 cm.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Electroencephalogram, Hypotonia, Unresponsive to stimuli
Clinical narrative: Approximately 15-20 minutes after vaccination child became unresponsive, no respiratory distress. Mother emergently brought infant back to office. Infant was limp but with good vital signs. Quickly required consciousness in office. Monitored for 15 minutes. Released to home - EEG ordered.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Gaze palsy, Musculoskeletal stiffness, Respiratory rate increased, Skin discolouration, Staring
Clinical narrative: About 5-10 min after vaccination given, the patient had a blank stare, turned gray, rapid breathing, got stiff eyes, eyes rolled back, arm and legs stiff and shook some, + urinary incontinence. No h/o seizures in the past.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Tremor, Urinary incontinence
Clinical narrative: About 5-10 min after vaccination given, the patient had a blank stare, turned gray, rapid breathing, got stiff eyes, eyes rolled back, arm and legs stiff and shook some, + urinary incontinence. No h/o seizures in the past.
Age: 0.8
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever to 102 degrees and diffuse urticaria. Began the AM after vaccine administered. Given antihistamine as treatment.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Seen on 4/10/09 left deltoid noted to have about 4" round increased redness, warmth and swelling. Instructed to use ice packs prn.  This is in follow-up to report(s) previously submitted on 04/10/09/ Immun. given 4/8/09. Pt. returned 4/10/09 with swelling/redness @ L arm site. He did not know when reaction occurred and had no complaints. (He was being seen at the office 4/10 for another reason.)
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Child received vaccination on 3-27-2009 and came in office with chickenpox on 4-8-09.
Age: 35.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Pt reported swelling and hardness at site (L) arm of inj, progressed down arm to below elbow. Described as hard, warm, very tender, entire circumference of affected area lasting 5-6 days. Did not seek medical attention while affected.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, PNC
Symptoms: Erythema, Rash macular, Swelling
Clinical narrative: Blue blotches over body, especially elbows, knees and hands with swelling and redness within 5 hrs of vaccination.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Rash generalised, Swelling
Clinical narrative: 2 mo old male received vaccines 4/10/09.  2hrs after vaccine started develop rash to body, which spread the following day with swelling.  Seen in ER that day of increase spread of rash + given shot which decrease rash, given Benadryl + Prednisone.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Full blood count normal, Injection site erythema, Injection site swelling, Pyrexia, Urine analysis normal
Clinical narrative: Rec'd varicella 4/7/09. At 3:30am on 4/9/09 woke up w / 104 Temp. Used fever control methods. Saw PCP at 9:30am on 4/9/09, temp at 99. Large, raised red area on arm where immunization given. This was #2 varicella, #1 was given in 2003. Had a few "spots" come up at that time.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Dizziness, Headache, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Patient had swelling and pain of injection site >5cm about 8 hours after injection. 12-18 hours after injection developed dizziness, nausea and headache which lasted about 2 hours, he still had swelling and pain of arm at 4 days.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Patient had swelling and pain of injection site >5cm about 8 hours after injection. 12-18 hours after injection developed dizziness, nausea and headache which lasted about 2 hours, he still had swelling and pain of arm at 4 days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient came down with shingles within days of receiving Zostavax.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site vesicles, Pain in extremity, Rash
Clinical narrative: Patient developed painful rash with vesicles at site of injection and mid back.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Shingles vaccine administered 04/15/2009; 36 hrs. later I had 3.5 cm indurated, red, sore, warm vaccination site w/surrounding erythema accompanied by chills, aching, drowsiness and itching at site and up and down arm. By 48 hrs. post-injection a non-vesicular rash appeared on the injection site, about 3.5 cm circumference. I had no fever at any time. On days 4 and 5 post-injection symptoms began to receed. Day 5 only a painful, burning shingles-like itch and burning sensation extending to about three inches above the elbow and upwards into the armpit and a 3 cm. induration with erythema at injection site remained. Although symptoms continue to subside, I was seen by my physician today for examination. The injection site is less red, less painful and itching and burning are diminished. The rash lasted approx. 24 hrs. and dissipated.