chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Blindness, Dizziness
Clinical narrative: Client was seen at the health department about 3:30 on 3/24/08.  Client left the building after receiving a Hepatitis B shot, dose 3, and became pale, dizzy, and weak, and lost vision in his right eye.  Mom took him to Hospital and was told it was not an allergic reaction when talked with staff in walk in clinic so she took him home.  He continued to be very weak and remained home from school the next day with headache and dizziness.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Oedema peripheral, Skin warm
Clinical narrative: Parent brought child in, she had cellulitis on both legs. R leg was 13x13cm L leg was 13x7cm. Parent had taken child to the hospital on 3/8/08 due to legs swollen and warm to touch. child was placed on Bactrim.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Tenderness
Clinical narrative: RIGHT THIGH IS DIFFUSELY ERYTHAMTOUS FROM PANTY LINE TO KNEE, AND MUCH MORE TENDER TO TOUCH THAN THE LEFT THIGH. RX WITH IBUPROFEN AND BENADRYL FOR 4 DAYS. PATIENT WAS SEEN ~2 DAYS AFTER VACCINE GIVEN. 3-25-08 Mom states leg looks normal and child walks normaly.
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: My son received his ChickenPox Vaccine (booster) on Monday, March 17, 2008 and on Wed., March 19, 2008 what appeared to be a rash broke out on the small of his back.  The rash proceeded to get worse so we took him back in to see Dr. on Sat., March 22.  Dr. diagnosed patient with Shingles and perscribed:  Acyclovir 200mg (2 teaspoonsful 4 times a day) and Hydroxyzine 10 mg (1 teaspoonful every 8 hours as needed for itch).  Today is Wednesday, March 25 and the "rash" is still getting worse.  I was told by Dr. that it could take upto 3 weeks to see improvement.
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Herpes zoster
Clinical narrative: My son received his ChickenPox Vaccine (booster) on Monday, March 17, 2008 and on Wed., March 19, 2008 what appeared to be a rash broke out on the small of his back.  The rash proceeded to get worse so we took him back in to see Dr. on Sat., March 22.  Dr. diagnosed patient with Shingles and perscribed:  Acyclovir 200mg (2 teaspoonsful 4 times a day) and Hydroxyzine 10 mg (1 teaspoonful every 8 hours as needed for itch).  Today is Wednesday, March 25 and the "rash" is still getting worse.  I was told by Dr. that it could take upto 3 weeks to see improvement.
Age: 7.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Induration, Pruritus, Rash, Rash erythematous
Clinical narrative: RASH ON RT THIGH- ON 2/29/2008- CAME IN BECAUSE OF ITCHING. ON EXAM PT HAS A 7 CM X 8 CM ERYTHEMATOUS INDURATED AREA ON THE RT. ANTERIOR THIGH. CONSISTENT WITH REACTION TO VARICELLA. - LARGE VARICELLA VACCINE REACTION.- RECOMMEND BENADRYL AND MOTRIN. RTC IF ANY WORSENING.
Age: 7.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site inflammation
Clinical narrative: RASH ON RT THIGH- ON 2/29/2008- CAME IN BECAUSE OF ITCHING. ON EXAM PT HAS A 7 CM X 8 CM ERYTHEMATOUS INDURATED AREA ON THE RT. ANTERIOR THIGH. CONSISTENT WITH REACTION TO VARICELLA. - LARGE VARICELLA VACCINE REACTION.- RECOMMEND BENADRYL AND MOTRIN. RTC IF ANY WORSENING.
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: RAISED RED AREA SIZE OF A QUARTER- ON HER RT ANTERIOR THIGH. REACTION FROM VARICELLA VACCINE
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site inflammation
Clinical narrative: RAISED RED AREA SIZE OF A QUARTER- ON HER RT ANTERIOR THIGH. REACTION FROM VARICELLA VACCINE
Age: 1.05
Sex: F
Vaccine: MMR, PPV, VARCEL
Symptoms: Rash, Vertigo, Vomiting
Clinical narrative: Variable Fever over three days (99.8-104.2) with intermediate vomiting.  Mild rash on trunk.
Age: 5.0
Sex: M
Vaccine: DTIPV, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever and Rash over arms, legs, tommy, back, feet and hands. 24 hours duration. He got the Rash 8 days after vaccination. Treated with Benadryl only.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Convulsion, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lost consciousness in a 20-year-old male subject who was vaccinated with Havrix 1440 (GlaxoSmithKline).  On an unspecified date in February 2008, the subject received the 1st dose of Havrix 1440 (unknown, left arm).  Immediately after vaccination with Havrix 1440, the subject lost consciousness, then experienced a seizure.  The healthcare professional reported that the subject presented to the emergency room and was observed for a "couple of hours", but was not admitted to the hospital.  The subject had no prior history of seizures.  This case was assessed as medically serious by GSK.  At the time of reporting, the events were resolved.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Facial palsy, Headache
Clinical narrative: 3/17/08 Zostavax given.  3/18/08 Right side of head painful & "burning".  3/20/08 Right side of face Bell's palsy.  Medical office visit 3/24/08.  03/26/2008 MR received from PCP for OV 3/24/08 with c/o burning pain on the R ear and R-sided head pain x 1 week. On ~3/20/08 pt noted R side of face and eye drooping. R eye watering. DX:  Bell's Palsy
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Autopsy, Death
Clinical narrative: Our office was informed 3/14/08 of patients demise - no side effects in office. 5/15/08-records received-Cause of death:Sudden Infant Death Syndrome (SIDS). Manner of death:natural.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema
Clinical narrative: Pt received vaccine 3/18/2008 - came to office on 3/20/2008 with local erythema/edema to area.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, abd cramps. Pt given Pepcid OTC instructions.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: slight erythema and swelling at site (Rt. thigh) of injection.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt reports having a full blown case of shingles but stated she had never had chicken pox. Pt was treated by family physicians starting on 1/7/08 with Valtrex 1mg, Prednisone 20mg and Lortab.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Blister, Blood pressure, Body temperature normal, Erythema
Clinical narrative: Pt reports having a full blown case of shingles but stated she had never had chicken pox. Pt was treated by family physicians starting on 1/7/08 with Valtrex 1mg, Prednisone 20mg and Lortab.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Respiratory rate
Clinical narrative: Pt reports having a full blown case of shingles but stated she had never had chicken pox. Pt was treated by family physicians starting on 1/7/08 with Valtrex 1mg, Prednisone 20mg and Lortab.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema
Clinical narrative: Local erythema - 4 cm. Arm became itchy 3/17 PM - Erythema noted 3/18/08 AM. Rx - observation. Erythema faded within 2 days.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea
Clinical narrative: Donor felt lightheaded, nauseous and dizzy about 15 minutes after receiving 2nd Hep B shot.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Drooling, Full blood count, Lip swelling, Swelling face
Clinical narrative: Facial swelling (orbital swelling, lips swollen, mud drooling).  10:45AM shots given, approximately 10:55AM cinaphylactic.  Treatment noted.  (No fever, no seizure, no respiratory distress).
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Fatigue, Irritability, Pain in extremity, Pyrexia
Clinical narrative: Severe pain in both legs, increases when bearing weight.  Started at ankles, now all the way up his legs.  Fevers since the 19th.  Fatigued and irritable.
Age: 18.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Urticaria
Clinical narrative: On 3/12/08 hives that were coming and going.  Treatment of Predisone and Claritin samples.  3/14/08 rash still coming and going with 2cm in left axillary.  Given Augmentin.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chest X-ray abnormal, Chronic obstructive pulmonary disease, Diagnostic procedure, Granuloma, Musculoskeletal chest pain
Clinical narrative: Pt seen 06/18/07 for report of chest wall pain on the right side. Patient had chest xray, ultrasound. Had Zostavax on 06/20/07. Per patient had rash on right chest which started 06/22/07. Pt not seen again till 09/24/07 at our office. Pt had numerous tests and was referred to gastro and neuro. Patient still reports pain-right chest wall.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Ultrasound scan
Clinical narrative: Pt seen 06/18/07 for report of chest wall pain on the right side. Patient had chest xray, ultrasound. Had Zostavax on 06/20/07. Per patient had rash on right chest which started 06/22/07. Pt not seen again till 09/24/07 at our office. Pt had numerous tests and was referred to gastro and neuro. Patient still reports pain-right chest wall.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chest X-ray, Musculoskeletal chest pain, Rash, Ultrasound scan
Clinical narrative: Pt seen 06/18/07 for report of chest wall pain on the right side. Patient had chest xray, ultrasound. Had Zostavax on 06/20/07. Per patient had rash on right chest which started 06/22/07. Pt not seen again till 09/24/07 at our office. Pt had numerous tests and was referred to gastro and neuro. Patient still reports pain-right chest wall.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Bone scan, Chest X-ray, Computerised tomogram, Erythema
Clinical narrative: Pt seen 06/18/07 for report of chest wall pain on the right side. Patient had chest xray, ultrasound. Had Zostavax on 06/20/07. Per patient had rash on right chest which started 06/22/07. Pt not seen again till 09/24/07 at our office. Pt had numerous tests and was referred to gastro and neuro. Patient still reports pain-right chest wall.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Pt seen 06/18/07 for report of chest wall pain on the right side. Patient had chest xray, ultrasound. Had Zostavax on 06/20/07. Per patient had rash on right chest which started 06/22/07. Pt not seen again till 09/24/07 at our office. Pt had numerous tests and was referred to gastro and neuro. Patient still reports pain-right chest wall.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Mammogram, Pain, Pruritus, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Pt seen 06/18/07 for report of chest wall pain on the right side. Patient had chest xray, ultrasound. Had Zostavax on 06/20/07. Per patient had rash on right chest which started 06/22/07. Pt not seen again till 09/24/07 at our office. Pt had numerous tests and was referred to gastro and neuro. Patient still reports pain-right chest wall.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Skin papilloma, Smear cervix abnormal, Vaccine positive rechallenge
Clinical narrative: Information has been received from a certified nurse midwife concerning a 27 year old female with high risk human papilloma virus diagnosed in July 2007 as a result of a cervical smear and no condyloma, who on 05-OCT-2007 at 15:30 was vaccinated in the left deltoid with a first dose of Gardasil. There were no illnesses at the time of the vaccination. On 19-DEC-2007 the patient was diagnosed with one wart. On 21-DEC-2007 at 09:30 the patient was vaccinated in the left deltoid with a second dose of Gardasil. Subsequently, in the next two months, the patient developed clusters of warts. At the time of the report, the patient had not recovered. The reporter considered the cluster of warts to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Hypoaesthesia, Sensation of heaviness, Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on an unspecified date was vaccinated with the first dose of Gardasil (Lot # 659653/1448U).  On approximately 14-MAR-2008 (also reported as "or 17-MAR-2008) the patient fainted and had a seizure after receiving her first dose.  It was reported that the patient felt that her arm became heavy and numb before she fainted.  The patient sought unspecified medical attention.  At the time of this report the patient was recovering on therapy.  No product quality complaint was involved.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, TTOX, VARCEL
Symptoms: Immediate post-injection reaction, Respiratory arrest, Urinary incontinence
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 16 female who in February 2008, was vaccinated IM with a 0.5mL dose of GARDASIL. Concomitant suspect vaccination included VARIVAX. Other concomitant vaccinations included tetanus toxoid and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. In less than two minutes post vaccination the patient stopped breathing. The patient was treated with ammonia salts but it took one minute for the patient to take a breath rather then immediately. The patient then urinated while in the waiting room. The patient went to the emergency room for observation. No laboratory diagnostics were performed. The patient recovered on the same day that the vaccination was administered. No product quality complaint was involved. This is one of two reports from the same source. The breathing difficulty and urinary incontinence were considered to be other important medical events. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Intussusception, X-ray abnormal
Clinical narrative: Information has been received from a physician concerning a 9-month-old female who on 28-AUG-2007 was vaccinated with an oral 2 ml dose of ROTATEQ.  Concomitant vaccination included PEDVAXHIB (OMPC) (manufacturer unknown), PEDIARIX and PREVNAR.  On 19-MAR-2008 the patient experienced abdominal pain after receiving ROTATEQ.  The patient was taken to the emergency room and was diagnosed with intussusception and was hospitalized.  A barium enema was given and the patient was released on 20-Mar-2008.  The outcome was reported as recovering.  No product quality complaint was involved.  Additional information has been requested.  4/30/2008 MR reeived for DOS 3/19-20/2008 with Final DX: Intussusception s/p reduction by air enema. Pt presented to ER with 4 day hx of abdominal pain and NBNB emesis.  PE (+) for slight abd distention. Successfully reduced by Air Enema.  No further vomiting or fever. Left purulent ear effusion noted prior to d/c. Sent home with azithromycin if pt develops ear pain.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: C-reactive protein increased, Cervical spinal stenosis, Dysphonia, Electromyogram abnormal, Influenza like illness
Clinical narrative: This case was received from a consumer on 22 January 2008.  An 88-year-old female patient, with a history of hypertension, received a left deltoid injection of Fluzone (lot number U2506AA) in November 2007; route and exact date of administration were not provided.  Approximately two days after vaccination, the patient began complaining of pain in her left arm.  The pain subsequently spread to the right arm, shoulders, and lower extremities.  The patient was seen by a physician, and was being treated with Celebrex and "Ulhamer".  Bloodwork and x-rays had been performed, but results were not provided.  At the time of the report, the pain was ongoing, and the patient was scheduled to see a neurologist.  Follow-up information was received 04 March 2008 from a consumer.  According to the reporter, the patient had been seen and evaluated by the neurologist.  Results of the neurologist's consultation were not provided.  The reporter indicated that the patient's condition had worsened and described the patient as having "Flu like symptoms" and clarified flu like symptoms as "constant aches and pains".  For about a month now, the patient had episodes that come and go, which consisted of hoarseness where she can barely speak.  No further information was provided at the time of the report.  Follow-up information was received from a health professional on 17 March 2008.  Based on the new information received, the case was determined to be serious.  SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  According to the reporter, the patient had severe diffuse myalgias with proximal muscle weakness and an increased CRP.  An electromyelogram and nerve conduction studies showed polyneuropathy.  The patient still had ongoing pain, and treatment included Ultram (previously reported as "Ulhamer"), Lyrica, Cymbalta, and Motrin.  Based on the available information, the patient had been diagnosed with "cervical spine pathology, stenosis as alternative diagnosis".  The patient had been seen by a neurologist, and contact information was provided.  The event had not yet resolved.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Musculoskeletal pain, Myalgia, Nerve conduction studies abnormal, Pain
Clinical narrative: This case was received from a consumer on 22 January 2008.  An 88-year-old female patient, with a history of hypertension, received a left deltoid injection of Fluzone (lot number U2506AA) in November 2007; route and exact date of administration were not provided.  Approximately two days after vaccination, the patient began complaining of pain in her left arm.  The pain subsequently spread to the right arm, shoulders, and lower extremities.  The patient was seen by a physician, and was being treated with Celebrex and "Ulhamer".  Bloodwork and x-rays had been performed, but results were not provided.  At the time of the report, the pain was ongoing, and the patient was scheduled to see a neurologist.  Follow-up information was received 04 March 2008 from a consumer.  According to the reporter, the patient had been seen and evaluated by the neurologist.  Results of the neurologist's consultation were not provided.  The reporter indicated that the patient's condition had worsened and described the patient as having "Flu like symptoms" and clarified flu like symptoms as "constant aches and pains".  For about a month now, the patient had episodes that come and go, which consisted of hoarseness where she can barely speak.  No further information was provided at the time of the report.  Follow-up information was received from a health professional on 17 March 2008.  Based on the new information received, the case was determined to be serious.  SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  According to the reporter, the patient had severe diffuse myalgias with proximal muscle weakness and an increased CRP.  An electromyelogram and nerve conduction studies showed polyneuropathy.  The patient still had ongoing pain, and treatment included Ultram (previously reported as "Ulhamer"), Lyrica, Cymbalta, and Motrin.  Based on the available information, the patient had been diagnosed with "cervical spine pathology, stenosis as alternative diagnosis".  The patient had been seen by a neurologist, and contact information was provided.  The event had not yet resolved.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Polyneuropathy, Speech disorder, Spinal disorder
Clinical narrative: This case was received from a consumer on 22 January 2008.  An 88-year-old female patient, with a history of hypertension, received a left deltoid injection of Fluzone (lot number U2506AA) in November 2007; route and exact date of administration were not provided.  Approximately two days after vaccination, the patient began complaining of pain in her left arm.  The pain subsequently spread to the right arm, shoulders, and lower extremities.  The patient was seen by a physician, and was being treated with Celebrex and "Ulhamer".  Bloodwork and x-rays had been performed, but results were not provided.  At the time of the report, the pain was ongoing, and the patient was scheduled to see a neurologist.  Follow-up information was received 04 March 2008 from a consumer.  According to the reporter, the patient had been seen and evaluated by the neurologist.  Results of the neurologist's consultation were not provided.  The reporter indicated that the patient's condition had worsened and described the patient as having "Flu like symptoms" and clarified flu like symptoms as "constant aches and pains".  For about a month now, the patient had episodes that come and go, which consisted of hoarseness where she can barely speak.  No further information was provided at the time of the report.  Follow-up information was received from a health professional on 17 March 2008.  Based on the new information received, the case was determined to be serious.  SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  According to the reporter, the patient had severe diffuse myalgias with proximal muscle weakness and an increased CRP.  An electromyelogram and nerve conduction studies showed polyneuropathy.  The patient still had ongoing pain, and treatment included Ultram (previously reported as "Ulhamer"), Lyrica, Cymbalta, and Motrin.  Based on the available information, the patient had been diagnosed with "cervical spine pathology, stenosis as alternative diagnosis".  The patient had been seen by a neurologist, and contact information was provided.  The event had not yet resolved.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain, Chest pain, Diarrhoea, Erythema, Local swelling
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 19 March 2008 from a nurse.  A 14-year-old male patient, with past medical history of cyclic vomiting, and who had not received any other vaccinations with four weeks of 18 March 2008, had received an intramuscular, left deltoid dose of Adacel (lot # C2899AA); and an intramuscular, right deltoid dose of Menactra (lot # U2562AA) on 18 March 2008.  Forty-five minutes post-vaccination, the patient complained of abdominal itching, abdominal pain, chest pain, and he had broke out in hives with red blotchy skin in the face and neck area.  The patient also had swelling in the face and neck, and had episodes of diarrhea.  The patient sought medical attention at the local emergency room and was treated with intravenous Solu-Medrol and was released the same day with a prescription of prednisone and Benadryl.  No diagnostic tests were performed.  As of 19 March 2008, the patient was feeling better, but had not fully recovered.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pruritus, Rash macular, Swelling face, Urticaria
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 19 March 2008 from a nurse.  A 14-year-old male patient, with past medical history of cyclic vomiting, and who had not received any other vaccinations with four weeks of 18 March 2008, had received an intramuscular, left deltoid dose of Adacel (lot # C2899AA); and an intramuscular, right deltoid dose of Menactra (lot # U2562AA) on 18 March 2008.  Forty-five minutes post-vaccination, the patient complained of abdominal itching, abdominal pain, chest pain, and he had broke out in hives with red blotchy skin in the face and neck area.  The patient also had swelling in the face and neck, and had episodes of diarrhea.  The patient sought medical attention at the local emergency room and was treated with intravenous Solu-Medrol and was released the same day with a prescription of prednisone and Benadryl.  No diagnostic tests were performed.  As of 19 March 2008, the patient was feeling better, but had not fully recovered.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis injection site
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Rash on upper chest and breast.  No itching.  Onset 3-20-08.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Edema with redness at Sub Q site.
Age: 1.52
Sex: M
Vaccine: DTAP, FLU3, IPV, PNC
Symptoms: Incorrect dose administered
Clinical narrative: Child given age-inappropriate Influenza vaccine incensed for age 4 + years.  No adverse event reported.
Age: 55.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Pain in extremity
Clinical narrative: Client received a TDaP and MMR in her left arm, Hep A in her right arm.  Complained that her left upper arm has been very painful when she tries to move it.  No redness.  If continues advised to see MD.
Age: 6.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site cellulitis, Local reaction
Clinical narrative: Post-vaccine cellulitis left deltoid about 14-16 hrs after varicella and influenza to left deltoid. 14x15 cm. diameter. ? Just local reaction
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Local reaction, Rash pustular, Skin lesion
Clinical narrative: Large local reaction - pustule on left arm site with lesions left leg.  Local ice, Keflex PO.
Age: 9.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: (At site of injection of varicella) - onset of bright red approximately 4cm x 3cm with irregular edges, slight raised, white center approximately 0.5cm round. Benadryl 25mg IM given at 950 AM
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration
Clinical narrative: 1 day after Varivax developed large (6cm x 8cm) area of erythema, induration. 4cm x 3cm honey colored caused lesion in center
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Arthralgia, Pain in extremity, Screaming
Clinical narrative: Legs hurt, thighs and knees - child screams at night.  Still hurting after 4 days.  Tylenol and Motrin ineffective.  No redness or swelling.
Age: 17.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Cellulitis, Erythema, Feeling hot, Oedema peripheral, Tenderness
Clinical narrative: Client reports redness in the lateral lower portion of her right upper arm on 2/14/08 in AM.  Upon observation of the arm on 2/15/08 at 2:45PM, this same area was tender, red, swollen (approximately 6 inches in diameter) and hot to the touch.  Client's M.D. diagnosed Cellulitis and prescribed antibiotics later the same day, per client.  As of 2/20/08, client's mother reports symptoms have subsided and no other problems.
Age: 22.0
Sex: M
Vaccine: YF
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Patient c/o chest pain and SOB approximately 1 hour post vaccination. Called clinic and instructed to call 911 to be transported to ED for treatment.
Age: 55.0
Sex: M
Vaccine: HEPA, IPV, TYP
Symptoms: Nasal inflammation, Rash
Clinical narrative: Patient returned after Typhoid pills with nasal "sores" then returned again with rash on arms.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Oral mucosal blistering, Pruritus, Rash, Rash generalised
Clinical narrative: (3-20-08) Patient noticed rash on both arms when awaking pruritic - Spread to entire body by that evening. Also developed blisters in mouth with lips swelling that evening (3-20-08). States Benadryl on 3/22/08. Began improving on 3/23/08.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Irritability, Rash pustular
Clinical narrative: Toddler very crabby after immunization for 7 days.  On day 5 developed pustule on right arm that rapidly enlarged with surrounding erythema.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAP, HEPA, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Facial palsy
Clinical narrative: 4 day history of sudden facial deviation to the right.  Not able to close her eye.  (Bell's Palsy).  Plan: Moisturize cornea.
Age: 1.3
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Left upper arm swollen and red; Tylenol given and cool compress applied.
Age: 0.0
Sex: F
Vaccine: HEP, HIBV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Vaccine given 2 months early.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Injection site pain, Lymphadenopathy, Musculoskeletal pain, Nausea
Clinical narrative: Parent describes pain left arm at site of injection immediately after receiving immunization. Pain slowly up arm, shoulder neck and head. Headache began 2 hours after injection. Compresses applied to injection site and Ibuprofen taken. Began vomiting x2 at 2AM. 11AM Now pale and doesn't feel right. Taking liquids and solid foods without further vomiting. Denies hives or itching. Has pain neck, head and arm. No vomiting; has nausea. reports "gland" left side under chin tender and swollen. Left arm can feel knot at site of injection when massage site. Swelling size of baseball; left arm at injection site.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Neck pain, Pain in extremity, Pallor, Tenderness, Vomiting
Clinical narrative: Parent describes pain left arm at site of injection immediately after receiving immunization. Pain slowly up arm, shoulder neck and head. Headache began 2 hours after injection. Compresses applied to injection site and Ibuprofen taken. Began vomiting x2 at 2AM. 11AM Now pale and doesn't feel right. Taking liquids and solid foods without further vomiting. Denies hives or itching. Has pain neck, head and arm. No vomiting; has nausea. reports "gland" left side under chin tender and swollen. Left arm can feel knot at site of injection when massage site. Swelling size of baseball; left arm at injection site.
Age: 0.51
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, RV5
Symptoms: Diarrhoea, Inappropriate schedule of drug administration, Vomiting
Clinical narrative: Client presented for 6mo. shots.  Parents had declined Rotavirus.  By mistake he received Rotavirus for the 1st. time @ this visit.  Talked to parents the next day re. the mistake of receiving the Rota. vaccine.  They said that the infant was feeling fine @ that time.  10 days later mother called to say that the infant came down with vomiting and diarrhea and that it affected both parents and older sibling.  She said their family physician told them it was from the one dose of Rotavirus.  There was no treatment except to keep family well hydrated; no one, including client, was hospitalized.
Age: 1.23
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Body temperature increased
Clinical narrative: Elevated temperature per parent (tactile).  Patient received adult dose of Hepatitis A vaccine.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Impetigo, Induration, Local reaction, Skin lesion
Clinical narrative: Patient received VZV on 3-24-08 into the right upper arm during an office visit for irritation to the right angle of her mouth.  Presented in the office 3-26-08 for a local reaction at the injection site.  The site was tender, firm to touch, with an erythematous area approximately 12 x 6 cm.  The child also presented, 3-26-08, with lesions to the right corner of her mouth, which was diagnosed as Impetigo.  Cephalexin oral susp., 250mg/5mL, 2 teaspoons po BID for 10 days was prescribed along with cool compresses to right upper arm and Tylenol.  Brother had a very similar VZV local reaction on 2-12-08.  See VAERS report # E-21343.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Stomatitis, Tenderness
Clinical narrative: Patient received VZV on 3-24-08 into the right upper arm during an office visit for irritation to the right angle of her mouth.  Presented in the office 3-26-08 for a local reaction at the injection site.  The site was tender, firm to touch, with an erythematous area approximately 12 x 6 cm.  The child also presented, 3-26-08, with lesions to the right corner of her mouth, which was diagnosed as Impetigo.  Cephalexin oral susp., 250mg/5mL, 2 teaspoons po BID for 10 days was prescribed along with cool compresses to right upper arm and Tylenol.  Brother had a very similar VZV local reaction on 2-12-08.  See VAERS report # E-21343.
Age: 0.63
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site rash
Clinical narrative: Papular eruption over injection site bilaterally.  ?contact dermatitis.
Age: 38.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Erythema multiforme, Injection site erythema, Injection site pain, Lymph node pain, Malaise
Clinical narrative: Patient presented to ER on 3/23/08 with c/o L arm pain with surrounding redness to his smallpox vaccination site. He also reported malaise and tender lymph node under the arm. MD diagnosed with Erythema Multiforme and prescribed Benadryl and Keflex. He was given quarters and instructed to follow up at the Medical Clinic. Seen at the Medical Clinic on 3/24/08 Continued c/o red swollen arm. Given ice and Tylenol to treat. Quarters continued for 48 hours.
Age: 38.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Oedema peripheral
Clinical narrative: Patient presented to ER on 3/23/08 with c/o L arm pain with surrounding redness to his smallpox vaccination site. He also reported malaise and tender lymph node under the arm. MD diagnosed with Erythema Multiforme and prescribed Benadryl and Keflex. He was given quarters and instructed to follow up at the Medical Clinic. Seen at the Medical Clinic on 3/24/08 Continued c/o red swollen arm. Given ice and Tylenol to treat. Quarters continued for 48 hours.
Age: 38.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chills, Erythema, Erythema multiforme, Pain in extremity
Clinical narrative: Patient presented to ER on 3/23/08 with c/o L arm pain with surrounding redness to his smallpox vaccination site. He also reported malaise and tender lymph node under the arm. MD diagnosed with Erythema Multiforme and prescribed Benadryl and Keflex. He was given quarters and instructed to follow up at the Medical Clinic. Seen at the Medical Clinic on 3/24/08 Continued c/o red swollen arm. Given ice and Tylenol to treat. Quarters continued for 48 hours.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Balance disorder, Clumsiness, Fall, Mood altered, Poor quality sleep
Clinical narrative: A red, raised, closely clustered, rash of small spots covered patients body for approximately 7 days after DTaP vaccination, at which point the rash dried and disappeared. The rash appeared approximately 24 hours after administration of the vaccine. The DTaP vaccine was the only shot administered. Patient who was an established walker since 10 months of age also appeared clumbsy and off-balance. Patient began to walk with head to the side or infront of his body within 24 hours after the vaccination and repeatedly bumped into things and fell alot. Patient also ran a fever of 102 deg. within a few hours of the vaccination which lasted approximately 48 hours, accompanied by general grumpiness and whining and had restless sleep for the week following the DTaP vaccination.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Rash erythematous, Rash papular
Clinical narrative: A red, raised, closely clustered, rash of small spots covered patients body for approximately 7 days after DTaP vaccination, at which point the rash dried and disappeared. The rash appeared approximately 24 hours after administration of the vaccine. The DTaP vaccine was the only shot administered. Patient who was an established walker since 10 months of age also appeared clumbsy and off-balance. Patient began to walk with head to the side or infront of his body within 24 hours after the vaccination and repeatedly bumped into things and fell alot. Patient also ran a fever of 102 deg. within a few hours of the vaccination which lasted approximately 48 hours, accompanied by general grumpiness and whining and had restless sleep for the week following the DTaP vaccination.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Injection site erythema, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: Client received vaccine on 03/21/2008. This was her third dose of HPV. She reported soreness and skin at injection site, slightly red. Denies edema, soreness and redness since time of injection 5 days ago. She denies edema or drainage. She says skin may be slightly warm but not hot. She also noticed and neck and upper back around shoulders is a little sore but unsure if related to injection.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Skin warm
Clinical narrative: Client received vaccine on 03/21/2008. This was her third dose of HPV. She reported soreness and skin at injection site, slightly red. Denies edema, soreness and redness since time of injection 5 days ago. She denies edema or drainage. She says skin may be slightly warm but not hot. She also noticed and neck and upper back around shoulders is a little sore but unsure if related to injection.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Headache, Malaise, Musculoskeletal stiffness, Rash erythematous
Clinical narrative: 3/7/08 Child was picked up from school with c/o red itchy rash all over body, sores in mouth, stiff neck, headache, and feeling very fatigued. 3/8/08 Child felt worse this day and was taken to clinic...@ that time no meds or treatment were given.  Caregiver was told to let it run it's course and child was sent home. 3/11/08 Child still not feeling well and not any better and all before mentioned symptoms were still present.  child was then taken to primary care provider and dx with a viral condition.  Prednisone dose pack was given. 3/13/08 caregiver states child is feeling 100% and is back in school today.  Still has a rash but not itchy and sores in mouth are better.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Rash generalised, Rash pruritic, Stomatitis, Viral infection
Clinical narrative: 3/7/08 Child was picked up from school with c/o red itchy rash all over body, sores in mouth, stiff neck, headache, and feeling very fatigued. 3/8/08 Child felt worse this day and was taken to clinic...@ that time no meds or treatment were given.  Caregiver was told to let it run it's course and child was sent home. 3/11/08 Child still not feeling well and not any better and all before mentioned symptoms were still present.  child was then taken to primary care provider and dx with a viral condition.  Prednisone dose pack was given. 3/13/08 caregiver states child is feeling 100% and is back in school today.  Still has a rash but not itchy and sores in mouth are better.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Autism, Condition aggravated, Depressed level of consciousness, Eczema, Hypotonia
Clinical narrative: After DTaP, Hib, IPV, Prevnar, HepB vaccine, baby slept for 3 hours, unarousable. After he woke up, he becaome pale, limp, unresponsive for 10 minutes. He subsequently had a worsening of his eczema (started after his first hep B vaccine at 2 weeks). He then signs of autism.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: After DTaP, Hib, IPV, Prevnar, HepB vaccine, baby slept for 3 hours, unarousable. After he woke up, he becaome pale, limp, unresponsive for 10 minutes. He subsequently had a worsening of his eczema (started after his first hep B vaccine at 2 weeks). He then signs of autism.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Blood culture negative, CSF culture negative, Computerised tomogram normal, Convulsion, Culture urine negative
Clinical narrative: 6 mth old boy with history of perinatal HIV exposure, negative HIV test, with new-onset, afebrile, focal (left sided) seizure.  Required Ativan x2, then fosphenytoin IV, requiring intubation.  Patient admitted to pediatric intensive care unit.  07/09/2008 MR received for DOS 3/25-26/2008 with D/C DX: Afebrile, focal new onset seizure.  Perinatal HIV exposure.  Status Epilepticus.  Benign Hygroma, mild external Hydrocephalus. Infant transfered from local hospital intubated following new onset seizure in status epilepticus.  Parent noted unusual noises from crib and found infant with L sided jerking and eyes deviated down.  EMS called and attempted rectal Diastat without improvement.  In ER loaded with Ativan and fosphenytoin and intubated due to resp depression.  Extubated in current facility shortly after arrival.  Tx with abx/antivirals.  No further seizures.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: HIV test, Herpes simplex serology, Human herpes virus 6 serology, Intensive care, Intubation
Clinical narrative: 6 mth old boy with history of perinatal HIV exposure, negative HIV test, with new-onset, afebrile, focal (left sided) seizure.  Required Ativan x2, then fosphenytoin IV, requiring intubation.  Patient admitted to pediatric intensive care unit.  07/09/2008 MR received for DOS 3/25-26/2008 with D/C DX: Afebrile, focal new onset seizure.  Perinatal HIV exposure.  Status Epilepticus.  Benign Hygroma, mild external Hydrocephalus. Infant transfered from local hospital intubated following new onset seizure in status epilepticus.  Parent noted unusual noises from crib and found infant with L sided jerking and eyes deviated down.  EMS called and attempted rectal Diastat without improvement.  In ER loaded with Ativan and fosphenytoin and intubated due to resp depression.  Extubated in current facility shortly after arrival.  Tx with abx/antivirals.  No further seizures.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Partial seizures, Polymerase chain reaction
Clinical narrative: 6 mth old boy with history of perinatal HIV exposure, negative HIV test, with new-onset, afebrile, focal (left sided) seizure.  Required Ativan x2, then fosphenytoin IV, requiring intubation.  Patient admitted to pediatric intensive care unit.  07/09/2008 MR received for DOS 3/25-26/2008 with D/C DX: Afebrile, focal new onset seizure.  Perinatal HIV exposure.  Status Epilepticus.  Benign Hygroma, mild external Hydrocephalus. Infant transfered from local hospital intubated following new onset seizure in status epilepticus.  Parent noted unusual noises from crib and found infant with L sided jerking and eyes deviated down.  EMS called and attempted rectal Diastat without improvement.  In ER loaded with Ativan and fosphenytoin and intubated due to resp depression.  Extubated in current facility shortly after arrival.  Tx with abx/antivirals.  No further seizures.
Age: 0.04
Sex: M
Vaccine: HEP
Symptoms: Eczema, Rash generalised, Rash pruritic
Clinical narrative: Baby developed itchy rash all over body, later diagnosed as eczema.
Age: 54.0
Sex: F
Vaccine: HEP, HEPA, IPV, TYP, YF
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus
Clinical narrative: On 3/25/08- client returned to office for second Hepatitis B dose. Pt. stated that 6-7 days after receiving her initial vaccines of hepatitis A and B, Polio, Typhoid oral and Yellow Fever, she said the site that the YF vaccine was given started itiching and had a small brownish bruise and the area was tender. She stated that it bothered her and she did not expect that since she did not have any issues prior to that 6th or 7th day. She stated that it went away in 2 days and no further problems noted. No medications taken or visits to the doctor.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Vomiting x 2 days after vaccination.
Age: 31.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Chills, Dyspnoea, Headache, Myalgia, Nausea
Clinical narrative: 8th Anthrax Vaccination given.  About 90 minutes after vaccination he began to have nausea, headache, myalgias, shaking chills.  Later he admitted to slight SOB.  No hives, rash, erythema.  Vital Signs remained normal.  Was sent via ambulance to Emergency Department about 25 minutes after he presented due to increasing severity of symptoms.
Age: 31.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Tremor, Vital capacity
Clinical narrative: 8th Anthrax Vaccination given.  About 90 minutes after vaccination he began to have nausea, headache, myalgias, shaking chills.  Later he admitted to slight SOB.  No hives, rash, erythema.  Vital Signs remained normal.  Was sent via ambulance to Emergency Department about 25 minutes after he presented due to increasing severity of symptoms.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Local reaction, Pain
Clinical narrative: Large local reaction to vaccine, presume pertussis component. Right armpit is very sore, difficult to move without pain.
Age: 51.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Feeling hot, Hyperaesthesia, Hypokinesia, Injection site irritation
Clinical narrative: This is in follow-up to report (s) previously submitted on 03/26/2008. After recieving the injection my arm started to burn at the injection site. and then started to spread across to my shoulder towards my clavicle midway, down my arm mid way towards my elbow. There are blotches of reddened areas that feel like burns. Sensitive to touch and feel warm. It hurts to extend my arm. Dr. has seen the area and has perscribed Keflex and has told me that it has developed into cellulitis. He told me to use ice to the site. Thru out each day it has gotten worse. The injection was given 4:30PM on Monday 3/24/08 and each day there is more red areas and an increase in pain. There is swelling of the arm also. Initial and follow-up information has been received from a healthcare worker concerning a 51 year old female registered nurse (employee nurse) with allergies to penicillin and BIAXIN, who on 24-MAR-2008 at 16:30 was vaccinated IM in the left arm with a first dose of PNEUMOVAX 23 (lot #659150/1384U). There were no illnesses at the time of the vaccination. On 24-MAR-2008 at 16:30 the patient experienced burning at the injection site that spread across the shoulder midway towards the clavicle and then down the arm midway towards the elbow. The patient developed blotches of reddened areas that were reported to feel like burns. The area was sensitive and warm to touch. The patient reported that it hurt to extend her arm. On 27-MAR-2008, the nurse presented to the office with shoulder pain and welts over her entire arm (treatment not specified). The doctor examined the area and said tht it had developed into cellulitis. The patient was prescribed KEFLEX and was advised to apply ice to the site. It was reported that each day the symptoms have gotton worse, there are more red areas, an increase in pain, and swelling of the arm. At the time of this report, the nurse was not recovered. A healthcare worker requested a lot check be performed. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satifactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This in one of 2 reports from the same source. No further information is available.