chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Cough, Emotional distress, Irritability, Labyrinthitis
Clinical narrative: Influenza vaccine administered at well checkup 1/9/08 about 3:30pm.  Mom reports he became very fussy that night and had barky cough.  Neb treatment with Albuterol no help.  Next AM, more panic and screaming, seen in office by Dr., did have big inner ear infection but in more distress than expected, saying "it's an emergency", "I can't breath" and in tears.  Difficult to console in office.  Given ear drops (acralfan), Motrin, and then Benadryl, finally about 10 min after Benadryl he fell asleep.  Patient seemed to be in a panic, which is out of character for him.  Sent home on Zithromax for ear infection and Benadryl every 6 hours.  (Exam showed no hives, no swelling, no wheezing, no respiratory distress but very panicked.)
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Panic reaction, Screaming
Clinical narrative: Influenza vaccine administered at well checkup 1/9/08 about 3:30pm.  Mom reports he became very fussy that night and had barky cough.  Neb treatment with Albuterol no help.  Next AM, more panic and screaming, seen in office by Dr., did have big inner ear infection but in more distress than expected, saying "it's an emergency", "I can't breath" and in tears.  Difficult to console in office.  Given ear drops (acralfan), Motrin, and then Benadryl, finally about 10 min after Benadryl he fell asleep.  Patient seemed to be in a panic, which is out of character for him.  Sent home on Zithromax for ear infection and Benadryl every 6 hours.  (Exam showed no hives, no swelling, no wheezing, no respiratory distress but very panicked.)
Age: 16.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt got extra dose of varicella
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Low grade fever, fatigue, body aches, headaches, stomach ache.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcal identification test, Streptococcal identification test negative
Clinical narrative: Low grade fever, fatigue, body aches, headaches, stomach ache.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia, Rash generalised, Rash papular
Clinical narrative: Flu vax given 1/3/08 afternoon, rash (papular) developed that night, itchy, low grade fever, spread and whole body. Treated at ED- tx'd wih Atarax, Prednisolone
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: After Menactra & Tdap to deltoid pt had pain & some numbness symmetrically arms, hands.  Trouble lifting arms/arthralgias.  Still with symptoms.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: over exact location where he received his SQ Varicella vacc a cluster of clear fluid filled veiscles on a red base 3.5 cm round
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Chills, body aches,? fever, extreme fatigue. Pt was not seen in clinic for symptoms. Spoke with RN and MD via telephone
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Patient developed soreness, fever approx. 6 hours after Tdap.  Was OK during night.  Developed fever to 102 degrees with headache, chills, paleness.  Redness & tenderness at site.  Seen today in office.  Dx with cellulitis at injection site.  Put on Keflex 250 TID x10d, Advil 200 mg 1 6-8 hrs & Benadryl 125 q 6 hr.  Fever resolved today (1/11/08).
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pallor, Pyrexia
Clinical narrative: Patient developed soreness, fever approx. 6 hours after Tdap.  Was OK during night.  Developed fever to 102 degrees with headache, chills, paleness.  Redness & tenderness at site.  Seen today in office.  Dx with cellulitis at injection site.  Put on Keflex 250 TID x10d, Advil 200 mg 1 6-8 hrs & Benadryl 125 q 6 hr.  Fever resolved today (1/11/08).
Age: 35.0
Sex: U
Vaccine: HEP, MMR
Symptoms: Arthralgia, Pain
Clinical narrative: 10-31-07 Employee declined to get Influenza vaccine, says she has had joint pain x 2 wks, that it is worse in her knees. Said she would let me know if it did not resolve. 1-11-08 pt reports only has burning pain in her knees and it is worse at night. Referred to MD.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: 20-25 area redness, swollen area, sore.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: contracted (dr. diagnosed) chickenpox after receiving 2 Varicella shots mild case <50 lesions-onset 1-3-08
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: Cellulitus with reaction to vaccine on left deltoid-edema and erythema 10cm X 16cm. Treatment-Keflex 250mg/5cc- give 10cc twice a day times 7 days. Ice pack to area as needed for pain/edema. Follow up with doctor for any problems as needed.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: CSF test normal, Fontanelle bulging, Laboratory test abnormal, Lumbar puncture
Clinical narrative: CHILD TAKEN TO PHYSICIAN ON 1/10/08 FOR SYMPTOMS OF BULGING FONTANELLE.  HAD RECEIVED IMMUNIZATIONS ON 1-7-08.  EVALUATED BY PHYSICIAN, SPINAL TAP NEGATIVE FOR MENINGITIS, LAB WORK WITHIN NORMAL LIMITS.  CHILD DID NOT APPEAR ILL.  CHILD RELEASED TO HOME.
Age: 45.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Two patches of hives appeared on patient's back. The patches are on the midsection of the right side of the patient's back.   Hives appeared on January 7 and are still present to date - January 11.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient complained of itching & hives on right arm & chest.  Benadryl 25 mg po given after consultation with Dr.  Monitored for 1 hr.  Discharged wtih instructions to take Benadryl 25 mg po q 6 hr for today & follow up with PCP.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy muscle abnormal, Blood test, Musculoskeletal stiffness, Myalgia, Myofascitis
Clinical narrative: Pt developed swelling of her arms and shoulders towards the later part of the summer with muscle pain and hardening of the muscles beginning in September 2007.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Swelling
Clinical narrative: Pt developed swelling of her arms and shoulders towards the later part of the summer with muscle pain and hardening of the muscles beginning in September 2007.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Cough, Haemoptysis, Headache, Injected limb mobility decreased
Clinical narrative: First day felt sluggish and had expected severe pain in arm (L.) that was injected, could not use that arm for several hours. Second day woke up with the beginnings of a sore throat and had random arthritis-like pain in left hand and in knees and ankles when walking. Second day sore throat was severe and painful, was coughing up a lot of mucus, sinuses extremely congested so had to breathe out of mouth, felt warm and had some headaches, 3rd day the sore throat was still severe and was coughing up traces of blood and what felt and looked like tissue, and took temperature for the first time on a reliable digital thermometer (102.8), fourth day (today) fever is lower (averaging 99-100) but still coughing, sinus congestion, and extremely painful and inflamed sore throat, being this sick and having a fever this high is VERY unusual for me, in fact I have NEVER to my knowledge had a fever this high.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Nasal congestion, Pain in extremity, Pharyngeal oedema, Pharyngolaryngeal pain, Rhinorrhoea
Clinical narrative: First day felt sluggish and had expected severe pain in arm (L.) that was injected, could not use that arm for several hours. Second day woke up with the beginnings of a sore throat and had random arthritis-like pain in left hand and in knees and ankles when walking. Second day sore throat was severe and painful, was coughing up a lot of mucus, sinuses extremely congested so had to breathe out of mouth, felt warm and had some headaches, 3rd day the sore throat was still severe and was coughing up traces of blood and what felt and looked like tissue, and took temperature for the first time on a reliable digital thermometer (102.8), fourth day (today) fever is lower (averaging 99-100) but still coughing, sinus congestion, and extremely painful and inflamed sore throat, being this sick and having a fever this high is VERY unusual for me, in fact I have NEVER to my knowledge had a fever this high.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Sinus congestion, Skin warm, Sluggishness
Clinical narrative: First day felt sluggish and had expected severe pain in arm (L.) that was injected, could not use that arm for several hours. Second day woke up with the beginnings of a sore throat and had random arthritis-like pain in left hand and in knees and ankles when walking. Second day sore throat was severe and painful, was coughing up a lot of mucus, sinuses extremely congested so had to breathe out of mouth, felt warm and had some headaches, 3rd day the sore throat was still severe and was coughing up traces of blood and what felt and looked like tissue, and took temperature for the first time on a reliable digital thermometer (102.8), fourth day (today) fever is lower (averaging 99-100) but still coughing, sinus congestion, and extremely painful and inflamed sore throat, being this sick and having a fever this high is VERY unusual for me, in fact I have NEVER to my knowledge had a fever this high.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Injected limb mobility decreased, No reaction on previous exposure to drug, Pain in extremity
Clinical narrative: Patient describes since recieving flu shot on 12/11/07 she has been experiencing discomfort in her upper arm making it painful to move arm in certain directions.  She doesn't believe this is a normal reaction because she has had flu shots in the past with no difficulty.  She spoke to a pharmacist at a local pharmacy, not ours who stated that the needle may have punctured a vein or nerve.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Diarrhoea, Eczema, Food allergy, Rash erythematous
Clinical narrative: Mother phoned and described patient's eczema worsening the evening after receiving a one month preservative free 0.25cc booster dose of influenza vaccine (1/10/2007).  Two episodes of diarrhea noted by mother today.  The child was diagnosed with an egg allergy (3 on 1-10 scale per mother) by allergist Dr. after receiving his initial vaccination.  The child had received the first dose without incident and had ingested eggs without adversity.  I made the referral to Dr. upon noting a diffuse patchy flaking erythematous rash on the otherwise well appearing child prior to receiving the first influenza dose of his lifetime.  The child's mother applied topical cortisone cream that evening per MD order.  Child's condition resolved to baseline by am.  Mother now states "He's doing just fine.  He is happy and playing."  Denies fever or worsening of rash.  Clear fluids and bland diet recommended with visit to MD for follow up if child's symptoms worsen or if the diarrhea remains unresolved for >24 hours.  Mother also instructed to keep child's urine clear and mucous membranes moist through oral hydration.  Mother verbalized understanding and was grateful for her son's care.
Age: 0.35
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HEP, IPV, PNC, RV5
Symptoms: Enema administration, Intussusception, Irritability, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Developed 1 d hx of fussiness and vomiting and found to have intussusception and reduced by barium enema.  01/23/2008 Vax record received and Rotateq Lot # updated.  It appears that the reported lot # was for the 9/18/07 dose not the 11/13/07 dose. 5/30/2008 MR received for DOS 1/2-3/2008 with DX:  Intussusception.  Infant presented to local hospital with belly pain, vomiting and bloody diarrhea. Pt had been feeding poorly and had fewer wet diapers. Reduced by Barium enema and admitted for o/n obs.
Age: 0.35
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HEP, IPV, PNC, RV5
Symptoms: Abdominal pain, Barium enema abnormal, Diarrhoea haemorrhagic, Enema administration, Intussusception
Clinical narrative: Developed 1 d hx of fussiness and vomiting and found to have intussusception and reduced by barium enema.  01/23/2008 Vax record received and Rotateq Lot # updated.  It appears that the reported lot # was for the 9/18/07 dose not the 11/13/07 dose. 5/30/2008 MR received for DOS 1/2-3/2008 with DX:  Intussusception.  Infant presented to local hospital with belly pain, vomiting and bloody diarrhea. Pt had been feeding poorly and had fewer wet diapers. Reduced by Barium enema and admitted for o/n obs.
Age: 0.35
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HEP, IPV, PNC, RV5
Symptoms: Irritability, Oral intake reduced, Ultrasound abdomen abnormal, Urine output decreased, Vomiting
Clinical narrative: Developed 1 d hx of fussiness and vomiting and found to have intussusception and reduced by barium enema.  01/23/2008 Vax record received and Rotateq Lot # updated.  It appears that the reported lot # was for the 9/18/07 dose not the 11/13/07 dose. 5/30/2008 MR received for DOS 1/2-3/2008 with DX:  Intussusception.  Infant presented to local hospital with belly pain, vomiting and bloody diarrhea. Pt had been feeding poorly and had fewer wet diapers. Reduced by Barium enema and admitted for o/n obs.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Feeling abnormal, Immediate post-injection reaction, Loss of consciousness, Somnolence
Clinical narrative: Approximately 5 minutes after receiving the HPV vaccination, patient passed out and experienced involuntary jerking of arms and hands for about 20 - 30 seconds.  After regaining consciousness she felt sleepy and "mentally foggy" for about 30 minutes.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: A day after receiving my third Gardasil injection, I got hives on my upper body, specifically my chest, neck, back, shoulders, arms, hands, and face. Dr. prescribed Atarax to relieve itching.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Faeces discoloured, Irritability, Pyrexia
Clinical narrative: Over 8 liquid stools (clear to yellow in color) on 11/13/2007.  Fussy on 11/12/2007 and 11/13/2007.  Fever up to 40 C on 11/12 and 37 C on 11/13.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: REDNESS, SWELLING, AND PAIN AT THE SITE OF THE INJECTION.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Myalgia, Neck pain
Clinical narrative: Muscle soreness to right arm that ascends to the right neck and is painful to the touch. Pain severe enough to prevent patient from using full ROM. Patient is able to use full ROM when she forces through the pain. States that soreness started almost immediately after the injection and has not improved. States that she was required to do push ups in PE class on 1/11/08 that might have made the pain worsen. Patient has been using a heating pad and ibuprofen for treatment.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Visual disturbance
Clinical narrative: Within 30 minutes of receiving vaccine, patient had severe headache, visual disturbances.
Age: 34.0
Sex: F
Vaccine: ANTH, HEP, SMALL
Symptoms: Injection site nodule, Injection site pain, Pain
Clinical narrative: Reports 12 Jan 2008 with symptoms of dull ache in right arm. 2 cm nodule found center of tender area (deltoid)  Ache extends down forearm at night. Slightly sore during the day. No signs/symptoms of infection noted.  MD reccomended treatment with anti-inflammatories and follow up in one month.
Age: 16.0
Sex: M
Vaccine: FLUX
Symptoms: Anorexia, Chills, Headache, Influenza like illness, Pain
Clinical narrative: FOUR DAYS OF SEVERE FLU LIKE SYMPTOMS INCLUDING SEVERE HEADACHE, BODY ACHES, LOSS OF APPETITE, CHILLS, FEVER.
Age: 16.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: FOUR DAYS OF SEVERE FLU LIKE SYMPTOMS INCLUDING SEVERE HEADACHE, BODY ACHES, LOSS OF APPETITE, CHILLS, FEVER.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: An 11-year-old female patient with no reported past medical history, had received a first, intramuscular, left deltoid dose of Menactra (lot number U2277AA), and a first, intramuscular left deltoid dose of Gardasil (manufacturer Merck, lot number 1245V, expiration date July 10 [year not reported) on 10 December 2007 at 11:00 a.m.  A few hours later in the afternoon, the patient developed pain, numbness, and tingling in the lower left arm distal to the injection site.  There was no loss of strength in the left arm, but the patient was keeping the arm bent, and was guarding the arm as the forearm and wrist hurt.  There was no adverse event associated with the actual injection site itself.  The patient was evaluated by a physician; and follow-up information is forthcoming.  Treatment received, and diagnostic testing performed were not reported.  At the time of this report, the recovery status of the patient was "unknown."
Age: 65.0
Sex: F
Vaccine: TD, TD
Symptoms: Autoimmune disorder, Chest discomfort, Dyspnoea, Muscle spasms, Pruritus
Clinical narrative: A 65-year-old female patient received a right deltoid intramuscular injection of Decavac on 12 December 2007 (lot number reported as ZV1958BA; not a valid lot number). The patient had a history of post-infectious migratory arthritis secondary to Shingella gastrointestinal infection (1991-1992). She had suffered severe arthritis for two years following the infection, but other than a flare in 1996 following a knee injury, the condition had settled down. Relevant medical history also included positive anti-nuclear antibodies and positive human leukocyte antigen B27. Concomitant medications included daily aspirin and Restasis eye drops. On 15 December 2007, three days after vaccination, the patient was awoken at midnight with bilateral thigh cramps which she described as "the worst pain she had ever experienced in her life". The cramps persisted for approximately five hours, and then resolved. On 24 or 25 December 2007, she began to notice a maculopapular, erythematous, pruritic rash which began on her upper chest and spread to her entire chest, neck, upper arm, and axillary area. At the time of the report, the rash was fading on the chest, but persisted on the arms. She also developed pruritis of both lower legs, with no associated rash. She had seen a physician who informed her that the rashes were "due to the Td vaccination" and they were "related to her underlying autoimmune disease". In addition, approximately five to six days post-vaccination, the patient reported chest tightness and mild shortness of breath after swimming; this resolved within a couple of days. She was scheduled to see her rheumatologist for follow-up.
Age: 65.0
Sex: F
Vaccine: TD, TD
Symptoms: Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: A 65-year-old female patient received a right deltoid intramuscular injection of Decavac on 12 December 2007 (lot number reported as ZV1958BA; not a valid lot number). The patient had a history of post-infectious migratory arthritis secondary to Shingella gastrointestinal infection (1991-1992). She had suffered severe arthritis for two years following the infection, but other than a flare in 1996 following a knee injury, the condition had settled down. Relevant medical history also included positive anti-nuclear antibodies and positive human leukocyte antigen B27. Concomitant medications included daily aspirin and Restasis eye drops. On 15 December 2007, three days after vaccination, the patient was awoken at midnight with bilateral thigh cramps which she described as "the worst pain she had ever experienced in her life". The cramps persisted for approximately five hours, and then resolved. On 24 or 25 December 2007, she began to notice a maculopapular, erythematous, pruritic rash which began on her upper chest and spread to her entire chest, neck, upper arm, and axillary area. At the time of the report, the rash was fading on the chest, but persisted on the arms. She also developed pruritis of both lower legs, with no associated rash. She had seen a physician who informed her that the rashes were "due to the Td vaccination" and they were "related to her underlying autoimmune disease". In addition, approximately five to six days post-vaccination, the patient reported chest tightness and mild shortness of breath after swimming; this resolved within a couple of days. She was scheduled to see her rheumatologist for follow-up.
Age: 65.0
Sex: F
Vaccine: TD, TD
Symptoms: Chest discomfort, Condition aggravated, Dyspnoea, Muscle spasms, Pruritus
Clinical narrative: A 65-year-old female patient received a right deltoid intramuscular injection of Decavac on 12 December 2007 (lot number reported as ZV1958BA; not a valid lot number). The patient had a history of post-infectious migratory arthritis secondary to Shingella gastrointestinal infection (1991-1992). She had suffered severe arthritis for two years following the infection, but other than a flare in 1996 following a knee injury, the condition had settled down. Relevant medical history also included positive anti-nuclear antibodies and positive human leukocyte antigen B27. Concomitant medications included daily aspirin and Restasis eye drops. On 15 December 2007, three days after vaccination, the patient was awoken at midnight with bilateral thigh cramps which she described as "the worst pain she had ever experienced in her life". The cramps persisted for approximately five hours, and then resolved. On 24 or 25 December 2007, she began to notice a maculopapular, erythematous, pruritic rash which began on her upper chest and spread to her entire chest, neck, upper arm, and axillary area. At the time of the report, the rash was fading on the chest, but persisted on the arms. She also developed pruritis of both lower legs, with no associated rash. She had seen a physician who informed her that the rashes were "due to the Td vaccination" and they were "related to her underlying autoimmune disease". In addition, approximately five to six days post-vaccination, the patient reported chest tightness and mild shortness of breath after swimming; this resolved within a couple of days. She was scheduled to see her rheumatologist for follow-up.
Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Lumbar puncture, Nuclear magnetic resonance imaging, Scan brain
Clinical narrative: Initial case received on 04 January 2008 from a health care professional.  A 6-month-old female patient had received a second dose injection of Fluzone No Preservative 2007-2008, lot number U2481GA, on an unknown date.  At an "unknown" time post-vaccination, the patient experienced a cerebrovascular accident requiring hospitalization.  A CT of the head, MRI, and spinal tap were performed, but results were not provided.  Past medical history, illness at the time of vaccination, and other medications were unknown.  The reporter considered the event to be life threatening.  Per the reporter, details were limited at this time.  At the time of this report, the patient had not recovered.
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Blood immunoglobulin G normal, Culture wound negative, Erythema, Flow cytometry, Immunoglobulins normal
Clinical narrative: Seriousness criteria: other-Medically Significant. From initial information received on 07 January 2008 from a literature report: it was reported that "a 27-month-old female was evaluated because of a history of recurrent sterile abscess formation at the sites of routine childhood vaccinations. She had an uneventful course after her first series of vaccinations at age 2 months, which included Daptacel, IPOL, Comvax (manufacturer Merck) and Prevnar (manufacturer Wyeth). One month after the patient's second set of vaccinations at age 4 months, she developed a draining abscess on her left thigh at the site of Daptacel and IPOL administration. Her right thigh, where she received Comvax and Prevnar, was unaffected. The lesion healed after an incision and drainage and a course of oral antibiotics. At age 6 months, the patient received Daptacel and Prevnar in her right thigh. One month later, she developed an abscess in that extremity. The lesion was incised. Wound culture and Gram's stain were negative, and she was given an empirid couse of antibiotics. At age 18 months, she received the MMR II vaccine (manufacturer Merck), with no complications. At age two years, she received Comvax in her left arm, and one month later developed an abscess at the site. The lesion healed after an incision and drainage, but without antibiotics. Wound culture was negative, and a tissue biopsy was obtained from the base of the abscess. The patient had no history of other skin lesions or frequent infections. Her mother reported that umbilical cord separation was not delayed. Quantitative immunoglobulins and IgG subclasses were normal at age 8 months. The white blood cell count at that time was 10,300, with 20% neutrophils and 72% lymphocytes. Flow cytometry for CD11b/CD18, performed to exclude leukocyte adhesion defect type 1, was normal. It was felt that the patient's hypersensivitity to a common ingredient in Daptacel, IPOL, Comvax, or Prevnar vaccines was the cause of the recurrent lesions. Aluminium, formaldehyde, 2-phenoxythanol, and thimerosal were considered as possible causes of the reactions. Notably the MMR II vaccine, which contains gelatin and neomycin, was not associated with abscess formation in this patient. Patch testing was performed for aluminium (2% aluminum chloride solution), for undiluted DAPTACEL, and for a normal saline control by applying 0.1 mL of each solution to 1-cm gauze patches, applied to the upper arm and occluded with Tegaderm. The patches were examined at 12 hours. The control patch was negative, and minimal erythema was noted at the DAPTACEL site. A moderate reaction, characterized by erythema, multiple papules, and scattered vesicles, was seen at the aluminium chloride site. Patch testing on a negative control subject was negative for all three solutions. We diagnosed aluminium hypersensitivity in our patient, and recommended that she not receive any more aluminium-containing vaccines." The patient recovered from these abscesses.
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Incisional drainage, Injection site abscess, Injection site discharge, Lymphocyte percentage increased, Neutrophil count decreased
Clinical narrative: Seriousness criteria: other-Medically Significant. From initial information received on 07 January 2008 from a literature report: it was reported that "a 27-month-old female was evaluated because of a history of recurrent sterile abscess formation at the sites of routine childhood vaccinations. She had an uneventful course after her first series of vaccinations at age 2 months, which included Daptacel, IPOL, Comvax (manufacturer Merck) and Prevnar (manufacturer Wyeth). One month after the patient's second set of vaccinations at age 4 months, she developed a draining abscess on her left thigh at the site of Daptacel and IPOL administration. Her right thigh, where she received Comvax and Prevnar, was unaffected. The lesion healed after an incision and drainage and a course of oral antibiotics. At age 6 months, the patient received Daptacel and Prevnar in her right thigh. One month later, she developed an abscess in that extremity. The lesion was incised. Wound culture and Gram's stain were negative, and she was given an empirid couse of antibiotics. At age 18 months, she received the MMR II vaccine (manufacturer Merck), with no complications. At age two years, she received Comvax in her left arm, and one month later developed an abscess at the site. The lesion healed after an incision and drainage, but without antibiotics. Wound culture was negative, and a tissue biopsy was obtained from the base of the abscess. The patient had no history of other skin lesions or frequent infections. Her mother reported that umbilical cord separation was not delayed. Quantitative immunoglobulins and IgG subclasses were normal at age 8 months. The white blood cell count at that time was 10,300, with 20% neutrophils and 72% lymphocytes. Flow cytometry for CD11b/CD18, performed to exclude leukocyte adhesion defect type 1, was normal. It was felt that the patient's hypersensivitity to a common ingredient in Daptacel, IPOL, Comvax, or Prevnar vaccines was the cause of the recurrent lesions. Aluminium, formaldehyde, 2-phenoxythanol, and thimerosal were considered as possible causes of the reactions. Notably the MMR II vaccine, which contains gelatin and neomycin, was not associated with abscess formation in this patient. Patch testing was performed for aluminium (2% aluminum chloride solution), for undiluted DAPTACEL, and for a normal saline control by applying 0.1 mL of each solution to 1-cm gauze patches, applied to the upper arm and occluded with Tegaderm. The patches were examined at 12 hours. The control patch was negative, and minimal erythema was noted at the DAPTACEL site. A moderate reaction, characterized by erythema, multiple papules, and scattered vesicles, was seen at the aluminium chloride site. Patch testing on a negative control subject was negative for all three solutions. We diagnosed aluminium hypersensitivity in our patient, and recommended that she not receive any more aluminium-containing vaccines." The patient recovered from these abscesses.
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Skin test negative, White blood cell count increased
Clinical narrative: Seriousness criteria: other-Medically Significant. From initial information received on 07 January 2008 from a literature report: it was reported that "a 27-month-old female was evaluated because of a history of recurrent sterile abscess formation at the sites of routine childhood vaccinations. She had an uneventful course after her first series of vaccinations at age 2 months, which included Daptacel, IPOL, Comvax (manufacturer Merck) and Prevnar (manufacturer Wyeth). One month after the patient's second set of vaccinations at age 4 months, she developed a draining abscess on her left thigh at the site of Daptacel and IPOL administration. Her right thigh, where she received Comvax and Prevnar, was unaffected. The lesion healed after an incision and drainage and a course of oral antibiotics. At age 6 months, the patient received Daptacel and Prevnar in her right thigh. One month later, she developed an abscess in that extremity. The lesion was incised. Wound culture and Gram's stain were negative, and she was given an empirid couse of antibiotics. At age 18 months, she received the MMR II vaccine (manufacturer Merck), with no complications. At age two years, she received Comvax in her left arm, and one month later developed an abscess at the site. The lesion healed after an incision and drainage, but without antibiotics. Wound culture was negative, and a tissue biopsy was obtained from the base of the abscess. The patient had no history of other skin lesions or frequent infections. Her mother reported that umbilical cord separation was not delayed. Quantitative immunoglobulins and IgG subclasses were normal at age 8 months. The white blood cell count at that time was 10,300, with 20% neutrophils and 72% lymphocytes. Flow cytometry for CD11b/CD18, performed to exclude leukocyte adhesion defect type 1, was normal. It was felt that the patient's hypersensivitity to a common ingredient in Daptacel, IPOL, Comvax, or Prevnar vaccines was the cause of the recurrent lesions. Aluminium, formaldehyde, 2-phenoxythanol, and thimerosal were considered as possible causes of the reactions. Notably the MMR II vaccine, which contains gelatin and neomycin, was not associated with abscess formation in this patient. Patch testing was performed for aluminium (2% aluminum chloride solution), for undiluted DAPTACEL, and for a normal saline control by applying 0.1 mL of each solution to 1-cm gauze patches, applied to the upper arm and occluded with Tegaderm. The patches were examined at 12 hours. The control patch was negative, and minimal erythema was noted at the DAPTACEL site. A moderate reaction, characterized by erythema, multiple papules, and scattered vesicles, was seen at the aluminium chloride site. Patch testing on a negative control subject was negative for all three solutions. We diagnosed aluminium hypersensitivity in our patient, and recommended that she not receive any more aluminium-containing vaccines." The patient recovered from these abscesses.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Computerised tomogram normal, Dysphagia, Feeling abnormal, Muscular weakness
Clinical narrative: 8 hrs after vaccine admin., sudden onset of weakness bilateral arms & legs.  Difficulty with speech, swallowing & ineffective cough.  Overall sensation of feeling "wet" and "burning" flesh pain & paralysis.  Not recovered but some improvements seen.  2/8/08 Reviewed hospital medical records which reveal patient experienced arm & leg pain, slurred speech & right facial droop.  Admitted 12/13-12/29/2007.  Progressed to paresthesias & then paralysis.  Swallowing & urination compromised.  Neuro consult done & felt non reversible.  Transferred to hospice. FINAL DX: cervical cord compression 2nd to severe spinal stenosis; neuropathic pain in upper & lower extremities 2nd to cord compression. Annual Follow-up Information 18-FEB-2009: There was partial paralysis of the lower extremities that remained - unable to rehab pt. after receiving vaccine. Pt died approx 5 weeks ago (Jan 16) Sepsis due to bladder infection, being bedridden at nursing home and advanced age.  Pt. passed away 35 days after receiving this vaccine (Jan 16th 09). His residual symptoms were lower extremity (partial) paralysis. The upper extremity paralysis. Resolved shortly after initial onset but unable to rehab the lower lungs. Spots from bilateral infection had to hi.sdeath
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Paralysis
Clinical narrative: 8 hrs after vaccine admin., sudden onset of weakness bilateral arms & legs.  Difficulty with speech, swallowing & ineffective cough.  Overall sensation of feeling "wet" and "burning" flesh pain & paralysis.  Not recovered but some improvements seen.  2/8/08 Reviewed hospital medical records which reveal patient experienced arm & leg pain, slurred speech & right facial droop.  Admitted 12/13-12/29/2007.  Progressed to paresthesias & then paralysis.  Swallowing & urination compromised.  Neuro consult done & felt non reversible.  Transferred to hospice. FINAL DX: cervical cord compression 2nd to severe spinal stenosis; neuropathic pain in upper & lower extremities 2nd to cord compression. Annual Follow-up Information 18-FEB-2009: There was partial paralysis of the lower extremities that remained - unable to rehab pt. after receiving vaccine. Pt died approx 5 weeks ago (Jan 16) Sepsis due to bladder infection, being bedridden at nursing home and advanced age.  Pt. passed away 35 days after receiving this vaccine (Jan 16th 09). His residual symptoms were lower extremity (partial) paralysis. The upper extremity paralysis. Resolved shortly after initial onset but unable to rehab the lower lungs. Spots from bilateral infection had to hi.sdeath
Age: 1.1
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMR, PNC
Symptoms: Febrile convulsion, Full blood count normal, Influenza serology negative, Metabolic function test normal, Urine analysis normal
Clinical narrative: Febrile sz w/i 24 hours of 1 yr vaccines.  01/14/2008 VAERS report submitted with MR attached for ER visit 12/27 2007 with DX febrile seizure.  Child developed fever night of vax, went limp, vomited , then began shaking which last ~5-10 minutes.  Temp was 104. Returned to hospital with fever again 1/2/08, no seizure activity
Age: 1.1
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMR, PNC
Symptoms: Virus serology test
Clinical narrative: Febrile sz w/i 24 hours of 1 yr vaccines.  01/14/2008 VAERS report submitted with MR attached for ER visit 12/27 2007 with DX febrile seizure.  Child developed fever night of vax, went limp, vomited , then began shaking which last ~5-10 minutes.  Temp was 104. Returned to hospital with fever again 1/2/08, no seizure activity
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngolaryngeal pain
Clinical narrative: Noticed two days post vaccine - C/O sore throat and no other symptoms - symptoms about two days and then improved - OK now.
Age: 56.0
Sex: F
Vaccine: YF
Symptoms: Erythema, Inflammation, Local reaction
Clinical narrative: Delayed local reaction to Yellow fever vaccine.  Reddened inflammed non raised approximately 6cmx4cm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Enuresis
Clinical narrative: He has been wetting the bed, sometimes twice a night starting one day after the shots. Normally he only has an accident once a month.
Age: 7.0
Sex: M
Vaccine: IPV, MMR, TD
Symptoms: Cough, Eye swelling, Pruritus, Pyrexia
Clinical narrative: 01-11-2008 pm developed fever (low grade most of time except on 01-13-2008 temp. went to 102), complaint of being itchy since 01-11-2008 (no rash), Right eye swollen.  Has a bad cough. Has not sought medical treatment.
Age: 1.32
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Injection site mass, Swelling
Clinical narrative: URI- Treatment Accuhist. Lump on right deltoid -  no treatment was given. Mom described that it was red and swollen after vaccination was given on 11-26-2007.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Ear infection, Injection site erythema, Pyrexia
Clinical narrative: Multiple blister-like areas noted with erythema around vaccination site approximately 1.5 cm in diameter. Symptoms started on 1-11-2008. Patient seen by Pediatrician, reports he also had an ear infection and low grade fever.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Received well child visit.  Received immunizations of Diphtheria, Tetanus, Pertussis, Poliomyelitis, Measles, Mumps and Rubella, on June 22, 2006 at approximately 2pm EST. Patient was on no medications, no past medical history other than speech delay, which referral to speech was given. His physical was, "Pass" with no restrictions.  On 1/11/2006, Patient was seen in a pediatric urgent care center at approx. 5pm for symptoms of Diabetes.  Patient was diagnosed with Type 1 insulin dependent diabetes on 1/12/2006 and started on subcutaneous insulin that same day.  Currently, patient remains on Sub Q insulin and is considered a brittle diabetic.  Patient is now six years old.  01/16/2008 Vax info obtained and updated in database. Date of vax was 2006, not 2005, per vax record. 01/18/2008 TC with mom to verify dates.  Confirmed vax date of 6/22/2006 and date of onset 1/2007 (not 2005 and 2006 as reported on VAERS form). Mom reports speech loss after 1st MMR and onset of diabetes 7 months after 2nd MMR in 6/2006. MR received for several OVs dated 1/12/2007, 2/15/2007 and 5/17/2007 with diagnosis new onset Type I Diabetes. Child developed increased thirst and urination following a febrile illness on 1/1/07. Pt was incontinent of urine and increasingly irritable. Seen in urgent care center with blood sugar of 365.   OV 2/15/07  doing well with glucose control. Skin dry with (+) eczema and skin reactions to insulin injections. 02/15/2008 TC from parent/reporter who reports pt became allergic to multiple insulins and developed Hashimoto's Thyroiditis following Varicella vax received on December 18,2007. This is a new development since original report.   02/15/2008 Vax and medical records recd from PCP showing WCC 12/18/07 with Varicella Vax (Merck 0720U) given.  OV 1/16/2008 due to allergy to insulin. Referred to Allergist.  OV 1/31/2008 due to anti-thyroid and anti-gliadin antibodies. Referred to endocrinologist. DX:  Thyroiditis and Celiac Disease. Referred to immunologist.  3/31/08 New VAERS report submitted 308413 by parent re: Varicella rxn. See 308413. 4/18/08 MR received from allergy/immunology consult from 1/17-2/14/2008 with DX:  Insulin Hypersensitivity, Recent h/o Hashimoto's Disease and Autoimmune Polyglandular Syndrome. Pt developed possible adverse reaction/allergy/hypersensitivity to insulin injections following Varicella vax.  Insulin injections sites with significant redness, swelling and induration, as well as facial redness. Pt also with recent increase in TSH from 1/10/08 to 1/18/2008.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: A single bloody/mucousy stool 2 days after Rotateq #1.  Otherwise healthy breast fed infant.  No symptoms of GI illness.  No fever, diarrhea, vomiting, abd pain/fussiness.
Age: 17.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received Twinrix vaccine. 1st dose given at 16 y/o (10/24/2006) and second dose given at age 17 (10/25/2007).  Vaccine approved for patients 18 years of age and older.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Employee reports flu shot was given Lt upper arm on 10/23/07. Employee reports he had pain at injection site LT upper arm with onset 3-4 day after the injection was given and this pain resolved after one week. Employee reports he then developed pain Lt Scapular area radiating to Lt Deltoid and Lt Bicep areas, rates pain was 6-7 on 1-10 scale. Employee also reports he had numbness and tingling to Lt thumb  lasting 2-3 weeks. Employee reports muscle "soreness" continues Lt Deltoid area, "is not as severe and improves daily". EE reports numbness and tingling have resolved.  EE is a physician, self treated with massage, anti inflammatory and topical agents. Employee reports he is still using Topical cream that contains NSAID and feels this has given him the response. Ee denies wanting medical care for sx.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Employee reports flu shot was given Lt upper arm on 10/23/07. Employee reports he had pain at injection site LT upper arm with onset 3-4 day after the injection was given and this pain resolved after one week. Employee reports he then developed pain Lt Scapular area radiating to Lt Deltoid and Lt Bicep areas, rates pain was 6-7 on 1-10 scale. Employee also reports he had numbness and tingling to Lt thumb  lasting 2-3 weeks. Employee reports muscle "soreness" continues Lt Deltoid area, "is not as severe and improves daily". EE reports numbness and tingling have resolved.  EE is a physician, self treated with massage, anti inflammatory and topical agents. Employee reports he is still using Topical cream that contains NSAID and feels this has given him the response. Ee denies wanting medical care for sx.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN3, IPV, MMR
Symptoms: Inflammation, Injection site induration, Rash erythematous, Rash pruritic
Clinical narrative: On the night of 1/9/08 the patient developed a red inflammed prurtic rash on the left upper arm. On exam, 1/10/08, the patient presented with an erythematous rash slight indurated on the left upper deltoid with no tenderness to touch noted and no heat. The patient was afebrile on the day of the exam. The patient was prescribed Benadryl 6.25 mg q8h prn for induration and pruritis on the left upper arm and hydrocortisone 2.5% topically BID prn to rash while present.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope, Urticaria
Clinical narrative: The evening after receiving the shot the patient developed hives not relieved with Benadryl, lasting 24 hrs, and he also fainted the evening after receiving the shot.  He was not taken to the ER.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Injection site warmth, Swelling
Clinical narrative: Had injection on 10/15/07, noticed increased redness and swelling on 10/16/07, site was sore and warm.  On 10/18/07, pt was sent to med ctr physician Dr and he provided her with a prescription of Keflex, which seemed to take care of the problem.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became hot, swollen, and itchy one hour after injection.  Pt given ibuprofen 800 and Benadryl 25mg, this took care of the problem.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Hyperhidrosis, Injection site erythema
Clinical narrative: This 41 year old reported receipt of first Anthrax vaccine 26 Nov 2002 with complaints of burning, sore to his left arm, and site redness that lasted a couple of days.  His second AVA vaccine was given 23 Dec 2002 had similar complaints of site redness, soreness, however he experienced an acute onset of chest heaviness and shortness of breath while driving in traffic. He stated he had to pull off the road and calm himself down. He admitted to some nausea with radiating left arm, neck, jaw and substernal-left shoulder chest pain 5-6/10 pain scale. He described as a sharp pain 2 hours post vaccination with lasting 20+ minutes changing to a dull pain for next several hours. He remembers touching his AVA site noting increasing pain to chest so assumed it was radiating pain and not cardiac related. Position did not affect chest pain, but movement aggravated. No medical care was sought.  He received his third AVA vaccination 13 Jan 2003 with similar site burning, but worsening site redness and tenderness. Approximately 1-2 hours later he experienced reoccurring midsternal chest pain with shortness of breath 3/10 pain scale that was sharp and lasted about 30 -120 minutes. Position did not affect his pain, but rest did help resolve. Again, since he'd had similar chest pain with previous AVA, he again assumed vaccine related and non-cardiac in origin.  He did not seek medical care.  He received his fourth AVA vaccination 24 Nov 2003 with complaints of increasing site redness and tenderness (worse than previous 3 vaccinations) localized to deltoid region of left arm. He did not experience any chest pain.  He received his fifth AVA 01 Nov 2006 again to the left deltoid with immediate site burning, soreness, redness, and now immediate chest pain with shortness of breath. His appearance changed as patient asked if he was okay. He admitted to chest pain with shortness of breath but told patient he was fine as this had happened after previous AVA vaccines. He sat in the clinic for approximately 20 minutes until symptoms resolved. He quantified the pain on a 5/10 scale similar to initial chest pain following AVA #2 with radiating symptoms to neck, jaw, left arm, nausea w/o vomiting and mildly diaphoretic. No medical care was sought and no reoccurrence of symptoms since.